Omron Avail PM601 Instruction Manual

Omron Avail PM601 Instruction Manual

Wireless dual channel tens

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Summary of Contents for Omron Avail PM601

  • Page 2: Table Of Contents

    Part Names And Functions on the Device ........12 Usage of Storage Case And Pad Holder ........... 13 Regulatory Compliance Information Part Names And Functions of the Omron TENS App ..... 14 FCC Statement .................. 42 Operating Instructions Important Information Regarding Electro Magnetic Compatibility (EMC) ................
  • Page 3: Introduction

    Nerve Stimulation) technology and microcurrent therapy through the understand these instructions or have any questions, contact 1-800- simple, convenient control of the Omron TENS iOS or Android app. 634-4350 before attempting to use this device. Premium, contouring pads allow for discreet and convenient placement on multiple pain locations on the body.
  • Page 4: Contraindication

    ANd INSpECTION Remove this device from the packaging and inspect all package contents for damage. If there is any damage, DO NOT USE and contact Omron Healthcare Customer Service at 1-800-634-4350. SAVE THESE INSTruCTIONS...
  • Page 5: Symbols Glossary

    SymBOLS gLOSSAry For symbol information, visit: OmronHealthcare.com/symbols-glossary Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. WArNINg Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to CAuTION the equipment or other property.
  • Page 6: Important Safety Information

    ImpOrTANT SAFETy INFOrmATION Do not place the pads near or on cancerous lesions, diseased skin, WArNINgS open wounds, rashes, swollen, red, infected or inflamed areas or skin Keep this device and the pads out of the reach of infants, toddlers and eruptions such as phlebitis, thrombophlebitis and varicose veins.
  • Page 7 ImpOrTANT SAFETy INFOrmATION Do not apply stimulation in the presence of electric monitoring Do not place the charger within 6 inches (approx. 15 cm) to any equipment such as cardiac monitors and ECG alarms because the person who is using pacemakers or implantable cardioverter equipment may not operate properly when the device is in use.
  • Page 8: Cautions

    ImpOrTANT SAFETy INFOrmATION CAuTIONS Use caution if you have a tendency to bleed internally, such as TENS is not effective for pain of central origin, including headache. following an injury or fracture. TENS is not a substitute for pain medications and other pain Consult with your physician prior to using the device after a recent management therapies.
  • Page 9 ImpOrTANT SAFETy INFOrmATION Clean or change the pad when it loses adhesion. Do not overlap or put the pads on top of each other because therapy may weaken or stop. Do not put any metal object, such as coin, clip or other metal on the charger. Do not leave the pads placed on the skin after treatment.
  • Page 10: Adverse Reactions

    ImpOrTANT SAFETy INFOrmATION AdVErSE rEACTIONS • You may experience skin irritation and burns beneath the stimulation electrodes applied to your skin. • You may experience headache and other painful sensations during or following the application of electrical stimulation near your eyes and to your head and face.
  • Page 11: How The Device Works

    HOW THE dEVICE WOrkS Recommended Session Time TENS therapy suggests that electrical stimulation therapy may work in several ways: Recommended Max minutes Max times per 1 session per session 1. The gentle electrical pulses move through the skin to nearby nerves TENS 30 minutes 60 minutes...
  • Page 12: Know Your Device

    kNOW yOur dEVICE pACkAgE CONTENTS Devices Pads Storage Case and Pad Holder Large Pad = L Medium Pad = M Instruction Manual Charger AC Adapter...
  • Page 13: Part Names And Functions On The Device

    pArT NAmES ANd FuNCTIONS ON THE dEVICE Display of Indicator Lights Indication Description Front Indicator Lights green, orange, white and Blinks green slowly The power is turned on and waiting for purple. (every 1 second) pairing or connecting to smartphone. Power button Blinks green quickly Before selecting the therapy setting.
  • Page 14: Usage Of Storage Case And Pad Holder

    uSAgE OF STOrAgE CASE ANd pAd HOLdEr Pad holder 1. Open the storage case. 3. Attach the pad to the pad 4. Place the pad holder back holder. into the storage case. 2. Remove the pad holder from the storage case and 5.
  • Page 15: Part Names And Functions Of The Omron Tens App

    NAmES ANd FuNCTIONS OF THE OmrON TENS App Therapy Setting Screen Tap to make the first connected device active. You can select a treatment area that the first connected device will be placed. Tap to make the second connected device active. You can select a treatment area that the second connected device will be placed.
  • Page 16 NAmES ANd FuNCTIONS OF THE OmrON TENS App Session Screen Tap to save your favorite therapy setting. When tapped, it will change to “ ”. “ ” indicates that this setting is not favorite. “ ” indicates that this setting is favorite.
  • Page 17: Operating Instructions

    1. Recharge the battery to full. 2. Install the Omron TENS app and open it. STEp 1 – rECHArgINg THE BATTEry 3. Turn on the device and pair it to your smartphone by using the app.
  • Page 18 1. Make sure the Bluetooth in your smartphone is turned on. ® • When the battery is fully charged, the indicator light will go off. 2. Download and install the free “Omron TENS” app on your smartphone. 3. Open the app on your smartphone. Charger...
  • Page 19 prEpArINg FOr uSE STEp 3 – pAIrINg THE dEVICE TO yOur SmArTpHONE STEp 4 – ATTACHINg THE dEVICE ONTO THE pAd For first time use, remove the pad from the sealed plastic bag and attach 1. Turn on the device, following the app instructions. the device.
  • Page 20: Get Started With Your Therapy

    STArTEd WITH yOur THErApy STEp 1 – SELECTINg A TrEATmENT ArEA Before Use • Open the Omron TENS app. • Confirm the device(s) is connected. • Make sure to always keep the smartphone near you during the session. Treatment Area Selection 1. Tap on one of the suggested locations to Select the body part you want to treat.
  • Page 21 gET STArTEd WITH yOur THErApy Removing the Plastic Film STEp 2 – pAd pLACEmENT For the first time use, remove and discard the plastic film from the back Clean and dry treatment area so it is free of all lotions, oils and sweat. of the pad.
  • Page 22 gET STArTEd WITH yOur THErApy STEp 2 – pAd pLACEmENT (continued) LOWEr BACk JOINT Place the pad on the lower back according to your pain. (ELBOW) For optimal therapy, place the pad on the muscle of the lower back. Do Place so that the pad is on either side of the joint with pain.
  • Page 23 gET STArTEd WITH yOur THErApy STEp 2 – pAd pLACEmENT (continued) JOINT (kNEE) (CALF) Place so that the pad is above the knee or below Place so that the pad is on the calf where you feel pain. the joint with pain.
  • Page 24 gET STArTEd WITH yOur THErApy STEp 2 – pAd pLACEmENT (continued) SHOuLdEr Place so that pad is on the shoulder where you feel pain. Do not place this device across your chest or near your heart because the introduction of electrical current into the chest may cause rhythm disturbances to your heart.
  • Page 25 gET STArTEd WITH yOur THErApy NEVER APPLY THE PADS TO THESE BODY AREAS: Do not place the pads on both sides Do not place the pads on or near of the chest cavity simultaneously the head, mouth or face. (lateral or front and back), or across your chest because the Do not place the pads over your introduction of electrical current...
  • Page 26 gET STArTEd WITH yOur THErApy 2. Select your session time. STEp 3 – SELECTINg A THErApy Select a session time. Swipe vertically to select the time. 1. Tap “TENS” or “MICROCURRENT” to Select a therapy. TENS: 5 to 60 minutes select a therapy.
  • Page 27 gET STArTEd WITH yOur THErApy 9 mOdES IN TENS ANd mICrOCurrENT Mode What does the therapy deliver? Mode What does the therapy deliver? STEADY Continuous pulsations at the same rate. Recommended for Joint Medium to high rate tapping. Followed by tingling and pulsations.
  • Page 28 gET STArTEd WITH yOur THErApy STEp 4 – STArTINg A SESSION 1. The session screen opens and then you can select your intensity level. • On the screen, tap “+” or “–” to increase or 29 : 41 decrease the intensity to a comfortable level. QUIT • The session time starts to count down.
  • Page 29: Other App Features

    OTHEr App FEATurES dIAry FuNCTION duAL SCrEEN FuNCTION To register your pain level in the pain diary: To change view orientation: 1. Tap the “ ” icon in the menu bar. 1. Tap the “ ” icon to change your smartphone screen to landscape 2.
  • Page 30: How To Control And Reduce Your Pain

    HOW TO CONTrOL ANd rEduCE yOur pAIN When Should a Session Start? When to Stop Using the Device? Use Avail as soon as your pain begins. Start with one session. Stop using the device if you experience an adverse reaction (skin irritation/redness/burns, headache or other painful sensation) or if you Recommended Duration of Use feel any unusual discomfort.
  • Page 31: After Daily Use

    AFTEr dAILy uSE STOrAgE ANd rEmOVINg 2. Place the pad holder onto the storage case. STOrINg THE pAdS ON THE pAd HOLdEr • In between uses, keep the pads on the pad holder in the pad case. • Do not keep the device in areas subject to direct sunlight, high or low temperatures, humid areas, near fire, vibration, or shock.
  • Page 32: Cleaning And Disposal

    CLEANINg ANd dISpOSAL Cleaning the Device With proper storage and use, you may extend the life of your pad to 30 uses. The life of the pads may vary due to skin and storage conditions. 1. Turn the device off. 2.
  • Page 33: Appendix

    • The device was lent to someone and it was returned to you after being used. 3. Reset the App Settings • The Omron TENS app is unresponsive even after it is reinstalled. 3-1. Open the Omron TENS app and tap to open the settings.
  • Page 34: Troubleshooting

    TrOuBLESHOOTINg If this happens... Possible causes... Try this solution... If this happens... Possible causes... Try this solution... The intensity is not Are the pads stacked Check placement of pads. The device's power Are the batteries Recharge the battery felt. together or do pads Refer to “Pad Placement”...
  • Page 35 TrOuBLESHOOTINg If this happens... Possible causes... Try this solution... If this happens... Possible causes... Try this solution... Power cut off during Is the battery charge Recharge the battery The adhesive side of The adhesive surface Replace the pad. use. extremely low? fully.
  • Page 36 Reset button was Do the following steps: The devices, the The devices, the Unplug the AC adapter pressed accidentally. 1. Open the Omron charger or the charger or the AC from the charger TENS app and tap AC adapter are adapter may be immediately.
  • Page 37 TrOuBLESHOOTINg If the issue is not resolved, follow the steps below. 1. Open the Omron TENS app. 2. Tap 3. Tap “Contact Us”. 4. Select an issue and type the detail of your problem. 5. Tap “Send E-mail”. Your email client app automatically opens.
  • Page 38: Accessories

    ACCESSOrIES Large Pad (PMWPAD-L) Medium Pad (PMWPAD-M) AC Adapter (HHP-AM01) Approx. 8.6" (W) × 3.3" (H) × 0.4" (D) Approx. 7" (W) × 3.1" (H) × 0.4" (D) (220 × 83.5 × 9.3 mm) (180 × 79.5 × 9.3 mm) To order, visit: OmronHealthcare.com...
  • Page 39 SpECIFICATIONS Product Name Avail Transportation -4 to 140 °F (-20 to 60 °C), Model # PM601 HV-F601T-Z Temperature, Humidity 10 to 90 % RH (non-condensing) Power Source AC adapter (INPUT AC 120 V, 60 Hz) Weight Device: Approx. 1.5 oz (42 g) 1 Lithium-ion battery (3.7 V;...
  • Page 40: Specifications

    SpECIFICATIONS To confirm the latest list of the compatible smartphones and OS, visit: Wireless Frequency range: 2.4 GHz (2400 - 2483.5 MHz) OmronHealthcare.com Communication Modulation: GFSK Effective radiated power: <20 dBm Durable Period Device: 5 years (Service Life) Pad: 30 times (30 minutes/use) Charger: 5 years AC adapter: 5 years Auto Power Off...
  • Page 41: Limited Warranty

    LImITEd WArrANTy To obtain warranty service, contact Customer Service by calling Your Avail device is warranted to be free from defects in materials 1-800-634-4350 for the address of the Inspection Center and and workmanship appearing within 1 year from the date of purchase, when used in accordance with the instructions provided.
  • Page 42 SOME STATES (COUNTRIES AND PROVINCES) DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS, SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU. OMRON SHALL NOT BE LIABLE FOR LOSS OF USE OR ANY OTHER SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT COSTS, EXPENSES OR DAMAGES. SOME...
  • Page 43: Regulatory Compliance Information

    rEguLATOry COmpLIANCE INFOrmATION FCC STATEmENT FCC CAUTION Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
  • Page 44: Important Information Regarding Electro Magnetic Compatibility (Emc)

    Nevertheless, special precautions need to be observed: • The use of accessories and cables other than those specified by OMRON, with the exception of cables sold by OMRON as replacement parts for internal components, may result in increased emission or decreased immunity of the device.
  • Page 45 ImpOrTANT INFOrmATION rEgArdINg ELECTrO mAgNETIC COmpATIBILITy (EmC) The PM601 is intended for use in the electromagnetic environment specified below. The customer or the user of the PM601 should assure that it is used in such environment. Electromagnetic emissions IEC60601-1-2 Emissions test Compliance Electromagnetic environment - guidance RF emissions...
  • Page 46 ImpOrTANT INFOrmATION rEgArdINg ELECTrO mAgNETIC COmpATIBILITy (EmC) Electromagnetic immunity IEC60601-1-2 Immunity test IEC 60601 Test level Compliance level Electromagnetic environment –guidance Electrostatic discharge, Contact discharge: Contact discharge: The relative humidity should be at least 5 %. ±8 kV ±8 kV (IEC 61000-4-2) Air discharge: Air discharge:...
  • Page 47 ImpOrTANT INFOrmATION rEgArdINg ELECTrO mAgNETIC COmpATIBILITy (EmC) Electromagnetic immunity IEC60601-1-2 Immunity test IEC 60601 Test level Compliance level Electromagnetic environment –guidance 0 % U 0 % U for 0.5 cycle for 0.5 cycle Mains power quality should be that of a typical home, 0 % U 0 % U commercial or hospital environment.
  • Page 48 ImpOrTANT INFOrmATION rEgArdINg ELECTrO mAgNETIC COmpATIBILITy (EmC) Electromagnetic immunity IEC60601-1-2 Immunity test IEC 60601 Test level Compliance level Electromagnetic environment –guidance Portable and mobile RF communications equipment should be used no closer to any part of the PM601 including cables, than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter.
  • Page 49 ImpOrTANT INFOrmATION rEgArdINg ELECTrO mAgNETIC COmpATIBILITy (EmC) Electromagnetic immunity IEC60601-1-2 Immunity test IEC 60601 Test level Compliance level Electromagnetic environment –guidance 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 meters (m).
  • Page 50 ImpOrTANT INFOrmATION rEgArdINg ELECTrO mAgNETIC COmpATIBILITy (EmC) Recommended separation distance between portable and mobile RF communications equipment and the PM601 The PM601 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customers or the users of the PM601 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PM601 as recommended below, according to the maximum output power of the communications equipment.
  • Page 51 ® Bluetooth SIG, Inc. and any use of such marks by OMRON HEALTHCARE Co., Ltd. is under license. Other trademarks and trade names are those of their respective owners. Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S.
  • Page 52 For questions call: 1-800-634-4350 Pads are for Single Patient Use Only. OmronHealthcare.com 3125420-0E...

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