TENS UNITS Magic Combo Electrotherapy Device User Manual

TENS UNITS Magic Combo Electrotherapy Device

Combo Electrotherapy Device
Model: Magic

This manual is valid for the Magic Stimulator
Be sure to read this instruction manual before operating and keep it where safe.

• Shenzhen Roundwhale Technology Co., Ltd. does not guarantee its contents and reserves the right to improve and amend it at any time without prior notice. However, Amendments will be published in a new edition of this manual.
• All Rights Reserved.
• Magic Rev.Vl.0© 2020, printed inJuly 30th,2020.

Declaration of conformity
Shenzhen Roundwhale Technology Co., Ltd. declares that the device complies with following normative documents: IEC60601-l, IEC60601-l-2, IEC60601-l-ll, IEC60601-2-10, IEC62304, ISO10993-5, ISO10993-10, ISO10993-l, ISO14971

FOREWORD

Introduction

• The device Magic is a dual channel output TENS, EMS and MASSAGE stimulator. Before using, please read all the in­structions in this user manual carefully and keep it safe for future use.
• The COMBO stimulator belongs to the group of electrical stimulation systems. It has three basic functions- TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Elec­tronic Muscle Stimulation) and MASSAGE.
• Function of the COMBO stimulator: The device has 22 programs ( 9 TENS programs, 8 EMS programs and 5 MASSAGE programs) and applies electric currents in the low-frequency range for therapy. Each program controls the generated electric impulses, their intensity, frequency and pulse width.
• Based on simulating the body’s natural pulses, the mecha­nism of electrical stimulation equipment is to create elec­tric impulses that are transcutaneous transmitted to nerves or muscle fibers through the electrode. The intensity of the dual channel can be adjusted independently and app­lied individually to one body part. This dual channel device can be used with four pieces of electrodes, which allow you to stimulate one muscle groups simultaneously with a wi­de selection of standard programs. The electrical pulse is fir­stly transmitted to the tissue, then it affects the transmission of stimulation in nerves as well as muscle tissues in the body parts.

Medical background

1. ABOUT PAIN

2. Pain is an important signal in the human body warning sys­tem. It reminds us that something is wrong, without which, abnormal conditions may go undetected, causing damage or injury to vital parts of our bodies. Even though pain is a necessary warning signal of trauma or malfunction in the body, nature may have gone too far in its design.

3. Aside from its function in diagnosis, long-lasting persistent pain serves useless purpose.

4. Pain does not occur until encoded message travels to the brain where it is decoded, analyzed, and reacted to, from the injured area along the small nerves leading to the spinal cord. There the message is transmitted to different nerves that travel up the spinal cord to the brain. Then the pain message is interpreted, referred to and pain is felt.

5. WHAT IS TENS?
   TENS (Transcutaneous Electrical Nerve Stimulation) is ef­fective in relief of pain. It is daily used and clinically proven by physiotherapists, caregivers and top athletes around the world. High-frequency TENS currents activates the pain-in­hibiting mechanisms of the nervous system. Electrical im­pulses from electrodes, placed on the skin over or near the pain area, stimulate the nerves to block the pain signals to the brain, causing the pain go unperceived. Low-frequen­cy TENS currents facilitate the release of endorphins, the body’s natural painkillers.

6. WHAT IS EMS?
   Electrical Muscle Stimulation is an internationally accepted and proven way of treating muscular injuries. It works by sending electronic pulses to the muscle needing treatment that causes the muscle to exercise passively. It is a product deriving from the square waveform, originally invented by John Faraday in 1831. Through the square wave pattern it is able to work directly on muscle motor neurons. The EMS System has low frequency and this in conjunction with the square wave pattern allows direct work on muscle group­ings.

7. WHAT IS MASSAGE?
   The massage function is non-medical function. The Massage stimulation program provides relaxing muscle vibration to loosen tight muscles.

SAFETY INFORMATION

Intended use

• TENS mode
  It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

• EMS mode

  • This mode is designed to be used for stimulate healthy m­uscles in order to improve and facilitate muscle performa­nce.
  • The device can be used at home, and users must be 18 years or older of adults.

Important Safety Precautions and Warnings
It is important that you read all the warnings and precautions included in this manual because they are intended to keep you safe, prevent risk of injury and avoid a situation that could result in damage to the device.

SAFETY SYMBOLS USED IN THIS MANUAL

Contraindication

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

2. The device should not be used when cancerous lesions or other lesions are present in the treatment area.

3. Stimulation should not be applied over swollen, infect­ed, inflamed areas or skin eruptions (e.g. phlebitis, thrombophlebitis, varicose veins, etc.).

4. Electrode placements must be avoided in the carotid sinus area (anterior neck) or tran-scerebrally (through the head).

5. This device should not be used in overly enervated areas.

6. Inguinal hernia.

7. Do not use on scarred areas following a surgery for at least 10 months after the operation.

8. Do not use with serious arterial circulatory problems in the lower limbs.

WARNING

1. If you have had medical or physical treatment for your pain, consult with your physician before use.
2. If your pain is not subdued, whice becomes more th­an mild, or lasts for more than five days, stop using the device and consult with your physician.
3. Do not apply stimulation over your neck 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.
4. 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.
5. Do not apply stimulation over, or in proximity to, can­cerous lesions.
6. Do not apply stimulation in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when electri­cal stimulation device is in use.
7. Do not apply stimulation when in bath or shower.
8. Do not apply stimulation while sleeping.
9. Do not apply stimulation while driving, operating ma­chinery, or during any activity when electrical stimula­tion can put you at risk of injury.
10. Apply stimulation only to normal, intact, clean, healthy skin.
11. The long-term effects of electrical stimulation are un­known. Electrical stimulation device cannot replace drugs.
12. Stimulation should not take place while the user is con­nected to high-frequency surgical equipment, which may cause burn injuries on the skin under the elec­trodes, as well as problems with the stimulator.
13. Do not use the stimulator in the vicinity of shortwave or microwave therapy equipment, since this may affect the output power of the stimulator.
14. Never use it near the cardiac area. Stimulation electrodes should never be placed any  where on the front of the thorax (marked by ribs and breastbone), but above all not on the two large pectoral muscles. There it can increase the risk of ventricular fibrillation and lead to cardiac arrest.
15. Never use it on the eye, head and face area.
16. Never use it near the genitals.
17. Never use it on the areas of the skin which lack normal sensation
18. Keep electrodes separate during treatment. It could re­sult in improper stimulation or skin burns if electrodes a re in contact with each other.
19. Keep the stimulator out of reach of children.
20. Consult your doctor if you are in any doubt whatsoever.
21. Discontinue it and do not increase the intensity level if you feel discomfort during use.

Precautions

1. TENS is not effective for pain of central origin including headache.
2. TENS is not a substitute for pain medications and other pain management therapies.
3. TENS is a symptomatic treatment and, as such, sup­presses the sensation of pain that would otherwise serve as a protective mechanism.
4. Effectiveness is highly dependent upon patient selec­tion by a practitioner qualified in the management of pain patients.
5. 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.
6. The safety of electrical stimulation during pregnancy has not been established.
7. You may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conduc­tive medium (silica gel).
8. If you have suspected or diagnosed heart disease or epilepsy, you should follow precautions recommended by your physician.
9. Caution if you have a tendency to bleed internally, e.g. following an injury of fracture.
10. Consult with your physician prior to use the device after a recent surgical procedure, because stimulation may disrupt the healing process.
11. Caution if stimulation is intended to be applied over the menstruation or pregnant uterus.
12. For single patient use only.
13. This stimulator should not be used by patients who is noncom pliant and emotionally disturbed including whom with dementia or low IQ.
14. The instruction of use is listed and should be obeyed; any improper use may be dangerous.
15. Rare cases of skin irritation may occur at the site of the electrode placement following long-term application.
16. Do not use this device in the presence of other equip­ment which sends electrical pulses to your body.
17. Do not use sharp objects such as a pencil or ballpoint tip to operate the buttons on the control panel.
18. Check the electrode connections before each use.
19. Electrical stimulators should be used only with the electrodes recommended for use by the manufacturer.

Adverse Reactions

1. Possible skin irritation or electrode burn under the electrodes may occur.
2. On very rare occasions, first-time users of EMS report feeling light-headed or faint. We recommend that you use the product while seated until you become accus­tomed to the sensation.
3. If the stimulation makes you uncomfortable, reduce the stimulation intensity to a comfortable level and contact your physician if problems continue.

GETTING TO KNOW YOUR DEVICE

Accessories

LCD display

Function description

1 Key locking symbol
2 Symbol of Channel 1
3 Symbol of pause
4 Intensity for Channel 1
5 Treatment time
Function description

6 Program NO.
7 Treatment mode
8 Intensity for Channel 2
9 Battery symbol
10 Symbol of Channel 2

Device illustration

7

8

| [M] button: At standby mode, press the [Ml button select to treatment mode.
---|---
USB socket and Charger indicator: When the device is charging, the indicator light will be red. When charging is completed, the indicator light will be green.
9| Belt Clip
10| Output socket

SPECIFICATION

Technical information

• Input: 100-240V AC, 50/60Hz,0.2A;
• Output: 5V DC, 300mA

Output channel| Dual channel
Waveform| Bi-phase square-wave pulse
Output current| Max. 120mA (at 500ohm load)
Output intensity| Oto 40 levels, adjustable
Treatment mode:| TENS, EMS and MASSAGE mode
0perating condition – 5° C to 40° C with a relative humidity of 15%-93%, atmospheric pressure from 700 hPa to 1060 hPa
Storage condition|

• -10° C to 55° C with a relative humidity of 10%-
• 95%, atmospheric pressure from 700 hPa to 1060 hPa

Dimension| 133.8’66.8′ 18.8mm (L x W x T)
Weight| About 140g
Automatic shutoff| 1 minute
Classification| BF type applied part, internal powerequiprnent,IP22
Electrode detected – The electric current level will be reset to O mA, lion function  when the amplitude level is 6 or greater and an open circuit at either channel is detected.

Size of electrodes pad 2’x2′, 2’x4′
Output precision  ±20% error is allowed for all the output parameters

Technical Specifications

• ITENS: 9 programs Number of programs
• ITEMS : 8 programs
• MASSAGE: 5 programs

|
Pulse Amplitude| Max. 120V (at 500 ohm load)
P.W. (pulse width)| 50-260µs
P.R. (Frequency)| 2- 120Hz
T r eatment time| 10-90 minutes (adjustable)

For TENS Programs
When using any of the TENS programs for pain relief always start with the lowest intensity and gradually increase the level of intensity until you feel a “tingling” sensation. All programs are different and therefore feel differently. You may try all programs 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 or 10 minutes until your body gets used to the stimulation.

decrease gradually after treatment.
2| Two channels output alternately, with a sense of ‘work’ and ‘rest’
3| Comfortable pulsing sensation. The underlying pain should decrease almost immediately.
4| Variable comfortable tingling and pulsing sensation (sensation should appear to come in waves). Pain should ease and there should be relief aftertreatment
5| Continuous comfortable tingling. The underlying pain should decrease gradually after treatment.
6| Variable comfortable tingling and pulsing sensation (sensation should appear to come in waves). Pain should ease and there should be relief after treatment
7| Continuous comfortable tingling. The underlying pain should decrease gradually after treatment.
8| Variable comfortable mild tingling sensation (sensation will appear to come in waves}.
9| sensation will appear to come in waves

For EMS Programs
When using the device for muscle stimulation (EMS) any of the 8 programs may be used. The intent is to cause a muscle to contract, and then release. All 8 programs will achieve contraction and vary mainly by the rate and duration of the contractions. As with any exercise regiment, start out slowly with low intensity levels for a warm-up (5~ 10 min). You may increase intensity level and treatment time as you progress with your muscle performance. Use the device regularly over a longer period of time as to maintain the benefit you may have gained during “exercise” .

Mode| Program

NO .

| You should feel
---|---|---
EMS| 1| Simulate the process of muscle training. During the exercise, there are ‘work’ and ‘rest’ phases
2| This program produces muscle twitches at very low frequency and it feels like a tapping massage, for muscle recovery from fatigue and becoming more relaxed with reduced stiffness
3| Simulate the process of muscle training. During the exercise, there are ‘work’ and ‘rest’ phases
4| Simulate the process of muscle training. During the exercise, there are ‘work’ and ‘rest’ phases
5| Simulate the process of muscle training. During the exercise, there are ‘work’ and ‘rest’ phases
6| This program is similar to P2, except that the muscle twitch rate slows down during the session. It feels like a tapping massage, but softer than P2
7| Simulate the process of muscle training. During the exercise, there are ‘work’ and ‘rest’ phases
8| Simulate the process of muscle training. During the exercise, there are ‘work’ and ‘rest’ phases

For MASSAGE Programs

Mo de| Program

NO.

| Yo u should feel
---|---|---
MASSAGE| 1| Comfortable pulsing sensation. The underlying pain should decrease almost immediately.
2| Low-frequency stimulation that produces visible muscle contractions.
3| I t feels like a patting massage
4| I t feels like a kneading massage
5| I t feels like a rubbing massage

 OPERATING INSTRUCTION

Connect electrode pads to electrode wires
Insert the electrode wires connector into electrode connec­tor. Make sure they are properly connected to ensure the good performance. Please refer to the picture.
Caution
Always use the electrode pads which comply with the re­quirements of the IEC/EN60601-1, 1SO10993-1/-5/-10 and IEC/ EN60601-1-2, as well as CE and FDA 510(K) regulation.

Connect electrode pads to electrode wires

• Before proceeding to this step, ensure that the device is completely switched OFF. Hold the insulated portion of the electrode wire connector, and insert the plug into the re­ceptacle on the top of the main device.
• Ensure the electrode wires are inserted correctly. The de­vice has two output receptacles controlled by Channel A and Channel Bat the top of the unit. You may choose to use one channel with one pair of electrode wires or both channels with two pairs of electrode wires.
• Using both channels gives the user the advantage of stimu­lating two different areas at the same time .

Caution
Do not insert the plug of the electrode wires into any AC power supply socket.

Electrode

1. Electrode options
   The electrodes should be routinely replaced when they start to lose their adhesiveness. If you are unsure of your electrode adhesive properties, please order new replace­ment electrodes. Replacing electrodes should be re-or­dered under the advice of your physician or the device manufacturer to ensure proper quality. Follow application procedures outlined on electrode packing when using the new replacement electrodes to maintain optimal stimula­tion and to prevent skin irritation.

2. Place electrodes on skin
   Place the electrode on the body part in need of treatment, according to the instruction of this user manual. Please make the skin clean before use and ensure the skin and electrode connect well.

Caution

1. Always remove the electrodes from the skin with a mod­erate pull in order to avoid injury in the event of highly sensitive skin.
2. Before applying the self-adhesive electrodes, it is recom­mended to wash and degrease the skin, and then dry it.
3. Do not turn on the device when the self-adhesive elec­trodes are not positioned on the body.
4. To remove or move the electrodes, switch off the device or the appropriate channel first in order to avoid unwant­ed irritation.
5. It is recommended that, at minimum, 1.97″ x 1.97″ self-adhesive square electrodes are used at the treatment area.
6. Never remove the self-adhesive electrodes from the skin while the device is still on.

Electrode placement
Magic is a kind of OTC stimulator, suitable for home use. You only have to use according to the user manual, place the electrode on the position where you feel pain. Conduct exercise, treatment and adjustment based on your own feeling.

Position of electrode placement under TENS programs

Position of electrode placement under EMS programs

INSTRUCTIONS FOR USE

1. Turn on
   Press the [ON/OFF] button to turn on the device, the LCD will be lit. And then it goes into the standby mode as the picture shown below.

2. Select treatment mode
   Press the [M] button to select which treatment mode ( TENS – EMS- MASS) you will use. The LCD displays as follows:

3. Select treatment program
   Based on your need, Press the[ ] button to select the trea­tment program. The LCD displays as follows :

4. Adjust the treatment time
   Based on your need, press [ ] button to increase the treatment time. The LCD displays as follows

5. Start treatment
   Press the[+] button to increase the intensity of the selected treatment channel. The LCD displays as follows:

6. Adjust the output intensity

7. Press the[+] button to increase output intensity. It will be increased to a higher level after each press. The device has totally 40 levels of output intensity. Please adjust the inten­sity to the condition that you feel comfortable. The level of output intensity will be shown on the LCD:

8. During treatment, if there is no keystroke for 20 seconds, the device will turn on the key lock function, and the LCD displays the’ ‘symbol, It will lock out the ability to accidentally increase the intensity. To unlock, press[-] button.

9. If you feel it too strong, you can press [-] button to decr­ease the intensity to a lower level each time. When the ou­tput intensity of both channels decrease to zero, the sti­mulator will return to the standby mode. The LCD display as follows: Caution:
   If you feel or become uncomfortable, reduce the stimulation intensity to a more comfortable level and consult with your medical practitioner if problems insist.

10. Stop the treatment and turn off the device
    Press the [ON/OFF] button to stop treatment during the treating mode. Press the [ON/OFF] button again to turn off the stimulator, and the LCD will be blank.

11. Load detection
    It will automatically detect the load if the intensity is above level 5. If it hasn’t detected the load or the electrode con­tacts the skin not well enough, the intensity will automati­cally return to level O and the symbol or twinkles. And the stimulator returns to the standby mode.

12. Battery voltage detection
    When the battery is low, the icon will twinkle to indi­cate it, stop the device and charge the battery.

Charging the Battery
Proceed as follows to recharge the battery

• This device cannot be used while charging.
• Make sure that the device is no longer connected to the patient (the output cables and electrodes must be dis­connected).
• Connect the USB cable to the charging port on the device.
• Connect the USB cable to the charger.
• When the device is charging, the indicator light will be red.
• It could take up to 2 hours to reach a full charge.
• When charging is completed, the indicator light will be green.

The life of a rechargeable battery depends on the number of recharging/rundown cycles it undergoes and how these cycles are performed.

The following suggestions will help prolong the life of the battery

• Whenever the device is not used frequently, charge the battery once a month.
• For longer battery life, discharge the battery as much as possible.

Usage of electrode pads

1. The electrode may only be connected with the COMBO stimulator. Make sure that the device is turned off when attaching or removing the electrode pads.
2. If you want to reposition the electrode during the appli­cation, turn the device off first.
3. The usage of electrode may lead to skin irritations. If you experience such skin irritations, e.g. redness, blistering or itching, discontinue using them. Do not use the COMBO stimulator permanently on the same body part, as this may also lead to skin irritations.
4. Electrode pads are private and intended for single per­son use. Please avoid using them by different persons.
5. The electrode must connect entirely to the skin surface to prevent hot spots, which may lead to skin burns.
6. Do not use the electrode pads for more than approx. 10 times, as connection between the electrodes and the skin deteriorates over time.
7. The adhesive force of the electrodes depends on the skin properties, storage condition, and the number of applications. If your electrode pads no longer fully stick to the skin’ surface, replace them with new ones. Stick the electrode pads back onto the protective foil after use and store them in the storage bag to prevent them from drying out. This retains the adhesive force for a longer period.

Caution:

1. Before applying the electrode, it is recommended for us­ers to wash and degrease the skin, and then dry it.
2. Never remove the electrode from the skin while the de­vice is still on.
3. Only use the electrode pads provided by the manufac­turer. Usage of other companies’ products could result in injuries to the user.

Where do I attach electrode pads?

1. Each person reacts differently to electric nerve stimu­lation. Therefore, the placement of the electrodes may deviate from the standard. If application is not success­ful, contact your physician to find out which placement techniques are best for you.
2. Do not use any adhesive electrodes with a size smaller than those the original manufacturer attached. Other­wise the current density may be too high and cause inju­ries.
3. The size of the adhesive pads may not be changed, e.g. by clipping off parts of them.
4. Make sure that the region radiating the pain is enclosed by the electrodes. In case of painful muscle groups, at­tach the electrodes in such a way that the affected mus­cles are also enclosed by the electrodes.

CLEANING AND MAINTENANCE

Fully comply with the following necessary daily maintena­nce requirements to make sure the device is intact and gu­arantee its long-term performance and safety.

Cleaning and care for the device

1. Pull the electrodes out of the stimulator, clean the device with a soft, slightly damp cloth. In case of hea­vier dirt build-up, you may also apply a mild detergent.
2. Do not expose the COMBO stimulator to moisture or dampness. And do not hold the COMBO stimulator under running water, nor submerge it in water or ot­her liquids.
3. The COMBO stimulator is sensitive to heat and may not be exposed to direct sunlight. And do not place it  on hot surfaces.
4. Clean the surface of the electrode pads carefully with a damp cloth. Make sure the device is turn off!
5. For reasons of hygiene, each user should use his/her own set of electrodes.
6. Do not use any chemical cleaners or abrasive agents for cleaning.
7. Ensure that no water penetrates into the machine. Should this happen, use the device again only when it is completely dry.
8. Do not clean the device during treatment. Be sure that  the device is turned off and the battery is unloaded before cleaning.

Maintenance

1. The manufacturer didn’t authorize any maintenance agencies abroad. If your device has any problems, please contact the distributor. The manufacturer will not be responsible for the results of maintenance or repairs by unauthorized persons.
2. The user must not attempt any repairs to the device or any of its accessories. Please contact the retailer for repair.
3. Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to warranty.
4. Each product in manufacturing has been inspected through systematic validation. The performance is stable and does not need to undertake calibration and validation.
5. If your product can’t reach the expected performance and the basic function has changed in normal use, please con­tact the retailer.

TROUBLESHOOTING

Should any malfunction occur while using the device, check whether the parameters are set appropriately for therapy, and adjust the control correctly. Please see the fol­lowing table

No sensation of stimulation or weak stimulation|

1. The electrode does not connect well to the skin.
2. If the connection between electrode connects well to the stimulator.
3. The battery is used up.
4. The skin is too dry.

|

1. Check and repasted it on skin.
2. Check the connection.
3. Charge.
4. Wipe the electrode and the skin with a wet cotton cloth.

---|---|---
Automatic halt in the treatment|

1. The electrode loses connection with the skin.
2. If the battery is used up.

|

1. Check and place the electrode properly on the skin.
2. Charge

Rash or tickle on the skin occurs in the treatment|

1. The treatment time lasts too long.
2. The electrode does not stick well to the skin.
3. The interface of the electrodes is dirty or dry.
4. The skin is sensitive to the electrode.

|

1. Do the treatment once a day and shorten the treatment time.
2. Wipe the electrode with a wet cotton cloth before use.
3. Check your allergic history. Please change the sticking place or shorten the treatment time. If your skin is over-sen­sitive, you should stop the treatment or go to see a doctor.

---|---|---

STORAGE

Storing the Electrode Pads and Lead Wires

1. Turn the device off and remove the lead wires from the unit.
2. Remove the electrodes from your body and disconnect the lead wires from the electrodes.
3. Place the electrodes onto the plastic film and then store into the sealed package.
4. Wrap the lead wires and store into the sealed package.

Storing the Unit

1. Place the unit, electrodes, lead wires and manual back into the gift box. Store the box in a cool, dry place, -l0°C ~ SS°C; 10% ~ 90% relative humidity.
2. Do not keep in places that can be easily reached by chil­dren

DISPOSAL

• Spent batteries do not belong to the household wastes. Disposal of the battery according to the current regulations. As a consumer, you have the obligation to dispose of batteries correctly. – Consult your municipal authority or your dealer for information about disposal.
• At the end of the product lifecycle, do not throw this prod­uct into the normal household garbage, but bring it to a collection point for the recycling of electronic equipment. Obsolete electrical and electronic equipment may have potentially harmful effects on the environment. Incorrect disposal can cause toxins to build up in the air, water and soil and jeopardize human health.

 ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES

Guidance and manufacture’s declaration – electromagnetic emis­ sions

The device is intended for use in the electromagnetic environment specified below. The customer or the user has to assure that it is

used in such environ m en t. ———————————————– <

Emissions tes t Compliance Electromagnetics environment- guidance
RF emissions CISPRll| Group 1 —| The device uses RF energy only for its internal function. Therefore, its RF emissions are ve r y low and are not likely to cause any interference in nearby electronic equipment.
---|---|---
RF emissions Crispell| Class B| The device is suitable for use in all es­
Not applitablishments including those directly IEC 61000_3_2 cable   connected to the public low-voltage power supply network that supplies
Flicker emissions cable       purposes IEC 61000-3-3 __
| |
Guidance and manufacture’s declaration – el e ctromagneti c 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 environment.
Immunity test| IEC 60601 Test level| Compliance level| Electromagnetic environment-guidance
Electrostatic discharge (ESD) IEC 61000-4-2| ±SkVdirect & indirect co n tact;

±15kVair discharge

| ±SkVdirect & indirect contact;

±15kV air discharge

| Floors should be wood, concreter ceramic tile. If floors are covered with synthetic material, the relative humidity should beatleast30%
Electrical fast transient/burst IEC 61000-4-4| ±2 kV for power supply lines| not applicable| not applicable (for INTERNALLY POWERED ME EQUIPMENT)
| | | not applicable
Surge| ± 1 kV line(s)| not applicable| (for INTERNALLY
IEC 61000-4-5| to line(s)| | POWERED ME
| | | EQUIPMENT)
| < 5%UT| |
---|---|---|---
| (>95%dipin| |
| U,)| |
| for0.5cycle| |
Voltage dips,| 40%U,| |
short interrup­ tions and volt- age var i ations on power supply

input lines

| (60J6dip in U,) for5cycles 70%U, (30%dip in U,)| not applicable| not applicable (For INTERNAL- LY POWERED ME EQUIPMENT
IEC 61000-4-11| for25cycles| |
| < 5%UT| |
| (>95%dipin| |
| U,)| |
| for5sec| |
Power frequency (50Hz/60Hz) magnetic field IEC 61000-4-8| 10V/m| 10 V/m| Power frequency magnetic fields should be at levels characteristic of a typical location in typical commercial or hospital environment.
NOTE U, 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 device should assure that it is used in such environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
Radiated RF

IEC

61000-4-3

| l0V/m & table 9| l0V/m & table 9| Portable and mobile RF communi­cations equipment should be used not 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 80 MHz to 800 MHz 800 MHz to 2.5 GHz

Where Pips the maximum output power rating of the transmitter in watts (W) according to the trans­mitter manufacturer and dis the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagne t ic site survey/

should be less than the compliance level in each frequency range. b Interference may occur in the v i cin ­ ity 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. Elec cryomagnetic propagation is affected by absorption and reflection fr om struc t ures , objects and people.

• 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 reorienting or relocating the device.

• Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [Vi] V/m.

N O TE If it is necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m.The 1 m test distance is permitted by IEC 61000-4-3.

1. For some services, only the uplink frequencies are included.
2. The carrier shall be modulated using a 50 % duty cycle square wave signal.
3. As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because it does not rep- resents actual modulation. It would be worst case.

NORMALIZED SYMBOLS

–| Electrical devices are recyclable material and should not be disposed of with household waste after use! Help us protect the en­vironment and save resources and take this device to the appropriate collection points. Please contact the organization which is re­sponsible for waste disposal in your area if any questions.
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| Applied part of type BF
| Refer to instruction manual
IP22| The first number 2: Protect against solid foreign objects of 12,5 mm ()) and greater. The second number: Protect against vertically falling water drops when enclosure titled up to 15°. Vertically falling drops shall have no harm­ful effects when the enclosure is titled at any angle up to 15°, on either side of the vertical.
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| Manufacturer information: The manufacturer Shenzhen Round whale Technology Co., LTD.
| Manufacture date

WARRANTY

Please contact your dealer or the device center in case of a claim under the warranty. If you have to return the unit, en­closing a copy of your receipt with clear statement of defect description.

The warranty terms are as below

1. The warranty period for this device is 1 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.
2. Repairs under warranty should be in the warranty period either for the device or for the replacement parts.
3. The following cases are excluded under the warranty
4. All damages that arise due to improper operation, e.g. nonobservance of the user instruction.
5. All damages due to repairs or tampering by the cus­tomer or unauthorized third parities.
6. Damage which has arisen during transport from the manufacturer to the consumer or the service centre.
7. Accessories which are subject to normal wear and tear.
8. Device damages due to privately dissembling devices.
9. Liability for direct or indirect consequential losses caused by the unit is excluded even if the damage to the unit is accepted as a warranty claim

Distributor: NOTO-TECH ELECTRONICS CO., LTD Address: Room 803, Cheval House 45-51 Chatham Road South, Tsim Sha Tsui, KL
E-mail: nicwellcare@outlook.com
Shenzhen Roundwhale Technology Co., Ltd.
Address: 202, 2 / F, Building 27, Dafa Industrial Park,Longxi Community, Longgang District,Shenzhen, China

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