Functional Test; Assembly; Packaging; Steam Sterilization - Braun Aesculap TSPACE PEEK Instructions For Use/Technical Description

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3.11.2 Functional test

CAUTION
Damage (metal cold welding /friction corrosion) to
the product caused by insufficient lubrication!
►
Prior to function checks, lubricate moving parts
(e.g. joints, pusher components and threaded
rods) with maintenance oil suitable for the
respective sterilization process (e.g. for steam
sterilization: STERILIT® I oil spray JG600 or
STERILIT® I drip lubricator JG598).
►
Assemble disassembled products, see Assembly.
►
Check that the product functions correctly.
►
Check that all moving parts are working property
(e.g. hinges, locks/latches, sliding parts etc.).
►
Check for compatibility with associated products.
►
Immediately put aside inoperative products and
send them to Aesculap Technical Service, see Tech-
nical service.

3.12 Assembly

SN305R insertion instrument
►
Turn the switch 2 to the left (direction ).
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Insert the rod 6 into the tube 1, see Fig. 12.
►
Turn the rotary nut 3 counterclockwise ("loosen"
direction) to push the rod 6 forward, see Fig. 1.

3.13 Packaging

►
Place the product in its holder or on a suitable tray.
Ensure that sharp edges are covered.
►
Package trays appropriately for the sterilization
process (e.g. in Aesculap sterile containers).
►
Ensure that the packaging provides sufficient pro-
tection against contamination of the product dur-
ing storage.
18

3.14 Steam sterilization

Note
SN305R insertion instrument may only be sterilized in
disassembled state.
►
Check to ensure that the sterilizing agent will come
into contact with all external and internal surfaces
(e.g., by opening any valves and faucets).
►
Validated sterilization process
– Disassemble the product
– Steam sterilization using fractional vacuum
process
– Steam sterilizer according to DIN EN 285 and
validated according to DIN EN ISO 17665
– Sterilization using fractionated vacuum process
at 134 C/holding time 5 min
►
If several devices are sterilized at the same time in
the same steam sterilizer: Ensure that the maxi-
mum permitted load according to the manufactur-
ers' specifications is not exceeded.

3.15 Storage

►
Store sterile products in germ-proof packaging,
protected from dust, in a dry, dark, temperature-
controlled area.
4.

Technical service

CAUTION
Modifications carried out on medical technical
equipment may result in loss of guarantee/warranty
rights and forfeiture of applicable licenses.
►
Do not modify the product.
►
For service and repairs, please contact your
national B. Braun/Aesculap agency.
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.