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11. GUIDANCE AND MANUFACTURER’S DECLARATION

OMRON Total Power + Heat Information for Accompanying Documents in the Scope of

IEC60601-1-2:2014

Important information regarding Electromagnetic Compatibility (EMC)

PM800 conforms to IEC60601-1-2:2014 Electromagnetic Compatibility (EMC) standard.

Further documentation in accordance with this EMC standard is available at

OmronHealthcare.com/emc. Refer to the EMC information for PM800 on the website.

Содержание Total Power + Heat PM800

Страница 1: ...er Levels Warms Muscles Relieves Pain War War r W ms ms m Mus Muscle cle e cl c s s s s s HEAT Relieves Pain TENS INSTRUCTION MANUAL TENS Therapy Pain Relief Total Power HeatTM PM800 Pads are for Single Patient Use Only ENGLISH ...

Страница 2: ...9 1 KNOW YOUR DEVICE 10 2 PREPARATION 12 3 GET STARTED WITH YOUR THERAPY 16 4 HOW TO CONTROL AND REDUCE YOUR PAIN 27 5 MAINTENANCE 28 6 TROUBLESHOOTING 30 7 OPTIONAL ACCESSORIES 33 8 SPECIFICATIONS 34 9 FCC STATEMENT 35 10 LIMITED WARRANTY 36 11 GUIDANCE AND MANUFACTURER S DECLARATION 37 ...

Страница 3: ... 800 634 4350 before attempting to use this device Intended Use The OMRON Total Power Heat is intended for The relief of pain associated with sore or aching muscles of the lower back arms legs shoulder or foot due to strain from exercise or normal household work activities When used for the symptomatic relief and management of chronic intractable pain and relief of pain associated with arthritis u...

Страница 4: ...n that lack normal sensation Any area of pain with swelling or inflammation the condition may worsen DO NOT apply the pads over your neck because this may 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 the pads on the head the mouth or any area of the face DO NOT apply the pads near the heart ...

Страница 5: ...due to more sensitivity of the skin NEVER bend or fold the pads with gels The pad can ONLY be used with the gel If you have any serious illness consult with your physician before using this device For arthritis pain relief consult with your physician before using Combo Modes using heat The efficacy of TENS Heat combination therapy for arthritis pain relief has not been demonstrated The pad with ge...

Страница 6: ... fire or explosion do not throw into a fire apply heat puncture or crush use or leave in a high temperature environment CAUTION Indicates a potentially hazardous situation which if not avoided may result in minor or moderate injury to the user or patient or cause damage to the equipment or other property TENS is not effective for pain of central origin including headache TENS is not a substitute f...

Страница 7: ...EVER share the pads with another person DO NOT plug the cord into any device other than this device DO NOT move the pads to another location while the device is on DO NOT overlap pads or put them on top of each other because therapy may weaken or stop Gels may also stick together and cause the gels to be removed when separating DO NOT leave the pads attached to the skin after treatment DO NOT appl...

Страница 8: ...ore using Using this device after an extreme temperature change could lead to an improper operation OMRON recommends waiting for approximately 2 hours for the device to warm up or cool down when the device is used in an environment within the temperature specified as operating conditions after it is stored either at the maximum or at the minimum storage temperature For operating storage and transp...

Страница 9: ...at TENS therapy may work in several ways 1 Gentle electrical pulses move through the skin to nearby nerves to block or shut out the pain message from ever reaching the brain from the source of the pain 2 Gentle electrical pulses increase the production of the body s natural pain killers such as endorphins 3 Blood circulation improves as muscles contract and relax with the flow of the electrical st...

Страница 10: ...ual o Quick Start Guide Pad Placement Guide 1 2 Part Names and Functions on the Device Device AC Adapter Jack SET START button Press to set a mode or start therapy Cord Jack Intensity Button Set the intensity level according to your needs Press or for higher intensity Press or for lower intensity Power Button Press to turn the device on Press again to turn off Screen ...

Страница 11: ...utes Left of Therapy Pad symbol If the pad detaches will appear Battery symbol If the battery is low the Battery symbol will appear Intensity Level HEAT Cord with Pads Pads Cord plug Cord Gel Dark side 1 KNOW YOUR DEVICE ...

Страница 12: ... AC adapter jack on the device 2 Plug the AC adapter into an electrical outlet CAUTION DO NOT use any AC adapter other than the one provided in the packaging of this device Note Make sure not to place your device in a location where it is difficult to plug and unplug the AC adapter When charging the battery the Battery symbol flashes on the screen Charging When fully charged the symbol will flash ...

Страница 13: ...e is full Battery charge is about half full Battery is close to low Battery is depleted Battery Life Your device will last up to four 30 minute uses per charge depending on the use and the storage condition Battery lifespan Battery life depends on usage and storage conditions When fully charged the rechargeable battery will last for up to 500 uses when used one time per day in normal temperatures ...

Страница 14: ...s or a fire 2 Assemble gels For first time use remove the gels from the sealed plastic bag Note The pads and the gels must be used together for safety and effectiveness Clean and dry affected area so it s free of all lotions oils sweat 3 Place gels onto the pads Each gel has two plastic films Remove the non printed side of plastic films and place gels squarely onto the dark side of the pads Make s...

Страница 15: ...15 2 PREPARATION STORING THE PADS ON THE PAD HOLDER Remove the plastic film and place the adhesive side of the gel on either side of the pad holder Pad facing down Pad holder Adhesive side up ...

Страница 16: ... at least 1 inch 3 cm apart for optional results Therapy will not work with just one pad You MUST use two pads at the same time DO NOT overlap pads or put them on top of each other because therapy may weaken or stop Gels may also stick together and cause the gels to be removed when separating DO NOT apply any lotion cream or ointment to the pads or to your skin because the pads will not function p...

Страница 17: ...duction of electrical current into the chest may cause rhythm disturbances to your heart which could be lethal On both legs such as calves at the same time because cardiac disturbance may occur On the bottom of both feet at the same time because cardiac disturbance may occur Open wounds or rashes or over swollen red infected or inflamed areas or skin eruptions such as varicose veins phlebitis thro...

Страница 18: ...ER SESSION LOWER BACK Attach both pads on the lower back according to your pain Place pads on muscle of the lower back not on spine LOWER BACK Attach one pad below and above the region in pain both on same side 3 GET STARTED WITH YOUR THERAPY ...

Страница 19: ...re you feel pain JOINT ELBOW Attach pads on each side of the joint with pain LEG HIP THIGH Attach pads on each side of the area with pain JOINT KNEE Attach both pads above the knee or above and below the joint with pain 3 GET STARTED WITH YOUR THERAPY ...

Страница 20: ... as calves at the same time because cardiac disturbance may occur Outside Inside FOOT ANKLE Attach pads on the left for pain on the outside of your ankle foot Attach the pads on the right for pain on the inside of your ankle foot WARNING DO NOT apply the pads to the bottom of both feet at the same time because cardiac disturbance may occur ...

Страница 21: ...nt and back of your shoulder WARNING DO NOT apply the pads on both sides of the chest cavity simultaneously lateral or front and back DO NOT apply the pads 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 the pads near the heart ...

Страница 22: ...d on body parts or pains described in this manual or Quick Start Guide Pad Placement Guide Select the mode to treat your unique pain Therapies designed for Shoulder Lower Back Arm Leg What does the therapy deliver Series of low to high rate tapping pulsing kneading and massage like sensations Series of high to low rate tingling sensations followed by tapping With higher intensity you may feel knea...

Страница 23: ...s of medium to high rate tapping pulsing sensations Series of low rate tapping pulsing sensations Series of low rate tapping sensations Series of medium rate pulsing sensations to mimic massage Series of high rate pulsing sensations to mimic hands rubbing 3 GET STARTED WITH YOUR THERAPY ...

Страница 24: ...AT HEAT HEAT HEAT HEAT HEAT HEAT HEAT Combo Therapy delivers heat and TENS alternately for a total of 30 minutes of therapy TENS Therapy 15 min 30 min START TENS Therapy provides only TENS for 30 minutes Approximate pattern not exact 3 GET STARTED WITH YOUR THERAPY ...

Страница 25: ...nately HEAT lights orange during HEAT and the orange light goes off during TENS TENS therapy 1 Press or or or button after HEAT is visible 2 Press the SET START button after HEAT is no longer visible to select the TENS therapy Note All therapies automatically stop after 30 minutes To change therapies turn the device off then on again ...

Страница 26: ...e intensity level properly for my pain If the stimulation sensation becomes weaker or disappears increase the intensity until it is restored If the sensation is at all uncomfortable press or button to decrease the intensity Press or button for higher intensity Press or button for lower intensity How long does the therapy last The device automatically stops after 30 minutes We recommend a maximum o...

Страница 27: ... pain has reduced or stopped 1 session Max minutes session Max times day 30 minute 30 minutes 3 times per day automatic shut off CAUTION Possible Adverse Reactions DO NOT use to treat one region for extended periods of time more than 30 minutes per a session up to three times day or muscles in that region may become exhausted and sore When to stop using the device Stop using this device If you exp...

Страница 28: ... the cord around the pad holder Do not keep in areas subject to direct sunlight high or low temperatures humid areas near a fire vibration or shock Do not wrap the cord around the device because it may damage the cord WARNING NEVER bend or fold the pads with gels Keep this device out of the reach of infants toddlers and children Storage temperature 32 F to 104 F 0 C to 40 C 30 to 80 relative humid...

Страница 29: ... 1 800 634 4350 or going to OmronHealthcare com Cleaning the device 1 Turn the device off and disconnect the cord with pads from the device 2 Wipe the surface of the device with a soft cloth that has been moistened with water or neutral detergent then dry completely using a soft cloth Do not use chemicals such as thinner and benzene to clean the device Do not let water get into the internal area o...

Страница 30: ...ck at the bottom of the device The intensity is set too low Press or button The adhesive surface is damaged Replace the gel The battery is depleted Charge the battery fully The skin turns red or feels irritated The adhesive surface of gel is dirty Replace the gel The therapy duration is too long Shorten therapy to less than 30 minutes The two pads are not adhered to the body properly Refer to the ...

Страница 31: ... skin Shave the immediate area for proper gel adhesion The gels were stored under the high temperature high humidity or direct sunshine The gels are unable to be used because of the storage condition Replace both gels The device or the AC adapter is abnormally hot when charging the battery The device or the AC adapter may be damaged Unplug the AC adapter from the electrical outlet and the cord plu...

Страница 32: ...ed If the error is still displayed the cord may be broken damaged Replace the cord with pads E2 is displayed The cord is internally shortcircuited Stop using the device immediately and replace the cord with pads E3 is displayed There are errors in the device The device may be damaged Stop using the device immediately and contact 1 800 634 4350 E4 is displayed The device is being used outside of th...

Страница 33: ...33 7 OPTIONAL ACCESSORIES Gels 3 pairs PMGEL REF HV PAD 3Z To order visit OmronHealthcare com ...

Страница 34: ...10 to 95 RH Weight Approx 6 7 oz 190 g Outer Dimension Approx 4 1 W 4 1 H 1 1 D 103 mm 103 mm 29 mm Classification of ME equipment Internally powered ME equipment operating Class II charging IP classification Device IP 22 AC adapter IP21 Operation Mode Continuous operation Applied Part Type BF Pads Maximum temperature of the applied part Lower than 109 4 F 43 C Durable period Service Life Device 5...

Страница 35: ...armful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed 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 televi...

Страница 36: ...ne number and description of the specific problem Pack the product carefully to prevent damage in transit Because of possible loss in transit we recommend insuring the product with return receipt requested THE FOREGOING IS THE SOLE WARRANTY PROVIDED BY OMRON IN CONNECTION WITH THIS PRODUCT AND OMRON HEREBY DISCLAIMS ANY OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING IMPLIED WARRANTIES OF MERCHANTAB...

Страница 37: ...e of IEC60601 1 2 2014 Important information regarding Electromagnetic Compatibility EMC PM800 conforms to IEC60601 1 2 2014 Electromagnetic Compatibility EMC standard Further documentation in accordance with this EMC standard is available at OmronHealthcare com emc Refer to the EMC information for PM800 on the website ...

Страница 38: ...ALTHCARE Co Ltd 53 Kunotsubo Terado cho Muko Kyoto 617 0002 JAPAN Distributed by OMRON HEALTHCARE INC 1925 West Field Court Lake Forest IL 60045 U S A OmronHealthcare com 2019 OMRON HEALTHCARE INC Made in China ...

Страница 39: ...thcare helps you make positive lifestyle changes with innovative home health products that you can use safely and accurately at home OmronHealthcare com For questions 1 800 634 4350 Get general pain info OmronHealthcare com ...

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