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3 IN 1 COMBO STIMULATOR INSTRUCTION MANUAL MA LT3011A REF.LTK545 EN 01 B_02-2015 Manufacturer: Name: Shenzhen Dongdixin Technology Co., LTD. Add: No.3 Building XiliBaimang Xusheng Industrial Estate, Nanshan Shenzhen, China 518108 Tel: 0086-755-27652316 Authorized EC-representative: Shanghai International Holding Corp. GmbH (Europe) Eiffestraße 80, 20537 Hamburg Germany Tel: 0049-40-2513175 Fax: 0049-40-255726 Copyright 2013 by Shenzhen Dongdixin Technology Co., LTD. Edition: V1.2 Distributed by: Via Bruxelles, 3 - Meleto 52022 Cavriglia (Arezzo) Tel. +39 055 96 21 11 Fax. +39 055 96 21 200 www.morettispa.com info@morettispa.com

3 IN 1 COMBO STIMULATOR - Ausisan en.pdf · The goal of electrical muscle stimulation is to achieve contractions or vibrations in the muscles. ... stimulator) with electrodes attached

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Page 1: 3 IN 1 COMBO STIMULATOR - Ausisan en.pdf · The goal of electrical muscle stimulation is to achieve contractions or vibrations in the muscles. ... stimulator) with electrodes attached

3 IN 1 COMBO STIMULATOR

INSTRUCTION MANUAL

MA

LT

30

11A

RE

F.LT

K5

45

EN

01

B_0

2-2

015

Manufacturer: Name: Shenzhen Dongdixin Technology Co., LTD. Add: No.3 Building XiliBaimang Xusheng Industrial Estate, Nanshan Shenzhen, China 518108Tel: 0086-755-27652316

Authorized EC-representative: Shanghai International Holding Corp. GmbH (Europe)Eiffestraße 80, 20537 Hamburg GermanyTel: 0049-40-2513175 Fax: 0049-40-255726

Copyright 2013 by Shenzhen Dongdixin Technology Co., LTD. Edition: V1.2

Distributed by:Via Bruxelles, 3 - Meleto52022 Cavriglia (Arezzo)Tel. +39 055 96 21 11

Fax. +39 055 96 21 [email protected]

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This manual is valid for the LT3011A REF.LTK545

This user manual is published by Shenzhen Dongdixin Technology Co., LTD.

Shenzhen Dongdixin Technology Co., LTD. does not guarantee its contents and reserves the right to improve and amend it at any time without prior notice. Amendments will however be published in a new edition of this manual.

All Rights ReservedLT3011A REF. LTK545 Stimulator Rev.V1.2 2013 Dongdixin

Declaration of conformity:Shenzhen Dongdixin Technology Co., LTD. declares that

the LT3011A REF.LTK545 complies with following normative documents:

Table of Contents

1. Foreword.......................................................................... 41.1 Introduction1.2 Medical background2. Safety information.............................................................72.1 Indication for use 2.2 Contraindication2.3 Warning2.4 Precautions2.5 Adverse reactions 3. Presentation....................................................................123.1 Accessories3.2 Presentation of the device3.3 LCD display3.4 Technical information4. Operation instrucions......................................................164.1 Check batteries4.2 Connect electrodes to lead wires4.3 Connect lead wires to device4.4 Place electrodes on skin4.5 Turn on 4.6 Select the therapy mode and treatment part4.7 Select the therapy program4.8 Adjust the intensity and start to treatment4.9 User program setting4.10 Checking the memory4.11 Turn the device off4.12 Replace batteries4.13 Low battery indicator

-1- -2-

EN/IEC60601-1, EN/IEC60601-1-2, EN/IEC60601-2-10,EN/IEC60601-1-11, ISO10993-5, ISO10993-10, ISO 10993-1

Complies with MDD 93/42/EEC and amended by directive 2007/47/EC requirements

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5. Therapy program............................................................246. Cleaning and maintenance.............................................296.1 Cleaning the device6.2 Cleaning the electrodes6.3 Cleaning the Electrodes cords6.4 Maintenance7. Troubleshooting..............................................................328. Storage...........................................................................349. Disposal..........................................................................3410. Normalized symbols.....................................................3511. Warranty.......................................................................36

Appendix:Stimulation position.............................................37

1.1 IntroductionThe LT3011A Ref.LTK545 is a battery operated pulse generator that sends electrical impulses to the body and reach the nerves and underlying muscle group,this is a unit to be used for pain relief,muscle stimulation and massage.The device provides two controllable output channels,each independent of each other,a pair of electrodes can be connected to each output channel.The parameters of units are controlled by button.Its intensity level is adjustable according to the needs of patients.

1.2 Medical backgroundWhat is TENS?TENS (Transcutaneous Electrical Nerve Stimulation) gives good results in acute and chronic pain conditions of many kinds. It is clinically proven and used daily by physiotherapists, other caregivers and top athletes around the world. High-frequency TENS activates the pain-inhibiting mechanisms of the nervous system. Electrical impulses from electrodes, placed on the skin over or near the painful area, stimulate the nerves to block the pain signals to the brain, and the pain is not perceived. Low-frequency TENS stimulates the release of endorphins, the body's natural painkillers. TENS is a safe treatment method and has, in contrast to drugs and other pain relief methods, no side effects. It may be sufficient as the only treatment form, but it is also a valuable complement to other pharmacological

-3- -4-

1. Foreword

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and/or physical treatments. TENS does not always treat the cause of pain. Consult your doctor if pain persists.

How Does TENS Control Pain?The device provides pain relief in two ways. The first is the gate control method. When the body is injured, both pain and non-pain impulses are sent to the brain from the ervous system. These pulses travel through the cutaneous nerves to the deeper, afferent nerves, and then to the spinal cord and brain. Along the path are many areas referred to as “gates,” which determine which impulses are allowed to continue on to the brain. The gates prevent the brain from receiving too much information too quickly. Since the same nerve cannot carry a pain and a non-pain impulse at the same time, the stronger, non-pain impulse from the device “controls the gate.” The second method of pain control is the endorphin release method. The device can be set to trigger the body's natural pain killers, called endorphins. These chemicals interact with receptors, blocking the perception of pain. This is similar to the way the pharmaceutical drug morphine works, but without the side effect associated with morphine. No matter which pain control method is employed, the Device has been proven useful in pain management. By reading this manual and carefully following the treatment instructions provided by your clinician, you can attain maximum benefit from your device.

What is EMS?EMS (Electrical muscle stimulation) is achieved by sending small electrical impulses through the skin to the underlying motor units (nerves and muscles) to create an involuntary

muscle contraction. Neuromuscular stimulation has many uses beyond its traditional application to prevent disuse atrophy.

How does EMS work?Because the transdermal stimulation of nerves and muscles may be accomplished by electrical pulses, this modality can help prevent disuse atrophy. Accordingly, incapacitated patients can receive therapeutic treatment to create involuntary muscle contractions thereby improving and maintaining muscle tone without actual physical activity.The goal of electrical muscle stimulation is to achieve contractions or vibrations in the muscles. Normal muscular activity is controlled by the central and peripheral nervous systems, which transmit electrical signals to the muscles. EMS works similarly but uses an external source (the stimulator) with electrodes attached to the skin for transmitting electrical impulses into the body. The impulses stimulate the nerves to send signals to a specifically targeted muscle, which reacts by contracting, just as it does with normal muscular activity.

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2.1 Indications for useThis device is used in following instance: 1) Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain. 2) Increase of blood flow in the treatment area. 3) Relaxation of muscle spasm. 4) Immediate post-surgical stimulation of muscles to prevent venous thrombosis. 5) Prevention or retardation of disuse atrophy. 6) Muscle re-education 7) Maintaining or increasing range of motion.

2.2 Contraindications1) This device should not be used when cancerous lesions are present in the treatment area.2) Stimulation should not be applied over swollen, infected, inflamed areas or skin eruptions (e.g. phlebitis, thrombophlebitis, varicose veins, etc.).3) Safety has not been established for the use of therapeutic electrical stimulation during pregnancy.4) Demand type implanted pacemaker or defibrillator.5) Epilepsy6) Serious arterial circulatory problems in the lower limbs7) Abdominal or inguinal hernia8) No suitable for use during pregnancy or labor women9) Do not use this device when pain syndromes are undiagnosed. Use only after origin of pain has been diagnosed.

-7-

2.3 Warning1)

2) 3)

4)

5)

6)

7)

8)

9)

10)

The long-term effects of chronic electrical stimulation are unknown. For external use only.This device should be used only under the continued supervision of a licensed medical practitioner.Stimulation should not be applied over the carotid sinus nerves, particularly in patients witha known sensitivity to the carotid sinus reflex.Do not apply stimulation over thyroid or carotid sinus region of the neck or mouth, or from electrodes placed on the chest and the upper back, because this could severe muscle spasms resulting in closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may cause cardiac arrhythmias.Stimulation should not take place while the user is connected to high-frequency surgical equipment, it may cause burn injuries on the skin under the electrodes, as well as problems with the stimulator.Do not use the stimulator in the vicinity of shortwave or microwave therapy equipment, since this may affect the output power of the stimulator.Never use in environments with high humidity such as in the bathroom or when having a bath or shower.Never use near the heat. Stimulation electrodes should never be placed anywhere on the front of the thorax (marked by ribs and breastbone),but above all not on the two large pectoral muscles. Here it can increase the -8-

2. Safety information

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-9- -10-

2.4 Precautions

1)

2)

3)

4)

5)

6)

7)

8)

9)

10)

11)

12)

13)

14)

The stimulator is suitable for private use.

Caution should be used for patients with suspected or

diagnosed heart problems.

Some patients may experience skin irritation or

hypersensitivity due to the electrical stimulation or gel. If

rash develops or pain persists, discontinue use and

consult a doctor.

Electrode placement and stimulation settings should be

based on the guidance of prescribing practitioner.

Effectiveness is highly dependent upon patient selection

by a person qualified in the management of pain

afflicted patients.

Isolated cases of skin irritation may occur at the site of

the electrode placement following long-term application.

The electrodes are only to be placed on healthy skin.

Avoid skin irritation by ensuring that good contact is

achieved between electrodes and skin.

If the stimulation levels are uncomfortable or become

uncomfortable, reduce the stimulation amplitude to a

comfortable level and contact your physician if problems

persist.

The device may not be used whilst driving a car or whilst

operating and controlling machinery.

Never use the device in rooms where aerosols(sprays)

are used or pure oxygen is being administered.

Do not use it near any highly flammable substances,

gases or explosives.

Do not use this device at the same time as other

equipment which sends electrical pulses to your body.

Do not confuse the electrode cables and contacts with

your headphones or other devices, and do not connect

the electrodes to other devices.

Do not use sharp objects such as pencil point or

ballpoint pen to operate the buttons on the control panel.

risk of ventricular fibrillation and lead to cardiac arrest.Never use on the eye area, or applied across or through the head.Never use near the genitals.Never use on the areas of the skin which lack normal sensationThis stimulator is never use by patients who have noncompliant, emotionally disturbed, dementia, or low IQ.Apply the electrodes to clean, dry, and unbroken skin only.Keep electrodes separate during treatment, electrodes in contact with other could result in improper stimulation or skin burns.Keep the stimulator out of reach of children.Consult your doctor if you are in any doubt whatsoever.

11)

12)13)

14)

15)

16)

17) 18)

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3.1 Reception of equipment and accessoriesYour stimulator is supplied with case containing: A. 1pc the stimulator B. 2pcs electrode cable C. 4pcs Electrode pad (40x40mm) D. 1pc user manual E. 4pcs AAA battery

3.2 Presentation of the device

Inspect Applicator cables and associated connectors

before each use.

Electrical stimulators should be used only with the leads

and electrodes recommended for use by the

manufacturer.

Possible skin irritation or electrode burn under the

electrodes may occur.

Possible allergic skin reaction to tape or gel may occur.

-11-

15)

16)

2.5 Adverse Reactions1)

2)

-12-

1

3

456

7

11

12

1098

2

15 16

14

3. Presentation

(1) LED for channel 1(2) LED for channel 2(3) LCD(4) [ ] key: ◆ Turn on or turn off the device; ◆ In working mode:Stop the treatment; ◆ In memory mode:Exit from the memory state. ◆ In setting mode: Exit from the setting state

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-13-

(5) [CH1+] key: ◆ Increasing the output intensity of channel 1.(6) [ ] key: ◆ In user select mode: To select the user (U1 or U2); ◆ In memory mode: To check the memory data and confirm whether remove the memory data; ◆ In working mode: Pause treatment and resume treatment(7) [ ] key: ◆ Decreasing the output intensity of channel 1. ◆ In setting mode: To select the next parameter .(8) [ ] key: ◆ In waiting mode: To select the therapy program. Press and hold to enter setting mode.(9) [ ] key: ◆ Decreasing the output intensity of channel 1. ◆ In setting mode: Adjust the user program parameter.(10) [ ] key: ◆ In user select mode: Confirm to select U1 or U2; ◆ In waiting mode: To select the treatment part circularly; ◆ In waiting mode: Press and hold on 3 seconds to enter memory mode; ◆ In memory mode: Press and hold on 3 seconds to ask whether remove the memory data.(11) [ ] key: ◆ Increasing the output intensity of channel 1. ◆ In setting mode: Adjust the user program parameter.(12) [ ] key: ◆ In waiting mode: To select the therapy mode: “TENS”, “MASS”, “EMS”.

-14-

3.3 LCD display

1) Therapy mode: TENS, MASS, EMS2) Therapy part: SHOULDER, NECK, BACK, ELBOW, HIP, ANKLE, FOOT, WRIST, KNEE3) Pause indicator4) Setting mode indicator5) Pulse width and Output intensity of channel 16) Treatment time7) Pulse rate and Output intensity of channel 28) Low battery indicator9) Intensity lock indicator

8

9

765

4

3

2

1

(14) Battery cover(15) Socket for channel 1(16) Socket for channel 2

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4 .1 Check BatteryInsert a fresh 4xAAA batteries into the battery compartment. Make sure you are installing the battery properly.The battery is inserted in the casing on the back of the stimulator.Be sure to match the positive and negative ends of the battery to the markings in the battery compartment of unit.To remove the battery cover, press and pull down following the direction of on the battery cover.

Remove the batteries if the device is not in use for long periods of time.Do not mix old and new batteries or difference type of batteries.Warning: If batteries leak and come into contact with the skin or eyes, wash immediately with copious amounts of water.Batteries must be handled by an adult. Keep batteries out of the reach of children.Only batteries of the same or equivalent type are recommended.Remove exhausted batteries from the unit.Dispose of batteries safety according to local regulation.

1. 2. 3.

4. 5.

6. 7.

-16--15-

3.4 Technical informationMaterial:-------------------------------ABSChannel:-------------------------------Two channelPower supply:----------------------- 4x AAA batteriesWaveform:----------------------------Biphase square-wave pulsePulse duration:---------------------- 30-350μsPulse frequency:--------------------1-290HzTreatment time:--------------------- 5 to 90minIntensity:------------------------------ Adjustable from 0 to 90mA (at 1000 ohm )Operating conditions:--------------5°C to 40°C with a relative humidity of 30%-85%, Atmospheric pressure from 700 hpa to 1060 hpaStorage conditions:---------------- -10°C to 50°C with a relative humidity of 10%~90%, atmospheric pressure from 700 hpa to 1060 hpaDimensions:--------------------------117x60x25mmWeight:--------------------------------110g (without batteries) 140g (with batteries)Service life of the device:---------3 yearsService life of the battery:---------With new super heavy duty batteries, approx. 20 days when used for 30 minutes a day in TENS NECK P01 program at 40mA intensity.

4. Instructions for use

Caution:

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4.2 Connect electrodes to lead wiresInsert the lead wire connector into electrodes connector. Make sure no bare metal of the pins is exposed.

Caution:Always use the electrodes with CE mark, or which are legally marketed in the US under 510(K) procedure.

4.3 Connect lead wires to the deviceLT3011A Ref.LTK545 has two output channels, the user can use one channel with a pairs of electrode pads or use both channels with two pairs of electrode pads. Before Connect lead wires to the device, please make sure the device is completely turned off. Hold the cable plug and insert into the socket on the top of the device.

Caution:For the safety, please always use lead wires which supplied by manufacturer or distributor.

4.4 Place electrodes on skinApply electrodes to the exact site indicated by your physician (Recommend stimulation position please refers to Appendix: Stimulation position). Before applying electrodes, be sure the skin surface over which electrodes are placed is thoroughly cleaned and dried. Make sure the electrodes are

Before applying the self-adhesive electrodes, it is recommended to wash and degrease the skin, and then dry it. Do not switch the device on when the self-adhesive electrodes is not positioned on the body. Never remove the self - adhesive electrodes from the skin while the device is still switched on.It is recommended that, at minimum,4cm x 4cm self - adhering based, square electrodes are used at the treatment area

1.

2. 3.

4.

-17-

placed firmly to the skin and make good contact between the skin and the electrodes. Place the electrodes over the skin; attach them properly, firmly, and evenly.

Caution:

4.5 Turn on Before using the device for the first time, you are strongly advised to take careful note of the contraindications and safety information of this manual. As this powerful equipment is neither a toy nor a gadget!In order to turn on the device, press [ ] button and the device will enter into user select mode, LCD displays like figure I:

Figure I

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You can select U1 or U2 by press [ ] button, the device will enter into waiting mode after press [ S ] button.

Caution:1)The device will enter into user select mode too, after you insert batteries.2) The device will enter into waiting mode too if no any button to press in 5 seconds.

4.6 Select the therapy mode and treatment partThere are three therapy modes in this device, Press [ M ] button to select therapy mode: “TENS”, “MASSAGE” or “EMS”. The therapy mode which you selected will flash like figure II.There are 9 treatment parts display on LCD, press [ S ] button to select therapy part circularly. The therapy part will flash like figure II when you selected it.

Figure II

-19-

4.7 Select the therapy programThere are 3 therapy modes and 9 treatment parts in this device, each treatment part has 3 or 4 programs in one therapy mode. So, the total therapy program is 78, among them, TENS program and EMS program each is 27 and MASSAGE program is 24. The details please refer to “Therapy program” in page 24.Press [P ] button to select the therapy program for the treatment part which you selected. The LCD will display program number like figure II.

4.8 Adjust the intensity and start to treatmentPress [CH1+] or [CH2+] button to increase the output intensity of channel 1 or channel 2, and the device start to work. Press [CH1-] or [CH2-] button to decrease the output intensity of channel 1 or channel 2. The LCD will display the current output intensity like Figure III, the remaining working time also display on LCD.

Figure III

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Caution:

4.9 User program settingEach treatment body part has one user program-U1 in TENS and EMS mode. Turn on the device and select the user program by press [P] button, and then press and hold [P] button to enter into the setting mode. In this mode, you can set the pulse width from 50 to 350µs, pulse rate from 1 to 150Hz and treatment time from 5 to 90min.

-21-

1) Select the parameterPress [CH1-] button to switch the parameters- pulse rate, pulse width, and treatment time.2) Adjust the parameterPress [CH2+] or [CH2-] button to adjust the parameter.Press [ ] button to confirm the parameters and the device enter into the waiting mode.Note:Press and hold [CH2-] button until you install all batteries, the parameter will come back to factory default.

4.10 Checking the memoryThe device will record the treatment parameter (e.g. recording number, program, treatment part, the average intensity and treatment time) after you finished treatment. The maximum memory number is 30, the front of record will be deleted when the memory number over 30.If you want to check the memory data, please press and hold [S] button for 3 seconds, the device will enter into memory mode. Press [ ] button to read the memory parameter, and press [CH1] button to read the next record when the LCD display memory number.

The strength/intensity of stimulation may be adjusted depending upon the individual requirement of the user.The maximum intensity level is 90, 1level/step.Before removing the electrode pads please make sure the device turned off first.The safety lock feature automatically activates after there is no press any button in 20 seconds. You cannot increase the output intensity when the indicator " " display on LCD. You can press [CH1-] or [CH2-] button to unlock the device. When the remaining working time returns to zero, the output intensity will stop automatically.If there is any emergency happen, Please press [ ] button to stop treatment, the device will enter into waiting mode, or press [ ] button to pause treatment and press again to continue the treatment. If the device is locked, please press [CH1-] or [CH2-] button to unlock the device first.The amplitude level will be reset to 0mA when the amplitude level is 10mA or greater and an open circuit at either channel is detected.

1.

2.3.

4.

5.

6.

7.

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Caution:

4.11 Turn the device off You can Press and hold [ ] button to turn the device off Note:Except for working mode, the device will automatically turn off after there is no press any button in 3min.

4.12 Replace batteriesTo replace the batteries, open the lid cover and extract the battery. Replace it with new AAA batteries. Make sure you insert the battery correctly.

4.13 Low battery indicatorWhen the low power indicator flashes, the batteries should be replaced with new batteries as soon as possible. However, the stimulator will continue to operate for several more hours.

-24--23-

(5) [CH1+] key: ◆ Increasing the output intensity of channel 1.(6) [ ] key: ◆ In user select mode: To select the user (U1 or U2); ◆ In memory mode: To check the memory data and confirm whether remove the memory data; ◆ In working mode: Pause treatment and resume treatment(7) [ ] key: ◆ Decreasing the output intensity of channel 1. ◆ In setting mode: To select the next parameter .(8) [ ] key: ◆ In waiting mode: To select the therapy program. Press and hold to enter setting mode.(9) [ ] key: ◆ Decreasing the output intensity of channel 1. ◆ In setting mode: Adjust the user program parameter.(10) [ ] key: ◆ In user select mode: Confirm to select U1 or U2; ◆ In waiting mode: To select the treatment part circularly; ◆ In waiting mode: Press and hold on 3 seconds to enter memory mode; ◆ In memory mode: Press and hold on 3 seconds to ask whether remove the memory data.(11) [ ] key: ◆ Increasing the output intensity of channel 1. ◆ In setting mode: Adjust the user program parameter.(12) [ ] key: ◆ In waiting mode: To select the therapy mode: “TENS”, “MASS”, “EMS”.

3.3 LCD display

1) Therapy mode: TENS, MASS, EMS2) Therapy part: SHOULDER, NECK, BACK, ELBOW, HIP, ANKLE, FOOT, WRIST, KNEE3) Pause indicator4) Setting mode indicator5) Pulse width and Output intensity of channel 16) Treatment time7) Pulse rate and Output intensity of channel 28) Low battery indicator9) Intensity lock indicator

The device will return to waiting mode when you press [ ] button or 30 seconds later.Press and hold [S ] button for 3 seconds, the total recording number will flash on LCD when the device in memory mode. If you want to delete the memory, please press [ ] button to delete them; if you want to keep them, you should press [ ] button and the device return to waiting mode.

1.

2.There are 3 therapy modes (TENS, EMS and MASSAGE) and 9 treatment parts (SHOULDER, NECK, BACK, ELBOW, HIP, ANKLE, FOOT, WRIST and KNEE) in this device, each treatment part has 3 or 4 programs in one therapy mode. So,the total therapy program is 78, among them, TENS program and EMS program each is 27 and MASSAGE program is 24. The factory default details please refer to following:

5.1 TENS program:

5. Therapy program

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Ther

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prog

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P1

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(min

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2~80 2

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100~

200

70~

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350

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rt

prog

ram

P1

Trea

t-m

ent

time

(min

)

P2

U1(

Def

ault)

SHO

ULD

ER

NEC

K

BA

CK

ELB

OW

HIP

AN

KLE

FOO

T

WR

IST

KN

EE

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efor

mW

avef

orm

Wav

efor

mP

ulse

rate

(Hz)

40 2~8

80 50 50 50 65 50 40

Pul

se w

idth

(μs)

200

300

150

350

350

200

200

350

350

30

Pul

sera

te(H

z)

50 2~60 65 50 40 65 50 50/8

50

Pul

se w

idth

(μs)

200

100~

200

350

200

200

200

200

200

350

Pul

sera

te(H

z)

80 1 50 50 65 50 50 50 50

Pul

se w

idth

(μs)

150

50 350

150

350

200

200

200

350

Conti

nuou

sPu

lse ra

te mo

dulat

ed

Asyn

chron

ous

Asyn

chron

ous

Async

hronou

s

Sim

ple

mod

ulat

ed

puls

e

5.2 EMS program:

-25- -26-

Page 15: 3 IN 1 COMBO STIMULATOR - Ausisan en.pdf · The goal of electrical muscle stimulation is to achieve contractions or vibrations in the muscles. ... stimulator) with electrodes attached

-27- -28-

5.3 MASSAGE program:

P1

P2

P3

SHOULDERNECKBACKELBOWHIPANKLEFOOTWRISTKNEE

P1,P2, P3,P4P2,P3,P4P1,P2,P3P2,P3P1,P2,P3,P4P3,P4P3,P4P2,P3P1,P2

Therapy part program

Work time(s)

Rest time(s)

TreatmentTime(min)PhaseProgram

11234567891011121312345

Pulse width(µs)100

30~22030~22030~22030~220

200200200200200

30~22030~22030~22030~22050~22050~22050~22050~22050~220

Pulserate(Hz)

82525334353697969534333252583100111118132

43.52.51.91.30.90.70.50.70.71.31.92.53.54

3.83.12.62.3

/1.00.90.90.80.70.60.50.60.60.80.90.911

0.80.720.60.6

30

P3

P4

Work time(s)

Rest time(s)

TreatmentTime(min)PhaseProgram

678123456789

1011

Pulse width(µs)

50~22050~22050~220

30~220~15030~220~15030~220~15030~220~15030~220~15030~220~15030~220~15030~220~15030~220~15030~220~15030~220~150

Pulserate(Hz)118111100147169196237285290238197191168150

2.62.83.3

12.010.38.56.85.15.76.38

8.59.1

10.8

0.60.70.81.00.90.60.60.40.50.50.60.70.80.9

30

Page 16: 3 IN 1 COMBO STIMULATOR - Ausisan en.pdf · The goal of electrical muscle stimulation is to achieve contractions or vibrations in the muscles. ... stimulator) with electrodes attached

-29- -30-

Remove the batteries from the device every time before cleaning.Clean the device with a soft,slight moistened cloth. In case of more extreme soiling you can also moisten the cloth with mild soapy water.Do not use any chemical cleaners or abrasive agents for cleaning.

1.

2.

3.

Use the device only with the leads and electrodes provided by the manufacturer. Use only the electrode placements and stimulation settings prescribed by your practitioner.It is recommended that, at minimum 4cm * 4cm self- adhering based, square electrodes are used at the treatment area.Inspect your electrodes before every use. Replace electrodes as needed.Reusable electrodes may cause slight skin irritation, lose adhesion and deliver less stimulation if over used.

1.

2.

3.

Attach the electrode to the lead wire.Remove the protective backing from the electrode surface. Do not throw away the protective backing because it is reused after the treatment session has been completed.Place the tacky surface to the prescribed skin area by pressing the electrode firmly against the skin.

1.2.

3.

Lift the corner of the electrode and gently remove it from the skin.Apply the protective backing to the tacky side of the electrode.Place the electrode on the side of the protective backing that is labeled with the word, on.Store the electrodes in the resalable pouch or a plastic bag.

1.

2.

3.

Do not pull on the electrode wire. Doing so may damage the and electrode.Always use the electrodes with CE mark, or are legally marketed in the US under 510(K) procedure.

1.

2.

To use these electrodes:

To remove your electrodes:

Caution:

6.3 Cleaning the Electrodes cordsClean the electrode cords by wiping them with damp cloth. Coating them lightly with talcum powder will reduce tangles and prolong the life.

6. Cleaning and maintenance

6.1 Cleaning the device

6.2 Electrodes

Page 17: 3 IN 1 COMBO STIMULATOR - Ausisan en.pdf · The goal of electrical muscle stimulation is to achieve contractions or vibrations in the muscles. ... stimulator) with electrodes attached

-31- -32-

Maintenance and all repairs should only be carried out by an authorized agency. The manufacturer will not be held responsible for the results of maintenance or repairs by unauthorized persons. The user may not attempt any repairs to the device or any of its accessories. Please contact the retailer for repair.Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to warranty. Check the device before each use for signs of wear and/or damage. Replace wear items as required.

1.

2.

3.

4.

7.Trouble-shooting6.4 Maintenance

If your device does not seem to be operating correctly, refer to the chart below to determine what may be wrong. Should none of these measures correct the problem, the device should be serviced.

Page 18: 3 IN 1 COMBO STIMULATOR - Ausisan en.pdf · The goal of electrical muscle stimulation is to achieve contractions or vibrations in the muscles. ... stimulator) with electrodes attached

-33- -34-

For a prolonged pause in treatment, store the device in a dry room and protect it against heat, sunshine and moisture.Store the device in a cool, well-ventilated placeNever place any heavy objects on the device.

1.

2.3.

8. STORAGE

9. DISPOSAL

Used fully discharged batteries must be disposed of in a specially labeled collection container, at toxic waste collection points or through an electrical retailer. You are under legal obligation to dispose of batteries correctly.

Please dispose of the device in accordance with the directive 2002/96/EC WEEE (Waste Electrical and Electronic Equipment). Contact your local distributor for information regarding disposal of the unit and accessories.

Page 19: 3 IN 1 COMBO STIMULATOR - Ausisan en.pdf · The goal of electrical muscle stimulation is to achieve contractions or vibrations in the muscles. ... stimulator) with electrodes attached

The following is excluded under the warranty:

Liability for direct or indirect consequential losses caused by the unit are excluded even if the damage to the unit is accepted as a warranty claim.

All damage which has arisen due to improper treatment, e.g. nonobservance of the user instruction.All damage which is due to repairs or tampering by the customer or unauthorized third parities.Damage which has arisen during transport from the manufacturer to the consumer or during transport to the service centre.Accessories which are subject to normal wear and tear.

a.

b.

c.

d.

4.

5.

-35-

LOT

S N

-36-

The warranty period for LT3011A Ref.LTK545 products is one year from date of purchase. In case of a warranty claim, the date of purchase has to be proven by means of the sales receipt or invoice.Defects in material or workmanship will be removed free of change within the warranty period.Repairs under warranty do not extend the warranty period either for the unit or for the replacement parts.

1.

2.

3.

Please contact your dealer or the device centre in case of a claim under the warranty. If you have to send in the unit, enclose a copy of your receipt and state what the defect is.The following warranty terms apply:

10. Normalized symbols 11. Warranty

Applied part of type BF

Disposal in accordance with Directive 2002/96/EC (WEEE)

Batch code

Serial number

Refer to instruction manual because of the higher levels of output

Keep dry

Complies with the European Medical DeviceDirective (93/42/EEC) and amended bydirective 2007/47/EC requirements. Notifiedbody TÜV Rheinland (CE0197)

The name and the address of the manufacturer

Page 20: 3 IN 1 COMBO STIMULATOR - Ausisan en.pdf · The goal of electrical muscle stimulation is to achieve contractions or vibrations in the muscles. ... stimulator) with electrodes attached

-37- -38-

Appendix: Stimulation position

Muscular groupsPlantar archmuscles

Calf muscles

Tibialisanterior

Take up a seatedposition with your feet placed under a piece of furniture, to avoid any ankle bending

Contract your tibialis anterior muscles while vigorously trying to raise the tip of your foot against an object that resists and prevents this movement

Vigorously contract your calf muscles while strongly trying to push the tip of your foot against an object that resistsand prevents this movement

Take up a seated position with your back and feet firmly placed against supports This position is easy to adopt by sitting, for example,in a doorframe

Peroneousmuscles

Placement ofelectrodes

Stimulation positions

Take up a seatedposition with yourfeet resting on the floor

Take up a seated position with yourfeet resting on the floor

Contract your peroneous muscles by exercising a vigorous pressure on the floor with your big toe, while also trying to raise the outer toes from the floor

Vigorously contract the muscles of your plantar arch,trying to dig your toes into the floor

Voluntary start of thecontraction phase

1

2

3

4

1 2

Contract vigorously the muscles on the back of the thigh (hamstrings) while trying to bend your knees

Lie flat on your stomach with your ankles fixed in a convenient way

Take up a seated position and place a rigid(but comfortable) object between your kneesTake up a seated position The work can be done in two ways:statically, if you have taken the necessary measures to block the movement of your knees dynamically, if you want to emphasise work with movement, against an object offering resistance created by using heavy weights Lie down on your stomach or stand up Special recommendations: For the buttocks, the mode requires very good muscular qualities and is not compatible with certain morphological configurations In the event of repeated failures with the mode, we recommend work on the buttocks in the “classic” mode

Strongly contract your quadriceps, while trying to extend your legs

Vigorously contract your buttock muscles, while strongly trying to close your buttocks and trying to bring your thighs behind your trunk

Buttocks

Strongly contract your adductors, while vigorously trying to bring yourknees together

Hams-trings

Adductors

Quadriceps

Muscular groups

Placement ofelectrodes

Stimulation positions

Voluntary start of thecontraction phase

5

1 2

6

1 2

7

1 2

8

1 2

Page 21: 3 IN 1 COMBO STIMULATOR - Ausisan en.pdf · The goal of electrical muscle stimulation is to achieve contractions or vibrations in the muscles. ... stimulator) with electrodes attached

Lie down stretched out on your back, which can be slightly raised. The work can be done in two ways: statically, if you are simply trying to voluntarily start themuscular contraction phase exercise with the movement that dynamically, if you want to associate an consists of bringing the trunk towards the thighs;in this case,take care not to accentuate the lumbar region arch(lordosis); to do this, it is essential to work always with your knees well bent Take up a seated position.Special recommendations: Because of the anatomical and morphological specificity of the low back muscles region, it is necessary to have muscles with particularly good performance to work in the mode. In the event of repeated failures with this work mode, we recommend work in the “classic”mode or to use the recommended placement for combined stimulation of the low back muscles and erector spinalis; in this case, always take care to position the system at the level of the dorsal region muscles, as shown in the picture. The application “Preparation for a sportsman who wishes to improve the efficiency of the muscular reinforcement of his abdomen” of the Sportcategory gives advice for work on the abdominal and the low back muscles with the greatest effectiveness

Strongly contract your abdominal muscles, while strongly trying to raise your head and shoulders from their support

Vigorously contract the low back muscles, while making an effort to sit as tall as possible

Abdominal muscles

Low back muscles

Muscular groups

Placement ofelectrodes

Stimulation positions

Voluntary start of thecontraction phase

1 2

10

91

2

21

11

Erector spinalis

Cervical muscles

Trapezius

Deltoids

Latissimus dorsi

Take up a seated position

Take up a seated position

Take up a seated position

Take up a seated position, with your elbows placed inside armrests to create resistance of the arms to their movement away from the body Take up a seated position, with your elbows placed outside armrests to create resistance of the arms to their movement towards the body

Vigorously contract the dorsal region muscles, while making an effort to sit as tall as possible.

Vigorously contract the dorsal region muscles, while making an effort to sit as tall as possible

Strongly contract your trapezius muscles, while vigorously trying to shrug your shoulders

Vigorously contract your deltoids, while strongly trying to move your elbows away from your body

Vigorously contract your latissimus dorsi, while strongly trying to move your elbows towards your body

Muscular groups

Placement ofelectrodes

Stimulation positions

Voluntary start of thecontraction phase

1 2

12

1 2

13

14

1

2

15

1

2

16

1

2

-40--39-

Page 22: 3 IN 1 COMBO STIMULATOR - Ausisan en.pdf · The goal of electrical muscle stimulation is to achieve contractions or vibrations in the muscles. ... stimulator) with electrodes attached

-42-

Pectoralis

Triceps

Biceps

Hand extensors

Take up a seated position, with the palms of your hands in contact with each other Current international standards require that a warning be given concerning the application of to the thorax: increased risk of cardiac fibrillati

Vigorously contract your pectoral muscles, while trying to press strongly the palms of your hands against each other electrodeson

Vigorously contract your triceps, while strongly trying to dig the palms of your hands into the armrests

Vigorously contract your biceps, while trying strongly to move the palms of your hands towards your shoulders

Vigorously contract your hand extensors muscles, while trying to raise yourhands

Take up a seated position, with your forearms and hands resting on armrests

Take up a seated position, with your forearms resting on armrests and the palms of your hands imperatively facing upwards. Use a fixing system to avoid any movement of your elbows during stimulationTake up a seated position, with your forearms and the palms of your hands resting on armrests Fix your hands solidly to the armrests

Muscular groups

Placement ofelectrodes

Stimulation positions

Voluntary start of thecontraction phase

18

1

2

17

19

20

-41-

Hand flexors

Strongly contract your hand flexors muscles, while strongly trying to grip the object that you were holding in your hands

Take up a seated position, with your forearms resting on armrests. Hold a crush-proof object in your hands so that your fingers are slightly bent

Muscular groups

Placement ofelectrodes

Stimulation positions

Voluntary start of thecontraction phase

21