Safety And Functional Checks; Tests After Defibrillation; Decommissioning; Disposal - Schiller CARDIOVIT CS-104 User Manual

15 Maintenance

15.3 Safety and Functional Checks

Page 154
15.3 Safety and Functional Checks
 The MS-12 USB recorder is connected to a PC/Laptop via the USB cable. This
configures a medical system and it is therefore the responsibility of the user that
the system complies with the requirements of IEC/EN 60601-1.
 A recurrent test must be carried out at a minimum of every two years by a certified
authority according to the CARDIOVIT CS-104 service handbook.
15.4

Tests After Defibrillation

Return the unit to an authorised SCHILLER facility for Recurrent test and test after
repair according to IEC / EN62353.t
15.5

Decommissioning

Please observe the following points concerning the decommissioning and storage of
the equipment:
• Backup all program data
• Disconnect all couplings and connections
• Clean all devices and components and disinfect them if necessary
• Correctly pack and, if applicable, correctly mark/label each individual component
• Observe the environmental conditions for storage and transportation
15.6

Disposal

15.6.1

Electronic Parts

At the end of the life cycle, the device and accessories must be disposed of in
accordance with the applicable international and national waste control regulations for
electronic components. Parts must be collected separately from ordinary unsorted
municipal waste when marked with the label for separate collection of electronic and
electric waste.
Please contact SCHILLER if you have any questions concerning the disposal of your
equipment.
15.6.2

Consumables

Consumables must be disposed of in compliance with national and international rules
and regulations.
Contamination Risk
– Depending on their classification consumables may be disposed as domestic
waste or clinical waste.
 Consumables may be contaminated. The operator / customer is obliged to
establish a quality management system for the handling of contaminated waste.
 The pertinent risk analysis must include the accessories and consumables,
especially the disposables intended for single use.
CARDIOVIT CS-104