Omron Pocket Pain Pro PM400 Instruction Manual Download Page 34

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15. GUIDANCE AND MANUFACTURER’S DECLARATION

OMRON Pocket Pain Pro Information for Accompanying Documents in the Scope of

IEC60601-1-2:2014

Important information regarding Electromagnetic Compatibility (EMC)

PM400 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 PM400 on the website.

Summary of Contents for Pocket Pain Pro PM400

Page 1: ...INSTRUCTION MANUAL TENS Therapy Pain Relief Pocket Pain Pro PM400 Pads are for Single Patient Use Only All for Healthcare ENGLISH ...

Page 2: ......

Page 3: ... WARNINGS 7 5 HOW POCKET PAIN PRO WORKS 13 6 KNOW YOUR UNIT 14 7 ASSEMBLY STEPS 16 8 GET STARTED WITH YOUR THERAPY 18 9 HOW TO CONTROL AND REDUCE YOUR PAIN 23 10 CLEANING AND STORAGE 25 11 TROUBLESHOOTING 27 12 LIMITED WARRANTY 30 13 SPECIFICATIONS 31 14 FCC STATEMENT 33 15 GUIDANCE AND MANUFACTURER S DECLARATION 34 ...

Page 4: ...it for the first time Keep this instruction manual in a convenient place or store with the unit for future reference Keep your purchase receipt as proof of purchase for warranty coverage This box contains the following components Pocket Pain Pro Unit Electrode Cords 2 LONG LIFE PADS Pad Holder 2 AAA Batteries Instruction Manual Quick Start Guide Pad Placement Guide ...

Page 5: ...lder or foot due to strain from exercise or normal household and work activities When used for the symptomatic relief and management of chronic intractable pain and relief of pain associated with arthritis use the Mode 1 Arm Shoulder or Mode 3 Leg Foot of stimulation Environments of Use Clinics hospital and home environments Patient Population Adult ...

Page 6: ...ion visit OmronHealthcare com symbols glossary Contraindication Do not use this device 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 ...

Page 7: ... and Clinics Simultaneous connection of a patient to a high frequency surgical ME equipment may result in burns at the site of the stimulator electrodes and possible damage to the stimulator For Hospitals and Clinics operation in close proximity e g 1m to a shortwave or microwave therapy ME equipment may produce instability to the stimulator output DO NOT USE THIS UNIT UNDER THESE CONDITIONS Consu...

Page 8: ...ADS TO THESE BODY AREAS The head the mouth or any area of the face The neck or any area of the throat because this could cause severe muscle spasms resulting in closure of the airway difficulty in breathing or adverse effects on heart rhythm or blood pressure Near the heart or on genital area Both sides of the chest cavity simultaneously lateral or front and back or across your chest because the i...

Page 9: ...n before using this unit DO NOT ALTER THE UNIT Do not plug this cord into anything other than this unit No modification of this unit is allowed Use this unit only with the pads leads electrodes and accessories recommended by the manufacturer to avoid damage to the unit WARNINGS REGARDING THE PADS Apply pads to normal healthy dry clean skin of adult patients because it may otherwise disrupt the hea...

Page 10: ...ay also stick together and cause gel to be removed when separating Do not use pads after Exp date Do not apply pads with wet hands Do not leave pads attached to the skin after treatment Do not bend or fold pads because the gel may get damaged and it won t stick or function properly To avoid damage to the adhesive surface of the pads put the pads only on the skin or on the plastic pad holder provid...

Page 11: ...ing treatment Do not bend or pull the end of the cord When pulling out the cord from the unit hold the plug and pull Replace the cord when broken or damaged BATTERY Do not throw the batteries into a fire The batteries may explode Dispose of the unit batteries and components according to applicable legal regulations Unlawful disposal may cause environmental pollution Do not mix alkaline and mangane...

Page 12: ... electrical stimulation or electrical conductive medium gel Keep unit away from young children The unit contains small pieces that may be swallowed Immediately contact your physician Ensure that this device has acclimated to room temperature before using Using this device after an extreme temperature change could lead to an improper operation OMRON recommends waiting for approximately 2 hours for ...

Page 13: ... Stimulation has been used for over 40 years by medical professionals such as physical therapists and chiropractors Acute pain refers to sore or achy muscles due to strain from exercise or normal household and work activities How does it work Scientific theory suggests that electrical stimulation therapy may work in several ways 1 The gentle electrical pulses move through the skin to nearby nerves...

Page 14: ...tandard FEATURES 1 Five pre set modes Arm Shoulder Lower Back Leg Foot Knead Steady 2 Ten intensity levels 1 low to 10 high 3 Pair of pads durable re usable washable up to 150 uses Only use OMRON manufactured pads or cords with this unit 4 Automatic 15 minute shut off 5 The lights indicate what mode and intensity level the device is set 6 Battery Light lights up to remind you to replace the batter...

Page 15: ...de Mode Intensity Button Press Set Start to select the mode Select mode and intensity according to your needs If the battery is low battery light will light up Press once for ON and again for OFF If the pad detaches pad light will blink GET STARTED WITH YOUR THERAPY STEP 2 and the Back of Main Unit GET STARTED WITH YOUR THERAPY STEP 2 GET STARTED WITH YOUR THERAPY STEP 3 GET STARTED WITH YOUR THER...

Page 16: ... leakage STEP 1 INSERT BATTERIES Battery Cover 1 Turn the unit over and remove the battery cover using a hard object such as the tip of a pen thin screwdriver 2 Insert batteries Make sure the signs correspond when inserting batteries 3 Reinstall the battery cover STEP 2 ATTACH ELECTRODE CORD TO THE MAIN UNIT Attach the electrode cord plug to the bottom of the main unit 7 ASSEMBLY STEPS ...

Page 17: ...ds will not stick if the skin has too much hair We recommend shaving the area for effective treatment STEP 4 REMOVE AND DISCARD PLASTIC FILM FROM PADS For the first time use remove the clear plastic film from the back of the pad Discard the plastic film backing as well as the clear packaging STORING PADS ON PAD HOLDER Remove plastic film and put the sticky side of the pads on either side of the pa...

Page 18: ...kin or pads Do not share pads Before starting your therapy rate your pain from 1 low to 10 high This mental check gives you a basis you can compare to once the session is complete Attach both pads on the shoulder according to your pain Attach one pad on the front and on the back of your shoulder SHOULDER WARNING Do not use near the heart on both sides of the chest cavity or across your chest becau...

Page 19: ... HIP THIGH Attach both pads on either side of the area with pain CALF Attach both pads on the calf where you feel pain WARNING Pads should not be placed simultaneously on the calves of both legs Outside Inside 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 put the pads on the bottom of b...

Page 20: ...r button k Press the Up or Down button to choose 1 of the 5 modes Modes cannot be combined l Press the Set Start button to select the mode It will start the therapy at the intensity level of 1 Mode Press Set Start Button Mode Intensity Button Press Power Button Select a pain mode 1 Arm Shoulder 2 Lower Back 3 Leg Foot Select a massage like mode 4 Knead 5 Steady 8 GET STARTED WITH YOUR THERAPY ...

Page 21: ...Guide Pad Placement Guide Select the mode that feels right for your unique pain Therapies designed for Arm Shoulder Lower Back Leg Foot Mode Light and the Back of Main Unit What does the therapy deliver Series of low to high rate tapping pulsing kneading and massage like sensations Series of high rate to low tingling sensations followed by tapping With higher intensity you may feel kneading or mas...

Page 22: ...ess for lower intensity If the pad light is blinking the unit will automatically turn off after 30 seconds TROUBLESHOOTING What intensity level is my unit on Press the Up Down button to increase decrease the intensity The intensity light moves up down after pressing it once or twice as shown below Therefore the light may not move up down but the intensity level does increase decrease each time you...

Page 23: ...nit off with the pads still on Rate your pain to check your progress 1 low to 10 high Stop your therapy session if pain has reduced or stopped Press the Power button to continue therapy for another 15 minute session 1 session 15 minute automatic shut off Max minutes session 30 minutes Max times day 3 times CAUTION Excessive treatment and strong stimulation may cause muscular fatigue and may genera...

Page 24: ...annot address Remember this unit does not cure your pain or the original cause of the pain It provides temporary relief or reduction of pain so that you can control your life and activities better Before using check to make sure all components are working properly 1 Make sure the cord is not broken 2 Check that the pad adhesive sticks and is not damaged 3 The electrode cord connection is not broke...

Page 25: ...tely ten times for up to 150 uses Do not wash the pads too long or too frequently 4 Dry the pads and let the adhesive surface air dry completely Do not wipe with a tissue paper or cloth 5 Pads are replaceable and can be purchased when needed by calling 1 800 634 4350 or go to OmronHealthcare com The life of the pads may vary by how often you wash the pads the skin condition and how you store the p...

Page 26: ...it pads with electrode cords on pad holder Pad Placement Guide and Instruction Manual inside the original box Do not keep in areas subject to direct sunlight high or low temperatures humid area near to fire vibration or shock Storage temperature 32 F 104 F 0 C 40 C 30 80 relative humidity Do not keep in places that can be easily reached by children When not in use for a long period remove the batt...

Page 27: ...ug correctly into the jack at bottom of this unit Is the intensity setting getting weak Press the Up button Is the gel damaged Replace pad Are the batteries weak Replace both AAA batteries Is the intensity 1 Press the Up button The skin turns red or the skin feels irritated Is the adhesive surface of pads dirty or dry Wash adhesive surface of pads softly with your fingertips for about 3 seconds un...

Page 28: ...or Is your skin too wet Dry the pad or dry the skin The pad gel may be damaged Replace the pad Is there too much hair on your skin Shave the immediate area for proper pad adhesion Is the adhesive surface of pads dirty or dry Wash adhesive surface of pads softly with your fingertips for about 3 seconds under slow running cold water Are you using pad during perspiring Dry the pad placement area Have...

Page 29: ...d Peel off film on the adhesive surface of pads Is the cord properly connected to the main unit Connect cord plug correctly into the jack at the bottom of the main unit Is the adhesive surface of pads dirty or dry Wash adhesive surface of pads softly with your fingertips for about 3 seconds under slow running cold water If the above measures are not effective contact us at 1 800 634 4350 11 TROUBL...

Page 30: ...GIVES YOU SPECIFIC LEGAL RIGHTS AND YOU MAY HAVE OTHER RIGHTS THAT VARY FROM STATE TO STATE OR BY COUNTRY OR PROVINCE 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 MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE IMPLIED WARRANTIES AND OTHER TERMS THAT MAY B...

Page 31: ...F to 140 F 20 C to 60 C 10 to 95 RH 700 to 1060 hPa Weight Approx 2 6 oz 75 g incl batteries Outer Dimension Approx 3 W X 2 8 H X 0 9 D 75 X 70 X 22 mm Classification of ME equipment Internally powered IP classification IP 22 Operation Mode Continuous operation Applied Part Type BF Pads Durable period Service Life Device 5 years Pad 150 uses NOTE These specifications are subject to change without ...

Page 32: ...32 Accessories replacement parts To order OmronHealthcare com PMLLPAD L 3 x4 5 75 mm 114 mm PMLLPAD 2 5 x4 63 mm 102 mm 13 SPECIFICATIONS ...

Page 33: ...at 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 by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and recei...

Page 34: ...e of IEC60601 1 2 2014 Important information regarding Electromagnetic Compatibility EMC PM400 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 PM400 on the website ...

Page 35: ...ho Muko Kyoto 617 0002 JAPAN Distributed by OMRON HEALTHCARE INC 1925 West Field Court Lake Forest IL 60045 U S A For questions 1 800 634 4350 Get general pain info OmronHealthcare com 2019 OMRON HEALTHCARE INC Made in China HV F013 Z2 4616057 0A ...

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