4. 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.
User manuel
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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 car
rying out the check.
5. Disposal of the Unit
To dispose of the unit, its accessories and packing materials, take appropriate actions in accordance with the rules and
regulations in force in your area to prevent adverse ecological effects.
6. Warranty period
We give a warranty of 1 year from the date of purchase on TENS and Muscle Stimulator. This warranty does not cover cables
and electrodes.
7. Manufacturer information
Shenzhen As-Tec Technology Co., Ltd.
8E XinBaoYi Indu
strial Bld, Houting Village Beiting Road, Shajing Shenzhen Guangdong, CHINA 518012
VI. Electromagnetic Compatibility
Important information regarding Electro Magnetic Compatibility (EMC)
With the increased number of electronic devices such as PC and mobile (cellular) telephones, radio transceivers, mobile
radio transmitters, radio-controlled toys, and so on, Medical devices in use may be susceptible to electromagnetic interference
from other device. Elect
romagnetic interference may result in incorrect operation of the medical devices and create a
potentially unsafe situation. Medical devices should also not interfere with other devices.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product
situations, the IEC 60601-1-2: 2014 standard has been implemented. This standard defines the levels of immunity to
electromagnetic interference as well as maximum
levels of electromagnetic emissions for medical devices.
This unit has been thoroughly tested and inspected to assure proper performance and operation! This product needs
special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided,
the following tables recommend minimum separation distances between portable and mobile RF communications equipment
and the TENS unit.
Caution:
* The use of accessories and
cables other than those specified by the manufacturer , with the
manual
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