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29-5000 Pneumatik holder_EN C
04.06.12/03.12.2018
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VI - TECHNICAL SPECIFICATIONS - CARE/MAINTENANCE
VI-1 Specifications
Class I medical device classified according to the EEC/93/42 Directive on Medical
Devices
In compliances with FDA 510K, class II product.
CO
2
or compressed air pressure supply from 5 to 8 bar.
The resistance and torque depends on the pressure of the gas.
Main materials used:
• Mechanical parts: stainless steel 316L, aluminium 2017A + hard anodization
(rail clamp)
• Screws, pins, springs: stainless steel 302
• Seals, hoses: Viton, PTFE, and silicone
• Elastic ball joints: POM (Delrin) medical grade
No part or accessory is composed by latex
VI-2 Care - Maintenance
The essential care and maintenance of the Pneumatic Endoscope Holder consists of
following cleaning instructions (see section IV) and regular inspection of all sensitive
parts such as seals, mobile parts, and pneumatic hoses.
IMPORTANT:
An annual general inspection by the manufacturer is necessary to keep the
device in good working order.
This maintenance procedure includes a complete
inspection of the device, replacement of worn parts, and the final factory inspection is
repeated.
Only by this, proper function is guaranteed for every 12 month past of general
inspection.
In the absence of this annual inspection, the manufacturer ceases to guarantee
that the Pneumatic Endoscope Holder’s operation conforms to specifications.
A service manual including technical information on the product is available on request.
All the maintenance and repair operations have to be performed by people trained and
qualified for repairing the Pneumatic Endoscope Holder, as well as
using only
original spare parts.
The manufacturer declines responsibility in case of accident or if the device is used
without correct maintenance or if it has been modified.
Note:
