MEND Technology Wellness User manual

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MEND WellnessTM (IS02LCDs)
User’s Manual
Ver 1.7 2020.11.15

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Technical Support:
Website: https://www.mendtechnology.com
Email: [e-mail]
Company Address:
MEND Technology
10117 SE Sunnyside Road Ste F40
Clackamas, OR 97015
Phone: [phone]
Fax: [phone]
© 2020 MEND Tech, LLC. All rights reserved. MEND Technology and the logo are the trademarks of
MEND Tech, LLC. Trademarks or registered trademarks are the property of their respective holders.
Software and specifications are subject to change without notice.

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Table of Contents
Introduction................................................................................................................5
Safety Precautions......................................................................................................5
Indications ..................................................................................................................5
Contraindications, Warning, Precautions, and Adverse Effects ............................6
Warranty and Service................................................................................................7
MEND Wellness Device and Accessories..................................................................8
Top Panel and Keypad.............................................................................................8
Rear Panel ................................................................................................................9
USB Port ...................................................................................................................9
Microcurrent Output Ports...................................................................................10
Accessories..............................................................................................................10
Operations ................................................................................................................11
Prepare for Operations..........................................................................................11
Install Batteries .................................................................................................11
Connect Wires to the MEND WellnessTM device...............................................11
Connect Wires to Gloves, Strips, or Electrodes ................................................12
Basic Operations ......................................................................................................12
Power ON................................................................................................................12
PROTOCOLS button - All, Recent, History, and Batch Protocols....................13
Select a Protocol .....................................................................................................13
To quickly jump to a protocol ...........................................................................14
To see details of a protocol................................................................................14
Run a Therapy Protocol / HOLD the timer .........................................................14
Pause the Therapy Protocol / SKIP a frequency pair .........................................15
Stop the Therapy Protocol.....................................................................................15
Turn on the Back Light .........................................................................................15
Turn Power OFF ....................................................................................................15
Advanced Operations and Display Information ...................................................16
Protocol Run Information and Status ..................................................................16
Make Run Time Changes ..................................................................................17
To change output current intensity µA..............................................................17
To HOLD the current frequency pair ................................................................17
To SKIP the current frequency pair...................................................................17
Batch Protocols.......................................................................................................17
To go into Batch Protocols................................................................................17
Select a slot .......................................................................................................17
Select a protocol for the slot..............................................................................17
Select from other protocols ...............................................................................18
Assign a protocol to the slot..............................................................................18
Select protocols for other slots ..........................................................................18
Remove a protocol from batch..........................................................................18
Run a batch of protocols ...................................................................................18
Skip a protocol in batch ....................................................................................18
Stop the batch....................................................................................................18
Settings – MAIN MENU..........................................................................................19
To change Settings ............................................................................................19

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To turn ON/OFF key beeping ...........................................................................19
To turn ON/OFF protocol end beeping .............................................................19
To change the OUTPUT Drive..........................................................................19
About.........................................................................................................................19
To go to About...................................................................................................19
Version ..............................................................................................................19
Battery Status ....................................................................................................19
Low Battery Indication .....................................................................................20
Disclaimer .........................................................................................................20
Maintenance & Troubleshooting ............................................................................20
Pre-Use Inspection ............................................................................................20
Sanitizing ..........................................................................................................21
Life of Service...................................................................................................21
Disposal ............................................................................................................21
Troubleshooting ................................................................................................21
Technical Manual .....................................................................................................22
Technical Specifications....................................................................................22

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Introduction
Congratulations on your purchase of the MEND WellnessTM (IS02LCDs) device. The
MEND WellnessTM is the most advanced two channel programmable transcutaneous
electrical nerve stimulator or "TENS" device currently available. MEND Technology
is a leading innovator and distributor of state-of-the-art medical devices.
The MEND WellnessTM is a high-end precision medical device used for the relief of
pain. This device generates low intensity current pulses at microampere levels and
frequency of pulses. Your licensed health care practitioner is able to program
frequency pairs with a variety of parameters including current intensity, frequency,
time, modulated wave period, wave slope, and polarity.
The MEND WellnessTM is a small, portable device that is designed for use in a doctor's
office, clinic or hospital as well as self-administered treatment at home under your
practitioner’s supervision.
Please read this entire manual thoroughly before using it.
CAUTION
Federal Law (USA) restricts this device to sale by or on the order of a
licensed health care practitioner.
Safety Precautions
•The device is designed to be applied to the human body. It can be used
externally only.
•The device has micro amperage current output. The plugs must be inserted
completely into the jacks. The patient may experience prickling sensation if the
skin contact is too dry.
•Use alkaline batteries only. It cannot be connected to external power source.
Any attempt to do so would cause damage of the device and possibly cause
harm to the patient.
•Do not immerse the device into water. Do not use the device close to flammable
mixtures or concentrated flammable fumes such as gasoline.
•The device can only be opened and repaired by the manufacturer.

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Indications
The MEND WellnessTM is intended for the symptomatic relief of chronic intractable
pain. The degree of efficiency will vary with patient selection.
Contraindications, Warnings, Precautions, and Adverse
Effects
CONTRAINDICATIONS
Do not use MEND WellnessTM:
-on patients who have a demand type pacemaker or any other implanted
electronic device that cannot be turned off
-over the carotid sinus
-on pregnant women
-for central pain
Safety of microcurrent stimulation has not been established during pregnancy or
birth. Microcurrent stimulation is not effective for pain of central origin including
headache.
WARNINGS
The electrodes or gloves of the MEND WellnessTM can't be placed over the carotid
sinus (upper side of neck) region. The electrodes/gloves of MEND WellnessTM can't be
placed over regions through which current will flow transcerebrally (through the head).
MEND WellnessTM should not be used on patients whose pain syndromes are not
diagnosed and etiology is not established. If another garment electrode is used as a
dispersive electrode, placement of the dispersive electrode should ensure transthoracic
stimulation is not possible.
The MEND WellnessTM should be used only under the continued supervision of a
licensed health care practitioner. The MEND WellnessTM has no curative value. The
MEND WellnessTM is a symptomatic treatment and as such suppresses the sensation
of pain which could otherwise serve as a protective mechanism.
The electrodes should not be placed over or in proximity of cancerous lesions, infected
or inflamed areas of the skin with open lesions.
Do not allow children to use or handle this device.
Do not operate vehicles or potentially dangerous machinery during periods of
stimulation.
Electronic monitoring equipment such as ECG monitors and ECG alarms may not
operate properly when The MEND WellnessTM is in use.
PRECAUTIONS
Isolated cases of skin irritation may occur at the site of conductive materials following
long-term application. The effectiveness of the MEND WellnessTM device is highly
dependent upon patient selection by a practitioner qualified in the management of pain.
Electrode placement and stimulation settings should be based on the guidance of the
prescribing practitioner. Patients should not use the device while under the influence

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of alcohol, controlled substances or narcotic drugs, directly on the eyeball, or over a
vessel that may contain a blood clot.
Caution should be used for persons with suspected or diagnosed epilepsy.
ADVERSE EFFECTS
Please consult your health care practitioner about possible adverse effects which may
arise from the therapy protocols your health care practitioner is using. Skin irritation
and electrode burns have been reported at the site of electrode placement following
long-term application. To reduce the risk of skin irritation or burns, keep electrodes
directly against the skin during application.
Warranty and Service
The MEND WellnessTM has a one year warranty. MEND Technology warrants that
the Product is manufactured by Inspirstar Inc in accordance with the specifications.
There is no warranty of merchantability nor of fitness for a particular use. The
Product is marketed under section 510(K) of the Federal Food, Drug and Cosmetic
Act as a device substantially equivalent to a device in commerce. Inspirstar Inc. and
MEND Technology expressly disclaim any claim that the Product can treat or cure any
medical condition or illness. The user must consult with his or her health care
practitioner as to the recommended use. The Product may only be used under the
direct supervision of a licensed health care provider. There are no other warranties,
expressed or implied. MEND Technology sole liability hereunder is to replace the
Product with the same or a substitute product. In no event shall Inspirstar Inc. and/or
MEND Technology be liable for personal injury or death of any person using or
misusing the Product.
The MEND WellnessTM unit may be repaired or replaced with the same or a substitute
product within one year of purchase based on the determination of the manufacturer.
Lead wires have a limited warranty of 3 months. To replace products or obtain service,
first call your doctor or MEND Technology. If necessary, send the entire unit with the
carrying case and accessories, insured, postage prepaid, and well packaged, along with
the Return Merchandise Authorization number obtained from MEND Technology.
Please remove the batteries before returning your device.
Contact suppor[email protected] for RMA and shipping information.

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MEND Wellness Device and Accessories
Top Panel and Keypad
Figure 1 Top Panel
1. Display Area: Menu selection, protocol information, running information and
status, etc. are displayed on LCD screen.
2. Channel Status: LED CH1 and CH2 indicate if the output current can reach their
peak current value in the protocol for channel 1 and channel2, respectively. If the
LED is flashing or ON, check the connection of the electrode to the body.
3. Protocol Running Control:
•Key START/ON to turn on the device, or to start the selected
protocol.
•Key PAUSE to pause the running of the current protocol. Use key
START to resume the running.
•Key STOP to stop the protocol in running, or to turn off the device.
4. Arrow Keys:
• Left Arrow: Back to previous menu level or move cursor to left.
• Right Arrow: Enter menu selection or move cursor to right.
• Up Arrow: Move cursor up or increase number
• Down Arrow: Move cursor down or decrease number
5. Set Number key:

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• Press this key to go into and finish the number editing mode. In Number
Editing mode, use arrow keys to change the digits of the number. Press this
key again to move to next number or to finish editing numbers.
• In the Main Menu->Settings, use the SET key to jump to the next field and
SET new value.
6. Protocols: Press this key to cycle between “All Protocols”, “Recent
Protocols”, “History Protocols” and “Batch Protocols”.
7. Back Light: turn on or off the back light of the LCD display.
8. Current Keys: to increase or decrease the output current intensity. Your
practitioner should have these set at a typical default setting for you. Range is 20
μA to 400 μA.
Rear Panel
Figure 2 MEND WellnessTM Output Jacks and USB port
USB Port
The micro USB port is for communication with the computer only, not to supply power
to the MEND Wellness device. The MEND Wellness only operates with battery power
supply.
Equipment that is connected to the Micro USB port interfaces must be
certified according to the respective EN/IEC/UL standards.
Certified computer has one or more of the following markings on the
power supply unit:
Combined Channel Jacks: Refer to user’s manual for safety cautions.
Positive Jack +: Positive leads of CH1 and CH2
Negative Jack -: Negative leads of CH1 and CH2
Device is Body Floating (BF) Type.
Micro USB
connectio
n to PC
IEC 60950-1
IEC 60950-22
CAN/CSA-C22.2 No. 60950-1
CAN/CSA-C22.2 No. 60950-22
UL 60950-1
UL 60950-22
Information Technology
Equipment Power Supply
I.T.E. Power Supply
ITE Power Supply
QQGQ7 Power Supply

Microcurrent Output Ports
Output Jacks
Plugs
Connection
Wire Connectors. If you
have alternate colored leads,
ensure you know which
output is each polarity.
Combined Channel Output Jacks
Positive Jack (+)
Tip
CH2+
Red
Ring
CH1+
Yellow
Negative Jack(-)
Tip
CH2-
Blue
Ring
CH1-
Green
Table 1 Color Mapping of Output Ports to Wire Connectors
Accessories
The MEND device can be used with various accessories that can be purchased individually.
For example, gloves, electrodes, push pin leads, conductive strips and conductive material.
To purchase additional accessories visit www.mendtechnology.com
Electrodes, conductive strip &
Gloves
Combinable Leadwires
Carrying Case
Alligator clips
Conductive Gel

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Operations
Prepare for Operations
The MEND WellnessTM device can be used inside the carrying case. If you have the soft
carrying case, there are two Velcro strips attached inside. Use them to attach to the back panel
of the MEND WellnessTM device.
Install Batteries
The MEND WellnessTM device uses two alkaline batteries in size “AA”. Remove the
batteries when the device is not going to be used for more than one month.
Note: DO NOT use rechargeable Lithium Ion batteries because the voltage is not
compatible with our devices.
Connect Wires to the MEND WellnessTM device
Insert the plugs into the jacks on the rear panel of the MEND WellnessTM device. Match
the color of the plug with the color on the rear panel.
Insert batteries here

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Connect Wires to Gloves, Strips or Electrodes
Snap the button or insert the pins on gloves, strips or electrodes.
Please follow your health care practitioner’s instructions on where to place the electrodes,
gloves, towels or strips on the body. Gloves, towels, and strips need to be wet to provide
conduction.
It is recommended to leave the wires and buttons connected to the gloves and leave the
plugs inserted in the MEND WellnessTM after use. If you want to unbutton the electrode
wires from the gloves, hold the button base on the gloves instead of holding the fiber part
of the gloves to avoid damage to the gloves.
DO NOT WEAR THE GLOVES ON BARE HANDS UNLESS YOU ARE
TREATING YOUR OWN HANDS.
To isolate the conductive gloves from bare hands, wear latex or nitrile gloves first then put
on the conductive Electrode Gloves. The gloves must be wet during treatment.
Basic Operations
Power ON
Press START/ON to power on the unit. The Power-On Initial Screen displays the last
protocol number previously run. Press START to run this last used protocol.

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PROTOCOLS BUTTON - All, Recent, History and Batch Protocols
All Protocols lists all protocols in the profile.
Recent Protocols lists the protocols that were recently used. Use Recent Protocols to
quickly select a protocol that is frequently used.
History Protocols lists the actual protocol running history. The latest used protocol is
displayed on the top of the list. Use History Protocols to check the therapy history and
also select a protocol to run again. Note: the history will show the exact usage, so you
may see the same protocol multiple times in the history.
Select a Protocol
There are a number of stored therapy protocols in the MEND WellnessTM IS02LCDs.
Please follow your health care practitioner’s instruction regarding the protocols to be used
for your pain complaints.
To browse for a protocol: Press the PROTOCOLS key to get to the All Protocols screen.
To switch between All
Protocols, Recent Protocols,
History Protocols or Batch
Protocols: press Protocols key
to cycle between the four
protocol list screens.
Use the arrow keys UP and
DOWN to browse through the
protocol list.

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To quickly jump to a protocol number: When the “All Protocols” screen is displayed,
press the SET key and look to the top right corner of the display. The edit cursor will flash
on either the ones or tens digit of the protocol number. Use the UP and DOWN keys to
change the value. Use the LEFT arrow to move to the tens digit and use UP and DOWN to
change the value. Use the RIGHT arrow to move to the ones digit. Press SET again when
done. Alternatively, press and hold the up or down arrow to scroll quickly.
To see details of a protocol: Press the
RIGHT arrow key to see the details. Use
keys UP and DOWN to scroll through the
screen to see details.
Run a Therapy Protocol
Press the START key to run a protocol.
The protocol will start to run and there
will be microcurrent from the output
jacks. The protocol will stop after the
programmed run time. If you do not start
another protocol, the unit will
automatically turn off.

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Pause the Therapy Protocol
While a protocol is running, press
the PAUSE key if you need to
temporarily stop a protocol, press
START to continue running. While
paused, no current is running. The
maximum time for a PAUSE is 30
minutes.
Stop the Therapy Protocol
At any time during a protocol, you
can press the STOP key to stop
running a therapy protocol.
Turn on the Back Light
To turn on the LCD back light: quickly press the Back Light key to turn on the LCD
back light. The back light will stay on when the key pad operations occur within 10
seconds.
To turn off the LCD back light: press the Back Light key to turn off the back light
immediately.
To turn on the LCD back light for 30 seconds: press and hold the Back Light key for 3
seconds, the light will remain on for 30 seconds.
Turn power off
Depending on which screen you are on,
continue to press the STOP/OFF key to
turn off the MEND WellnessTM. The
unit will power off automatically if the
unit is not in use for 60 seconds.

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Advanced Operations and Display Information
Protocol Run Information and Status
When a protocol is running, the screen will display the protocol information and status.
During the running of the protocol, the MEND WellnessTM uses two LED lights to
indicate the output connection. If the channel status LED CH1 or CH2 turns on or flashes,
check that your leads are inserted firmly into the jacks and your pins are plugged into the
conductive material. The common problems are loose plugs, plugs are not inserted, the
button or push pin is not inserted into gloves or electrodes, dry skin contact needs moisture
or broken leadwires.
Note: During a treatment you may experience a mild tingling sensation as a result of the
stimulating current flow.
Protocol number and name
Remaining time for the running
frequency pair (Pair 1 of 10).
Remaining time for all 10 frequency
pairs in the protocol.
Output current
polarity
(±) and
intensity (μA)
Waveform name
Output channel
frequencies

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Make Run Time Changes
To change output current intensity μA:Press the ‘+’key to increase the current
intensity value or press the ‘-‘key to
decrease the current intensity value. Or
press the Number SET key and use the
arrow keys to change the value. Changes
made are only applied to the active pair.
Range: 20-400μA
To HOLD the current frequency pair,
press and hold the START key for 2
seconds to hold the timer. Press the
START key to resume the timer.
To SKIP the current frequency pair,
press and hold the PAUSE key for 2
seconds to skip to the next pair. The new
values will be applied onto the
microcurrent output in 3 seconds after
changed. The change of Current Intensity
will be carried into the next frequency pair in the protocol if the next frequency pair has the
same parameters as the current frequency pair. All Run Time changes are dismissed when
the protocol is finished or stopped.
Batch Protocols
Batch Protocols allows you to add up to 9 protocols and run as a batch.
Protocols will run in order.
To go into Batch Protocols: press Back
key to Main Menu and use UP/DOWN to
select Batch Protocols and press RIGHT
arrow to enter.
Select a slot: There are 9 protocol slots in
the batch. Each slot can be assigned to any
protocol in the IS02. Use UP/DOWN to
move the selection symbol “>” up and
down.
Select a protocol for the slot: Press
RIGHT key to enter to the protocol
selection menu.

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Select from other protocols: Press
Protocols key to rotate between All
Protocols, Recent Protocols and
History Protocols. Use UP/DOWN arrows
to select a protocol. See Select a Protocol
on page 17.
Assign a protocol to the slot: press
START key to assign the protocol to the
slot. The assigned protocol will be shown
in the slot in the batch.
Select protocols for other slots: repeat the
above steps for other slots.
Remove a protocol from batch: select
the batch slot and press and hold STOP
key for 2 seconds until the slot is
changed to empty. You can have
empty slot between protocols in the batch.
The empty slot will be skipped during
running.
Run a batch of protocols: move the
selection cursor “>” to the protocol to start
with in the batch, and press START key
to start running the protocols. The slot
number in the batch is shown in front of
protocol number.
Skip a protocol in batch: press STOP key to skip the current protocol. The next
protocol in the batch will start.
Stop the batch: press and hold STOP key for 2 seconds to stop running the batch of
protocols.

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Settings – MAIN MENU
To change Settings: press the BACK arrow
key to go to Main Menu and use the
UP/DOWN arrows to select Settings, then
press the RIGHT arrow to enter into the
Settings screen.
To turn ON/OFF Key beeping: press the
Number SET key until the edit cursor has
moved to the ON/OFF of key beeping, use
UP/DOWN to change the value. Press SET
again when the new value is set.
To turn ON/OFF Protocol end beeping:
press the SET key until the edit cursor has
moved to the Protocol end beeping field, use
UP/DOWN to change the value. Press SET to
enter the new value.
To change the Output Drive: press the SET
key a couple of times to go to “3. Output
Drive”. Use UP/DOWN arrows to change the
value between HIGH, MEDIUM AND LOW.
Press SET.
If the user is sensitive to current, use “Low”. If the user has high skin resistance, use “High”.
The recommendation is to hydrate the patient and especially the skin.
The new settings will take effect after you press BACK arrow key to the Main Menu.
About
To go to About: press the LEFT arrow to go
to the Main Menu and use the DOWN arrow
key to scroll down to About and press the
RIGHT arrow key to enter into the About
screen.
Version: shows the hardware and firmware
information.
Battery Status: shows the battery voltage and
estimated time that the batteries could run for
protocols. The battery run time varies on the
output current levels of the protocols. (Note
for software users: If you update your
firmware, always use NEW batteries.)

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Low Battery Indication
“Low Battery” will be indicated either in the startup screen or protocol running screen. You
can continue to use the device but it may shut down unexpectedly at any time. It is
recommended that you change the batteries when you see the Low Battery message.
Disclaimer: shows the disclaimer for the device. Machine is approved for pain use only.
Names & descriptions are solely to assist in most appropriate protocol selection. No claims
can be made beyond use of pain.
Maintenance & Troubleshooting
There are no serviceable parts inside the IS02 main unit. Do not open the
units.
Pre-Use Inspection
To ensure the IS02 device and leadwires are in good working order, perform the following
steps.
•Power on the unit, check the display and keypad are working normally.
•Plug the leadwires without electrodes into the output ports on the rear of the IS02
unit.
•Press START key to run a protocol. There should be no error on starting.
•Test the continuity for CH1. Use the YELLO pin to touch the GREEN pin. The
CH1 LED on the unit should not flash. This is the indication of good continuity
through the leadwires. Separate the touch of the two pins. The CH1 LED should
start to flash to indicate that the continuity is broken.
One startup screen On protocol running screen