zewa SpaBuddy Mini Go, 21022 Instruction Manual

Instruction Manual
SpaBuddy Mini GO
Item # 21022
Carefully read the instruction manual before using this device. Be sure to comply with all “CAUTIONS” and “WARNINGS” in the manual. Failure to follow the instruc­tions may be harmful to user or damage the device. Keep this manual in a safe place for future reference.
WARNING: To avoid accidents, keep the TENS device away from
children and the inrm.
If you do not understand any part of these instructions, contact Zewa Customer Service at 1-888-993-3592.
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Contents
Introduction ......................................................... 3
Statement Of Intended Purpose ................... 3
How SpaBuddy Mini GO Works................... 3
TENS E󰀩cacy ............................................... 4
Unpacking Your SpaBuddy Mini GO .................. 4
Parts of the SpaBuddy Mini GO ........................ 5
Contra-Indications, Safety Instructions and
Precautions ......................................................... 6
Usage ........................................................... 6
Device Use Warnings ................................... 6
User Precautions........................................... 7
Adverse Reactions ....................................... 8
Preparing for Use ................................................ 8
Installing or Changing the Device Battery...... 9
Connecting the Device and Electrode Pad ... 9
Electrode Pad Skin Placement ................... 10
Device Operation ........................................ 10
At the Completion of Treatment .................. 10
Cleaning, Maintenance and Storage ................. 11
Device ......................................................... 11
Electrode .................................................... 12
Troubleshooting Guide ...................................... 13
Disposal............................................................. 14
Device Certication ........................................... 15
Technical Specications .................................... 15
References ........................................................ 15
Appendix 1:
Placement of Electrode...................................... 17
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Introduction
Congratulations on the purchase of your new SpaBuddy Mini GO. Transcutaneous (through the skin) Electrical Nerve Stimulation, known as TENS, is a non-invasive therapy used to relieve pain. Unlike strong pain medication, TENS does not cause nausea, drowsiness or lead to depen­dence.
Reviewing the medical literature confirms the beneficial effect of TENS therapy on relieving acute and chronic pain, soothing bodily fatigue in congested limbs and improving blood circulation in treated areas.
Statement of Intended Purpose
The SpaBuddy Mini GO is a high frequency medi­cal device intended for the relief of both acute and chronic pain. This device may be used to relieve a variety of painful complaints including sciatica, period pain, migraine, nocturnal leg cramps, mus-
cular pain and sti󰀨ness due to sport, domestic or
work activities.
How TENS Works
The mechanism of action for TENS is unclear but is believed to involve a series response within the body against pain. The SpaBuddy Mini GO trans­mits electrical impulses through electrodes placed on the painful area. These impulses, which are comparable to body’s natural bioelectricity, are felt as a tingling sensation on the skin initially exer­cising muscles, warming the area and improving local circulation. After several minutes of treatment the release of Endorphins and Enkephalins is stimulated. These substances are the body’s natu­ral pain relieving hormones and act by raising the threshold of pain perception.
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The nal e󰀨ect associated with TENS therapy re-
sults from prolonged electrical stimulation of nerve bres causing the establishment of a neural block­ade of pain message transmission to and from the brain. This further reduces pain perception.
TENS E󰀩cacy
Clinical studies show TENS to be an e󰀨ective and
safe, alternate method for the relief of pain, even pain that hasn’t responded to other treatments. TENS provides symptomatic pain relief that can be used individually or in combination with other treatments including medication, physiotherapy, infrared therapy, etc to the improve pain manage­ment.
TENS efficacy is affected by several factors in­cluding the nature of the pain, how easily the electrode application site can be identied, the op­timal use of electronic frequencies and intensities for treatment, the duration of each treatment and
the individual’s physical condition. The e󰀩cacy of
treatment therefore may not always be effective for every user.
Unpacking Your TENS
Remove and examine the carton’s contents to ensure all the listed items are supplied and are undamaged. If an item is missing or damaged call Zewa Customer Service at 1-888-993-3592.
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NOTE: Retain the carton and packing materials
for use in shipping or storing the unit.
The SpaBuddy Mini GO TENS includes the follow­ing items:
1 x TENS Device
1 x Self-Adhesive Electrode Pad
1 x 3V CR2032 Battery
1 x User Manual
Parts of the SpaBuddy Mini GO
The parts of the SpaBuddy Mini GO device and electrode pad are shown below in Figure 1.
FIGURE 1: The parts of the SpaBuddy Mini GO device and electrode pad
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Contra-Indications, Safety Instructions and Precautions
Please read this information carefully before using this device.
Usage Contra-Indications
ⓘ Do NOT use this device if:
You have a cardiac pacemaker, implanted
debrillator or any other implanted metallic or
electronic device.
You have undiagnosed chronic pain.
You are in the rst trimester of pregnancy
You are being treated for or have symptoms of deep venous thrombosis (DVT)
Device Use Warnings
Consult with your doctor before using this device, if you have any medical condition that requires the continuing care of a doctor, including:
Suspected or a diagnosed serious heart prob­lem, epilepsy or cancer.
A tendency to excessive internal bleeding after an injury.
Do not use this device on children under 12 years of age without consulting your doctor.
Do not place the electrode pad so that electri­cal impulses pass directly across the front of the throat, neck, eyes or head (trans- cranially), on the genitals, across the chest or close to the heart as this may be harmful.
Place the SpaBuddy Mini GO electrode pad only on healthy, clean and dry skin. Do not place it on open wounds, rashes, scars or over
swollen, infected or inamed skin.
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Do not use this device on skin areas that lack normal sensations, including skin that tingles, feels “pins and needles” or is numb.
Do not use this device when asleep, driving, operating machinery, swimming or bathing.
The safe use of TENS therapy during pregnan­cy has not been established.
User Precautions
Turn off the device if the stimulation feels unpleasant or does not provide pain relief. If
acute pain continues beyond ve days, consult
your doctor as a more comprehensive treat­ment plan including medication, physiother­apy, infrared therapy, etc may be required to achieve improvement.
Before removing the device, ensure it is turned OFF, to avoid an unpleasant stimulation.
Some people experience skin irritation or an intense skin sensitivity due to electrical stimu­lation. If this occurs, stop using the device and consult your doctor.
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Adverse Reactions
Side e󰀨ects of TENS therapy are generally mild,
even with extended use. The most common side-
e󰀨ects include:
Muscle Soreness and Twitching
The constant pulsing of TENS therapy can cause muscle soreness and twitching due to electrical over-stimulation. This condition generally allevi­ates by applying shorter treatment times or de­creasing the frequency of daily therapy.
Skin Reddening and Soreness
Minor redness at the site of electrode placement is a normal skin reaction. It is not considered as skin irritation and normally disappears within 30 min­utes after the electrode is removed. If the redness does not resolve after 30 minutes, stop treatment until any excessive redness has cleared.
If the skin under the electrode is irritated when using long treatment times, decrease the length of treatment. Cleansing the skin beneath the pad with alcohol and applying ultrasonic gel will in­crease the conductivity of the electrodes and may protect the skin from irritation.
If any e󰀨ects are especially bothersome, consult
your doctor.
Preparing for Use
Before using this device ensure you are famil­iar with the contra-indications, safety notes and precautions for use stated on pages 6 to 8 of this manual.
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Installing or Changing the Device Battery
FIGURE 2: BATTERY REPlACEMENT
Install or change the battery in this device by slid­ing the battery compartment cover, located at the back of the device, to the right. Insert a CR2032 battery in the battery compartment with the posi­tive (+) polarity facing up (See Figure 2). To check
that the battery has been tted correctly press the
ON/UP button once and the led will glow green.
Hence press the OFF/DOWN button to switch-o󰀨
the device. Replace the battery compartment cov­er.
Connecting the Device and Electrode Pad
Place the electrode with the contact plugs facing
upward on a at surface. Place the TENS device
with the contact jacks facing down onto the elec­trode pad so that plugs and jacks are aligned. Then press down the device until it is securely connected to the electrode pad.
Do not remove the plastic lm from the electrode
pad until ready to place it on the skin.
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Electrode Pad Skin Placement
Ensure the skin is clean and dry before placing the electrode pad. Remove the plastic film from the electrode pad by holding the edge of electrode and peeling it away from the plastic. Place elec­trode pad on the selected skin and smooth it down
with rm pressure.
Do not discard the electrode’s plastic lm as it will
be required to store the electrode pad at the com­pletion of the treatment.
Device Operation
Switch the device on by pressing the ON/+ button and the function display light will illuminate. By pressing the On/+ button again, the device begins treatment at its lowest intensity level. The device has 10 intensity levels to allow the selection of appropriate treatment strength. Select the desired intensity level by pressing the On/+ button the re­quired number of times.
This device will automatically stop and switch o󰀨
after 20 minutes of treatment.
Treatment may be discontinued at any time by pressing -/OFF button repeatedly (depending on the level of intensity selected) until the function
display light turns o󰀨.
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At the Completion of Treatment
Never remove the TENS device from the skin while it is switched on.
Remove the electrode pad from the skin by lifting it at the edge and pulling carefully. Replace the
electrode pad directly back onto the plastic lm.
NOTE:
Do not switch on the device before positioning the electrode pad on the skin.
Do not store or leave the electrode pad in di­rect sunlight.
Device Cleaning, Maintenance and Storage
The TENS device does not require any special maintenance.
Remove the battery from the device before under­taking any cleaning procedures.
Remove any stains from the device’s casing with a soft, slightly moistened cloth. Never use aggressive cleaning products or stiff brushes on the device’s casing.
Protect the device from water, ensuring no wa­ter penetrates the device during cleaning.
Do not use the device for further treatments
until it is completely dry.
Remove the battery from the device if it is to be unused for an extended period of time.
Protect the device from prolonged heat expo­sure, dirt and moisture.
Store the device, with the electrode pad on the
protective plastic lm, in a cool, dry place.
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Electrode Cleaning, Maintenance and Storage
Cleaning the electrode pad’s gel surface after use will prolong the pad’s skin adhesion. Moisten the gel on the electrode pad with a drop of water and
allow it to dry briey. Then replace the electrode back onto the protective lm.
The length of time the electrode pad can be re­used depends on its storage, your skin type and usage time per treatment. As a guide, the elec­trode pad generally provides 20 to 30 treatments of 20 minute duration.
Replace the electrode pad when it is no longer ad­hesive, cracks or becomes discolored.
Use only original SpaBuddy Mini GO Self Adhe­sive Electrode Pads.
Store the electrode pad on the protective plastic
lm, in a cool, dry place.
NOTE: Electrode pads are for single person
use only. Use a separate electrode pad for each user.
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Troubleshooting Guide
Problem Cause Remedy
LED fails to illuminate
No battery in the device or the
battery is at
Battery is insert­ed incorrectly
The device is not switched on
The plastic lm
between the battery and the device has not been removed
Replace the battery
Insert battery with the positive (+) facing up
Switch the de­vice on
Remove the
plastic lm
between the battery and the device
LED illuminates but only weakly
low battery Replace the
battery
Weak device output
Electrode pad dirty
Device not ap­plied properly
Clean/replace electrode pad
Re-apply Device
LED illuminates but there is no power output
Flat battery
Electrode pad dirty or short-cir­cuited
Replace battery
Check the electrode pad and replace if necessary
Device switches
o󰀨 prematurely
The battery is
at
The electrode pad worn out or dirty
Device is applied incorrectly
Replace the battery
Check the electrode pad and replace it if necessary
Re-apply device
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Contact Zewa Customer Service at 1-888-993­3592, if your problem does not rectify.
NOTE:
Do not disassemble the TENS device as it can­not be serviced at home.
Unauthorised disassembly of this device will void the warranty.
Disposal
Waste medical products should not be disposed of with household waste. If this device is no longer required or it is no longer serviceable, dispose of the device and its accessories in com­pliance with local regulations. Please recycle where facilities exist.
Check with your local Council for recy­cling information
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Technical Specications
SpaBuddy Mini GO
Channel Single Channel
Output Voltage 0~30V +/- 20% (at 500 Ohm
load)
Pulse intensity Adjustable from 0~60mA +/-
20%
Pulse Width 150~250 µS
Pulse Rate 30~60 Hz
Power Source 1 lithium Cell Battery CR-2032
Timer 20 minutes
Operating 50°F to 104°F (10°C to 40°C)
Conditions 4 0 % - 9 0 % m a x .
Relative Humidity
Storage 14°F to 140° (-10°C to 60°C)
Conditions 3 0 % - 9 5 % m a x . Relative Humidity
Weight 12.3g (0.5oz) including battery
Dimensions 9 x 30 x 12.15mm (2.3 x 1.2 x 0.5in) Electrodes Model AI-T2302
Specication 72x57 mm, Snap Type
References
1.
Tugay N. et al. E󰀨ectiveness of transcutaneous
electrical nerve stimulation and interferential current in primary dysmenorrhea. Pain Med.
May-Jun 2007; 8(4):295-300.
2.
lewers D. et al., Transcutaneous Electrical Nerve Stimulation in the Relief of Primary Dys­menorrhea. Physical Therapy. Jan 1989, 69:3-9.
3.
Parsa P. et al., E󰀨ect of transcutaneous elec­trical nerve stimulation (TENS) on primary dys­menorrhea in adolescent girls. J Postgrad Med Inst. 2013; 27(3):326-30.
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Appendix 1: Electrode Placement Options
Electrode Positioning
This manual provides a series of body maps to illustrate electrode positioning for various painful conditions. The body maps provided have been selected on the basis of the SpaBuddy Mini GO appropriateness in the treatment of the complaint. Correct electrode placement will improve the e󰀩­ciency of pain relief therapy.
Multiple TENS units may be applied at the same time, for example one on each side of the pelvic area. neck thigh, calf, etc if extra pain relief is re­quired.
Please review the electrode pad placement pre­cautions on page 10 of this manual. Ensure the TENS device is OFF prior to the electrode pad
being applied to or removed o󰀨 the skin.
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Placement of Electrode
Manufactured for Zewa, Inc. 12960 Commerce Lakes Dr. # 29 Fort Myers, FL 33913 USA
www.zewa.com
Toll Free Customer Service: 1-888-993-3592
Made In Taiwan
IM-23-047 RevA18
FDA-2301A
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