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Chapter 22 Conformity to Safety Standards
STATEMENT OF EMC
The AMS-4 EMS devices are in compliance with IEC 60601-1-2: 1993.
CONFORMITY TO MDD REQUIREMENTS
The AMS-4 EMS devices are in compliance with
IEC60601-1 safety standard and FDA 510K standards.
Chapter 23 : WARRANTY
All AMS-4 EMS models carry a warranty of three year from the date of
delivery. The warranty applies to the stimulator only and covers both parts and
labour relating thereto.
The warranty does not apply to damage resulting from failure to follow the
operating instructions, accidents, abuse, alteration or disassembly by unautho-
rized personnel.
Manufacturer:
MEDICAL DEPOT INC DBA DRIVE MEDICAL
99 Seaview Boulevard
Port Washington, NY 11050
Phone # : 516-998-4600
Edition : V1.3
Printed in February , 2007
Chapter 20: SAFETY-TECHNICAL CONTROLS
For safety reasons, check your AMS-4 EMS each week based on the following
checklist.
1. Check the device for external damage.
- deformation of the housing.
- damaged or defective output sockets.
2. Check the device for defective operating elements.
- legibility of inscriptions and labels.
- make sure the inscriptions and labels are not distorted.
3. Check Led
- led must be illuminated when switched on.
4. Check the usability of accessories.
- patient cable undamaged.
- electrodes undamaged.
Please consult your distributor if there are any problems with device and
accessories.
Chapter 21 MALFUNCTIONS
Should any malfunctions occur while using the EMS, check
- whether the switch/control is set to the appropriate form of therapy. Adjust
the control correctly.
- whether the cable is correctly connected to the device. The cables should be
inserted completely into the sockets.
- whether the impulse display led is illuminated. If necessary, insert a new battery.
- for possible damage to the cable. Change the cable if any damage is detected.
* If there is any other problem, please return the device to your distributor. Do
not try to repair a defective device.
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