SHARPER IMAGE 49 Remote WIreless Tens/EMS User Manual

: June 9, 2024
: Sharper Image

SHARPER IMAGE 49 Remote WIreless Tens/EMS

SHARPER-IMAGE-49-Remote-WIreless-Tens-EMS-PRODUCT

This manual is valid for the Hi-Dow Wireless TENS/EMS System (Model HD-5N-N)
This user manual is published by Hi-Dow International Inc.
Hi-Dow International Inc. reserves the right to improve and amend it at any time without prior notice. Amendments may however be published in new editions of this manual.
All rights Reserved. REV.06.11.16.22

Indications for Use

TENS

To be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. Choose Mode 3, 4, 5, 8.

EMS
It is intended for muscle conditioning, used for stimulating muscles including abdomen muscles in order to improve or facilitate muscle performance. Choose Mode 1, 2, 6, 7, 9.

GENERAL DESCRIPTION

The Hi-Dow Wireless TENS/EMS System is a battery operated wireless pulse generator that sends electrical impulses from a REMOTE control to a RECEIVER (round disk) with ELECTRODES attached to them that are placed on the body to stimulate the nerves causing pain. When this happens, the nerves “FEEL” gentle electrical sensations instead of the pain.
The Wireless REMOTE controls the INTENSITY and MODE functions of the RECEIVER. The RECEIVER with the electrodes attached to it adheres easily and firmly to the skin.
The LCD display shows the exact modes and values of the functions being used.
See the pictures in this Manual that show the different COMPONENTS and CONTROLS of the Hi-DOW System and how to operate it properly to get the best PAIN RELIEF.
Because the Hi-Dow system is Wireless – Needing No Lead Wires – you must use only Hi-Dow SNAP Electrodes.

PULSE PARAMETERS

Wireless-49| TABLE: PULSE parameters
Rated Supply Voltage (V) ……….| DC 3.7 V
Load Resistance (0) …………….| 1000 0
PULSE

duration(µs)

| PULSE repetition frequencies(Hz)| PULSE repetition amplitudes(Vrms)| DC component (V)| Mode decomposition| Remarks
100| 51| 50~90| —| See Remark| Mode 1
100| 6| 50~90| —| See Remark| Mode 2
100| 1.16| 50~90| —| See Remark| Mode 3
100| <50| 50~90| —| See Remark| Mode 4.1; 4.2
100| 8| 50~90| —| See Remark| Mode 5
100| <60| 50~90| —| See Remark| Mode 6.1; 6.2; 6.3; 6.4
100| 51| 50~90| —| See Remark| Mode 7.1; 7.2
100| <70| 50~90| —| See Remark| Mode 8.1; 8.2; 8.3; 8.4
100| <60| 50~90| —| See Remark| Mode 9.1; 9.2; 9.3

Mode Description when used as TENS (Pain Relief)0

Mode#3 -Tapping: simulates a second heart beat. By tapping the muscle you increase the body’s natural blood flow and oxygen supply to target area. This also helps flush any inflammation or swelling in target area.
Mode #4 – Reflexology: This mode has been designed for the shoes. It simulates a reflexology session through the socks and/or shoes using several different stimulation patterns.
Mode #5 – Auricular Therapy: This mode is also known as “alpha stim” or “micro current”. When used properly you should use the earflap attachment. It works 2 ways. By simulating an alpha wave in the brain it has been known to help sleep patterns, behavior, and endorphin release. Also, it will relax the sub occipital muscles and vaso dilate, helping with migraines and headaches.
Mode #8 – Ramping wave: This mode is designed to start out with number 3, tapping. It will get faster and deeper into the belly of the muscle as it continues until it goes to a fully facilitated contraction. Then it will allow the muscle to release. This has been used to increase endurance and build fatigue resistance.

Mode Description when used as EMS (Muscle Stimulation)

Mode #1 – Kneading: simulates the thumbs fingers and palms of a real massage therapist. The sensation should feel like a vibration. Focuses on hypertension and stress and helps to break that down returning full range of motion and flexibility.
Mode #2 – Acupressure: a much more rapid and focused pulse that focuses on any knot or adhesion in the body. It outs enough pressure on it to break it down and release any acidic (lactic) content within.
Mode #6 – Atlas: It is used for muscle confusion and athletic enhancement.
Mode #7 – Contract and Hold: This mode is the longest contraction on the machine. It is designed to simulate a flex movement to help build muscle tissue.
Mode #9 – Tapping and kneading: a mixture of the fast and slow contractions.

CONTRAINDICATIONS

Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death.

WARNINGS

The long-term effects of chronic electrical stimulation are unknown.
If you are in the care of a physician, consult with your physician before using this device.
If you have had medical or physical treatment for your pain, consult with your physician before using this device.
If your pain does not improve, becomes more than mild, or continues for more than five days, stop using the device and consult with your physician.
Do not apply stimulation over your neck or mouth because this could cause severe muscle spasms resulting in closure of your airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.
Do not apply stimulation across your chest because the introduction of electrical current into the chest may cause rhythm disturbances to your heart, which could be lethal.
Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins).
Do not apply stimulation over, or in proximity to, cancerous lesions.
Do not apply stimulation in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when the electrical stimulation device is in use.
Do not apply stimulation when in the bath or shower.
Do not apply stimulation while sleeping.
Do not apply stimulation while driving, operating machinery, or during any activity in which electrical stimulation can put you at risk of injury.
Do not use the device on children, if it has not been evaluated for pediatric use.
Consult with your physician before using this device, because the device may cause lethal rhythm disturbances to the heart in susceptible individuals; and
Apply stimulation only to normal, intact, clean, healthy skin.
The device can’t be used while charging.
The device should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex.

FCC WARNING STATEMENT

Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the device.
This device complies with Part 15 of the FCC rules. Operation is subject to the following two conditions:
- This device may not cause harmful interference, and
- This device must accept any interference received, including interference that may cause undesired operation.

PRECAUTIONS

Hi-Dow Wireless TENS/EMS System is not effective for pain of central origin, including headache.
Hi-Dow Wireless TENS/EMS System is not a substitute for prescribed pain medications and other pain management therapies.
Hi-Dow Wireless TENS/EMS System have no curative value.
Hi-Dow Wireless TENS/EMS System is a symptomatic treatment and, as such, suppresses the sensation of pain that would otherwise serve as a protective mechanism.
The long-term effects of electrical stimulation are unknown.
Since the effects of stimulation of the brain are unknown, stimulation should not be applied across your head, and electrodes should not be placed on opposite sides of your head.
The safety of electrical stimulation during pregnancy has not been established.
You may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium (gel).
If you have suspected or diagnosed heart disease, you should follow precautions recommended by your physician.
If you have suspected or diagnosed epilepsy, you should follow precautions recommended by your physician.
Use caution if you have a tendency to bleed internally, such as following an injury or fracture.
Consult with your physician prior to using the device after a recent surgical procedure, because stimulation may disrupt the healing process.
Use caution if stimulation is applied over the menstruating or pregnant uterus.
Use caution if stimulation is applied over areas of skin that lack normal sensation.
Keep this device out of the reach of children.
Use this device only with the leads, electrodes, and accessories recommended by the manufacturer.
Replace self-adhesive electrodes when they do not adhere (stick) firmly to the skin.
The device should not be used while driving, operating machinery, or during any activity in which involuntary muscle contractionsmay put the user at undue risk of injury.

ADVERSE REACTIONS

You may experience skin irritation and burns beneath the stimulation electrodes applied to your skin.
You may experience headache and other painful sensations during or following the application of electrical stimulation near your eyes and to your head and face.
You should stop using the device and should consult with your physician if you experience adverse reactions from the device.

GENERAL INFORMATION

SHARPER-IMAGE-49-Remote-WIreless-Tens-EMS-
FIG-1

Included in this package

1 REMOTE Control
2 RECEIVERS（NUMBERED 1 and 2）
1 piece of Lower back sized adhesive electrode pads (4×9 inches – rectangular shape)
1 set of LARGE single sided adhesive electrode pads (2.4×2.4 inches – round shape)
2 Electrode Wires (8 inches)
AC Adapter
USB Cable for Recharging
User Manual

QUICK START GUIDE FOR SIMPLE USE

Snap the electrode pads onto the round RECEIVER. Both connection points on the RECEIVERS must be engaged.
Remove the electrode pad film and securely place the adhesive pads directly on the skin over the pain area.
Turn on the REMOTE using the ON/OFF switch on the side. Then turn on the RECEIVER by pressing the power button.
Choose Channel 1 or Channel 2 by pressing “C” on the REMOTE, number 1 or 2 will display on LCD screen. For more RECEIVERS by pushing “C” on the REMOTE and seeing 3 or 4 appear in the LCD display.
Set the mode of the selected RECEIVER to Mode 1, Mode 2, Mode 3, Mode 4, Mode 5, Mode 6, Mode 7, Mode 8 or Mode 9 by pressing “M” on REMOTE, 1, 2, 3, 4, 5, 6, 7, 8, 9 will appear in the LCD display next to the “M”.
(This function will only work when both the REMOTE and the RECEIVER are turned ON)
Adjust the Intensity of the selected RECEIVER by pushing + or – on the REMOTE. Do this until the sensation under the RECEIVER and electrode pads is felt as being comfortable. NOTE: The intensity level will need to be adjusted each time the mode is changed.
(This function will only work when both the REMOTE and the RECEIVER are turn ON)

Notes:

The patient is an intended OPERATOR. While using the unit, no service and no maintenance shall be done.
The device is very safe at the maximum output value.
It is recommended that, at a minimum, 3×4.5 (cm) self-adhering electrode pads are used at the treatment area.

INSTRUCTIONS FOR USE

The REMOTE control is the sleek looking handset. It has a LCD display, C button for choosing RECEIVER
1/Channel 1 or RECEIVER 2/Channel 2 (For more RECEIVERS, RECEIVER 3/Channel 3, RECEIVER 4/Channel 4), and M button to control the MODE functions of the RECEIVERS.
The default setting time of REMOTE is 45 minutes. The REMOTE will shut off automatically after that time, or you can manually turn off.

ON/OFF
The ON/OFF button is located on the side of the REMOTE. The LCD display illuminates when the REMOTE is “ON”. If the LCD display is blank, the unit is “OFF” or the REMOTE and/or the RECEIVERS need to be recharged.

RECEIVER(S) CONTROL
Push and hold the power button on each RECEIVER until you can see the green light. Push again, and the RECEIVER turns off. If the green light becomes red, the RECEIVER needs to be recharged.

INTENSITY
INTENSITY adjusting on the REMOTE is just below the LCD Screen figured as + and -. The more you push + the higher up the Intensity level of the Channel shown in the LCD display goes. The more you push – the lower down the Intensity level of the Channel shown in the LCD display goes.

CHANNEL and RECEIVER CONTROLS

This is a 4 Channel TENS/EMS unit.
There are 2 ROUND RECEIVERS – the CHANNELS labeled as 1 and 2.
Both CHANNELS are controlled by the REMOTE.
Push the “C” on the REMOTE to set CHANNEL 1, 2, 3 and 4. CHANNEL 1, 2, 3 or 4 will appear on the LCD screen. Then set the MODE for CHANNEL 1, 2, 3 or 4 by pushing the ‘M’ on the REMOTE.

Note: To add more RECEIVERS, first match the REMOTE and RECEIVERS, please refer to the “Troubleshooting” on page 27.
Note: Each Round Receiver must be connected to either 1 large (2 pins on it) or 2 small (1 pin on each) electrodes to function. Using only 1 small electrode will result in non-function.

MODES – Pre-Programmed Mode Functions
Simply push the “M” button on the REMOTE to change from Mode 1 to Mode 2 and so on up to Mode 9. The MODE FUNCTION being used will appear in the LCD screen as 1, 2, 3, 4, 5, 6, 7, 8, 9.

MAINTENANCE, STORAGE, and DISPOSAL

Maintenance

Make sure your skin is free from any dirt, oil or lotions.
Before applying the electrodes, suggest spraying HiDow conductor on your fingers and rub them on both pads. This will help the electrodes maintain their adhesiveness.
When you finish using the device, turn it off.
Take off the electrodes.
Place the protective films back on the electrodes or place the electrodes on the pad holder.
Place back in the box until next use.

Storage

For prolonged application, store the device in a cool, dry room and protect it against heat, sunshine and moisture.
Store the device in a cool, well-ventilated place.
Never place any heavy objects on the device.

Disposal

The device must be disposed in accordance with the laws in your area.
The electrodes are disposable and should be routinely replaced before they start to lose their adhesive nature. And the electrodes should be disposed in accordance with the laws in your area.
Note: The expected service time of the device is 3 years, and expected service time of electrodes is 2 years.

SUGGESTED MODE USES

Legs, Arms, Hands – Mode1, Mode 3, Mode 7, Mode 8, Mode 9
Feet – Mode 4
Ears – Mode 5
Calorie Consumption- Mode 6
Knees – Mode 1, Mode 3
Lower Neck, Hip, Stomach – Mode 1, Mode 2, Mode 3, Mode 7, Mode 8, Mode 9
Shoulders, Upper Back- Mode 1, Mode 2, Mode 3, Mode 7, Mode 8, Mode 9
Neck – Mode 1, Mode 2, Mode 3, Mode 7, Mode 8, Mode 9
Combination Waves Mode 7, Mode 8 and Mode 9 are for multiple types of sensations that alternate automati cally for your convenience and work well on all Pain Conditions.

Note: When using any of these modes always start with the lowest intensity and gradually increase the level of intensity until you feel a “tingling” sensation. All modes are different and therefore feel different. You may try all modes in the beginning and choose one that feels pleasant. Never increase the intensity to a level so that it hurts, always stay under the point of discomfort. Start with short sessions of 5-10 minutes until your body gets used to the stimulation.

ELECTRODE OPTIONS

Follow application procedures outlined in electrode packing, to maintain stimulation and prevent skin irritation. Use “ONLY” Hi-DOW SNAP electrodes with this WIRELESS system. Replace Electrodes when they don’t stick any longer.
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.

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 user to try the various styles of electrode placement to nd which method best fits his or her needs.

Every user 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.
NOTE: You may have to ask for help if you cannot reach the area to be stimulated.

APPLICATION OF RE-USABLE SELF ADHESIVE ELECTRODES

Application

Clean and dry the skin area thoroughly with soap and water prior to application of electrodes.
Remove the electrode pad film and securely place the adhesive pad attached to the RECEIVER firmly onto the skin over or near the pain area.

Care and Storage

Between uses, store the electrodes in the resealed bag in a cool dry place.
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.

Notes

Do not apply to broken skin.
The electrodes should be discarded when they are no longer adhering.
The electrodes are intended for single patient use only.
If irritation occurs, discontinue use and consult your clinician.

TIPS FOR SKIN CARE: To avoid skin irritation, especially if you have sensitive skin, follow these suggestions:

Wash 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.
Excess hair may be clipped with scissors; do not shave stimulation area.
Wipe the area with the skin preparation your clinician has recommended. Let this dry. Apply electrodes as directed.
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.
To minimize the “pulling stress”, tape extra lengths of lead wires to the skin in a loop to prevent tugging on electrodes.
When removing electrodes, always remove by pulling in the direction of hair growth.
It may be helpful to rub skin lotion on electrode placement area during application down time when you are not wearing electrodes.
Never apply electrodes over irritated or broken skin.

BATTERY INFORMATION

Rechargeable Batteries

Prior to the use of a new unit, the rechargeable battery in the REMOTE and the RECEIVER may need to be charged.
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.

Battery Charging for REMOTE and RECEIVER

Via a standard wall outlet

Connect the AC adapter to any standard wall outlet.
Connect the small end of the USB cable to the unit and the bigger end to the AC adapter.
REMOTE: The unit is finished charging when the battery icon indicates full.
RECEIVER: While charging, the indicator light is yellow, and the light is green after finishing.

Via a computer USB port

1. Connect the small end of the USB cable to the unit and bigger end to the USB port on a computer (computer must be turned on).
2. REMOTE: The unit is finished charging when the battery icon indicates full. RECEIVER: While charging, the indicator light is yellow, and the light is green after finishing.

Notes

The adapter is a separate power supply to the device, NOT a part of the ME EQUIPMENT, and it is a combination of a ME EQUIPMENT SYSTEM.
The device can’t be used while charging.

REGULAR APPLICATION PRINCIPLES

Find the exact pain point. The points which the electrode pads are attached to should be the most painful point in normal time.
Intensity – The intensity must be gradually increased and it’s better to reach the highest intensity you can stand, without feeling uncomfortable.
Application duration: 2-3 times/day, 45 minutes every time, over 10 days for one course.There are two ways to place the pads, in twin and opposed modes.

Figure 1: Twin mode
Fix the two pads at the top and bottom or both ends on the same side of the human body
Figure 2: Opposed mode
Fix the two pads respectively on the opposite sides of the application position, as shown below

REGULAR APPLICATION METHODS

Pain in the trunk

Probably pain points in the trunk
According to traditional Chinese medicine (TCM), the most sensible pressure pain point is the key point, the most proper position to be applied. Find the pressure pain point with reference to Fig.1. Apply one pad onto it. Apply the other pad onto a proper point symmetrical to the chosen pressure pain point or near to it, but the two pads should not be overlapping. If there are several separated pressure pain points, apply them one by one.
Recommended positions of pads for application on the neck, shoulder and back (See Fig.3)
Figure 3
Mode 1 for 30 minutes, Mode 2 or Mode 3 for 30 minutes by turns for A, B and C. Longer time is needed for those parts of great pain. It is advisable to use fairly large intensity.
Recommended positions of pads for application of the waist (See Fig. 4) Figure 4
Mode 1 for 30 minutes, Mode 2 for 20 minutes or Mode 7, 8, 9 for 30 minutes. It is advisable to do some waist exercise after the application.
Long application is needed for more serious aches and pains.

Pain in the joints and limbs

Pain in the joints, sport injuries, soft tissue injuries, may cause joint aches, which often occur in the joints of shoulder, elbow, knee, wrist, ankle, etc.

Position of pads For joint pain, two pads should be applied to the two symmetrical sides of the painful point, see Fig. 2 (opposed mode).
Mode and length of operation time
Mode 1 for 30 minutes, then Mode 3 for 30 minutes, 2-3 times a day.

Pain in the muscles and tendons of the limbs, it is often caused by sport injury, overstrain or some other factors. The common signs are muscular pain, swelling and spasm.

Position of pads Apply the pads to each end of the painful muscle or apply one pad to the muscle and the other to the tendon. The position can be slightly regulated according to sensation.
Mode and length of time
Mode 2 for 20 minutes, then Mode 3 for 20 minutes. Consult the doctor if the injury has laceration of muscle or tendon.

Electrode placement variations

SHARPER-IMAGE-49-Remote-WIreless-Tens-EMS-FIG-10

TROUBLESHOOTING

SHARPER-IMAGE-49-Remote-WIreless-Tens-EMS-FIG-11

CONFORMITY TO SAFETY STANDARDS

Hi-Dow International Inc. declares that the device complies with the following normative documents:

Statement of EMC
IEC 60601-1-2:2014
Conformity to MDD Requirements
IEC 60601-1:2005+AMD1:2012/ANSI/AAMI ES60601-1:2005+A1:2012, IEC 60601-1-11:2015, IEC 60601-2-10:2012
Conformity to FCC Requirements
The devices are in compliance with FCC Part 15 Subpart C.

TECHNICAL INFORMATION

Channel	Dual, independent intensity control

Power Supply

| Remote: DC3.7V
Receiver: DC3.7V

Dimensions

| Remote: 108mm x 53.6mm x 14.9mm
Receiver: Φ57mm x 12mm

Net weight

| Remote: 64g
Receiver: 24g

Operating conditions

| 5℃ to 40℃（41℉ to 104℉）with a relative humidity (non-condensing） of 30% – 75%, atmospheric pressure from 700 to 1,060 HPa
Storage and transportation conditions| -10℃ to 55℃（14℉ to 131℉）with a relative humidity (non-condensing) of 10% – 90%, atmospheric pressure from 700 to 1,060 HPa

ACCESSORIES LIST

NO	Accessories Name	Quantity	Specification

1

| ****

AC adapter

| ****

1 piece

| ****

Input:AC 100-240V 50/60Hz 0.5A

2

| ****

Lower back sized adhesive electrode pads

| ****

1 piece

| ****

4×9 inches – rectangular shape

3

| ****

LARGE single sided adhesive electrode pads

| ****

1 pair

| ****

2.4×2.4 inches – round shape

4

| ****

USB cable

| ****

1 piece

| ****

39 inches

5

| ****

Electrode Wires

| ****

2 pcs

| ****

8 inches

EXPLANATION OF SYMBOLS

	Class II equipment

Date of manufacture.

| Manufacturer
SN| Specifies serial number
|

Type BF applied part

|

DISPOSAL: Do not dispose this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary.

WIRELESS SPECIFICATIONS

Frequency band: 2400-2483.5Mhz Modulation method: GFSK
Transmit Power: 0dBm (1mW)
Receiver Sensitivity: -88dBm
Effective transmission distance: ≤8 meters

DESCRPTIONS FOR SAFE WIRELESS TRANSMISSION

The Remote and the Receivers have a unique address. Before leaving the factory, the Remote and the Receivers will be matched. The address information to each other is saved as to prevent any unauthorized access. In the wireless transmission, the address information will be sent out together; only the correct address information can be received.

ELECTROMAGNETIC COMPATIBILITY DESCRIPTIONS

This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment.

Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit.
Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation!
Caution: This machine should not be used adjacent to or stacked with other requirement and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used.

| |
---|---|---
| Guidance and manufacture’s declaration – electromagnetic emission
| The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
| Emissions test| Compliance| Electromagnetic environment – guidance
| RF emissions CISPR 11|

Group 1

| The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in

nearby electronic equipment.

| RF emissions CISPR 11| Class B| The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
| Harmonic

emissions

IEC 61000-3-2

| Class A
| Voltage fluctuations / flicker emissions IEC 61000-3-3|

Complies

| |
---|---|---
| Guidance and manufacture’s declaration – electromagnetic immunity
| The device is intended for use in the electromagnetic environment specified below. The customer or the user of

device should assure that it is used in such an environment.

| Immunity test| IEC 60601 test

level

| Compliance

level

| Electromagnetic environment – guidance
| Electrostatic discharge (ESD)

IEC 61000-4-2

| ±8 kV contact

±15 kV air

| ±8 kV contact

±15 kV air

| Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.
| Electrical fast transient/burst| ±2 kV for power supply lines| ±2kV for power supply lines| Mains power quality should be that of a typical commercial or hospital environment.
IEC 61000-4-4| ±1 kV for input

/output lines

| |
| Surge

IEC 61000-4-5

| ± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

| ±1 kV

differential mode

| Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| <5% UT

(>95% dip in UT ) for 0.5 cycle

40% UT

(60% dip in UT ) for 5 cycles

| <5% UT

(>95% dip in UT ) for 0.5 cycle

40% UT

(60% dip in UT ) for 5 cycles

| Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.
---|---|---|---
| 70% UT

(30% dip in UT ) for 25 cycles

| 70% UT

(30% dip in UT ) for 25 cycles

|
| <5% UT

(>95% dip in UT ) for 5 sec

| <5% UT

(>95% dip in UT ) for 5 sec

|
| for 5 sec| |
Power frequency (50Hz/60Hz)

magnetic field

| 3 A/m & 30 A/m| 3 A/m & 30 A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
IEC 61000-4-8| | |
NOTE UT is the a.c. mains voltage prior to application of the test level.

| Guidance and manufacture’s declaration – electromagnetic immunity|
| The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
| Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
|

Conducted RF IEC 61000-4-6

|

3 Vrms & 6 Vrms

150 kHz to 80 MHz

|

3 Vrms& 6 Vrms

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

Recommended separation distance

Radiated RF IEC 61000-4-3

|

3 V/m & 10 V/m

|

3 V/m & 10 V/m

| d=1,2 P

d=1,2 P 80 MHz to 800 MHz

| 80 MHz to 2.6 GHz| | d=2,3 P 800 MHz to 2,5 GHz
| | | Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b

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

---|---|---|---
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and r eflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between

portable and mobile RF communications equipment and the device .

The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended

below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

(W)

| Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz

d=1,2 P

| 80 kHz to 800 MHz

d=1,2 P

| 800 kHz to 2,5 GHz

d=2,3 P

0,01| 0.12| 0.12| 0.23
0,1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

WARRANTY

All Hi-Dow TENS models carry a warranty of two years from the date of purchase. The warranty applies to the TENS/EMS stimulator REMOTE and RECEIVER only.
The warranty does not apply to damage resulting from failure to follow the operating instructions, accidents, abuse, alteration or disassembly by unauthorized personnel.

CONTACT INFORMATION

Customer Service
Hi-Dow International Inc. 2555 Metro Blvd,
Maryland Heights, MO 63043 U. S. A.
Email: manager@hidow.com
www.hidow.com|
www.hidow.com