Drive Medical Design AGF-602 User Manual

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Drive Medical Design AGF-602 User Manual

Port Washington, NY 11050

V1.3

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INDEX

Chapter Contents

Page

Index..................................................................................

1

1.Introduction………………………………………..……………..2

2.Cautions…………………………………………….....………….3

3.Warnings…………………………………………….....…………4

4.

General Description……………………………….....………… 5

5.

Construction………………………………………….....………. 5

6.

Technical Specifications ……………………………...……….. 6

7.

Replaceable Parts…………………………………….....……… 7

8.

Accessories………………………………………………...…....

7

9.

Graphic Symbols…………………………………………..…....

8

10.

Parameter Controls………………………………………......

 

… 8

11.

Attachment of Electrodes Lead Wires………………....

….. 10

12.

Lead Wire Maintenance…………………………………....

…. 10

13.

Electrode Options…………………………………………......

 

10

14.

Electrode Placement……………………………………....

….. 11

15.

Tips For Skin Care…………………………………….…....

…. 11

16.

Application of Re-usable Self Adhesive Electrodes…...…. 12

17.

Adjusting the Controls……………………………………......

 

13

18.

Battery Information………………………………………....

… 16

19.

Maintenance, Transportation and Storage of

 

 

 

TENS Device…...............................................................

… 17

20.Safety Control……………………………………………...….. 18

21.Malfunctions……………………………………………....…… 18

22.

Conformity to Safety Standards..…………………….....….. 19

23.

Warranty……………………………………………...……...…... 19

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Chapter 1 : INTRODUCTION

EXPLANATION OF PAIN

Pain is a warning system and the body’s method of telling us that something is wrong. Pain is important; without it abnormal conditions may go undetected, causing damage or injury to vital parts of our bodies.

Even though pain is a necessary warning signal of trauma or malfunction in the body, nature may have gone too far in its design. Aside from its value in diagnosis, long-lasting persistent pain serves no useful purpose. Pain does not begin until coded message travels to the brain where it is decoded, analyzed, and then reacted to. The pain message travels from the injured area along the small nerves leading to the spinal cord. Here the message is switched to different nerves that travel up the spinal cord to the brain. The pain message is then interpreted, referred back and the pain is felt.

EXPLANATION OF TENS

Transcutaneous Electrical Nerve Stimulation is a non-invasive, drug-free method of controlling pain. TENS uses tiny electrical impulses sent through the skin to nerves to modify your pain perception. TENS does not cure any physiological problem; it only helps control the pain. TENS does not work for everyone; however, in most patients it is effective in reducing or eliminating the pain, allowing for a return to normal activity.

HOW TENS WORKS

There is nothing “magic” about Transcutaneous Electrical Nerve Stimulation (TENS). TENS is intended to be used to relieve pain. The TENS unit sends comfortable impulses through the skin that stimulate the nerve (or nerves) in the treatment area. In many cases, this stimulation will greatly reduce or eliminate the pain sensation the patient feels. Pain relief varies by individual patient, mode se-

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lected for therapy, and the type of pain. In many patients, the reduction or elimination of pain lasts longer than the actual period of stimulation (sometimes as much as three to four times longer). In others, pain is only modified while stimulation actually occurs. You may discuss this with your physician or therapist.

Chapter 2: CAUTIONS

1.Precautions:

Isolated cases of skin irritation may occur at the site of electrode placement following long-term application. Effectiveness is highly dependent upon patient selection by a person qualified in the management of pain patients.

2.Contradictions:

TENS devices can affect the operation of demand type cardiac pacemakers. TENS is not recommended for patients with known heart disease without physical evaluation of risk. Do not use TENS on the carotid sinus (neck) region. Do no apply TENS for undiagnosed pain syndromes until etiology is established. Do not stimulate on the site that may cause current to flow transcerebrally - (through the head).

3.Adverse Reactions

Possible allergic to gel, skin irritation and electrode burn are potential adverse reactions.

4.Read operation manual before use of TENS.

5.We emphasize that patient with an implanted electronic device (for example, a pacemaker) should not undergo TENS treatment without first consulting a doctor. The same applies to patients with any metallic implants.

6.If TENS therapy becomes ineffective or unpleasant, stimulation should be dis continued until its use is reevaluated by the physician or therapist.

7.Avoid adjusting controls while operating machinery or vehicles.

8.Turn the T.E.N.S. off before applying or removing electrodes.

9.T.E.N.S. devices have no AP/APG protection.

Do not use it in the presence of explosive atmosphere and flammable mixture.

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Chapter 3 : WARNINGS

1.Caution should be used in applying TENS to patients suspected of having heart disease. Further clinical data is needed to show there are no adverse results.

2.The safety of TENS devices for use during pregnancy or birth has not been established.

Do not use TENS during pregnancy.

3.TENS is not effective for pain of central origin. (This includes headache.)

4.TENS devices should be used only under the continued supervision of a physician.

5.TENS devices have no curative value.

6.TENS is a symptomatic treatment and as such suppresses the sensation of pain, which would otherwise serve as a protective mechanism.

7.Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when TENS stimulation is in use.

8.There should be a prominently placed statement warning that stimulus deliv ered by this device may be sufficient to cause electrocution. Electrical current of this magnitude must not flow through the thorax because it may cause a cardiac arrhythmia.

9.Do not place electrodes on the front of the throat as spasm of the Laryngeal and Pharyngeal muscle may occur.

10.Care should be taken so that when operating potentially dangerous machinery the stimulator controls are not changed abruptly.

6. Electrodes should not be placed over the eyes, in the mouth, or internally.

11.Keep this device out of the reach of children.

12.Caution: Federal law restricts this device to sale by or on the order of a physician.

Chapter 4: GENERAL DESCRIPTION

The AGF-602 TENS is a battery operated pulse generator that sends electrical impulses electrodes to the body and reach the nerves causing pain. The device is provided with two controllable output channels, each independent of each other. An electrode pair can be connected to each output channel.

The electronics of the AGF-602 TENS create electrical impulses whose Intensity, duration, number per second and modulation may be altered with the controls or switches. Dial controls are very easy to use and the slide cover prevents accidental changes in the setting.

Chapter 5 : CONSTRUCTION

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