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Guidance and manufacturer’s declaration - electromagnetic immunity

The  EM-6300A  is  intended  for  use  in  the  electromagnetic  environment 

specified below. The customer or the user of the EM-6300A should assure 

that it is used in such an environment.

IMMUNITY test

Electrostatic
discharge (ESD)
IEC 61000-4-2

Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5

Voltage dips, short 
interruptions and 
voltage variations on 
power supply
input lines IEC 
61000-4-11

Power frequency 
(50/60 Hz) magnetic 

field IEC 61000-4-8

IEC 60601 test 
level
± 6 kV contact
± 8 kV air

± 2 kV for power 
supply lines

± 1 kV line(s) 
to line(s) and 
neutral
<5 % U

T

(>95 % dip in U

T

)

for 0,5 cycle
40 % U

T

(60 % dip in U

T

)

for 5 cycles
70 % U

T

(30 % dip in U

T

)

for 25 cycles
<5 % U

T

(>95 % dip in U

T

)

for 5 s
3 A/m

Compliance level

± 6 kV contact
± 8 kV air

± 2 kV for power 
supply lines

± 1 kV line(s) to 
line(s) and neutral

<5 % U

T

(>95 % dip in U

T

)

for 0,5 cycle
40 % U

T

(60 % dip in U

T

)

for 5 cycles
70 % U

T

(30 % dip in U

T

)

for 25 cycles
<5 % U

T

(>95 % dip in U

T

)

for 5 s
Not applicable

Electromagnetic environment - 
guidance
Floors should be wood, concrete 

or ceramic tile. If floors are covered 

with synthetic material, the relative 
humidity should be at least 30 % .
Mains power quality should be that 
of a typical commercial or hospital 
environment.
Mains power quality should be that 
of a typical commercial or hospital 
environment.
Mains power quality should be that 
of a typical commercial or hospital 
environment. If the user of the 
EM-6300A requires continued 
operation during power mains 
interruptions, it is recommended 
that the EM-6300A be powered 
from an uninterruptible power 
supply or a battery.

Not applicable

NOTE U

T

 is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration - electromagnetic immunity

The EM-6300A is intended for use in the electromagnetic environment 

specified below. The customer or the user of the EM-6300A should assure 

that it is used in such an environment.

IMMUNITY test

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

IEC 60601 test 
level

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2,5 GHz

Compliance level

3 Vrms

3 V/m

Electromagnetic environment . guidance

Portable and mobile RF communications 
equipment should be used no closer to 
any part of the EM-6300A , including 
cables, than the recommended separation 
distance calculated from the equation
applicable to the frequency of the 
transmitter.
Recommended separation distance

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 strengths from fixed RF transmitters, as 

determined by an electromagnetic site survey.

Interference may occur in the vicinity of 
equipment marked with the following symbol: 

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE  2  These  guidelines  may  not  apply  in  all  situations.  Electromagnetic  propagation  is 

affected by absorption and reflection from structures, objects and people.
a    Field  strengths  from  fixed  transmitters,  such  as  base  stations  for  radio  (cellular/cordless) 

telephones  and  land  mobile  radios,  amateur  radio, AM  and  FM  radio  broadcast  and  TV 
broadcast  cannot  be  predicted  theoretically  with  accuracy.  To  assess  the  electromagnetic 

environment due to fixed RF transmitters, an electromagnetic site survey should be considered. 

If  the  measured  field  strength  in  the  location  in  which  the  EM-6300A  is  used  exceeds  the 
applicable  RF  compliance  level  above,  the  EM-6300A  should  be  observed  to  verify  normal 
operation. If abnormal performance is observed, additional measures may be necessary, such 
as re-orienting or relocating the EM-6300A .

b  Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

d

 = 1,2

√P

d

 = 1,2

√P   

80 MHz bis 800 MHz  

d

 = 2,3

√P   

800 MHz bis 2,5 GHz  

Содержание EM-6300A

Страница 1: ...FOR THE INSTRUCTION MANUAL INSTRUCTION MANUAL INSTRUCTION MANUAL Premier Combo Plus DIGITAL TENS EMS Distributed by V1 0 0434 Read Before Use Model No EM 6300A ...

Страница 2: ...ctrode Lead Wires 20 15 Lead Wire Maintenance 21 16 Electrode Options 21 17 Electrode Placement 21 18 Tips for Skin Care 22 19 Application of Reusable self adhesive electrodes 22 20 Adjusting the Controls 24 21 Battery Information 32 22 Maintenance Transportation and Storage 34 23 Safety Technical Controls 34 24 Malfunctions 35 25 Conformity to Safety Standards 35 26 Warranty 36 Manufacturer 36 Re...

Страница 3: ...reases the muscle contracts as in physical exercise Then when the pulse ceases the muscle relaxes and the cycle starts over again Stimu lation Contraction and Relaxation Powered muscle stimulators Chapter 1 GENERAL DESCRIPTION The Premier Combo Plus TENS EMS is a fully digital battery oper ated pulse generator that sends electrical impulses to the nerves and underlying muscle groups This unit is a...

Страница 4: ...mmended for use by the manufacturer 10 Portable powered muscle stimulators should not be used while driving operating machinery or during any activity in which involuntary muscle contractions may put the user at undue risk of injury should only be used under medical supervision for adjunctive thera py for the treatment of medical diseases and conditions IMPORTANT SAFETY INFORMATION Read instructio...

Страница 5: ...ay be strong enough to close the airway or cause difficulty in breathing 4 Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may cause cardiac arrhythmias 5 Stimulation should not be applied transcerebrally 6 Stimulation should not be applied over swollen infected or inflamed areas or skin eruptions e g phlebitis thrombophlebitis vari...

Страница 6: ...table 1 8 seconds 1 Sec step The On time will increase and decrease in the setting value 13 Mode Six TENS Modes B Burst N Normal M Modulation Rate Width S1 Modulation Width S2 Modulation Width and P Three EMS Modes C Constant S Synchronous A Alternate 14 Burst Mode Burst rate Adjustable 0 5 5Hz Pulse width adjustable 50 300µs Frequency fixed 100 Hz 15 Normal Mode The pulse rate and pulse width are...

Страница 7: ...s 1 second In this mode pulse rate 2 150Hz and pulse width 50 300µs are fully adjustable 17 S1 Mode Pulse width is automatically varied in a cyclic pattern over a nominal 10 second period Pulse width decreases over a period of 4 seconds from the initial setting to a value 40 less The narrower pulse width continues for 1 second It then increases over a period of 4 seconds to its initial setting The...

Страница 8: ...all SYN 80 300 3 10 5 20 muscle P15 Spasm SYN 80 250 2 8 4 20 Postoperative P16 Arthroscopy SYN 25 200 2 6 30 15 P17 Disuse atrophy SYN 35 300 2 5 15 30 P18 Shoulder SYN 50 300 5 15 50 15 Subluxation P19 Range of motion SYN 40 250 3 6 21 30 muscle re education of hips P20 Muscle training SYN 50 250 2 10 10 20 P21 Muscle training SYN 50 250 2 14 14 20 P22 Muscle training SYN 35 400 2 10 10 20 P23 M...

Страница 9: ... replace the other parts of a device PARTS 1 Lead Wires 2 Electrodes 3 Belt Clip 4 Lead Connector 5 Main PCB 6 Press Buttons 7 LCD Cover 8 9V Battery 9 Device Case Chapter 10 ACCESSORIES Each Premier Combo Plus Digital TENS EMS comes complete with standard accessories and the standard labels as given below I Accessories REF NO DESCRIPTION Q TY 1 KF4040 40x40mm Adhesive Electrodes 4 pieces 2 KE 24 ...

Страница 10: ...007 47 EC Notify body Det Norske Veritas DNV 15 Power Chapter 12 OPERATING INSTRUCTIONS 1 Insert the 9V battery into the device s battery compartment Make sure that the plastic seal on the 9V battery is removed Line up the positive and negative terminals on the battery with their corresponding terminals in the device Make sure that the unit is turned off 2 Insert the lead wires into the lead wire ...

Страница 11: ...rve accommodation by continuously cycling the treatment intensity Advise the patient to increase the intensity very slowly when using modulation mode INTENSITY Each patient responds differently to different levels of intensity due to varying degrees of tissue resistance enervation skin thickness etc Intensity instructions are therefore limited to the following settings Perception The intensity is ...

Страница 12: ...he jacks see drawing one or two sets of wires may be used After connecting the wires to the stimulator attach each wire to an electrode Use care when you plug and unplug the wires Jerking the wire instead of holding the insulated connector body may cause wire breakage CAUTION Do not insert the plug of the patient lead wire into any AC power supply socket Chapter 15 LEAD WIRE MAINTENANCE Clean the ...

Страница 13: ...trode placement area when not wearing electrodes 8 Never apply electrodes over irritated or broken skin Chapter 19 APPLICATION OF RE USABLE SELF ADHESIVE ELECTRODES Application 1 Clean and dry the skin at the prescribed area thoroughly with soap and water prior to application of electrodes 2 Insert the lead wire into the pin connector on the pre wired electrodes 3 Remove the electrodes from the pr...

Страница 14: ...ct with the skin Pause 3 Mode Control There are 5 TENS modes B N M S1 S2 and 3 EMS modes C S A available The mode is selected by pressing the Mode control When a TENS mode is selected the LCD shows TENS When EMS mode is selected the LCD shows EMS 4 Set Control By pressing the Set control you select the setting you intend to adjust The value is set by pressing the Increment or Decrement controls wh...

Страница 15: ...be stored immediately after selected There are 12 preset programs of your option on P mode Press or to select a program desired after P mode is selected These programs are not adjustable c Set Pulse Width Pulse Width is adjustable from 50 µs to 300 µs Press SET control to enter this menu then press or to adjust the setting If no instructions regarding the pulse width are given in therapy set the c...

Страница 16: ...stal display After a mode is selected always press Set to enter next setting and press or to adjust its value The settings will be stored immediately after selected After a mode is selected always press Set to enter next setting and press or to adjust its value The settings will be stored immediately after selected There are 12 preset programs of your option on P mode Press or to select a program ...

Страница 17: ...Hz range h Set Timer The treatment time is adjustable between 5 60 minutes and Continue C Press SET control to enter this menu then press Increment or Decrement to adjust the setting The liquid crystal will show the balance treatment time after the stimulation is started Output will be terminated when time is up Turn off the unit when the output is off i Adjust Intensity There are 99 steps within ...

Страница 18: ...g periods of storage batteries should be charged prior to use BATTERY CHARGING 1 Plug the charger into any working 110 or 220 240v mains electrical outlet The use of any attachment not supplied with the charger may result in the risk of fire electric shock or injury to persons 2 Follow the battery manufacturer s instructions for charging time 3 After the battery manufacturer s recommended charging...

Страница 19: ...Combo Plus DIGITAL TENS EMS 1 Check the device for external damage deformation of the housing damaged or defective output sockets 2 Check the device for defective operating elements legibility of inscriptions and labels make sure the inscriptions and labels are not distorted 3 Check the usability of accessories patient cable undamaged electrodes undamaged Battery is not corroded Please consult you...

Страница 20: ...t cause any interference with other devices in the proximity It is recommended that you do not place the device on top of or close to other electronic devices Should you notice any inter ference with other electrical devices move the device or connect it to a different socket Radio equipment may affect the operation of this device Guidance and manufacturer s declaration electromagnetic emissions T...

Страница 21: ... the electromagnetic environment specified below The customer or the user of the EM 6300A should assure that it is used in such an environment IMMUNITY test Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 IEC 60601 test level 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz Compliance level 3 Vrms 3 V m Electromagnetic environment guidance Portable and mobile RF communications equipment shoul...

Страница 22: ...paration distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electro magnetic propagation is affected by absorption and reflection from structures objects and people Recommended separation distances between portable and mobile RF communications equipment and the EM 6300A The EM 6300A is intended for use in an electromagnetic environment in which ...

Страница 23: ...V pk pk Pulse Width 300µs 2 N MODE Normal Load 500 ohm Pulse Rate 150Hz Pulse Width 300µs Appendix II Waveform of EM 6300A Digital TENS EMS TENS 1 B Mode Burst Load 500 ohm Pulse Rate 150Hz Pulse Width 300µs Scope A VERT 10 0V DIV HORIZ 2mS OUTPUT 57 1875Vpk pk Pulse Rate 100Hz Scope B VERT 10 0V DIV HORIZ 50mS Pulse Rate 5 000Hz ...

Страница 24: ... 150µs 3 M MODE 50 Pulse Width Rate Modulation Load 500 ohm Pulse Rate 150Hz Pulse Width 300µs Scope C Modulation 50 Scope A VERT 20 0V DIV HORIZ 200 µs OUTPUT 50 0V pk pk Pulse width 184 µs Scope B VERT 20 0V DIV HORIZ 200 µs OUTPUT 56 9V pk pk Pulse width 302 µs 4 S1 MODE 40 Pulse Width Modulation Load 500 ohm Pulse Rate 150Hz Pulse Width 300 µs ...

Страница 25: ...6 9Vpk pk Pulse width 302 µs 5 S2 MODE 70 Pulse Width Modulation Load 500 ohm Pulse Rate 150Hz Pulse Width 300µs Scope A VERT 10 0V DIV HORIZ 2mS OUTPUT 59 1825V pk pk Pulse Rate 148 8Hz Scope B VERT 10 0V DIV HORIZ 100µs OUTPUT 59 1825V pk pk PulseWidth 300µs EMS 1 C MODE Load 500 ohm Pulse Rate 150Hz Pulse Width 300 µs ...

Страница 26: ...00 ohm Pulse Rate 150Hz Pulse Width 300µs Contratction Time 12 Sec Relation Time 12 Sec Ramp Time 6 Sec 3 A MODE Alternate Load 500 ohm Pulse Rate 150Hz Pulse Width 300µs Contratction Time 12 Sec Relation Time 12 Sec Ramp Time 6 Sec ...

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