Zynex Medical NexWave User manual

NexWave
User’s Manual

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NexWave
Table of Contents
Contact Information / Customer Service / Supplies / Support 4
About the NexWave 5
Safety Information 6
Electrodes and Lead Wires Setup 9
Programming Instructions 12
Preprogrammed Modes 13
Controls 15
Operating Instructions 16
Protocols 17
Indications, Contraindications and Warnings 32
Precautions and Adverse Reactions 41
Troubleshooting 42
Specifications and Accessories 43
Electrodes, Batteries, Cleaning 44
Warranty 45

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Zynex Medical
Contact Information
CUSTOMER SERVICE 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 800-495-6670
303-703-4906
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 800-495-6695
303-347-9153
MAILING ADDRESS
Zynex Medical, Inc.
9555 Maroon Circle
Englewood, CO 80112
USA
EMAIL [email protected]
WEBSITE www.zynex.com
EUROPEAN REPRESENTATIVE
Zynex Europe
Faelledvej 1, Box 19 BDO
DK-5100 Odense C
Denmark

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About the NexWave
The NexWave is a multiple-mode stimulator which allows users a choice of treatment
options. This device incorporates Interferential Current (IFC), Transcutaneous
Electrical Nerve Stimulation (TENS), and Neuromuscular Electrical Stimulation
(NMES).
Interferential Current (IFC)
The left channel (channel 1) produces a signal at a frequency of 4000 Hz. A slightly
higher frequency (4001-4128 Hz) is produced by the right channel (channel 2). When
applied to the skin, the signals from the two channels “interfere” with each other, and
create a difference frequency which is felt during treatment. IFC therapy requires the
use of both channels (four electrodes).
Transcutaneous Electrical Nerve Stimulation (TENS)
TENS delivers electrical impulses through the skin in the range of 1-125 Hz. TENS
treatments can range from 10 minutes to many hours and can be applied as needed
for pain relief. Patients can use one or two channels (two or four electrodes) for TENS
therapy.
Neuromuscular Electrical Stimulation (NMES)
NMES delivers electrical impulses to muscle motor points at a frequency of 35 Hz. The
stimulation is set by the user at a level to cause muscle contraction. There are three
different programs to choose from and each program has a preset stimulation “On
Time” of 10 seconds. The “rest period” (no stimulation) varies from 10 seconds to 30
seconds depending on which program is used. The 10:10 program setting has a rest
period of 10 seconds, the 10:20 program setting has a rest period of 20 seconds, and
the 10:30 program setting has a rest period of 30 seconds. For all programs, the
stimulation ramp up time is 3 second and the ramp down is 1 seconds. Channel 1
and Channel 2 have the same “On” and “Off” Times and when used together will
operate simultaneously.
Important: This device must be ordered or prescribed by a licensed physician.

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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 NexWave is
classified as follows:
 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.
 Medical Device Directive (MDD) Classification
The NexWave a Class IIa medical device per the European Medical Device
Directive.
 Internally Powered Equipment
When the NexWave is powered by the internal, 9 VDC, MN1604, battery it is
classified as Internally Powered Equipment.
 Class II Medical Equipment
When powered by the external, 12 VDC, medical grade, power supply, the
NexWave is classified as Class II Medical Electrical (ME) Equipment. Note:
When the external power supply is connected to the NexWave device, the
power supply is considered part of the ME equipment.
 Electromagnetic Compatibility
Conforms to IEC 60601-1-2.
 Temperature
Operating temperature range: 0° - 40° C (32° - 104° F)
Storage temperature range: -20° - 70° C (-4° - 158° F)
 Water Ingress
Ordinary equipment. This device does not have protection against ingress
of water.
 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.

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Safety Information
 Mode of Operation
This device is suitable for continuous operation.
 Symbols
Safety symbols shown on this device above are defined below.
On/Off. This symbol indicates that the labeled switch electronically
cycles the DC power on and off for part of the equipment. Note: To
disconnect the external power supply, unplug the power cord of the
supplied AC adapter from the AC mains outlet.
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.

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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 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. Contact Zynex
Medical for factory re-calibration if necessary.

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Electrode Connector Plastic Backing
Electrode
IFC modality requires all 4 electrodes
(2 channels)
TENS and NMES modalities can use 2
electrodes (1 channel) or 4 electrodes
(2 channels)
NexWave
Electrode and Lead Wire Setup
Step 1 Open electrode package and remove electrodes from package. Keep
electrodes on plastic backing.
Note: Only Zynex Medical electrodes are approved for use with the
NexWave. P/N 300027 are provided standard. Sterile electrodes, P/N
300100, are optionally available (for U.S. only). See additional accessories
on page 43.
Step 2 Insert lead wire pin connectors into electrode connectors as shown below.
RED lead wire connectors on one side and BLACK lead wire connectors on
the other side.

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NexWave
Electrode and Lead Wire Setup (continued)
Step 3 Remove each electrode from the plastic backing and place on the
treatment site according to the type of modality selected.
Electrode Arrangement
When using the IFC modality, RED and BLACK lead wires must be placed
in a crisscrossed pattern as shown in the diagram below.
TENS or NMES:
Using both channels and crisscrossing the electrodes is
optional.
IFC
Crisscrossed Pattern
TENS or NMES
Up and Down Pattern