MEND Technology IS02PRO Manual de usuario

MEND ProfessionalTM IS02PRO

Owner’s Manual

Ver 1.0, 2016.3.4

Warranty & Repairs

Company Address:

MEND Technology, LLC

ATTN: Returns – RMA #

10117 SE Sunnyside Road Ste F40

Clackamas, OR 97015

Phone: 503-594-4045

Fax: 503-594-4046

logo are the trademarks of MEND Technology, LLC. Trademarks or registered

trademarks are the property of their respective holders. Software and specifications are

subject to change without notice.

Technical Support:

Website: https://www.mendtechnology.com

Email: support@mendtechnology.com

Table of Contents

Introduction .........................................................................................6

Indications.......................................................................................6

Warnings, Contraindications, Adverse Effects, & Precautions ...........7

Warnings & Contraindications .....................................................7

Adverse Effects ...........................................................................7

Precautions and Safety Precautions..............................................8

Warranty and Service .......................................................................8

Main Unit andAccessories.................................................................10

Top Panel and Keypad....................................................................10

Rear Panel .....................................................................................12

Accessories....................................................................................13

Operations .........................................................................................13

Prepare for Running.......................................................................13

Install Batteries..........................................................................13

Connect Wires to IS02PRO........................................................14

Connect Wires to Gloves, Strips, or Electrodes...........................14

Basic Operations............................................................................15

Power ON..................................................................................15

All, Recent and History Protocols ..............................................15

Select a Protocol........................................................................16

Run a Therapy Protocol .............................................................17

Pause the Therapy Protocol........................................................17

Stop the Therapy Protocol..........................................................17

Turn On Back Light...................................................................18

Turn Power Off..........................................................................18

Advanced Operations and Information............................................19

Protocol Run Information and Status..........................................19

Make Run Time Changes...........................................................20

Manual Run Mode-change F1/F2, current, polarity, waveform....22

Settings......................................................................................25

About........................................................................................26

Troubleshooting.................................................................................27

1 Introduction

Congratulations on your purchase of the MEND ProfessionalTM device.

The MEND ProfessionalTM is the most advanced two channel manual

mode and programmable transcutaneous electrical nerve stimulator or

"TENS" device currently available. MEND Technology, LLC is a

leading innovator and distributor of state-of-the-art medical devices.

The MEND ProfessionalTM is a high-end precision medical device used

for the relief of pain. This device generates low intensity current pulses

at microampere level 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 ProfessionalTM is a small, portable device that is designed

for use in a doctor's office, clinic or hospital.

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.

1.1 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.

1.2 Indications

The MEND ProfessionalTM is intended for the symptomatic relief of

chronic intractable pain. The degree of efficiency will vary with patient

selection.

1.3 Contraindications, Warnings, Precautions,

and Adverse Effects

CONTRAINDICATIONS

Do not use MEND ProfessionalTM:

-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 ProfessionalTM can't be placed

over the carotid sinus (upper side of neck) region. The electrodes/gloves

of MEND ProfessionalTM can't be placed over regions through which

current will flow transcerebrally (through the head). MEND

ProfessionalTM 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 ProfessionalTM should be used only under the continued

supervision of a licensed health care practitioner. The MEND

ProfessionalTM has no curative value. The MEND ProfessionalTM 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 ProfessionalTM is in

use.

The MEND ProfessionalTM is not a life-saving device.

PRECAUTIONS

Isolated cases of skin irritation may occur at the site of conductive

materials following long-term application. The effectiveness of the

MEND ProfessionalTM 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 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.

1.4 Warranty and Service

MEND Technology, LLC 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, LLC 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, LLC 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,

LLC be liable for personal injury or death of any person using or

misusing the Product.

The MEND ProfessionalTM unit may be replaced with the same or a

substitute product within one year of purchase. Electrode Gloves and

electrode wires may be replaced with the same or a substitute product

within 3 months of purchase. 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.

2 MEND Pro Device and Accessories

2.1 Top Panel and Keypad

Figure 1 MEND Professional IS02PRO Top Panel

Channel Status Indication: LED CH1 and CH2 indicate if the output

current can reach their peak current value in the protocol for

channel 1 and channel 2, respectively. If the LED is flashing or ON,

check the connection of the electrode to the body.

Display Area: Menu selection, protocol information, active protocol

parameter information and status are displayed on the LCD screen.

Protocol Running Control:

Press the START/ON key to turn on the unit or to start a

selected protocol.

Press the PAUSE key to pause a running protocol. Use the

START key to resume the protocol.

Press the STOP key to stop a running protocol or to turn off

the MEND ProfessionalTM device.

Display Area

Function and

Number

Keypad

Back light

To select

protocol

number

Protocol

Running

Control

UP/DOWN

Arrow Keys

Channel Status Indication

LEFT/RIGHT

Arrow Keys

Arrows:

LEFT arrow key: Back to previous menu level or move cursor

to the left.

RIGHT arrow key: Enter into menu selection or move cursor

to the right.

UP arrow key: Move cursor up or increase number

DOWN arrow key: Move cursor down or decrease number

Number SET: Press the Number SET key to finish editing the

protocol number. In Number SET mode, use the arrow keys or

numeric keys to change the digits of the frequency numbers or

parameters. Press this key again to move to the next number or to

finish entering numbers or parameters. In Manual Run Mode, use

the Number SET key to enter the CH1 and CH2 frequencies after

they are selected on the number pad.

Protocols: Press this key to cycle between “All Protocols”, “Recent

Protocols” and “History Protocols”.

0~9: Number Keypad to input protocol number, select a numbered

menu item enter CH1/CH2 frequencies in Manual Mode.

Function keys: CH1, CH2, Current +/-, Time +/-, WF(waveform),

POL(polarity): During manual operation or run time control, use

these keys to change respective parameters.

Function keys: HLD (hold), SKP (skip): While protocols are

running, use the HLD key to hold/release the timer and use the SKP

to advance to next frequency pair in a protocol.

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