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7 Maintenance, servicing, repairs, and disposal
7.1 Maintaining the product
If they are not described in more detail here, maintenance activities may only be performed by
KARL STORZ or by a company authorized by KARL STORZ.
7.1.1 Maintenance
The following maintenance intervals are recommended:
Interval
annually
Check the device configuration after every software update.
7.2 Safety inspection in accordance with IEC 62353
WARNING
Risk of injury due to product degradation!
Patients, users and third parties may be injured as a result of product and accessory degradation.
Shut down the product.
Have the deficiencies repaired by persons authorized by KARL STORZ.
Regardless of the national accident prevention regulations and testing intervals for medical devices,
for this device safety checks must be performed as repeat inspections according to IEC 62353 and
recorded by a qualified electrician at least once a year. Detailed specifications regarding the scope
and execution of the safety inspection can be found in the service manual.
7.2.1 Visual inspection
1.
Check the product and accessories for any mechanical damage.
2.
Check labels for readability.
7.2.2 Electric measurements
Limit values for electrical measurements can be found in the current IEC 62353.
1.
Measure the protective ground resistance.
2.
Measure the earth leakage current.
3.
Measure the touch current.
4.
Measure the patient leakage current.
7.2.3 Functional test
1.
Perform a functional test in line with the instructions for use.
2.
Document the results of the safety inspection.
7.3 Repairing the product
Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ.
The interventions described in this instruction manual are exempt from this rule.
Instructions for use • TELE PACK + • CQH848_EN_V2.0_08-2022_IFU_CE-MDR
Maintenance, servicing, repairs, and disposal
Activity
Safety test
To be performed by
KARL STORZ service techni-
cians
42
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