Roscoe Medical TENS 3000 Analog Unit User Manual
- June 24, 2024
- Roscoe Medical
Table of Contents
Roscoe Medical TENS 3000 Analog Unit User Manual
CHAPTER 1: INTRODUCTION
EXPLANATION OF PAIN
Pain is a warning system and the body’s method of telling you 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 a 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, the 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 occurs. You may discuss this with your physician or therapist.
Chapter 2: CAUTIONS
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.
Contradictions
TENS devices can affect the operation of demand-type cardiac pacemakers. TENS
is not recommended for patients with known heart disease without a physical
evaluation of risk. Do not use TENS on the carotid sinus( neck) region. Do not
apply TENS for undiagnosed pain syndromes until the etiology is established.
Do not stimulate on the site that may cause current to flow trans cerebrally
(through the head).
Adverse Reactions
- Possible allergic to gel, skin irritation and electrode bum are potential adverse reactions.
- Read the operation manual before using TENS.
- We emphasize that patients 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 metallic implants.
- If TENS therapy becomes ineffective or unpleasant, stimulation should be discontinued until its use is reevaluated by the physician or therapist.
- Avoid adjusting controls while operating machinery or vehicles.
- Turn the TENS off before applying or removing electrodes.
- TENS devices have no AP/APG protection. Do not use it in the presence of explosive atmosphere and flammable mixture.
Chapter 3: WARNINGS
- 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.
- The safety of TENS devices for use during pregnancy or birth has not been established.
- Do not use TENS during pregnancy.
- TENS is not effective for pain of central origin. (This includes headaches.)
- TENS devices should be used only under the continued supervision of a physician.
- TENS devices have no curative value.
- TENS is a symptomatic treatment and as such suppresses the sensation of pain which would otherwise serve as a protective mechanism.
- Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when TENS stimulation is in use.
- There should be a prominently placed statement warning that the stimulus delivered by this device may be sufficient to cause electrocution.
- An electrical current of this magnitude must not flow through the thorax because it may cause a cardiac arrhythmia.
- Do not place electrodes on the front of the throat as spasms of the Laryngeal and Pharyngeal muscles may occur.
- Care should be taken so that when operating potentially dangerous machinery the stimulator controls are not changed abruptly.
- Electrodes should not be placed over the eyes, in the mouth, or internally.
- Keep this device out of the reach of children.
- Caution: Federal law restricts this device to sale by or on the order of a physician.
Chapter 4: GENERAL DESCRIPTION
The TENS 3000 is a battery-operated pulse generator that sends electrical
impulses electrodes to in the body and reaches the nerves causing pain. The
device is provided with two controllable output channels, each independent of
the other. An electrode pair can be connected to each output channel. The
electronics of the TENS 3000 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
Chapter 6: TECHNICAL SPECIFICATIONS
The technical specification details of the TENS 3000 are as follows:
| MECHANISM| TECHNICAL DESCRIPTION
---|---|---
01.| Channel| Dual, isolated between channels
02.| Pulse Amplitude| Adjustable, 0-80mA at 500 ohm load each channel
03.| Pulse Rate| Adjustable, from 2 to 150 Hz
04.| Pulse Width| Adjustable, from 30 to 260 microseconds
05.| Modulation| Pulse rate is automatically varied in a cyclic pattern over
an interval of nominally 10 seconds (in max 150 Hz). Pulse rate decreases
lineally over a period of 4 seconds from the control setting to a value which
is 40% less. The lower pulse rate will continue for 1 second. Then increase
linearly over a 4 second period to its original value. The original pule rate
will continue for 1 second. The cycle is then repeated.
06.| Burst Mode| Bursts occur twice every second. Pulse width (adjustable),
frequency = 100Hz.
07.| Wave Form| Asymmetrical Bi-Phasic Square Pulse.
08.| Timer| 15, 30 minutes or continuous.
09.| Voltage| 0 to 40 V (Load: 500 ohm).
10.| Max. Charge per Pulse| 20 micro-coulombs.
11.| Power Supply| One 9 Volt Battery (alkaline or nickel-cadmium
rechargeable).
12.| Battery Life| Approximately 50 hours at nominal settings.
13.| Size| 95 (H) x 65 (W) x 23.5 (D) mm.
14.| Weight| 115 grams (battery included)
Chapter 7: REPLACEABLE PARTS
The replaceable parts and accessories of TENS devices are as given below,
except leads, electrodes battery, and battery case cover, please do not try to
replace the other parts of a device.
| PIECES
---|---
01| ELECTRODES LEADS
02| ELECTRODES
03| 9V BATTERY, TYPE 6F22
04| BELT CLIP
05| BATTERY CASE COVER
06| LEAD CONNECTOR
07| MAIN PCB
08| INTENSITY KNOB
09| B-N-M SWITCH
10| PULSE WIDTH KNOB
11| PULSE RATE KNOB
Chapter 8: ACCESSORIES
Each set of TENS 3000 is completed with standard accessories and standard
labels as given below:
DESCRIPTION QUANTITY
- 40 X 40 mm Adhesive Electrodes 4 pieces
- Electrode Leads 2 pieces
- 9 V Battery, type 6F22 1 piece
- Instruction Manual 1 piece
- Carrying Case 1 piece
Chapter 9: GRAPHIC SYMBOLS
- Equipment capable of delivering output values over 10mA r.m.s. or 10V r.m.s. averaged over any period of 5s.
- Type BF applied part.
- Do not insert the plug into the AC power supply socket.
- Direct Current (DC power source)
- Refer to the Instruction Manual.
Chapter 10: PARAMETER CONTROLS
PULSE DURATION
Wider Pulse Duration settings will deliver stronger stimulation for any given
intensity setting. As mentioned in the Controls Section, by using a
combination of intensity and pulse duration, it is felt that various pulse
widths are capable of stimulating different groups of nerve fibres. The choice
of which pulse duration to use is partially dependent upon the Treatment Mode
and Protocol selected (refer to the appropriate section).
PULSE RATE
The Pulse Rate (hertz or pulses per second) chosen depends greatly upon the
type of electrode placement given to the patient. When using contiguous and
dermatome electrode placements (i.e. stimulating directly through the area of
pain or localized enervation), a quick pulse rate (setting greater than 80Hz
on the Pulse Rate Control) is desired. The patient should not perceive
individual pulses but rather have the sensation of steady continuous
stimulation. Despite the above recommendations, these individual patients may
require slight variations of the above settings, according to the nature of
their condition.
TREATMENT MODE
Normal or Conventional TENS offers the practitioners complete control over all
the various treatment parameters of the instrument. Burst Mode is analogous to
the Low Rate TENS technique except that the low-frequency individual pulses
are replaced by individual “bursts” of 7-10 individual pulses. It is thus a
combination of Conventional TENS and Low Rate TENS. In Burst Mode, the
treatment frequency is fixed by the instrument and is not adjustable with the
Frequency Rate Control.
Modulated Mode attempts to prevent nerve accommodation by continuously cycling the treatment intensity. When using Modulated Mode increase the intensity only when the unit is at the maximum intensity of the modulation cycle. If the intensity is increased during a low-intensity period of the cycle, the patient may turn up the control very slowly, so that they may feel the intensity any higher.
TIME DURATION
The onset of pain relief should occur shortly after the intensity setting has
been determined. However, in some cases, pain relief may take as long as 30
minutes to achieve. TENS units are typically operated for long periods, with a
minimum
of 20 – 30 minutes and in some post-operation protocols, as long as 36 hours.
In general, pain relief will diminish within 30 minutes of the cessation of
stimulation.
Chapter 11: ATTACHMENT OF ELECTRODE
LEAD WIRES
The wires provided by the system are inserted into the jack sockets located on
top of the device. Holding the insulated portion of the connector, push the
plug end of the wire into one of the jacks (see drawing); one or two sets of
wires may be used. After connecting the wires to the stimulator, attach each
wire to an electrode. Use care when you plug and unplug the wires. Jerking the
wire instead of holding the insulated connector body may cause wire breakage.
CAUTION
Do not insert the plug of the patient lead wire into the AC power supply
socket.
Chapter 12: LEADING WIRE MAINTENANCE
Clean the wires by wiping them with a damp cloth. Coating them lightly with
talcum powder will reduce tangling and prolong life.
Chapter 13: ELECTRODE OPTIONS
Your clinician will decide which type of electrode is best for your
condition. Follow application procedures outlined in electrode packing, to
maintain stimulation and prevent skin irritation. Using the legally marketed
TENS electrode is recommended. The device is completed with standard carbon
film adhesive electrodes in size 4x4cm.
Chapter 14: ELECTRODE PLACEMENT
The placement of the electrodes can be one of the most important parameters in
achieving success with TENS therapy. Of utmost importance is the willingness
of the clinician to try the various styles of electrode placement to find
which method best fits the needs of the individual patient.
Every patient responds to electrical stimulation differently and their needs may vary from the conventional settings suggested here. If the initial results are not positive, feel free to experiment. Once an acceptable placement has been achieved, mark down the electrode sites and the settings on the patient’s reference sheet of this manual so the patient can easily continue treatment at home.
CONTIGUOUS PLACEMENT
This is the most common placement technique. It involves placing th electrodes
alongside the area of the localized pain site, in such a way as to direct the
flow of current through or around the area of pain. In a single-channel
application, this would involve placing each pad on either side of the pain
site if the pain is localized on a limb and deep within the tissue.
Pad placement on the posterior and anterior aspects of the affected limb will all the current to flow completely through the limb and thus through the endogenous pain With a two-channel application, the clinician may either direct the current flow to cross through the pain site or, in what is called the “bracket” method allowing the current flow on either side of the painful area, generally through the nerve branches that feed into the pain site.
Chapter 15: TIPS FOR SKIN CARE
To avoid skin irritation, especially if you have sensitive skin, follow these
suggestions:
- Wash the area of skin where you will be placing the electrodes, using mild soap and water before applying electrodes, and after taking them off. Be sure to rinse soap off thoroughly and dry skin well.
- Excess hair may be clipped with scissors; do not shave the stimulation area.
- Wipe the area with the skin preparation your clinician has recommended. Let this dry. Apply electrodes as directed.
- Many skin problems arise from the “pulling stress” from adhesive patches that are excessively stretched across the skin during application. To prevent this, apply electrodes from the centre outward; avoid stretching over the skin.
- To minimize “pulling stress”, tape extra lengths of lead wires to the skin in a loop to prevent tugging on electrodes.
- When removing electrodes, always remove them by pulling them in the direction of the hair growth.
- It may be helpful to rub skin lotion on the electrode placement area when not wearing electrodes.
- Never apply electrodes over irritated or broken skin.
Chapter 16: APPLICATION OF RE-USABLE
SELF ADHESIVE ELECTRODES
Application
- Clean and dry the skin at the prescribed area thoroughly with soap and water before the application of electrodes.
- Insert the lead wire into the pin connector on the pre-wired electrodes.
- Remove the electrodes from the protective liner and apply the electrodes firmly to the treatment site.
Removal
- Lift at the edge of the electrodes and peel; do not pull on the lead wires because itmay damage the electrodes.
- Place the electrodes on the liner and remove the lead wire by twisting and pulling at the same time.
Care and Storage
- Between uses, store the electrodes in the reseaLED bag in a cool dry place.
- It may be helpful to improve repeated application by spreading a few drops of cold water over the adhesive and tum the surface up to air dry. Over saturation with water will reduce the adhesive properties.
Important
- Do not apply to broken skin.
- The electrodes should be discarded when they are no longer in use.
- The electrodes are intended for single-patient use only.
- If irritation occurs, discontinue use and consult your clinician.
- Read the instructions for the use of self-adhesive electrodes before application.
Chapter 17: ADJUSTING THE CONTROLS
Slide Cover:
A slide-on panel cover covers the controls for Pulse Width, Pulse Rate, Mode
Selector, and Modulation Selector. Your medical professional may wish to set
these controls for you and request that you leave the cover in place.
Display LED
Each of the LEDs illuminates whenever the electronics of the device create a
current impulse. Due to the capacity of the human eye, the illumination of the
lamp can only be recognized up to a frequency of approximately 30Hz. At higher
frequencies, the lamp will appear to be constantly illuminated.
On/Off Switch and Intensity Control
If both controls are in the off-position (white markings on the housing), then
the device is switched off. By turning the controls clockwise, the appropriate
channel is switched on and the impulses display LED will illuminate and begin
to pulse according to the frequency set. The current strength of the impulses
transmitted to the electrodes increases further when the control is turned
clockwise. To reduce the current strength or switch the device off, turn the
control counterclockwise to the required setting or off-position.
Lead Connector
The connection of the electrodes is made with a two-lead connector. The device
must be switched off before connecting the cables. both intensity controls
must be in the Off position. Electrodes must be pressed firmly on the skin.
Mode Control
Expose the controls by sliding the front cover down from the top of the unit.
This switch has 3 positions; B for Burst stimulation, N for Constant
Stimulation, and M for modulation stimulation. Push the Mode Selector until
engaged in the position desired.
Pulse Rate Control
This dial determines how many electrical impulses are applied through the skin
each second. By turning these controls, the number of current impulses per
second (Hz) for both channels can be continually adjusted. Unless otherwise
instructed, turn the pulse rate.
Pulse Width Control
This dial adjusts the length of time each electrical signal is applied through
the skin, which controls the strength and sensation of the stimulation. If no
instructions regarding the pulse width are given in therapy set the control to
the suggested 70-120 µs.
Timer Control
The treatment time of TENS can be preset with Timer Control. This switch has 3
positions – 15, 30 and C (Continuous). Push the Timer Control until engaged in
the position desired.
Check/Replace the Battery
- Over time, to ensure the functional safety of TENS, changing the battery is necessary.
- Make sure that both intensity controls are switched to the off position.
- Slide the battery compartment cover and remove it.
- Remove the battery from the compartment.
- Insert the battery into the compartment. Note the polarity indicated on the battery and in the compartment.
- Replace the battery compartment cover and slide to close.
Chapter 18: BATTERY INFORMATION
TENS 3000 can be used with a rechargeable battery when necessary. If you use
rechargeable batteries, please follow the instructions.
RECHARGEABLE BATTERIES (NOT INCLUDED)
Before the use of a new unit, the rechargeable battery should be charged
according to the battery manufacturer’s instructions. Before using the battery
charger, read all instructions and cautionary markings on the battery and the
instruction manual. After being stored for 60 days or more, the batteries may
lose their charge. After long periods of storage, batteries should be charged
before use.
BATTERY CHARGING
- Plug the charger into any working 110 or 220/240v mains electrical outlet. The use of any attachment not supplied with the charger may result in the risk of fire, electrical shock, or injury to persons.
- Follow the battery manufacturer’s instructions for charging time.
- After the battery manufacturer’s instructions recommended charging time has been completed, unplug the charger and remove the battery.
- Batteries should always be stored in a fully charged state. To ensure optimum battery performance, follow these guidelines.
- Although overcharging the batteries for up to 24 hours will not damage them, repeated overcharging may decrease useful battery life.
- Always store batteries in their charged condition. After a battery has been discharged, recharge it as soon as possible. If the battery is stored for more than 60 days, it may need to be recharged.
- Do not short the terminals of the battery. This will cause the battery to get hot and can cause permanent damage.
- Avoid storing the batteries in your pocket or purse where the terminals may accidentally come into contact with coins, keys or any metal objects.
WARNINGS
- Do not attempt to charge any other types of batteries in your charger, other than the nickel-cadmium rechargeable batteries.
- Other types of batteries may leak or burst.
- Do not incinerate the rechargeable battery as it may explode!
Chapter 19: MAINTENANCE, TRANSPORTATION AND STORAGE OF THE TENS DEVICE
- The non-flammable cleaning solution is suitable for cleaning the device. Note: Do not smoke or work with open flames (for example, candles, etc.) when working with flammable liquids.
- Stains and spots can be removed with a cleaning agent.
- Do not submerge the device in liquids or expose it to large amounts of water.
- Return the device to the carrying box with sponge foam to ensure that the unit is well-protected before transportation.
- If the device is not to be used for a long period, remove the batteries from the battery compartment (acid may leak from used batteries and damage the device).
- Put the device and accessories in the carrying box and keep them in a cool dry place.
- The packed TENS device should be stored and transported under the temperature range of -20 °C ~ +60 °C, relative humidity 20% ~ 95%, and atmosphere pressure 500 hPa ~ 1060 hPa.
Chapter 20: SAFETY-TECHNICAL CONTROLS
For safety reasons, check your TENS 3000 each week based on the following
checklist.
- Check the device for external damage.
- Deformation of the housing.
- Damaged or defective output sockets
- Check the device for defective operating elements.
- Legibility of inscriptions and labels.
- Make sure the inscriptions and labels are not distorted.
- Check LED.
- LED must be illuminated when switched on.
- Check the usability of accessories.
- The patient cable is undamaged.
- Electrodes undamaged.
Please consult your distributor if there are any problems with the device and accessories.
Chapter 21: MALFUNCTIONS
Should any malfunctions occur while using the TENS, check the following:
- Whether the switch/control is set to the appropriate form or therapy. Adjust the control correctly.
- Whether the cable is correctly connected to the device. The cables should be inserted completely into the sockets.
- Whether the impulse display LED is illuminated. If necessary, insert a new battery.
- For possible damage to the cable. Change the cable if any damage is detected.
- If there is any other problem, please return the device to your distributor. Do not try to repair a detective device.
Chapter 22: CONFORMITY TO SAFETY STANDARDS
The TENS 3000 devices are in compliance with EN/IEC60 601-1: 1990+A1:
1993+A2:1995.
Chapter 23: WARRANTY
All TENS 3000 models carry a warranty of one year from the date of delivery.
The warranty applies to the stimulator only and covers both parts and labour
relating thereto. The warranty does not apply to damage resulting from failure
to follow the operating instructions, accidents, abuse, alteration or
disassembly by unauthorized personnel.
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