Zynex Medical InWave User Manual
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Zynex Medical InWave User Manual

Multiple-mode stimulator
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Summary of Contents for Zynex Medical InWave

  • Page 1 InWave User’s Manual...
  • Page 2 This page intentionally left blank.

  • Page 3: Table Of Contents

    InWave Table of Contents Contact Information / Customer Service / Supplies / Support ......4 Description ...................... 5 Safety Information ................... 6 Probe Setup...................... 9 Programming Instructions ................12 Preprogrammed Modes ................... 13 Controls ......................14 Operating Instructions ..................15 Indications, Contraindications and Warnings ........

  • Page 4: Contact Information / Customer Service / Supplies / Support

    Durable Medical Equipment (DME) or questions about an Explanation of Benefits form you received in the mail FAX NUMBER 1-800-495-6695 MAILING ADDRESS Zynex Medical, Inc. 9990 Park Meadows Drive Lone Tree, CO 80124-6739 EMAIL info@zynexmed.com WEBSITE www.zynex.com...

  • Page 5: Description

    Description The InWave is a multiple-mode stimulator which allows users a choice of treatment options. The InWave causes muscle contractions which exercise and strengthen the pelvic floor muscles. The InWave requires no special skills, knowledge, or training. Simply follow the instructions given in this User’s Manual and by your therapist or doctor.

  • Page 6: Safety Information

    The InWave is a Class IIa medical device per the European Medical Device Directive.  Internally Powered Equipment The InWave is powered by an internal, 9 VDC, MN1604, battery and is classified as Internally Powered Equipment.  Electromagnetic Compatibility Conforms to IEC 60601-1-2.
  • Page 7  Flammable Anesthetics This device is not suitable for use in the presence of a flammable anesthetic mixture with air, or in the presence of a flammable anesthetic mixture with oxygen or nitrous oxide.  Mode of Operation This device is suitable for continuous operation. Symbols ...
  • Page 8 Do not remove the cover. There are no user serviceable parts. Refer all service to authorized personnel. No modification of the equipment is allowed.  No preventative inspections are required. Factory testing and calibration ensure equipment accuracy and response. Contact Zynex Medical for factory re-calibration if necessary.

  • Page 9: Probe Setup

    Probe Setup Step 1 Remove probe from package. Note: Only use probes approved by Zynex Medical that are compatible with the InWave. P/N 400024 is provided as a standard accessory. (Manufacturer’s P/N PR-03J) See Page 27 for optional probes. Step 2 Insert vaginal probe into the vagina as shown in Fig.
  • Page 10 Probe Setup (cont.) Fig. 1...
  • Page 11 Probe Setup (cont.) Verify that a battery has been inserted into the InWave, then plug the Step 3 probe connector into the top of the device. If necessary, insert battery according to the instructions on page 28. Step 4 Proceed to page 15 to start treatment, or page 12 to program device.

  • Page 12: Programming Instructions

    Programming Instructions Turn the device on by pressing the black On/Off button. Select the desired Modality by pressing the “STRESS”, “URGE”, or “MIX” button as instructed by your physician or healthcare practitioner. Press the Up or Down Program button until the arrow on the display is next to the desired program.

  • Page 13: Preprogrammed Modes

    Similar to 10/10 program except the 5/10 Stress program only runs for two minutes and the 10/3 Urge program only runs for two minutes.. The InWave should be used daily for 15 to 20 minutes per session, for 1 to 3 months, or as directed by a physician.

  • Page 14: Controls

    Controls Display Probe Connection Channel 1 Turns Unit On/Off On/Off Button Channel 1 Intensity Control Program Select Up and Down Button Up and Down Button Unlock Button Controls Unlock Button Stress, Urge, Mixed Modality Buttons Treatment Timer Treatment Timer Button...

  • Page 15: Operating Instructions

    See pages 9-11 for instructions. Turn InWave on by pressing the On/Off button. Set the desired program using the Modality and Program buttons. Increase the stimulation level by pressing the Intensity Up button until a strong but comfortable stimulation level is felt.
  • Page 16 Display Alerts: Check Connections: The probe may not be connected properly. Check all connections and try again (see page 26). If the problem persists, call Zynex Technical Support (see page 4). Low Battery: Replace the battery immediately. Locked: The stimulation level and mode cannot be changed until the Unlock button is pressed.
  • Page 17 The maximum peak voltage that the InWave can produce is 100 V (2 KΩ load). The maximum peak current that the InWave can produce is 80 mA (1 KΩ load). The maximum output power that the InWave can produce is 64 mW (1 KΩ load).
  • Page 18 (1 to 80 mA).  The long-term effects of chronic electrical stimulation are unknown.  Safety has not been established for the use of the InWave during pregnancy.  Discontinue use of this device in the event of pain or bleeding.
  • Page 19 Safety References Zynex Medical, Inc. is responsible for the safety, reliability, and function of the device only when repairs and adjustments have been made by persons authorized by Zynex Medical, Inc., and the device has been used in accordance with the user’s manual.

  • Page 20: Indications, Contraindications And Warnings

    The maximum peak voltage that the InWave can produce is 100 V (2 KΩ load). The maximum peak current that the InWave can produce is 80 mA (1 KΩ load). The maximum output power that the InWave can produce is 16 mW (1 KΩ load).

  • Page 21: Precautions And Adverse Reactions

    (1 to 80 mA).  The long-term effects of chronic electrical stimulation are unknown.  Safety has not been established for the use of the InWave during pregnancy.  Discontinue use of this device in the event of pain or bleeding.
  • Page 22 Safety References Zynex Medical, Inc. is responsible for the safety, reliability, and function of the device only when repairs and adjustments have been made by persons authorized by Zynex Medical, Inc., and the device has been used in accordance with the user’s manual.
  • Page 23 The maximum peak voltage that the InWave can produce is 100 V (2 KΩ load). The maximum peak current that the InWave can produce is 80 mA (1 KΩ load). The maximum output power that the InWave can produce is 64 mW (1 KΩ load).
  • Page 24 (1 to 80 mA).  The long-term effects of chronic electrical stimulation are unknown.  Safety has not been established for the use of the InWave during pregnancy.  Discontinue use of this device in the event of pain or bleeding.
  • Page 25 Safety References Zynex Medical, Inc. is responsible for the safety, reliability, and function of the device only when repairs and adjustments have been made by persons authorized by Zynex Medical, Inc., and the device has been used in accordance with the user’s manual.

  • Page 26: Troubleshooting

    Troubleshooting Problem Solution Unit stays on even Hold Off button down for two seconds to shut unit off. after treatment ends. Otherwise unit will shut off automatically after five minutes of no stimulation. Alternatively you can start a new treatment session after the last one ends. Cannot increase Press and release Unlock button to unlock this safety stimulation level from...

  • Page 27: Specifications And Accessories

    Specifications and Accessories Stress UI Mode Output Current: 0-80 mA (1 KΩ load, 20% accuracy) Frequency: 50 Hz (20% accuracy) Pulse Width: 200 µs (20% accuracy) Stress Programs: 5/10, 3/10, 5/5 On Time: 3 or 5 sec. (20% accuracy) Off Time: 5 or 10 sec.

  • Page 28: Care, Maintenance, And Disposal

    Remove the battery if the device will be inactive for greater than two weeks. The InWave operates normally even if the 9 V battery is inserted with reverse polarity. Dispose of properly in accordance with all local, federal and international regulations.
  • Page 29 Before disposing, to avoid the risk of biohazards, thoroughly disinfect probe by washing it with soap and water, rinsing it, and then drying. Dispose of properly in accordance with all local, federal and international regulations. Probes may also be returned to Zynex Medical or the distributor.

  • Page 30: Warranty

    During that time, Zynex Medical, Inc. will repair or replace, at its discretion, the InWave device that has been used in a standard manner. This warranty does not cover misuse or use contrary to the operating instructions supplied.
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  • Page 32 Manufactured by: Zynex Medical, Inc. 9990 Park Meadows Dr. Lone Tree, CO 80124 Phone: 1-800-495-6670 Fax: 1-800-495-6695 Internet: www.zynexmed.com Email: info@zynexmed.com P/N 300422, Rev. 2.1, 4/28/14...

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