Storz UNIDRIVE Select, Инструкция по эксплуатации, Страница: 44 / 64

Maintenance, servicing, repairs, and disposal
Instructions for use • UNIDRIVE Select • PCC270_EN_V1.0_02-2022_IFU_CE-MDR 44
7.3 Safety inspection in accordance with IEC 62353
WARNING
Risk of injury due to product deficiencies!
Patients, users, and third parties may be injured as a result of deficiencies with the product and
accessories.
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.
7.3.1 Visual inspection
1. Check the product and accessories for any mechanical damage.
2. Check labels for readability.
7.3.2 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.
7.3.3 Functional test
Check the following components:
– Power switch
– Handpiece
– Pump
Check the following functions:
– Footswitch detection
– Handpiece detection
– Change in the direction of rotation
– Reading out of system information
Document the results of the safety test.
7.4 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.
Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of
subsidiaries).
Contaminated devices may not be shipped. To prevent contact infections and airborne
infections, products must first be decontaminated. KARL STORZ reserves the right to send
back contaminated products.