TWIN STIM® III
INSTRUCTION MANUAL
This manual is valid for the InTENSityTM Twin Stim
III TENS/EMS Combo Stimulator
This user manual is published by Current Solutions™, LLC
Current Solutions™, LLC does not guarantee its contents and reserves the right to improve and amend it at any time without prior notice. Amendments may however be published in new editions of this manual.
All Rights Reserved.Rev.V1.1 © 2010
: United States Federal Law restricts this device to sale by or on the order of a physician or licensed practitioner
Declaration of conformity:
Current Solutions™, LLC declares that the device complies with following normative documents:
IEC60601-1, IEC60601-1-2, I EC60601-2-10, IEC60601-1-4,
ISO10993-5, ISO10993-10, ISO10993-1
Table of Contents
1.SAFETY INFORMATION………………………………………………………………….... 4
1.1General description
1.2Medical background
1.3Indication for use
1.4Contraindications
1.5Warnings, Cautions, Adverse Reactions
2.PRESENTATION………………………………………………………………..………………... 12
2.1Front and Rear panel
2.2LCD display
3.SPECIFICATION……………………………………………………………..………………….... 15
3.1Accessories
3.2Technical information
3.3The waveforms of the stimulation programs
4.INSTRUCTIONS FOR USE………………………………..………………………......... 19
4.1Battery
4.2Connect electrodes to lead wires
4.3Connect lead wires to device
4.4Electrodes
4.5Turn ON
4.6Select the Therapeutic Mode
4.7Steps to set a new program
4.8Adjust Channel Intensity
4.9Safty lock feature
4.10Stop the treatment
4.11Turn OFF
4.12Low battery indicator
5.PROGRAM...........................................................................................................................… 28
6.CLEANING AND CARE…………………………………………………….……………….. 29
6.1Tips for skin care
6.2Cleaning the device
6.3Electrodes
6.4Cleaning the Electrode cords
6.5Maintenance
7.TROUBLESHOOTING …………………………………………………………………….... 32
8.STORAGE……………………………………………………………………………………............. 33
9.DISPOSAL…………………………………………………………………………………................ 33
10. ELECTROMAGNETIC COMPATIBITY (EMC) TABLES |
…… 33 |
|
11. |
GLOSSARY OF SYMBOLS |
35 |
12. |
WARRANTY |
46 |
3
1.Safety information
1.1 General
InTENSityTM Twin Stim
III is a portable electrotherapy device featuring two therapeutic modes: Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulation (EMS), which are used for pain relief and electrical muscle stimulation. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of device are controlled by the buttons on the?front panel. The intensity level is adjustable according to the needs of patients.
1.2 Medical background
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 the 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 (TENS) is a noninvasive, 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;
4
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 selected 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.
Electrical Muscle Stimulation (EMS) is an internationally accepted and proven way of treating muscular injuries. It works by sending electronic pulses to the muscle needing treatment; this causes the muscle to exercise passively. It is a product derived from the square waveform, originally invented by John Faraday in 1831. Through the square wave pattern it is able to work directly on muscle motor neurons. This device has low frequency and this in conjunction with the square wave pattern allows direct work on muscle groupings. This is being widely used in hospitals and sports clinics for the treatment of muscular injuries and for the reeducation of paralyzed muscles, to prevent atrophy in affected muscles and improving muscle tone and blood circulation.
HOW EMS WORKS
The EMS units send comfortable impulses through the skin that stimulate the nerves in the treatment area. When the muscle receives this signal it contracts as if the brain has sent the signal itself. As the signal strength increases, the muscle flexes as in
5
physical exercise. Then when the pulse ceases, the muscle relaxes and the cycle is repeated. The goal of electrical muscle stimulation is to achieve contractions or vibrations in the muscles. Normal muscular activity is controlled by the central and peripheral nervous systems, which transmit electrical signals to the muscles. EMS works similarly but uses an external source (the stimulator)with electrodes attached to the skin for transmitting electrical impulses into the body. The impulses stimulate the nerves to send signals to a specifically targeted muscle, which reacts by contracting, just as it does with normal muscular activity.
InTENSityTM Twin Stim
III Stimulator?may be used for 
For Transcutaneous Electrical Nerve Stimulator therapeutic modes (TENS):
1) Symptomatic relief of chronic intractable pain.
2) Post traumatic pain.
3) Post surgical pain.
For Electrical Muscle Stimulation / Neuromuscular Stimulation therapeutic mode (EMS):
1) Relaxation of muscle spasm.
2) Increase of blood flow circulation.
3) Prevention of disuse atrophy.
4) Muscle re-education.
5) Maintaining or increasing range of motion.
imulation of lower leg muscles to prevent venous thrombosis.
IMPORTANT SAFETY INFORMATION!
Read the instruction manual before operation. Be sure to comply with all “Contraindications”,“Warnings”, “Cautions” and “Adverse reactions” in the manual. Failure to follow instructions can cause harm to user or device.
1.4 Contraindications
1.5 Warnings, Cautions and Adverse?Reactions
7
8
out of reach of children.
you are in any doubt whatsoever.
CAUTIONS:
?
13)Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or silicone rubber. If rash develops or pain persists, discontinue use and consult a doctor.
14)Electrode placement and stimulation settings should be based on the guidance of prescribing practitioner.
15)Effectiveness is highly dependent upon patient selection by a person qualified in the management of pain afflicted patients.
16)Isolated cases of skin irritation may occur at the site of the electrode placement following long-term application. If this occurs, discontinue use and consult your physician.
17)The electrodes are only to be placed on healthy skin. Avoid skin irritation by ensuring that good contact is achieved between electrodes and skin.
18)If the stimulation levels are uncomfortable or become uncomfortable, reduce the stimulation Intensity to a comfortable level and contact your physician if problems persist.
19)This device should not be used while driving, operating machinery, close to water, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury.
20)Never use the device in rooms where aerosols (sprays) are used or pure oxygen is being administered.
21)Do not use it near any highly flammable substances, gases or explosives.
22)Do not use this device at the same time as other equipment which sends electrical pulses to your body.
23)Do not confuse the electrode cables and contacts with your headphones or other devices, and do not connect the electrodes to other devices.
24)Do not use sharp objects such as pencil point or ballpoint pen to operate the buttons on the control panel.
25)Inspect Applicator cables and associated connectors before each use.
26)Turn the device off before applying or removing electrodes.
27)Electrical stimulators should be used only with the leads and electrodes recommended for use by the manufacturer.
28)This device has no AP/APG protection. Do not use it in the presence of explosive atmosphere and flammable mixture.
Adverse Reactions:
?
2. Presentation
2.1 Front and Rear Panel
?
12
Loading...