Inspection By An Authorised Service Agent; Return Procedure; Disposables - COOK Medical K-MAR-5200 Handbuch

K-MAR-5200 Instructions for Use
WARNING: No user serviceable
parts inside!
1
WARNING: BIOLOGICAL
HAZARD. The returned product
must be clearly marked with a
contamination warning and should
be sealed in a plastic bag and sealed
within a second plastic bag!
When shipping the Vacuum Pump
ensure that any connected Disposable
Vacuum Line with Hydrophobic Filter is
removed prior to transport!
IMPORTANT NOTE: When
returning goods, use the original
packaging. The manufacturer does not
take responsibility for damage that has
occurred during transportation if the
damage was caused by inadequate
transport packaging.

7. Disposables

IMPORTANT NOTE: For optimal
functioning of the Vacuum Pump, use
only original disposables.
The Disposable Vacuum Line with
Hydrophobic Filter has been designed
and tested to handle the full vacuum
range of the Vacuum Pump.
Other vacuum lines may not be able to
withstand the full vacuum range.
The Disposable Vacuum Line with
Hydrophobic Filter (K-DVLF-240) is a
single use device.

6.3 Inspection by an Authorised Service Agent

Inspections at least once a year
Authorised service agents
Liability
Certification
Technical documentation

6.4 Return Procedure

All devices or disposables that are returned must be prepared as described below for the protection of the service
agent and for safety during transportation.
1. Clean as detailed in §6.1.
2. Seal in a plastic bag and seal within a second plastic bag.
3. Place in the original packaging.
4. Enclose the following information:
• Owner's name
• Owner's address
• Model type
• Serial number of the equipment (see identification plate)
• Description of the damage or fault.
The manufacturer has the right to refuse to carry out repairs if the products it receives are contaminated.
Order No. Description
K-DVLF-240 Disposable Vacuum Line with Hydrophobic Filter.
Consists of a 240 cm low volume aspiration line and a one way hydrophobic filter.
1-13
For ongoing operational safety of the device, an authorised service
agent must maintain the Vacuum Pump annually as per SMA30001. The
service agent will assess the operational functionality of the vacuum
system.
All services such as alterations, repairs, calibrations etc., may only be
performed by the manufacturer or by service agents who are authorised
by the manufacturer as per SMA30001.
The manufacturer is free from all liability for the operational safety of the
Vacuum Pump if the device has been wilfully opened and unauthorised
persons have performed repairs or alterations on it during the warranty
period.
The device owner will receive a signed certificate from the service agent
for all inspections or repairs. This certificate states the type and scope
of the services rendered, the service date and the name of the service
company.
If the manufacturer provides technical documentation, this does not
authorise the user to perform repairs, adjustments or alterations to the
Vacuum Pump or disposables.
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