Almagia ALMAG+, Руководство по эксплуатации

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OPERATION MANUAL
LIST OF STANDARDS USED
IEC 60601-1;2005 «Medical electrical equipment. Part 1. General requirements
for basic safety and essen al performance».
IEC 60601-1-2:2007 «Medical electrical equipment. Part 1-2. General require-
ments for basic safety and essen al performance. Collateral standard. Electromag-
ne c compa bility. Requirements and tests».
ISO 10993-1:2009 «Medical devices. Biological evalua on of medical devices.
Part 1. Evalua on and tes ng».
MAINTENANCE
Maintenance of the device does not require special skills, and it will be conduct-
ed by representa ves of the healthcare ins tu on where the device is operated, or
by the user himself/herself at home.
Maintenance scope includes preven ve inspec on and monitoring of the techni-
cal condi on of the device including:
• Integrity checks of housings/casings/bodies and cables of the Control Unit and
inductor coils as well as accessory fastener integrity check;
• Func onal checks of control bu ons, light and sound indica on elements of
the Control Unit;
• Troubleshoo ng (sound signal and treatment Mode2/Mode 3 LED blinking, see
Table 8).
• Inductor coils disinfec on a er their use (if necessary).