For questions call: 1-800-634-4350 Pads are for Single Patient Use Only. OmronHealthcare.
TABLE OF CONTENTS Introduction................................................................................................ 2 Safety Instructions............................................................................... 2 Intended Use......................................................................................... 2 Contraindication................................................................................... 3 Receiving and Inspection....................................................
Introduction Thank you for purchasing the Omron® AvailTM. Avail is a wireless, independent dual channel wearable electrotherapy device that is designed to alleviate chronic muscle and joint pain on multiple body locations. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology and microcurrent therapy through the simple, convenient control of the Omron TENS iOS or Android app. Premium, contouring pads allow for discreet and convenient placement on multiple pain locations on the body.
Introduction 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. Receiving 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.
Symbols Glossary For symbol information, visit: OmronHealthcare.com/symbols-glossary WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property. Type BF applied part. (Pads) Class II equipment. Catalogue number. Consult instructions for use.
Important Safety Information Do not place the pads near or on cancerous lesions, diseased skin, open wounds, rashes, swollen, red, infected or inflamed areas or skin eruptions such as phlebitis, thrombophlebitis and varicose veins. Warnings Keep this device and the pads out of the reach of infants, toddlers and children. Keep out of the reach of young children because the AC adapter cord could cause strangulation.
Important Safety Information Do not apply stimulation in the presence of electric monitoring equipment such as cardiac monitors and ECG alarms because the equipment may not operate properly when the device is in use. Do not place the charger within 6 inches (approx. 15 cm) to any person who is using pacemakers or implantable cardioverter defibrillators (ICDs). The charger emits electromagnetic fields, which may affect pacemakers or ICDs. Never bend or fold the pads.
Important Safety Information Cautions Use caution if you have a tendency to bleed internally, such as following an injury or fracture. TENS is not effective for pain of central origin, including headache. TENS is not a substitute for pain medications and other pain management therapies. Consult with your physician prior to using the device after a recent surgical procedure because stimulation may disrupt the healing process. TENS devices have no curative value.
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. Do not put the pad on your body where it cannot be reached by your own hand. Do not apply any lotion, cream or ointment to the pads. Do not place the storage case within 2 inches (approx.
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. • You should stop using the device and should consult with your physician if you experience adverse reactions from the device.
How the Device Works Recommended Session Time TENS therapy suggests that electrical stimulation therapy may work in several ways: Recommended 1 session 1. The gentle electrical pulses move through the skin to nearby nerves to block or shut out the pain message from reaching the brain from the source of the pain. 2. The gentle electrical pulses increase the production of the body’s natural pain killer, such as endorphins. 3.
Know Your Device Package Contents Devices Pads Storage Case and Pad Holder Large Pad = L Medium Pad = M Instruction Manual Charger 11 AC Adapter
Part Names And Functions on the Device Display of Indicator Lights Front Indication Indicator Lights green, orange, white and purple. Blinks green slowly (every 1 second) The power is turned on and waiting for pairing or connecting to smartphone. Power button Blinks green quickly (every 0.5 seconds) Before selecting the therapy setting. Lit green The device is connected to smartphone. Blinks orange Battery is being recharged. (When the battery is fully charged, the indicator light will go off.
Usage of Storage Case And Pad Holder Pad holder 1. Open the storage case. 2. Remove the pad holder from the storage case and plastic bag. 4. Place the pad holder back into the storage case. 3. Attach the pad to the pad holder. 5. Close the storage case. For more details, refer to “Storing the Pads on the Pad Holder” on page 30.
Part Names And Functions of the Omron TENS App Therapy Setting Screen 3 1 A 2 B 1 A Tap to make the first connected device active. You can select a treatment area that the first connected device will be placed. 2 B Tap to make the second connected device active. You can select a treatment area that the second connected device will be placed. Battery charge is full. I J A Battery charge is close to low. K B 4 5 6 7 Battery charge is about half full. 3 8 Screen design may be changed.
PART 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. 1 A 1 2 B 3 STEADY 2 4 (For iPhone) Tap to show the caption for app’s display. To close caption, tap “ ”. (For Android) 5 7 0 QUIT 10 29:41 20 6 3 Tap to switch view orientation. 4 Tap to change the mode. 5 Tap to decrease intensity.
Operating Instructions Preparing for Use Notes: • Once fully charged, the battery will last for approximately 6 uses at 1 time per day for 30 minutes. Once the battery has been depleted, it takes about 8 hours to charge. • If the device is not being used for more than 3 months, recharge it. • The battery may not be charged at all under extreme environmental conditions such as high heat or cold temperatures. Before using the device, inspect these items and ensure that: 1. The pads are not damaged. 2.
Preparing for Use 4. Once the battery is fully charged, unplug the AC adapter and remove the devices from the charger. STEP 1 - RECHARGING THE BATTERY (continued) 2. Insert the AC adapter into an outlet. Battery Life The rechargeable battery will last for up to 500 uses when fully charged and under the following conditions: new battery was fully charged and used one time per a day in normal temperatures. Battery life depends on usage and storage conditions.
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 the device. Do not remove the plastic film at this time. 1. Turn on the device, following the app instructions. 2. Confirm the device is paired successfully. When the device is successfully paired to the smartphone, there will be a steady green indicator light on the device. 1.
Get 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 area you are going to place the pad. Select the body part you want to treat.
Get Started with Your Therapy Removing the Plastic Film For the first time use, remove and discard the plastic film from the back of the pad. Step 2 – Pad Placement Clean and dry treatment area so it is free of all lotions, oils and sweat. The pad should be applied only to normal, intact, clean, healthy skin that is not experiencing any swelling or inflammation. Plastic film Before therapy, make sure that the pads stick to the skin.
Get Started with Your Therapy STEP 2 – PAD PLACEMENT (continued) LOWER BACK JOINT Place the pad on the lower back according to your pain. For optimal therapy, place the pad on the muscle of the lower back. Do not place the adhesive surface of the pad on the spine. (ELBOW) Place so that the pad is on either side of the joint with pain.
Get Started with Your Therapy STEP 2 – PAD PLACEMENT (continued) JOINT LEG (KNEE) Place so that the pad is above the knee or below the joint with pain. (CALF) Place so that the pad is on the calf where you feel pain.
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.
Get Started with Your Therapy NEVER APPLY THE PADS TO THESE BODY AREAS: Do not place the pads on or near the head, mouth or face. Do not place the pads over your neck 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.
Get Started with Your Therapy 2. Select your session time. Swipe vertically to select the time. TENS: 5 to 60 minutes MICROCURRENT: 30 to 180 minutes Step 3 – SELECTING A THERAPY 1. Tap “TENS” or “MICROCURRENT” to select a therapy. Select a therapy. TENS Notes: • If you have already saved favorite settings, “FAVORITE” is displayed. To use your favorite setting, tap it and select a setting. • If you selected “TENS”, you will then select a mode. Scroll through the list and select a mode.
Get Started with Your Therapy 9 MODES IN TENS AND MICROCURRENT Mode STEADY ACUPUNCTURE LIKE What does the therapy deliver? Continuous pulsations at the same rate. Low rate pulsations which mimic a massage. KNEAD Medium rate pulsations which mimic a massage. Low to medium rate tapping sensations. High rate to low tingling sensations, followed by tapping. With higher intensity, you may feel kneading or massage-like sensations. Low to medium rate tapping and pulsations.
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. • The session time starts to count down. • Tap “ ” to pause the session. Press it again to restart the session. • If you want to stop or interrupt the session, tap “QUIT”. • White light on the device blinks during the session. 0 10 20 QUIT 2.
Other App Features Dual Screen Function Diary Function To register your pain level in the pain diary: 1. Tap the “ ” icon in the menu bar. To change view orientation: 1. Tap the “ view. 2. Select a body part that is aching. 3. Select from the various face icons on the app screen, then tap “OK”. • To cancel the registration, tap “Cancel”. • To add multiple body parts, repeat this step. ” icon to change your smartphone screen to landscape 2.
How to Control And Reduce Your Pain When to Stop Using the Device? Stop using the device if you experience an adverse reaction (skin irritation/redness/burns, headache or other painful sensation) or if you feel any unusual discomfort. When Should a Session Start? Use AvailTM as soon as your pain begins. Start with one session. Recommended Duration of Use Start with one 30-minute session for TENS and MICROCURRENT. Always turn the device off with the pads still on your skin.
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. Never bend or fold the pads. Storage case Storage temperature 32 to 104 °F (0 to 40 °C), 30 to 80 % relative humidity. 3. Close the storage case.
Cleaning And Disposal 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. Cleaning the Device 1. Turn the device off. Cleaning the Pads When the pad has become dirty or soiled: 1. Remove the device from the pad before cleaning the pads. 2. Wipe the surface with a soft cloth moistened with water or a neutral detergent, then wipe the surface with a dry soft cloth to remove extra water.
Appendix Reset the Device Try step 1 if any of the following situations occur: • There is no response when the device’s power button is pressed. • You want to clear all the information stored in your device. • You changed the smartphone to new one. • You received another person’s device that was paired with his/her smartphone. To reset the device, follow the steps below: 1. Reset the Device Press the reset button on the back of the device. 2.
Troubleshooting If this happens... Possible causes... Try this solution... If this happens... Possible causes... Try this solution... The intensity is not felt. The intensity level is too weak. Are the pads stacked together or do pads overlap? Was TENS therapy selected? Check placement of pads. Refer to “Pad Placement” on page 20. If “MICROCURRENT” is selected, you will not feel any intensity. The device's power cannot be turned on.
Troubleshooting If this happens... Possible causes... Try this solution... If this happens... Possible causes... Try this solution... Power cut off during use.
Troubleshooting If this happens... Possible causes... Try this solution... If this happens... Possible causes... Try this solution... Unable to tap “START” button. The pad may be damaged. Is the device power on? The devices, the charger or the AC adapter may be damaged. Replace the pad. Connection failure. Had the device been connected with another smartphone? Refer to “Reset the Device” on page 32 and follow step 1-3. Reset button was pressed accidentally. Do the following steps: 1.
Troubleshooting If the issue is not resolved, follow the steps below. 1. Open the Omron TENS app. 2. Tap or . 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. 6. Send email. 7. Our support stuff will respond to your email as soon as possible. If you are not able to perform the above steps successfully, please contact us at 1-800-634-4350.
Accessories Large Pad (PMWPAD-L) Approx. 8.6" (W) × 3.3" (H) × 0.4" (D) (220 × 83.5 × 9.3 mm) Medium Pad (PMWPAD-M) Approx. 7" (W) × 3.1" (H) × 0.4" (D) (180 × 79.5 × 9.3 mm) To order, visit: OmronHealthcare.
Specifications Product Name Model # Power Source Rechargeable Battery Frequency PULSE Duration Maximum Output Voltage Power Control Operating Temperature, Humidity, Air Pressure (When using product) Transportation and Storage Between Uses Temperature, Humidity Temperature During Battery Charging AvailTM PM601 REF HV-F601T-Z AC adapter (INPUT AC 120 V, 60 Hz) 1 Lithium‑ion battery (3.7 V; Approx.
Specifications Wireless Communication Durable Period (Service Life) Auto Power Off To confirm the latest list of the compatible smartphones and OS, visit: OmronHealthcare.com Frequency range: 2.4 GHz (2400 - 2483.
Limited Warranty To obtain warranty service, contact Customer Service by calling 1-800-634-4350 for the address of the Inspection Center and shipping and handling charges that may apply. Enclose the Proof of Purchase. Include a letter, with your name, address, phone 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.
Limited Warranty This warranty provides you with specific legal rights, and you may have other rights that vary by jurisdiction. Because of special local requirements, some of the above limitations and exclusions may not apply to you. THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS, AND YOU MAY HAVE OTHER RIGHTS THAT VARY FROM STATE TO STATE (OR BY COUNTRY OR PROVINCE).
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.
Important Information Regarding Electro Magnetic Compatibility (EMC) • The medical devices should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is necessary, the medical device should be observed to verify normal operation in the configuration in which it will be used. • Do not use mobile (cellular) telephones and other devices, which generate strong electrical or electromagnetic fields, near the medical device.
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 CISPR 11 Group 1 The PM601 uses RF energy only for its internal function.
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, ESD (IEC 61000-4-2) Contact discharge: ±8 kV Air discharge: ±15 kV Contact discharge: ±8 kV Air discharge: ±15 kV The relative humidity should be at least 5 %.
Important Information Regarding Electro Magnetic Compatibility (EMC) Electromagnetic immunity IEC60601-1-2 Immunity test Voltage dips, short interruptions and voltage variations on power supply IEC 61000-4-11 Power frequency (50/ 60 Hz) magnetic field IEC 61000-4-8 IEC 60601 Test level Compliance level 0 % UT for 0.5 cycle 0 % UT for 0.
Important Information Regarding Electro Magnetic Compatibility (EMC) Electromagnetic immunity IEC60601-1-2 Immunity test Conducted RF IEC 61000-4-6 IEC 60601 Test level 3 V rms 150 kHz to 80 MHz 3 V rms 150 kHz to 80 MHz 6 V rms 6 V rms bands between 150 kHz to 80 MHz bands between 150 kHz to 80 MHz 10 V/m 80 MHz to 2.7 GHz 10 V/m 80 MHz to 2.
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).
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 Bluetooth® word mark and logos are registered trademarks owned by 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. and other countries. App Store is a service mark of Apple Inc. Android and the Google Play logo are trademarks of Google Inc. Manufactured for : OMRON HEALTHCARE Co., Ltd.
For questions call: 1-800-634-4350 Pads are for Single Patient Use Only. OmronHealthcare.
