Negative
Pressure Wound
Therapy Clinical
Guidelines
NPWT customer care details
Smith & Nephew Customer Care Center
USA
970 Lake Carillon Drive
Suite 110
St. Petersburg, FL 33716
Canada
2280 Argentia Road
Mississauga Ontario
L5N 6H8
Advice/Service details
24/7 NPWT Clinical Support
1 800-876-1261
Consult your local Smith &
Nephew representative if you
have any questions about
operation or use. Information
on RENASYS™ or PICO™ devices
can be found in the user device
manual or on the web at
www.myrenasys.com or
www.possiblewithpico.com
These guidelines are recommendations to help clinicians to establish condition-specific treatment
guidelines when using NPWT as part of the treatment protocol. Please consult the patient’s primary
physician or clinician about individual conditions and treatment. These guidelines are not intended
as a guarantee of results, outcome or performance of NPWT.
1
Introduction
Indications for use
Contraindications
Warnings
Precautions
4
6
6
7
8
2
General therapy considerations
Wound assessment
Choosing a wound filler/wound interface
Considerations for pump selection
RENASYS™ portfolio – pumps and canisters
Dressing change frequency
Tips and trick for improving dressing wear time
NPWT pressure settings
RENASYS Soft Port – considerations for use
Physician orders
How do I know if the RENASYS therapy device is working?
10
10
11
14
15
16
16
16
18
19
19
3
RENASYS-G Gauze Dressing Kit with Soft Port
Kit sizes and components
Application technique
20
20
24
4
RENASYS-F Foam Dressing Kits with Soft Port
Kit sizes and components
Application technique
26
26
29
5
RENASYS High Output Dressing Kit
Kit components
Application technique
31
31
32
6
RENASYS AB Abdominal Kit with Soft Port
Kit components
Indications
Contraindications
Warnings
Precautions
Application technique
35
35
36
36
36
37
39
7
Advanced-complex dressing techniques
Bridging – managing multiple wounds
Y-Connector – managing multiple wounds
Undermining and/or tunnelling
Skin grafts (Split and full-thickness)/skin substitutes
Circumferential extremity dressing
42
42
43
44
46
47
8
RENASYS accessories
RENASYS Adhesive Gel Patch
RENASYS Drain Accessory Kits
49
49
53
9
PICO™ Single Use Negative Pressure Wound Therapy System
Description
Indications for use
Contraindications
Warnings
Precautions
Dressing change
Guidance on wound suitability for management with PICO
Instructions for use
56
56
56
56
57
57
59
59
60
10
Clinical Hotline
62
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Appendix
Appendix I – Negative Pressure Product Portfolio – Products and Accessories
Appendix II – Instructions for Use – RENASYS Foam and Gauze Dressing Kits with Soft Port
Appendix III – Instructions for Use – RENASYS AB Abdominal Dressing Kit with Soft Port
Appendix IV – Instructions for Use – RENASYS High Output Dressing Kit
Appendix V – Instructions for Use – RENASYS Drain Accessory Kit
Appendix VI – Instructions for Use – PICO Single Use Negative Pressure Wound Therapy System
Appendix VII – Frequently asked questions and answers
Appendix VIII – References
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77
Section
1
1.
Introduction
Negative pressure Wound Therapy (NPWT) is an
established therapy that has changed the way serious
wounds are treated. Smith & Nephew has been
involved in wound care since 1856. As global provider
of wound care solutions, Smith & Nephew is known
for providing innovative enhancements and greater
options for NPWT use, and for placing the option for
NPWT use within a broader continuum of care.
Smith & Nephew has an extensive portfolio in wound
care and therapies that cover all of its major aspects.
The concept is well established that wounds are
managed across a continuum of healing and require
different therapies at each step in the continuum.
NPWT is no exception. Smith & Nephew offers NPWT
as part of a complete range of wound care products
to use along the patients’ journey towards healing.
The key to deciding which product to use at each
stage of the continuum is to identify the barriers to
healing and a treatment goal to combat those issues.
The treatment goal can be a variety of steps along the
wound healing continuum such as to control infection or generate a healthy granulating wound bed. Different
products are appropriate to address different treatment goals and the correct product choice is necessary not
only to achieve positive outcomes, but to also provide efficient use of resources.
When NPWT was initially introduced it was reserved for use on the most complex wounds. Today, however,
NPWT is widely adopted as a standard treatment for patients with both acute and chronic wounds. A variety
of formats are now available, and, as the wound progresses along the continuum, a switch from one format
to another may be the most appropriate course. NPWT has been shown to be cost effective when used
appropriately. However, it is important to guard against over-use of NPWT in order to maintain these health
economic benefits. Knowledge of when NPWT is most appropriate and when alternative therapies may be
more appropriate is vitally important to maintain an efficient use of resources while not effecting wound
outcomes negatively.
Negative Pressure Wound Therapy (NPWT) involves the application of controlled levels of sub-atmospheric
(negative) pressure to a wound. The systems described in these guidelines consist of a suction pump to
generate negative pressure and a variety of wound dressing kits to deliver the therapy to the wound site.
The benefits of NPWT go well beyond drainage management. Studies have shown NPWT improves granulation
tissue formation, may decrease bacterial burden, protects from the outside environment, promotes moisture
balance within the wound bed, and may decrease the frequency of dressing changes.1
The following Clinical Guidelines are meant to be used as recommendations for treating specific wound types.
The Guidelines cannot guarantee positive outcomes, wound healing or proper function of the Smith & Nephew
NPWT device. As with any medical device, consult the physician/clinician concerning the patient's individual
condition and prescribed treatment. Always consult and follow all applicable user manuals, product inserts,
instructions for use, safety information and references guides for product use, operation and application.
The purpose of this document is to describe the most appropriate use of NPWT as an integral part of wound
bed preparation to ensure optimal healing and cost-effective wound care.
6
Wound bed preparation
Wound bed preparation has been defined as the process of
removing the barriers to healing. Removal of these barriers is
thought to allow the wound repair process to progress normally.
Wound bed preparation represents a combination of both scientific
knowledge and practical skill; its application can help correct
abnormalities in acute and chronic wounds and stimulate or
progress the healing process.2 To optimize the use of NPWT, it is
essential that clinicians ensure wound bed preparation is achieved
prior to, during and after therapy.
T
Tissue nonviable
or deficient
I
Infection
or inflammation
M
Moisture
imbalance
1. Prepare the wound environment
2. Use NPWT
3. Know when to stop or change treatment
Optimal healing/cost-effective wound care
E
Epidermal margin/
extracellular matrix
Negative pressure wound therapy (NPWT)
Skin care
Hydrosurgery
system
Antibacterial
dressing
Foam
Skin care
Foam Ag
Cadexomer iodine
1. Debride wound
Effective debridement may:
• Reveal extent of tissue
damage
• Reduce biochemical
imbalance, senescent cells
• Reduce bacterial burden
• Reduce odor
• Optimize healing potential
Consequences of ineffective
debridement are:
• Delayed healing
• Potential for infection
• Physical barrier preventing
accurate assessment
• Reduced patient Quality of
Life (QoL)
• Psychological aspects
2. Optimize healing
• Remove excess fluid edema
• Assist in wound contraction
• Stimulate granulation tissue
• Protect from outside
contaminants
• Increase vascular perfusion
• May reduce wound bioburden
• Remodel connective tissue
matrix
• Encourage maturation of
epithelial cells
• Maintain a moist wound
healing environment
Collagen
matrix
3. Know when to stop or change
treatment
• Initial therapy objectives have
been met
• 100% granulation tissue in the
wound bed
• Granulation tissue level with
the surrounding skin
• Patient’s overall condition/
wound is improving
• Wound bed ready to take a
skin graft/flap
• Exudate levels less than
20–50mLs per day
• No improvement/reduction in
size is seen in the wound bed
following two consecutive
dressing changes
Negative Pressure Wound Therapy Clinical Guidelines
7
Section 1
RENASYS™ EZ Plus/RENASYS GO
RENASYS-F Foam Dressing Kits with Soft Port
RENASYS-G Gauze Dressing Kits with Soft Port
Indications for use
The RENASYS system is indicated for patients who would benefit from a suction device
(negative pressure wound therapy) as it may promote wound healing by removing fluids,
including irrigation and body fluids, wound exudates and infectious materials.
Examples of appropriate wound types include:
Chronic
Acute
Traumatic
Sub-acute and dehisced wounds
Ulcers (such as pressure or diabetic)
Flaps and grafts
Partial-thickness burns
Contraindications
The use of the RENASYS system is contraindicated in the presence of:
Necrotic tissue with eschar
Untreated osteomyelitis
Malignancy in wound (with exception of palliative care to enhance quality of life)
Exposed arteries, veins, organs or nerves
Non-enteric, unexplored fistulas
Anastomotic sites
8
RENASYS™ EZ Plus/RENASYS GO
Warnings
Note: Full device operation instructions are found in the User Guide for each RENASYS device
1. Patients must be monitored closely for bleeding. If sudden or increased bleeding is observed,
immediately discontinue therapy, take appropriate measures to stop bleeding and contact the
treating clinician.
2. Patients suffering from difficult hemostasis or who are receiving anticoagulant therapy have an
increased risk for bleeding. During therapy, avoid using hemostatic products that, if disrupted, may
increase the risk of bleeding
3. Sharp edges or bone fragments in a wound must be covered or removed prior to using the RENASYS
system due to risk of puncturing organs or blood vessels while under negative pressure.
4. Do not use the RENASYS device directly on exposed blood vessels, organs or nerves.
5. In the event defibrillation is required, disconnect the device from the wound dressing prior to
defibrillation. Remove the wound dressing if the location will interfere with defibrillation.
6. The RENASYS device is not MRI or CT compatible. Disconnect the pump from the patient and do not
bring the device into the MRI suite or scanner range.
7. When operating, transporting, repairing or disposing of RENASYS device and its accessories, the
risk of infectious liquids being aspirated or contamination of the device cannot be eliminated.
Universal precautions should be observed whenever working with potentially contaminated parts or
equipment.
8. RENASYS devices have not been studied on pediatric patients. Patient size and weight should be
considered when prescribing this device.
9. RENASYS devices are not suitable for use in areas where there is danger of explosion (e.g. hyperbaric
oxygen unit).
Special precautions for Hyperbaric Oxygen Chambers (HBO): oil-emulsion and Petrolatum based
dressings are not recommended for use on patients undergoing HBO therapy and should be
removed prior to therapy and/or a consideration of use under the NPWT dressing on patients
undergoing HBO therapy.
10. The RENASYS devices (pumps) and the RENASYS canister kits are provided non-sterile and should
not be used in a sterile field.
Negative Pressure Wound Therapy Clinical Guidelines
9
Section 1
RENASYS™ EZ Plus/RENASYS GO
Precautions
Note: Full device operation instructions are found in the User Guide for each RENASYS device
1. Precautions should be taken for patients who are or maybe:
• Receiving anticoagulant therapy or platelet aggregation inhibitors, actively bleeding or have weakened
blood vessels or organs.
• Suffering from difficult wound hemostasis.
• Untreated for malnutrition.
• Noncompliant or combative.
• Suffering from wounds in close proximity to blood vessels or delicate fascia.
2. Infected wounds may require more frequent dressing changes. Regular monitoring of the wound must be
maintained to check for signs of infection.
3. Therapy should remain ON for the duration of the treatment. There may be situations when the patient
needs to be disconnected from the NPWT device, for example, for activities of daily living and diagnostic
testing. If the patient needs to be disconnected, the suction tubing should be disconnected and the ends
of the tubing capped. How long patients may be disconnected from the NPWT device is a clinical decision
based on individual characteristics of the patient and the wound. Factors to be considered would include
amount of drainage, location of the wound, integrity of the dressing seal, assessment of bacterial burden
in the wound and patient’s risk of infection. The RENASYS devices have an Intermittent Mode with a 5
minute ON/2 minute OFF cycle appropriate for wound care usage as prescribed by the treating clinician.
5. This device should only be used by qualified and authorized personnel. The user must have the
necessary knowledge of the specific medical application for which the RENASYS system is being used.
6. If the device has been at temperatures below freezing, bring the device to room temperature prior to use
or the unit may be damaged.
7. Ensure that tubing is installed completely, connected correctly and without any kinks to avoid leaks or
blockages in the vacuum circuit.
8. Position the device and tubing appropriately to avoid the risk of causing a trip hazard and of the patient
lying on the tubing. Where possible, the device system tubing should be positioned horizontal with or
below the wound.
9. When bathing/showering, the patient must be disconnected from the device.
10. If any liquids penetrate the device, discontinue use and return to your authorized provider for service.
11. Do not apply NO-STING SKIN-PREP™ directly onto open wounds.
12. Maintain regular monitoring of the RENASYS device and the wound site during therapy to ensure
therapeutic treatment and patient comfort. The vacuum level should never be painful. If the patient
reports discomfort with the vacuum level, consider reducing the pressure.
13. Underlying structures, such as bone and tendon, must be covered by the non-adherent dressing layer.
14. A RENASYS device is only to be used with Smith & Nephew authorized components.
15. Ensure the dressing clamp is engaged prior to switching off the device. For reconnection to the device,
ensure that the device is active prior to opening the dressing clamp.
10
Additional device (pump) specific precautions:
RENASYS™ GO carry bag contains magnets which may influence the function of certain
electrical devices, including pacemakers.
RENASYS EZ Plus:
1. Contains an in-line overflow protection/bacteria guard. Inspect the Bacterial Overflow Guard
on the canister and replace the canister as necessary. At minimum, the canister should be
changed weekly.
2. Should only be used with Smith & Nephew 250mL S- (Sealed) and 800mL S-Canister Kits.
3. The device should only be used in the upright position.
Negative Pressure Wound Therapy Clinical Guidelines
11
2. General therapy considerations
Section 2
Wound assessment
Success of the NPWT treatment depends heavily upon the quality of the clinical wound
assessment. The wound should have a detailed assessment at the initiation of the NPWT
treatment regime and with every dressing change thereafter. The following areas should be
addressed with every wound assessment:
Wound size: length, width, depth
• NPWT has the ability to assist with removal of interstitial fluid and sloughy necrosis. With the
removal of the space filling materials, the volume of the wound may increase slightly. This will
likely happen within the first few dressing changes, especially if the wound is in the inflammatory
phase of wound healing.
Granulation tissue: amount and description
• Healthy granulation tissue should be beefy red and not bleed easily. No trauma should occur to
the granulation tissue with dressing removal. A Non-Adherent dressing or a contact layer may be
used.
Epithelialization: amount and description
• Epithelialization should be “silvery” in appearance. The new cells are very fragile. If undermining is
present, it is important to fill the undermined areas with gauze or foam to prevent the edges from
rolling under.
Necrotic tissue: type and amount
• NPWT, along with the autolytic environment established by the Transparent Film, may result in a
decrease in necrotic slough.
• Presence of eschar is a contraindication. Eschar should be debrided before NPWT is initiated.
Exudate: type, amount and consistency
• Assess wound exudate for type, amount, color and consistency. Evaluate the wound exudate for
consistent characteristics with the wound type and the anticipated exudate. Significant changes
in exudate warrant a re-assessment of the wound.
Odor: present/absent, description
• It is important to note that body fluids that have been contained in a sealed system for an
extended period of time will likely have an unpleasant odor. This odor is not a direct indication of
wound infection. Remove the soiled dressing from the wound and discard per facility protocol.
Clean wound per protocol, and then, if an odor persists, an assessment for presence of an
infection may be necessary.
Pain: use facility approved tool for rating pain
• There should not be pain with the RENASYS™-G Gauze Dressing Kit. If the patient experiences
pain, decrease the amount of pressure. The pressure range is 40-120mmHg which should allow
for pressure adjustment to ensure pain-free NPWT therapy.
• When using the RENASYS-F Foam Dressing Kit, tissue adherence may be reduced by use of a
contact layer, decreasing the pressure, and/or increasing the frequency of the dressing changes.
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12
Choosing a NPWT wound filler/wound interface
Factors to consider include:
• Wound size and volume
• Contour of wound bed
• Amount and type of exudate
• Patient comfort and preference
• Characteristics of granulation tissue
• Caregiver skills
Wound size considerations:
• Small to moderate size wounds with shallow to deep depth: both foam and gauze may be used
with similar ease of application
• Moderate to large surface area wounds with shallow depth: gauze is generally considered easier
to apply
• Moderate to large surface area wounds with deep depth: foam may be considered easier to use
Wound bed contour considerations:
• Distribution of pressure requires intimate contact with entire wound surface.
- Smooth wound bed contour
- Irregular contour – undermining or tunneling
• Ease of application.
- Surface area
- Wound depth
- Anatomical location
Wound bed contour3
Wound bed with irregular
contour
Gauze wound filler easily
maintains contact with
irregular surface
Foam wound filler may not
intimately contact irregular
shape spaces in wound bed
Negative Pressure Wound Therapy Clinical Guidelines
13
Section 2
The choice of wound filler will be influenced by the amount and
consistency of wound exudate
Wound exudate level
Low
High
Gauze
Foam
Note: In wounds with large amounts of exudate a wound interface (non-adherent layer) is
generally not recommended.
If using gauze with larger amounts of exudate, the drain should be placed close to the
wound bed over a single layer of gauze.
Patient comfort4
• The RENASYS™-G Gauze Dressing Kit should be changed 48 hours after initiating therapy to assess
the patient’s response to the therapy. If the patient is comfortable and the wound is responding
positively to the therapy, the subsequent dressing change frequency is 2-3 times per week.
• Pain is a very subjective experience and will vary with each patient. Research has validated that
patients report less pain with gauze.
Pain/discomfort
Lower level
Gauze
Higher level
Foam
Granulation tissue
• NPWT with foam wound filler has historically been used to prepare wounds for grafting. More
recently gauze has been used by plastic surgeons and feedback suggests that the granulation
tissue is smoother, less inflamed and an excellent bed for receiving a STSG.5
Skin grafts
• NPWT with gauze has been found to give excellent results on irregular and mobile surfaces.6
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14
Gauze/foam combination therapy:
RENASYS™-G Gauze Dressing and RENASYS-F Foam Dressing can be used in combination in a
wound being treated with negative pressure wound therapy. While combination therapy may
be of benefit for optimizing the best wound healing environment for the patient, this option is
dependent on the individual wound characteristics and clinical judgment.
It is appropriate to use a combination foam/gauze therapy where the HCP determines the
necessity for this combination therapy. Examples may include wounds that have explored tunnels,
undermining or sinus tracts with an open central area. The moistened gauze can be placed in
these areas with foam placed on top ensuring the foam is in contact with the gauze. Another type
of wound that may be appropriate for combination therapy is a circumferential wound where the
gauze is wrapped around an extremity in combination with the foam placed in areas to assist in
managing removal of exudate.
NPWT and combination therapy for infected wounds:
If the wound is infected, consider using one of the Smith & Nephew’s ACTICOAT™ products to
address the infection. ACTICOAT Flex 3 and ACTICOAT Flex 7 are both compatible with either
RENASYS systems or PICO Single Use Negative Pressure Wound Therapy System. ACTICOAT 3
or ACTICOAT 7 may also be used with the RENASYS systems if the dressings are fenestrated
for application.
Negative Pressure Wound Therapy Clinical Guidelines
15
Section 2
Considerations for pump selection
Both the RENASYS™ EZ Plus and RENASYS Go devices can be used on a variety of wounds.
Optimally the RENASYS EZ Plus is
recommended for:
• Moderate to large volume wounds
• Difficult to seal locations
• High exudate levels
• Large surface area wounds
• Open abdominal wounds
• Acute setting/hospitalized, limited
ambulatory patients
16
Optimally the RENASYS GO is
recommended for:
• Small to medium volume wounds
• Low to moderate exudate levels
• Home care setting
• Ambulatory patients
16
RENASYS™ portfolio – pumps and canisters
These NPWT Clinical Guidelines are for use with the RENASYS and PICO™ systems. The systems do not have
the same features or require the same guidelines. Refer to specific quick reference guides, Instructions for
Use (IFU) or specific product user manuals for additional instructions. There may be certain unique indications,
contraindications, precautions and warnings for each individual product.
•
•
•
•
RENASYS EZ Plus
RENASYS GO
Component list
Pump
Canister holder kit
Power cord
Quick reference guide
Component list
Pump
Power cord
Quick reference guide
Strap
•
•
•
•
800mL S-Canister
•
•
•
•
Component list; 10 kits per case
Sealed canister
With or without solidifier
Overflow guard with silicone tubing
Canister tubing
RENASYS GO Large
Canister (750mL)
Component list; 5 per case
• Sealed canister
• Solidifier
• Canister tubing
250mL S-Canister
•
•
•
•
Component list; 10 kits per case
Sealed canister
Solidifier
Overflow guard with silicone tubing
Canister tubing
RENASYS GO
Canister (300mL)
•
•
•
•
Component list; 5 per case
Sealed canister
Solidifier
Overflow guard with silicone tubing
Canister tubing
Negative Pressure Wound Therapy Clinical Guidelines
17
Section 2
Dressing change frequency
The RENASYS™-G Gauze and/or RENASYS-F Foam Dressing Kits should be changed 48 hours after
initiating therapy to assess the patient's response to the therapy. If the patient is comfortable and
the wound is responding positively to the therapy, the subsequent dressing change frequency is
2-3 times per week or 48 to 72 hours.
Check dressings at regular intervals.
Infected wounds may require more frequent dressing changes. Monitor the wound to assess for
changes in signs or symptoms of infection.
Throughout treatment, monitor for any signs of local or systemic infection. If there are any signs
of systemic infection or advancing infection at the wound site, contact the treating physician/
clinician immediately.
Tips and tricks for improving dressing wear time
To enhance dressing wear time, use these basic wound care tips:
• SKIN-PREP™ should be routinely used to protect the periwound area. If skin in the periwound area
is damaged or fragile, a hydrocolloid or adhesive film may be used to protect the area prior to
applying the cover Transparent Film.
• Apply SKIN-PREP barrier to edges of Transparent Film to prevent rolling.
• Apply Ostomy Strip Paste and/or the RENASYS Adhesive Gel Patch to skin irregularities such as
abdominal skin folds or cleft at sacrococcygeal juncture. This will help to decrease depth of the
skin irregularity.
• Border Transparent Film with Waterproof Tape.
NPWT pressure settings
General guidelines:
• Recommended pressure range for the RENASYS NPWT systems is 40mmHg to 120mmHg.
• Generally a pressure level of 80mmHg is used with gauze and 120mmHg with foam. If a patient
experiences discomfort, it may help to reduce the pressure level. A lower pressure range between
40mmHg-80mmHg provides less painful NPWT while handling most exudate levels, types, and
consistencies.
• An increase in the pressure may be necessary according to size of wound, viscosity of exudate,
amount of exudate and clinical judgment of desired wound outcomes.
• Anatomical location and tissue pliability may also influence pressure level utilized.
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18
Recommended pressure settings
Wound type
Suggested
filler
Pressure setting
Wound contact
layer
Special considerations
Acute/traumatic
Gauze or
foam
-80 to -120mmHg
If tendon, bone,
and/or other fragile
structures are
exposed
Infected wounds and fragile structures should be
protected and care taken to avoid desiccation of
tendon if exposed
Partial thickness abdominal
(muscle intact)
Foam
-80 to -120mmHg
Not required unless
adhesion occurs
Layer the filler into the wound to ensure it fits the
cavity from the bottom up to ensure contact with the
wound margins
Full thickness
abdominal
(muscle
intact)
Decompression
& closure
Abdominal
dressing
with OPL
-60 to -120mmHg
OPL large enough
to cover all fragile
structures should be
used
The lead clinician must take full responsibility for
treatment choices and materials/method of NPWT
and pressure setting used
Healing by
secondary
intention
Gauze
-60 to -120mmHg
Essential to protect
exposed fragile
structures
Use a single layer of wound contact layer to ensure
any fragile structures are protected and to ensure it
is removed and replaced at each dressing change.
Extra care should be taken when patients have
inflammatory bowel disorders/infected/inflamed
bowel. Lead clinician must be consulted prior to
commencement of therapy
Pressure ulcers
Gauze
-60 to -80mmHg
Yes if tendon/bone
exposed
Always address underlying aetiology and factors
affecting healing – if slough or necrosis present
debride prior to commencement of NPWT or
consider using foam
Diabetic foot ulcers post surgery
Gauze
-60 to -80mmHg
Yes if tendon/bone
exposed
Dressing should be placed as soon after surgery as
is practical once hemostasis is achieved
Diabetic foot ulcers
Gauze or
foam
-60 to -80mmHg
Yes if tendon/bone
exposed
Sharp debridement of any devitalized tissue should
occur prior to placement of NPWT
Meshed grafts/bioengineered
tissue
Gauze
-50 to -80mmHg
Yes to avoid
adherence of filler to
the graft
Dressings are typically removed after 5 days or as
per clinician instructions
Flaps
Gauze
-50 to -80mmHg
Yes to avoid
adherence of filler to
the graft
Dressings are typically removed after 5 days or as
per clinician instructions
Dehisced surgical wounds
Foam
-80 to -120mmHg
Yes if tendon, bone,
and/or other fragile
structures are
exposed
Consideration should be taken to debride any
devitalized tissue prior to commencement of NPWT
Chronic wounds
Gauze
-80mmHg
Yes if tendon/bone
exposed
Always address underlying etiology and factors
affecting healing
Enteric fistula (explored)
Gauze or
foam
-80mmHg
Yes to protect
exposed fragile
structures
See RENASYS™ High Output Dressing Kit application
technique, page 32
Negative Pressure Wound Therapy Clinical Guidelines
19
Section 2
RENASYS™ Soft Port – considerations for use
• Each RENASYS Dressing Kit with Soft Port contains 1 Soft Port.
• Each Soft Port is surrounded by 4.5 inch x 5.5 inch (11.4cm x 14cm) of polyurethane film.
• The Soft Port film extends from the suction opening to ensure an effective seal of the Soft Port to the top
of the Transparent Film covering the wound.
• It is important to align the opening of the Soft Port with the opening in the Transparent Film to ensure a
good seal and decrease the risk for a false blockage alarm.
• The Soft Port opening is .25 inches (0.6cm) in diameter. It is important that the opening in the wound
Transparent Film be .25 inches (0.6cm) in diameter as well.
• When making the opening in the wound Transparent Film, remove any loose edges from the film to prevent
aspiration into the Soft Port, possibly causing a false blockage alarm.
• Single Soft Ports are available to assist when Y-Connecting multiple wounds and/or other applications.
• Single Soft Ports are sold separately in the RENASYS Port Kit – individually wrapped and sterile.
• All Soft Port dressings can be left in place up to 72 hours
The Soft Port is encased in a white covering
1. Patient dignity – exudate in the Soft Port channel is more discreet with the opaque white covering
2. The white coloring reflects any color changes occurring within the fluid – most prominently, blood and
color changes that may be associated with presence of bacteria. For example:
Bright red coloration
The visual appearance of a bright red color
within the RENASYS Soft Port may signal
a more critical concern, as this is normally
associated with high concentrations of
whole blood.
Important customer reminders:
• If blood is visible in the Soft Port before the
blockage alarm activates, clinicians should
stop therapy immediately and take the
relevant corrective actions.
• The RENASYS Soft Port IFU states
haemostasis should always be achieved
prior to initiating NPWT.
20
Blue/green coloration
• The visual appearance of a blue/green color
within the RENASYS Soft Port supports a
conclusion that Pseudomonas species has
colonized the wound.
• The color is from a pigment created by the
Pseudomonas species called pyocyanin.
• A characteristic smell may also be noted
when this type of effect is noted.
• You may also see gauze dressings similarly
colored in this way.
20
Physician orders
Prior to placement of the RENASYS™ device, the medical professional treating the wound
must assess how best to use the system for an individual wound. It is important to carefully
assess the wound and the patient to ensure clinical indications for NPWT are met.
All Rx orders should include:
• Wound location, size, and type
• Smith & Nephew wound dressing kit type
• Vacuum settings (recommended ( -40mmHg to -120mmHg)
• Frequency of dressing changes
• Adjunctive dressings
How do I know if the RENASYS therapy device is
working?
While the RENASYS GO therapy device is turned on a green light will illuminate. The
illuminated light located at the top of the device tells you the device is on and vacuum is
working. If the device is set to CONTINUOUS mode (recommended) the selected pressure is
displayed on the screen. If the device is set to INTERMITTENT mode, the gauge will show 0
pressure during “off time” and the set pressure while vacuum is occurring.
While RENASYS EZ Plus is turned on you will hear the device running and the set pressure
will show on the gauge.
It is important to monitor the activity of the device while you are using the therapy.
Does the dressing have a raisin-like appearance?
Gauze with drain
Gauze with Soft Port
Foam with Soft Port
Negative Pressure Wound Therapy Clinical Guidelines
21
Section
3
3.
RENASYS™-G
Gauze Dressing Kit with Soft Port
Kit sizes and components
The RENASYS-G Gauze Dressing Kit is part of the Smith & Nephew RENASYS NPWT system. The RENASYS-G
Gauze Dressing Kit contains everything you need to perform the dressing change with the exception of gloves and
scissors. The RENASYS-G Gauze Dressing Kit is designed to provide the clinician with many options to address
most wound types, locations, and exudate levels. The table below will help guide you to the appropriate Kit size for
your patients' wounds.
Kit Contents
Small
Medium
Large
X-Large
Sterile with Soft Port
Saline 30ml Bullet
1 bullet, 30mL
1 bullet, 30mL
1 bullet, 30mL
2 bullets, 30mL
–
Wound Ruler
1 wound ruler
1 wound ruler
1 wound ruler
1 wound ruler
–
NO-STING SKIN-PREP™
1 sachet
1 sachet
1 sachet
2 sachets
–
Soft Port
1 – Length 27in (69cm) 1 – Length 27in (69cm) 1 – Length 27in
(69cm)
Applicator head
Applicator head
1 – Length 27in (69cm) 1 – Length 27in (69cm)
6in x 4in
(15cm x 10cm)
6in x 4in
(15cm x 10cm)
Applicator head
6in x 4in
(15cm x 10cm)
Applicator head
6in x 4in
(15cm x 10cm)
Applicator head
6in x 4in
(15cm x 10cm)
1 dressing –
6in x 6.7in
(15cm X 17cm)
2 dressings –
6in x 6.7in
(15cm X 17cm)
1 roll –
4.5in x 4.1yd
(11cm x 4m)
2 rolls –
4.5in x 4.1yd
(11cm x 4m)
1 dressing –
6in x 6.7in
(15cm x 17cm)
AMD Gauze Dressing
1 roll –
4.5in x 4.1yd
(11cm x 4m)
Transparent Film
1 – 8in x 12in
(20cm x 30cm)
1 – 8in x 12in
(20cm x 30cm)
2 – 8in x 12in
(20cm x 30cm)
3 – 8in x 12in
(20cm x 30cm)
3 – 8in x 12in
(20cm x 30cm)
Non-Adherent Gauze
1 – 3in x 8in
(8cm x 30cm)
1 – 3in x 8in
(8cm x 30cm)
2 – 3in x 8in
(8cm x 30cm)
4 – 3in x 8in
(8cm x 30cm)
–
22
Antimicrobial Gauze (included in RENASYS™-G
Gauze Dressing Kits and separately in RENASYS
Accessory Kits)
• The primary purpose of the gauze is to fill the wound space.
• When contracted under suction it serves two functions:
- it equally distributes negative pressure across the wound bed
- provides a pathway or conduit for wound fluid to exit the wound
• The gauze is impregnated with 0.2% polyhexamethylene biguanide or
PHMB. This antimicrobial agent is present to inhibit the proliferation of
bacteria in the dressing.
• It is important to always moisten the gauze prior to placement in the
wound bed.
• Moistening the gauze also ensures that the entire wound surface is in
contact with the gauze.
• The Antimicrobial Gauze has been studied to sustain its antimicrobial
effectiveness for 72 hours.
• If wound is exposed to fecal matter, urine, or other undesirable
elements, it is suggested that the dressing be removed, wound
cleaned per protocol, and a new dressing applied.
• The 72 hour efficacy of the Antimicrobial Gauze does not dictate the
dressing change frequency. The frequency of the dressing change
should be determined by a thorough assessment of the wound
including exudate levels.
• If the system is applied correctly and the seal is maintained, the
gauze will not dry out due to the occlusive nature of the sealed
dressing system.
Note: The Antimicrobial Gauze is not indicated to be moistened
with any solution except saline, tap water, or sterile water.
Negative Pressure Wound Therapy Clinical Guidelines
23
Section 3
Non-Adherent Gauze
• A Non-Adherent Gauze on the wound bed maybe used to reduce the
risk of pain and bleeding during dressing changes.
• This gauze is an oil-emulsion dressing that protects fragile tissue at
the time of the dressing change.
• It is recommended that a Non-Adherent Gauze be placed over any
exposed bone, tendon, or fragile structures as well as any part of the
wound bed that may need protection.
• It is recommended that a Non-Adherent layer or contact layer
be placed under the foam and/or gauze interface over meshed
grafts and some bioengineered tissues (as recommended by the
manufacturer).
• Cut a single layer to the size and shape of the wound bed.
• Non-Adherent Gauze is meant to be used as a contact layer.
• The Non-Adherent Gauze is air and exudate permeable.
Special precautions for Hyperbaric Oxygen Chambers (HBO): Oilemulsion and petrolatum based dressings are not recommended
for use on patients undergoing HBO therapy and should be
removed prior to therapy and/or a consideration of use under the
NPWT dressing on patients undergoing HBO therapy. The pump
should be disconnected and NPWT discontinued during HBO
therapy.
Note: It is recommended not to use the Non-Adherent Gauze
under ACTICOAT™ 3, ACTICOAT 7, ACTICOAT Flex 3, or ACTICOAT
Flex 7 as the oil-emulsion dressing may interfere with the
effectiveness of the silver and antimicrobial effectiveness of the
ACTICOAT dressings.
24
Transparent Film
• The Transparent Film is a gas permeable membrane
designed to create a seal.
• It creates a barrier to outside contaminants.
• It needs to cover the entire wound and at least 2
inches (5.1cm) of the intact periwound skin.
• It can also be used for patching if a leak situation
occurs.
• Note: In highly exuding wounds, adding
SKIN-PREP™ to the periwound skin will reduce
the risk of maceration.
• The Transparent Film may be cut into strips for easier
application.
Saline (0.9% Sodium Chloride)
30ml Bullet
A Saline bullet may be provided in the RENASYS™-G
Gauze Dressing Kit and can be used to moisten
the Antimicrobial Gauze prior to placing in the
wound bed.
NO-STING SKIN-PREP™ Barrier Pad
• NO-STING SKIN-PREP is used to protect the
patient’s skin upon dressing removal and to assist
with the adherence of the Transparent Film.
• Do not apply directly on to open wound.
Tips for increasing the dressing longevity:
• SKIN-PREP™/NO-STING SKIN-PREP should routinely be used to protect the periwound area. If skin in the
periwound area is damaged or fragile, a hydrocolloid or adhesive film may be used to protect the area prior to
applying the cover Transparent Film.
• Apply SKIN-PREP barrier to edges of Transparent Film to prevent rolling.
• Apply RENASYS Adhesive Gel Patch to skin irregularities such as abdominal skin folds or cleft at
sacrococcygeal juncture. This will help to reduce depth of skin irregularity.
• Border Transparent Film with Waterproof Tape.
Negative Pressure Wound Therapy Clinical Guidelines
25
Section 3
RENASYS™-G Gauze Dressing with Soft Port application technique
Use clean or sterile/aseptic techniques protocol. Only use RENASYS Dressing Kits approved
for use with the RENASYS System.
Clean and debride
Debride any devitalized or necrotic eschar tissue. Cleanse the wound and pat dry as per
local protocol.
If desired, protect the periwound skin from exposure to moisture and adhesive through the
use of a skin sealant.
If desired, a non-adherent wound contact layer may be applied. Trim a single layer of
Non-Adherent Gauze to fit the wound dimensions and lay across the wound bed.
If the wound is infected, consider using one of Smith & Nephew’s ACTICOAT™ products to
address the infection. ACTICOAT Flex 3 and ACTICOAT Flex 7 may be used in conjunction
with RENASYS NPWT treatments. ACTICOAT 3 or ACTICOAT 7 may also be used if the
dressings are fenestrated for application.
Dress the wound with gauze
Apply a layer of saline-moistened antimicrobial gauze to wound bed.
Continue to apply in layers until the gauze loosely fills the entire wound cavity.
Avoid over packing the wound.
If multiple pieces of gauze are used to fill the wound, count and record how many pieces
are present to ensure all pieces are removed at a dressing change.
26
Seal the wound
Remove panel #1 of the Transparent Film, exposing the adhesive. Apply over the wound
and remove the remaining panel #2 to seal. Once placed, remove the top panel #3.
Continue to apply until the gauze is completely covered and the wound is sealed.
Apply the Soft Port
Cut a small hole (no less than 2.0cm) in the center of the film, over the gauze. Remove any
loose Transparent Film and dispose.
Remove the adhesive backing panel from the Soft Port dressing and align directly over
the hole in the Transparent Film. Use gentle pressure to anchor it to the Transparent Film.
Smooth the dressing down while removing the Soft Port stabilization frame.
Secure the Soft Port to the patient according to your institutional protocol. Ensure
the aeration disc, located near the Quick-Click Connector, is not covered or
otherwise occluded by the method used to secure the Soft Port.
Aeration
disc
Connect the Soft Port tubing to the canister tubing by pushing on the Quick-Click
Connectors together. An audible click indicates the connection is secure.
Activate the RENASYS™ device and adjust the prescribed therapy level. Finished
dressings should be firm to the touch.
Negative Pressure Wound Therapy Clinical Guidelines
27
Section
4
4.
RENASYS™-F
Foam Dressing Kit with Soft Port
Kit sizes and components
The RENASYS Soft Port simplifies and enhances negative pressure wound therapy by reducing the need for
bridging which saves time and materials. The Soft Port reduces the risk of pressure-related injuries and eases
patient discomfort by replacing the hard tubing with a soft, cushioned channel, while maintaining the ability to
operate at peak performance when compressed, twisted or kinked by a patient or surrounding object. RENASYS-F
Foam Dressing Kit is sterile, rendering it perfect for use in all care settings, from OR to home care.
Kit contents*
Small
Medium
Soft Port
1 – Length 27in (69cm)
X-Large
Soft Port StandAlone Kit
1 – Length 27in (69cm) 1 – Length 27in (69cm)
1 – Length 27in (69cm)
Length 27in (69cm)
Applicator head
6in x 4in
(15cm x 10cm)
Applicator head
6in x 4in
(15cm x 10cm)
Applicator head
6in x 4in
(15cm x 10cm)
Applicator head
6in x 4in
(15cm x 10cm)
Applicator head
6in x 4in
(15cm x 10cm)
Foam block
1 – 4in x 3in x 1in
(10cm x 8cm x 3cm)
1 – 8in x 5in x 1in
(20cm x 13cm x 3cm)
1 – 10in x 6in x 1in
(25cm x 15cm x 3cm)
1 – 20in x 25in x 0.6in
(50cm x 63cm x 1.5cm)
–
Transparent
Film
1 – 8in x 12in
(20cm x 30cm)
2 – 8in x 12in
(20cm x 30cm)
3 – 8in x 12in
(20cm x 30cm)
6 – 8in x 12in
(20cm x 30cm)
–
*5 kits per case
28
Large
RENASYS™-F Foam Dressing
• Reticulated open pore hydrophobic polyurethane foam.
• Cut foam to size and shape of the wound.
• Foam should fill the wound cavity. Do not force or pack foam into any areas of the wound.
• It may be necessary to stack pieces of foam in deeper wounds.
• A contact layer may be used under the foam if adherence or pain is a concern. Example of contact
layers are Non-Adherent Gauze, ACTICOAT™ 3, ACTICOAT 7, ACTICOAT Flex 3, or ACTICOAT Flex 7.
It is suggested to fenestrate the ACTICOAT 3 or ACTICOAT 7 on more heavily exuding wounds.
• Rub the edges of the foam after cutting to remove any loose fragments.
• Do not cut foam directly over wound bed to avoid foam fragments from falling into the wound bed.
• It is recommended to document the number of foam pieces placed in the wound to ensure all are
removed at dressing change.
• Do not place foam into blind or unexplored tunnels.
• If foam dressing adheres to wound bed:
1. Power down device.
2. Apply normal saline into the wound dressing and let set for 15-30 minutes.
3. Gently remove dressing.
4. Dispose of dressing in accordance with local guidelines.
• Tissue adherence may be reduced by use of a contact layer, decreasing the pressure and/or
increasing the frequency of the dressing changes.
Negative Pressure Wound Therapy Clinical Guidelines
29
Section 4
RENASYS™ Transparent Film
• Stronger, proprietary adhesion formulation developed by Smith & Nephew provides superior adhesion to skin in
a wide variety of skin moisture conditions, yet is safe and gentle for regular use and removal. It has a long, proven
history of superior performance to many other types of acrylic adhesives available in the market, decreasing the
chance of undesired film removal from the skin.
• Thicker film minimizes the risk of undesired tearing of the film and increases the ease of handling during
application.
• More breathability allows for greater skin moisture vapor permeability without negatively affecting the seal
strength. May help decrease risk of periwound skin maceration.
• More extensible film contours more easily to challenging anatomical geometries. Extends more easily with the
skin to reduce leakage.
• The Transparent Film is a gas permeable membrane designed to create a seal.
• With proper use, it allows appropriate moisture balance within the dressing/wound which is essential to healing.
• It creates a barrier to outside contaminants.
• It needs to cover the entire wound and at least 2 inches (5.1cm) of the intact periwound skin.
• It can also be used for patching if a leak situation occurs.
• The Transparent Film may be cut into strips for easier application.
RENASYS Transparent Film is sold separately.
RENASYS Transparent Film
RENASYS Transparent Film X-Large
Component list; 10 kits per case
10 – Transparent Films per kit
8in x 12in (20cm x 30cm)
Component list; 10 kits per case
5 – Transparent Films per kit
16in x 25in (40cm x 60cm)
30
RENASYS™-F Foam Dressing with Soft Port application technique
Use clean or sterile/aseptic techniques protocol. Only use RENASYS Dressing Kits approved
for use with the RENASYS System.
Clean and debride
Debride any devitalized or necrotic eschar tissue. Cleanse the wound and pat dry as per
local protocol.
If desired, protect the periwound skin from exposure to moisture and adhesive through the
use of a skin sealant.
If desired, a non-adherent wound contact layer may be applied. Trim a single layer of
Non-Adherent Gauze to fit the wound dimensions and lay across the wound bed.
If the wound is infected, consider using one of Smith & Nephew’s ACTICOAT™ products to
address the infection. ACTICOAT Flex 3 and ACTICOAT Flex 7 may be used in conjunction
with RENASYS NPWT treatments. ACTICOAT 3 or ACTICOAT 7 may also be used if the
dressings are fenestrated for application.
Dress the wound with foam
Cut foam dressing to fit the size and shape of the wound. Foam should completely fill the
wound.
Do not cut the foam directly over the wound bed and after cutting brush the sides to
dislodge small fragments of foam.
Place the cut foam into the wound. Avoid over packing. Do not force foam into the wound
or place within an unexplored tunnel. It may be necessary to stack pieces of foam in
deep wounds.
If multiple pieces of foam are used to fill the wound, count and record how many pieces
are present to ensure all pieces are removed at a dressing change.
Negative Pressure Wound Therapy Clinical Guidelines
31
Section 4
Seal the wound
Remove panel #1 of the Transparent Film, exposing the adhesive. Apply over the wound
and remove the remaining panel #2 to seal. Once placed, remove the top panel #3.
Continue to apply until the foam is completely covered and the wound is sealed.
Apply the Soft Port
Cut a small hole (no less than 2.0cm) in the center of the film, over the foam. Remove any
loose Transparent Film and dispose.
Remove the adhesive backing panel from the Soft Port dressing and align directly over
the hole in the Transparent Film. Use gentle pressure to anchor it to the Transparent Film.
Smooth the dressing down while removing the Soft Port stabilization frame.
Secure the Soft Port to the patient according to your institutional protocol. Ensure
the aeration disc, located near the Quick-Click Connector, is not covered or
otherwise occluded by the method used to secure the Soft Port.
Aeration
disc
Connect the Soft Port tubing to the canister tubing by pushing on the Quick-Click
Connectors together. An audible click indicates the connection is secure.
Activate the RENASYS™ device and adjust the prescribed therapy level. Finished
dressings should be firm to the touch.
32
5. RENASYS™ High Output Dressing Kit
Kit components
The RENASYS High Output Dressing Kit from Smith & Nephew, in conjunction with the
RENASYS EZ Plus pump, is an intuitive, cost-effective, and clinically proven NPWT solution
for managing explored enterocutaneous fistulas and other high output type wounds.
Component list; 10 kits per case
2 – 30mL saline bullets
4 – strips waterproof tape
1 – strip paste
1 – wound ruler
2 – sachets of NO-STING SKIN-PREP™
1 – 28 Fr round aspiration/irrigation drain 3ft (92cm)
2 – Non-Adherent Gauze 3in x 8in (8cm x 20cm)
2 – AMD gauze rolls 4.5in x 4.1yd (11cm x 4m)
3 – RENASYS Transparent Films 8in x 12in (20cm x 30cm)
The RENASYS High Output Kit should be used with the RENASYS EZ Plus device.
NOTE: The High Output Dressing Kit is not compatible with the RENASYS GO Device.
Irrigation/Aspiration Lumen
• This is a round, perforated, 28 French, double lumen, 7 foot long drain.
• Irrigation port for irrigating the wounds or decreasing the viscosity of the exudate.
• Double lumen allows for irrigation and instilling medication per clinician discretion.
Irrigation/
aspiration lumen
28 French round
large bore
Negative Pressure Wound Therapy Clinical Guidelines
33
Section 5
RENASYS™ High Output Dressing Kit application technique
High output/thin consistency dressing procedure
• Cover wound bed, including fistula opening, with Non-Adherent Gauze or with one layer of saline
moistened AMD gauze.
• Place drain in close proximity to fistula opening and in dependent/inferior position.
• Fill remaining wound deficit with additional saline moistened AMD gauze.
• Cover with Transparent Film.
• Secure drain with Waterproof Tape using Chevron Technique.
• Apply Negative Pressure at 40-120mmHg.
Dressing change frequency
• Dressing change frequency may be greater than 3 times per week.
• If output is high, e.g. 800cc per shift or greater, the dressing integrity may only last up to 24 hours.
• This improves patient comfort by reducing dressing change frequency and is also more cost effective
than traditional, non-NPWT methods of addressing a fistula.
Sediment laden output considerations
• Sediment may not flow through the gauze layer.
• May require NPWT dressing and an ostomy pouch/wound management pouch device.
Sediment laden dressing procedure
• Cover entire wound bed, excluding fistula opening, with one layer of Non-Adherent Gauze OR saline
moistened AMD gauze.
• Place Irrigation/Aspiration drain in close proximity to fistula opening and in dependent/inferior
position.
• Fistula opening is exposed.
• Fill wound deficit with additional saline moistened AMD gauze, continue to leave fistula opening
exposed.
• Cover entire wound with Transparent Film.
• Create opening in Transparent Film over fistula opening.
• An ostomy pouch may be placed over fistula opening/hole in the Transparent Film and secured.
• Apply negative pressure at 40-120mmHg.
Note: Non-enteric, unexplored fistulae are contraindicated for NPWT.
34
Drain position
• Always position drain inferior or “dependent” of fistula opening to
assist with fluid removal.
• Place drain openings in close proximity to fistula opening to quickly
remove fluid as it is produced.
Fistula precautions
• Never place drain into fistula opening.
• Never lay drain on top of fistula opening.
• Patient’s fluid levels should be closely monitored, particularly with
infants, children, and geriatrics.
Fistula location and fluid description
• The higher the fistula occurs in the bowel...the thinner, more caustic
and heavier the output.
• The lower the fistula occurs in the bowel...the thicker or pastier the
output.
Higher output fistula considerations
• Large volumes of thin fluids.
• Must be able to pass through gauze.
Note: Non-enteric, unexplored fistulae are contraindicated
for NPWT.
Negative Pressure Wound Therapy Clinical Guidelines
35
Section 5
Types of fistulas
Drain recommendation: Irrigation/Aspiration Drain
(contained in the RENASYS™ High Output Dressing Kit)
• Fistulas can be internal or external:
- Internal – communication is between a body cavity or hollow organ to another body cavity
or hollow organ.
- External – communication between a hollow organ and the skin.
• Fistula terminology – Described by the anatomic location or the site of origin and the site of
termination.
Name
From
To
Type
Enterocutaneous
Intestine
Skin
External
Recto-vaginal
Rectum
Vagina
Internal
Vesicocutaneous
Bladder
Skin
External
• Fistulas may also be described by amount of output:
- High output – 500cc or more/24 hours
- Moderate output – 200-500cc/24 hours
- Low output – less than 200cc/24 hours
• The wound surrounding the fistula opening should respond as any other wound on NPWT
by displaying decreased size, decreased drainage, and increase in granulation tissue.
The fistula opening will likely require surgical intervention or pouching depending on the
maturation of the fistula.
• Smith & Nephew recommends the gauze based interface when addressing high output
fistulas.
Note: Patient's PO intake should be considered. Patient's fluid levels should be closely
monitored, particularly with infants, children and geriatrics.
Note: Non-enteric, unexplored fistulae are contraindicated for NPWT.
36
6. RENASYS™ AB Abdominal Kit with Soft Port
Kit components
RENASYS AB Abdominal Dressing Kit is designed for use with the RENASYS EZ Plus device as a
complete negative pressure wound therapy for managing open abdominal wounds.
The RENASYS AB Dressing Kit includes the following components:
Organ Protection Layer (OPL) x 1
Pre-shaped Foam x 2
Transparent Adhesive Film x 6
RENASYS Soft Port Dressing x 1
Component list; 5 kits per case
1 – Soft Port – length 27in (69cm)
applicator head 6in x 4in (15cm x 10cm)
2 – foam blocks 17in x 12in x 1in (43cm x 30cm x 3cm)
6 – RENASYS Transparent Films 8in x 12in (20cm x 30cm)
1 – Organ Protection Layer 35in x 26in (89cm x 66cm)
Negative Pressure Wound Therapy Clinical Guidelines
37
Section 6
RENASYS™ AB Abdominal Kit with Soft Port
Indications
The RENASYS AB Abdominal Dressing Kit with Soft Port is intended for use in conjunction with the RENASYS
EZ Plus device and canisters as a complete NPWT system for managing open abdominal wounds.
• RENASYS AB is indicated for temporary bridging of abdominal wall openings where primary closure is not
possible and/or repeat abdominal entries are necessary.
• It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to
abdominal compartment syndrome.
• RENASYS AB is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and
should ideally be applied in the operating room.
Contraindications
The use of RENASYS AB is contraindicated:
• For non-enteric, unexplored fistulae
• For untreated osteomyelitis
• For malignancy in the wound (with the exception of palliative care to enhance quality of life)
• When vital organs and structures are not covered with the Organ Protection Layer (OPL)
• For the presence of necrotic tissue with eschar
• For use in patients with on-going or high potential for hemorrhage and/or enteric leak
Warnings
• Hemostasis must be achieved prior to dressing application. Carefully monitor patients undergoing treatment
with RENASYS AB for signs of sudden or increased bleeding. If such symptoms are observed, immediately
discontinue therapy, take appropriate measures to control the bleeding, and contact the treating clinician.
Precautions should be taken for patients who are, or may be:
- Receiving anticoagulant therapy or platelet aggregation inhibitors
- Actively bleeding or have friable blood vessels or organs
- Suffering from abnormal wound hemostasis
- Untreated for malnutrition
- Noncompliant or combative
- Suffering from wounds in close proximity to blood vessels or friable fascia
• Sharp edges such as bone fragments must be covered or removed prior to initiating therapy, due to risk of
puncturing organs or blood vessels drawn closer under the action of negative pressure.
• Foam must not be tightly packed or forced into any wound area. Foam must only be placed in the wound defect
once the OPL has been placed.
38
• In the event defibrillation is required, disconnect the device from the wound dressing only if its location will interfere
with defibrillation.
• RENASYS™ EZ Plus is not MRI compatible. Do not bring device into MRI suite.
• When operating, transporting, repairing or disposing of RENASYS devices and accessories, the risk of infectious liquids
being aspirated, or contamination of the device assembly through incorrect use, cannot be eliminated. Universal
precautions should be observed whenever working with potentially contaminated parts or equipment.
• RENASYS EZ Plus and RENASYS AB have not been studied on pediatric patients. Patient size and weight should be
taken into account when prescribing this device.
• RENASYS devices are unsuitable for use in areas where there is a danger of explosion (e.g. hyperbaric oxygen unit, or in
the presence of a flammable anesthetic mixture with air or nitrous oxide). Disconnect the device from the dressing prior
to entering an area where this equipment will be used.
• RENASYS devices and canister kits are provided non-sterile and should not be used in a sterile field.
Precautions
Note: Full device operation instructions are found in the user guide for RENASYS EZ Plus.
• While using RENASYS AB, therapy should remain on in the CONTINUOUS mode for the duration of the treatment. If the
patient must be disconnected from the device, protect the tube ends by inserting the tethered caps of the Quick-Click
Connector immediately before turning off the device.
• CT scans and X-ray have the potential to interfere with some electronic medical devices. When possible, move the
device out of the X-ray or scanner range, check that it is functioning correctly following the procedure.
• Whenever possible, the device and system tubing should be positioned level with or below the wound.
• The length of time a patient may be disconnected from the RENASYS EZ Plus device is a clinical decision based on
individual characteristics of the patient and the wound. Factors to consider include the volume of drainage, integrity of
the dressing seal, assessment of bacterial burden in the wound, and patient’s risk of infection.
• As a condition of use, RENASYS AB with the RENASYS system must only be applied and operated by qualified and
authorized personnel. The user must have the necessary knowledge of the specific medical application for which
RENASYS AB in indicated.
• During therapy, maintain regular monitoring of the device and tubing, from wound site to canister, to ensure therapeutic
benefit and patient comfort.
• Position the device and tubing appropriately to avoid the risks of causing a trip hazard and of the patient lying on the
tubing.
• Check the Bacterial Overflow Guard on the canister and replace the canister as necessary. Minimally, a weekly canister
change is recommended. Always use the smallest practical canister size, based on the patient’s size and weight to
avoid risk of significant and or unintended fluid and blood loss.
• The lowest recommended therapy pressure for using RENASYS AB with the RENASYS EZ Plus device is 80mmHg.
• If any liquids penetrate the pump, discontinue use and return to your authorized provider for service.
• While using RENASYS AB, apply Universal Precautions according to your institution’s protocols, to minimize the risk of
contact with any blood-borne pathogens. Measures may include use of sterile gowns and eye protection with severely
contaminated wounds.
Negative Pressure Wound Therapy Clinical Guidelines
39
Section 6
Precautions specific to RENASYS™ AB
Note: Ensure aseptic technique is used during the application of all components of RENASYS AB.
Ensure the abdomen and its contents are adequately visualized, controlled and protected throughout
application of dressing.
• Medical intervention with RENASYS AB should only be undertaken as part of a holistic medical management
strategy, with the goal of reducing the patient’s intra-abdominal pressure to normal levels. Factors to consider
should include the etiology of the patient’s intra-abdominal hypertension (IAH) or Abdominal Compartment
Syndrome (ACS), as well as other factors (including the patient’s size, weight and unique clinical situation).
• Frequent, standardized measurements of the intra-abdominal pressure (IAP) and/or abdominal perfusion
pressure (APP) are recommended before, during and after treatment with RENASYS AB, as a means of guiding
clinical decisions concerning management of the open abdomen.
• RENASYS AB is not intended to provide primary treatment for infection in the open abdomen. RENASYS AB
may, however, be used on septic open abdomens, which are being managed in accordance with institutional
clinical protocols for infection abatement, as an adjunct to the standard treatment regimen, and/or to provide a
barrier to bacterial penetration.
• Use of the Organ Protection Layer is necessary to protect exposed bowel from the abdominal wall. Preventing
adhesions or obstructions that may otherwise form during open abdominal wound management is a critical
parameter in achieving timely primary fascial closure and reducing the chance of fistula formation. The OPL
must completely cover all exposed viscera, prior to application of wound filler and subsequent activation of the
NPWT system.
• Use caution when utilizing RENASYS AB with patients suffering from intestinal obstruction in the small or large
bowel, which may include (but is not limited to) hernias, adhesions from previous abdominal surgery or from
underlying pathologies such as Chrohn’s Disease or Irritable Bowel Syndrome (IBS). Obstructions may often
be complicated by dehydration and/or loss of electrolytes – this is especially the case if the patient has bowel
exposed.
• Patients with circulatory or intestinal anastomoses (including, but not limited to arterial grafts or gastric bypass)
require careful consideration while using RENASYS AB. Patients with enteric fistula have an increased risk of
abdominal contamination if output is not carefully managed during the course of treatment with RENASYS AB.
• During the course of treatment, the RENASYS AB dressing and RENASYS NPWT system will remove third space
fluid in the abdominal compartment. Large volumes of fluid can be collected during the course of treatment.
The volume and appearance of the fluid in both the canister and tubing should be checked and recorded
frequently while the patient receiving therapy. The canister should be replaced prior to reaching full-capacity.
Viscous exudates increase the risk of blockage in the system, monitor closely.
• The fluid level in the canister may be used as an approximate guide when considering the necessity of fluid
resuscitation. Planning for fluid replacement should be a clinical consideration in all patients undergoing
therapy with RENASYS AB.
• Planning for fluid replacement should be a clinical consideration in all patients undergoing therapy with
RENASYS AB.
• Protection of the periwound skin area from moisture and adhesive irritation may be accomplished through the
use of a skin sealant. Because of the risk of further damage to the periwound area, foam should never overlap
onto intact skin without first protecting the skin with additional Transparent Film or a hydrocolloid dressing.
40
RENASYS™ AB Abdominal Kit with Soft Port application technique
Use clean or sterile/aseptic techniques protocol. Only use RENASYS Dressing Kits
approved for use with the RENASYS System.
Open abdominal wound preparation
Warning: Review all RENASYS NPWT system safety information before beginning
wound preparation. Ensure adequate hemostasis has been achieved prior to
dressing placement.
1. Sharp edges or bone fragments must be eliminated from wound area or covered
2. Ensure any areas of necrosis are appropriately debrided
3. Irrigate abdominal wound as needed
4. Clean and dry the periwound area
Organ Protection Layer (OPL) application
Warning: Protect vital structures such as bowel and abdominal organs with the OPL
at all times during therapy. Foam should never be placed in contact with exposed
bowel, arteries, veins, organs or nerves. The OPL is designed to allow application
directly over exposed internal organs and can be cut or folded as desired. Either side
of the OPL may be placed against the viscera.
Remove contents from pouch and prepare the OPL on a sterile field. If cutting the OPL to a
different size, ensure that each piece removed has been properly disposed of, away from
the open wound.
Ensure gloves are wet before applying the OPL. Gently position the OPL evenly into the
abdominal cavity, distributing the sides into both of the lateral paracolic gutters. Any
excess material on the sides of the OPL may be folded back onto itself.
Ensure complete coverage of all viscera in the abdominal compartment with the OPL prior
to filling the wound defect with foam.
Negative Pressure Wound Therapy Clinical Guidelines
41
Section 6
Pre-shaped Foam application
Size the foam to the desired proportions by tearing along the pre-scored perforations. The
foam should fit directly over the OPL while maintaining contact with the wound margins.
Foam may be cut if required. Do not cut the foam directly over the wound bed. Always rub
the edges of any cut foam to remove loose fragments.
Do not allow foam to contact intact skin without use of an appropriate barrier such as
Transparent Film or a hydrocolloid. It may be necessary to stack multiple pieces of foam
depending on the wound profile. If multiple pieces of foam are required, count and record
how many pieces are used to ensure all pieces are removed upon bandage changes.
Gently place the perforated foam into the wound cavity over the OPL. Ensure the foam
is sized to fit loosely in the wound defect and does not go below the level of the
abdominal wall.
Transparent Film application
Holding the Transparent Film, expose one side of the adhesive backing by removing a
single panel and apply it to the foam.
Apply film to the foam removing adhesive panels as well as the carrier film to seal.
Cover the foam with Transparent Film. The film should extend at least 5cm beyond the
wound margin to facilitate a good seal.
When using multiple pieces of film ensure the edges overlap by a minimum of 7.5cm. Avoid
stretching or pulling the film to minimize tension or trauma to the periwound skin.
42
RENASYS™ Soft Port application
Cut a hole no smaller than 2cm in the center of the film. Remove any excess trimmed film
and dispose of away from the wound.
Remove the adhesive panel from the Soft Port dressing and align the port opening over the
hole in the Transparent Film. Use gentle pressure to anchor the Soft Port dressing to the
Transparent Film.
Smooth the dressing down while removing the stabilization frame from the Soft
Port dressing.
Initiation of therapy
Ensure the canister is installed correctly and connect the in-line Bacterial Overflow Guard
to the device. To prevent airflow into the device ensure the guard tubing is fully inserted
past the 4th ridge into the device vacuum port. Connect the Soft Port to the canister tubing
by pushing the Quick-Click Connectors together.
Activate the RENASYS EZ Plus device on continuous mode. Set the pressure to 80mmHg to
commence and check the dressing has a good seal.
The finished dressing should collapse and be firm to the touch. If required, adjust the
pressure setting to desired level. The recommended pressure range for temporary
abdominal closure is 80-120mmHg.
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Section
7
7.
Advanced-complex
dressing techniques
Bridging – managing multiple wounds
with the RENASYS™-G Gauze Dressing
Kit or the RENASYS™-F Dressing Kit
and the Soft Port Dressing
Transparent Film
Bridging Technique – this technique is used to
join two wounds that are close in proximity and/
or to position the Soft Port in an area away from
the wound.
Transparent Film
• Apply non-adherent layer to both wounds to cover
fragile tissue and/or as a non-adherent if using
gauze as the filler.
• Protect intact skin in area under bridge and between
the wounds with Transparent Film.
• Cut additional foam or gauze and place on top of
Transparent Film to form the bridge.
• Maximum distance between wounds for bridging is
10 inches (25.4cm). If the distance is greater than 10
inches a Y-Connector should be considered.
• Important: Contact must be made between the
bridge foam/gauze and the foam/gauze filler in
the wound bed (overlap).
• Complete NPWT dressing application technique
for the RENASYS-F Foam or RENASYS-G Gauze
dressings – covering both the wound and bridge
with Transparent Film.
• Initiate negative pressure.
44
Cut hole in Transparent Film 0.25in.
(0.6cm) in diameter and place the
Soft Port dressing
Y-Connector – managing multiple wounds
Y-Connectors are available to connect multiple wounds to a single unit.
• Compatible with RENASYS™-F Foam Dressing and RENASYS-G Gauze Dressing Kits.
• Compatible with RENASYS GO and RENASYS EZ Plus devices.
Y-Connector instruction
• Connect canister tubing to selected RENASYS Canister (if applicable). RENASYS GO
canister tubing is pre-assembled.
• Attach Y-Connector tubing to canister tubing via Quick Click Connector.
• After completing the wound dressings, attach each dressing tubing to the “Y” arms of the
Y-Connector using the Quick Click Connectors.
• Pressure level recommendations are the same as when addressing one wound:
40-120mmHg.
• Do not cut tubings.
• Y-Connectors are sold separately.
• It is recommended to change the Y-Connector a minimum of one time per week. Or, as a
rule, change the Y-Connector with the canister change.
Dressing integrity must be maintained at each dressing site.
• It is not recommended to connect an infected wound (pressure ulcer) to a non-infected
wound (closed incision or graft site) via the Y-Connector.
• Do not connect wounds requiring different pressure settings.
Y-Connector vs. bridging
• Y-Connect when the distance between the two wounds is greater than 10 inches or
25.4cm.
• Bridging should be possible when the distance between the two wounds is less than 10
inches or 25.4cm.
Tips for success
• When utilizing two Soft Ports with Y-Connector, blockages are not detected unless
both Soft Ports are blocked.
• If both wounds must be monitored, consider a bridging technique using a single Soft
Port instead of a Y-Connector
• When treating separate wounds the clinician should regularly check the wound being
treated with the drain or Soft Port to ensure the dressing is compressed
• When utilizing Y-Connector with the Soft Port, consider utilizing RENASYS EZ Plus
pump.
Negative Pressure Wound Therapy Clinical Guidelines
45
Section 7
Undermining and/or tunneling
Undermining
Undermining is a lateral tissue defect or pocket under the edges of the wound. The surface opening is
smaller than the base of the wound.
Ways to address undermined wounds:
• Utilizing saline moistened gauze, fill the undermined areas and any dead space of the wound.
• Once the undermined areas have been filled with moistened AMD gauze, gauze or foam may be used to fill
the remainder of the wound making sure that all areas of the wound are in contact with wound filler.
• Cover with Transparent Film as normal.
Tunneling or sinus tracts
A tunnel or sinus tract is a narrow opening in the wound bed that extends into adjacent tissue.
Ways to address tunnels or sinus tracts
Option 1 –
• Fill tunnels or sinus tract with moistened AMD Gauze, sterile packing strips, or ACTICOAT™ Flex; pulling out/
back 0.5 to 1cm to allow for healing distal to proximal.
• Make sure the tunnel filler material is visible in the wound bed to assure removal upon dressing change.
• Continue with RENASYS™ dressing application technique utilizing AMD Gauze or Foam assuring that all areas of
the wound are in contact with the wound filler.
Option 2 –
• Use channel drain, please see drain accessory.
• Measure tunnel by inserting the channel drain to base of tunnel.
• Pull back on the drain be 0.5-1cm to prevent pressure and allow for healing at distal end of tunnel.
• The portion of the drain in the tunnel/sinus tract is left unwrapped and free of wound filler material.
• Wrap the remainder of the train with saline moistened AMD gauze assuring that the drain hub or drain
junction is in the middle of the wound and at least one layer of moistened AMD gauze is between the drain
and wound bed.
• Fill any dead space or remainder of the wound with additional saline moistened AMD gauze or foam filler.
• Cover with Transparent Film as normal and follow drain accessory kit dressing application.
46
Tips for success
• It is important to note the exudate level of the wound.
• Make sure the drain chosen adequately manages the wound's exudate level.
- The Flat drain handles minimal to heavy drainage.
- The Channel Drain handles scant to moderate drainage, no thick drainage, no
sediment.
• The portion of the drain that goes into the tunnel does not have to be wrapped
with saline moistened gauze.
• It is not necessary to wrap the portion of the drain contained to the wound bed as
long as there is at least one layer of gauze between the drain and the wound bed.
• Make sure the level of the gauze is slightly higher than skin level to ensure the dead
space is filled once the suction collapses the gauze.
• Ensure all dead space is filled with saline moistened gauze and/or packing strips.
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47
Section 7
Skin grafts (Split and full-thickness)/skin substitutes
Treatment goal
• Bolster the graft in place to prevent sheering and ultimate loss of the
graft.
• Eliminate excess moisture that could lead to the graft lifting, preventing
graft take.
Suggested pressure setting and dressing change frequency
• Pressure setting recommendation is 40-120mmHg.
• Ultimately, the pressure setting is a decision to be determined by the
physician/clinician. Generally, lower pressure setting are utilized
(60-80mmHg) for skin grafts and over skin substitutes.
NOTE: It is recommended that you follow the manufacturer’s
guidelines for NPWT use over skin substitutes.
• Initial dressing change at 3-5 days post application depending on
physician/clinician preferences.
• Exudate level should decrease after the first 24-48 hours.
• Duration of therapy is also a physician/clinician decision (generally 3-10
days).
• It is required that NPWT therapy remains on continuously to ensure the
graft remains bolstered at all times.
RENASYS™-F Foam Dressing with Soft Port or RENASYS-G Gauze
Dressing with Soft Port
• Cover the entire graft with a non-adherent layer, such as ACTICOAT™ Flex
3 or ACTICOAT Flex 7. ACTICOAT 3 or ACTICOAT 7 may also be used if
the dressings are fenestrated for application.
• Extend the contact layer at least 1 inch (2.54cm) past the suture/staple
line.
• Cut foam or gauze to the size and shape of the contact layer.
• Place cut foam or gauze on top of the contact layer.
• Cover foam or gauze with Transparent Film and apply Soft Port per
dressing application technique in the instructions for use.
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Circumferential extremity dressing
Application guide to lower limb wound with RENASYS™ Soft Port
Measure the Transparent Film and trim to size if required.
Expose one side of the adhesive backing by removing panel #1.
Gently position the Transparent Film under the patient’s limb.
Wrap the Transparent Film around the limb and remove panel #2 to seal.
Smooth the Transparent Film dressing down.
Remove the top stabilization panel #3 from either the side or the central split.
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49
Section 7
Wrap the opposing Transparent Film around the limb. Remove adhesive panel #2
to seal.
Smooth the Transparent Film dressing down around the limb.
Remove the other top stabilization panel #3 from either the side or central split.
If required use additional Transparent Film to ensure the dressing edges are
adequately sealed.
Apply RENASYS™ Soft Port in desired location avoiding any pressure points. (See
IFU for application of port)
Connect the Soft Port to the canister tubing. Activate the RENASYS device at
desired pressure and commence therapy.
Tips for success
• A leak in this type dressing is easily identified by a tactile coolness at the
site of the leak. Patch leak with Waterproof Tape or Transparent Film to
secure seal.
• Dressing should be comfortable. Remove dressing if any signs of
discomfort are experienced and seek alternative treatment regime.
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8. RENASYS™ accessories
RENASYS Adhesive Gel Patch
The RENASYS Adhesive Gel Patch is designed for use with the existing Smith & Nephew NPWT
dressing kits. RENASYS Adhesive Gel Patch is a sterile, single use dressing. It is intended for
fixation of drainage tubing and is a useful accessory to help improve seals, especially in challenging
anatomical areas or with challenging wound and skin conditions. The Gel Patch is made of an
adhesive hydrogel sheet. This adhesive Gel Patch can be used as a replacement to Ostomy Paste.
The wear time is 72 hours.
Component list; 5 boxes per case
10 gel patches per box – 4in x 2.8in (10cm x 7cm)
Double sided silicone adhesive hydrogel
Application Tips
• The RENASYS Adhesive Gel Patch is intended to be used on intact skin. It is primarily used to
improve seals and avoid leaks.
• Used under the RENASYS Transparent Film, the Gel Patch can be cut and placed around the
periwound area prior to sealing with the RENASYS Transparent Film.
• It may be easier to cut or shape the RENASYS Gel Patch prior to removing the adhesive backing.
• When using gloves, remove one side of the adhesive backing and apply to the skin. Remove the
remaining panel once placed.
• The Gel Patch has absorbent properties, which means it has the ability to absorb reasonable
amounts of fluid. Depending on the wound output and conditions, it is possible to overwhelm the
dressing if enough fluid comes in contact. More frequent dressing changes may be needed as
directed in the Instructions for Use for RENASYS-G Gauze or RENASYS-F Foam Dressing Kits.
• The adhesive is designed to release off the skin with little or no adhesive remaining. If some
adhesive remains utilize Smith & Nephew’s REMOVE™ or another appropriate adhesive remover.
• Use gentile pressure to apply the RENASYS Adhesive Gel Patch to the dressing or skin site.
Negative Pressure Wound Therapy Clinical Guidelines
51
Section 8
RENASYS™ Adhesive Gel Patch application technique
Creating a seal around drain tubing or to lift drain
off skin
Cut the Gel Patch into strips in a direction that allows the backing
removal ends to remain accessible.
Remove the backing on one side only and apply to skin with gentle
pressure.
Remove the remaining backing and apply tubing.
Apply another strip using the same technique over the top of the tubing.
Ensure that the Gel Patch completely surrounds the tubing to create
a seal and remove the backing. Continue with normal dressing
application.
52
Creating a seal in challenging anatomical areas
Cut the Gel Patch into strips in a direction with backing removal ends
accessible.
Remove the backing on one side only and apply to skin with gentle
pressure. Ensure the fold is addressed first.
Remove the backing. Apply Transparent Film over the foam or gauze
interface and the Gel Patch to create a seal and finish the dressing.
Creating a seal around wound margins
Cut Gel Patch into several strips. Remove the backing on one side only
and apply to skin with gentle pressure. Remove the backing.
Continue to apply Gel Strips around wound margins ensuring that the
strips overlap to create a good seal. Continue with normal dressing
application.
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53
Section 8
Creating a seal in challenging areas of the foot
Cut the Gel Patch into strips in a direction with backing removal ends
accessible.
Remove the backing on one side only and apply to skin with gentle
pressure. Remove the backing. Apply Transparent Film over the foam
or gauze interface and the Gel Patch to create a seal and finish the
dressing.
Creating a seal around external fixation pins
Cut Gel Patch into strips and to a length that will cover the pin
circumference. Remove the backing on one side only. Apply the lead
end of the Gel Strip to the base of the pin. Gently apply pressure to the
backing to ensure initial adhesion to the pin. Wrap the Gel Strip around
the pin while simultaneously removing the backing.
Apply Transparent Film over the foam or gauze interface and the Gel
Patch. Pinch the film at the Gel Patch/pin interface to create a seal and
finish the dressing.
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RENASYS™ Drain Accessory Kits
The RENASYS system offers a variety of drains to handle multiple wound types in all care
settings.
RENASYS drains provide a conduit for negative pressure and removal of exudate from the
wound cavity.
RENASYS Drain Accessory Kits are offered to complement the treatment of wounds. In
addition to RENASYS Soft Port, experienced clinicians who wish to enhance the treatment
regime of complex wound shapes and depths, locations, and challenging exudate
conditions can choose from several options.
All drains are silicone and include a radiopaque strip for visualization under X-ray. Utilized
in conjunction with the Soft Port, drains may further improve the removal of exudate from
wounds with the following characteristics:
• Irregular contours
• Challenging anatomical conditions
• Explored fistulae
• Significant wound depth, involving undermining, sinus tracts and tunneling.
The RENASYS-G Dressing Technique with the drains and/or Soft Port is the constant
factor that keeps the dressing change simple and cost effective. The variety of drains will
accommodate any wound size or exudate level and may be used in combination with the
Soft Port based upon clinical judgment, wound characteristics and desired clinical outcome
The RENASYS System allows the physician/clinician the flexibility to choose the
appropriate drain for the specific wound characteristics.
RENASYS 10 Fr Round Drain Accessory Kit
• The 10 French is designed for small, shallow wounds with minimal to no drainage. The
drain is perfect for addressing lightly exuding wounds.
• The drain can be curled inside the wound to increase the suction potential or used in a
linear fashion if curling is not possible.
• The design makes the round drain great for accommodating wounds with undermining.
• The drain is 100% silicone and radiopaque.
Component list; 10 kits per case
1 – RENASYS Y-Connector
1 – 10 Fr round drain
1 – strip paste
2 – strips waterproof tape
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55
Section 8
RENASYS™ 10mm Flat Drain Accessory Kit
• The 10mm Flat Drain is soft and perforated.
• Internal baffles prevent the drain from collapsing.
• The Flat Drain can be used on both deep and shallow wounds with minimal to heavy
drainage.
• The drain is 100% silicone and radiopaque.
Component list; 10 kits per case
1 – RENASYS Y-Connector
1 – flat drain 0.4in (10mm)
1 – strip paste
2 – strips waterproof tape
RENASYS 15 Fr Channel Drain Accessory Kit
• The Channel Drain can be used for wounds with up to moderate drainage.
• It is not designed for thick or sediment laden exudate.
• Its non-hollow, non-perforated design allows for insertion directly into tunnels without
being wrapped with gauze.
• A layer of gauze is recommended between the drain and the wound bed, but is not
necessary within the tunnel.
• The channel drain has four channels that run the length of the drain that perform as gutters
to guide exudate to the suction source.
• The drain is 100% silicone and radiopaque.
• It is important to note that the “hub” or suction source must be contained inside the wound
bed.
• The “hub” is the junction between the drain and the tubing.
Component list; 10 kits per case
1 – RENASYS Y-Connector
1 – 5 Fr. channel drain
1 – strip paste
2 – strips waterproof tape
56
RENASYS™ Y- Connector (included in Drain Accessory Kit and
separately in Kit Accessories)
• Compatible with RENASYS-F Foam Dressing and RENASYS-G Gauze Dressing Kits with
Soft Port
• Compatible with RENASYS EZ Plus and RENASYS GO canister tubing
Component list; 10 kits per case
1 – Y-Connector per kit
Ostomy Strip Paste (included in Drain Accessory Kit)
• Ostomy Strip Paste is utilized to obtain the initial dressing seal and maintain the seal
throughout the duration of the dressing.
• Ostomy Strip Paste prevents the drain from coming into contact with the patient's skin
where the drain exits the wound. This decreases the risk of pressure related breakdown in
this area.
• The Ostomy Paste can also be used to alleviate any skin irregularities that may make
getting a seal difficult (e.g. abdominal skin folds, cleft at the sacrococcygeal region).
• The Ostomy Paste can be used to completely border a wound located in an area that is
difficult to get a seal (e.g. perirectal).
Waterproof Tape (included in Drain Accessory Kit)
• Waterproof Tape has a Zinc based adhesive that ensures proper adherence while
remaining friendly to the patient’s intact skin.
• Waterproof Tape is used to secure the drain to prevent accidental removal from the wound
bed.
• The Chevron technique is utilized with the Waterproof Tape to secure the drain. This
technique was developed by nurses to secure IV tubing.
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57
Section
9
9.
PICO™
Single Use Negative Pressure Wound Therapy System
Description
The PICO Single Use Negative Pressure Wound Therapy System consists of a pump and two
sterile dressing kits. The PICO pump maintains negative pressure wound therapy at 80mmHg
(nominal) +/- 20mmHg to the wound surface. Exudate is managed by the dressing through a
combination of absorption and evaporation of moisture through the outer film. PICO is intended
for use in wound sizes (surface area x depth) up to 400cm3 which are considered to be low to
moderately exuding. The kit is intended to be used for a maximum of 7 days on low exuding
wounds and 6 days on moderately exuding wounds. Therapy duration of the kit may be less than
indicated if clinical practice or other factors such as wound type, wound size, rate or volume of
exudate, orientation of the dressing or environmental conditions, result in more frequent
dressing changes.
Indications for use
PICO is indicated for patients who would benefit from a suction device (negative pressure wound
therapy) as it may promote wound healing via removal of low to moderate levels of exudate and
infectious materials.
Examples of appropriate wound types include:
• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or pressure)
• Flaps and grafts
• Closed surgical incisions
PICO Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital
and homecare setting.
Contraindications
The use of PICO is contraindicated in the presence of:
• Patients with malignancy in the wound bed or margins of the wound (except in palliative care to
enhance quality of life).
• Previously confirmed and untreated osteomyelitis.
• Necrotic tissue with eschar present.
• Exposed arteries, veins, nerves or organs.
• Anastomotic sites.
• Emergency airway aspiration.
• Pleural, mediastinal or chest tube drainage.
• Surgical suction.
58
Warnings
1. Certain patients are at high risk of bleeding complications which, if uncontrolled, could potentially
be fatal. Patients must be closely monitored for bleeding. If sudden or increased bleeding is
observed, immediately discontinue therapy, leave dressing in place, take appropriate measures
to stop bleeding and seek immediate medical assistance.
2. The use of anticoagulants does not deem a patient inappropriate for treatment with PICO™
however hemostasis must be achieved before applying the dressing. Patients suffering from
difficult hemostasis or who are receiving anticoagulant therapy have an increased risk of
bleeding. During therapy, avoid using hemostatic products that, if disrupted, may increase
the risk of bleeding. Frequent assessment must be maintained and considered throughout
the therapy.
3. At all times care should be taken to ensure that the pump and tubing does not:
• Lie in a position where it could cause pressure damage to the patient.
• Trail across the floor where it could present a trip hazard or become contaminated.
• Present a risk of strangulation or a tourniquet to patients.
• Rest on or pass over a source of heat.
• Become twisted or trapped under clothing or bandages so that the negative pressure is
blocked.
4. Sharp edges or bone fragments in a wound must be covered or removed prior to using PICO due
to risk of puncturing organs or blood vessels while under negative pressure.
5. In the event that defibrillation is required, disconnect the pump from the dressing prior to
defibrillation. Remove the dressing if it is positioned in a location that will interfere with
defibrillation.
6. MRI unsafe. PICO is not MRI compatible. Do not take PICO into the MRI suite.
7. PICO has not been studied on pediatric patients. Patient size and weight should be considered
when prescribing this therapy.
8. PICO is unsuitable for use in areas where there is danger of explosion (e.g. hyperbaric oxygen
unit).
Precautions
1. Precautions should be taken in the following types of patients who are at high risk of bleeding
complications:
• Receiving anticoagulant therapy or platelet aggregation inhibitors or actively bleeding.
• Having weakened or friable blood vessels or organs in or around the wound as a result of, but
not limited to; anastomoses, infection, trauma or radiation.
• Suffering from difficult wound hemostasis.
• Untreated for malnutrition.
• Noncompliant or combative.
• Suffering from wounds in close proximity to blood vessels or delicate fascia.
2. PICO dressings should only be applied by a healthcare professional. Dressings are not to be
removed or changed by the patient.
3. Where PICO is used on infected wounds, more frequent dressing changes may be required.
Regular monitoring of the wound should be maintained to check for signs of infection.
4. If deemed clinically appropriate, care should be taken that the application of a circumferential
dressing does not compromise circulation.
Negative Pressure Wound Therapy Clinical Guidelines
59
Section 9
5. PICO™ does not contain audible alarms. The pump should be carried so that it is accessible
and the patient/healthcare professional can check the status routinely.
6. Although PICO can be used under clothing/ bedding, it is important that occlusive
materials e.g. film dressings, are not applied over the pad area of the dressing as this will
impair device performance.
7. Where PICO is used on patients with fragile skin, a skin protectant such as SKIN-PREP™
should be used on areas of skin where fixation strips are to be applied. Inappropriate use
or repeated application of fixation strips may otherwise result in skin stripping.
8. If reddening or sensitization occurs discontinue use and contact the treating healthcare
professional.
9. Do not use PICO with oil-based products such as Petrolatum as it may compromise
establishing an effective seal.
10. The use of negative pressure presents a risk of tissue ingrowth into foam when this is
used as a wound filler. When using foam filler with PICO, tissue ingrowth may be reduced
by using a wound contact layer or by increasing the frequency of dressing changes.
11. PICO may be used in conjunction with surgical drains provided the dressing is not placed
over tubing where it exits the skin. Any surgical drain should be routed under the skin
away from the edge of the dressing and function independently of the PICO Single Use
Negative Pressure Wound Therapy System.
12. When showering the PICO pump should be disconnected from the dressing. Ensure the
end of the tubing attached to the dressing is facing down so that water does not enter the
top of the tube.
13. Do not take the pump apart.
14. The dressing should not be used with any other suction pump.
15. Do not alter or cut tubing configuration or pull on the tubing.
16. Do not cut the dressing as this may lead to loss of NPWT application.
17. Always ensure that the dressing is positioned centrally over the wound. The port should be
positioned uppermost on intact skin and not extend over the wound so that the risk of fluid
collecting around the port and potentially blocking the negative pressure is minimized.
18. CT scans and X-ray have the potential to interfere with some electronic medical devices.
Where possible, move the device out of the X-ray or scanner range. If the device has been
taken into the CT scan or X-ray range, check that it is functioning correctly following the
procedure.
19. This device is single use only. Use of any part of this system on more than one patient may
result in cross contamination that may lead to infection.
20. High temperatures and humidity may reduce wear times of dressings.
21. During transport, there is a potential for radio frequency interference that could affect PICO
performance. If the device malfunctions, replace batteries. If not corrected, contact your
caregiver to replace the device. PICO is not intended for use aboard aircraft, the batteries
should be removed during air travel.
22. The potential for electromagnetic interference in all environments cannot be eliminated.
Use caution if PICO is near electronic equipment such as RFID (Radio Frequency
Identification) readers, anti-theft equipment or metal detectors.
23. Excessive bleeding is a serious risk associated with the application of suction to wounds
which may result in death or serious injury. Careful patient selection, in view of the above
stated contraindications, warnings and precautions is essential. Carefully monitor the
wound and dressing for any evidence of a change in the blood loss status of the patient.
Notify the healthcare professional of any sudden or abrupt changes in the volume or the
color of exudate.
60
Dressing change frequency
1. Dressings should be changed in line with standard wound management guidelines,
typically every 3-4 days. More frequent dressing changes may be required depending
on the level of exudate, condition of the dressing, wound type/size, orientation of the
dressing, environmental considerations or other patient considerations; e.g. when
PICO is used on infected wounds. At the healthcare professional’s discretion a PICO™
dressing may be left in place for up to 7 days.
2. Inspect the dressing regularly. If the dressing appears ready for changing (see
diagrams A-C), press the orange button and disconnect the dressing from the pump.
The fixation strips should be stretched away from the skin and the dressing lifted at
one corner and peeled back until it has been fully removed. Apply another dressing,
connect to the pump and press the orange button to reinitiate the therapy.
A
B
C
(A) Dressing properly positioned and is
acceptable to be left in place
(B) Dressing requires change – Port may
block with fluid
(C) Dressing requires change –
Absorbent area is full
Guidance on wound suitability for management
with PICO
PICO should be used on wounds which fit comfortably within the area of the pad,
observing precautions on port positioning (on intact skin and not extending over
the wound).
As a guide:
Depth – Wounds greater than 0.5cm (1/4in.) in depth are likely to require a foam or
gauze NPWT filler to ensure adequate treatment of all the wound surfaces. Wounds
treated with the larger dressing sizes of the PICO system should generally be no more
than 2cm (4/5in.) in depth.
Exudate – PICO is intended for use on wounds where the level of exudate is low
(nominally 0.6g of liquid exudate/cm2 of wound area/24 hours) to moderate (nominally
1.1g of liquid exudate/cm2 of wound area/24 hours). 1g of exudate is approximately
equal to 1ml of exudate. When used on a moderately exuding wound, the size of the
wound should generally be no more than 25% of the dressing pad area.
Negative Pressure Wound Therapy Clinical Guidelines
61
Section 9
Instructions for use
Application
1. Remove any excess hair to ensure close approximation of the dressing to the wound. If
necessary, irrigate the wound with sterile saline and pat the wound dry.
2. Using a clean technique, peel off the central release handle and place the dressing
centrally over the wound to reduce the chance of wound fluid coming into contact with
the port. The port should be uppermost from the wound (depending on the patient’s
primary position), placed on intact skin and not extend over the wound to prevent fluid
pooling around the port and blocking the negative pressure. Remove the other two
handles and smooth the dressing around the wound to prevent creasing. Reposition if
required to ensure border is not creased.
3. Once the dressing is in place, remove the pump and the batteries from the tray. Insert
the batteries. Replace the cover. Following this all three lights should flash once (refer to
Appendix VI – PICO™ IFU, table 1 on page 72).
4. Join the pump to the dressing by twisting together the tubing connectors. Press the
orange button to start the application of negative pressure. The green light will start to
flash indicating the system is working properly.
Depending on the size of the wound, the pump should take up to 30 seconds to establish
negative pressure wound therapy.
If after 30 seconds the system has not established negative pressure wound therapy,
the amber air leak light will illuminate. To troubleshoot refer to section (ii) of Appendix VI –
PICO IFU, table 1 on page 72.
5. If using SKIN-PREP™ prior to application of the fixation strips (see Precautions), wipe the
area surrounding the dressing and allow skin to dry.
6. Apply the fixation strips to each of the four sides of the dressing. Remove top carrier on
the strip after each one has been applied. These strips maintain the seal over the wear
time of the dressing. In awkward areas, it may be useful to apply the strips to help achieve
a seal prior to switching on the pump. Place each strip so that it overlaps the dressing
border by approximately 1cm (2/5in.). Ensure tubing is not twisted or trapped between
clothing.
Please note that if at any time the fixation strips are removed, the dressing should also
be replaced.
62
Use with fillers and wound contact layers
PICO™ is compatible with standard gauze and foam fillers used in traditional NPWT where this is
clinically appropriate – for example on a defect wound. When a filler is used, the filler and the PICO
dressing should be changed 2 to 3 times a week, according to local clinical protocol and manufacturer’s
instructions. Gauze should loosely fill to the surface of the wound. Avoid over packing.
PICO may be used over the top of a non-adherent layer if required, for example over a skin graft. On
infected wounds or wounds at risk of infection. ACTICOAT™ Flex Silver-coated Antimicrobial Dressings
may be used under PICO.
General use
Showering and bathing
Light showering is permissible; however, the pump should be disconnected (see Precautions) and placed
in a safe location where it will not get wet. The dressing should not be exposed to a direct spray or
submerged in water. Ensure the end of the tubing attached to the dressing is facing down so that water
does not enter the top of the tube.
Cleaning
Adherence to clinical directives concerning hygiene is of prime importance. The pump may be wiped
clean with a damp cloth using soapy water or a weak disinfectant solution.
Negative Pressure Wound Therapy Clinical Guidelines
63
Section
10
10.
Clinical
Hotline
For clinical support regarding Smith & Nephew NPWT
devices call 1-800-876-1261.
A Clinical Hotline is available to assist patients and healthcare
providers with any questions related to Smith & Nephew's NPWT
System. This includes generalized questions from the dressing
techniques to troubleshooting an alarm situation.
The Hotline is available 24 hours a day, 7 days a week.
Or visit www.myrenasys.com or www.possiblewithpico.com.
64
11. Appendix
Appendix I
RENASYS GO NPWT System
Negative Pressure Wound
Therapy product portfolio
RENASYS GO device
Smith & Nephew prides itself in delivering an innovative
and comprehensive NPWT product portfolio that
offers flexibility and clinical excellence. Our extensive
selection of pumps, canisters, kits and accessories
are each conformably designed to meet the unique
complexities of your patients’ wounds. The RENASYS™
NPWT System helps improve the overall patient
experience by promoting wound healing throughout the
entire continuum of care.
Component list
Pump
Power cord
Quick reference guide
Strap
RENASYS EZ Plus NPWT System
•
•
•
•
Product code
RENASYS GO
Smith & Nephew
66800164
Acute Care (UHS)
ZNG
Home Care (Apria)
M040511
RENASYS GO canisters
RENASYS GO Large Canister (750mL)
Component list; 5 per case
• Sealed canister
• Solidifier
750mL with solidifier:
Smith & Nephew
66800916
Acute Care (UHS)
2012250
• Canister tubing
RENASYS EZ Plus device
Product description
Product code
RENASYS EZ Plus
Smith & Nephew
66800697
Component list
Pump
Canister holder kit
Power cord
Quick reference guide
•
•
•
•
Product description
Acute Care (UHS)
ZNP
Home Care (Apria)
M046689
RENASYS GO
Canister (300mL)
•
•
•
•
Component list; 5 per case
Sealed canister
Solidifier
Overflow guard with silicone tubing
Canister tubing
300mL with solidifier:
Smith & Nephew
66800914
Acute Care (UHS)
2012000
Home Care (Apria)
M047406
RENASYS GO accessories
RENASYS EZ Plus canisters
800mL S-Canister
•
•
•
•
Component list; 10 kits per case
Sealed canister
With or without solidifier
Overflow guard with silicone tubing
Canister tubing
250mL S-Canister
•
•
•
•
Component list;
10 kits per case
Sealed canister
Solidifier
Overflow guard with silicone tubing
Canister tubing
800mL with solidifier:
Smith & Nephew
66800912
Acute Care (UHS)
2012025
Home Care (Apria)
M047411
Acute Care (UHS)
TBD
250mL with solidifier:
Smith & Nephew
66800913
RENASYS EZ Plus accessories
(accommodates all canister sizes)
1 per case
RENASYS EZ Power Cord
Hospital Grade
1 per case
Smith & Nephew
66800161
1 per case
Home Care (Apria)
R037398
RENASYS GO
Carrying Case
Smith & Nephew
66800162
1 per case
800mL without solidifier:
Smith & Nephew
66801066
Acute Care (UHS)
2012225
RENASYS EZ Plus
Canister Holder Kit
RENASYS GO
Power Supply
External Cord
Acute Care (UHS)
1901102
Acute Care (UHS)
2009525
Home Care (Apria)
R037471
RENASYS GO
Carrying Straps
Component list; 1 per case
• Straps include fix-lock
buckles, shoulder pad
and strap extender
Smith & Nephew
66800163
Acute Care (UHS)
2009550
Home Care (Apria)
R037472
PICO™ Single Use NPWT System
Smith & Nephew
66800060
PICO device
Acute Care (UHS)
2009475
Product description
Product code
Dressing size 4in x 8in
(10cm x 20cm) 3 kits/case
Smith & Nephew
66800862
Dressing size 4in x 12in
(10cm x 30cm) 3 kits/case
Smith & Nephew
66800863
Smith & Nephew
66800193
Acute Care (UHS)
2008025
Negative Pressure Wound Therapy Clinical Guidelines
65
Section 11
Product description
Product code
Dressing size 6in x 6in
(15cm x 15cm) 3 kits/case
Smith & Nephew
66800865
Dressing size 6in x 8in
(15cm x 20cm) 3 kits/case
Smith & Nephew
66800866
Carry Bag 1/each
Smith & Nephew
66800918
Product description
RENASYS-G
•
•
•
•
Gauze Dressing Kit Sterile with Soft Port
Component list; 5 kits per case
1- Soft Port – length 27in (69cm)
applicator head 6in x 4in (15cm x 10cm)
1- AMD gauze dressing 6in x 6.7in (15cm x 17cm)
1 - AMD gauze roll 4.5in x 4.1yd (11cm x 4m)
3 - RENASYS Transparent Films 8in x 12in (20cm x 30cm)
RENASYS High Output Dressing Kit
Gauze
Product description
Product code
RENASYS™-G
Smith & Nephew
66800933
Gauze Dressing Kit with Soft Port – Small
Component list; 5 kits per case
1 - saline bullet 30mL
1 - wound ruler
1 - sachet of NO-STING SKIN-PREP™
1 - Soft Port – length 27in (69cm)
applicator head 6in x 4in (15cm x 10cm)
• 1 - AMD gauze dressing 6in x 6.7in (15cm X 17cm)
• 1 - RENASYS Transparent Films 8in x 12in (20cm x 30cm)
• 1 - non-adherent gauze 3in x 8in (8cm x 30cm)
•
•
•
•
Acute Care (UHS)
2012275
Home Care (Apria)
M047408
•
•
•
•
•
•
•
•
•
Component list; 10 kits per case
2 - 30mL saline bullets
4 - strips waterproof tape
1 - strip paste
1 - wound ruler
2 - sachets of NO-STING SKIN-PREP
1 - 28 Fr round aspiration/irrigation drain 3ft (92cm)
2 - non-adherent gauze 3in x 8in (8cm x 20cm)
2 - AMD gauze rolls 4.5in x 4.1yd (11cm x 4m)
3 - RENASYS Transparent Films 8in x 12in (20cm x 30cm)
•
•
•
•
•
•
•
RENASYS-G
Smith & Nephew
66800934
Component list; 5 kits per case
1 - saline bullet 30mL
1 - wound ruler
1 - sachet of NO-STING SKIN-PREP
1 - Soft Port – length 27in (69cm)
applicator head 6in x 4in (15cm x 10cm)
2 - AMD gauze dressings 6in x 6.7in (15cm x 17cm)
1 - RENASYS Transparent Film 8in x 12in (20cm x 30cm)
1 - non-adherent gauze 3in x 8in (8cm x 30cm)
Acute Care (UHS)
2002225
RENASYS-G
Smith & Nephew
66800935
Gauze Dressing Kit with Soft Port – Large
Component list; 5 kits per case
1 - saline bullet 30mL
1 - wound ruler
1 - sachet of NO-STING SKIN-PREP
1 - Soft Port – length 27in (69cm)
applicator head 6in x 4in (15cm x 10cm)
• 1 - AMD gauze roll 4.5in x 4.1yd (11cm x 4m)
• 2 - RENASYS Transparent Films 8in x 12in (20cm x 30cm)
• 2 - non-adherent gauze 3in x 8in (8cm x 30cm)
•
•
•
•
RENASYS-G
Gauze Dressing Kit with Soft Port – X-Large
Component list; 5 kits per case
• 2- saline bullets 30mL
• 1 - wound ruler
• 1 - Soft Port – length 27in (69cm)
applicator head 6in x 4in (15cm x 10cm)
• 2 - sachets of NO-STING SKIN-PREP
• 4 - non-adherent gauze 3in x 8in (8cm x 20cm)
• 2 - AMD gauze rolls 4.5in x 4.1yd (11cm x 4m)
• 3 - RENASYS Transparent Films 8in x 12in (20cm x 30cm)
66
Smith & Nephew
66800961
Acute Care (UHS)
2012325
Smith & Nephew
66800932
Acute Care (UHS)
2011100
Home Care (Apria)
TBD
Foam
Product description
Product code
RENASYS-F
Smith & Nephew
66800794
Foam Dressing Kit with Soft Port – Small
Gauze Dressing Kit with Soft Port – Medium
Product code
Home Care (Apria)
M047409
Component list; 5 kits per case
• 1 - Soft Port – length 27in (69cm)
applicator head 6in x 4in (15cm x 10cm)
• 1 - foam block 4in x 3in x 1in (10cm x 8cm x 3cm)
• 1 - RENASYS Transparent Film 8in x 12in (20cm x 30cm)
RENASYS-F
Foam Dressing Kit with Soft Port – Medium
Component list; 5 kits per case
• 1 - Soft Port – length 27in (69cm)
applicator head 6in x 4in (15cm x 10cm)
• 1 - foam block 8in x 5in x 1in (20cm x 13cm x 3cm)
• 2 - RENASYS Transparent Films 8in x 12in (20cm x 30cm)
Acute Care (UHS)
2002200
Home Care (Apria)
M047410
RENASYS-F
Foam Dressing Kit with Soft Port – Large
Component list; 5 kits per case
• 1 - Soft Port – length 27in (69cm)
applicator head 6in x 4in (15cm x 10cm)
• 1 - foam block 10in x 6in x 1in (25cm x 15cm x 3cm)
• 3 - RENASYS Transparent Films 8in x 12in (20cm x 30cm)
RENASYS-F
Foam Dressing Kit with Soft Port – X-Large
Smith & Nephew
66800936
Acute Care (UHS)
2012300
Component list; 5 kits per case
• 1 - Soft Port – length 27in (69cm)
applicator head 6in x 4in (15cm x 10cm)
• 1 - foam block 20in x 25in x 0.6in (50cm x 63cm x 1.5cm)
• 6 - RENASYS Transparent Films 8in x 12in (20cm x 30cm)
Acute Care (UHS)
2012050
Home Care (Apria)
M047414
Smith & Nephew
66800795
Acute Care (UHS)
2012075
Home Care (Apria)
M047415
Smith & Nephew
66800796
Acute Care (UHS)
2012100
Home Care (Apria)
M047407
Smith & Nephew
66800797
Acute Care (UHS)
2012125
RENASYS AB
Smith & Nephew
66800980
Component list; 5 kits per case
Acute Care (UHS)
2012150
Abdominal Dressing Kit with Soft Port
• 1 - Soft Port – length 27in (69cm)
applicator head 6in x 4in (15cm x 10cm)
• 2 - foam blocks 17in x 12in x 1in (43cm x 30cm x 3cm)
• 6 - RENASYS Transparent Films 8in x 12in (20cm x 30cm)
• 1 - organ protection layer 35in x 26in (89cm x 66cm)
Kit accessories
Product description
Product code
Product description
Product code
NPWT Antimicrobial Large Gauze Roll
Smith & Nephew
66800391
RENASYS Adhesive gel patch
Smith & Nephew
66801082
Component list; 10 kits per case
• 5 - rolls of gauze
individually packaged
per kit
RENASYS™ Transparent Film
Component list; 10 kits per case
• 10 - Transparent Films per kit
8in x 12in (20cm x 30cm)
Acute Care (UHS)
2007700
Home Care (Apria)
M039970
Component list; 5 boxes per case
• 10 gel patches per box
4in x 2.8in (10cm x 7cm)
• Double sided silicon adhesive hydrogel
Acute Care (UHS)
TBD
Home Care (Apria)
TBD
Smith & Nephew
66800394
Acute Care (UHS)
2007775
Home Care (Apria)
M040105
RENASYS Transparent Film X-Large
Component list; 10 kits per case
• 5 - Transparent Films per kit
16in x 25in (40cm x 60cm)
RENASYS Y-Connector
Component list; 10 kits per case
• 1 - Y-Connector per kit
Smith & Nephew
66800853
Acute Care (UHS)
2012200
Smith & Nephew
66800971
Acute Care (UHS)
2002250
Home Care (Apria)
M047412
RENASYS Soft Port Stand-Alone Kit
Component list; 5 kits per case
• 1 - Soft Port per kit
Length 27in (69cm)
applicator head 6in x 4in
(15cm x 10cm)
RENASYS 10 Fr Round Drain Accessory Kit
•
•
•
•
Component list; 10 kits per case
1- RENASYS Y-Connector
1- 10 Fr round drain
1- strip paste
2-strips waterproof tape
RENASYS 10mm Flat Drain Accessory Kit
•
•
•
•
Component list; 10 kits per case
1- RENASYS Y-Connector
1- flat drain 0.4in (10mm)
1- strip paste
2-strips waterproof tape
RENASYS 15 Fr Channel Drain Accessory Kit
•
•
•
•
Component list; 10 kits per case
1- RENASYS Y-Connector
1- 15 Fr. channel drain
1- strip paste
2-strips waterproof tape
Smith & Nephew
66800799
Acute Care (UHS)
2012350
Smith & Nephew
66800972
Acute Care (UHS)
2012375
Smith & Nephew
66800973
Acute Care (UHS)
2012400
Smith & Nephew
66800974
Acute Care (UHS)
2012425
Negative Pressure Wound Therapy Clinical Guidelines
67
Section 11
EN
Appendix II
RENASYS™
Foam and Gauze Dressing Kits with Soft Port
Negative Pressure Wound Therapy
Keep dry
Examples of appropriate wound types include:
gChronic
gAcute
gTraumatic
gSub-Acute and dehisced wounds
gUlcers (such as pressure or diabetic)
gPartial-thickness burns
gFlaps and grafts
CONTRAINDICATIONS
The use of NPWT is contraindicated for:
gUntreated osteomyelitis
gExposed arteries, veins, organs or nerves
gNecrotic tissue with eschar present
gMalignancy in the wound (with exception of palliative care to
enhance quality of life)
gNon-enteric and unexplored fistulas
gAnastomotic sites
WARNINGS
1. Carefully monitor patients for signs of sudden or increased bleeding. If such symptoms are observed, immediately discontinue
therapy, take appropriate measures to control the bleeding, and
contact the treating clinician.
2. Patients suffering from difficult hemostasis or who are receiving
anticoagulant therapy have an increased risk of bleeding. During
therapy, avoid using hemostatic products that, if disrupted, may
increase the risk of bleeding.
3. Do not use on exposed blood vessels or organs. Sharp edges
such as bone fragments must be covered or removed prior to initiating therapy, due to risk of puncturing organs or blood vessels drawn
closer under the action of negative pressure.
4. Foam or gauze must not be tightly packed or forced into any
wound area.
5. In the event defibrillation is required, disconnect the device from
the wound dressing prior to defibrillation. Remove the wound dressing only if its location will interfere with defibrillation.
6. RENASYS devices are not MRI compatible. Do not bring the
RENASYS device into the MRI suite.
7. When operating, transporting, repairing or disposing of
RENASYS devices and accessories, the risk of infectious liquids
being aspirated, or contamination of the device assembly through
incorrect use, cannot be eliminated. Universal precautions should
be observed whenever working with potentially contaminated parts
or equipment.
8. NPWT has not been studied on pediatric patients. Patient size
and weight should be considered when prescribing RENASYS
devices.
9. RENASYS devices are unsuitable for use in areas where there is
danger of explosion (e.g., hyperbaric oxygen unit, or in the presence
of a flammable anesthetic mixture with air or nitrous oxide). Disconnect the device from the dressing prior to entering an area where
this equipment will be used.
10. Canister kits are provided non-sterile and should not be placed
within a sterile field.
PRECAUTIONS
NOTE: Full device operation is found in the User Guide for each
RENASYS device.
1. Precautions should be taken for patients who are or may be:
gReceiving anticoagulant therapy or platelet aggregation inhibitors.
gActively bleeding or have friable blood vessels or organs.
gSuffering from abnormal wound hemostasis.
gUntreated for malnutrition.
gNoncompliant or combative.
gSuffering from wounds in close proximity to blood vessels or friable fascia.
2. CT scans and x-ray have the potential to interfere with some
electronic medical devices. Where possible, move the device out of
the x-ray or scanner range. If the device has been taken into the CT
scan or x-ray range, check that it is functioning correctly following
the procedure.
3. As a condition of use, the RENASYS device should only be used
by qualified and authorized personnel. The user must have the
necessary knowledge of the specific medical application for which
NPWT is being used.
4. If the RENASYS device has been at temperatures below freezing,
the device must be brought to room temperature prior to use or the
pump unit may be damaged.
5. Inspect the bacterial overflow guard on the canister and replace
the canister as necessary. At minimum, the canister should be
changed weekly. Always use the smallest canister volume possible
– do not use a large canister on patients with a high risk of bleeding.
6. If any liquids penetrate the RENASYS device, discontinue use and
return to your authorized provider for service.
7. Do not use a dressing kit with breached or damaged packaging.
8. The use of NPWT presents a risk of tissue in-growth. Tissue
in-growth may be reduced by reducing therapy pressure, using
a wound contact layer or by increasing the frequency of dressing
changes.
9. Underlying structures, such as tendons, ligaments and nerves
should be covered with natural tissue or a non-adherent dressing
layer prior to applying the NPWT dressing kit.
10. If multiple pieces of foam or gauze are needed to fill the wound
profile, count and record how many pieces are present to ensure all
the pieces are removed at a dressing change.
11. Infected wounds may require more frequent dressing changes.
Regular monitoring of the wound should be maintained to check for
signs of infection.
12. NPWT should remain on for the duration of the treatment. If the
patient must be disconnected, the ends of the tubing should be
protected using the tethered cap. The length of time a patient may
be disconnected from the RENASYS device is a clinical decision
based on individual characteristics of the patient and the wound.
Factors to consider include the location of the wound, the volume
of drainage, the integrity of the dressing seal, the assessment of
bacterial burden and the patient’s risk of infection.
13. Ensure that tubing and Soft Port is installed completely and without any kinks to avoid leaks or blockages in the vacuum circuit. Position the RENASYS device and tubing appropriately to avoid the risks
of causing a trip hazard. Wherever possible, the device and system
tubing should be positioned level with or below the wound.
14. When bathing or showering, the patient must disconnect from
the RENASYS device and should protect both ends of the tubing
using the tethered cap. Ensure that the aeration disc, located near
the quick click connector, is free of excess moisture before reactivation of therapy.
15. NPWT should not be painful. If the patient reports discomfort,
consider reducing the pressure.
16. Maintain regular monitoring of the RENASYS device and wound
site during therapy to ensure therapeutic treatment and patient
comfort.
17. As with all adhesive products apply and remove the dressing
carefully from sensitive or fragile skin to avoid skin stripping, especially after frequent dressing changes.
PRECAUTIONS SPECIFIC TO FOAM
1. Foam should be cut to fit loosely into wound bed. Never force or
tightly pack foam into any areas of the wound, to avoid damaging
underlying tissue.
2. Never place foam into blind or unexplored tunnels. If a tunnel
of known depth presents, cut the foam longer than the tunnel, to
ensure direct contact is made with the foam in the primary wound
cavity.
3. Do not cut the foam directly over the wound cavity to avoid foam
fragments from falling into the wound. Rub the edges of the foam,
away from the open wound, to remove loose fragments after cutting.
CLEAN AND DEBRIDE
Use clean or aseptic techniques for application, according to your
institutional protocol. Thorough wound cleansing should occur with
each dressing change.
1. Cover intact skin with transparent film wherever bridge will be
placed.
INITIATE THERAPY
1. Debride any devitalized or necrotic eschar
tissue. Cleanse the wound bed and pat dry.
2. Layer additional foam or gauze on top of the wound filler and any
film intended to support bridging materials. Ensure contact with the
filler in the wound cavity is made.
3. Proceed to “SEAL THE WOUND”
SEAL THE WOUND
2. If desired, protect periwound skin from
exposure to moisture and adhesive through the
use of a skin sealant.
1. While holding the transparent film, expose
one side of the adhesive backing by removing
a single panel, and apply over the wound.
2. Cover wound filler with transparent film,
removing remaining adhesive panels to seal,
then the top stabilization panel.
3. If desired, a non-adherent dressing may be
applied. Trim a single layer of non-adherent
gauze and lay across wound bed.
Note: Skin sealant and wound contact layer is not included as part
of RENASYS-F or RENASYS-G Sterile Kit.
Note: Avoid stretching or pulling the transparent film to minimize
tension or trauma to the periwound skin.
Recommendations:
DRESS WOUND WITH FOAM OR GAUZE
Review Precautions Specific To Foam before continuing. It is
critical that foam is not forced into any wound, or placed within an
unexplored tunnel.
äß<F
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gBEFLAHNE=>QM>G=:ME>:LMä<F;>RHG=
wound margin and be securely anchored to
periwound area to maintain a good seal.
g(O>KE:IMA>>=@>LH?MA>MK:GLI:K>GM?BEF;R:FBGBFNFH?æä<F
4. Foam: Cut the foam dressing to fit the size
when using multiple pieces of transparent film.
and shape of the wound and place the cut
foam into the wound. Avoid over packing. Foam
should completely fill the wound cavity. It may APPLY RENASYS SOFT PORT:
be necessary to stack pieces of foam in deep
1. Cut a small opening (no less than 2cm)
wounds.
in the center of the film, over the wound
4. Gauze: Apply a layer of saline-moistened
gáß<F
filler. Remove any loose transparent film and
antimicrobial gauze to wound bed (saline
dispose of away from the wound.
not included in RENASYS-G Sterile OR Kit).
2. Remove the adhesive panel
Continue to apply in layers, until the gauze
from the Soft Port dressing, and
loosely fills the entire wound cavity. Avoid over
align the port opening directly over
packing the wound.
the hole in the transparent film.
Precaution: If multiple pieces of wound filler are needed to fill the
Use gentle pressure to anchor the Soft Port to the transparent film.
wound cavity, count and record how many pieces are present to
3. Smooth the dressing down while removing
ensure all wound filler pieces are removed at a dressing change.
the Soft Port’s top stabilization frame.
BRIDGING AWAY FROM WOUND
Under normal circumstances using Soft Port, it should not be
necessary to bridge away from wounds. If this is the case proceed
to “SEAL THE WOUND.” If there is still concern that the Soft Port
may create pressure at the wound, due to the wound’s location and
conditions, or if the wound is smaller than the Soft Port opening
(1.5 cm), utilize the bridge technique. This technique will allow the
Soft Port to be redirected to a non-weight bearing area.
68
Do not reuse
INDICATIONS FOR USE
The RENASYS-F foam dressing kits and the RENASYS-G gauze
dressing kits with Soft Port are intended to be used in conjunction
with Smith & Nephew Negative Pressure Wound Therapy (NPWT)
Systems. The Smith & Nephew RENASYS NPWT System is indicated
for patients who would benefit from a suction device (negative
pressure wound therapy) as it may promote wound healing via
the removal of fluids including irrigation and body fluids, wound
exudates and infectious materials.
4. Secure the Soft Port to the patient
according to your institutional protocol. Ensure
the aeration disc, located near the quick
click connector, is not covered or otherwise
occluded by the method used to secure the
Soft Port.
1. Connect the RENASYS Soft Port to the canister tubing by pushing
the quick click connectors together. An audible click indicates the
connection is secure.
2. Activate the RENASYS device and adjust to the prescribed
therapy level. The recommended therapeutic pressure range is
40 – 120 mmHg.
gThe vacuum level is a decision each healthcare provider must
make, based on an individual assessment of the particular
wound.
gLower levels of vacuum are generally effective and more tolerable.
gThe vacuum level should never be painful. If the patient reports
discomfort with the vacuum level, it can be reduced.
3. Finished dressings should be firm to the touch and leak-free.
DRESSING CHANGES
1.H:F=K>LLBG@LLAHNE=;><A:G@>=>O>KRãçMHæáAHNKL:?M>KMA>
initial application of therapy. If no leak is present and the patient is
comfortable, dressing changes should occur no less than 3 times
per week.
2. Gauze dressings should be changed 48 hours after the initial
application of therapy. If no leak is present and the patient is
comfortable, dressing changes should occur 2-3 times per week.
3. In the event of heavy drainage or drainage with sediment, more
frequent dressing changes may be needed.
4. Ensure all wound filler material placed in the wound has been
removed before redressing the wound. If foam dressing adheres
to the wound, apply normal saline into the wound dressing and
let it set for 15-30 minutes before gently removing the foam.
Appropriately discard used wound dressings observing your
institution’s protocol for medical waste handling.
5. As with all adhesive products apply and remove the dressing
carefully from sensitive or fragile skin to avoid skin stripping,
especially after frequent dressing changes.
6. Check the dressing regularly. Throughout treatment, monitor the
patient for any signs of local or systemic infection. Infected wounds
may require more frequent dressing changes. If there are any signs
of systemic infection or advancing infection at the wounded area,
contact the treating clinician immediately.
7. If the RENASYS device reports a blockage alarm, inspect the
dressing and canister tubing for any blockages which may be
manually remedied. If a blockage cannot be identified or resolved,
replace the device canister first, and then replace the dressing and
Soft Port as necessary.
EN
H:FLAHNE=G>O>K;>IE:<>=BG<HGM:<MPBMA>QIHL>=
bowel, arteries, veins, organs, or nerves.
Utilize the OPL at all times when using the RENASYS AB
with the RENASYS NPWT System.
WARNINGS
g!>FHLM:LBLFNLM;>:<AB>O>=IKBHKMH=K>LLBG@:IIEB<:
tion. Carefully monitor patients undergoing treatment with
+',2,?HKLB@GLH?LN==>GHKBG<K>:L>=;E>>=BG@"?
such symptoms are observed, immediately discontinue
therapy, take appropriate measures to control the bleed
ing, and contact the treating clinician. Precautions should
be taken for patients who are, or may be:
– Receiving anticoagulant therapy or platelet aggregation
inhibitors.
– Actively bleeding or have friable blood vessels or organs.
– Suffering from abnormal wound hemostasis.
– Untreated for malnutrition.
– Noncompliant or combative.
– Suffering from wounds in close proximity to blood ves
sels or friable fascia.
gSharp edges such as bone fragments must be covered
or removed prior to initiating therapy, due to risk of punc
turing organs or blood vessels drawn closer under the
action of negative pressure.
gH:FFNLMGHM;>MB@AMERI:<D>=HK?HK<>=BGMH:GR
PHNG=:K>:H:FFNLMHGER;>IE:<>=BGMA>PHNG=
defect once the OPL has been placed.
g"GMA>>O>GM=>?B;KBEE:MBHGBLK>JNBK>==BL<HGG><MMA>
device from the wound dressing prior to defibrillation.
Remove the wound dressing only if its location will inter
fere with defibrillation.
g+',2,3:G=+',2,3)%.,=>OB<>L:K>GHM&+"
<HFI:MB;E>HGHM;KBG@MA>=>OB<>BGMHMA>&+"LNBM>
gWhen operating, transporting, repairing or disposing of
RENASYS devices and accessories, the risk of infectious
liquids being aspirated, or contamination of the device
assembly through incorrect use, cannot be eliminated.
Universal precautions should be observed whenever
working with potentially contaminated parts or equipment.
g+',2,3:G=+',2,3)%.,=>OB<>L:G=
RENASYS AB have not been studied on pediatric patients.
Patient size and weight should be taken into account
when prescribing this device.
gRENASYS devices are unsuitable for use in areas where
there is danger of explosion (e.g., hyperbaric oxygen unit,
or in the presence of a flammable anesthetic mixture
with air or nitrous oxide). Disconnect the device from the
dressing prior to entering an area where this equipment
will be used.
g+',2,=>OB<>L:G=<:GBLM>KDBML:K>IKHOB=>=GHG
sterile and should not be used in a sterile field.
PRECAUTIONS SPECIFIC TO RENASYS AB
NOTE: Ensure aseptic technique is used during the appli
cation of all components of RENASYS AB. Ensure the abdo
men and its contents are adequately visualized, controlled
and protected throughout application of the dressing.
g&>=B<:EBGM>KO>GMBHGPBMA+',2,LAHNE=HGER
be undertaken as part of a holistic medical manage
ment strategy, with the goal of reducing the patient’s
BGMK::;=HFBG:EIK>LLNK>MHGHFBG:EE>O>EL:<MHKLMH
<HGLB=>KLAHNE=BG<EN=>MA>>MBHEH@RH?MA>I:MB>GMdLBGMK:
:;=HFBG:EARI>KM>GLBHG"!HK;=HFBG:EHFI:KMF>GM
Syndrome (ACS), as well as other factors (including the
patient’s size, weight, and unique clinical situation).
gK>JN>GMLM:G=:K=BS>=F>:LNK>F>GMLH?BGMK::;=HF
BG:EIK>LLNK>"):G=HK:;=HFBG:EI>K?NLBHGIK>LLNK>
(APP) are recommended before, during and after treat
ment with RENASYS AB, as a means of guiding clinical
decisions concerning management of the open abdomen.
g+',2,BLGHMBGM>G=>=MHIKHOB=>IKBF:KRMK>:M
ment for infection in the open abdomen. RENASYS AB
may, however, be used on septic open abdomens, which
are being managed in accordance with institutional clinical
protocols for infection abatement, as an adjunct to the
*smith&nephew
PRECAUTIONS
NOTE:NEE=>OB<>HI>K:MBHGBL?HNG=BGMA>.L>K NB=>?HK
RENASYS EZ and RENASYS EZ PLUS.
g0ABE>NLBG@+',2,MA>K:IRLAHNE=K>F:BGHGBG
MA>('-"'.(.,FH=>?HKMA>=NK:MBHGH?MA>MK>:MF>GM
"?MA>I:MB>GMFNLM;>=BL<HGG><M>=?KHFMA>=>OB<>
protect the tube ends by inserting the tethered caps of
MA>JNB<D<EB<D<HGG><MHKBFF>=B:M>ER;>?HK>MNKGBG@H??
the device.
g-L<:GL:G=QK:RA:O>MA>IHM>GMB:EMHBGM>K?>K>PBMA
some electronic medical devices. Where possible, move
MA>=>OB<>HNMH?MA>QK:RHKL<:GG>KK:G@>"?MA>=>OB<>
A:L;>>GM:D>GBGMHMA>-L<:GHKQK:RK:G@><A><DMA:M
it is functioning correctly following the procedure.
g0A>K>O>KIHLLB;E>MA>=>OB<>:G=LRLM>FMN;BG@LAHNE=
be positioned level with or below the wound.
gThe length of time a patient may be disconnected from
RENASYS EZ or RENASYS EZ PLUS device is a clinical deci
sion based on individual characteristics of the patient and
MA>PHNG=:<MHKLMH<HGLB=>KBG<EN=>MA>OHENF>H?=K:BG
age, integrity of the dressing seal, assessment of bacterial
burden in the wound, and patient’s risk of infection.
gL:<HG=BMBHGH?NL>+',2,PBMAMA>+',2,
NPWT system must only be applied and operated by
qualified and authorized personnel. The user must have
the necessary knowledge of the specific medical applica
tion for which RENASYS AB is indicated.
gNKBG@MA>K:IRF:BGM:BGK>@NE:KFHGBMHKBG@H?MA>
device and tubing, from wound site to canister, to ensure
therapeutic benefit and patient comfort.
g)HLBMBHGMA>=>OB<>:G=MN;BG@:IIKHIKB:M>ERMH:OHB=MA>
risks of causing a trip hazard and of the patient lying on
the tubing.
gA><DMA>HO>K?EHPIKHM><MBHG;:<M>KB:?BEM>KHGMA><:G
BLM>K:G=K>IE:<>MA><:GBLM>K:LG><>LL:KR&BGBF:EER:
weekly canister change is recommended. Always use the
smallest practical canister size, based on the patient’s size
and weight, to avoid risk of significant and or unintended
fluid and blood loss.
g-A>EHP>LMK><HFF>G=>=MA>K:IRIK>LLNK>?HKNLBG@
RENASYS AB with the RENASYS EZ or RENASYS EZ PLUS
=>OB<>BLçßFF!@
g"?:GREBJNB=LI>G>MK:M>MA>INFI=BL<HGMBGN>NL>:G=
return to your authorized provider for service.
gHGHMNL>B?I:<D:@BG@BLHI>G>=HK=:F:@>="GMA>
event packaging is breached, please contact Smith &
Nephew customer service.
g0ABE>NLBG@+',2,:IIER.GBO>KL:E)K><:NMBHGL
according to your institution’s protocols, to minimize the
KBLDH?<HGM:<MPBMA:GR;EHH=;HKG>I:MAH@>GL&>:LNK>L
may include use of sterile gowns and eye protection with
severely contaminated wounds.
standard treatment regimen, and/or to provide a barrier to
bacterial penetration.
g.L>H?MA>()%BLG><>LL:KRMHIKHM><M>QIHL>=;HP>E
from the abdominal wall. Preventing adhesions or obstruc
tions that may otherwise form during open abdominal
wound management is a critical parameter in achieving
timely primary facial closure and reducing the chance of
fistula development. The OPL must completely cover all
exposed viscera, prior to application of wound filler and
subsequent activation of the NPWT system.
g.L><:NMBHGPA>GNMBEBSBG@+',2,PBMAI:MB>GML
suffering from intestinal obstruction in the small or large
bowel, which may include (but is not limited to) hernias,
adhesions from previous abdominal surgery, or from un
=>KERBG@I:MAHEH@B>LLN<A:LKHAGdLBL>:L>HK"KKBM:;E>
HP>E,RG=KHF>",(;LMKN<MBHGLF:RH?M>G;><HFIEB
cated by dehydration and/or loss of electrolytes – this is
especially the case if the patient has bowel exposed.
g):MB>GMLPBMA<BK<NE:MHKRHKBGM>LMBG:E:G:LMHFHL>LBG
cluding, but not limited to arterial grafts or gastric bypass)
require careful consideration while using RENASYS AB.
Patients with enteric fistula have an increased risk of ab
dominal contamination if output is not carefully managed
during the course of treatment with RENASYS AB.
gNKBG@MA><HNKL>H?MK>:MF>GMMA>+',2,=K>LL
ing and NPWT system will remove third space fluid in the
abdominal compartment. Large volumes of fluid can be
collected during the course of treatment. The volume and
appearance of the fluid in both canister and tubing should
be checked and recorded frequently while patient is
receiving therapy. The canister should be replaced prior to
K>:<ABG@?NEE<:I:<BMR/BL<HNL>QN=:M>LBG<K>:L>MA>KBLD
of blockage in the system; monitor closely.
g-A>?ENB=E>O>EBGMA><:GBLM>KF:R;>NL>=:L:G:I
proximate guide when considering the necessity of fluid
resuscitation. Planning for fluid replacement should be a
clinical consideration in all patients undergoing therapy
with RENASYS AB.
g)KHM><MBHGH?MA>I>KBPHNG=LDBG:K>:?KHFFHBLMNK>:G=
adhesive irritation may be accomplished through the use
H?:LDBGL>:E:GM><:NL>H?MA>KBLDH??NKMA>K=:F:@>
to the periwound area, foam should never overlap onto
intact skin without first protecting the skin with additional
transparent film or a hydrocolloid dressing.
RENASYS™ AB
Abdominal Dressing Kit
with Soft Port
w
w
he
sm
OP ith
SIT &n
E™ ep
*
w
COMPATIBLE CANISTERS
he
sm
OP ith
SIT &n
E™ ep
90
100
40
200
700ml
120
80
90
100
40
200
120
80
70
140
70
3."KKB@:M>:;=HFBG:EPHNG=:LG>>=>=
w
sm
OP ith
SIT &n
E™ ep
*
400ml
300ml
w
he
w
200ml
sm
OP ith
SIT &n
E™ ep
*
w
sm
RE ith
NA &n
SY ep
S™ he
*
w
sm
RE ith
NA &n
SY ep
S™ he
*
sm
RE ith
NA &n
SY ep
S™ he
*
w
w
sm
RE ith
NA &n
SY ep
S™ he
w
2. Ensure any areas of necrosis are appropriately de
brided.
sm
RE ith
NA &n
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S™ he
he
1. Eliminate any sharp edges or bone fragments from
PHNG=:K>:K>?>KMH)+.-"(',,-"('
100ml
Soft Port
1 ea.
PERFORATED FOAM APPLICATION
1. Size the provided foam to the
=>LBK>=IKHIHKMBHGL:EHG@IK>
scored perforations. Cutting the
wound filler may be performed
if desired. Do not cut the foam
wound filler directly over the
wound bed to avoid foam frag
ments from falling into the wound. Rub the edges of
any cut foam, away from wound, to remove any loose
fragments which may result. The foam should be placed
directly over the OPL while maintaining contact with the
margins of the wound.
4. Clean and dry the periwound area.
2. Do not allow foam to contact intact skin without use of
appropriate barrier, such as transparent film or a hydrocol
EHB="MF:R;>G><>LL:KRMHLM:<DIB><>LH??H:FBG=>>I
WARNING: Protect vital structures such as bowel and
PHNG=L=>I>G=BG@HGMA>PHNG=IKH?BE>"?FNEMBIE>
abdominal organs at all times with the Organ Protection
pieces of foam are needed, count and record how many
%:R>K()%=NKBG@MA>K:IRH:FLAHNE=G>O>K;>IE:<>= foam pieces are used.
in contact with exposed bowel, arteries, veins, organs, or
G>KO>LK>?>KMH('-+"'"-"(',,-"('
3. >GMERIE:<>I>K?HK:M>=?H:F
NOTE: Either side of the OPL may be applied to exposed
in the wound cavity over the OPL.
organs. The OPL may be cut or folded to accommodate
Ensure that foam is sized to fit
the specific needs of the patient.
loosely into the wound defect
and there is sufficient material to
1. Remove kit contents from pouch and prepare the OPL
top the surface of the abdominal
HG:LM>KBE>?B>E="?<NMMBG@MA>()%MH:=B??>K>GMLBS>
wound (do not under fill the
ensure that each piece removed has been disposed of
wound).
properly, away from the open wound.
WARNING: Do not tightly pack or force foam into any
areas of the wound.
2. >GMERIHLBMBHGMA>()%=K>LL
ing evenly into the abdominal
cavity, distributing the sides into
TRANSPARENT FILM APPLICATION
both of the lateral paracolic gut
1. While holding the transparent
ters. Any excess material on the
film, expose one side of the adhe
sides of the OPL may be folded
sive backing by removing a single
back onto itself.
panel and apply it to the foam.
ORGAN PROTECTION LAYER (OPL) APPLICATION
500ml
180
50
2
Transparent Film
6 ea.
PREPARATION OF OPEN ABDOMINAL WOUND
WARNING: Review all RENASYS NPWT System safety
information prior to beginning Wound Preparation. Ensure
that sufficient hemostasis has been achieved prior to
:IIERBG@MA>+',2,=K>LLBG@K>?>KMH0+'"' ,
,-"('
*
&n
E™ ep
Perforated Foam
2 ea.
160
60
2
*
sm
OP ith
SIT
Organ Protection Layer (OPL)
1 ea.
600ml
140
160
180
50
he
w
w
sm
RE ith
NA &n
SY ep
S™ he
*
w
sm
RE ith
NA &n
SY ep
S™ he
*
sm
RE ith
NA &n
SY ep
S™ he
*
w
w
w
he
&n
E™ ep
sm
RE ith
NA &n
SY ep
S™ he
sm
RE ith
NA &n
SY ep
S™ he
sm
OP ith
SIT
*
*
*
2
2
2
Sterilized using
ethylene oxide
Storage
temperature
800ml
2
60
2
Keep
dry
w
2
*
w
sm
RE ith
NA &n
SY ep
S™ he
*
2
w
w
sm
RE ith
NA &n
SY ep
S™ he
*
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sm
RE ith
NA &n
SY ep
S™ he
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RE ith
NA &n
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S™ he
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RE ith
NA &n
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&n
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RE ith
NA &n
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SY ep
S™ he
sm
OP ith
SIT
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*
2
*
w
2
*
he
&n
E™ ep
sm
RE ith
NA &n
SY ep
S™ he
sm
RE ith
NA &n
SY ep
S™ he
sm
OP ith
SIT
*
*
*
2
Do not use
if packge is
damaged
Do not
reuse
COMPATIBLE DEVICES
w
RENASYS AB ABDOMINAL DRESSING KIT 66800980 INCLUDES:
*
Appendix III
INDICATIONS FOR USE
The RENASYS™ AB Abdominal Dressing Kit with Soft Port
(RENASYS AB) is intended for use in conjunction with
RENASYS EZ and RENASYS EZ PLUS devices and
canisters as a complete Negative Pressure Wound
Therapy (NPWT) System for managing open abdominal
wounds with NPWT.
g+',2,BLBG=B<:M>=?HKM>FIHK:KR;KB=@BG@H?
abdominal wall openings where primary closure is not
possible and/or repeat abdominal entries are necessary.
g"MBLBGM>G=>=MH;>NL>=BGHI>G:;=HFBG:EPHNG=L
with exposed viscera, including but not limited to
abdominal compartment syndrome.
g-A>NL>H?+',2,BLBGM>G=>=?HKNL>BG:<NM>
hospital care settings (trauma, general and plastic surgery
wards) and should ideally be applied in the operating
theatre.
CONTRAINDICATIONS
The use of RENASYS AB is contraindicated:
gHKGHG>GM>KB<NG>QIEHK>=?BLMNE:>
gHKNGMK>:M>=HLM>HFR>EBMBL
gHKF:EB@G:G<RBGMA>PHNG=PBMA>Q<>IMBHGH?I:EEB:MBO>
care to enhance quality of life)
g0A>GOBM:EHK@:GL:G=LMKN<MNK>L:K>GHM<HO>K>=PBMA
the Organ Protection Layer (OPL).
gHKIK>L>G<>H?G><KHMB<MBLLN>PBMA>L<A:K
gHKNL>BGI:MB>GMLPBMAHG@HBG@HKAB@AIHM>GMB:E?HK
hemorrhage and/or enteric leak.
5.0cm
7.5cm
RENASYS EZ
66800059
RENASYS EZ PLUS
66800697
2. Cover foam with transparent
film, removing remaining adhesive
panels to seal, as well as the re
F:BGBG@<:KKB>KI:G>EBEFLAHNE=
extend at least 5cm beyond
wound margin and be securely
anchored to periwound area to
maintain a good seal.
800ml
ååçßßèàá
66800937
250ml
ååçßßèàâ
66800938
INITIATION OF THERAPY
1. Ensure canister is installed correctly. Connect the
suction port tubing to the canister tubing by pushing the
connectors together. An audible click indicates the con
nection is secure.
2. Activate the RENASYS EZ or RENASYS EZ PLUS device
HG('-"'.(.,FH=>;>@BGGBG@PBMAçßFF!@:G=
check that the dressing has a good seal. The recom
NOTE: Overlap the edges of the transparent film by a
F>G=>=IK>LLNK>K:G@>BLçßàáßFF!@
minimum of 7.5cm when using multiple pieces of transpar
ent film.
3.BGBLA>==K>LLBG@LAHNE=;>?BKFMHMA>MHN<A
NOTE: Avoid stretching or pulling the transparent film to
minimize tension or trauma to the periwound skin.
SOFT PORT APPLICATION
ßå<F
1. Cut a small opening (no less
than 0.6cm) in the center of the
film, over the wound filler. Remove
any loose transparent film and
dispose of away from the wound.
4."?K>JNBK>=:=CNLMIK>LLNK>L>MMBG@MHMA>=>LBK>=E>O>E
DRESSING CHANGES
PRECAUTION: Protect the tube ends by inserting the
M>MA>K>=<:ILH?MA>JNB<D<EB<D<HGG><MHKBFF>=B:M>ER
before turning off the device.
NOTE: When negative pressure is switched off, ensure the
abdomen is adequately supported.
1. Remove and dispose of dressing per institutional
protocol. Thoroughly inspect the wound to ensure all foam
2. Remove the adhesive panel from
pieces have been removed.
the Soft Port dressing, and align the
port opening directly over the hole 2. Count and record number of foam pieces removed.
in the transparent film.
3. As with all adhesive products, apply and remove the
dressing carefully from sensitive or fragile skin to avoid
Use gentle pressure to anchor the skin stripping – especially if frequent dressing changes
will be needed.
Soft Port to the transparent film.
3. Smooth the dressing down
while removing the Soft Port’s top
stabilization frame.
1
1
*smith&
nephew
*smith&
nephew
RENASYS™
4. Dressings should be changed every 48 hours, or more
frequently, based on continual monitoring of patient
<HG=BMBHG"GMA>>O>GMH?A>:OR=K:BG:@>=K:BG:@>PBMA
sediment or infected wounds, more frequent dressing
changes may be needed. Check dressings regularly and
monitor the wound to check for signs of infection, bleed
BG@HK:;=HFBG:E<HGM:FBG:MBHG"?MA>K>:K>:GRLB@GLH?
systemic infection or advancing infection at the wound
site, contact the treating clinician immediately.
*smith&
nephe
nephew
RENASYS™
*smith&
*
nephew
R
RENASYS™
1
1
*smith&
*
smith&nep
nephew
RENASYS™
hew
*smith&
h&nnephew
RENASYS™
R
w
YS
*smith&
nephew
RENASYS™
*
*smith&
th&nnephew
RENASYS™
NAS
*smith&
nephew
RENASYS™
*ssmi
*sm
smith&nep
RE
RENASYS™
hew
2
*
*smith&
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nephew
RENASYS™
NASY
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mith&
ith&n
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REN
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RENA
ENA
NASYS™
NAS
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mith&ne
mith&n
h&nephew
h&nep
RENA
R
REN
EENAS
NASYS™
2
2
3. Ensure complete coverage of all
exposed bowel in the abdominal
cavity with the OPL, prior to filling
the wound defect with foam.
4. Secure the Soft Port to the
patient according to your
institutional protocol. Ensure
the aeration disc, located near
the quick click connector, is not
covered or otherwise occluded by
the method used to secure the
Soft Port.
Negative Pressure Wound Therapy Clinical Guidelines
69
Section 11
Appendix IV
EN
RENASYS™
High Output Dressing Kit
NOTE: The High Output Dressing Kit is not compatible with the
RENASYS GO device.
Indications for Use
The RENASYS High Output Dressing Kit is intended to be used
in conjunction with Smith & Nephew Negative Pressure Wound
Therapy (NPWT) Systems to deliver negative pressure to the wound.
Smith & Nephew NPWT Systems are indicated for patients who
would benefit from a suction device, particularly as the device may
promote wound healing.
NPWT is appropriate for use on the following wounds:
gAKHGB<
g<NM>
g-K:NF:MB<
g,N;:<NM>:G==>ABL<>=PHNG=L
g.E<>KLLN<A:LIK>LLNK>HK=B:;>MB<
g):KMB:EMAB<DG>LL;NKGL
gE:IL:G=@K:?ML
Do not reuse
Keep dry
Contraindications
The use of NPWT is contraindicated for:
g.GMK>:M>=HLM>HFR>EBMBL
gQIHL>=:KM>KB>LO>BGLHK@:GLHKG>KO>L
g'><KHMB<MBLLN>PBMA>L<A:KIK>L>GM
g&:EB@G:G<RBGPHNG=PBMA>Q<>IMBHGH?I:EEB:MBO><:K>MH>GA:G<>
quality of life)
g'HG>GM>KB<:G=NG>QIEHK>=?BLMNE:L
gG:LMHFB<LBM>L
Warnings
1. Patients must be closely monitored for bleeding. If sudden or
increased bleeding is observed, immediately discontinue therapy,
M:D>:IIKHIKB:M>F>:LNK>LMHLMHI;E>>=BG@:G=<HGM:<MMA>MK>:MBG@
clinician.
2. Patients suffering from difficult hemostasis or who are receiving
:GMB<H:@NE:GMMA>K:IRA:O>:GBG<K>:L>=KBLDH?;E>>=BG@NKBG@
therapy, avoid using hemostatic products that, if disrupted, may
BG<K>:L>MA>KBLDH?;E>>=BG@
3. Sharp edges or bone fragments in a wound must be covered or
K>FHO>=IKBHKMHNLBG@')0-=N>MHKBLDH?ING<MNKBG@HK@:GLHK
blood vessels while under negative pressure.
4.HGHMMB@AMERI:<DHK?HK<>@:NS>BGMH:GR:K>:LH?MA>PHNG=
5.HGHMNL>')0-HG>QIHL>=;EHH=O>LL>ELHKHK@:GL
6. In the event defibrillation is required, disconnect the NPWT device
from the wound dressing prior to defibrillation. Remove the wound
dressing if it will interfere with defibrillation.
7. -A>')0-=>OB<>BLGHM&+"HK-<HFI:MB;E>HGHM;KBG@BGMH
MA>&+"LNBM>HKL<:GG>KK:G@>
8. When operating, transporting, repairing or disposing of NPWT de
OB<>L:G=:<<>LLHKB>LMA>KBLDH?BG?><MBHNLEBJNB=L;>BG@:LIBK:M>=
or contamination of the device assembly through incorrect use, can
GHM;>>EBFBG:M>=.GBO>KL:EIK><:NMBHGLAHNE=;>H;L>KO>=PA>G
>O>KPHKDBG@PBMAIHM>GMB:EER<HGM:FBG:M>=I:KMLHK>JNBIF>GM
9. ')0-A:LGHM;>>GLMN=B>=HGI>=B:MKB<I:MB>GML):MB>GMLBS>
and weight should be considered when prescribing NPWT devices.
10. NPWT is unsuitable for use in areas where there is danger of
>QIEHLBHG>@ARI>K;:KB<HQR@>GNGBM
Precautions
1. )K><:NMBHGLLAHNE=;>M:D>G?HKI:MB>GMLPAH:K>HKF:R;>
g+><>BOBG@:GMB<H:@NE:GMMA>K:IRHKIE:M>E>M:@@K>@:MBHGBGAB;BMHKL
:<MBO>ER;E>>=BG@HKA:O>P>:D>G>=;EHH=O>LL>ELHKHK@:GL
g,N??>KBG@?KHF=B??B<NEMPHNG=A>FHLM:LBL
g.GMK>:M>=?HKF:EGNMKBMBHG
g'HG<HFIEB:GMHK<HF;:MBO>
g,N??>KBG@?KHFPHNG=LBG<EHL>IKHQBFBMRMH;EHH=O>LL>ELHK
delicate fascia.
2.-A>NL>H?')0-IK>L>GML:KBLDH?MBLLN>BG@KHPMA-BLLN>
BG@KHPMAF:R;>K>=N<>=;RK>=N<BG@MA>K:IRIK>LLNK>NLBG@
a wound contact layer or by increasing the frequency of dressing
changes.
3. Infected wounds may require more frequent dressing changes.
+>@NE:KFHGBMHKBG@H?MA>PHNG=LAHNE=;>F:BGM:BG>=MH<A><D?HK
signs of infection.
4.')0-LAHNE=K>F:BGHGBGMA>('-"'.(.,FH=>?HKMA>
duration of the treatment. There may be situations when the patient
G>>=LMH;>=BL<HGG><M>=?KHFMA>')0-=>OB<>?HK>Q:FIE>
for activities of daily living and diagnostic testing. If the patient
needs to be disconnected, the dressing tubing should be clamped
and the ends of the tubing protected. How long patients may be
disconnected from the NPWT device is a clinical decision based
HGBG=BOB=N:E<A:K:<M>KBLMB<LH?MA>I:MB>GM:G=MA>PHNG=:<MHKL
to be considered would include; amount of drainage, location of
the wound, integrity of the dressing seal, assessment of bacterial
;NK=>GBGMA>PHNG=:G=I:MB>GMdLKBLDH?BG?><MBHG
5. As a condition of use, the NPWT device should only be used by
JN:EB?B>=:G=:NMAHKBS>=I>KLHGG>E-A>NL>KFNLMA:O>MA>G><>L
L:KRDGHPE>=@>H?MA>LI><B?B<F>=B<:E:IIEB<:MBHG?HKPAB<A')0-
is being used.
6."?MA>')0-=>OB<>A:L;>>G:MM>FI>K:MNK>L;>EHP?K>>SBG@
the device must be brought to room temperature prior to use or the
pumping unit may be damaged.
7.GLNK>MA:MMN;BG@BLBGLM:EE>=<HFIE>M>ER:G=PBMAHNM:GRDBGDLMH
:OHB=E>:DLHK;EH<D:@>LBGMA>O:<NNF<BK<NBM
8. Position the NPWT device and tubing appropriately to avoid the
KBLDLH?<:NLBG@:MKBIA:S:K=:G=H?MA>I:MB>GMERBG@HGMA>MN;BG@
9. When bathing/showering, the patient must clamp off the dressing
tubing and disconnect from the NPWT device.
10. Inspect the overflow protection/bacteria filter on the canister
and replace the canister as necessary. At minimum, the canister
LAHNE=;><A:G@>=P>>DER
11..G=>KERBG@LMKN<MNK>LLN<A:LM>G=HGLEB@:F>GML:G=G>KO>L
LAHNE=;><HO>K>=PBMAG:MNK:EMBLLN>HK:GHG:=A>K>GM=K>LLBG@
E:R>KIKBHKMH:IIERBG@MA>')0-=K>LLBG@DBM
12. NPWT should not be painful. If the patient reports discomfort,
consider reducing the pressure.
13. Always use the smallest canister volume possible – do not use
MA>çßßFE<:GBLM>KHGI:MB>GMLPBMA:AB@AKBLDH?;E>>=BG@
14.&:BGM:BGK>@NE:KFHGBMHKBG@H?MA>')0-=>OB<>:G=PHNG=LBM>
during therapy to ensure therapeutic treatment and patient comfort.
15. If any liquids penetrate the NPWT device, discontinue use and
K>MNKGMHRHNK:NMAHKBS>=IKHOB=>K?HKL>KOB<>
16. As with all adhesive products apply and remove the dressing
<:K>?NEER?KHFL>GLBMBO>HK?K:@BE>LDBGMH:OHB=LDBGLMKBIIBG@>LI>
cially after frequent dressing changes.
17.HGHMNL>B?I:<D:@BG@BL;K>:<A>=HK=:F:@>=
18.:GBLM>KDBML:K>IKHOB=>=GHGLM>KBE>:G=LAHNE=GHM;>NL>=BG
a sterile field.
Precautions Specific to the RENASYS High Output Dressing Kit
Pressure Settings Recommendations
g.MBEBS>=>OB<>IK>LLNK>L>MMBG@L;>MP>>GãßàáßFF!@
g-A>NL>H?IK>LLNK>L>MMBG@LPAB<A:K>AB@A>KMA:GMA>K><HF
F>G=>=F:QBFNFH?àáßFF!@BL:=><BLBHGMH;>F:=>;RMA>
treating physician/clinician and the individual needs of the patient
LAHNE=;>M:D>GBGMH:<<HNGM
Precautions for Treating Enterocutaneous Fistulae
g'>O>KE:R=K:BG=BK><MERBG<HGM:<MPBMAMA>BGM>LMBG:EFN<HL::MMA>
top of fistula opening.
gNKBG@MA><HNKL>H?MK>:MF>GMI:MB>GMdL?ENB=E>O>ELFNLM;>
closely monitored.
Recommendations Based on Fistula Location and Fluid Description
The anatomical location of the fistula in the intestine will influence
the amount and type of the output:
g-A>AB@A>KMA>?BLMNE:H<<NKLBGMA>;HP>EMA>MABGG>KFHK>
caustic and heavier the output.
g-A>EHP>KMA>?BLMNE:H<<NKLBGMA>;HP>EMA>MAB<D>KHKI:LMB>KMA>
output.
&H=B?RMA>:IIEB<:MBHGH?MA>!B@A(NMINMK>LLBG@$BM:L=>L<KB;>=
below in accordance with the location and the fluid properties.
Step 6: Place transparent dressing over the
wound and seal.
,M>KBEBS>=NLBG@
>MARE>G>HQB=>
Negative Pressure Wound Therapy
Dressing Application
Use aseptic or sterile techniques for application depending on institutional protocol. Use only Smith & Nephew Dressing Kits approved
for use with the NPWT device.
NOTE: The drain in the High Output Dressing Kit is equipped with
an irrigation port for irrigating the wound surface with an appropriate
solution. If the objective is to bathe the wound surface for a period
of time, the NPWT device should be turned off during that period.
When the irrigation port is not in use, the cap should be applied to
the port.
Step 1:E>:GL>PHNG=:K>::G=I:M=KRI>K
protocol. Thorough wound cleansing should
occur with each dressing change.
Step 2: IIERLDBGL>:E:GMMHI>KBPHNG=:K>:
gHGHM:IIER'H,MBG@,DBG)K>Ik=BK><MERHG
open wound.
Step 3:HO>KPHNG=;>=BG<EN=BG@?BLMNE:
HI>GBG@PBMAGHG:=A>K>GM@:NS>HKPBMAHG>
E:R>KH?L:EBG>FHBLM>G>=@:NS>
CAUTION:"MBLBFIHKM:GMMA:MMA>@:NS>BL
moistened with normal saline prior to filling the wound.
Dressing Changes
PRECAUTION: Before removing the dressing, clamp the dressing
tubing immediately before turning off the device.
Step 1: Remove and dispose of dressing per institutional protocol.
-AHKHN@AERBGLI><MMA>PHNG=MH>GLNK>:EE@:NS>IB><>LA:O>;>>G
removed.
70
High Output/Thin Consistency Dressing Procedure
Step 4:)E:<>áçK=K:BGBG<EHL>IKHQBFBMR
to fistula opening and in dependent/inferior
position.
Caution:.MBEBS>LMHF:I:LM>NG=>KG>:MA
=K:BG:MPHNG=>=@>MHFBGBFBS>IK>LLNK>
point.
Fistula
WARNING: The drain should never be placed
directly in the fistula tract.
Step 5:BEEK>F:BGBG@PHNG==>?B<BMPBMA:=
=BMBHG:EL:EBG>FHBLM>G>=@:NS>
Sediment Laden Dressing Procedure
Step 4:)E:<>áçK=K:BGBG<EHL>IKHQBFBMR
to fistula opening and in dependent/inferior
IHLBMBHGBLMNE:HI>GBG@LAHNE=K>F:BG
>QIHL>=
Drain
position WARNING: The drain should never be placed
directly in the fistula tract.
Step 7:,><NK>MA>áçK=K:BGPBMAP:M>KIKHH?
tape.
Step 8: Remove the canister tube supplied
with the canister and discard. Attach the
canister to the RENASYS device.
Step 9:HGG><MMA>=K:BG=BK><MERMHMA><:GBL
ter by joining the blue connector of the drain to
the canister input.
PRECAUTION: Ensure dressing tubing clamp is open and there are
GHDBGDLBGMA>MN;BG@
Step 5:BEEPHNG==>?B<BMPBMA:==BMBHG:E
L:EBG>FHBLM>G>=@:NS>:G=<HGMBGN>MHE>:O>
?BLMNE:HI>GBG@>QIHL>=
Step 10:<MBO:M>MA>+',2,=>OB<>HG('-"'.(.,FH=>
;>@BGGBG@PBMAçßFF!@A><DMA:MMA>=K>LLBG@A:L:@HH=L>:E
BGBLA>==K>LLBG@LLAHNE=;>?BKFMHMA>MHN<A"?K>JNBK>=:=CNLM
pressure setting to the desired level.
Step 2: As with all adhesive products, apply and remove the dress
BG@<:K>?NEER?KHFL>GLBMBO>HK?K:@BE>LDBGMH:OHB=LDBGLMKBIIBG@
especially if frequent dressing changes will be needed.
Step 3:K>LLBG@LLAHNE=;><A:G@>=>O>KRãçAHNKLHKFHK>
frequently, based on continual monitoring of patient condition. In
the event of heavy drainage, drainage with sediment or infected
wounds, more frequent dressing changes may be needed.
Step 4: A><D=K>LLBG@LK>@NE:KER:G=FHGBMHKMA>PHNG=MH<A><D
for signs of infection or bleeding. Infected wounds may require
more frequent dressing changes. If there are any signs
of systemic infection or advancing infection at the wound
site, contact the treating clinician immediately.
Appendix V
EN
RENASYS™
Drain Accessory Kit
Negative Pressure Wound Therapy
INDICATIONS FOR USE
The RENASYS dressing kits and related accessories are
intended to be used in conjunction with Smith & Nephew
Negative Pressure Wound Therapy (NPWT) Systems. The
Smith & Nephew RENASYS NPWT Systems are indicated
for patients who would benefit from a suction device
(Negative Pressure Wound Therapy) as it may promote
wound healing via the removal of fluids including irrigation
and body fluids, wound exudates and infectious materials.
ååçßßèæà
2<HGG><MHK
ååçßßèæá
àßKKHNG=PHNG==K:BG:<<>LLHKRDBM
ååçßßèæâ
10mm flat wound drain accessory kit
ååçßßèæã
àäK<A:GG>EPHNG==K:BG:<<>LLHKRDBM
ååçßßæèè
RENASYS Soft Port
*smith&nephew
:NMBHG.,>=>K:EE:PK>LMKB<MLMABL=>OB<>
to sale by or on the order of a physician
HGHMK>NL>
Examples of appropriate wound types include:
g<NM>
gAKHGB<
g-K:NF:MB<
g,N;<NM>:G==>ABL<>=PHNG=L
g.E<>KLLN<A:LIK>LLNK>HK=B:;>MB<
g):KMB:EMAB<DG>LL;NKGL
gE:IL:G=@K:?ML
WARNINGS AND PRECAUTIONS
$>>I=KR
CONTRAINDICATIONS
The use of NPWT is contraindicated for:
g.GMK>:M>=HLM>HFR>EBMBL
gQIHL>=:KM>KB>LO>BGLHK@:GLHKG>KO>L
g'><KHMB<MBLLN>PBMA>L<A:KIK>L>GM
g&:EB@G:G<RBGMA>PHNG=PBMA>Q<>IMBHGH?I:EEB:MBO>
care to enhance quality of life)
g'HG>GM>KB<:G=NG>QIEHK>=?BLMNE:L
gG:LMHFHMB<LBM>L
Y-CONNECTOR AND WOUND BRIDGING PRECAUTIONS
gHGG><MBG@MPHPHNG=LH?=B??>K>GM>MBHEH@B>L
(e.g., surgical dehiscence and explored fistula) via the
2<HGG><MHKHK:;KB=@>BLGHMK><HFF>G=>==N>MHMA>
risk of cross contamination.
USING A Y-CONNECTOR
gHGG><MBG@MPHPHNG=LH?=B??>KBG@BG?><MBHGLM:MNLOB:
2<HGG><MHKL<HGG><MMPHPHNG=LMH:LBG@E>=>OB<>HK
MA>2<HGG><MHKHK:;KB=@>GHGBG?><M>=PBMABG?><M>=BL
multiple suction adaptors to one large wound.
not recommended due to the risk of cross contamination.
g.L>:2<HGG><MHK?HKMPHPHNG=LPBMAFHK>MA:Gáä<F g"G<HKIHK:MBG@FNEMBIE>2<HGG><MHKLMH:LBG@E>=>OB<>
between them.
presents additional demands on the RENASYS device;
gHGLB=>K;KB=@BG@MA>MPHPHNG=LNLBG@PHNG=?BEE>K?HK battery power may deplete more rapidly and/or result in
PHNG=LL>I:K:M>=;R:=BLM:G<>E:K@>KMA:Gáä<F
additional leak alarms, depending on the extent of the
g NB=:G<>F:R;>?HNG=BGMA>".?HK+',2,H:F
demand on the unit.
:G= :NS>=K>LLBG@$BML
gEHL>ERFHGBMHKMA>=K>LLBG@LPA>GMK>:MBG@PBMA:
g2<HGG><MHKLF:R;>NMBEBS>=MH<HF;BG>:+',2,
2<HGG><MHKEH<D:@>LPAB<AA:O>?HKF>=BGHGERHG>H?
Soft Port with either another Soft Port or a RENASYS drain. MA>MPHLN<MBHG:=:IMHKL<HGG><M>=MHMA>2<HGG><MHK
gA:G@>2<HGG><MHKLP>>DER:M:FBGBFNFHKPBMA>:<A may not be detected by the RENASYS device. Always
canister change.
check dressings for compressed appearance. If dress
ings are not visibly compressed, and no leak alarm has
sounded, a blockage is present.
g"?MPH=K:BGL:K>2<HGG><M>=PBMAHNM:,H?M)HKM
tightly sealed, low exuding wounds may present a risk of
nuisance blockage alarms from the RENASYS device. If this
occurs, replace one drain with a Soft Port.
g0A>GMPHHKFHK>+',2,,H?M)HKML:K>NL>=PBMA:
2<HGG><MHKGHKF:EHI>K:MBHGPBMA+',2, (LAHNE=
;>>QI><M>="GLHF><:L>L=>I>G=BG@HGMA>LBS>H?
those wounds and their respective seal, a leak alarm from
+',2, (F:RK>LNEM+',2,3)%.,F:R;>
used, which will offer significantly greater tolerance for
E>:DLL><HG=+',2, (F:R:ELH;>NMBEBS>=BGIE:<>
H?:2<HGG><MHKMHA:G=E>MA>:==BMBHG:E=>F:G=H?:EE
wounds.
g-A>K:IRE>O>ELH?çßMHàáßFF!@:K>K><HFF>G=>=
PA>GFNEMBIE>PHNG=L:K><HGG><M>=PBMAMA>2<HGG><MHK
ACCESSORY DRAIN SELECTION
2.IIER:E:R>KH?L:EBG>FHBLM>G>=:GMBFB<KH;B:E
@:NS>MHMA>PHNG=;>=:G=IHLBMBHG=K:BGHG
MHIH?@:NS>
g-K:GLI:K>GMBEFLAHNE=>QM>G=:ME>:LMä<F;>RHG=MA>PHNG=
margin and be securely anchored to the periwound area to main
tain a good seal.
a.HKA:GG>E=K:BGPK:I:E:R>KH?@:NS>
around drain (Note: if placing directly into a sinus
MK:<MGH@:NS>BLG><>LL:KRHGMA>IHKMBHGH?MA>
drain in the tract.)
g(O>KE:IMA>>=@>LH?MA>MK:GLI:K>GM?BEF;R:FBGBFNFH?æä<F
when using multiple pieces of transparent film.
HK:?NEEEBLMH?P:KGBG@L:G=IK><:NMBHGLIE>:L>K>?>KMH
MA>"GLMKN<MBHGL?HK.L>".IKHOB=>=PBMA:+',2,
H:F:G= :NS>K>LLBG@$BM
RENASYS drains provide a conduit for negative pressure and
removal of exudate from the wound cavity.
+',2,K:BG<<>LLHKRDBML:K>H??>K>=MH<HFIE>F>GMMA>MK>:M
ment of wounds in addition to RENASYS Soft Port for experienced
clinicians who wish to enhance the treatment regime of complex
wound shapes and depths, locations, and challenging exudate
conditions.
EE=K:BGL:K>LBEB<HG>:G=BG<EN=>:K:=BHI:JN>LMKBI?HKOBLN:EBS:
MBHGNG=>KQK:R.MBEBS>=BG<HGCNG<MBHGPBMA,H?M)HKM=K:BGLF:R
further improve the removal of exudate from wounds with the
following characteristics:
g"KK>@NE:K<HGMHNKL
gA:EE>G@BG@:G:MHFB<:E<HG=BMBHGL
gQIEHK>=BLMNE:>
g,B@GB?B<:GMPHNG==>IMABGOHEOBG@NG=>KFBGBG@LBGNLMK:<ML:G=
tunneling.
DRAIN APPLICATION WITH RENASYS SOFT PORT
A CLEAN AND DEBRIDE
.L><E>:GHK:L>IMB<M><AGBJN>L?HK:IIEB<:MBHG:<<HK=BG@MHRHNK
institutional protocol. Thorough wound cleansing should occur with
each dressing change.
1. >;KB=>:GR=>OBM:EBS>=HKG><KHMB<>L<A:KMBL
LN>E>:GL>MA>PHNG=;>=:G=I:M=KR
2. If desired, protect the periwound skin from
exposure to moisture and adhesive through the
use of a skin sealant.
3."?=>LBK>=:GHG:=A>K>GM=K>LLBG@F:R;>
:IIEB>=-KBF:LBG@E>E:R>KH?GHG:=A>K>GM
@:NS>:G=E:R:<KHLLPHNG=;>=
Note: Skin sealant and wound contact layer is not included as part
H?+',2,HK+',2, ,M>KBE>$BM
B PLACE DRAIN AND DRESS WOUND WITH GAUZE
1. NMMA>=K:BG:IIKHQBF:M>ERáä<FLAHKM>KMA:G
MA>;:L>H?MA>PHNG=NKEMA>=K:BGB?NLBG@:
channel or round drain.
Warning:K:BG<A:GG>ELFNLM;><HGM:BG>=PBMABGMA>PHNG=;>=
to achieve a seal.
b. Apply a strip of ostomy paste
to the wound edge to secure
the drain in position; place the
remainder over the top of the
drain and pinch in place.
3.HGMBGN>MH:IIER@:NS>BGE:R>KLNGMBEMA>
@:NS>EHHL>ER?BEELMA>>GMBK>PHNG=<:OBMROHB=
over packing the wound.
CAUTION: If using a drain with foam, ensure the drain is placed on
top of the foam dressing and not in direct contact with the wound
bed.
C SEAL THE WOUND
1. While holding the transparent film, expose
one side of the adhesive backing by removing a
single panel, and apply over the wound.
2.HO>KMA>PHNG=?BEE>KPBMAMK:GLI:K>GM?BEF
removing the remaining adhesive panels to seal,
MA>GMA>MHILM:;BEBS:MBHGI:G>E
3.K>:M>:L>:E;RIBG<ABG@MA>LMKBII:LM>
4. Secure the drain tubing with waterproof tape.
Notes:
gAvoid stretching or pulling the transparent film
MHFBGBFBS>M>GLBHGHKMK:NF:MHMA>I>KBPHNG=
skin.
D APPLY RENASYS SOFT PORT
1. NM:LF:EEHI>GBG@GHE>LLMA:Gßå<FBGMA>
center of the film, over the wound filler. Remove
any loose transparent film and dispose of away
from the wound.
2. Remove the adhesive backing from
the Soft Port dressing, and align the
port opening directly over the hole in
MA>MK:GLI:K>GM?BEF.L>@>GME>IK>L
sure to anchor the Soft Port to the transparent film.
3. Smooth the dressing down while removing the
RENASYS Soft Port’s frame.
4. Secure the Soft Port to the patient according to
your institutional protocol.
CAUTION: Ensure the aeration disc, located
near the quick click connector, is not covered or
otherwise occluded by the method used to secure the Soft Port.
5.HGG><MMA>=K:BG:G=MA>+',2,,H?M)HKMMH@>MA>KNLBG@:
+',2,2<HGG><MHK
E INITIATE THERAPY
1.HGG><M;HMAMA>+',2,,H?M)HKM:G=MA>=K:BGMHMA>
<:GBLM>KMN;BG@;RCHBGBG@MA>JNB<D<EB<DHGMA>2<HGG><MHKMH
the canister connector. An audible click indicates the connection
is secure.
2. Activate the RENASYS device and adjust to the prescribed
therapy level. The recommended therapeutic pressure range is 80
MHàáßFF!@PABE>:2<HGG><MHKBLNMBEBS>==NKBG@MK>:MF>GM
3. BGBLA>==K>LLBG@LLAHNE=;>?BKFMHMA>MHN<A:G=E>:D?K>>
Notes: The vacuum level is a decision each healthcare provider
must make, based on an individual assessment of the particular
wound. Adhere to the following general guidelines:
g%HP>KE>O>ELH?O:<NNF:K>@>G>K:EER>??><MBO>:G=FHK>MHE>K:;E>
gThe vacuum level should never be painful. If the patient
reports discomfort with the vacuum level, it can be reduced.
Negative Pressure Wound Therapy Clinical Guidelines
71
Section 11
Appendix VI
Single Use Negative
Pressure Wound
Therapy System
PICO™ is supplied sterile, single use. Do
not use if package is open or damaged.
wound healing via removal of low to moderate
levels of exudate and infectious materials.
1. Description
Examples of appropriate wound types
include:
• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
The PICO Single Use Negative Pressure
Wound Therapy System consists of a
pump and two sterile dressing kits. The
PICO pump maintains negative pressure
wound therapy (NPWT) at 80 mmHg
surface. Exudate is managed by the
dressing through a combination of
absorption and evaporation of moisture
through the outer film.
PICO is intended for use in wound
sizes (surface area x depth) up to 400<Fâ
which are considered to below to
moderately exuding.
The kit is intended to be used for a
maximum of 7 days on low exuding
wounds and 6 days on moderately exuding
wounds. Therapy duration of the kit may be
less than indicated if clinical practice or
other factors such as wound type, wound
size, rate or volume of exudate, orientation
of the dressing or environmental
conditions, result in more frequent
dressing changes.
2. Indications for use
PICO is indicated for patients who would
benefit from a suction device (negative
pressure wound therapy) as it may promote
US
18504653 35363
4. Warnings
1. Certain patients are at high risk of
bleeding complications which, if
uncontrolled, could potentially be fatal.
Patients must be closely monitored for
bleeding. If sudden or increased
bleeding is observed, immediately
discontinue therapy, leave dressing in
place, take appropriate measures to
stop bleeding and seek immediate
medical assistance.
2. The use of anticoagulants does not
deem a patient inappropriate for
treatment with PICO however
hemostasis must be achieved before
applying the dressing. Patients
suffering from difficult hemostasis or
who are receiving anticoagulant
therapy have an increased risk of
bleeding. During therapy, avoid using
hemostatic products that may increase
the risk of bleeding, if disrupted.
Frequent assessment must be
maintained and considered throughout
the therapy.
3. At all times care should be taken to
ensure that the pump and tubing
does not:
• Lie in a position where it could cause
pressure damage to the patient.
• Trail across the floor where it could
present a trip hazard or become
contaminated.
• Present a risk of strangulation or a
tourniquet to patients.
72
4.
5.
6.
7.
8.
• Rest on or pass over a source
of heat.
• Become twisted or trapped under
clothing or bandages so that the
negative pressure is blocked.
Sharp edges or bone fragments in a
wound must be covered or removed
prior to using PICO due to risk of
puncturing organs or blood vessels
while under negative pressure.
In the event that defibrillation is
required, disconnect the pump from
the dressing prior to defibrillation.
Remove the dressing if it is positioned
in a location that will interfere with
defibrillation.
MR Unsafe. PICO is not MRI
compatible. Do not take PICO into the
MRI suite.
PICO has not been studied on
pediatric patients. Patient size and
weight should be considered when
prescribing this therapy.
PICO is unsuitable for use in areas
where there is danger of explosion
(e.g. hyperbaric oxygen unit).
5. Precautions
1. Precautions should be taken in the
following types of patients who are at
high risk of bleeding complications:
2.
3.
4.
5.
6.
• Receiving anticoagulant therapy or
platelet aggregation inhibitors or
actively bleeding.
• Having weakened or friable blood
vessels or organs in or around the
wound as a result of, but not limited
to; anastomoses, infection, trauma
or radiation.
• Suffering from difficult wound
hemostasis.
• Untreated for malnutrition.
• Noncompliant or combative.
• Suffering from wounds in close
proximity to blood vessels or
delicate fascia.
PICO dressings should only be applied
by a healthcare professional.
Dressings are not to be removed or
changed by the patient.
Where PICO is used on infected wounds,
more frequent dressing changes may be
required. Regular monitoring of the
wound should be maintained to check
for signs of infection.
If deemed clinically appropriate, care
should be taken that the application of
a circumferential dressing does not
compromise circulation.
PICO does not contain audible alarms.
The pump should be carried so that it
is accessible and the patient/
healthcare professional can check the
status routinely.
Although PICO can be used under
clothing/ bedding, it is important that
occlusive materials e.g. film dressings,
• Ulcers (such as diabetic or pressure)
• Flaps and grafts
• Closed surgical incisions
PICO Single Use Negative Pressure Wound
Therapy System is suitable for use both in
a hospital and homecare setting.
3. Contraindications
The use of PICO is contraindicated in the
presence of:
• Patients with malignancy in the wound
bed or margins of the wound (except in
palliative care to enhance quality of life).
• Previously confirmed and untreated
osteomyelitis.
• Necrotic tissue with eschar present.
• Exposed arteries, veins, nerves
or organs.
• Anastomotic sites.
• Emergency airway aspiration.
• Pleural, mediastinal or chest tube
drainage.
• Surgical suction.
are not applied over the pad area of
the dressing as this will impair device
performance.
7. Where PICO is used on patients with
fragile skin, a skin protectant such as
of skin where fixation strips are to be
applied. Inappropriate use or repeated
application of fixation strips may
otherwise result in skin stripping.
8. If reddening or sensitisation occurs
discontinue use and contact the
treating healthcare professional.
9.
products such as petrolatum as it
may compromise establishing an
effective seal.
10. The use of negative pressure presents a
risk of tissue ingrowth into foam when
this is used as a wound filler. When
using foam filler with PICO, tissue
ingrowth may be reduced by using a
wound contact layer or by increasing
the frequency of dressing changes.
11. PICO may be used in conjunction with
surgical drains provided the dressing is
not placed over tubing where it exits the
skin. Any surgical drain should be routed
under the skin away from the edge of the
dressing and function independently of
the PICO Single Use Negative Pressure
Wound Therapy System.
12. When showering the PICO pump
should be disconnected from the
dressing. Ensure the end of the tubing
attached to the dressing is facing
13.
14.
15.
16.
17.
down so that water does not enter the
top of the tube.
Do not take the pump apart.
The dressing should not be used with
any other suction pump.
Do not alter or cut tubing configuration
or pull on the tubing.
Do not cut the dressing as this may
lead to loss of NPWT application.
Always ensure that the dressing is
positioned centrally over the wound.
The port should be positioned
uppermost on intact skin and not
extend over the wound so that the risk
of fluid collecting around the port and
potentially blocking the negative
pressure is minimised.
18.
to interfere with some electronic
medical devices. Where possible,
scanner range. If the device has been
check that it is functioning correctly
following the procedure.
19. This device is single use only. Use of
any part of this system on more than
one patient may result in cross
contamination that may lead
to infection.
20. High temperatures and humidity may
reduce wear times of dressings.
21. During transport, there is a potential for
radio frequency interference that could
affect PICO performance. If the device
malfunctions, replace batteries. If not
corrected, contact your caregiver to
replace the device. PICO is not intended
for use aboard aircraft, the batteries
should be removed during air travel.
22. The potential for electromagnetic
interference in all environments cannot
be eliminated. Use caution if PICO is
near electronic equipment such as RFID
(Radio Frequency Identification) readers,
6. Adverse Reactions
Excessive bleeding is a serious risk
associated with the application of suction to
wounds which may result in death or serious
injury. Careful patient selection, in view of the
above stated contraindications, warnings and
precautions is essential. Carefully monitor the
wound and dressing for any evidence of a
change in the blood loss status of the patient.
Notify the healthcare professional of any
sudden or abrupt changes in the volume or
the color of exudate.
7. Instructions for use
7.1. Guidance on wound
suitability for management
with PICO
PICO should be used on wounds which
fit comfortably within the area of the pad,
observing precautions on port positioning
(on intact skin and not extending over
the wound).
7.3. Dressing change
1. Dressings should be changed in line
with standard wound management
5. If using SKIN PREP prior to application
of the fixation strips (see Precautions),
wipe the area surrounding the
dressing and allow skin to dry.
6. Apply the fixation strips to each of the
four sides of the dressing. Remove top
carrier on the strip after each one has
been applied. These strips maintain
the seal over the wear time of the
dressing. In awkward areas, it may be
useful to apply the strips to help
achieve a seal prior to switching on the
pump. Place each strip so that it
overlaps the dressing border by
approximately 1cm (2/5 in.). Ensure
tubing is not twisted or trapped
between clothing.
Please note that if at any time the fixation
strips are removed, the dressing should
also be replaced.
More frequent dressing changes may
be required depending on the level of
exudate, condition of the dressing,
wound type/size, orientation of the
dressing, environmental considerations
or other patient considerations; e.g.
when PICO is used on infected wounds.
At the healthcare professional’s
discretion a PICO dressing may be left
in place for up to 7 days.
2. Inspect the dressing regularly. If the
dressing appears ready for changing
button and disconnect the dressing from
the pump. The fixation strips should be
stretched away from the skin and the
dressing lifted at one corner and peeled
back until it has been fully removed.
Apply another dressing as per section
7.2, connect to the pump and press the
orange button to reinitiate the therapy.
A
B
C
(A) Dressing properly positioned and is
acceptable to be left in place
(B) Dressing requires change – Port may
block with fluid
(C) Dressing requires change – Absorbent
area is full
As a guide:
1
Depth – Wounds greater than 0.5cm ( /4
in.) in depth are likely to require a foam or
gauze NPWT filler to ensure adequate
treatment of all the wound surfaces.
Wounds treated with the larger dressing
sizes of the PICO system should generally
be no more than 2cm (4/5 in.) in depth.
Exudate – PICO is intended for use on
wounds where the level of exudate is low
(nominally 0.6g of liquid exudate/cm2 of
wound area/24 hours) to moderate
(nominally 1.1g of liquid exudate/cm2 of
wound area/24 hours). 1g of exudate is
approximately equal to 1ml of exudate. When
used on a moderately exuding wound, the
size of the wound should generally be no
more than 25% of the dressing pad area.
7.2. Application
1. Remove any excess hair to ensure
close approximation of the dressing to
the wound. If necessary, irrigate the
wound with sterile saline and pat the
wound dry.
2. Using a clean technique, peel off the
central release handle and place the
dressing centrally over the wound to
reduce the chance of wound fluid
coming into contact with the port. The
port should be uppermost from the
wound (depending on the patient’s
primary position), placed on intact skin
3. Based on dressing change frequency,
a new PICO Single Use Negative
Pressure Wound Therapy System kit
will be required dependent on
either when both dressings have been
used or after 7 days when the pump
automatically stops functioning (all the
lights will turn off at this point).
4. The dressing should be disposed of as
clinical waste. The batteries should be
removed from the pump; and both
batteries and pump disposed of
according to local regulations.
5. For additional information on disposal
requirements see:
www.possiblewithpico.com
7.4. Use with fillers and
wound contact layers
PICO is compatible with standard gauze and
foam fillers used in traditional NPWT where
this is clinically appropriate – for example on
a defect wound. When a filler is used, the
filler and the PICO dressing should be
changed 2 to 3 times a week, according to
local clinical protocol and manufacturer’s
instructions. Gauze should loosely fill to the
surface of the wound. Avoid over packing.
and not extending over the wound to
prevent fluid pooling around the port and
blocking the negative pressure. Remove
the other two handles and smooth the
dressing around the wound to prevent
creasing. Reposition if required to ensure
border is not creased.
3. Once the dressing is in place, remove
the pump and the batteries from the
tray. Insert the batteries. Replace the
cover. Following this all three lights
should flash once. (Refer to Table 1).
4. Join the pump to the dressing by
twisting together the tubing
connectors. Press the orange button to
start the application of negative
pressure. The green light will start to
flash (indicates system working OK,
see Table 1).
Depending on the size of the wound,
the pump should take up to 30
seconds to establish negative pressure
wound therapy.
If after 30 seconds the system has not
established negative pressure wound
therapy, the amber air leak light will
illuminate. To troubleshoot refer to
section (ii) of Table 1.
antimicrobial dressings may be used
under PICO.
8. General use
8.1. Showering and bathing
Light showering is permissible; however,
the pump should be disconnected (see
Precautions) and placed in a safe location
where it will not get wet. The dressing
should not be exposed to a direct spray or
submerged in water. Ensure the end of the
tubing attached to the dressing is facing
down so that water does not enter the top
of the tube.
8.2. Cleaning
Adherence to clinical directives concerning
hygiene is of prime importance. The pump
may be wiped clean with a damp cloth
using soapy water or a weak disinfectant
solution.
9. Faults and technical
assistance
If your device develops a fault or there are
signs of damage, refer to Table 1.
adherent layer if required, for example over
a skin graft.
On infected wounds or wounds at risk of
Negative Pressure Wound Therapy Clinical Guidelines
73
Section 11
Table 1 – Pump status indication, alarms and faults
Section (ii) – Alarms and faults
PICO has visual alarms to let the user know when there is an issue. PICO does not contain
audible alarms. The pump should be carried so that it is accessible and the
patient/healthcare professional can check the status routinely.
Display status
Indicator status
Possible cause
Comments/trouble shooting
Amber ‘leak’
light flashes.
Air leak detected
possibly due to a
creased dressing/
border/strip.
Smooth down the dressing and the
strips to remove any creases that are
allowing air into the system.
Pump is in auto
pause. NPWT is
not being applied
to the wound.
Press the orange button to restart the
therapy. The green “OK” light will
flash as the pump tries to establish
therapy.
The pump will auto
pause for 1 hour
and then will
automatically try to
If the air leak remains, the amber
leak light will start to flash after
approximately 30 seconds.
If this happens, repeat smoothing
actions and press the orange button.
If the leak is resolved the green light
will continue to flash.
Section (i) – Normal function
Display status
Indicator status
Possible cause
Comments/trouble shooting
All lights off.
The pump is OFF.
The therapy has been paused.
Pressing the orange button will
restart the therapy and the green
light will flash.
All lights
flash once.
Green ‘OK’
light flashes.
The pump has
reached the end
of its life.
After 7 days of therapy the pump
will automatically cease functioning,
in this case all the lights will turn off.
Pressing the orange button will not
provide a green flashing light.
The batteries are
no longer
functional.
If the pump has had less than 7
days usage, the batteries may not
be functional and should be
replaced as below.
This reflects the
pump self test
once batteries
have been inserted
and the cover has
been replaced.
This is expected.
Dressing applied,
and full system is
functioning
properly.
The pump may be heard running
occasionally as it maintains the
negative pressure. This is normal. If
this occurs frequently (several times
an hour) smooth down the dressing
to remove any creases that may be
allowing air into the system. NPWT is
still being applied in this situation.
No issues.
therapy
if no remedial
action is taken.
Green ‘OK’
light flashes.
System on and
functioning properly.
Change of batteries required in <24 hours.
Pause the therapy by pressing the orange
button.
Amber ‘battery
low’ light flashes.
Battery power low.
Push open the battery cover at the top of
the pump and remove the old batteries.
Insert 2 new lithium (L91) batteries.
Replace the cover. Press the orange
Amber ‘leak’
light flashes.
Creased dressing/
border/strip.
Address air leak as above.
Amber ‘battery
low’ light flashes.
Battery power low.
Change of batteries or device
required in <24 hours as above.
All lights solidly
illuminated.
Pump failed.
Contact S&N representative.
System is not
usable.
Apply new pump and dressing.
green light will flash.
10. Specifications
Maximum Dimensions
85 x 85 x 25mm (3.5 x 3.5 x 1.0”)
Weight
<120g
Operating Time
7 days
Battery Type
Lithium AA (L91)
Power (Battery)
3V DC
Ingress Protection
IPX4
Maximum Vacuum
100 mmHg
Mode of Operation
Continuous
Patient Protection
Type BF
Storage/Transport
5 – 25°C, 10 – 75% RH
700 to 1060 mbar atmospheric pressure
Operating Environment
5 – 35°C, 10 – 95% RH
700 to 1060 mbar atmospheric pressure
Compliance
CAN/CSA C22.2
11. Safety and
electromagnetic
compatibility
Guidance and manufacturer’s
declaration –
electromagnetic immunity
When used in accordance with the
manufacturer’s instructions, PICO
complies with the general requirements for
safety of electrical medical equipment IEC
PICO is intended for use in the
electromagnetic environment specified below.
The healthcare professional or the user of
PICO should assure that it is used in such
an environment.
requirements of electrical medical
for PICO is that the device should not deliver
a Negative Pressure to the patient
Electromagnetic
compatibility
This equipment has been tested and
found to comply with the limits for medical
designed to provide reasonable protection
against electromagnetic interference
typical of medical installations and home
use environment. Portable and mobile RF
communication equipment can affect
Medical Electrical Equipment.
This equipment generates, uses and can
radiate radio frequency energy and if not
installed and used in accordance with the
instructions, may cause harmful interference
to other devices in the vicinity. However,
there is no guarantee that interference will
not occur in a particular installation.
74
Immunity test
IEC 60601 test level
Compliance level
Immunity test
Electromagnetic environment – guidelines
Electrostatic discharge (ESD)
±6 kV contact
±8 kV air
±8 kV contact
±25 kV air
Electrostatic discharge (ESD)
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the relative humidity
should be at least 30%.
Electrical fast transient/burst
±2 kV for power supply lines
±1 kV for input/output lines
Not Applicable
Electrical fast transient/burst
Not Applicable
±1 kV line(s) to line(s)
±2 kV line(s) to earth
Not Applicable
Voltage dips, short interruptions
and voltage variations on power
supply input lines
<5% UT (>95% dip in UT) for 0.5 cycles
40% UT (60% dip in UT) for 5 cycles
70% UT (30% dip in UT) for 25 cycles
<5% UT (>95% dip in UT) for 5 cycles
Not Applicable
Power frequency (50/60Hz)
3 A/m
50 A/m
Conducted RF
3 Vrms
150kHz to 80MHz
Not Applicable
Radiated RF
3 V/m
80 MHz to 2.5 GHz
30 V/m
80 MHz to 2.5 GHz
Not Applicable
Voltage dips, short interruptions
and voltage variations on power
supply input lines
Not Applicable
Power frequency (50/60Hz)
Power frequency magnetic fields should be at levels characteristic
of a typical location in a typical commercial or hospital environment.
Conducted RF
Not Applicable
Radiated RF
Recommended separation distance
d = 0.175√P (80 MHz to 800 MHz)
d = 0.35√P (800 MHz to 2.5 GHz)
where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and ‘d’ is the
recommended separation distance in metres (m).
Note 1: At 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which PICO is used exceeds 3V/m, PICO should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating PICO.
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey (a),
should be less than the compliance level in each
frequency range. Interference may occur in the
vicinity of equipment marked with the following symbol:
WARNING: PICO should not be used adjacent to, or stacked with other electrical equipment and that if adjacent or stacked use
is necessary, PICO should be observed to verify normal operation in the configuration in which it will be used.
Recommended separation distances between portable and
mobile RF communications equipment and PICO
PICO is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The healthcare professional or the user of PICO can help
prevent electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and PICO as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter (W)
0.01
0.1
1
10
100
80 MHz to 800 MHz
d = 0.175 P
800 MHz to 2.5 GHz
d = 0.35 P
Not applicable
Not applicable
Not applicable
Not applicable
Not applicable
0.02
0.06
0.18
0.55
1.8
0.04
0.11
0.35
1.1
3.5
For transmitters rated at a maximum output power not listed above, the recommended separation distance ‘d’
in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Compliance
Electromagnetic environment – guidelines
RF emissions CISPR 11
Group 1
PICO uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause interference in nearby electronic equipment.
RF emissions CISPR 11
Class B
Harmonic emissions IEC
Not Applicable
Voltage fluctuations/flicker
Not Applicable
Cautions
This user guide is not intended as a
guarantee or warranty. It is intended only
as a guide. For medical questions please
consult a physician.
The product must be used in accordance
with this user guide and all applicable
labelling.
Note 1: At 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
Guidance and manufacturer’s declaration –
electromagnetic emissions
PICO is intended for use in the electromagnetic environment specified below.
The healthcare professional or the user of PICO should assure that it is used in such an
environment.
The RF emissions characteristic of PICO make it
use environments.
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
Not applicable
Emissions test
PICO is packed in the UK with individual
components made in the following countries:
Dressing – UK
Fixation strips – Belgium
Pump – China
Batteries – Origin as marked
Covered by or for use under U.S. Pat.
7964766, 8080702, D642594, D648353.
Date of issue 05/2012
12. System variants
8 sizes of dressing are available in kits
which contain 2 dressings, 1 pump and
secondary fixation strips:
10cm x 20cm
10cm x 30cm
10cm x 40cm
15cm x 15cm
15cm x 20cm
15cm x 30cm
20cm x 20cm
25cm x 25cm
/
/
/
/
/
/
/
/
4in. x 8in.
4in. x 11¾in.
4in. x 16in.
6in. x 6in.
6in. x 8in.
6in. x 11¾in.
8in. x 8in.
10in. x 10in.
66800951
66800952
66800953
66800954
66800955
66800956
66800957
66800958
Carry bag
Smith & Nephew Medical Limited
101 Hessle Road, Hull, HU3 2BN England
™Trade Marks of Smith & Nephew
The pump may be carried in the patient’s
pocket. Alternatively, a bag for carrying the
pump is also available. This can be
ordered with the following code:
©
PICO Carry bag
Smith & Nephew
66800918
Negative Pressure Wound Therapy Clinical Guidelines
75
Section 11
13. Glossary of symbols
Do not use if the package is
opened or damaged
Equipment Classification:
Isolation Type BF applied part
Keep product out of sunlight
Manufacturer
Leak alert
International classification
Date of manufacture
Keep dry
LOT
Lot Number
EU: Not for general waste
25°C/
77°F
STERILE EO
Product is sterilised by
Ethylene Oxide
Battery power indication
OK
Pump is functioning properly
only
Caution: Federal (USA) law
restricts this device to sale by
or on order of a physician
Storage temperature
CE Mark
0086
Start/pause/resume therapy
Attention:
See instructions for use
76
Appendix VII
Frequently asked questions and answers
What is the suction pressure of your machine or the range of pressure that the machine achieves?
RENASYS™ GO, 40mmHg-200mmHg
RENASYS EZ Plus, 40mmHg-200mmHg
PICO™ – operates at continuous negative pressure of nominally 80mmHg
Is the pressure pre-set?
The pressure is not pre-set on the RENASYS EZ Plus or the RENASYS GO. The pressure is pre-set on the PICO
system and it operates at continuous negative pressure of nominally 80mmHg.
Can it be changed?
The pressure setting on the RENASYS devices can be changed. With both pumps, the pressure can be set at
different levels. The device resumes at the same level of pressure as was set when it was last turned off or put
on standby.
The pressure cannot be changed on the PICO system.
Is there an Intermittent feature?
The RENASYS devices have an Intermittent feature. The PICO system does not have an Intermittent feature.
Is there a cut off which stops suction if the canister is full?
The RENASYS canisters are protected by a filter. An audible alarm will sound and a visual light flashes when
the canister is full, but the devices do not turn off. The PICO system is canister-free. The larger the PICO
dressing, the more fluid can be managed. Traditional NPWT may be the best option to manage wound fluid
that is expected to exceed greater than 50cc in 24 hours.
Is there a one-way valve to prevent fluid from coming back through the tubing towards the patient?
The RENASYS and PICO systems have a filter that prevents fluid from coming back through the tubing toward
the patient.
How long does the battery last?
RENASYS GO, 20 hours
RENASYS EZ Plus, 40 hours
The PICO system runs on two AA batteries that can be changed out if required, but should not be necessary. It
is indicated for use up to 7 days, at which time the system is disposable
How much does the machine weight? (How portable is it?)
RENASYS GO is 2.4 lbs, and comes with a shoulder strap and carry bag.
RENASYS EZ Plus is 7.4 lbs, and can be mounted on an IV pole and bed rail attachments.
PICO is less than 4.2 oz, and is small enough to easily fit in a pocket, like a smart phone.
What is the interface with the wound?
For the RENASYS systems, the wound interfaces are foam or AMD gauze. The PICO system employs a
revolutionary dressing technology that manages exudate, eliminating the need for canisters.
How often do you recommend changing the dressing?
We recommend changing foam and/or AMD gauze dressings every 48-72 hours. The PICO system may be left
in place for up to 7 days, depending on level of exudate.
Negative Pressure Wound Therapy Clinical Guidelines
77
Section 11
Can you “Y” wounds together and if so how many?
Yes, we recommend Y-connecting a maximum of two wounds. PICO™ dressing cannot be Y-connected.
How do you handle undermining?
The RENASYS™-F Foam Dressing and RENASYS-G Gauze Dressing Kits with Soft Port are both indicated
for undermining. We also recommend use of the RENASYS Channel Drain Kit with moistened gauze for
its ability to conform to these types of wounds. The PICO system can be used to handle undermining in
wounds with the addition of either a foam or gauze filler.
How do you handle fistulas?
We offer the RENASYS High Output Dressing Kit that includes a large 28Fr round irrigation aspiration drain.
This kit is indicated for explored fistulas and other high output wounds.
How do you handle exposed tendon or bone?
For the RENASYS systems, we offer a Non-Adherent Gauze in our gauze kits and recommend the use of a
non-adherent with a foam interface to protect exposed tendon or bone while it is under NPWT.
Do you have any special recommendations for high bioburden or infection?
We recommend the use of Smith & Nephew ACTICOAT™ Flex as a wound contact layer for wounds with
a high bioburden or infection. ACTICOAT Flex is compatible for use with gauze or foam NPWT interface
materials. ACTICOAT Flex is also indicated for use with PICO.
78
Appendix VIII
References
1. Chariker ME, Jeter KF, Tintle TE, Bottsford JE. Effective management of incisional and cutaneous fistulae with closed suction wound drainage.
Contemp Surg. 1989:34:59-63.
2. Schultz et al. Wound bed preparation: a systematic approach to wound management. Wound Rep Reg (2003) 11: 1-28.
3. Jeffery LC. Advanced wound therapies in the management of severe military lower limb trauma: a new perspective. Eplasty. 2009 Jul 21;9e28.
4. Dorafshar AH, Franczyk M, Lohman R, Gottlieb LJ. 2009. Prospective Randomized Study Comparing Gauze Suction Negative Pressure Wound
Therapy with Standard Vacuum Assisted Closure Device. Abstract presented at American Association Of Plastic Surgeons, 88th Annual
Meeting and Symposium March 21-25, 2009
5. Malmsjö M, Borgquist O. NPWT Settings and Dressing Choices Made Easy. Wounds International 2010; 1(3).
6. Negative Pressure Wound Therapy as a Dressing for Split-Thickness Skin Grafts: Our Experience. O’Brien, et al. Presented at CSAWC San
Antonio Oct 2009.
Additional resources
Afshin Rahmanian-Schwarz et al. A novel option in negative pressure wound therapy (NPWT) for chronic and acute wound care. Burns, 2011.
(in press)
Birke-Sorensen H et al. Evidence-based recommendations for negative pressure wound therapy: Treatment variables (pressure levels, wound
filler and contact layer) e Steps towards an international consensus*. Journal of Plastic, Reconstructive & Aesthetic Surgery (2011) 64, S1-S16.
Bondokji S. et al. Clinical efficacy of a new variant of foam-based NWPT system. journal of wound care vol 20 , no 2 , February 2011.
Campbell PE, Smith GS, Smith JM. Retrospective clinical evaluation of gauze-based negative pressure wound therapy. Int. Wound J. 2008
Jun;5(2):280-6.
Chariker ME, Jeter KF, Tintle TE, Bottsford JE. Effective management of incisional and cutaneous fistulae with closed suction wound drainage.
Contemp Surg. 1989:34:59-63.
Dunn RM et al. Assessment of Gauze-Based Negative Pressure Wound Therapy in the Split-Thickness Skin Graft Clinical Pathway—An
Observational Study. www.e-plasty.com, 2011 :116-126.
Dunn R et al. Factors associated with positive outcomes in 131 patients treated with gauze-based negative pressure wound therapy. International
Journal of Surgery 9 (2011) 258-262.
Hurd T et al. Impact of gauze- based NPWT on the patient and nursing experience in the treatment of challenging wounds. Int Wound J 2010;
7(6):448–455.
Krug et al. Evidence-based recommendations for the use of Negative Pressure Wound Therapy in traumatic wounds and reconstructive surgery:
Steps towards an international consensus. Injury – International Journal of the Care of the Injured. 2011; 42, S1-S12.
Llanos S et al. Effectiveness of Negative Pressure Closure in the Integration of Split Thickness Skin Grafts. A Randomized, Double-Masked,
Controlled Trial. Ann Surg 2006;244: 700–705).
Malmsjo M et al. Wound Edge Microvascular Blood Flow Effects of Negative Pressure Wound Therapy Using Gauze or Polyurethane Foam. Ann
Plast Surg 2009;63: 676–681).
Malmsjo M et al. Negative-pressure wound therapy using gauze or open-cell polyurethane foam: Similar early effects on pressure transduction
and tissue contraction in an experimental porcine wound model. Wound Rep Reg (2009) 17 200–205.
Malmsjö M et al. NPWT settings and dressing choices made easy. Volume 1 | Issue 3 | May 2010.
Malmsjö M et al. NPWT in clinical practice made easy. Volume 1 | Issue 5 | Nov 2010.
Vig S et al. Evidence-based recommendations for the use of negative pressure wound therapy in chronic wounds: Steps towards an international
consensus*. Journal of Tissue Viability (2011)
Negative Pressure Wound Therapy Clinical Guidelines
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