19
18
- 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.
Chapter 22 Conformity to Safety Standards
STATEMENT OF EMC
The AGF-3X TENS devices are in compliance with IEC 60601-1-2: 1993.
CONFORMITY TO MDD REQUIREMENTS
The AGF-3X TENS devices are in compliance with IEC 60601-1 safety
Standard and FDA 510K standards.
Chapter 23 : WARRANTY
All AGF-3X TENS models carry a warranty of one 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 unau-
thorized personnel.
Manufacturer:
MEDICAL DEPOT INC DBA DRIVE MEDICAL
99 Seaview Boulevard
Port Washington, NY 11050
Phone # : 516-998-4600
Edition : V1.6
Printed in February , 2007
from the battery compartment (acid may leak from used batteries and
damage the device). Put the device and accessories in carrying box and
keep it in cool dry place.
6. The packed TENS device should be stored and transported under the
temperature range of -20
℃
~ + 60
℃
, relative humidity 20% ~ 95% , atmo
sphere pressure 500 hPa ~ 1060 hPa.
Chapter 20: SAFETY-TECHNICAL CONTROLS
For safety reasons, check your AGF-3X TENS 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 TENS, 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.
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