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InWave

User’s Manual

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Summary of Contents for InWave

Page 1: ...InWave User s Manual...

Page 2: ...This page intentionally left blank...

Page 3: ...ormation 6 Probe Setup 9 Programming Instructions 12 Preprogrammed Modes 13 Controls 14 Operating Instructions 15 Indications Contraindications and Warnings 17 20 23 Precautions and Adverse Reactions...

Page 4: ...urn envelope to return your device at no charge MAIN OFFICE 1 800 495 6670 Billing Questions Questions regarding insurance benefits and covered benefits for Durable Medical Equipment DME or questions...

Page 5: ...a resting period of 5 or 10 seconds between contractions Default treatment time is 15 minutes Urge Urinary Incontinence Treatment The output delivers electrical impulses at a frequency of 12 5 Hz whic...

Page 6: ...pment Medical Device Directive MDD Classification 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...

Page 7: ...mbol indicates that the labeled switch electronically cycles the power on and off General Warning Sign Follow warnings stated in the instruction manual to prevent potential hazards Refer to Instructio...

Page 8: ...ycling plant and in accordance with local ordinances See page 28 for disposal instructions Service and Calibration Do not remove the cover There are no user serviceable parts Refer all service to auth...

Page 9: ...ubricant should be applied to the tip of the probe to aid in insertion Initial placement of the vaginal probe and selection of the treatment program should be performed under the guidance of a physici...

Page 10: ...10 Probe Setup cont Fig 1...

Page 11: ...cont Verify that a battery has been inserted into the InWave then plug the probe connector into the top of the device If necessary insert battery according to the instructions on page 28 Proceed to p...

Page 12: ...ton as instructed by your physician or healthcare practitioner 2 Press the Up or Down Program button until the arrow on the display is next to the desired program 3 Press the Treatment Timer button un...

Page 13: ...ys on for ten seconds then ramps down to a zero level in 0 5 second The output stays off for three seconds The cycle repeats for the duration of the treatment time The default treatment time is 15 min...

Page 14: ...trol Up and Down Button Program Select Up and Down Button Probe Connection Channel 1 Turns Unit On Off On Off Button Stress Urge Mixed Modality Buttons Unlock Button Controls Unlock Button Treatment T...

Page 15: ...s been set to No Timer then the device will need to be shut off manually Refer to Programming Instructions on page 12 to adjust the Treatment Timer 4 To turn off the device manually press the On Off b...

Page 16: ...ected 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...

Page 17: ...ntion Warnings Output waveform power information When delivering stimulation energy the InWave in Stress UI mode is a constant current output device Therefore its output voltage current and power are...

Page 18: ...els are legible from a distance of 30 cm or less at a 90 angle or less and at 500 lux or greater luminous intensity Precautions Stimulation settings should be based on the guidance of the prescribing...

Page 19: ...ial adverse reaction Discontinue use at any sign of vaginal irritation Safety References Zynex Medical Inc is responsible for the safety reliability and function of the device only when repairs and ad...

Page 20: ...e pulse width and frequency of the output waveform The maximum peak voltage that the InWave can produce is 100 V 2 K load The maximum peak current that the InWave can produce is 80 mA 1 K load The max...

Page 21: ...els are legible from a distance of 30 cm or less at a 90 angle or less and at 500 lux or greater luminous intensity Precautions Stimulation settings should be based on the guidance of the prescribing...

Page 22: ...al adverse reaction Discontinue use at any sign of vaginal irritation Safety References Zynex Medical Inc is responsible for the safety reliability and function of the device only when repairs and adj...

Page 23: ...pulse width and frequency of the output waveform The maximum peak voltage that the InWave can produce is 100 V 2 K load The maximum peak current that the InWave can produce is 80 mA 1 K load The maxim...

Page 24: ...ls are legible from a distance of 30 cm or less at a 90 angle or less and at 500 lux or greater luminous intensity Precautions Stimulation settings should be based on the guidance of the prescribing p...

Page 25: ...ial adverse reaction Discontinue use at any sign of vaginal irritation Safety References Zynex Medical Inc is responsible for the safety reliability and function of the device only when repairs and ad...

Page 26: ...button to unlock this safety feature Then increase stimulation to the desired level intensity Intensity level is locked after twenty seconds of inactivity Display shows Check Connections The probe is...

Page 27: ...gular biphasic with zero DC current Mixed UI Mode Amplitude 0 80 mA 1 K load 20 accuracy Frequency 12 5 and 50 Hz 20 accuracy Pulse Width 200 s 20 accuracy Mix Modes 10 10 5 5 2 2 On Time 3 5 6 or 10...

Page 28: ...The battery compartment on the back of the device opens by sliding the cover downwards Low Battery is indicated by the battery icon in the display Replace with a new battery Remove the battery if the...

Page 29: ...erse the probe in water Dry the probe and store it in a safe location Before disposing to avoid the risk of biohazards thoroughly disinfect probe by washing it with soap and water rinsing it and then...

Page 30: ...device that has been used in a standard manner This warranty does not cover misuse or use contrary to the operating instructions supplied Warranty obligations are limited to replacement or repair of d...

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Page 32: ...Zynex Medical Inc 9990 Park Meadows Dr Lone Tree CO 80124 USA 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 Manufactured by...

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