GLYSURE CONTINUOUS INTRAVASCULAR GLUCOSE
SENSOR – CARDIAC APPLICATION
INSTRUCTIONS FOR USE
GLYSURE CONTINUOUS INTRAVASCULAR GLUCOSE SENSOR: DSP-04-01
L-0047-EN-03
INTENDED USE
WARNINGS AND CAUTIONS
The GlySure Continuous Intravascular Glucose
Monitoring System (system) is intended to quantitatively
and continuously measure intravascular blood glucose
levels, directly in whole blood.
All warning and safety notices should be read before use.
The device is safe for patients and clinicians when used
in accordance with the instructions and with the warning
and caution statements presented in this manual.
The device is a point-of-care, prescription use device, for
professional use only.
WARNING: The GlySure system is contraindicated for
use when mannitol is being administered to the patient,
either as a therapeutic agent, or as a constituent part of
any treatment modality. The use of mannitol as a
therapeutic or as a reconstitution fluid for red blood cells
which are subsequently used for blood transfusion may
affect the sensor. Note: fluids used to prime
extracorporeal tubing circuits frequently contain
mannitol. If mannitol is administered to a patient who has
a GlySure sensor inserted, monitoring should cease and
the sensor should be removed. For further information
regarding the use of mannitol, see the GlySure
Continuous Intravascular Glucose Monitoring
System Instructions For Use.
The GlySure Continuous Intravascular Glucose Sensor
(sensor) is intended for placement in the right internal
jugular vein.
The device is not intended for home use.
INDICATIONS FOR USE
The GlySure system is indicated for continuous
intravascular blood glucose monitoring in the ICU for the
adult cardiac surgery patient population to provide
clinical data, facilitating the practice of glycaemic control
using approved hospital protocols, guiding therapy and
patient management.
WARNING: The sensor tip is covalently bonded with a
heparin coating1 to reduce fibrin deposition and maintain
sensor performance. This may induce or aggravate preexisting heparin induced thrombocytopenia (HIT).
The device is a pointof-care, prescription use device, for
professional use only.
WARNING: The sensor is a single-use, disposable
device, and has been designed such that it cannot be reused.
The sensor is inserted into the right internal jugular vein
using the GlySure Central Venous Catheter (CVC) set.
This 5-lumen CVC is the only catheter that is compatible
with the GlySure sensor.
WARNING: Possible
complications
of
vascular
cannulation should be fully considered prior to insertion
of the sensor.
Continuous glucose monitoring is not a substitute for
intermittent laboratory assessment of blood glucose.
This product is available for sale only upon the order of
a physician or licensed health care professional.
WARNING: The sensor is only compatible with the
GlySure CVC, intended for placement in the right internal
jugular vein, and must not be inserted through any other
catheter. It must only be placed through the lumen
labelled ‘16G GLYSURE’, coloured blue, which is the
most proximal lumen.
WARNING: The sensor is sterile only if the pack is not
damaged or is unopened. Do not use if; the package is
damaged or broken, the y-site male luer/luer lock is not
connected to the calibration pod (Figure 2), the luer cap
is not connected to the y-site or if liquid can be seen
inside the pack.
Use of the sensor is limited to 48 hours.
CONTRAINDICATIONS FOR USE
The GlySure system is contraindicated for:
• Patients who are being administered mannitol,
either as a therapeutic agent, or as a constituent
part of any treatment modality.
• Patients with a history of pulmonary embolism (PE).
• Patients with a history of thrombosis.
• Patients with known hyper coagulation.
• Patients under 18 years of age.
WARNING: Only remove the sensor from its foil pouch
immediately prior to sensor calibration. Once removed,
the sensor must be calibrated immediately.
WARNING: Whilst the sensor is still in the calibration pod,
prior to removal for insertion to the patient, visually
inspect the sensor tip for signs of damage.
WARNING: The sensor should not be removed from the
calibration pod until calibration has been completed.
Once removed from the calibration pod, the sensor
should immediately be inserted into the GlySure CVC,
already established in the patient’s vascular system.
CAUTION: Hold the rigid blue moulding while retracting
the sensor to avoid stretching the clear tube and
potentially damaging the sensor.
1
SurModics HP-01 Photo-heparin
2 of 12
CAUTION: If on removal from the calibration pod the
sensor is seen to protrude beyond the luer taper
discontinue use of the sensor. Calibrate a new sensor
and return the discontinued sensor to GlySure.
WARNING: Use of excessive force should be avoided
during insertion/withdrawal of the sensor. Any resistance
to movement is to be carefully investigated before
proceeding.
WARNING: If the GlySure CVC needs to be removed
during the monitoring period, withdraw the sensor
according to the instructions detailed in section
COMPLETION OF MONITORING AND SENSOR
WITHDRAWAL. If further monitoring is required calibrate
a new GlySure sensor for insertion into a new GlySure
CVC. Do not re-use sensors.
CAUTION: Do not subject the sensor to extreme
bending, kinking, stretching or crushing.
CAUTION: If any damage is noted, discontinue use of
the sensor. Calibrate a new sensor and return the
discontinued sensor to GlySure.
WARNING: Ensure that the infusion line, including the
introducer y-site, has been completely purged and is free
from air before connecting to the blue sensor lumen of
the GlySure CVC.
WARNING: Once inserted into the blood vessel, the
sensor must not be retracted back into the introducer.
WARNING: Ensure the sensor is locked in place when
fully advanced. This is indicated by an audible click.
WARNING: The sensor includes a fine optical fibre and a
thermocouple; do not use haemostat clamps or any
similar instruments to occlude any section of the
introducer tubing.
WARNING: Do not over-tighten connections during the
monitoring period.
WARNING: Ensure the sensor is securely attached to the
patient following the instructions detailed in this
document.
WARNING: The GlySure sensor lumen must be
continuously flushed using 0.9% saline solution at 24ml/hr. This should be done using a syringe pump.
CAUTION: The sensor must never be flushed with
dextrose containing solutions.
WARNING: If blood samples are drawn from the GlySure
CVC, the samples should be drawn from the lumen
labelled ‘18G PROXIMAL’. This ensures the sample
consists of blood closest to the sensor site and minimises
the risk of contamination of the sample by any infusates
from the more distal medication lumens.
WARNING: If the data displayed appears anomalous or if
therapy is to be based on the data displayed, a
confirmatory blood glucose measurement should be
taken using a customary method of blood glucose
measurement.
WARNING: Never use bedside glucometers to analyse
correlation samples, or record data derived from these
types of instruments.
WARNING: If possible avoid disconnecting the sensor
from the monitor cable while in use. Disconnection of the
sensor may result in an additional blood sample request.
WARNING: Use of the sensor is limited to 48 hours.
WARNING: During the period of use, recognised
complications of vascular cannulation may be observed.
These include, but are not limited to; thrombosis, air
embolus, haemorrhage, vessel occlusion and sepsis.
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SYMBOLS
Specific warnings and cautions are associated with this medical device
Consult the instructions for use for details
Consult instructions for use
Do not use if package is damaged
Sterilised using ethylene oxide
Do not re-use
Do not resterilise
Keep dry
Keep away from sunlight
Temperature limit
Catalogue number
Batch number
Use-by date
Manufacturer
This way up
QTY
Quantity
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GLYSURE CONTINUOUS INTRAVASCULAR
GLUCOSE SENSOR
IN VITRO SPECIFICATION
The GlySure sensor is a single-use device intended to
quantitatively and continuously measure intravascular
blood glucose levels, directly in whole blood. The sensor
provides clinical data, facilitating the practice of
glycaemic control using approved hospital protocols,
guiding therapy and patient management.
The sensor (Figure 1) is supplied sterile. Inside the
packaging the sensor is enclosed in a disposable
calibration pod (Figure 2). Calibration is performed
automatically under software control.
The sensor comprises of a fine optical fibre, a
thermocouple and a strengthening wire. The sensor tip
is covalent bonded with a heparin coating2 to reduce
fibrin deposition and maintain sensor performance.
CAUTION: Do not use haemostat clamps or any similar
instruments to occlude any section of the introducer
tubing.
CAUTION: Do not subject the sensor to extreme
bending, kinking, stretching or crushing.
Measurement parameter
Blood Glucose
1- 28mmol/L
(20 - 500mg/dL)
≤350 seconds to 90% of
equilibrium value
Range
Mean response time
IN VIVO PERFORMANCE
Clinical trial data supports a Mean Absolute Relative
Difference (MARD) of 9.9% against a YSI Analyser3.
99.8% of individual glucose measurements, referenced
against a YSI Analyser, fall within the A+B zone of the
Consensus Error Grid (CEG), BS EN ISO 15197:2013.
SENSOR LIFETIME
Clinical trial data supports use of the GlySure sensor for
48 hours. Use of the sensor is limited to 48 hours.
STORAGE
The packaging also contains a small length
(approximately 100mm) of thin monofilament. This is
provided such that the calibration pod can be resealed
(after the sensor has been withdrawn) for shipping back
to the manufacturer if required.
Storage temperature: 18°C - 25°C.
Keep dry.
Ensure the product is stored in the orientation indicated
by the ‘This way up’ arrows on the carton.
The use-by date is indicated on the external packaging.
CAUTION: Upon removal from the packaging, inspect
the product to ensure no damage has occurred. Do not
use the sensor if damaged.
Luer cap
Y-site
Sensor
Rigid blue moulding
Male luer/
luer lock
Clear
tube
Clip
Black
tube
Optical/electrical
connector
Figure 1: Sensor introducer assembly
Calibration pod
Sensor
Luer cap
Luer lock
Figure 2: Sensor assembly - as supplied
2
SurModics HP-01 Photo-heparin
3
YSI 2300 STAT Plus™ Analyser manufactured by YSI
Life Sciences
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PRE-CALIBRATION
7.
When using the GlySure sensor users must refer to the
GlySure
Continuous
Intravascular
Glucose
Monitoring System Instructions For Use and GlySure
Central Venous Catheter Set Instructions For Use for
additional information.
1.
Completion of the system start-up prompts the
‘Connect sensor’ screen.
2.
Check the integrity of the seals of the sterile pack
and confirm that luer lock (Figure 2) is attached to
the calibration pod and the luer cap has remained in
place on the y-site.
3.
Remove the sensor/introducer with calibration pod
from the sterile packaging, check that there is no
liquid in the monitor patient cable connector.
4.
Connect the monitor patient cable connector to the
corresponding sensor connector by pushing the
connector halves together and rotating the locking
collar until the lock mechanism is felt to engage and
the grip features align (Figure 3).
A temperature check will automatically be initiated.
On completion of the temperature check the ‘Start
calibration’ screen will be displayed.
NOTE:
If the temperature check has been
completed successfully prior to the calibration pod
being inserted into the calibrator slot, the software
will automatically proceed to the ‘Start calibration’
screen.
8.
Press the ‘Calibrate’ button to start the calibration
before the time indicated at the top of the screen.
Refer to the GlySure Continuous Intravascular
Glucose Monitoring System Instructions For
Use for further calibration process details.
CAUTION: If any problems are detected while preparing
for calibration a message will be displayed along with
associated instructions. A full list of messages is shown
in the GlySure Continuous Intravascular Glucose
Monitoring System Instructions For Use.
CALIBRATION
Calibration is an automatic process that heats, stirs and
measures a glucose solution under full control of the
monitor. A progress bar will be updated during
calibration. The calibration will last approximately 60
minutes.
1.
Figure 3: Mating the connectors
5.
On connection of a valid sensor the system will
proceed to the ‘Insert calibrator’ screen.
6.
Gently push the calibration pod into the calibrator
via the calibrator slot, ensuring that it is fully inserted
(Figure 4). The alignment groove on the side of the
calibration pod should be facing up. The calibration
pod will be locked in place, and cannot be removed
unless the calibration is completed or the sensor is
disconnected.
The patient ID can be entered during or after
calibration. Users should ensure that the correct
patient ID is entered. The patient ID is a unique
identifier that is used instead of the patient’s name;
this could be the hospital ID assigned to the patient.
NOTE:
The patient ID cannot be modified once
monitoring has been started, so care should be taken to
ensure that the patient’s ID is entered correctly during
calibration.
NOTE:
The minimum length patient ID is 3
characters. The maximum length ID is 30 characters;
beyond this the patient ID will be truncated.
NOTE:
Symbols that are not compatible with the
system may be replaced with a ‘_’. These include the
characters: / : < and >.
CAUTION: Do not disconnect the two halves of the
sensor/ monitor connectors during calibration.
CAUTION: Do not pull on the calibration pod or remove
during calibration as this may terminate the calibration
process.
CAUTION: Do not withdraw the sensor from the
calibration pod until calibration has completed.
Figure 4. Insert calibration pod
CAUTION: Do not retract the sensor from the
calibration pod until calibration has completed.
CAUTION: The sensor should be connected prior to
the calibration pod being inserted into the calibrator
within the monitor.
CAUTION: Do not power down the monitor during
calibration.
These will result in a failed calibration – a new sterile
sensor will then need to be calibrated.
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SUCCESSFUL CALIBRATION
2.
Successful completion of calibration will be
displayed on the ‘Calibration complete’ screen and
is indicated by a fully filled progress bar and a
message with instructions.
3.
Leave the calibration pod in the monitor until ready
to begin sensor insertion.
NOTE:
The GlySure sensor must be inserted into the
patient’s right internal jugular vein (RIJV) via the blue
sensor lumen ‘16G GLYSURE’ of the GlySure CVC
before selecting the ‘Sensor inserted’ button. See
section SENSOR INSERTION for further details.
WARNING: The GlySure sensor is only compatible with
the GlySure CVC, intended for placement in the RIJV,
and must not be inserted through any other catheter. It
must only be placed through the lumen labelled ‘16G
GLYSURE’, coloured blue, which is the most proximal
lumen. For CVC insertion refer to the GlySure Central
Venous Catheter Set Instructions For Use.
CAUTION: The sensor must be calibrated and inserted
in the patient within 12 hours of removal from the sterile
pack. The time remaining to calibrate and insert the
sensor is displayed.
CAUTION: Do not touch the sensor once it has been
removed from the calibration pod as this will cause
contamination of the sensor.
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SENSOR INSERTION
Having set up the central venous access/infusion line in
accordance with approved hospital protocol, the sensor
is ready for positioning in the right internal jugular vein
(RIJV).
calibrator within the monitor. If the calibration pod
cannot be withdrawn easily, gently push the pod into
the calibrator and then remove. Do not force the
removal of the calibration pod from the monitor, as
this will damage the locking mechanism.
4.
CAUTION: Possible
complications
of
vascular
cannulation should be fully considered prior to insertion
of the sensor.
CAUTION: The GlySure system is contraindicated for
use when mannitol is being administered to the patient,
either as a therapeutic agent, or as a constituent part of
any treatment modality. The use of mannitol as a
therapeutic or as a reconstitution fluid for red blood cells
which are subsequently used for blood transfusion may
affect the sensor. Note: fluids used to prime
extracorporeal tubing circuits frequently contain
mannitol. If mannitol is administered to a patient who has
a GlySure sensor inserted, monitoring should cease and
the sensor should be removed. For further information
regarding the use of mannitol, see the GlySure
Continuous Intravascular Glucose Monitoring
System Instructions For Use.
Whilst the sensor is still in the calibration pod, prior
to removal for insertion to the patient, visually
inspect the sensor tip for signs of damage. If any
damage is noted, discontinue use of the sensor.
Calibrate a new sensor and return the discontinued
sensor to GlySure.
CAUTION: Do not remove the sensor from the
calibration pod until ready for sensor insertion as the
sensor will dehydrate.
5.
Remove and discard the clip, which consists of two
parts; a rigid moulding and a split silicone tube (see
Figure 5).
Clip
CAUTION: The sensor must be calibrated and inserted
in the patient within 12 hours after removal from the
sterile pack.
CAUTION: CVC position should be verified according to
approved hospital protocol prior to sensor insertion. This
may be done by x-ray or other imaging modality. Do not
insert a sensor if the CVC appears kinked or damaged.
1.
Establish a continuous 0.9% saline infusion in
accordance with approved hospital protocol. Use a
commercially available infusion pump capable of
delivering a 2-4ml/hr infusion.
2.
Connect the continuous saline infusion line (24ml/hr) to the blue sensor lumen ‘16G GLYSURE’
at the earliest convenience to maintain line patency.
Ensure that the line is completely purged of air and
flushed with a 5-10ml bolus of saline just prior to
connection.
CAUTION: The GlySure CVC blue sensor lumen
‘16G GLYSURE’ is the only lumen to be used for
insertion of the sensor.
CAUTION: Intravenous fluids containing dextrose or
dextrose/saline mixtures must not be infused
through the GlySure sensor lumen and over the
sensor as this will interfere with the blood glucose
reading measured by the sensor.
3.
When ready to insert the sensor, remove the
calibration pod and sensor/introducer from the
Calibration pod
Luer cap
Luer lock and y-site
Figure 6: Sensor withdrawal from calibration pod
Figure 5: Removing the white clip from black tube
6.
With the sensor still attached to the calibration pod,
hold the rigid blue moulding (to avoid stretching the
clear tube) and gently retract the sensor (black tube)
until a ‘stop’ is felt (Figure 6).
CAUTION: Hold the rigid blue moulding while
retracting the sensor to avoid stretching the clear
tube and potentially damaging the sensor.
7.
Ensure the sensor is fully retracted to a position
inside the y-site to prevent touch contamination.
8.
Undo the rotating luer lock and remove from
calibration pod.
CAUTION: If the sensor is protruding beyond the
luer lock, do not continue to use the sensor. Return
the sensor to GlySure and calibrate another sensor.
9.
The sensor is now ready for connection to the
vascular catheter/infusion line.
10. Remove luer cap from sensor y-site ensuring that
the prepared infusion line remains air-free.
Rigid blue moulding
Clear tube
Black tube
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Optical/electrical connector
11. Remove the saline infusion line from the sensor
lumen and couple the infusion line to the y-site side
arm.
12. Having completely purged air from the y-site,
connect the y-site and luer lock to the blue sensor
lumen ‘16G GLYSURE’ of the GlySure CVC.
Ensure the sensor line is flushed with a 5-10ml
bolus of saline just prior to connection.
CAUTION: Ensure the luer lock is connected
sufficiently tight to prevent any leakage but not overtightened.
19. Once sensor insertion is complete, secure the
introducer tubing to the patient just below the y-site
using the recommended fixation device (Grip-Lok®
3300M) in a manner that does not put strain upon
the introducer/catheter connection, does not bend
the sensor beyond a minimum bend diameter of
40mm (Figure 8), and does not interfere with
nursing care.
20. An additional fixation device (e.g. Grip-Lok® 3300M)
should be positioned behind the permanent
connector on the patient cable (Figure 8).
CAUTION: When securing the sensor, make sure
that there is no tension on the GlySure CVC blue
sensor lumen ‘16G GLYSURE’.
CAUTION: The sensor must never be placed in a
line which is used for dextrose infusions or solutions
containing any amount of dextrose in their
composition, including food supplements.
Blue 16G GLYSURE sensor lumen
Figure 7: The GlySure CVC with dedicated blue lumen for insertion of
the GlySure sensor, labelled ‘16G GLYSURE’
13. Establish a fast flush, approximately 2-5ml/min for
30-60 seconds prior to sensor introduction to avoid
any lumen occlusion.
14. Re-establish a KVO (keep vein open) rate of 24ml/hr.
15. Ensure the introducer remains as straight as
possible to minimise resistance to introduction.
16. Hold the sensor introducer carefully to avoid
buckling.
Slowly
and
consistently
(over
approximately 30 seconds) advance the inner black
tube into the outer clear tube. (It may assist the
insertion to turn the syringe pump driver supplying
the flush fluid to maximum rate).
CAUTION: Do not force the sensor forward. If there
is resistance, stop advancing the sensor and rotate
the inner black tube 30-45° allowing sensor to move
away from any obstruction and slowly advance
forward again.
Figure 8: Recommended sensor position and fixation device
locations. Refer to manufacturer’s instructions for further details
17. To secure the sensor, ensure that the moulding at
the rear of the clear tube has made an audible click
as it connects into the recess in the connector
indicating the sensor is fully advanced.
21. If blood samples are to be taken from the GlySure
CVC, re-establish the saline flush at a flow rate of 24ml/hr through the blood sampling lumen.
CAUTION: Ensure this lock is fully engaged as
failure to do so may well allow the sensor to
progressively retract back into the introducer tubing.
Once inserted into the blood vessel the sensor must
not be retracted back into the introducer.
22. The sensor is ready to commence continuous blood
glucose monitoring. Refer to the GlySure
Continuous Intravascular Glucose Monitoring
System Instructions For Use for additional
information.
CAUTION: Use of the sensor is limited to 48 hours.
18. Re-establish original flow rate of 2-4ml/hr over the
sensor after successful placement.
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CAUTION: Do not over-tighten connections during
the monitoring period.
COMPLETION OF MONITORING AND
SENSOR WITHDRAWAL
1.
2.
DISPOSAL
Clinical trial data supports use of the GlySure
sensor for 48 hours. A sensor can be removed prior
to 48 hours if no longer clinically warranted, or if
approved hospital protocol requires earlier removal.
Disconnect the sensor from the monitor cable by
rotating the locking collar until the lock mechanism
is felt to disengage. Pull the connector halves apart
to disengage (see Figure 9).
CAUTION: Follow approved hospital protocol, or contact
GlySure, when disposing of any part of the equipment.
CAUTION: Used CVCs and sensors should be treated as
bio-hazard waste and disposed of according to approved
hospital protocol. If CVCs or sensors are to be returned
to GlySure they should be packaged with bio-hazard
warning labels applied accordingly.
Figure 9: Sensor disconnection
3.
When the ‘Disconnect alert’ screen is displayed,
select the ‘End monitoring’ button to complete
monitoring of the patient. Press the button again to
confirm.
4.
The monitor can be powered off using the power
switch located on the rear of the monitor.
5.
If the GlySure CVC is to be removed at the same
time as completion of glucose monitoring, both the
CVC and the sensor/introducer should be removed
as a single unit. Use approved hospital protocol for
removing infusion lines.
6.
If the GlySure CVC is to remain in situ following the
completion of monitoring, loosen the rotating luer
lock that secures the introducer to the CVC. Slowly
withdraw the sensor/introducer from the CVC (the
sensor will be protruding from the y-site male luer).
7.
During removal apply compression to the blood
vessel at least 80mm beyond the blue CVC hub to
ensure that the sensor tip is not affected by the
compression point.
8.
Upon sensor removal, a freshly primed infusion line
should be connected to the CVC, and then
compression can be safely removed.
CAUTION: Do not use haemostat clamps or similar
instruments to clamp any of the sensor/introducer
tubings.
9.
In the unlikely event that the sensor encounters
resistance during the removal procedure, stop the
withdrawal immediately. The sensor/introducer and
catheter must then be removed as a single unit.
Removal over a guide wire will facilitate the use of
another vascular access device if required.
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