en
AESCULAP
®
STERILIT Power Systems oil spray GB600
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 Aesculap Power Systems prior to sterilization. Suitable for steam sterilization methods
validated 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
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.
►
Harmful to aquatic life with long-lasting effects.
►
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: TTSA-H6KK-X70D-22SP
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
►
Observe the instructions for use of the corresponding motor/handpiece.
►
Application using oil spray adapter, see Fig.
A
:
–
Attach a suitable adapter to the spray can.
–
Attach the adapter to the connector on the handpiece/motor.
–
Hold the oil spray can upright.
–
spray thoroughly for approx. 2s.
►
Apply using extension tube, see Fig.
B
:
–
Insert the enclosed red extension straw and make sure that it is firmly secured.
–
Hold the oil spray can upright.
–
Oil selected points.
►
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:
ats@aesculap.de
Other service addresses can be obtained from the address indicated above.
4.
Accessories
5.
Disposal
►
Adhere to national regulations when disposing of or recycling the product, its components and its packaging.
Art. no.
Designation
GB600
STERILIT Power Systems oil spray
STERILIT Power Systems adapter
For hand piece/motor
GB600840
Acculan 4
Acculan 3Ti
GB600880
Acculan 4 GA344
ELAN 4 GA844
GB600860
ELAN 4 electro
GB600850
ELAN 4 air
GB600870
ELAN 4 MIS shafts
microspeed uni XS
GB600820
microspeed uni
HiLAN
HiLAN XS
Hi-Line
Hi-Line XS
Hi-Line XXS
GB600810
micro-line
GB600830
mini-line
