Focus TENS Therapy for Knee PM710-M PM710-L Instruction Manual
Table of Contents Introduction 2 Safety Instructions.................................................................................................................2 Intended Use............................................................................................................................2 Receiving and Inspection....................................................................................................2 Symbols Glossary...............................................................
Introduction Thank you for purchasing the OMRON Focus TENS Therapy for Knee. Focus is a wearable, wireless TENS (Transcutaneous Electrical Nerve Stimulation) device that is designed to alleviate chronic, acute and arthritic pain. It delivers TENS technology through simple, convenient control. TENS is a safe and drug-free treatment for pain that has been used for over 40 years by medical professionals such as physical therapists and chiropractors.
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. Important Safety Information Read the Important Safety Information in this instruction manual before using this device. Follow this instruction manual thoroughly for your safety.
Important Safety Information • If your pain does not improve, becomes more than mild, or continues for more than five days, stop using the device and consult with your physician. • 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, which could be lethal.
Important Safety Information • DO NOT place the charger within 6 inches (approx. 15 cm) of any person who is using a pacemaker or implantable cardioverter defibrillator (ICD). The charger emits electromagnetic fields, which may affect pacemakers or ICDs. Battery Handling and Usage • To prevent the risk of overheating, fire or explosion: - DO NOT puncture, crush, disassemble or modify the device. - DO NOT throw the device into a fire.
Important Safety Information • Use caution if you have a tendency to bleed internally, such as following an injury or fracture. • Consult with your physician prior to using the device after a recent surgical procedure because stimulation may disrupt the healing process. • Use caution if stimulation is applied over the menstruating uterus. • Use caution if stimulation is applied over areas of skin that lack normal sensation.
Important Safety Information • DO NOT fasten the band too tight. • DO NOT use this device if the adhesive surface of the pad is damaged. • Ensure that this device has acclimated to room temperature before using. Using this device after an extreme temperature change could lead to improper operation.
How the Device Works The OMRON Focus is a wearable, wireless TENS device that provides relief of chronic, acute* and arthritic pain. Scientific theory suggests that electrical stimulation therapy may work in several ways: 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.
1. Know Your Device 1.1 Contents Device Knee Band M/ Knee Band L PM710-M: Knee Band M PM710-L: Knee Band L Soft Case AC Adapter HHP-AM01 Knee Pad Pad Holder Refer to sub-section 4.2 for instructions on how to use.
1.2 Part Names and Functions on the Device Front A B Back C D E F A Battery indicator Lights or flashes according to the battery status. Refer to sub-section 1.2.2. B Intensity level indicators Lights or flashes according to the intensity level or situation. Refer to sub-section 1.2.1. C Set the intensity level according to your needs. [Intensity] button Press [+] to increase intensity level. Press [-] to decrease intensity level. D [Power] button Press once to turn the device on.
1.2 Part Names and Functions on the Device 1.2.1 Intensity Level Indicators Indication Description The power is off. All indicators: off All indicators: flash 1st, 3rd, 5th indicators: flash On standby. Press [+] button to start your therapy. An error has occurred. Contact customer service. Refer to section 9. Refer to sub-section 3.2 for the description of intensity level indicators during treatment.
1.2 Part Names and Functions on the Device 1.2.2 Battery Indicator Indication Description Battery is close to low. Charge the battery. Flashes orange Lights orange, then the device turns off Battery is depleted. Charge the battery immediately. The battery is being charged. When it is fully charged, the indicator will go off.
2. Preparation 2.1 Charging Before using the device, inspect to ensure that: 1. The pad is not damaged. 2. The device is intact. 3. The AC adapter is not broken or damaged. • If you are using the device for the first time or the device has not been used for more than 3 months, charge the battery to full. • Once fully charged, the battery will last for approximately 10 uses (1 use: 30 minutes). Once the battery has been depleted, it takes about 8 hours to charge.
2.1 Charging 2 Plug the AC adapter into an electrical outlet. Electrical outlet 3 Note • Only use the AC adapter and charger provided with this device for charging. • Make sure not to place this device in a location where it is difficult to plug and unplug the AC adapter. Set the device on the charger to initiate charging. Battery indicator While charging the battery, the battery indicator on the right flashes orange. When the battery is fully charged, the battery indicator will go off.
2.2 Attaching the Device For first time use, remove the pad from the plastic bag and attach it to the device. Do not remove the plastic film on the back of the pad yet. Note: • To avoid damage, take care not to bend or damage metal connectors. 1 Put the connector of the pad through the band port. Metal connector Band port Pad Connector 2 3 4 15 Hook one side of the device onto the band. Attach the connector to the connection port and push the device until it clicks.
3. Using the Device 3.1 Attaching the Band Below Your Knee 1 2 Remove the protective sheet from the loop fastener. Remove the plastic films from the pad. For first time use, remove and discard the plastic film from the back of the pad. 3 Sit on a chair and bend your knee 90°.
3.1 Attaching the Band Below Your Knee 4 Align the device as shown in the following illustration. Place the band on your bare skin directly. Face the side with the indicator lights upward. Make sure the device is on the inside of your knee. If you attach the device on the left knee, align the mark “L” indicated on the band with the center of your knee. If you attach the device on the right knee, align the mark “R” indicated on the band with the center of your knee.
3.1 Attaching the Band Below Your Knee 5 Wrap the band below your knee, then attach the hook and loop fastener so that the band does not slip. Left Knee Placement Right Knee Placement Make sure the band is placed below your knee as shown in the following illustration. The device should be on the inside of your knee. This device stimulates the area preventing the knee pain, NOT the area you have pain. The stimulation prevents transmission of the pain and relieves it.
3.1 Attaching the Band Below Your Knee • • • • WARNING DO NOT use this device during vigorous exercise such as playing sports or climbing. DO NOT use this device in areas other than below the knee. Apply the pad ONLY to normal, intact, clean, healthy skin of adult patients. NEVER bend or fold the pad. NEVER APPLY THE PADS TO THESE BODY AREAS: • On or near the head, mouth or face.
3.2 Get Started with Your Therapy 1 Press the power button. 5 intensity level indicators on the left flash white. 2 Press the [+] button. The therapy will start at the lowest intensity level (1) and slowly increase by pressing the [+] button. You can select the intensity level by pressing the [+] or [-] button. Press the [+] button several times and find your most comfortable intensity level. If you press the [+] or [-] button once, the indicators on the left will flash for 2 seconds.
3.2 Get Started with Your Therapy Select intensity level from 1 - 20. Indicators change every 4 intensity levels. Intensity 20 19 Indicators (blink every 2 seconds) 5 indicators blink 18 Press the [+] button once to increase 1 intensity level. 17 16 15 4 indicators blink 14 13 12 11 3 indicators blink 10 Press the [-] button once to decrease 1 intensity level.
3.2 Get Started with Your Therapy 3 Start your therapy. 4 The session automatically stops after 30 minutes. To stop the session before 30 minutes, press the power button. The device will automatically turn off within 30 minutes when: • The battery is depleted. (The battery indicator will flash orange, then the power immediately turns off. Charge the battery fully.) • The pad has been removed from below your knee during the session. • The therapy has not started for more than 3 minutes.
4. Maintenance 4.1 Cleaning 4.1.1 Drying the Pad When the adhesive surface of the pad contains excess fluids such as sweat, dry it by following these instructions. Using the pad without drying it may cause peeling or shifting of the adhesive surface. Turn the device over and dry the adhesive surface of the pad. Air-dry it until moisture is gone (approximately 8 hours). • Avoid direct sunlight. • Drying the pad too long may cause adhesive strength to weaken. Store it immediately after drying.
4.1 Cleaning 3 Place the pad onto the pad holder to allow the adhesive surface to air-dry. • Do not wipe the adhesive surface with tissue or paper-based cloth. • If the adhesive surface is too wet, turn it over and let it air dry before placing the pad onto the pad holder. Pad holder 4.1.3 Cleaning the Band 1 2 Remove the device and pad from the band. Hand-wash and air-dry it in a shaded area. • • • • • Wash the band by hand according to the instructions indicated on the band.
4.1 Cleaning 4.1.5 When to replace the pad and band? • Replace the pad after 30 uses. The life of the pad may shorten due to your skin condition or the amount of perspiration that accumulates under the band while wearing it. If the adhesive surface peels off or slides or you feel that the treatment intensity has weakened, replace the pad immediately. • Replacing the band every 6 months is recommended. • To purchase a new pad or band, call 1-800-634-4350 or visit OmronHealthcare.
4.2 Storage In between uses, store the pad, band and device on the pad holder in the soft case. To extend the life of the pad, use and store properly. 1 Place the pad onto the pad holder. The pad can be placed onto either side of the pad holder. 2 • Make sure the device has been turned off. • Discard the plastic films that were removed from the pads prior to use. • The device, pad and band on the pad holder can be stored together. Pad holder Wrap the band around the pad holder.
5. Troubleshooting If any of the below problems occur, check to make sure that no other electrical device is within 12 inches (30 cm). If the problem persists, refer to the table below. Problem The intensity is not felt. The intensity level is too weak. The skin turns red or feels irritated. Possible cause Check placement of the pad. Refer to sub-section 3.1. Intensity is set too low. Press the [+] button. The adhesive surface is damaged. Therapy duration is too long.
5. Troubleshooting Problem The device cannot be charged. Possible cause Solution The AC adapter or the charger is not connected properly. Check to ensure that the AC adapter is properly connected to the charger. Check if the AC adapter is connected to an electrical outlet. Place the device properly on the charger. Make sure there are no foreign objects on the charger area. Under high heat or cold temperatures, the battery may stop charging and it may take more time to be fully charged.
5. Troubleshooting Problem Therapy does not start. Possible cause Refer to sub-section 3.1 and place correctly. Remove the device from the pad, then attach the device to the pad properly. Refer to sub-section 2.2. Plastic films have not been removed from the adhesive surface of the pad. The pad is damaged. Peel off the film from the adhesive surface of the pad. Plastic films have not been removed from the adhesive surface of the pad. The pad or your skin is wet. The adhesive surface is damaged.
6. Optional Accessories 6.1 Optional Accessories Knee Pad PMKNPAD HV-KNPAD-Z The same Knee Pad is used for either the Knee Band M or the Knee Band L. Knee Band M PMKBAND-M HV-KBAND-MZ 17.7'' (W) × 2.5'' (H) (450 mm × 64 mm) Band circumference: 12.5'' - 15'' (320 - 380 mm) Knee Band L PMKBAND-L HV-KBAND-LZ 20'' (W) × 2.5'' (H) (510 mm × 64 mm) Band circumference: 15'' - 17.7'' (380 - 450 mm) If the circumference of your knee is 15'' or greater, choose “Knee BAND L”.
6.2 Optional Accessories - How to Measure for Band Size Measure the circumference of your knee by following the steps below to select the appropriate band size for you. 1 Sit on a chair and bend your knee 90°. 90° 2 Measure the circumference that is two fingers (middle and forefinger) below your knee with a measuring tape. Make sure your knee is exposed when you measure the circumference. Refer to the illustration on the right.
7. Specifications Product name Model # Focus Power source AC adapter (INPUT AC 100-240 V, 50-60 Hz, 0.12-0.065 A) 1 Lithium‑ion battery (3.7 V; Approx. 295 mAh) Rechargeable battery Frequency Pulse duration Maximum output voltage Power control Operating conditions Transportation and storage between uses conditions Battery charging conditions Transportation conditions Weight Will last for 500 uses under the following conditions: new battery, fully charged, used 1 time/day in temperatures of 73.
7. Specifications Number of usable times per a charge Durable Period (Service Life) 10 uses (fully charged, 73.4 °F environment, intensity level 10, 30 minutes per a use) Auto Power Off The device power will automatically turn off when: • 30-minutes of therapy has been completed. • the therapy has not started within 3 minutes. • the pad has been removed from below your knee.
8. 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. This device complies with Part 15 and Part 18 of FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
9. Limited Warranty Your PM710 Focus is warranted to be free from defects in materials and workmanship appearing within 1 year from the date of purchase, when used in accordance with the instructions provided with the device. The pad is warranted to be free from defects in materials and workmanship appearing within 30 days from the date of purchase when the device is used in accordance with the instructions provided with the device. The above warranty extends only to the original retail purchaser.
10. Guidance and Manufacturer’s Declaration OMRON Focus Information for Accompanying Documents in the Scope of IEC60601-1-2:2014 Important information regarding Electromagnetic Compatibility (EMC) PM710-M and PM710-L 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 PM710-M and PM710-L on the website.
OMRON HEALTHCARE 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.
For questions, call: 1-800-634-4350 3144216-2B
