Zynex Medical InWave User manual

InWave
User’s Manual

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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..................................... 17, 20, 23
Precautions and Adverse Reactions.................................................... 18, 21, 24
Troubleshooting...............................................................................................26
Specifications and Accessories........................................................................27
Care, Maintenance, and Disposal ....................................................................28
Warranty..........................................................................................................29

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Zynex Medical
Contact Information
CUSTOMER SERVICE 1-866-940-7030
Supplies: To order more probes 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 and
covered benefits for 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
USA
EMAIL [e-mail]
WEBSITE www.zynex.com

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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.
Stress Urinary 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 Urinary 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 Urinary 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 manner
mentioned above.
CAUTION: Federal Law (USA) restricts this device to sale by or on
the order of a physician or licensed health care practitioner.

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Safety Information
Equipment Classification
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:
Type BF Equipment
Type BF equipment 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.

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 VDC, MN1604, battery and
is classified as Internally Powered Equipment.
Electromagnetic Compatibility
Conforms to IEC 60601-1-2.
Environmental Conditions for Operation
Temperature: 10° - 40° C (50° - 104° F)
Relative Humidity: 30 - 75%
Atmospheric Pressure: 50 – 106 kPa
Altitude: 0 - 2500 m (0 - 8202 ft.)
Environmental Conditions for Transportation and Storage
Temperature: -20° - 70° C (-4° - 158° F)
Relative Humidity: 10 - 90%
Atmospheric Pressure: 50 – 106 kPa
Altitude: 0 - 2500 m (0 - 8202 ft.)
Water Ingress
Ordinary equipment. This device does not have protection against
ingress of water.

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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
Safety symbols shown on the device above are defined below.
On/Off. This symbol 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 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 part (vaginal probe) is Type BF (floating from ground)
offering the user a specific level of safety.

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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 agency or
recycling 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 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.

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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. 1 on page 10.
If needed, a small amount of water-based lubricant 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 physician. Note: Overuse
of lubricant can cause lack of stimulation, and lead to ineffective
treatment.
See the directions included with the probe for further information.
Note: Vaginal probes are for single patient use only.
CAUTION: Do not insert or remove the probe when the device
is on. The device must be turned off prior to insertion or removal
of the probe.

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Probe Setup (cont.)
Fig. 1

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Plug into
Probe
Connector
Step 3
Step 4
Probe Setup (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 page 15 to start treatment, or page 12 to program device.

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Programming Instructions
Turn the device on by pressing the black On/Off button.
1.
Select the desired Modality by pressing the “STRESS”, “URGE”, or
“MIX” button 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 until the desired treatment time is set on
the display.
The device is now ready to use.
Treatment
Timer Button
Modality
Buttons
On / Off
Button
Unlock
Button

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Preprogrammed Modes
Stress Urinary Incontinence (UI) Mode
Program Description
5/10 The pulse width is 200 µs, and the frequency is 50 Hz. The output signal
ramps up to the stimulation level set by the user in one second. The output
stays on for five seconds, then ramps down to a zero level in one second.
The output stays off for ten seconds. The cycle repeats for the duration of
the treatment time. The default treatment time is 15 minutes.
3/10 Similar to 5/10 program except the on time is three seconds.
5/5 Similar to 5/10 program except the off time is five seconds.
Urge UI Mode
Program Description
10/3 The pulse width is 200 µs, and the frequency is 12.5 Hz. The output signal
ramps up to the stimulation level set by the user in one second. The output
stays 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 minutes.
6/3 Similar to 10/3 program except the on time is only six seconds.
10/10 Similar to 10/3 mode except the off time is ten seconds.
Mixed UI Mode
Program Description
10:10 A 5/10 Stress program runs for ten minutes, followed by a ten minute 10/3
Urge program. This cycle repeats for the duration of the treatment time.
The default treatment time is twenty minutes.
5:5 Similar to 10/10 program except the 5/10 Stress program only runs for five
minutes and the 10/3 Urge program only runs for five minutes.
2:2 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.

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Controls
Channel 1 Intensity Control
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 Timer
Treatment Timer Button
Display

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Operating Instructions
Start Treatment:
Before starting treatment, the probe must be inserted in the vagina and the
probe connector must be plugged into the opening on the top of the device.
See pages 9-11 for instructions.
1. Turn InWave on by pressing the On/Off button.
2. Set the desired program using the Modality and Program buttons.
3. Increase the stimulation level by pressing the Intensity Up button until a
strong but comfortable stimulation level is felt.
4. Once the desired level of stimulation is set, the unit will automatically shut
off at the preset treatment time shown on the display. If the Treatment
Timer has 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 button.
Note: If “Check Connections!” message is displayed on the screen, see “Display Alerts”,
Page 16 and “Troubleshooting”, Page 26.
During Treatment:
Note: The user should assume a seated, reclined, supine or standing relaxed
position, depending upon preference and/or level of comfort.
IMPORTANT: Button controls lock out after 20 seconds of inactivity. To
unlock button controls, press the Unlock button.
Increase Intensity:
To increase intensity press the Up Intensity button until the desired level of
stimulation is felt.
Decrease Intensity:
To decrease intensity press the Down Intensity button until desired level of
stimulation is felt.

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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.

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Indications for Use
Stress UI Mode
Indications
The 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 adult females.
Contraindications
The InWave should not be used in the presence of the following:
Following recent surgical procedures when muscle contraction may
disrupt the healing process.
During menstrual cycle or pregnancy.
Irregular menstrual cycles.
Urinary or vaginal infection.
History or current symptoms of urinary retention.
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 dependent upon the load as well as the pulse width and
frequency of the output waveform. 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).
Maximum peak output voltage (500 Ω load) = 40 V
Maximum peak output current (500 Ω load) = 80 mA
Maximum peak output voltage (1 KΩ load) = 80 V
Maximum peak output current (1 KΩ load) = 80 mA
Maximum peak output voltage (2 KΩ load) = 100 V
Maximum peak output current (2 KΩ load) = 50 mA
Pulse width: 200 µs
Frequency: 50 Hz

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Warnings
Stress UI Mode
Warnings (Cont.)
Maximum RMS voltage (500 Ω load) = 4 V
Maximum RMS current (500 Ω load) = 8 mA
Maximum output power (500 Ω load) = 32 mW
Maximum RMS voltage (1 KΩ load) = 8 V
Maximum RMS current (1 KΩ load) = 8 mA
Maximum output power (1 KΩ load) = 64 mW
Maximum RMS voltage (2 KΩ load) = 10 V
Maximum RMS current (2 KΩ load) = 5 mA
Maximum output power (2 KΩ load) = 50 mW
A yellow LED indicator is provided next to the probe connector to show
that the unit is delivering energy for any non-zero value of stimulation
output (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.
Do not use this device in water.
Warning labels 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
practitioner.
This device should be kept out of the reach of children.

This device should only be used with the vaginal probe(s)
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.
Patients with implanted electronic devices, e.g., a cardiac pacemaker,
should not use this device unless advised by a physician.
Simultaneous connection of a patient to high frequency surgical equipment
may result in burns at the site of the vaginal probe and possible damage to
the stimulator.
Operations within close proximity (within one meter) of shortwave or
microwave therapy equipment may produce instability in the stimulation
output.

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Precautions
Stress UI Mode
Precautions (Cont.)
Do not use this device while under the influence of drugs or alcohol.
Do not insert or remove the vaginal probe 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 probe should not remain inserted into the vagina when the
unit is not in use.
This device should not be used while sleeping or when anything else has
been inserted into the vagina such as a diaphragm or tampon.
Adverse Reactions
Vaginal irritation is a potential 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 adjustments have been made by persons
authorized by Zynex Medical, Inc., and the device has been used in accordance
with the user’s manual. Repairs and technical safety tests shall only be
performed by authorized personnel.
SEE PAGE 7 FOR SYMBOL DEFINITION
Stimulation from the vaginal probe should not be applied transthoracically,
placed on the chest and the upper back, or from the vaginal probe crossing
over the heart as this may cause cardiac arrhythmias.
Stimulation from the vaginal probe should not be applied directly on the
eyes, covering the mouth, or on the front of the neck (particularly the carotid
sinus).

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Indications for Use
Urge UI Mode
Indications
The 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 adult females.
Contraindications
The InWave should not be used in the presence of the following:
Warnings
Output waveform/power information:
When delivering stimulation energy, the InWave in Urge UI mode is a
constant current output device. Therefore its output voltage, current, and
power are dependent upon the load as well as the pulse width and
frequency of the output waveform. 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).
Maximum peak output voltage (500 Ω load) = 40 V
Maximum peak output current (500 Ω load) = 80 mA
Maximum peak output voltage (1 KΩ load) = 80 V
Maximum peak output current (1 KΩ load) = 80 mA
Maximum peak output voltage (2 KΩ load) = 100 V
Maximum peak output current (2 KΩ load) = 50 mA
Pulse width: 200 µs
Frequency: 12.5 Hz
Following recent surgical procedures when muscle contraction may
disrupt the healing process.
During menstrual cycle or pregnancy.
Irregular menstrual cycles.
Urinary or vaginal infection.
History or current symptoms of urinary retention.