22
23
* Refer to the user manual of the pads manufacturer (510K092546), or
reference to the following suggestions:
1)
Unplug the output cord from the output jack of the controller after each
use. Cover both pads with the protective film before storage. Never fold the
electrode pads.
2)
Between uses, store the electrodes in the reusable bag in a shady place.
Stockroom temperature: +5°C~+27°C (41-80°F) and humidity of 30%~80%.
No need to sterilize.
3)
Never apply the pads to any other surface other than your skin. If the pads
become soiled or dirty, the adhesive power may decrease. In this case,
moisten the surface of the pads with water and wipe away the dirty portion.
This will allow a temporary restoration of the adhesive power. However, too
much water will result in loss of the adhesive power.
4)
The life of the electrodes varies depending on skin conditions, storage,
amount of use, type of stimulation, and stimulation site. Electrode life may be
extended by carefully following this Instruction for Use. The expired
electrodes are to be recycled and do not harm environment.
Warning:
The electrodes are intended for single patient use only!
11.
Storage
Caution:
Do not store in a damp area. Dampness may affect the device and
cause rust.
-
Normal working ambient temperature: 5°C~40°C (40-104°F)
-
Normal working ambient humidity: ≤80%RH
-
Store and transport ambient temperature: -20°C~55°C (4° -131° F)
-
Store and transport ambient humidity: ≤93%RH
12.
Technical checks
Technical checks on the device should be performed every 24 months.
These include:
1.
Checking to see whether the user instructions and the medical device book are
included in the accompanying documentation.
2.
Checking the equipment for completeness.
3.
Visual check:
-
for mechanical damage
-
for damage to all cables and connections
4.
Functional safety
-
Checking the output signals with a load resistance of 500Ω real (current and
voltage)
-
Checking the frequency
-
Checking the pulse width.
These technical checks may only be performed by individuals with appropriate
training. The results must be noted in the medical device book along with the date
and name of the person carrying out the check.
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