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IFU-001 Rev D June 2014 

 

FDA 510(k) Cleared 

X.             INFORMATION REGARDING ELECTROMAGNETIC COMPATABILITY (EMC) 
 
 
 
 

 
 
 
                                                                  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
                                        

 

 
                                       
 
 
 

 

Table 1:    Guidance and Manufacturers Declarations 

- Electromagnetic Emissions 

 

The CP Relief Wand® is designed to produce very low levels of radio frequency 

(RF) emissions (interference), to be immune to the effects of interference 

produced by other equipment operating in the vicinity, and to be immune to 

damage due from electrostatic discharge, all when operating in a domestic or 

clinical environment. For more information, please refer to the tables below.  

Emissions 

Test 

 

Compliance 

 

Electromagnetic Environment Guidance 

RF 

Emissions 

CISPR 11 

 

 

Group 1 

 
 

The CP Relief Wand® uses RF energy only for 

its internal function. Therefore 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 including domestic 

establishments and those directly connected to 

the public low voltage power supply network 

that supplies buildings used for domestic 

purposes. 

Table 2:    Guidance and manufacturer’s declaration 

- electromagnetic immunity 

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

environment specified below. The customer or the user  

should assure that it is used in such environment 

 

Immunity 

test 

 

IEC 60601 

test level 

 

Compliance 

level 

Electromagnetic 

Environment 

guidance 

 

Electrostatic 

Discharge 

(ESD) IEC 

61000-4-2 

± 6 KV 

Contact 

 

± 8 KV  

air 

  ± 6 KV 

Contact 

 

  ± 8 KV 

air 

Floors should be wood, 

concrete, or ceramic tile.  

If floors are covered with 

synthetic material, the  

relative humidity should  

be at least 30% 

Summary of Contents for CP Relief WandCP 1000

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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