en
AESCULAP
®
STERILIT I oil spray JG600
1.
About this document
Note
General risk factors associated with surgical procedures are not described in these instructions for use.
1.1
Scope
These instructions for use apply to the product below:
1.2
Safety messages
Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the prod-
uct. Safety messages are labeled as follows:
WARNING
Indicates a possible threat of danger. If not avoided, minor or moderate injury may result.
2.
Clinical use
2.1
Product description
Oil for the maintenance of surgical instruments prior to sterilization. Suitable for steam sterilization methods vali-
dated according to EN ISO 17665.
Properties
■
Oil film permeable to water vapor
■
Oil film not affecting the effectiveness of sterilization
■
Lubrication and anticorrosion effect
■
Silicone-free, no staining or encrustations on instrument surfaces
2.2
Areas of use and limitations of use
2.2.1
Intended use
STERILIT is used within the reprocessing process to lubricate joints and movable parts in order to reduce friction and
prolong product life. It is used on the cleaned medical devices prior to steam sterilization validated according to EN
ISO 17665.
2.2.2
Indications
Note
The manufacturer is not responsible for any use of the product against the specified indications and/or the described
applications.
For indications, see Intended use.
2.2.3
Contraindications
No known contraindications.
2.3
Safety information
2.3.1
Clinical user
General safety information
To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and
liability:
►
Use the product only according to these instructions for use.
►
Follow the safety and maintenance instructions.
►
Ensure that the product and its accessories are operated and used only by persons with the requisite training,
knowledge and experience.
►
Store any new or unused products in a dry, clean, and safe place.
►
Prior to use, check that the product is in good working order.
►
Keep the instructions for use accessible for the user.
Note
The user is obligated to report all severe events in connection with the product to the manufacturer and the responsi-
ble authorities of the state in which the user is located.
Notes on surgical procedures
The medical professional will make decisions on concrete applicability based on the warranted properties and tech-
nical data.
2.3.2
Product specific safety information
Risk of injury and/or malfunction!
►
Check product for loose, bent, broken, cracked, worn or missing parts before every application.
►
Extremely flammable aerosol!
►
Pressurised container May burst if heated.
►
Keep out of reach of children.
►
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources.
►
No smoking.
►
Do not spray on an open flame or other ignition source.
►
Do not pierce or burn, even after use
►
Protect from sunlight.
►
Do not expose to temperatures exceeding 50 °C / 122 °F.
►
Ensure aerosols are completely empty before recycling.
►
Observe the Safety Data Sheet, see eifu.bbraun.com
Safe handling
►
Prior to the application of STERILIT, medical products must be cleaned and disinfected according to their respec-
tive instructions for use.
►
Only apply prior to sterilization.
►
Ensure adequate ventilation.
►
Store in a dry place.
►
Evaporative cooling effect during use!
Emergency telephone number
+49 (0) 6132-84463 GBK GmbH
■
24/7
■
190 languages
■
medical advice in case of poisoning
■
Advice in the event of an accident or other incidents
Unique Formula Identifier (UFI-Code)
UFI: Q8RA-E65F-E70F-5X9H
2.3.3
Sterility
The product is supplied non-sterile and shall be used under non-sterile conditions.
►
After removing its transport packaging and prior to first use, inspect the new product to ensure it is in proper
working condition.
2.4
Application
►
Check the product for cracks, dents and damaged seal before each use.
►
Observe the instructions for use of the corresponding instrument.
►
Insert the attached white plastic tube.
►
Apply the oil directly onto the joint area
►
Open and close the instrument several times so that the oil is evenly spread.
►
Remove excess oil using a lint-free cloth.
3.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone:
+49 7461 95-1601
Fax:
+49 7461 16-2887
E-Mail:
Other service addresses can be obtained from the address indicated above.
4.
Disposal
►
Adhere to national regulations when disposing of or recycling the product, its components and its packaging.
5.
Symbols on product and packaging
TA012083 2021-07 Change No. AE0060675
Art. no.
Designation
JG600
STERILIT I oil spray
Danger! Extremely flammable aerosol
Manufacturer’s order number
Nominal filling quantity
Conformity mark for pre-packaging ordinance
Full capacity volume
Conformity mark for aerosol packaging
Use by: see bottom
Emergency telephone number
Observe the instructions for use
Hold the oil spray can upright
This side up