HCEN12630 Revision 07.2015
Program version 1.xx
AK 98™ Dialysis Machine - General information 13
Complaints are important information and it will assist Gambro to improve the product
for you. The Complaint system is not valid for products, components or printed circuit
boards that isn't in its original delivered condition.
1.5 Responsibility and disclaimer
The manufacturer accepts responsibility for the safety, reliability, and performance of
this equipment only if the following conditions are fulfilled:
● Installation, operational procedures, maintenance, calibrations and repairs are
carried out by appropriately trained and suitable qualified people.
● All equipment modifications are authorised in writing by the manufacturer and
carried out by appropriately trained and suitable qualified people.
● The electrical installation of the relevant room complies with all applicable local
electrical codes and, if applicable, IEC requirements.
● The equipment is used in accordance with the published operator’s manual.
Gambro does not accept any responsibility or liability for use of accessories or
disposables other than those specified in this manual or if any specified accessory or
disposable is not used in accordance with this manual, online instructions and the
instructions for use accompanying those accessories and disposables.
The patient’s physician is responsible for counselling, home care follow-up and
medical maintenance that comes with the treatment. Gambro has no responsibility for
any of these activities.
1.6 Maintenance
To ensure proper operation of the AK 98 dialysis machine, an authorised service
technician shall perform a complete series of maintenance procedures at regular
intervals.
The maintenance and calibration information that you need to use is provided in this
service manual, refer to Section 8 “Maintenance manual” on page181 and Section 7
“Calibrations” on page151.
It is mandatory to perform preventive maintenance at least every second year. Yearly
maintenance is recommended. The rate of preventive maintenance may be different
due to variations of the operating conditions.
1.7 Competence of an authorised service technician
There is a certain minimum level of competence required for an authorised service
technician who maintains and repairs Gambro products, summarized as follows.
An authorised service technician has:
1. attended the AK 98 dialysis machine technical service course and has received a
certificate stating that the technician has passed the course
2. access to the test equipment and tools detailed in this service manual
3. access to the AK 98 Spare parts list
4. access to and understanding of the AK 98 operator's manual and the AK 98
service manual
In general, this policy implies that training will be carried out by Gambro Lundia AB,
while local markets are responsible for their own service organisation.
To Next Page
Loading...
Need help?
General
