N601 Instruction Manual V1.2 March 2011

INDEX Chapter Contents

Page

Index 1. Introduction...2 2. Cautions...3 3. Warnings...4 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...8 11. Attachment of Electrodes Lead Wires...11 12. Lead Wire Maintenance...11 13. Electrode Options...12 14. Electrode Placement...12 15. Tips For Skin Care...14 16. Application of Re-usable Self Adhesive Electrodes...14 17. Adjusting the Controls...16 18. Battery Information...19 19. Maintenance, Transportation and Storage of TENS Device...20 20. Safety Control... 21 21. Malfunctions... 22 22. Conformity to Safety Standards... 22 23. Warranty... 23 Manufacturer... 23 Representative in the EU...23

1

Chapter 1 : INTRODUCTION

stimulation will greatly reduce or eliminate the pain sensation the patient feels. Pain relief varies by individual patient, mode selected for therapy, and the type of pain. In many patients, the reduction or

EXPLANATION OF PAIN Pain is a warning system and the body’s method of telling us that

elimination of pain lasts longer than the actual period of stimulation

something is wrong. Pain is important; without it abnormal conditions

(sometimes as much as three to four times longer). In others, pain is

may go undetected, causing damage or injury to vital parts of our

only modified while stimulation actually occurs. You may discuss

bodies.

this with your physician or therapist.

Even though pain is a necessary warning signal of trauma or

Chapter 2 : CAUTIONS

malfunction in the body, nature may have gone too far in its design. Aside from its value in diagnosis, long-lasting persistent pain serves no useful purpose. Pain does not begin until a coded message

1. Read operation manual before use of TENS.

travels to the brain where it is decoded, analyzed, and then reacted

2. We emphasize that patient with an implanted electronic device (for

to. The pain message travels from the injured area along the small

example, a pacemaker) should not undergo TENS treatment without

nerves leading to the spinal cord. Here the message is switched to

first consulting a doctor. The same applies to patients with any

different nerves that travel up the spinal cord to the brain. The pain

metallic implants.

message is then interpreted, referred back and the pain is felt.

3. If TENS therapy becomes ineffective or unpleasant, stimulation should be discontinued until its use is reevaluated by the physician

EXPLANATION OF TENS

or therapist.

Transcutaneous Electrical Nerve Stimulation is a non-invasive, drug-

4. Do not use this stimulator device while operating machinery,

free method of controlling pain. TENS uses tiny electrical impulses

driving a motorized vehicle, using power tools, bathing or

sent through the skin to nerves to modify your pain perception.

swimming, or during any activity which could put the user at

TENS does not cure any physiological problem; it only helps control

undue risk of injury due to changes in stimulation level caused by

the pain. TENS does not work for everyone; however, in most

inadvertent movement of the stimulator controls or by the

patients it is effective in reducing or eliminating the pain, allowing for

electrodes or cables becoming disconnected from the device or

a return to normal activity.

becoming tangled. 5. Turn the T.E.N.S. off before applying or removing electrodes.

HOW TENS WORKS There is nothing “magic” about Transcutaneous Electrical Nerve Stimulation (TENS). TENS is intended to be used to relieve pain. The

6. Stimate T.E.N.S. devices have no AP/APG protection. Do not use it in the presence of explosive atmosphere and flammable mixture.

TENS unit sends comfortable impulses through the skin that stimulate the nerve (or nerves) in the treatment area. In many cases, this

2

3

Chapter 3 : WARNINGS

Chapter 5 : CONSTRUCTION

1. Caution should be used in applying TENS to patients suspected of 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 TENS during pregnancy. 3. Do not place electrodes on the front of the throat as spasm of the Laryngeal and Pharyngeal muscle may occur. Do not stimulate over the carotid nerve, particularly with patients with known sinus reflex sensitivity. 4. Care should be taken so that when operating potentially dangerous machinery the stimulator controls are not changed abruptly. 5. Cases of skin irritation at the electrode site have been reported. Stimula tion 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 internally. 7. Keep this device out of the reach of children.

Chapter 4 : GENERAL DESCRIPTION The Stimate N601 TENS is a battery operated pulse generator that sends electrical impulses electrodes to the body and reach the nerves causing pain. The device is provided with two controllable output channels, each independent of each other. An electrode pair can be connected to each output channel. The electronics of the Stimate N601 TENS create electrical impulses whose Intensity, duration, number per second and modulation may be altered with the controls or switches. Dial controls are very easy to use and the slide cover prevents accidental changes in the setting.

4

5

Chapter 6 : TECHNICAL SPECIFICATIONS

Chapter 7 : REPLACABLE PARTS

The technical specification details of N601 TENS are as follows

The replaceable parts and accessories of T.E.N.S. devices are as

MECHANISM 01 Channel

given below -

TECHICAL DESCRIPTION Dual, isolated between channels

02 Pulse Amplitude Adjustable, 0-80mA, max. output 80mA (peak to peak) into 500ohm load each channel. 03 Output Voltage

Adjustable, 0-40V, max. output 40V(peak to peak ) into 500ohm load each channel.

04 Wave Form

Asymmetrical Bi-Phasic Square Pulse

05 Power supply

One 9 Volt Battery, type 6F22

06 Size 07 Weight

95(H) x 65(W) x 23.5(T) mm 115 grams (battery included)

08 Pulse Rate

Adjustable, from 2 Hz to 150 Hz

09 Pulse Width

Adjustable, from 30µS to 260µs

10 Burst Mode (B Mode)

Bursts occur twice every second. Pulse width(adjustable), frequency fixed=100 Hz

11 Modulation

Pulse rate is automatically varied in a cyclic pattern

Except leads, electrodes and battery, battery case cover, please do not try to replace the other parts of a device. NO. PARTS 01 ELECTRODES LEADS 02 ELECTRODES 03 9V BATTERY, TYPE 6F22 04 BELT CLIP 05 BATTERY CASE COVER 06 LEAD CONNECTOR 07 MAIN PCB 08 NTENSITY KNOB 09 B-N-M SWITCH 10 PULSE WIDTH KNOB 11 PULSE RATE KNOB

over an interval of nominally 10 seconds.(in max 150Hz) Pulse rate decreases linearly over a period of 4 seconds from the control setting value to a value

Chapter 8 : ACCESSORIES

which is 40% less. The lower pulse rate will continue for 1 second.

Each set N601 TENS are completed with standard accessories and

Then increase linearly over a 4 seconds period to its

standard label as given below

original value. The original pulse rate will continue for

I. Accessories

1 second. 12 Operating Condition

The cycle is then repeated.

REF. NO.

DESCRIPTION

Q’TY

Temperature : 0°~40°C

1. KF4040

40 X 40 mm Adhesive Electrodes

4 pieces

Relative Humidity : 30%~75%

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

Atmosphere Pressure : 700Hpa~1060Hpa 13 Remark

There may be up to a +/- 5% tolerance of pulse width and pulse rate and +/- 20% tolerance of amplitude & voltage.

6

7

II. LABEL

PULSE RATE

The label attached to the back of d ev i c e c o n t a i n s i m p o r t a n t message about this device model, serial number, supply voltage, the name of manufacturer, CE number and classification. Please do not remove.

Chapter 9 : GRAPHIC SYMBOLS 1.

Note Operating Instructions

2.

Degree of Electrical Protection BF

3.

Do not insert the plug into AC power supply socket.

4.

Direct Current (DC power source)

5.

Consult Instructions for use

6.

Manufacturer

7.

Serial Number

Chapter 10 : PARAMETER CONTROLS PULSE DURATION Wider pulse duration settings will deliver stronger stimulation for any given intensity setting. As mentioned in the Controls section, by using a combination of intensity and pulse duration, it is felt that various pulse widths are capable of stimulating different groups of nerve fibers. The wider pulse duration is needed to recruit motor fibres, whereas the narrow pulse duration is used on the more sensory fibres. The choice of which pulse duration to use is partially dependent upon the Treatment Mode and Protocol selected (refer to the appropriate section).

8

The Pulse Rate (hertz or pulses per second) chosen depends greatly upon the type of electrode placement given to the patient. When 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). With 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. TREATMENT MODE Normal or Conventional TENS offers the practitioners complete control over all the various treatment parameters of the instrument. Burst Mode is analogous to the Low Rate TENS technique except the low frequency individual pulses are replaced by individual “bursts” of 7-10 individual pulses. It is thus a combination of Conventional TENS and Low Rate TENS. In Burst Mode, the treatment frequency is fixed by the instrument and is not adjustable with the Frequency Rate control. Modulated Mode attempts to prevent nerve accommodation by continuously cycling the treatment intensity. When using Modulated Mode increase the intensity only when the unit is at the maximum intensity of the modulation cycle. If the intensity is increased during a low intensity period of the cycle, the patient may turn up the control very slowly, so that they may feel the intensity any higher.

9

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 increased so that the patient can feel the stimulation, but there is not any muscular contraction. Slight Contraction - Intensity is increased to a barely visible muscular contraction that is not strong enough to move a joint. When using low pulse

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 portion of the connector, push the plug end of the wire into one of the jacks (see drawing); one or two sets of wires may be used.

rate settings, this will show as individual twitches. At higher pulse rates there will simply be increased muscle tension. Strong muscular contraction is typically not used in TENS therapy. However, muscular contraction may be useful if the pain involves a cramped or spastic muscle.The TENS can be used as a traditional muscle stimulator 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/or cease stimulation.

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

TIME DURATION The onset of pain relief should occur shortly after the intensity setting has been determined. However, in some cases, pain relief may take as long as 30 minutes to achieve, especially when using point electrode placements and slow pulse rates. TENS units are typically operated for long periods of

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

Chapter 12: LEAD WIRE MAINTENANCE

time, with a minimum of 20 - 30 minutes and in some post-operation protocols, Clean the wires by wiping with a damp cloth. Coating them lightly

as long as 36 hours. In general, pain relief will diminish within 30 minutes of the cessation of

with talcum powder will reduce tangling and prolong life.

stimulation. Pain relief obtained through point electrode placements may last longer (perhaps because of the presence of endorphins).

10

11

Chapter 13 : ELECTRODE OPTIONS

W ith a two channels application, the clinician may either direct the current flow to cross through the pain site or, in what is called the

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.

“bracket” method allowing the current flow on either side of the painful area, generally through the nerve branches that feed into the pain site. DERMATOMES, MYOTOMES AND SCLEROTOMES These are the regions of the body enervated by one spinal nerve. Electrode placement involves both stimulating across the similarly

Chapter 14 : ELECTRODE PLACEMENT The placement of electrodes can be one of the most important parameters in achieving success with TENS therapy. Of utmost importance is the willingness of the clinician to try the various styles of electrode placement to find which method best fits the needs of the individual patient. Every patient responds to electrical stimulation differently and their needs may vary from the conventional settings suggested here. If the initial results are not positive, feel free to experiment. Once an acceptable placement has been achieved, mark down the electrodes sites and the settings , so the patient can easily continue treatment at home. CONTIGUOUS PLACEMENT This is the most common placement technique. It involves placing the electrodes alongside the area of localized pain site, in such a way as to direct the flow of current through or around the area of pain. In a single channel application, this would involve placing each pad on either side of the pain site if the pain is localized on a limb and deep within the tissue. Pad placement on the posterior and anterior aspects of the affected limb will allow the current to flow completely through the limb and thus through the endogenous pain site.

12

enervated area and/or placing one electrode (or set of electrodes) at the pain site and another electrode (set) at the point where the nerve root joins the spinal cord. MOTOR, TRIGGER AND ACUPUNCTURE POINTS W hile these points of high tissue conductivity can differ in location and in theory of use, their use as an electrode site is identical. The easiest technique involves placing one pad directly over the point and completing the circuit by placing the second pad on some area on the affected side.

This second electrode site can be within a

nerve zone, or a master point located between the thumb and the forefinger on the dorsal web area between the two metacarpal bones. MULTIPLE PLACEMENT STRATEGIES Because the TENS has two independently operated channels, the clinician may take advantage of concurrent pad placement strategies. 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.

13

Chapter 15 : TIPS FOR SKIN CARE

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

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

Removal

1. Wash the area of skin where you will be placing the electrodes, using

1. Lift at the edge of electrodes and peel; do not pull on the lead wires

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 stimulation

because it may damage the electrodes. 2. Place the electrodes on the liner and remove the lead wire by twisting and pulling at the same time.

area. 3. Wipe 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.

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

To prevent this, apply electrodes from center outward; avoid stretching

drops of cold water over the adhesive and turn the surface up to air dry.

over the skin.

Over Saturation with water will reduce the adhesive properties.

5. To minimize “pulling stress”, tape extra lengths of lead wires to the skin in a loop to prevent tugging on electrodes. 6. When removing electrodes, always remove by pulling in the direction of

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

hair growth. 7. It may be helpful to rub skin lotion on electrode placement area when not

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

wearing electrodes. 8. Never apply electrodes over irritated or broken skin.

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

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 on the pre-wired electrodes.

14

15

Chapter 17 : ADJUSTING THE CONTROLS

4.Lead Connector Connection of the electrodes is made with two lead connector. The device

1. Slide Cover:

must be switched off before connecting the cables. Both intensity controls

A slide-on panel cover covers the controls for Pulse

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

Width, Pulse Rate, Mode Selector and Modulation Selector. Your medical professional may wish to set these controls for you and request that you leave the cover in place. 2. Display Led

5. Mode Control

Each of the leds illuminates whenever the electronics of the device create

Expose the controls by sliding front cover down from top of unit. This

a current impulse. Due to the capacity of the human eye, the illumination of

switch has 3 positions: B for Burst stimulation, N for Constant stimulation,

the lamp can only be recognized up to a frequency of approximately 30 Hz.

and M for modulation stimulation. Push the Mode Selector until engaged in

At higher frequencies, the lamp will appear to be constantly illuminated.

position desired.

3.On/Off Switch and Intensity Control : If both controls are in the off-position (white markings on the housing), the device is switched off. By turning the controls clockwise, the appropriate channel is switched on and the impulse display led will illuminate and begin to pulse according to the frequency set. The current strength of the impulses transmitted to the electrodes increases further when the control is turned

6.Pulse Rate Control:

clockwise. To reduce the current strength or switch the device off , turn

This dial determines how many electrical impulses are applied through the

the controls counter clockwise to the required setting or off- position.

skin each second. By turning these controls, the number of current impulses per second(Hz) for both channels can be continually adjusted. Unless otherwise instructed, turn the pulse rate control to the 70-120 Hz range.

16

17

7.Pulse Width Control:

Chapter 18 : BATTERY INFORMATION

This dial adjusts the length of time each electrical signal is applied through the skin, which controls the strength and sensation of the stimulation. If no instructions regarding the pulse width are given in therapy, set the control to the suggested 70-120 µs setting.

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. RECHARGEABLE BATTERIES(NOT INCLUDED)

8.Check/Replace the Battery: Over time, in order to ensure the functional safety of TENS, changing the battery is necessary. 1. Make sure that both intensity controls are switched to off position.

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.

2. Slide the battery compartment cover and remove. 3. Remove the battery from the compartment. 4. Insert the battery into the compartment. Note the polarity indicated on the battery and in the compartment. 5. Replace the battery compartment cover and slide to close

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

18

19

battery is stored more than 60 days, it may need to be recharged.

Chapter 20: SAFETY-TECHNICAL CONTROLS

(c )Do not short the terminals of the battery. This will cause the battery to get hot and can cause permanent damage. Avoid

For safety reasons, check your Stimate N601 TENS each week based on

storing the batteries in your pocket or purse where the terminals

the following checklist.

may accidentally come into contact with coins, keys or any

1. Check the device for external damage.

metal objects.

- deformation of the housing.

(d) WARNINGS:

- damaged or defective output sockets.

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. Check the device for defective operating elements. - legibility of inscriptions and labels. - make sure the inscriptions and labels are not distorted.

2. Do not incinerate the rechargeable battery as it may explode!

3. Check Led

Chapter 19: MAINTENANCE, TRANSPORTATION AND STORAGE OF TENS DEVICE

4. Check the usability of accessories.

- led must be illuminated when switched on. - patient cable undamaged. - electrodes undamaged. 1. Non-flammable cleaning solution is suitable for cleaning the device. Note: Do not smoke or work with open lights (for example, candles,

Please consult your distributor if there are any problems with device and accessories.

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

20

21

Chapter 21: MALFUNCTIONS Should any malfunctions occur while using the Stimate TENS, check - whether the switch/control is set to the appropriate form of therapy. Adjust the control correctly.

Chapter 23 : WARRANTY All Stimate N601 TENS 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.

- whether the cable is correctly connected to the device. The cables should be inserted completely into the sockets. - whether the impulse display led is illuminated. If necessary, insert a

The warranty does not apply to damage resulting from failure to follow the operating instructions, accidents, abuse, alteration or disassembly by unauthorized personnel.

new battery. - for possible damage to the cable. Change the cable if any damageis

Manufacturer:

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

Everyway Medical Instruments Co., Ltd. 3F., No.5, Ln. 155, Sec. 3, Beishen Rd., Shenkeng Dist., New Taipei City 22203,

Chapter 22: CONFORMITY TO SAFETY STANDARDS

Taiwan. (R.O.C.) Representative in the EU:

The Stimate N601 TENS devices are in compliance with the EN 60601-1-2:2001 and EN 60601-1:1990+A1:1993+A2:1995+A13: 1996 safety standards.

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. Edition : V1.2 Printed in March, 2011

22

23