B. Braun Aesculap micro-Line GD450M, Инструкция по эксплуатации

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6.9 Inspection, maintenance and checks
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Allow the product to cool down to room temperature.
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Inspect the product after each cleaning and disinfecting cycle to be sure it is: clean, functional, and undamaged.
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micro-Line Prior to sterilization, spray through the handpiece with Aesculap-STERILIT oil spray GB600 with
adapter GB600810 for approx. 1 s.
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Check the product for any damage, abnormal running noise, overheating or excessive vibration.
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Inspect tools for broken, damaged or blunt edges.
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Set aside the product if it is damaged.
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Prior to an extended period of non-use, store attachments cleaned, maintained and dried according to the
instructions.
6.10 Packaging
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Follow the instructions for use for the applied packaging and storage systems (e.g. instructions for use TA009721
for Aesculap Eccos storage system).
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Insert the product in its proper position in the Eccos holder, or put it on a tray in such a way that the product is
protected against damage. Ensure that all cutting edges are protected.
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Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers).
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Ensure that the packaging will prevent a recontamination of the product.
6.11 Steam sterilization
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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).
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Validated sterilization process
– Steam sterilization using fractionated 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
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When sterilizing several products at the same time in a steam sterilizer, ensure that the maximum load capacity
of the steam sterilizer specified by the manufacturer is not exceeded.
6.12 Sterilization for the US market
■
Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization.
■
Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave.
To achieve a sterility assurance level of 10
-6
, Aesculap recommends the following parameters:
*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an
Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles
may also be suitable, however individuals or hospitals not using the recommended method are advised to validate
any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility
after processing, such as a wrap, pouch, etc.
6.13 Storage
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Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
7. Maintenance
To ensure reliable operation, the product must be maintained at least once a year.
For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.
8. Troubleshooting list
9. Technical Service
►
For service and repairs, please contact your national B. Braun/Aesculapagency.
Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and for-
feiture of applicable licenses.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone:
+49 (7461) 95 -1601
Fax: +49 (7461) 14 -939
E-Mail: ats@aesculap.de
Or in the US:
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood
MO, 63042 USA
Aesculap Repair Hotline
Phone:
+1 (800) 214 -3392
Fax: +1 (314) 895 -4420
Other service addresses can be obtained from the address indicated above.
10. Accessories/Spare parts
11. Technical data
Classification acc. to Directive 93/42/EEC
Aesculap Orga Tray/Sterile container (perforated bottom)
Minimum cycle parameters*
Sterilization method Temp. Time Minimum drying time
Prevacuum 270 °F/275 °F 4 min 20 min
Malfunction Detection Cause Remedy
micro-Line straight
handpiece/angled hand-
piece not running Collet not locked Tension ring fixed/closed
or not tightened Turn the tension ring
against the direction of
the arrow until the marks
on the tension ring and
on the handle part are
aligned with each other
Marks on the tension ring
and on the handle part no
aligned with each other Tension ring fixed/closed
or not tightened Turn the tension ring
against the direction of
the arrow until the marks
on the tension ring and
on the handle part are
aligned with each other
Drive unit/motor not
reacting Drive unit/motor defec-
tive Check drive unit/motor
according to appropriate
instructions for use
Insufficient power Tool not cutting correctly Cutting edges worn Replace the tool
Drive unit/motor not run-
ning correctly Drive unit/motor defec-
tive Check drive unit/motor
according to appropriate
instructions for use
Tool change impossible Tension ring does not
rotate freely or does not
rotate at all Collet jammed Have repaired by manu-
facturer
Tool blocked Tool is jammed Have repaired by manu-
facturer
micro-Line straight
handpiece/angled hand-
piece vibrating Irregular running noise Bearing defective Have repaired by manu-
facturer
Tool shaft bent Tool damaged Replace the tool
micro-Line straight
handpiece/angled hand-
piece heating up during
operation Rapid temperature rise Bearing defective Have repaired by manu-
facturer
WARNING
Risk of injury and/or malfunction!
►
Do not modify the product.
Art. no. Designation
GD460R Spray nozzle for GD450M, GD455M, GD465M
GD461R Spray nozzle for GD451M, GD456M, GD466M
GD462R Spray nozzle for GD457M, GD467M
GB600 Aesculap STERILIT oil spray
GB600810 STERILIT micro-Line adapter
GB681R Eccos holder (for 3 handpieces)
GD682R Eccos holder (for 1 handpiece)
GB459R Eccos mounting set for holders
TA012581 Instructions for use for GD450M, GD451M, GD455M, GD456M,
GD457M, GD465M, GD466M, GD467M
see Aesculap catalog Power Systems -
Burrs & Blades Tools (e.g. GD025R)
Art. no. Designation Class
GD450M, GD451M,
GD455M, GD456M,
GD457M, GD465M,
GD466M, GD467M micro-Line straight handpiece/angled handpiece IIa
micro-Line straight hand-
piece/angled handpiece Gear
ratio Motor
drive rpm
(rpm) Tool speed
(rpm) Weight
(g) Tool
length
(mm,
max.) Class
GD450M 1:1 0–40 000 0–40 000 69 70 II a
GD451M 1:1 0–40 000 0–40 000 76 95 II a
GD455M 1:2 0–40 000 0-80 000 90 70 II a
GD456M 1:2 0–40 000 0-80 000 97 95 II a
GD457M 1:2 0–40 000 0-80 000 104 125 II a
GD465M 1:1 0–40 000 0–40 000 90 70 II a
GD466M 1:1 0–40 000 0–40 000 97 95 II a
GD467M 1:1 0–40 000 0–40 000 104 125 II a