Zynex NexWave User's Manual

Contact Information

Zynex Medical, Inc.
9555 Maroon Circle
Englewood, CO 80112
USA

Phone: 1-800-495-6670
Fax: 1-800-495-6695
Internet: www.zynex.com
Email: info@zynex.com

European Representative:
Zynex Europe
Fælledvej 1, Box 19 BDO
DK-5100 Odense C
Denmark

About the NexWave

The NexWave is a multi-mode stimulator offering Interferential Current (IFC), Transcutaneous Electrical Nerve Stimulation (TENS), and Neuromuscular Electrical Stimulation (NMES).

• IFC: Uses two channels (four electrodes) with frequencies around 4000 Hz to create a difference frequency felt during treatment.
• TENS: Delivers electrical impulses (1-125 Hz) through the skin for pain relief, usable with one or two channels (two or four electrodes).
• NMES: Delivers electrical impulses (35 Hz) to muscle motor points, with preset 'On Time' and variable 'rest periods' (10, 20, or 30 seconds).

Important: This device must be prescribed by a licensed physician.

Safety Information

• The NexWave is classified as Type BF Equipment and Class II Medical Electrical Equipment when powered by the external supply.
• Operating temperature: 0° - 40°C (32° - 104° F)
• Storage temperature: -20°-70°C (-4° - 158° F)
• The device is not waterproof and should not be immersed in liquids.
• Do not use in the presence of flammable anesthetic mixtures.
• Symbols:
• On/Off: Electronically cycles DC power. Unplug AC adapter to disconnect from mains.
• General Warning: Follow manual warnings to prevent hazards.
• Refer to Manual: Read and understand all instructions before use.
• Type BF Equipment: Indicates a specific level of safety for applied parts.

Electrodes and Lead Wires Setup

1. Open electrode package and remove electrodes.
2. Insert lead wire pin connectors into electrode connectors: RED on one side, BLACK on the other.
3. For IFC, use all 4 electrodes in a crisscrossed pattern.
4. For TENS and NMES, 2 or 4 electrodes can be used. Crisscrossing is optional.

Electrode Placement Diagrams: Detailed diagrams illustrate electrode placement for various body parts and modalities (Radicular Back Pain-Sciatica, Lumbar Back, Muscle Spasm, Post-Operative Knee, Cervical/Upper Back, Thoracic Back, Foot, Ankle, Shoulder, Elbow, Lateral/Medial Knee, Anterior Knee, Wrist, Hip, Back of Leg).

Device Programming Instructions

1. Place electrodes on skin before turning on the device.
2. Turn device on using the On/Off button.
3. Select desired Modality (IFC, TENS, or NMES) by pressing the respective button.
4. Select the desired program by repeatedly pressing the modality button until the arrow points to it.
5. Set Treatment Timer by pressing the Treatment Timer button.

The device is now ready for use.

Operating Instructions

Start Treatment:

1. Ensure electrodes are placed and connected.
2. Turn on the NexWave using the On/Off button.
3. Increase intensity using the Channel 1 Up button until comfortable. Repeat for Channel 2 if applicable.
4. The unit will automatically shut off at the preset time. If 'No Timer' is set, manual shut-off is required.
5. To turn off manually, press the On/Off button.

During Treatment:

• Button controls lock after 20 seconds of inactivity. Press the Unlock button to re-enable controls.
• Increase Intensity: Press the Up Intensity button for the desired channel.
• Decrease Intensity: Press the Down Intensity button for the desired channel.

Display Alerts:

• Check Connections: Ensure lead wires and electrodes are properly attached. Refer to page 42 or contact Technical Support.
• Low Battery: Replace battery or connect AC adapter.
• Locked: Stimulation level and mode are locked. Press Unlock button.

Preprogrammed Modes

Interferential Current (IFC)

• Low-High: Channel 2 frequency sweeps between 4001-4128 Hz every 15 seconds; Channel 1 is fixed at 4000 Hz.
• Low: Channel 2 frequency sweeps between 4001-4010 Hz every 15 seconds; Channel 1 is fixed at 4000 Hz.
• Combo: A three-cycle program repeating over the treatment duration.
• Cycle 1: Low Mode
• Cycle 2: High Mode (Channel 2 sweeps 4064-4128 Hz)
• Cycle 3: Muscle Mode (Channels cycle on/off at 6-second intervals)

Transcutaneous Electrical Nerve Stimulation (TENS)

• Sweep: Frequency decreases from 125 Hz to 11 Hz (4 sec), then 10 Hz to 1 Hz (2 sec), then increases from 1 Hz to 10 Hz (2 sec), and finally 11 Hz to 125 Hz (4 sec). Pulse width varies accordingly.
• Low Frequency Modulation (Lmd): Frequency sweeps 66.7-100 Hz over 12 seconds; pulse width decreases to 150 µs when frequency increases and returns to 300 µs when frequency decreases.
• High Frequency Modulation (Hmd): Similar to Lmd, but with a 2-second frequency shift interval.

Neuromuscular Electrical Stimulation (NMES)

• 30:10: 10 seconds on, 30 seconds off, 35 Hz frequency, 480 µs pulse width, 3 sec ramp-up, 1 sec ramp-down.
• 20:10: Same as 30:10, but with a 20-second off time.
• 10:10: Same as 30:10, but with a 10-second off time.

Indications for Use

Interferential Current (IFC)

• Management and symptomatic relief of chronic intractable, post-traumatic, and post-surgical pain.

Transcutaneous Electrical Nerve Stimulation (TENS)

• Management and symptomatic relief of chronic intractable, post-traumatic, and post-surgical pain.

Neuromuscular Electrical Stimulation (NMES)

• Muscle re-education
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Maintaining or increasing range of motion
• Relaxation of muscle spasms

Contraindications

• Do not use on patients with a cardiac demand pacemaker.
• Do not place electrodes where current will be applied to the carotid sinus region or transcerebrally.
• Do not use for undiagnosed pain syndromes until etiology is established.

Warnings

• When using the external power supply, unplug the AC adapter from the outlet to disconnect from mains. Ensure the AC outlet is accessible.
• Avoid current densities exceeding 2 mA RMS/cm² and output exceeding 0.5 W/cm².
• Maximum stimulation settings vary by electrode size (e.g., 50 mA for 1" round electrodes).
• Output waveform/power information is provided for various loads and modes.
• The safety of IFC, TENS, and NMES devices during pregnancy has not been established.
• This device is not effective for pain of central origin (e.g., headache).
• Use only under physician supervision.
• This device offers symptomatic treatment, not a cure.
• Keep out of reach of children.
• May interfere with electronic monitoring equipment (ECG monitors/alarms).
• Long-term effects of chronic stimulation are unknown.
• Do not apply stimulation over carotid sinus nerves.
• Do not apply stimulation over the neck or mouth, as severe spasms may affect breathing.
• Do not apply stimulation transthoracically, as it may cause cardiac arrhythmias.
• Do not apply stimulation transcerebrally.
• Do not apply over swollen, infected, or inflamed skin areas, or near cancerous lesions.
• Simultaneous use with high-frequency surgical equipment may cause burns or damage.
• Operations near shortwave or microwave therapy equipment may cause instability.

Precautions and Adverse Reactions

Precautions

• Isolated cases of skin irritation may occur at electrode sites.
• Effectiveness depends on patient selection.
• Use caution with patients having heart problems or epilepsy.
• Use caution during pregnancy or with suspected/diagnosed heart problems or epilepsy.
• Use caution in cases of hemorrhage tendency, recent surgical procedures, over the menstruating/pregnant uterus, or areas with lack of normal sensation.
• Skin irritation or hypersensitivity may occur; try alternate conductive medium or electrode placement.
• Electrode placement and settings should follow physician guidance.
• Keep device out of reach of children.
• Use only recommended leads and electrodes.
• Do not use while driving, operating machinery, or during activities where involuntary muscle contractions could cause injury.

Adverse Reactions

• Skin irritation and burns beneath electrodes are potential adverse reactions.

Troubleshooting

Specifications and Accessories

Equipment Classification

• Type BF Equipment
• Medical Device Directive (MDD) Classification: Class IIa
• Internally Powered Equipment (battery)
• Class II Medical Equipment (external power supply)
• Electromagnetic Compatibility: Conforms to IEC 60601-1-2

Temperature

• Operating: 0° - 40°C (32° - 104° F)
• Storage: -20°-70°C (-4° - 158° F)

Water Ingress

• Ordinary equipment; no protection against water ingress.

Flammable Anesthetics

• Not suitable for use with flammable anesthetic mixtures.

Specifications

• IFC: Amplitude 0-50 mA, Frequencies 4000 Hz (Ch1), 4001-4128 Hz (Ch2), Modes Low-High, Low, Combo, Muscle Mode 64 Hz, Waveform Symmetrical biphasic.
• TENS: Amplitude 0-100 mA, Frequency 1-125 Hz, Pulse Width 120-300 µs, Modes Sweep, Low frequency Modulation, High frequency Modulation, Waveform Symmetrical biphasic.
• NMES: Amplitude 0-100 mA, Frequency 35 Hz, Pulse Width 480 µs, Modes 30:10, 20:10, 10:10, Waveform Symmetrical biphasic.
• Other: Treatment timer 10-90 min, Dimensions 2.9 x 4.6 x 1.0 in., Weight 5.8 oz.

Accessories

• Lead wires: 104203 (black), 104204 (gray)
• Electrodes: 300027 (2" round, pkg of 4), 300100 (2"x2" square, pkg of 4)
• Power supply: 200109 (100-240 VAC input, 12 VDC output)
• Battery: 130010 (9 V alkaline)

Warranty

The NexWave device is warranted against defects in material, workmanship, and structural integrity for five years from the original purchase date for normal domestic use. Zynex Medical, Inc. will replace the device at its discretion if used in a standard manner. Misuse or use contrary to instructions voids the warranty. Warranty is limited to replacement of defective parts. This warranty is valid only for the original purchaser and is non-transferable.

For warranty service, contact Technical Support.

Electrodes, Batteries, Cleaning

Electrodes and Skin Care

Proper skin care enhances comfort. Wash treatment areas with mild soap and water, rinse, and dry thoroughly. Remove excess body hair if necessary. Sterile electrodes may be required for some post-operative applications.

Battery Power

• Uses one 9 V alkaline battery.
• Replace battery when the icon appears on the display.
• Insert battery bottom first, then press contacts.
• The device operates normally even with reverse polarity.
• Remove battery for storage. Dispose of used batteries properly.

AC Adapter

• The NexWave can be powered by an AC adapter (Zynex P/N 200109, 100-240 VAC).
• When plugged in, the device uses AC power, not battery power.

Device Cleaning

• Clean the case and display window with a lightly dampened soft cloth or paper towel and mild soap.
• Allow the unit to dry thoroughly before use.
• Do not spray cleaning solutions directly onto the unit or immerse it in water.

Waste Electrical and Electronic Equipment (WEEE)

This product may contain hazardous substances and should be disposed of properly at a local waste collection or recycling facility 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 modifications are allowed.
• Preventative inspections are not required; factory testing ensures accuracy.