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Guidance and manufacture’s declaration – electromagnetic immunity

The ACRL-9100 is intended for use in the electromagnetic environment specified below.

The user of the ACRL-9100 should assure that it is used in such an environment.

Immunity test

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to

80 MHz
3 V/m

80 MHz to

2.6 GHz

3 V RMS outside the

ISM band, 6 V RMS

in the ISM and

amateur radio

bands
10 V/m

Portable and mobile RF communications

equipment should be used no closer to any

part of the ACRL-9100, including cables,

than the recommended separation distance

calculated from the equation applicable to

the frequency of the transmitter.

Recommended separation distance

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Содержание ACRL-9100

Страница 1: ...Wireless 3 in 1 Pain Relief Device User Manual Clinically Proven Model ACRL 9100 ...

Страница 2: ...published in new editions of this manual The device complies with all the standards relating to Class ll electrical medical devices and to devices which use electrical stimulation for use at home All Rights Reserved Rev V1 0 2017 Conformity to safety standards Carex Health Brands declares that the device complies with following normative documents IEC60601 1 IEC60601 1 2 I EC60601 2 10 IEC62366 IE...

Страница 3: ...nts 14 Know your device 15 Charging 18 Easy steps to get started with your therapy with electrode pads 19 Cleaning and storage 26 Specifications 28 How to control and reduce your pain 30 Troubleshooting 32 Product Battery disposal 34 Glossary of symbols 34 Important information regarding electromagnetic compatibility EMC 35 FCC Compliance information 42 Warranty 43 ...

Страница 4: ...ully before using the device for the first time Keep this instruction manual in a convenient place or store with the device for future reference Indications for use n TENS The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder waist back neck upper extremities arm and lower extremities leg due to strain from exercise or normal househo...

Страница 5: ... injury WARNING Indicates a potentially hazardous situation which if not avoided could result in serious injury and equipment damage n Internally transplanted electronic medical devices such as a pacemaker n Electronic life support equipment such as respirators n Electronic medical devices attached to the body such as electrocardiographs CAUTION Indicates a potentially hazardous situation which if...

Страница 6: ...ore using this device because the device may cause lethal rhythm disturbances in certain susceptible individuals n On open wounds or rashes or over swollen red infected or 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 Stimulation should not take place while the user ...

Страница 7: ...ealthy dry clean skin of adult patients because it may otherwise disrupt the healing process n If you experience any skin irritation or redness after a session do not continue stimulation in that area of the skin n Pads should not touch each other when placed onto your skin n Pads must be placed at least 2 in apart n Both sides of the thorax simultaneously or across your chest because the introduc...

Страница 8: ...Placement illustrations n Make sure the components are connected well and the pads are fixed on the part of the body you wish to treat or the therapy may not be effective 8 CAUTION DO NOT USE YOUR PADS THIS WAY Pads should not touch each other when placed onto your skin Pads should be at least 2 in apart Do not place on your spine or backbone WARNING If you have suspected or diagnosed heart diseas...

Страница 9: ...e device Dispose of the device batteries and components according to applicable legal regulations Unlawful disposal may cause environmental pollution The size shape and type of pads may affect the safety and effectiveness of electrical stimulation The electrical performance characteristics of pads may affect the safety and effectiveness of electrical stimulation Using pads that are too small or in...

Страница 10: ...e device if it is closer than 12 inches 30 5cm to wireless communication equipment such as wireless home network routers cell phones cordless phones and their base stations and walkie talkies The electromagnetic interference of this wireless communication equipment may prevent the device from operating properly n If you have any problems with this device such as setting up maintaining or using ple...

Страница 11: ... 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 to your skin n You should stop using the device and consult with your physician if you experience adverse reactions from the device CAUTION ...

Страница 12: ...o modify your pain perception TENS does not cure any physiological problem it only helps control the pain TENS does not work for everyone however in most patients it is effective in temporarily reducing or eliminating the pain allowing for a return to normal activity Scientific theory suggests that electrical stimulation therapy may work in several ways n The gentle electrical pulses move through ...

Страница 13: ... similarly but uses an external source the stimulator with electrodes attached to the skin for transmitting electrical impulses into the body The impulses stimulate the nerves to send signals to a specifically targeted muscle which reacts by contracting just as it does with normal muscular activity How MASSAGE works The massage stimulation program is a type of low level EMS used to loosen tight mu...

Страница 14: ...ry completely Remove the protective film layer and apply the gel pad to the skin Press firmly to ensure adhesion See the Recommended Gel Pad Positions on reverse page 4 TURN ON THE ACRL 9100 UNIT AND START A SESSION THROUGH THE USE OF THE DEVICE APPLICATION Press the on off button so that the appliance is put on standby mode Continuous green light Standby mode ready for the session The App will de...

Страница 15: ...is button to turn on the device or turn off the device n Green Flashing indicator light The device hasn t connected with APP or the Remote Controller n Continuous green The device is in standby mode n Continuous Orange The device is in treatment mode n Orange flashing The device is in paused mode 2 Indicator light when charging n Continuous orange The battery is charging n Continuous green The bat...

Страница 16: ...16 Power ON OFF button Mode select TENS EMS MASSAGE LCD DISPLAY Intensity increase Treatment proqram select Neck Shoulder Arm LBack Joint Leg Tap Knead Rub Intensity decrease ...

Страница 17: ...LCD Display 17 Treatment time icon Treatment time display Treatment program Intensity icon Low battry icon Lock Icon Treatment mode Treatment intensity display ...

Страница 18: ...afely according to the local regulations n The life of a rechargeable battery depends on the number of recharging rundown cycles it undergoes and how these cycles are performed The service life of rechargeable battery is more than 300 recharging rundown cycles We provide the following suggestions to extend the life of the battery n Whenever the device is not used frequently we recommend recharging...

Страница 19: ...e male snap of the gel pad to the female snap of the device as shown in the picture on the right Clip excess hair from the treatment area and remove any jewelry that may come in contact with the stimulation of the device Wash area with soap and water and dry completely EASY STEPS TO GET STARTED WITH YOUR THERAPY WITH ELECTRODE PADS 19 Place electrodes on clean dry and healthy skin at least 2 in ap...

Страница 20: ... the use by date indicated on the re sealable bag n they have lost their adhesive power Never use plaster or tape to attach them to your skin n stimulation feels less strong n when stimulation is uncomfortable i e when you experience an unpleasant stinging or biting sensation Note Always replace the electrodes with electrodes recommended for this device by the manufacturer WARNING Make sure the de...

Страница 21: ...ULDER PAIN Attach one pad in front and one in back of the muscle CARPAL TUNNEL HAND PAIN Attach both pads on the hand where you feel pain LOWER BACK Attach both pads on the lower back with the backbone in the center DO NOT place on the backbone or spine UPPER ARM PAIN Attach both pads on either side of the region where you feel pain ELBOW PAIN Attach both pads on either side of the joint with the ...

Страница 22: ...DO NOT place electrode pads simultaneously to the calves of both legs ANKLE FOOT PAIN Attach pads per the illustration on the left for pain on the outside of your ankle foot Attach the pads per the illustration on the right for pain on the inside of your ankle foot DO NOT place electrode pads simultaneously to the soles of both feet Treat one at a time ...

Страница 23: ...tches off Press the on off button again to begin a session Step 6 Select the area to be treated In the case of a new session it is essential to select a treatment area and a program ACRL 9100 Step 7 Estimate the intensity of pain you are currently experiencing in the area to be treated in TENS mode On a scale of 1 to 10 evaluate the intensity of the pain For no pain press 0 for extremely intense p...

Страница 24: ...ies Make sure the positive and negative signs correspond with the markings in the device when inserting batteries Reinstall the battery cover Notes Please use 2 AAA batteries in this remote control Remove the batteries if the device is not in use for long periods of time Do not mix old and new batteries or different types of batteries Remove exhausted batteries from the remote control Step 2 Clean...

Страница 25: ... the button to decrease the intensity NOTE There are 60 levels of intensity STEP 6 Turn off the device You can turn device off in the following ways The device will turn off automatically after 30 minutes treatment time Press the power button continuously until the LED light turns off Turn the remote controlled device off by pressing the On Off button on the remote control n To turn off the device...

Страница 26: ...ow running cold water for several seconds do not use a sponge cloth sharp object like a nail on adhesive side do not use detergents chemicals or soap 4 Dry the pads and let the adhesive surface air dry completely do not wipe with a tissue paper or cloth CAUTION n The life of pads may vary by the frequency of washing skin condition and storage state n If the pad no longer sticks to your skin or the...

Страница 27: ... the electrodes n Always use electrodes that have been cleared for marketing in the US by the FDA n Always clean the electrodes after your treatment every time Storing the electrode pads Place clean dry pads on the plastic film and then store in the sealed package between uses Storing the unit n Place the unit electrodes and manual back in package Store the box in a dry place 14 F 131 F 10 C 55 C ...

Страница 28: ...5 RH 700hPa 1060hPa n Storage and transport conditions main device 14 F 131 F 10 C 55 C 10 RH 90 RH 700hPa 1060hPa n Size 14 17 L x2 32 W x0 45 H main device 4 53 L x2 09 W x0 98 H Remote control n Weight 36g main device 65g Remote control n Service life of the device 2 years n Service life of electrode pads 30 times n Applied part Electrode n Size of electrode 2 in x 2 in n IP classification syst...

Страница 29: ...imum Output Powers 0dBm The ACRL 9100 device uses the one on one connection of BLE4 0 and our device as a peripheral responds to the APP s connection request passively establishing a one on one connection with the APP After the ACRL 9100 device connects to the APP the device will not be connected to other wireless devices or controlled After the APP connects to the peripheral device the APP will s...

Страница 30: ...r progress 1 low to 60 high Intensity is based upon your level of comfort Begin the first session with a low intensity and a short duration while learning how to operate Stop therapy session if pain has reduced or stopped If your pain does not improve and you become sore from over use refrain from treating those areas for 2 days If this issue reoccurs reduce the treatment time and intensity settin...

Страница 31: ...ain is it best for This therapy works best on acute pain because it is localized Acute pain is pain in one area for less than 3 months If you have chronic pain you may have pain in more than one area and for longer than 6 months Chronic pain may be compounded by other issues that this device cannot address Remember this device does not cure your pain or the original cause of the pain It provides t...

Страница 32: ...es Electrodes do not stick to skin well Replace with new electrodes Stimulation is uncomfortable Intensity is too high Decrease intensity Electrodes are too close together Reposition electrodes to be at least 2 inches apart Electrode active area size is too small Replace electrodes with ones that no less than 2 in Is the device being operated according to the manual Please check the manual before ...

Страница 33: ...e immediately Electrodes are not adhered to the skin properly Ensure the electrodes are securely adhered to the skin The electrodes are dirty Clean the electrodes according to description in this manual or replace with new electrodes The surface of the electrode is scratched Replace with new electrodes Output current stops during therapy The electrodes come off the skin Turn off the device and pla...

Страница 34: ...o the appropriate collection points Please contact the organization which is responsible for waste disposal in your area if you have any questions Type BF Applied Part Refer to instruction manual The first number 2 Protected against solid foreign objects of 12 5 mm Ф and greater The second number Protected against vertically falling water drops when enclosure tilted up to 15o Vertically falling dr...

Страница 35: ...ution this machine should not be used adjacent to or stacked with other equipment 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 Compliance The ACRL 9100 is intended for use in the electromagnetic environment specified below The ...

Страница 36: ...Complies Guidance and manufacture s declaration electromagnetic immunity The ACRL 9100 is intended for use in the electromagnetic environment specified below The user of ACRL 9100 should assure that it is used in such an environment Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 8 kV contact 15 kV air Floors should be wood concrete or ceramic t...

Страница 37: ...tal environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the ACRL 9100 requires continued operation during power mains interruptions it is recommended that the ACRL 9100 be powered from an uninterruptible power supply or a battery Power frequency magnetic fiel...

Страница 38: ... IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 6 GHz 3 V RMS outside the ISM band 6 V RMS in the ISM and amateur radio bands 10 V m Portable and mobile RF communications equipment should be used no closer to any part of the ACRL 9100 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separatio...

Страница 39: ...eople 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 wit...

Страница 40: ...ion If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the ACRL 9100 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m The ACRL 9100 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the ACRL 9100 can help prevent electromagn...

Страница 41: ...ansmitter 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 Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 KHz to 80 MHz 0 0...

Страница 42: ...talled and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference ...

Страница 43: ...rranty do not extend the warranty period for the device or for the replacement parts 3 The following is excluded under the warranty n n n n All damage due to improper treatment e g nonobservance of the user instruction n All damage due to repairs or tampering by the customer or unauthorized third parties Damage during transport from the manufacturer to the consumer or during transport to the retai...

Страница 44: ...Manufactured for Carex Health Brands Middleburg Heights OH 44130 A division of Compass Health Brands Tel 800 328 2935 customerservice carex com Copyright 2017 by Carex Health Brands ...

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