Specifications; Standard Symbols; Emc Precautions - TensCare Flexistim IF Instructions For Use Manual

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18. SPECIFICATIONS

IFT:
Intensity
Up/down 60 steps, 0-60mA zero to peak at 500ohm load
Carrier
4000Hz fixed(CH1)
Frequency
Modulating
4004-4160Hz, in steps of 4Hz(CH2)
Frequency
Pulse Width
125μs
Waveform
Symmetrical balanced sine wave
Treatment Timer
Continuous, 10, 20, 30, 45, 60, 90min
Dimensions
61×123×22mm (exclude belt clip)
Weight
160g (with battery)
Power Supply
BL-6F Li-Ion battery 3.7V 1100mAh
Mains adaptor (Class II, IEC60601-1) with charging cradle
Input 100-240V
Output DC 5V 1000mA
Safety Classification
Type BF Designed for continuous use
IP22
Environmental
Operating Specifications
Humidity: 20 to 93% RH
Temperature range: 0 to 40C
Atmospheric Pressure: 700hPa to 1060hPa
Storage and
Humidity: 10 to 93% RH
Transport Specifications
Temperature range: -20 to 70C
Atmospheric Pressure: 700hPa to 1060hPa
Typical Operation Time
No less than 1 hour (@50%AMP
Expected Service Life
No less than 5 years
flexistimIF instructions final.indd 30-31
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19. STANDARD SYMBOLS

Type BF Applied part
Attention, consult accompanying document
Complies with WEEE regulations
CE marking
Manufacturer
The first number 2: Protected against access to hazardous parts with a finger, and
IP22
the jointed test finger of 12 mm Ф, 80 mm length, shall have adequate clearance from
hazardous parts, and protected against solid foreign objects of 12.5 mm Ф and greater.
The second number: Protected against vertically falling water drops when enclosure is
tilted up to 15º. Vertically falling drops shall have no harmful effects when the enclosure
is tilted at any angle up to 15'' on either side of the vertical.

20. EMC PRECAUTIONS

Wireless communications equipment such as wireless home network devices, mobile phones,
cordless telephones and their base stations, walkie-talkies can affect this equipment and
should be kept at least a distance d = 3,3 m away from the equipment.
(Note: As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone
with a maximum output power of 2 W yields d = 3,3 m at an IMMUNITY LEVEL of 3 V/m).
EC Declaration of Conformity
TensCare Ltd hereby declare that an examination of the production quality assurance
system has been carried out following the requirements of the UK national legislation
according to Annex V of the Directive 93/42/EEC on medical devices. We certify
that the production quality system conforms with the relevant provisions of the
aforementioned legislation, and the result entitles the organisation to use the CE 0473
marking on this product.
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24/11/2014 10:51

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