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This manual is valid for the AccuRelief™ Mini TENS ACRL-1000

This instruction manual is published by Carex Health Brands.

Carex Health Brands reserves the right to improve and amend this manual at any time without prior notice.

Amendments may however be published in new editions of this manual.

Conformity to safety standards

Carex Health Brands declares that the device complies with the following normative documents:

IEC60601-1, IEC60601-1-2, I EC60601-2-10, IEC62366,

ISO10993-5, ISO10993-10, ISO10993-1, ISO7010

Содержание MiniTENS ACRL-1000

Страница 1: ...Mini TENS Natural drug free pain relief 20 Minute Treatment Single Patient Use Model ACRL 1000 User Manual Clinically Proven ...

Страница 2: ...amend this manual at any time without prior notice Amendments may however be published in new editions of this manual All Rights Reserved Rev V 2 0 2014 20140512 Conformity to safety standards Carex Health Brands declares that the device complies with the following normative documents IEC60601 1 IEC60601 1 2 I EC60601 2 10 IEC62366 ISO10993 5 ISO10993 10 ISO10993 1 ISO7010 ...

Страница 3: ...ture 13 Battery information 14 Treatment information 15 Gel pad positioning 17 Maintenance and cautions 18 Disposal 18 Storage 18 Technical specifications 19 Program 19 Troubleshooting 20 Important information regarding electromagnetic compatibility EMC 21 Explanation of symbols 28 Warranty 29 ...

Страница 4: ...reaching the brain n The gentle electrical pulses increase the production of endorphins the body s natural pain killer INTRODUCTION Thank you for purchasing the AccuRelief Mini TENS Model ACRL 1000 for your pain relief solution Please read the complete manual carefully before using the device for the first time and keep this instruction manual in a convenient place or store with the device for fut...

Страница 5: ...ommon forms of pain For other areas of pain place the gel pads on either side of the pain area PLEASE NOTE Never place the gel pads on the head face heart chest area eyes oral cavity sexual organs or over the spine or bony premises How long can I use the Mini TENS unit You may use the Mini TENS unit for at least 20 minutes a day However initially you may need to wear it for longer Please seek medi...

Страница 6: ...PRECAUTIONS AND WARNINGS It is important that you read all the warning and precautions included in this manual because they are intended to keep you safe prevent injury and avoid a situation that could result in damage to the device DANGER This stimulator must not be used in combination with the following medical devices n Internally transplanted electronic medical devices such as pacemakers n Ele...

Страница 7: ...toring equipment e g cardiac monitors ECG alarms which may not operate properly when the electrical stimulation device is in use n On open wounds or rashes over swollen red infected inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins or on top of or in proximity to cancerous lesions n Over areas of skin that lack normal sensation n On the opposite sides of your head sinc...

Страница 8: ...ons as a very important warning telling us that something is wrong Therefore if you suffer from any serious illness consult your physician in order to confirm that it is advisable for you to use this TENS unit WARNINGS AND PRECAUTIONS REGARDING THE PADS n Apply pads to normal healthy clean dry skin of adult patients because it may otherwise disrupt the healing process n If you experience any skin ...

Страница 9: ...lready pre gelled and will adhere to your skin n To avoid damage to the adhesive surface of the pads put the pads only on the skin or on the plastic film provided n Place the pads at least 2 inches apart on your skin The pads should never touch each other n Always place clean pads in accordance with the illustrations provided Refer to page 17 for pad placement n Make sure the components are connec...

Страница 10: ...THE TENS unit n If the TENS unit is not functioning properly or you feel discomfort immediately stop using the device n Do not use for any other purpose except as described in this manual n Do not pull on the electrode cord during treatment n Do not use the TENS device while wearing electronic devices such as watches as this may damage the device n Do not use near a cell phone as this may cause th...

Страница 11: ...evices do not cure diseases or injuries n TENS is a symptomatic treatment and as such suppresses the sensation of pain that would otherwise serve as a protective mechanism n You may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium gel on the electrodes n If you have suspected or diagnosed heart disease you should follow precautions re...

Страница 12: ...lief brand electrode AccuRelief Supply Kit ACRL 0002 designed specifically for the ACRL 1000 Mini TENS device POSSIBLE ADVERSE REACTIONS n Do not use device to treat one region for extended periods of time more than 20 minutes a session up to 3 times day or muscles in that region may become exhausted and sore n You may experience skin irritation and burns beneath the stimulation electrodes applied...

Страница 13: ...13 PRODUCT STRUCTURE Mini TENS Back of unit Front of unit ...

Страница 14: ...ATTERY INFORMATION Warning If battery leaks and comes into contact with the skin or eyes wash immediately with large amounts of water The AccuRelief Mini TENS ships with the battery installed Before operating pull the plastic protective strip from the back of the positive electrode NOTES n Remove the battery if the device is not in use for long periods of time n Keep battery out of the reach of ch...

Страница 15: ...ng them in place NOTE Remove clear protective film on the face of and electrode buttons Step 3 Placing the gel pads Remove the layer of film and place that side of the gel pad to the skin positioning the gel pads on the area of pain Press to ensure adhesion Please read page 17 carefully to understand where to place the gel pads PLEASE NOTE n GEL PADS ARE REPLACEABLE AccuRelief Supply Kit ACRL 0002...

Страница 16: ...n for 3 seconds until you hear a mildly long beep NOTE The unit will automatically power off after the 20 minute treatment is complete PLEASE NOTE n If the continuous beeping persists please check if the pads are adhered well to your skin n Do not move the gel pads to another part of your body without turning off the power first n Never stick the gel pads to each other n Keep the gel pads clean an...

Страница 17: ...place the gel pads on either side of the area of pain PLEASE NOTE Never place the gel pads on the head face heart chest area eyes oral cavity sexual organs or over the spine or bony premises Do not immerse the TENS unit in water or any liquid Do not drop the device or throw it from any height After using the TENS unit remove the gel pads and place them on the protective transparent film provided ...

Страница 18: ...each of children n Store the TENS unit in a cool dry place 14 F 131 F 10 C 55 C 10 90 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 stick to your skin or the gel pads are broken you should replace them with new pads AccuRelief Supply Kit ACRL 0002 DISPOSAL Used fully discharged batteries must be disposed of ...

Страница 19: ...ns 10 RH 90 RH Size 169 L x 34 W x 10 H mm Weight 10 39 g without battery Service life of device 3 years Service life of battery With new battery approx 80 days if used for 20 min day in normal conditions Program Frequency Pulse width Time Description 1 2 125 Hz 100 200 μS 2 min The frequency and pulse width are modulation 2 40 Hz 100 150 μS 2 min The pulse width is changed between 100 us and 150 ...

Страница 20: ...on is uncomfortable Intensity is too high Decrease intensity Is the device being operated according to the manual Please check the manual before use The skin becomes red and or you feel a stabbing pain Use the gel pads on the same site every time Re position the gel pads The gel pads are not sticking to the skin properly Ensure the gel pads are securely placed on the skin The gel pads are dirty Re...

Страница 21: ... 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 Carex Health Brands conform to this IEC60601 1 2 2007 standard for both immunity and emissions IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC COMPATIBILIT...

Страница 22: ...issions 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 other than domestic and those directly connected to the public low voltage power supply network that supplies buildings...

Страница 23: ...V air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 Not applicable Not applicable Not applicable Surge IEC 61000 4 5 Not applicable Not applicable Not applicable Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 No...

Страница 24: ...uipment 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 d 1 2 P d 1 2 P 80 MHz to 800 MHz 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...

Страница 25: ... 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 should be observed to verify normal operation If abnormal performance i...

Страница 26: ...gnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and 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 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0...

Страница 27: ...mum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE I 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 Note EMC tests conducted including attached electrod...

Страница 28: ...28 EXPLANATION OF SYMBOLS Type BF Applied Part Disposal in accordance with Directive 2002 96 EC WEEE Refer to Instruction Manual Caution Keep Dry ...

Страница 29: ...anty 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 which is due to repairs or tampering by the customer or unauthorized third parties n Damage during transport from the manufacturer to the consumer or during transport t...

Страница 30: ...These warranties are effective only if the product is purchased and operated in the country in which the product is purchased A product that requires modifications or adoption to enable it to operate in any other country than the country for which it was designed manufactured approved and or authorized or repair of products damaged by these modifications is not covered under this warranty THESE WA...

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