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IFU-001 Rev D June 2014 

 

FDA 510(k) Cleared 

 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Power 

Frequency 

(50/60 Hz) 

Magnetic 

Field  

IEC 61000-4-8 

 

 

 

 

3 A/m 

 

 

 

 

3 A/m 

 
 
 
 
 
 
 

Power frequency magnetic 

fields should be at levels 

characteristic of a typical 

location in a typical 

commercial or hospital 

environment 

 

Table 3:    Guidance and manufacturer’s declaration 

- electromagnetic immunity  

The CP Relief Wand® is intended for use in the electromagnetic  

environment specified below. The customer or user  

should assure that it is used in such an environment. 

Immunity 

test 

IEC 60501 

Test level 

Compliance  

level 

Electromagnetic environment 

guidance 

 

 

 

Portable and mobile RF 
Communications equipment 
should be used no closer to any 
part of the device, including 
cables, than the recommended 
distance calculated from the 
equation applicable to the 
frequency of the transmitter’s 
recommended separation distance 

 

 

3 V/m 

 

Radiated 

RF  IEC 

61000-4-3 

 

3 V/m 

80 MHz to 

2.5 GHz 

Where “

P

” is the maximum output 

power rating of the transmitter in 
Watts (W) according to the 
transmitter manufacturer and “d” is 
the recommended separation distance 
in meters “m”. Field strength from 
fixed RF transmitters as determined 
by the electromagnetic site survey, a. 
should be less than the compliance 
level in each frequency range. b. 
interference may occur in the vicinity 
of equipment marked with the 
following symbol: 

 

 

 

80 MHz to 800 MHz 

d = 1.2 √

 

800 MHz to 2.5 GHz 

d = 2.3 √

 
  

 

Содержание CP Relief WandCP 1000

Страница 1: ...D June 2014 FDA 510 k Cleared CP Relief Wand Model CP 1000 Rx Only Mid America Medical Innovations LLC 2704 Industrial Drive Jefferson City MO 65109 USA 573 556 5569 844 226 1013 RoHS Compliant Opera...

Страница 2: ...se Contraindications Precautions Cautions Warnings Adverse Reactions III Operation CP Relief Wand Components CP Relief Wand Controls CP Relief Wand Battery Information CP Relief Wand Electrodes Skin P...

Страница 3: ...times almost everyone traveled long distances by foot and painful feet would have been a common problem Recovered ancient artifacts show that the Egyptians and Greeks knew of the pain reducing effects...

Страница 4: ...atients 6 The long term effects of electrical stimulation are unknown 7 Since the effects of stimulation of the brain are unknown the unit s electrodes should not be applied anywhere on the head 8 The...

Страница 5: ...on when the patient is in the bath or shower 7 Do not apply stimulation while the patient is sleeping or while the patient is driving operating machinery or during any activity in which electrical sti...

Страница 6: ...th Switch The Pulse Width Switch selects either 150 microsecond pulse width low or 230 microsecond uS pulse width high Choose the 150 microsecond uS setting for lowest power and maximum comfort during...

Страница 7: ...pads dry out you can moisten them with water for continued use After repeated usage the gel pads deliver less stimulation and should be replaced as needed Always use CP Relief Wand 2088 Gel Pads Skin...

Страница 8: ...an be rotated to a different angular position or the Wand can be moved to a different position Continue holding the CP Relief Wand in this position until some further reduction in pain is detected and...

Страница 9: ...Like any other stainless steel product after extended periods of use the stainless steel electrodes may tarnish due to the salts in your skin Stainless steel tarnish will not affect operation Should t...

Страница 10: ...age resulting from failure to follow the operating instructions accidents abuse alteration or disassembly by unauthorized personnel When returning to the factory a Return Authorization Number must be...

Страница 11: ...re its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class B The CP Relief Wand is suitable for use in all establishments...

Страница 12: ...ble and mobile RF Communications equipment should be used no closer to any part of the device including cables than the recommended distance calculated from the equation applicable to the frequency of...

Страница 13: ...ces are controlled The customer or user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitte...

Страница 14: ...2014 FDA 510 k Cleared XI GLOSSARY Rx Sold by Prescription Only Caution Type BF Applied Part Manufactured by Mid America Medical Innovations LLC 2704 Industrial Dr Jefferson City MO 65109 USA uS Hz H...

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