Innovo INV-942R iSoothe Скачать руководство пользователя страница 14

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TROUBLESHOOTING

PROBLEM

POSSIBLE CAUSES

POSSIBLE SOLUTION

The unit

does not

power on

he battery

exhausted

Recharge the battery.

Stimulation

weak

or cannot feel any

stimulation

Gel pads are dried out or dirty.

Replace with new gel pads.

Gel pads cannot

adhere

to skin

perly

Clean treatment area of dirt and/or oily

substances (lotion).

Battery has a low charge

Recharge the battery.

Stimulation is

uncomfortable

Intensity is too high.

Decrease intensity.

evice

is not

operated according to the manual

instructions

Please check the manual before use.

The skin becomes

red and/or you feel

a stabbing pain

Using the gel pad on the same site every time.

Re-position the gel pad.

The gel pad is not sticking onto the skin properly.

Ensure

that

the gel pad is securely

placed on t

reatment area

The gel pad is dirty.

Replace with new gel pad.

The surface of the gel pad is scratched.

Replace with new gel pad.

If problems persist.

Contact your physician.

If the unit does not operate after taking these measures, contact your nearest dealer.

IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC COMPATIBILITY (EMC)

With the increased number of electronic devices

such as computers and mobile (cellular) telephones,

medical devices in use may be susceptible to

electromagnetic interference from other devices.

Electromagnetic interference may result in incorrect

operation of the medical device and create a

potentially unsafe situation. Medical devices should

also not interfere with other devices.

In order to regulate the requirements for EMC

(Electromagnetic Compatibility) with the aim to

prevent unsafe product situations, the IEC60601-

1-2 standard has been implemented. This standard

defines the levels of immunity to electromagnetic

interferences as well as maximum levels of

electromagnetic emissions for medical devices.

Medical devices manufactured for

Innovo Groups

conform to this IEC60601-1-2:2007 standard for

both immunity and emissions.

Nevertheless, special precautions need to

be observed:

The use of accessories other than those

specified by

Innovo Groups

, may result in

increased emission or decreased immunity of

the device.

Refer to

the

EMC table guidance regarding the

EMC

environment in which the device

should be used.

Содержание INV-942R iSoothe

Страница 1: ...User Manual Clinically Proven By By iSoothe WIRELESS RECHARGEABLE TENS INV 942R Rechargeable Battery 20 Minute Treatment Timer 5 Preset Modes 15 Intensity Levels Auto Shut Off ...

Страница 2: ...ety standards Innovo Groups declares that the device complies with the following normative documents ISO13485 CMDCAS ISO9001 CERT ISO13485 UKAS TABLE OF CONTENTS Introduction 4 Important safety precautions and warnings 6 Package contents 13 Know your device 14 Battery information 15 Treatment information 15 Gel pad positioning 21 Maintenance and cautions 22 Storage 22 Technical specifications 23 P...

Страница 3: ...household activities This product is designed for the temporary relief of muscle joint and bone pain in the n Neck n Waist n Shoulder n Upper Extremities arms n Back n Lower Extremities leg The pain reliever should be applied to normal healthy clean and dry skin of adult patients What can I treat The TENS device can be used to manage many different types of pain Please refer to the diagrams on pag...

Страница 4: ...evices WARNING Consult with your physician before using this device The device may cause lethal rhythm disturbances in certain susceptible individuals DO NOT USE THIS DEVICE UNDER THESE CONDITIONS n 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 n Together with a lif...

Страница 5: ... n The head or any area of the face n The neck or any area of the throat because this can cause severe muscle spasms resulting in the closure of airway difficulty in breathing or adverse effects on heart rhythm or blood pressure n Both sides of the thorax simultaneously lateral or front and back or across your chest because the introduction of electrical current may cause rhythm disturbances which...

Страница 6: ...lation are unknown n Apply stimulation to only normal intact clean dry and healthy skin n TENS is not effective in treating the original source or cause of the pain including headache n TENS is not a substitute for pain medications and other pain management therapies n TENS devices do not cure diseases or injuries n TENS is a symptomatic treatment and as n Effectiveness is highly individual depend...

Страница 7: ...es in the treated region n You may experience skin irritation and burns beneath the stimulation electrodes n You should stop using the device and consult with your physician if you experience adverse reactions from using the device PACKAGE CONTENTS PACKAGE CONTENTS Protective Case Draw String Carrying Bag Instruction manual User Manual Clinical ly Proven By By iSoothe Wireless Rechargeable TENS IN...

Страница 8: ...w a complete charge Once fully charged the battery should last for at least 8 hours depending on intensity level used Standard For Battery Recharge 1 If you feel the stimulation is weak the LED is dim or the device cannot power on the battery may need to be recharged BATTERY INFORMATION STEP 1 Instructions For Use Before use it is recommended to charge the iSoothe device with the enclosed USB Cabl...

Страница 9: ...protective transparent film You will need to put it on the pad when the pad is not in use TREATMENT INFORMATION cont TREATMENT INFORMATION cont TM STEP 4 Placing the TENS unit n Place the pad on the treatment area see page 21 for placement suggestions Press down firmly to ensure full contact with skin NOTE GEL PADS ARE REPLACEABLE iSoothe Pain Relief Pad Supply Kit Item E 946R STEP 5 Power On n Pr...

Страница 10: ...th a beep There are 15 intensity levels in total MODE TYPE 1 Scraping 2 Massage 3 Tapping 4 Acupuncture 5 Combo NOTE See page 24 for mode details TREATMENT INFORMATION cont STEP 6 Changing Modes n Mode 1 is the default setting when you turn on TREATMENT INFORMATION cont STEP 8 Timer n Once you have found the desired intensity Mode the timer will begin n The timer counts down from 20 minutes n When...

Страница 11: ...place with a new replacement gel pad item E 946R n Do not clean the pad or adhesive gels with any chemical n Place the gel pads on clean skin only Do not place on cuts or damaged skin n The iSoothe is for single person use n Place the blue plastic film on the gel pad when not in use Front of Shoulder Back of Shoulder GEL PAD POSITIONING NOTE The illustrations below show 2 suggested treatment sites...

Страница 12: ... place 14 F 131 F 10 95 relative humidity n Do not expose the gel pads to direct sunlight and protect them against dirt and moisture n If the gel pads no longer adhere to your skin or or the gel pads are broken you should replace with new pads n The iSoothe INV 942R is intended for single patient use Do not share with others TECHNICAL SPECIFICATIONS Type Power supply Wave form Frequency Pulse widt...

Страница 13: ... 80Hz 50 100 μS 7 5 sec ON 1 sec OFF The pulse width changes in a cycle ranging from 50 100 μS at a frequency of 80Hz The cycle time is 8 5 seconds 5 N A N A N A Cycles through modes 1 4 at 30 second intervals PROGRAM The iSoothe INV 942R unit is preset with a combination program that delivers three phases of alternating therapy They are specified as follows DISPOSAL When the battery is dead and w...

Страница 14: ...tact your nearest dealer IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC COMPATIBILITY EMC With the increased number of electronic devices such as computers and mobile cellular telephones medical devices in use may be susceptible to electromagnetic interference from other devices Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe si...

Страница 15: ... 1 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY iSoothe electrical stimulators are intended for use in the electromagnetic environment specified below The customer or the user of these electrical stimulators should assure that it is used in such environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD lEC 6...

Страница 16: ...m 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 TABLE 3 NOTE I At 80 MHz ends 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by ab...

Страница 17: ... m 150 kHz to 80 MHz d 1 2 80 MHz to 800 MHz d 1 2 P 800 MHz 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 TABLE 4 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output po...

Страница 18: ... has to be proven by means of the sales receipt or invoice 2 Repairs under warranty do not extend the warranty period either for the device or for the replacement parts 3 The following is excluded under the warranty n All damage due to improper treatment e g non observance of the user instruction n All damage due to repairs or tampering by the customer or unauthorized third parties n Damage during...

Страница 19: ...s purchaser s sole and exclusive remedy INNOVO GROUPS will repair or at the discretion of INNOVO GROUPS replace this product without charge for such replacement parts or labor The purchaser shall bear all expenses related to returning this product to INNOVO GROUPS This warranty does not apply to any part of the product that has been subject to misuse abuse or alteration Improper or incorrectly per...

Страница 20: ...38 ...

Страница 21: ...Innovo Groups 406 Sterling Street Building 2 Camp Hill PA 17011 Tel 1 858 888 9781 www innovogroups com Email cs innovogroups com ...

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