Elite Implant senza 3 lingue
25-01-2010
10:29
elite implant
®
A-SILICONE IMPRESSION MATERIAL
FOR SURGICAL APPLICATIONS
elite implant
elite implant
elite implant
®
M E D I U M
®
H E A V Y EXTRA
RIGID
®
I
G
H
T
U140130/D Last Update: 01/2010
L
Zhermack SpA
Via Bovazecchino, 100
45021 Badia Polesine (Rovigo) - Italy
tel. +39 0425 597611 - fax +39 0425 53596
www.zhermack.com - [email protected]
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Elite Implant senza 3 lingue
25-01-2010
Elite implant (50 ml)
Instruction for use with D2 dispenser
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Elite Implant senza 3 lingue
25-01-2010
Instruction for use with siringe
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Elite Implant senza 3 lingue
elite®implant
25-01-2010
INSTRUCTIONS FOR USE
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EN
IMPRESSION ADDITION SILICONE (VINYLPOLYSILOXANE)
FOR SURGICAL APPLICATIONS
Read the instructions carefully before use.
Classification according to 93/42/EEC: Class IIa medical device
Description
ELITE IMPLANT is the first sterile, radiopaque, biocompatible impression material.
APPLICATIONS: Impressions in implantology and all surgical applications which require
a sterile, biocompatible and radiopaque material.
The range:
ELITE IMPLANT HEAVY
1 disposable cartridge, 50 ml
+ 1 mixing tip
+ 1 intraoral tip, in sterile pack
ELITE IMPLANT MEDIUM
1 disposable cartridge, 50 ml
+ 1 mixing tip
+ 1 intraoral tip, in sterile pack
ELITE IMPLANT LIGHT
1 disposable cartridge, 5 ml
+ 1 mixing tip
+ 1 intraoral tip, in sterile pack
COLOUR
APPLICATIONS
Light
blue
Impressions of dental arches with
implants alone
Blue
Impressions of dental arches with
implants and natural teeth
Light
Green
In combination with Elite Implant
Medium, applied next to impression transfers and/or dental
preparations, if present
The shades of the three viscosities of ELITE IMPLANT have been conceived to provide
the maximum contrast with the colour of tissues and oral fluids.
Base paste/catalyst mixing ratio: 1:1.
For further information, see the section “Normative references”.
PRECAUTIONS
• Use only in dental practices and operating theatres.
• Verify pack integrity before use. If the pack is not sealed or intact, sterility is not guaranteed; in this case, do not use the product.
• Only open the pack immediately before use.
TRAY
USE STERILE, DRY TRAYS.
All standard and/or special trays are recommended, provided that they are non-deformable and rigid.
ADHESIVE
The use of Iperlink SCT - LCT is recommended. An optimal adhesion between the
tray and Elite Implant can be obtained only with a correct selection and use of the
adhesive.
Open the pack flaps carefully, making sure that the contents are not dropped accidentally. Unscrew the bottle cap, immerse the brush supplied and apply an even, thin
layer of Iperlink SCT - LCT on the tray. Wait at least 30 seconds to permit volatile agent
evaporation.
For a better adhesion, we recommend to degrease the tray with ethyl alcohol before
Iperlink SCT - LCT application.
For further information, see Iperlink SCT - LCT Istructions for use.
CLEANING AND DISINFECTING THE DISPENSER
USE STERILE DISPENSERS.
To clean, disinfect or sterilize the dispenser, always follow the manufacturer’s instructions.
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ELITE IMPLANT MEDIUM – 50 ML CARTRIDGE
ELITE IMPLANT HEAVY – 50 ML CARTRIDGE
Device preparation
Open the pack flaps carefully, making sure that the mixing tip and the intraoral tip
contained therein are not dropped accidentally.
Pull the cartridge out of the sterile envelope.
Mount the device as follows:
Caution: Before mounting the tip, ensure that the two components (base and catalyst)
flow out evenly by gently pushing the dispenser lever and extruding a small amount of
material, which must be removed.
Only in case of application of the single stage technique with 1 viscosity, the intraoral tip
can be applied to the mixing tip for the direct application of the material near pick-ups
and/or implant abutments, and on any preparations. Such an operation must be carried
out after filling the tray.
The device is now ready to be used by pushing the dispenser lever.
To remove and replace the dispenser cartridge, follow the indications starting from the first step.
TRAY FILLING
Begin to fill the tray from one side, and continue till the opposite side always keeping
the tip immersed in the material to avoid air inclusion in the bulk. If two viscosities are
used (two stage technique with 2 viscosities), begin to apply ELITE IMPLANT LIGHT in
the oral cavity only when the tray has been at least half-filled by the assistant with the
Medium or Heavy viscosity. This avoids ELITE IMPLANT LIGHT setting before tray insertion in the mouth.
Follow the indications shown in the illustrated sheet and the maximum times indicated
in the table “Clinical use times and technical data”.
ELITE IMPLANT LIGHT – 5 ML CARTRIDGE
Device preparation
Open the pack flaps carefully, making sure that the mixing tip and the intraoral tip
contained therein are not dropped accidentally.
Mount the device as follows:
The device is now ready to be used by pushing the plunger.
Caution: Before mounting the tip, ensure that the two components (base and catalyst)
flow out evenly by gently pushing the plunger and extruding a small amount of material, which must be removed.
The use of the rubber dam on implant abutments or pick-ups in open flap impression situations is not necessary, since ELITE IMPLANT is sterile and biocompatible.
ELITE IMPLANT LIGHT application
IMPORTANT: Position ELITE IMPLANT LIGHT keeping the mixing tip or the intraoral tip
completely immersed in the extruded material, to avoid air inclusion.
Follow the indications shown in the illustrated sheet and the maximum times indicated
in the table “Clinical use times and technical data”.
Once ELITE IMPLANT LIGHT is positioned in the oral cavity, insert the tray, previously
filled with ELITE IMPLANT MEDIUM or HEAVY, in the mouth.
IMPRESSION REMOVAL FROM THE ORAL CAVITY: Remove any fixing screws from the
pick-ups and, with a firm movement, extract the tray following the dental or implant axis.
NOTE: Radiopacity.
In case of subsequent radiological controls, thanks to the characteristics of radiopacity
of the material, it is possible to ascertain or exclude the presence of any fragments of
impression material which may remain accidentally trapped inside the oral cavity.
IMPRESSION DISINFECTION: The impression can be immediately rinsed under running
water to remove any traces of organic fluids (blood or saliva). The impression must be
immediately disinfected. Ideal disinfecting is achieved by immersing the impression in
Zeta 7 solution (Zhermack) or spraying it with Zeta 7 spray (Zhermack).When using
other disinfectants, always follow the manufacturer’s instructions.
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IMPRESSION STORAGE AND MODEL CASTING: Store and transport ELITE IMPLANT
impression at room temperature inside the Safety Life Bag provided.
The model casting can be carried out immediately after disinfection (no waiting times
are required). ELITE IMPLANT impressions can be cast up to two weeks from impression taking, provided that they are stored as indicated above.
ELITE IMPLANT is compatible with all the best gypsums on the market, as well as with
polyurethane and epoxy resins. Use Elite Master, Elite Rock, Elite Rock Fast extra hard
die stone (Zhermack) and Elite Model / Elite Model Fast hard model dental stone
(Zhermack).
STORAGE: Store far from heat sources and at a temperature range from 5 to 27°C / 41°F
– 80°F.
ELITE IMPLANT impression materials are guaranteed for 36 months from the manufacture date. Sterility is guaranteed until the expiry date of the product, provided that the
pack is intact.
Do not use the product after the expiry date.
DISPOSAL: Do not disperse the product in the environment. Dispose of the device as
medical waste at risk of contamination, in accordance with the rules in force.
WARNINGS
• THE MATERIAL CANNOT BE REUTILIZED AND RE-STERILIZED IN THE AUTOCLAVE.
• The outer package has a removable adhesive label with Elite Implant identification data. This label can be removed and applied to the clinical record of the patient to
assure the complete traceability of the materials used during surgery.
• The direct contact of Elite Implant with rubber dams or latex gloves might inhibit setting.
NORMATIVE REFERENCES
STERILITY: According to UNI EN 556-1, a product must be considered sterile when the
theoretical probability of the presence of a vital micro-organism on/in the device itself is
less or equal to 1 out of 1 million (SAL = 10-6).
ELITE IMPLANT is a medical device which has been subjected to a sterilization process
by means of ionizing radiations (ß rays), and found compliant with EN 552.
RADIOPACITY: The product radiopacity allows for a rapid identification – through radiological control – of any fragments of material accidentally left inside the oral cavity during tray removal.
All radiopacity tests on ELITE IMPLANT have been carried out by measuring the optical
density of the material according to the method described by ISO 4049 (§ 7.14). Thus
it was possible to discern a 0.2 mm thick trace of material overlapped on incisors and
gingival tissues.
BIOCOMPATIBILITY: Biocompatibility has been evaluated by external laboratories, in accordance with UNI EN ISO 10993-5 and UNI EN ISO 10993-10. ELITE IMPLANT has not
caused irritating effects at skin level, and has not been found sensitizing and cytotoxic.
TECHNICAL DATA
ELITE IMPLANT
Hardness “Shore A”
Total working time*
Time in mouth
Setting time*
HEAVY
70
1:30 min
2:00 min
3:30 min
MEDIUM
55
1:30 min
2:00 min
3:30 min
LIGHT
50
1:30 min
2:00 min
3:30 min
*The above mentioned times are intended from the start of mixing, at 23°C./73°F.
IMPORTANT REMARKS: Advice on the use of our products, issued verbally, in writing or through demonstration, is based on our current medical knowledge. It must be considered as information not binding,
even in relation to any rights of third parties, and it does not exempt the user from personally controlling
product suitability for a specific application. The use and application on the part of the user take place
without the possibility of any control on the part of the Company, and therefore come under the responsibility of the user. Any responsibility for damages is limited to the value of the goods supplied by the
Company and used by the user.
FOR PROFESSIONAL USE ONLY
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