EV807 Instruction Manual V1.1

INDEX Chapter Contents

Page

Index...1 1.

Introduction...2

2.

Cautions...3

3.

Warnings...3

4.

General Description...4

5.

Construction...5

6.

Technical Specifications...6

7.

Replaceable Parts...7

8.

Accessories...7

9.

Graphic Symbols...8

10. Parameter Controls...9 11. Attachment of Electrodes Lead Wires ...11 12. Lead Wire Maintenance...12 13. Electrode Options...12 14. Electrode Placement...12 15. Tips For Skin Care...14 16. Application of Re-usable Self Adhesive Electrodes...15 17. Adjusting the Controls ...16 18. Battery Information...21 19. Maintenance, Transportation and Storage of EMS Device...23 20. Safety Control...24 21. Malfunctions ...24 22. Conformity to Safety Standards...25 23. Warranty/ Manufacturer/ Representative in the EU...26 24. Appendix...27

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Chapter 1 : INTRODUCTION

Chapter 2 : CAUTIONS 1. Read operation manual before use of EMS

EXPLANATION OF EMS

2. W e emphasize that patient with an implanted electronic device Electrical Muscle Stimulation is an internationally accepted and proven

(for example, a pacemaker) should not undergo EMS treatment

way of treating muscular injuries. It works by sending electronic

without first consulting a doctor. The same applies to patients

pulses to the muscle needing treatment; this causes the muscle to

with any metallic implants. 3. If EMS therapy becomes ineffective or unpleasant, stimulation

exercise passively. It is a product derived from the square waveform, originally invented by John Faraday in 1831. Through the square wave pattern it is able

should be discontinued until its use is reevaluated by the physi cian or therapist.

to work directly on muscle motor neurons. EMS has low frequency

4. Avoid adjusting controls while operating machinery or vehicles.

and this in conjunction with the square wave pattern allows direct

5. Turn the EMS off before applying or removing electrodes.

work on muscle groupings. This is being widely used in hospitals

6. EMS devices have no AP/APG protection.

and sports clinics for the treatment of muscular injuries and for the

Do not use it in the presence of explosive atmosphere and flam

re-education of paralyzed muscles, to prevent atrophy in affected

mable anaes thetic mixture.

muscles and improving muscle tone and blood circulation.

Chapter 3 : WARNINGS HOW EMS WORKS 1. Caution should be used in applying EMS to patients suspected of EMS is intended to be used to increase blood circulation and loosens tight and knotted fibers, stimulates muscle growth and also reduces stiffness in muscle joints. The EMS units send comfortable impulses through the skin that stimulate the nerves in the treatment area. When the muscle receives this signal it contracts as if the brain has

having heart disease. Further clinical data is needed to show there are no adverse results. 2. Electrical stimulation safety has not been established during pregnancy. Do not use EMS during pregnancy.

sent the signal itself. As the signal strength increases, the muscle

3. Do not place electrodes on the front of the throat as spasm of the

flexes as in physical exercise. Then when the pulse ceases, the

Laryngeal and Pharyngeal muscle may occur. Do not stimulate

muscle relaxes and the cycle starts over again, (Stimulation, Con-

over the carotid nerve, particularly with patients with known si-

traction and Relaxation.)

nus reflex sensitivity. 4. Care should be taken so that when operating potentially dangerous machinery the stimulator controls are not changed abruptly.

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5. Cases of skin irritation at the electrode site have been reported.

Chapter 5 : CONSTRUCTION

Stimulation should be stopped and electrodes removed until the cause of the irritation can be determined. 6. Electrodes should not be placed over the eyes, in the mouth, or (1) LEAD CONNECTOR

internally. 7. Keep this device out of the reach of children.

Chapter 4 : GENERAL DESCRIPTION

(2) INTENSI TY CONTROL (OUTPUT ON/OFF SW ITCH)

The EV-807 DIGITAL EMS is a battery operated pulse generator that

(3) LCD

sends electrical impulses through electrodes to the body and reaches

(4) FUNCTION SELECTORL

the underlying nerves or muscle group. The device is provided with

(5) PARAMETER INCREASE

two controllable output channels, each independent of each other.

CONTROL (6) PARAMETER DECREASE CONTROL

An electrode pair can be connected to each output channel. The electronics of the EV-807 DIGITAL EMS create electrical impulses whose Intensity, Pulse Width, Pulse Rate, Contraction, Relax-

SET

(7) BATTERY CASE

ation and Ramp may be altered with the switches. Press buttons are very easy to use and the slide cover prevents accidental changes in

(8) BATTERY STRI P

the setting.

(9) BELT CLIP

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Chapter 6 : TECHNICAL SPECIFICATION

Chapter 7 : REPLACEABLE PARTS

The technical specification details of EV-807 DIGITAL EMS are as follows.

The replaceable parts and accessories of EMS devices are as given

MECHANISM 01. Channel 02. Pulse Amplitude

TECHNICAL DESCRIPTION

below –

Dual, isolated between channels. Adjustable, 0-90 mA peak into 500 ohm

Except leads, electrodes and battery, battery case cover, please do

load each channel.

not try to replace the other parts of a device.

03. Output Voltage

Adjustable by intensity control knob,

04. Wave Form

0-45V peak into 500 ohm load each channel. Asymmetrical Bi-Phase Square Pulse

01

ELECTRODES LEADS

05. Power Supply

One 9 V battery (006P 9V)

02

ELECTRODES

06. Size

10cm(L) x 6cm(W) x 2.1cm(H)

03

9V BATTERY ,TYPE 6F22

07. Weight 08. Pulse Rate

120 grams with battery Adjustable, from 1 ~ 150 Hz , 1 Hz / step

04

BELT CLIP

09. Pulse Width

Adjustable, from 30 ~ 260µs , 10µs / step

05

BATTERY CASE COVER

10. Contraction Time

Adjustable, from 1 ~ 30 Seconds ,1 Sec. / step

06

LEAD CONNECTOR

11. Relaxation Time 12. Ramp Time

Adjustable, from 1 ~ 30 Seconds , 1 Sec. / step Adjustable, from 1 ~ 6 Seconds , 1 Sec. / step

07

MAIN PCB

08

INTENSITY KNOB

13. Timer

Adjustable, from 1 ~ 60 Minutes, 1 Min. / step

PARTS

14. Operating Condition Temperature:0° C ~ 40° C

Chapter 8 : ACCESSORIES

Relative Humidty:30% ~ 75% Atmosphere Pressure: 700 Hpa ~1060 Hpa 15. Remark

There maybe up to a +/- 5% tolerance of

Each set EV-807 DIGITAL EMS are completed with standard acces-

parameters and +/- 20% tolerance of Amplitude

sories and standard label as given belowI.

& Voltage.

Accessories

6

REF. NO.

PRODUCT

Q’TY

1. KF4040

40 X 40 MM Adhesive Electrodes

4 pieces

2. KB-24

Electrodes Leads

2 pieces

3. GC-01

9 V Battery, type 6F22

1 piece

4.

Instruction Manual

1 piece

5.

Carrying Case

1 piece

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II. LABEL

Chapter 10 : PARAMETER CONTROLS

The label attached to the back of device contains important message ab ou t t his d evi c em od el, s eri al number, supply voltage, the name of manufacturer, CE number and classification. Please do not remove.

PULSE DURATION Wider pulse duration settings will deliver stronger stimulation for any given intensity setting. As mentioned in the Controls section, by

Chapter 9 : GRAPHIC SYMBOLS

using a combination of intensity and pulse duration, it is felt that various pulse widths are capable of stimulating different muscles groups.

1.

Note Operating Instructions

2.

Degree of Electrical Protection BF

the narrow pulse duration is used on the more sensory fibres.

3.

Do not insert the plug into AC power supply socket

PULSE RATE

4.

Direct Current (DC power source)

5.

Pulse Rate

6.

Pulse Width

7.

Timer

8.

Parameter Increase

9.

Parameter Decrease

10.

Consult Instructions for use

11.

Manufacturer

12.

Serial Number

The wider pulse duration is needed to recruit motor fibers, whereas

The Pulse Rate (hertz or pulses per second) chosen depends greatly upon the type of electrode placement given to the patient. W hen using contiguous and dermatome electrode placements (i.e. stimulating directly through the area of pain or localized enervation), a quick pulse rate (setting greater than 80Hz on the Pulse Rate Control) is desired. The patient should not perceive individual pulses but rather have the sensation of steady continuous stimulation. When using point treatments, it has been suggested that slow pulses be utilized (less than 10Hz). W ith this setting the patient should be able to slightly perceive individual pulses. When using multiple electrode placement strategies, such as combinations of point and contiguous electrode placements, the quicker pulse rates are suggested. Despite above recommendations, these individual patients may require slight variations of the above settings, according to the nature of their condition.

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INTENSITY

however, it can not reach the expected level if the contraction time

Each patient responds differently to different levels of intensity, due

is less than the ramp time.

to varying degrees of tissue resistance, enervation, skin thickness, etc. Intensity instructions are therefore limited to the following

TIME DURATION

settings:

EMS units are typically operated for long periods of time, with a

Perception – The intensity is increased so that the patient can feel

minimum of 20 – 30 minutes. However, the time is varied subject to

the stimulation, but there is not any muscular contraction.

the treatment required. Please consult your physician before use of

Slight Contraction – Intensity is increased to a barely visible muscu-

EMS.

lar contraction that is not strong enough to move a joint. W hen using low pulse rate settings, this will show as individual twitches. At higher pulse rates there will simply be increased muscle tension. Strong muscular contraction is may be useful in spastic muscle group. The EMS can be used in the circumstances to quickly break the spasm. Use a quick pulse rate, wide pulse duration and set the intensity to visible contraction (still within patient tolerance). Twenty or thirty minutes of such a tetanized muscular contraction will generally break the spasm. In all cases, if the patient complains that the stimulation is uncomfortable, reduce intensity and cease stimulation. CONTRACTION / RELAXATION The contraction time and relaxation time of EMS is adjustable. Stimulation will continue at the setting contraction time and cease also at the setting relaxation time. Then the cycle starts over again – Stimulation, Contraction and Relaxation.

Chapter 11 : ATTACHMENT OF ELECTRODE LEAD WIRES The wires provided with the system insert into the jack sockets located on top of the device. Holding the insulated

LEAD WIRE

portion of the connector, push the plug end of the wire into

ELECTRODE

SOCKET

one of t h e j ac k s ( s ee 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.

RAMP In order to achieve a comfortable exercise and avoid startle because of electrical shock, each contraction course may be ramped so that the signal comes on gradually and smoothly. The intensity of

CAUTION Do not insert the plug of the patient lead wire into the AC power supply socket.

electrical current will reach the setting level within the Ramp time,

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Chapter 12: LEAD WIRE MAINTENANCE

CONTIGUOUS PLACEMENT

Clean the wires by wiping with a damp cloth. Coating them lightly

This is the most common placement technique. It involves placing the

with talcum powder will reduce tangling and prolong life.

electrodes alongside the affected muscles or muscle groups, in such a way as to direct the flow of current through or around the

Chapter 13 : ELECTRODE OPTIONS

area.

The electrodes are disposable and should be routinely replaced when they start to lose their adhesive nature. If you are unsure of your electrode adhesive properties, order replacement electrodes. Replacement electrodes should be re-ordered through or on the advice of your physician to ensure proper quality. Follow application procedures outlined in electrode packing, to maintain optimal stimulation and to prevent skin irritation.

DERMATOMES, MYOTOMES AND SCLEROTOMES

Chapter 14 : ELECTRODE PLACEMENT

MOTOR, TRIGGER AND ACUPUNCTURE POINTS

These are the regions of the body enervated by one spinal nerve. Electrode placement involves both stimulating across the similarly enervated area and/or placing one electrode (or set of electrodes) at the affected site and another electrode (set) at the point where the nerve root joins the spinal cord.

The placement of electrodes can be one of the most important pa-

W hile these points of high tissue conductivity can differ in location

rameters in achieving success with EMS therapy. Of utmost impor-

and in theory of use, their use as an electrode site is identical. The

tance is the willingness of the clinician to try the various styles of

easiest technique involves placing one pad directly over the point

electrode placement to find which method best fits the needs of the

and completing the circuit by placing the second pad on some area

individual patient.

on the affected side.

This second electrode site can be within a

nerve zone, or a master point located between the thumb and the Every patient responds to electrical stimulation differently and their

forefinger on the dorsal web area between the two metacarpal

needs may vary from the conventional settings suggested here. If

bones.

the initial results are not positive, feel free to experiment. Once an acceptable placement has been achieved, mark down the electrodes

MULTIPLE PLACEMENT STRATEGIES

sites and the settings, so the patient can easily continue treatment at home.

Because the EMS has two independently operated channels, the clinician may take advantage of concurrent pad placement strategies.

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For example, it is possible to use two different electrode placement strategies at the same time. One channel can be used to directly stimulate the pain site in a contiguous manner; the other channel can be placed along the involved dermatome or utilized for point therapy.

Chapter 15 : TIPS FOR SKIN CARE

Chapter 16 : 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 n the pre-wired

To avoid skin irritation, especially if you have sensitive skin, follow these suggestions:

electrodes. 3. Remove the electrodes from the protective liner and apply the electrodes firmly to the treatment site.

1. W ash the area of skin where you will be placing the electrodes, using mild soap and water before applying electrodes, and after taking them off. Be sure to rinse soap off thoroughly and dry skin well. 2. Excess hair may be clipped with scissors; do not shave stimula-

Removal 1. Lift at the edge of electrodes and peel; do not pull on the lead wires because it may damage the electrodes.

tion area. 3. W ipe the area with the skin preparation your clinician has recommended. Let this dry. Apply electrodes as directed. 4. Many skin problems arise from the “pulling stress” from adhesive patches that are excessively stretched across the skin during application. To prevent this, apply electrodes from center outward; avoid stretching over the skin. 5. To minimize “pulling stress”, tape extra lengths of lead wires to the skin in a loop to prevent tugging on electrodes. 6. W hen removing electrodes, always remove by pulling in the direc tion of hair growth. 7. It may be helpful to rub skin lotion on electrode placement area when not wearing electrodes. 8. Never apply electrodes over irritated or broken skin.

2. Place the electrodes on the liner and remove the lead wire by twisting and pulling at the same time. Care and Storage 1. Between uses, store the electrodes in the resealed bag in a cool dry place. 2. It may be helpful to improve repeated application by spreading a few drops of cold water over the adhesive and turn the surface up to air dry. Over Saturation with water will reduce the adhesive properties.

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Important 1. Do not apply to broken skin. 2. The electrodes should be discarded when they are no longer

Turn Power On Adjust Intensity

adhering.

Turn Power Off

3. The electrodes are intended for single patient use only. 4. If irritation occurs, discontinue use and consult your clinician. Con

5. Read the instruction for use of self-adhesive electrodes before

15

Con

sec.

15

sec.

application. 4. Lead Connector Connection of the electrodes is made with two-lead connector. The device must be switched off before connecting the cables.

Chapter 17 : ADJUSTING THE CONTROLS

Both intensity controls must be at the Off position. Electrodes must be pressed firmly on the skin.

1. Slide Cover:

PLUG

A slide-on panel covers the controls for Contraction

LEAD CONNECTOR

Time, Relaxation Time, Ramp Time, Pulse Width, and Pulse Rate. Your medical professional may wish to set these controls for you and request that you 5. Function Selector

leave the cover in place.

Expose the controls by sliding front cover down from top of unit. 2. Power On/Off Switch and Intensity Controls: If both controls are in the off-position , the device is switched off. By turning the controls clockwise, the appropriate channel is switched on and the indicator of power(a dot) will reveal on the LCD. The current strength of the impulses transmitted to the electrodes

This button Controlling the menu on the LCD. W hen the button is pressed, it can change menu from contraction time, relaxation time, ramp time, pulse rate, pulse width to timer. The parameter of each function can be adjusted when it is revealed on the menu.

increases further when the control is turned clockwise. To reduce the current strength or switch the device off, turn the control counter clockwise to the required setting or off-position,

SET

respectively.

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6. Parameter Increase Control

9. Step to Set Parameter

This button controlling the increase of parameter. When pressing

The parameter of a treatment course can be adjusted according

this button, the parameter will increase. Press the button until the

to the following steps.

value desired is reached.

Press “set” button to select the function you wish to set a value. a. Turn on the Intensity After the electrodes are placed firmly on skin and the lead wires are plugged in the socket of device, turn the on/off control clockwise. The menu will reveal on LCD. Notice the indication of

7. Parameter Decrease Control

power and function on the LCD.

This button controlling the decrease of parameter. W hen pressing this button, the parameter will decrease. Press the button until Con

the value desired is reached.

15

sec.

SET

8. Function Indicator

b. Set Contraction Time

The drawing on the top of LCD showing the function that is working.

The contraction time controls the time of stimulation. By pressing

Each part of the drawing represents one function of the course.

parameter controls, the contraction time can be pre-set. The range is adjustable from 1 second to 30 seconds.

Ramp Up Con

Contraction

15

sec.

c. Set Relaxation Time Ramp Down

The relaxation time determines the time of relaxation. The stimula tion ceases at setting relaxation time and then re-start in a cycle

Relaxation

pattern. The relaxation time of both channels is changed by press-

The defined area will flash when the device is working on that function.

ing the parameter controls. The range of it is adjustable from 1 second to 45 seconds.

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Rel

10

150

sec.

d. Set Ramp Time

g. Set Timer

This ramp time controlling the time of output current that increase

The treatment time is adjustable from 1 to 60 minutes.

from 0 to the setting level, and from the setting value to 0. W hen

60

the ramp time is set, each contraction may be ramped in order that signals come on and come off gradually and smoothly. The ramp time is adjustable from 1 to 6 seconds by pressing the parameter controls.

10.Check/Replace the Battery: Over time, in order to ensure the functional safety of EMS, changing the battery is

4

Ramp

necessary. sec.

e. Set Pulse Rate

1. Make sure that both intensity controls are

The pulse rate determines how many electrical impulses are applied through the skin each second. By pressing the parameter controls, the number of current impulses per second (Hz) for both

switched to off- position. 2. Slide the battery compartment cover and remove.

channels can be continually adjusted.

3. Remove the battery from the compartment.

The pulse rate is adjustable from 1 Hz to 150 Hz. Unless other-

4. Insert the battery into the compartment. Note the polarity indi-

wise instructed, turn the pulse rate control to the 70-120 Hz range.

cated on the battery and in the compartment. 5. Replace the battery compartment cover and slide to close.

150

Chapter 18 : BATTERY INFORMATION

f . Set Pulse Width The pulse width determines the length of time. Each electrical signal is applied through the skin, which controls the strength and sensation of the stimulation. The pulse width is adjustable from 2 to 260 µs. Press the buttons until the desired value is reached.

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PRECATIONS 1. Remove battery if equipment is not likely to be used for some time. 2. Please recycle the used battery in accordance with domestic regulation. 3. Do not throw the used battery into fire. If you use rechargeable batteries, please follow the instructions.

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RECHARGEABLE BATTERIES(NOT INCLUDED) Prior to the use of a new unit, the rechargeable battery should be charged according to the battery manufacturer’s instructions. Before using the battery charger, read all instructions and cautionary markings on the battery and in this instruction manual. After being stored for 60 days or more, the batteries may lose their charge. After long periods of storage, batteries should be charged prior to use.

(d)WARNINGS: 1.Do not attempt to charge any other types of batteries in your charger, other than the nickel-cadmium rechargeable batteries. Other types of batteries may leak or burst. 2. Do not incinerate the rechargeable battery as it may explode!

Chapter 19: MAINTENANCE, TRANSPORTATION AND STORAGE OF EMS DEVICE 1. Non-flammable cleaning solution is suitable for cleaning the device.

BATTERY CHARGING

Note: Do not smoke or work with open lights (for example, candles, (1)Plug the charger into any working 110 or 220/240v mains electri cal 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 time has been completed, unplug the charger and remove the battery. (4)Batteries should always be stored in a fully charged state. To ensure optimum battery performance, follow these guidelines: (a)Although overcharging the batteries for up to 24 hours will not damage them, repeated overcharging may decrease useful battery life.

etc.) when working with flammable liquids. 2. Stains and spots can be removed with a cleaning agent. 3. Do not submerge the device in liquids or expose it to large amounts of water. 4. Return the device to the carrying box with sponge foam to ensure that the unit is well-protected before transportation. 5. If the device is not to be used for a long period of time, remove the batteries from the battery compartment (acid may leak from used batteries and damage the device). Put the device and accessories in carrying box and keep it in cool dry place. 6. The packed EMS device should be stored and transported under

(b)Always store batteries in their charged condition. After a battery has been discharged, recharge it as soon as possible. If the

the tempera ure range of -20°C ~ + 60°C, relative humidity 20% ~ 95%, Aatmosphere pressure 500hPa ~ 1060hPa.

battery is stored more than 60 days, it may need to be recharged. (c )Do not short the terminals of the battery. This will cause the battery to get hot and can cause permanent damage. Avoid storing the batteries in your pocket or purse where the terminals may accidentally come into contact with coins, keys or any metal objects.

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Chapter 20: SAFETY-TECHNICAL CONTROLS

- for possible damage to the cable. Change the cable if any damage is detected.

For safety reasons, check your EV-807 DIGITAL EMS each week based on the following checklist.

* If there is any other problem, please return the device to your distributor. Do not try to repair a defective device.

1. Check the device for external damage. - deformation of the housing. - damaged or defective output sockets. 2. Check the device for defective operating elements.

Chapter 22 : CONFORMITY TO SAFETY STANDARDS

- legibility of inscriptions and labels. - make sure the inscriptions and labels are not distorted.

The EV-807 DIGITAL EMS devices are in compliance with the

3. Check LCD

EN 60601-1-2:2001 and EN 60601-1:1990+A1:1993+A2:1995+A13:

- Parameters must be visible on the LCD.

1996 safety standards.

4. Check the usability of accessories. - patient cable undamaged. - electrodes undamaged. Please consult your distributor if there are any problems with device and accessories.

Chapter 21 : MALFUNCTIONS Should any malfunctions occur while using the EMS, check - whether the controls or parameters are set to the appropriate form of therapy. Adjust the control correctly. - whether the cable is correctly connected to the device. The cables should be inserted completely into the sockets. - whether the LCD reveal the menu. If necessary, insert a new battery.

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Chapter 23 : WARRANTY

I. Test Environment SCOPE PROBE(GND)

All EV-807 DIGITAL EMS models carry a warranty of one year from the date of delivery. The warranty applies to the stimulator only and covers both parts and labor relating thereto.

LOAD 500 ohm

The warranty does not apply to damage resulting from failure to

SCOPE PROBE(INPUT)

follow the operating instructions, accidents, abuse, alteration or disassembly by unauthorized personnel.

3F., No.5, Ln. 155, Sec. 3, Beishen Rd., Shenkeng Dist., New Taipei City 22203, Taiwan. (R.O.C.)

SCOPE PROBE

Everyway Medical Instruments Co., Ltd.

Lead wire(BLACK)

Manufacturer:

Lead wire(RED)

Representative in the EU: REHAB EUROPA SL SANT GERVASI DE CASSOLES, 96 3o 4a 08022 BARCELONA, SPAIN. INFORMATION FOR DISTRIBUTOR: Please contact the above mentioned manufacturer for technical support and documentation when necessary.

Copyright © 2011 by Everyway Medical Instruments Co., Ltd.

EV-807

CH1 Oscilloscope Tektronic TDS310

Edition : V1.2 Printed in March, 2011

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II. Waveform Description

III. Ramp up in 6 sec Ramp up in 6 sec

Oscilloscope: Tektronic TDS310 Load: 500 ohm Pulse Rate: 150Hz Pulse Width: 260µs Ramp Time: 6 sec

Scoop: VERT. 10V/DIV HORIZ. 50µs/DIV OUTPUT: 46.4V pk-pk Pulse Width: 260.9µs The output current of each channel: 46.4 V / 500 Ohm = 92.8 mA

Ramp Down in 6 sec

Scoop: VERT. 10V/DIV HORIZ. 1.0mS/DIV OUTPUT: 44.8V pk-pk Pulse Width: 150.6Hz The output current of each channel: 44.8 V / 500 Ohm = 89.6 mA

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