Lumiscope LUMI-TENS Operation Manual

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Transcutaneous Electrical
Nerve Stimulation Device
Operation Manual
Read this manual before operating your LUMI-TENS.
Save this manual for future use.
The most current version of this manual can be found online at
www.grahamfield.com.
LUMI-TENS-INS-LAB-RevC14
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TABLE OF CONTENTS
INTRODUCTION TO TENS .......................................................3
INDICATIONS AND CONTRAINDICATIONS .................................3
WARNINGS ...........................................................................4
PRECAUTIONS/ADVERSE REACTIONS .......................................4
ABOUT THIS DEVICE ..............................................................5
UNIT CONTROLS ...................................................................6
ATTACHING THE LEAD WIRES .................................................6
ELECTRODE SELECTION AND CARE ..........................................7
TIPS FOR SKIN CARE .............................................................7
CONNECTING THE TENS DEVICE .............................................7
BATTERY INFORMATION .........................................................8
CARING FOR YOUR TENS DEVICE ............................................9
TROUBLESHOOTING ..............................................................9
SYSTEM COMPONENTS ...........................................................9
TECHNICAL SPECIFICATIONS ................................................10
OUTPUT SPECIFICATIONS .....................................................10
WARRANTY .........................................................................11
GF Health Products, Inc. is not responsible for typographical errors. For the most updated and current information on packaging, warranties, products and specifications, including the most current version of these instructions, please visit our website at www.grahamfield.com. Graham-Field and Lumiscope are registered trademarks of GF Health
Products, Inc.
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INTRODUCTION TO TENS
What is Pain?
Pain is the body’s warning system. Pain is important because it signals an unusual condition in the body and alerts us before additional damage or injury can occur. TENS was developed to help relieve some types of chronic and acute pain.
How does TENS work?
TENS is a method of treating pain that is non-invasive and does not use pharmaceuticals. The TENS device sends 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 felt by masking the original pain message sent to the brain.
It is also believed that TENS stimulation helps release endorphins into the blood stream thereby further reducing pain.
TENS devices are clinically proven t o b e useful in pain management for many patients. By reading this manual and carefully following the treatment instructions given to you by your clinician, you can attain the maximum benefit from your TENS device.
INDICATIONS AND CONTRAINDICATIONS
Read the operation manual before using TENS. Federal law (USA) restricts this device to sale by or on the order of a physician.
Indications
Transcutaneous Electrical Nerve Stimulation (TENS) is indicated to be used under a physician’s prescription for the symptomatic relief and management of chronic (long term) pain and for the treatment of postoperative or posttraumatic pain.
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Contraindications
Patients with implanted electronic devices (for example, a pacemaker) or metallic implants should not undergo TENS treatment without first consulting a physician.
Any electrode placement that applies current to the carotid (neck) region. Any electrode placement that causes current to flow transcerebrally
(through the head). The use of TENS whenever pain symptoms are undiagnosed, and the
etiology is unknown.
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WARNINGS
WARNING: TENS devices must be kept out of reach of children.
WARNING: The safety of TENS devices for use during pregnancy or delivery has not been established.
Always follow basic safety precautions, including the following:
SAFETY
WARNING: Indicates a potential hazard situation or unsafe practice that, if not avoided, could result in death or serious personal injury.
CAUTION: Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.
WARNING: TENS is not effective for pain of central origin (headaches).
WARNING: If TENS treatment becomes ineffective or unpleasant, stimulation should be discontinued until evaluated by a physician.
WARNING: Avoid adjusting controls while operating machinery or vehicles.
WARNING: Always turn the TENS device OFF before applying or removing electrodes.
WARNING: TENS may interfere with electronic monitoring equipment (ECG monitors/alarms).
WARNING: Electrodes should not be placed over the eyes, in the mouth,
WARNING: TENS devices have no curative value.
WARNING: TENS is a symptomatic treatment and as such suppresses the sensation if pain which would otherwise serve as a protective mechanism.
or internally.
WARNING: Notice for California Customers- California Proposition 65 WARNING:
This product contains a chemical known to the State of California
to cause cancer and reproductive or developmental harm.
PRECAUTIONS/ADVERSE REACTIONS
CAUTION: Isolated cases of skin irritation may occur at the site of electrode placement during long term application.
CAUTION: Effectiveness is highly dependent upon patient selection by a person qualified in the management of pain patients.
CAUTION: Skin irritation and electrode burns are potential adverse reactions.
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MODE
(uS)
PULSE WIDTH
30
60
100
150
200
220
260
(Hz)
PULSE RATE
2
3
4
5
10
20
70
130
150
120
250
Lead Connector
Intensity Controls
Indicator Light
Pulse Width Control
Mode Selector
Pulse Rate Control
Battery Compartment
Battery Strip
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ABOUT THIS DEVICE
Your TENS device is a battery operated device that includes two controllable output channels. This TENS device creates electrical impulses whose amplitude, duration, and modulation can be altered with the controls or switches. The TENS Intensity Controls are very easy to use, and the slide cover protects accidental changes in settings.
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UNIT CONTROLS
Panel Cover
A cover which conceals the controls for the Pulse Width, Pulse Rate, and Mode Selector. Press the top portion of the cover and pull down in order to open the cover.
Intensity
The Intensity Knobs located on the top of the unit affect the strength of the stimulation and also function as ON/OFF controls.
Mode
The Mode Switch is used to select the type of treatment utilized. The three modes are Burst (B), Continuous (C), and Modulation (M).
Pulse Width
The Pulse Width Knob regulates the Pulse Width for both channels.
Pulse Rate
The Pulse Rate Knob regulates the number of pulses per second for both channels.
Mode Functions
Burst (B) releases individual bursts twice per second, Pulse Width is adjustable and the Pulse Rate is set at 100Hz per second.
Continuous (C) stimulation is delivered continuously at the settings determined by Intensity, Rate, and Width Knobs.
Modulation (M) Pulse Width decreases the Pulse Width down to 60% of the original width setting. This decreased Pulse Width is maintained for 1.5
seconds before returning to the original width setting, which is maintained for
3.5 seconds. The cycle is then repeated. The Intensity and Pulse Rate are adjustable.
ATTACHING THE LEAD WIRES
The lead wires provided with the TENS device insert into the ports located on top of the unit. Holding the insulated portion of the connector, push the plug end of the wire into one of the ports; one or two sets of the wires may be used. After connecting the wires to the stimulator, attach each wire to an electrode. Lead wires provided with the TENS device are compliant with mandatory compliance standards set forth by FDA.
WARNING: Never insert the plug of the lead wire into an AC power supply socket. Personal injury and/or damage to the TENS unit could occur.
CAUTION: Use care when plugging and unplugging the wires. Pulling on the lead wire may cause wire breakage.
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ELECTRODE SELECTION AND CARE
Use the electrodes as prescribed. Follow application procedures outlined in electrode packaging to maintain
stimulation and prevent skin irritation. The electrode packaging provides instructions for care, maintenance and proper storage of electrodes.
TIPS FOR SKIN CARE
Good skin care is important for effective and comfortable use of your TENS device.
Always clean the electrode site with mild soap and water solution, rinse well and dry thoroughly prior to any electrode application.
Any excess hair should be clipped, not shaved, to ensure good electrode contact with the skin.
If a skin treatment is recommended by your physician, apply the skin treatment as recommended, let dry, and apply electrodes as directed. Following these recommendations will both reduce the chance of skin irritation and extend the life of your electrodes.
Avoid excessive stretching of the skin when applying electrodes. Proper application is best accomplished by applying the electrode, then smoothly pressing it in place from the center outward.
When removing electrodes, always remove by pulling in the direction of hair growth.
It may be helpful to rub skin lotion on electrode placement area when
not
wearing electrodes.
CONNECTING THE TENS DEVICE
1. Prepare the Skin:
Prepare the skin as previously discussed and according to instructions provided with your electrodes. Before attaching the electrodes, identify the area which your clinician has recommended for electrode placement.
2. Connect lead wires to the electrodes:
Connect the lead wires to the electrodes before applying the electrodes to the skin.
turned to the OFF position.
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WARNING: Ensure both Intensity Controls for Channel 1 and 2 are
3. Place electrodes on the skin:
Place the electrodes on the skin as recommended by your clinician.
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4. Insert the lead wire connector to the TENS device:
Plug the end of the lead wire into the lead connector port to be used, pushing plug in as far as it will go.
5. Select treatment settings:
Ensure the unit is set to the proper settings (Pulse Width, Pulse Rate, and Mode Selector), recommended by your physician.
6. Adjusting Channel Intensity Control:
Locate the Intensity Control Knob at the top of the unit. Turn Channel 1 or 2 clockwise. The indicator light will illuminate when unit is in operation. Slowly turn the Channel Control in a clockwise direction until you reach the intensity
recommended by your medical professional. Repeat for the other channel if both channels are to be used.
If the stimulation levels are uncomfortable or become uncomfortable, reduce the stimulation amplitude to a comfortable level or cease stimulation and contact your physician.
BATTERY INFORMATION
When the yellow indicator light located on the front of the unit will no longer illuminate, the battery has become too weak to power the unit and it is time to replace the battery. At this point the unit will shut off until the battery is replaced. Dispose of the old battery according to local guidelines and regulations.
Changing the battery
When the yellow indicator light on the front of the unit does not illuminate
when the unit is turned on, the battery should be replaced.
1. Remove the panel cover by pressing on the top and sliding down until it
is completely removed from the unit. This will reveal the battery compartment.
2. Remove the discharged battery from the device.
3. Place a new battery in the battery compartment. Note the proper polarity
alignment indicated on the battery and the compartment.
CAUTION: GF Health Products, Inc. recommends the use of only a 9V alkaline battery with this device.
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CARING FOR YOUR TENS DEVICE
Your TENS device may be cleaned by wiping gently with a damp cloth moistened with mild soap and water. Never immerse the device in water or other liquids.
Wipe lead wires with a damp cloth moistened with soap and water.
To properly store the TENS device for extended period of time, remove the battery from the unit. Place the unit and accessories in the carrying case and store in a cool, dry location.
TROUBLESHOOTING
If the TENS device does not function properly:
1. Make sure the battery is properly installed or replace the battery. Be sure to observe proper polarity markings when replacing the battery. If the yellow light on the front of the unit does not stay lit when the unit is turned on, replace the battery and check again.
2. If the ON/OFF Indicator Light is flashing and no stimulation is felt, check to ensure lead wires are properly connected and the electrodes are in place. If the unit appears to be functioning and no stimulation is felt, the lead wires or electrodes may need to be replaced.
3. If the battery appears to be charged and the unit is not functioning, turn both lntensity Control Knobs to the OFF position (counterclockwise). Then gradually turn the lntensity Control Knob to the ON position.
If any other problems occur, contact an authorized GF Health Products, Inc. distributor. Do not try to repair a defective device.
SYSTEM COMPONENTS
Your TENS device may include the following components or accessories:
- TENS unit
- Electrodes
- Hard case
Also required (not included): One 9-Volt alkaline battery.
- Lead wires
- Operation manual
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TECHNICAL SPECIFICATIONS
Dual, isolated between channels Burst, Continuous, Modulation Adjustable 0-80mA peak into 500 ohm
load each channel, constant current
2Hz-150Hz (adjustable) 30uS-260uS (adjustable) Burst consists 2 burst per sec at 100 Hz Asymmetrical Bi-Phasic square pulse 0-100 Volt (open current) 9 volt battery 95(H) x 65(W) x 23.5 (T) mm 115 grams (battery included)
OUTPUT SPECIFICATIONS
Channel:
Modes of Operations:
Pulse Intensity:
Pulse Rate:
Pulse Width:
Burst Mode:
Wave Form:
Voltage:
Power Source:
Dimensions:
Weight:
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ONE-YEAR LIMITED WARRANTY
SCOPE OF WARRANTY
GF Health Products, Inc. (“GF”) warrants to the original purchaser (“Customer”) only, that it will replace or repair components, at GF’s sole discretion, that are defective in material or workmanship under normal use for a period of one year after the purchase date unless there is an expiration date on the component in which case the warranty shall expire on the earlier of the warranty period or the expiration date. The warranty does not extend to non-durable parts and does not include labor or costs of shipping. This limited warranty is not transferable. All warranties are conditioned upon the proper use of the product strictly in accordance with good commercial practice and applicable GF instructions and manuals, including proper use and maintenance. The warranty is void if the defect is caused by any other reason not related to defects in materials or workmanship.
OBTAINING WARRANTY SERVICE
GF’s customer service team must be notified of any warranty claim within the applicable warranty period. Call 770-368-4700, or fax 770-368-2386 or e-mail cs@grahamfield.com. Failure to follow the specific directions provided by the GF customer service team will result in denial of the warranty claim.
ENTIRE WARRANTY, EXCLUSIVE REMEDY AND CONSEQUENTIAL DAMAGES DISCLAIMER
THIS WARRANTY IS GF’S ONLY WARRANTY AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED. GF MAKES NO IMPLIED WARRANTIES OF ANY KIND INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IF ANY MODEL OR SAMPLE WAS SHOWN TO THE CUSTOMER, SUCH MODEL OR SAMPLE WAS USED MERELY TO ILLUSTRATE THE GENERAL TYPE AND QUALITY OF THE PRODUCT AND NOT TO REPRESENT THAT THE PRODUCT WOULD NECESSARILY CONFORM TO THE MODEL OR SAMPLE IN ALL RESPECTS.
GF’S TOTAL LIABILITY FOR ANY PRODUCT OR SERVICE PROVIDED IS LIMITED TO THE COST OF THE PRODUCT GIVING RISE TO THE CLAIM. IN NO EVENT WHETHER IN CONTRACT, INDEMNITY, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE WILL GF BE LIABLE FOR ANY DIRECT, SPECIAL, INDIRECT, INCIDENTAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES, INCLUDING, BUT NOT LIMITED TO: DAMAGES FOR LOSS OF PROFITS OR INCOME, LOSS OF USE, DOWNTIME, COVER, OR EMPLOYEE OR INDEPENDENT CONTRACTOR WAGES, PAYMENTS AND BENEFITS.
This warranty gives you specific legal rights. You may have additional rights which vary from state to state.
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Manufactured for:
GF Health Products, Inc.
2935 Northeast Parkway
Atlanta, Georgia 30360
telephone: 770-368-4700
fax: 770-368-2386
© 2008 GF Health Products, Inc.
Made in Taiwan
www.grahamfield.com
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