InWave User ManualRev 01.pub (Read-Only)
Contents
1. FAX NUMBER 1 800 495 6695 MAILING ADDRESS Zynex Medical Inc 9990 Park Meadows Drive Lone Tree CO 80124 6739 USA EMAIL info zynexmed com WEBSITE www zynexmed com About the n Wave 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 Stress Incontinence Treatment The output delivers electrical impulses at a frequency of 50 Hz which produce smooth even muscle contractions This type of stimulation exercises and strengthens the pelvic floor muscles which aids in the control of stress incontinence Stimulation can be set to 3 or 5 second duration with a resting period of 5 or 10 seconds between contractions Default treatment time is 15 minutes Urge Incontinence Treatment The output delivers electrical impulses at a frequency of 12 5 Hz which produce a series of short rapid contractions This type of stimulation aids in the relaxation of involuntary muscle contractions which cause urge incontinence Stimulation can be set to 6 or 10 second duration with a resting period of 3 or 10 seconds Default treatment time is 20 minutes Mixed Incontinence Treatment Mixed treatment modes consist of a 2 5 or 10 minute stress treatment followed by a 2 5 or 10 minute urge treatment This combination of stimulation types aids in both stress and urge incontinence in the manners mentioned above2. One 9 Volt alkaline battery is used to power the InWave The battery compartment on the back of the device opens by sliding the cover downwards Rechargeable batteries are not recommended since they have only a short usage time and cannot be charged while in the InWave Battery replacement is indicated by the battery icon in the display Replace with a new 9 Volt alkaline battery The InWave operates normally even if the 9 Volt battery is inserted with reverse polarity Please dispose of used batteries properly Device Cleaning The InWave case and display window can be cleaned by lightly applying mild soap to a damp soft cloth or paper towel and using it to wipe the surfaces clean Allow the unit to dry thoroughly before using Do not spray cleaning solutions directly onto the unit or immerse it in water or other liquids 25 InWave Warranty Information The InWave device is warranted to be free from defects in material workmanship and structural integrity when subjected to normal domestic use and service for five years after the original purchase During that time Zynex Medical Inc will repair or replace at its sole 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 Warranty obligations are limited to replacement or repair of defective parts and components at the option of Zynex Medical Inc This Warranty is on
3. Caution Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner Safety Information Equipment Classification As per the International Electrotechnical Commission standard IEC 60601 1 and the European standard EN 60601 1 Medical Electrical Equipment General Requirements for Basic Safety and Essential Performance the InWave is classified as follows e Type BF Equipment A Type BF piece of equipment is one that provides a particular degree of protection against electric shock particularly regarding allowable leakage current Type BF applied part is one that is floating above ground and is isolated from all other parts of the equipment e Medical Device Directive MDD Classification The InWave is a Class medical device per the European Medical Device Directive e Internally Powered Equipment The InWave is powered by an internal 9 VDC MN1604 battery so it is classified as Internally Powered Equipment e Electromagnetic Compatibility Conforms to IEC 60601 1 2 e Temperature Operating temperature range 0 40 C 32 104 F Storage temperature range 20 70 C 4 158 F e Water Ingress Ordinary equipment This device does not have protection against ingress of water e 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 ni
4. 22 Troubleshooting Problem Unit stays on even after treatment ends Cannot increase level from its current set ting Solution Hold Off button down for 2 seconds to shut unit off Otherwise unit will shut off automatically after 5 minutes of no stimulation Alternatively you can start a new treatment session after the last one ends Press and release Unlock button to unlock this safety feature Then increase stimulation to the desired level of intensity Intensity level is always locked after 20 seconds of key press inactivity Display shows Check Connections Electrode alarm Check to see that the sensor is properly inserted Remove and re insert the sensor if necessary to establish a better electrical contact Verify that the sensor is correctly connected to the lead wire and that the lead wire is correctly connected to the InWave Connect the bare metal pins of the lead wire together to short circuit the output If the electrode alarm ceases the problem is with the sensor connection integrity Removing and re inserting the sensor may establish a better electrical contact 23 InWave Specifications and Accessories Stress Incontinence Mode Amplitude Frequency Pulse Width Stress Modes On Time Off Time Ramp Up Time Ramp Down Time Waveforms Urge Incontinence Mode Amplitude Frequency Pulse Width Urge Modes On Time Off Time Ramp Up Time Ramp Dow
5. Users Manual InWave Table of Contents Contact Information Customer Service Supplies 4 A bout thie a a lev EE E EE E 5 Safety Information si u pu su sasan ade 6 Sensor and Lead Wire Sep necrosi 9 Programming Instructions 12 Preprogrammed 13 COMMONS a awas sma aa p Su u 15 Operating Instrucfi9BS L i S D E E T us 16 Indications Contraindications and Warnings 17 19 21 Precautions and Adverse Reactions 18 20 22 Troubleshooting issi a unu uyu huuu 23 Specifications and 24 Sensor Batteries and Cleaning nasa 25 Walttanty nai oii ates Hits oe ANG ae UR ie a ae 26 Zynex Medical Contact Information CUSTOMER SERVICE 1 866 940 7030 Supplies To order more electrodes or other accessories Technical Support Questions or problems with using your device Device Return Order a postage paid return envelope to return your device at no charge MAIN OFFICE 1 800 495 6670 Billing Questions Questions regarding insurance benefits covered benefits for Durable Medical Equipment DME or questions about an Explanation of Benefits form you received in the mail
6. ettings should be based on the guidance of the prescribing practitioner This device should be kept out of the reach of children This device should only be used with the leads and vaginal sensor recommended for use by the manufacturer This device should not be used while driving operating machinery or during any activity in which involuntary muscle contractions may put the user at risk of injury Caution should be exercised when this device is used by patients with pacemakers and heart rhythm problems Do not use this device while under the influence of drugs or alcohol Do not insert or remove the vaginal sensor while the device is ON Do not use this device while in the close proximity of wireless devices Use this device only as directed Do not immerse the unit in water or any other liquid The vaginal sensor should not remain inserted in the vagina when the unit is not in use This device should not be used while sleeping or when anything else is in the vagina such as a diaphragm or tampon Adverse Reactions Skin irritation and electrode burns are potential adverse reactions Safety References Zynex Medical Inc is only responsible for the safety reliability and function of the device when repairs and adjustments have been made by persons authorized by Zynex Medical Inc and the device is used in accordance with the user s manual Repairs and technical safety tests shall only be performed by authorized personnel
7. ly valid for the original purchaser of this product and will not be honored if the product ownership is transferred or is resold To obtain warranty service please contact Technical Support at the number listed on page 4 of this manual 26 ZYNEX 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 European Representative Zynex Europe Fealledvej 1 Box 19 BDO DK 5100 Odense C Denmark P N 300422 Rev 01 08 09 2012
8. ment Program 10 10 5 5 252 Description A 10 minute 5 10 Stress program is run followed by a 10 minute 10 3 Urge program This cycle repeats for the duration of the treatment time Default treatment time is 20 minutes A 5 minute 5 10 Stress program is run followed by a 5 minute 10 3 Urge program This cycle repeats for the duration of the treatment time Default treatment time is 20 minutes A 2 minute 5 10 Stress program is run followed by a 2 minute 10 3 Urge program This cycle repeats for the duration of the treatment time Default treatment time is 20 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 14 InWave Device Controls 88888 Ch1 88888 ma Total TXs Total Min Mixed A 10 8 1020 3 10 F 6 3 5 5 P 5 5 amp 2 2 88 min On Off On Off Stress Urge Check Connections Display Attach Lead Wire Here Turns Unit On Off Lead Wire Connector On Standby Button Cycles Through Programs S Adjusts Treat t Intensit yusts Lreatment intensity Program Select Button ly Ure 5 eUpand Down Button Unlocks Control Buttons o9 wes lt Unlock Button STRESS URGE MIX Modality Buttons Adjusts Treatment Times Treatment Timer Button 15 InWave Device Operating Instructions Start Treatme
9. n Time Waveform Mixed Incontinence Mode Amplitude Frequency Pulse Width Mix Modes On Time Off Time Ramp Up Ramp Down Waveforms Other Specifications Treatment timer Compliance meter Dimensions Weight Warranty Accessories Lead wire Sensor Battery 0 80 mA 50 Hz 200 useconds 5 10 3 10 5 5 3 or 5 seconds 5 or 10 seconds 1 second 1 second Symmetrical biphasic 0 80 mA 12 5 Hz 600 seconds 10 3 6 3 10 10 6 or 10 seconds 3 or 10 seconds 1 second 0 5 seconds Symmetrical biphasic 0 80 mA 12 5 Hz and 50 Hz 200 pseconds and 600 useconds 10 10 5 5 2 2 3 5 6 or 10 seconds 3 5 or 10 seconds 1 second 0 5 or 1 second Symmetrical biphasic 5 to 25 minutes in 5 minute increments Records total usage time in minutes and number of times used 2 9x 4 6 x 1 0 in 5 8 oz including battery 5 year manufacturer s warranty on materials and workmanship Accessories excluded 104204 lead wire gray 400015 vaginal sensor 130010 battery 9 Volt alkaline MN1604 24 InWave Sensor Batteries and Cleaning Sensor Use The InWave is intended to be used with a re usable vaginal sensor Before and after each use clean the sensor with mild soap and water and dry the sensor Store the sensor in a safe location when not in use Follow directions of the prescribing physician Note The vaginal sensors are for single patient use only Battery Power
10. nt Before starting treatment the sensor must be inserted and the lead wire must be connected to the InWave See pages 9 11 for instructions 1 Turn the InWave on by pressing the On Standby button once and set the desired program using the Modality and Program buttons 2 Increase the stimulation level by pressing the upper portion of the Intensity button until a strong but comfortable stimulation level is felt NOTE Output increases in 1 2 mA increments up to the 4 mA level then increases in increments of I mA 3 Once the desired level of stimulation is set the InWave will automatically shut off after the preset treatment time shown on the display If the Treatment Timer has been set to No Timer then the InWave will need to be shut off manually Refer to Programming Instructions on page 12 to adjust the Treatment Timer 4 To turn off the InWave manually press the On Standby button Note If Check Connections message is displayed on the screen see Display Alerts below During Treatment IMPORTANT Button controls lock after 20 seconds of inactivity To unlock button controls press the Unlock button Increase Intensity To increase the intensity press the upper potion of the Intensity button until the desired level of stimulation is felt Decrease Intensity To decrease the intensity press the lower portion of the Intensity button until the desired level of stimulation is felt Display Alert
11. ogramming Instructions Turn device on by pressing the black On Standby button 1 2 3 Select the desired Modality by pressing the STRESS URGE or MIX button once Press the or portions of the Program button until the arrow on the LCD is next to the desired program Press the Treatment Timer button until the desired treatment time is set on the screen The InWave is now ready to use On Standby Button Modality Buttons 25 Oo F Treatment Timer Button 12 InWave Preprogrammed Modes Stress Incontinence Treatment 50 Hz Frequency 200 uSecond Pulse Width Program 5 10 3 10 5 5 Description The output signal ramps up to the level set by the user over a period of 1 second The output stays on for the remainder of the 5 second on time then ramps down to zero over a period of 1 second The output stays off for the remainder of the 10 second off time This cycle repeats for the duration of the treatment time Default is 15 minutes The output signal ramps up to the level set by the user over a period of 1 second The output stays on for the remainder of the 3 second on time then ramps down to zero over a period of 1 second The output stays off for the remainder of the 10 second off time This cycle repeats for the duration of the treatment time Default is 15 minutes The output signal ramps up to the level set by the user over a period of 1 sec
12. ond The output stays on for the remainder of the 5 second on time then ramps down to zero over a period of 1 second The output stays off for the remainder of the 5 second off time This cycle repeats for the duration of the treatment time Default is 15 minutes Urge Incontinence Treatment 12 5 Hz Frequency 600 Second Pulse Width Program 10 3 6 3 10 10 Description The output signal ramps up to the level set by the user over a period of 1 second The output stays on for the remainder of the 10 second on time then ramps down to zero over a period of 0 5 seconds The output stays off for the remainder of the 3 second off time This cycle repeats for the duration of the treatment time Default is 20 minutes The output signal ramps up to the level set by the user over a period of 1 second The output stays on for the remainder of the 6 second on time then ramps down to zero over a period of 0 5 seconds The output stays off for the remainder of the 3 second off time This cycle repeats for the duration of the treatment time Default is 20 minutes The output signal ramps up to the level set by the user over a period of 1 second The output stays on for the remainder of the 6 second on time then ramps down to zero over a period of 0 5 seconds The output stays off for the remainder of the 3 second off time This cycle repeats for the duration of the treatment time Default is 20 minutes 13 Mixed Incontinence Treat
13. re there is a tendency to hemorrhage following acute trauma or fracture Following recent surgical procedures when muscle contraction may disrupt the healing process Over the menstruating or pregnant uterus Over areas of the skin which lack normal sensation Irregular menstrual cycles Urinary or vaginal infection History of urinary retention or current symptoms Warnings e The long term effects of chronic electrical stimulation are unknown e Safety has not been established for the use of the InWave during pregnancy e The device is capable of generating currents and voltages in excess of 10 mA RMS and 10 V RMS respectively A yellow LED indicator is provided next to the lead wire connector to show that the unit is delivering energy for any non zero value of stimulation output 0 5 to 80 mA e Discontinue use of this device in the event of pain or bleeding e Do not use this device in water e Do not insert the lead wires into a mains power supply 19 InWave Precautions and Adverse Reactions Urge Incontinence Mode Precautions Stimulation settings should be based on the guidance of the prescribing practitioner This device should be kept out of the reach of children This device should only be used with the leads and vaginal sensor recommended for use by the manufacturer This device should not be used while driving operating machinery or during any activity in which involuntary muscle contractions may pu
14. s Check Connections The lead wire and or the sensor may not be attached properly Check all connections and try again see page 23 If the problem persists call 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 16 InWave Indications for Use Stress Incontinence Mode Please read the InWave User s Manual before using the InWave pelvic muscle stimulator CAUTION Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner This device should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions Indications e The Zynex Medical InWave is intended to provide electrical stimulation and neuromuscular re education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress urge and mixed urinary incontinence in women Contraindications e This InWave should not be used in the presence of the following Where there is a tendency to hemorrhage following acute trauma or fracture Following recent surgical procedures when muscle contraction may disrupt the healing process Over the menstruating or pregnant uterus Over areas of the skin which lack normal sensation Irregular menstrual cycles Urinary or vaginal infection History of urinary retention or current symp
15. s directed Do not immerse the unit in water or any other liquid The vaginal sensor should not remain inserted in the vagina when the unit is not in use This device should not be used while sleeping or when anything else is in the vagina such as a diaphragm or tampon Adverse Reactions Skin irritation and electrode burns are potential adverse reactions Safety References Zynex Medical Inc is only responsible for the safety reliability and function of the device when repairs and adjustments have been made by persons authorized by Zynex Medical Inc and the device is used in accordance with the user s manual Repairs and technical safety tests shall only be performed by authorized personnel 18 InWave Indications for Use Urge Incontinence Mode Please read the InWave User s Manual before using the InWave pelvic muscle stimulator CAUTION Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner This device should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions Indications e The Zynex Medical InWave is intended to provide electrical stimulation and neuromuscular re education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress urge and mixed urinary incontinence in women Contraindications e This InWave should not be used in the presence of the following Whe
16. ses and conditions Indications e The Zynex Medical InWave is intended to provide electrical stimulation and neuromuscular re education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress urge and mixed urinary incontinence in women Contraindications e This InWave should not be used in the presence of the following Where there is a tendency to hemorrhage following acute trauma or fracture Following recent surgical procedures when muscle contraction may disrupt the healing process Over the menstruating or pregnant uterus Over areas of the skin which lack normal sensation Irregular menstrual cycles Urinary or vaginal infection History of urinary retention or current symptoms Warnings e The long term effects of chronic electrical stimulation are unknown e Safety has not been established for the use of the InWave during pregnancy e The device is capable of generating currents and voltages in excess of 10 mA RMS and 10 V RMS respectively A yellow LED indicator is provided next to the lead wire connector to show that the unit is delivering energy for any non zero value of stimulation output 0 5 to 80 mA e Discontinue use of this device in the event of pain or bleeding e Do not use this device in water e Do not insert the lead wires into a mains power supply 21 InWave Precautions and Adverse Reactions Mixed Incontinence Mode Precautions Stimulation s
17. t the user at risk of injury Caution should be exercised when this device is used by patients with pacemakers and heart rhythm problems Do not use this device while under the influence of drugs or alcohol Do not insert or remove the vaginal sensor while the device is ON Do not use this device while in the close proximity of wireless devices Use this device only as directed Do not immerse the unit in water or any other liquid The vaginal sensor should not remain inserted in the vagina when the unit is not in use This device should not be used while sleeping or when anything else is in the vagina such as a diaphragm or tampon Adverse Reactions Skin irritation and electrode burns are potential adverse reactions Safety References Zynex Medical Inc is only responsible for the safety reliability and function of the device when repairs and adjustments have been made by persons authorized by Zynex Medical Inc and the device is used in accordance with the user s manual Repairs and technical safety tests shall only be performed by authorized personnel 20 InWave Indications for Use Mixed Incontinence Mode Please read the InWave User s Manual before using the InWave pelvic muscle stimulator CAUTION Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner This device should only be used under medical supervision for adjunctive therapy for the treatment of medical disea
18. tact Zynex Medical for factory re calibration if necessary InWave Sensor and Lead Wire Setup Step 1 Open the sensor package and remove the sensor Remove the electrode wire from the packaging and unbundle the wire Note Only Zynex Medical sensors are approved for use with the InWave P N 400015 are provided standard Step 2 Insert the lead wire pin connectors into the sensor connectors as shown below Sensor Connections Lead Wire Step 3 InWave Electrode and Lead Wire Setup continued Insert vaginal sensor as shown below If needed a small amount of water based lubricant can be applied to the tip of the sensor to aid in insertion Initial placement of the vaginal sensor and selection of the treatment program should be performed under the guidance of a physician Note Overuse of a lubricant can cause lack of stimulation and lead to ineffective treatment In order to avoid treatment interruption it may be necessary to empty the bladder and bowels before starting a treatment session See the directions included with the sensor for further information Note The vaginal sensors are for single patient use only 229 Vagina Urethra xa Pelvic Floor 10 InWave Electrode and Lead Wire Setup continued Step 4 Plug the lead wire into the top of the device Step 5 Proceed to page 16 to start treatment or page 12 to program device Electrode Connector 11 InWave Device Pr
19. toms Warnings e The long term effects of chronic electrical stimulation are unknown e Safety has not been established for the use of the InWave during pregnancy e The device is capable of generating currents and voltages in excess of 10 mA RMS and 10 V RMS respectively A yellow LED indicator is provided next to the lead wire connector to show that the unit is delivering energy for any non zero value of stimulation output 0 5 to 80 mA e Discontinue use of this device in the event of pain or bleeding e Do not use this device in water e Do not insert the lead wires into a mains power supply 17 InWave Precautions and Adverse Reactions Stress Incontinence Mode Precautions Stimulation settings should be based on the guidance of the prescribing practitioner This device should be kept out of the reach of children This device should only be used with the leads and vaginal sensor recommended for use by the manufacturer This device should not be used while driving operating machinery or during any activity in which involuntary muscle contractions may put the user at risk of injury Caution should be exercised when this device is used by patients with pacemakers and heart rhythm problems Do not use this device while under the influence of drugs or alcohol Do not insert or remove the vaginal sensor while the device is ON Do not use this device while in the close proximity of wireless devices Use this device only a
20. trous oxide Safety Information e Mode of Operation This device is suitable for continuous operation Symbols InWave e wq Safety symbols shown on the device above are defined below P C On Standby This symbol indicates that the labeled switch electronically cycles the DC power on and off for part of the equipment General Warning Sign Follow warnings stated in the instruction manual to prevent potential hazards Refer to Instruction Manual Booklet The operator must read understand and follow all instructions in the accompanying document including all warnings cautions and precautions before using this medical device Type BF Equipment This symbol indicates that the patient applied parts electrodes are Type BF floating from ground offering the user a specific level of safety z Waste Electrical and Electronic Equipment WEEE This product may contain substances known to be hazardous to the environment or to human health It should be disposed of properly for example at your local waste collection administration or recycling plant and in accordance with local ordinances Service and Calibration 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 Con
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