Body Clock Flexi TENS User manual

Flexi TENS
Instructions for use
Caution: Federal Law restricts this device to sale or use by or on
the order of a practitioner so licensed by the State.
TM
Flexi TENS Inst US 2009. x7:Layout 1 10/6/09 11:09 Page 1

The Flexi TENS is an ultra-
simple, yet power ul digital
TENS unit - lexible
because it can be used or
one or two pain areas -
ideal or numerous acute
and chronic pain
conditions.
TENS is recognised as a safe and highly
effective method of pain relief and is
regularly recommended by medical
professionals.
TENS is a drug free method of pain relief,
with no known side effects.
It can also be used in conjunction with
any additional medication if required.
Explanation of Symbols on Unit
Equipment providing a particular
degree of protection against
electric shock particularl
regarding allowable leakage
currents having an F t pe
(floating) applied part.
Warning – refer to accompan ing
documents i.e. these instructions.
Denotes a product which must be
disposed of safel .
1
Flexi TENS Inst US 2009. x7:Layout 1 10/6/09 11:09 Page 2

2
Contents
Introduction To Patient and Professional..........2
What is Tens and How Does it Work?..................2
Accessories..........................................................3
How to Place Electrodes......................................4
ead Wires ..........................................................4
Controls on the Flexi TENS ................................5
Additional Functions............................................5
User Display ........................................................5
The Assembly Stage............................................6
Using your Flexi TENS ........................................7
Contraindications ................................................8
Warnings..............................................................8
Precautions..........................................................8
Adverse Reactions ..............................................8
Maintenance and Care........................................9
General Precautions: ..........................................9
Checking System Performance: ..........................9
Device Failures ....................................................9
TENS Frequently Asked Questions....................10
Technical Data....................................................11
Guarantee ..........................................................14
Introduction to Patient and
Professional
The Body Clock Flexi TENS is designed for
the treatment of symptomatic relief and
management of chronic intractable pain
and/or as an adjunctive treatment in the
management of post-surgical and post-
traumatic acute pain.
The instructions in this manual are
designed to cover most operational issues.
However if you have any questions about
your particular condition or if problems
arise, please seek advice from your
physician or therapist.
hat is TENS and how
does it work?
TENS stands for Transcutaneous Electrical
Nerve Stimulation.
Flexi TENS Inst US 2009. x7:Layout 1 10/6/09 11:09 Page 3

The treatment consists of passing mild
electrical impulses through your skin into
the nerve fibers that lie below. Contact is
made with your skin via electrodes. TENS
electrodes are placed around or over the
painful area.
In 1965, researchers Melzack and Wall
presented their concept of a “gate” theory
for pain control. This theory says that a “T”
cell transmits signals to the dorsal horn,
and that the stimulation of large nerve
fibers may result in the blocking of pain
transmission. The TENS message is carried
to the spinal chord faster than a pain
message and closes a hypothetical gate,
inhibiting the pain message to the brain.
This applies when the pulse rate is set at a
higher frequency of 60-80 pulses per
second or more.
TENS can also work by stimulating the
body to release endorphins, the body’s
own pain killing substances. This applies
when the Pulse Rate is set below 4 pulses
per second – usually at 2 pulses per
second. This lower frequency treatment
produces slight muscle twitching (tapping).
Patients find this treatment takes longer, at
least 20-30 minutes to be effective, but the
resulting pain relief can last for a longer
period.
Accessories
The Flexi TENS is a dual channel TENS unit,
supplied with the following accessories:
1. 1 pack of 4 50mm x 50mm self adhesive
electrodes;
2. 2 x AAA battery;
3. 1 single lead wire;
4. 1 dual lead wire;
5. 1 manual;
6. 1 carrying pouch; and
7. 1 neck cord.
3
Flexi TENS Inst US 2009. x7:Layout 1 10/6/09 11:09 Page 4

How to place electrodes
Body Clock TENS units are supplied with 2
x 2 (50mm x 50mm) self-adhesive
rectangular electrodes These are
consumable items that can be re-ordered
from Body Clock.
• Store electrodes in packaging provided in
a cool dry place.
• A key to successful use of the stimulator
is finding the best placement for the
electrodes. You may need to try several
electrode locations before you find the
best one to intercept your pain.
• Before placing the electrodes on your
skin, wash the area with mild soap and
water and then thoroughly rinse and dry.
• Trim excess body hair, which could
interfere with smooth electrode contact
with the skin, but do not shave it.
• Do not place electrodes on cut, broken or
irritated skin.
• Moisturizing cream may be applied after
treatment, but not before.
• Never place or remove the electrodes,
test or wet them while the system is
turned on and connected to the
electrodes. Failure to comply can result
in a sudden unpleasant sensation on
your fingertips.
Lead ires
The lead wires are made of high quality
shielded wiring. They are made from fine
wire to be flexible and lightweight and if
treated gently are designed for long life.
The pin ends of the leadwires are inserted
into the electrodes.
4
Flexi TENS Inst US 2009. x7:Layout 1 10/6/09 11:09 Page 5

Controls on the Flexi TENS
5





Low battery
indicator.
Indicates the
mode in use.
Indicates the
intensity level
of the pulses.
POWER Key – Turns the Flexi TENS On and
Off.
User display – Indicates the mode in use
and the intensity level. (also see diagram
below).
MODE Key – Changes the mode in use.
Intensity UP – Increases the intensity of
the pulses.
Intensity Down – Decreases the intensity
of the pulses.
Additional Functions
oad Detector - If an electrode becomes
detached from the skin, the intensity will drop
back to zero.
ow Battery Indicator - A flashing battery
symbol will be shown on the display.
Automatic Power Off - When the unit intensity
levels are zero, and the Flexi TENS has not been
in use for about 5 minutes, the unit will shut off
automatically.
User Display
Flexi TENS Inst US 2009. x7:Layout 1 10/6/09 11:09 Page 6

The assembly stage
1. Slide open the battery cover on the back of
the unit to expose the battery compartment.
2. Insert the batteries according to the
diagram found in the battery compartment.
Replace the cover.
3. Select the leadwire that you wish to use for
your treatment:
a). The single leadwire can be used to
treat one pain area OR
b). The dual leadwire can be used to treat
two pain areas, or a large pain area such
as your back.
4. Insert the plug end of the leadwire into the
jack plug socket at the bottom of the Flexi
TENS.
5. Connect the electrodes to the pin ends of
the leadwire (see diagram right).
Insert a red
and black pin
(at the end of
the lead wire)
into each pair
of electrodes.
6
Flexi TENS Inst US 2009. x7:Layout 1 10/6/09 11:09 Page 7

7
Before first use of the Flexi TENS, please familiarise yourself with the
warnings and contraindications contained on page 10.
Using your Flexi TENS
The Flexi TENS has 4 TENS modes. Each has
been designed to provide a different sensation.
You can use any of the TENS modes to treat your
pain. The table below sets out a brief
description of the sensation each mode
provides:
Mode A Tapping
Mode B assage
Mode C Tapping massage
Mode D Extended burst
To commence treatment
Carefully peel the electrodes from the plastic
backing, using your forefinger and thumb.
Then position the electrodes in accordance with
the instructions provided with your electrodes
or preferably from your medical advisor.
Once the electrodes are positioned correctly,
switch the unit on. MODE A will start to flash on
the screen.
Select the mode that you wish to use by
pressing the MODE key. Once you have selected
your mode, gradually increase the intensity
using the arrow UP key, until the sensation is
comfortable. Intensity can be reduced by using
the arrow DOWN key.
Flexi TENS Inst US 2009. x7:Layout 1 10/6/09 11:09 Page 8

8
Contraindications
1. Any electrode placement that applies
current to the carotid sinus (neck)
region.
2. Any use of TENS on patients who have a
demand-type cardiac pacemaker.
3. Any electrode placement that causes
current to flow transcerebrally (through
the head).
4. The use of TENS whenever pain
syndromes are undiagnosed, until
etiology is established.
arnings
1. The safety of TENS devices for use
during pregnancy or birth has not been
established.
2. TENS is not effective for pain of central
origin (This includes headache).
3. TENS devices should be used only under
the continued supervision of a physician.
4. TENS devices have no curative value.
5. TENS is a symptomatic treatment and as
such suppresses the sensation of pain
which would otherwise serve as a
protective mechanism.
6. The user must keep this device out of
the reach of children.
7. Electronic monitoring equipment (such
as ECG monitors and ECG alarms may
not operate properly when TENS
stimulation is in use.
Precautions
1. Isolated cases of skin irritation may
occur at the site of electrode placement
following long term application.
2. Effectiveness is highly dependent upon
patient selection by a person qualified in
the management of pain patients.
Adverse Reactions
Skin Irritation and electrode burns are
potential adverse reactions.
Flexi TENS Inst US 2009. x7:Layout 1 10/6/09 11:09 Page 9

9
Maintenance and Care
Guidelines for Optimum Performance:
• Change the battery regularly.
• The unit must be switched off when
changing the battery.
• The unit should be wiped clean period-
ically using a very slightly dampened
cloth. A mild soap may be used but DO
NOT apply solvents.
General Precautions:
• Do not yank or twist the leadwires –
treat them gently for long life. They are
made from fine wire to be flexible and
lightweight.
• Do not immerse your TENS in water or
any other liquid
• Do not place it close to any source of
excess heat
• Do not operate your unit in the presence
of flammable gases
• Do not attempt to open the TENS unit
• Do not use battery or power sources
other than those specified
• Do not drop this unit onto a hard
surface
Checking system performance:
• If your unit does not appear to be
operating properly, first change the
battery. Replacing the battery can
eliminate most operational problems.
• Ensure that the leadwire attachment is
properly fixed to the unit.
• Check the electrodes are firmly attached
to the pins of the leadwire.
• Make sure that the leadwire is not
damaged or broken.
Device Failures
• Please do not attempt to repair
damaged devices yourself.
Flexi TENS Inst US 2009. x7:Layout 1 10/6/09 11:09 Page 10

10
• In case of further inquiries, always state
the model of your device (as indicated
on the back of the unit).
• Body Clock TENS should be repaired by
qualified technical personnel.
• Body Clock TENS units are guaranteed
for a period of 5 years against
manufacturer’s defects.
• Note: the guarantee is null and void if
any attempt is made to open the unit by
unauthorized personnel.
• In the event of a fault please contact the
supplier (address found on the invoice
or delivery note) or
Body Clock, 108 George ane,
South Woodford, E18 1AD.
Tel: [phone]
Fax: [phone]
email: [e-mail]
TENS - Frequently Asked Questions
Q.Is it safe?
A.Yes, TENS is used widely for pain relief
and is recommended by medical
professionals.
Q.Can I use it with other medications?
A.Yes. TENS is drug free so you can use it
with any other medication including
paracetamol.
Q.What conditions can TENS be used to
treat?
A.TENS can be used to treat numerous
pain conditions. If you are unsure about
using TENS please consult your medical
adviser or contact Body Clock Health
Care.
Flexi TENS Inst US 2009. x7:Layout 1 10/6/09 11:09 Page 11

11
Technical Data
Display
Operation ode Four modes
- A
- B
- C
- D
Pulse (Hz) Pulse Display
Frequency Width (us)
A 45 208 A
B 55 100 B
C 44 208 C
D 90 100 D
Memory emorises latest selections
when switched on
Automatic
Power O 5 inutes
Output Channel ONE Channel
Output Voltage ± 70V adjustable in 14 steps
(500Ω load, peak to peak)
Output Intensity 0 - 140 mA adjustable in
14 steps (500Ω load)
Output Wave orm Symmetrical multiphase
bipolar rectangular
Output Jacks CE Touch-proof jacks
Load Detector Contact detection between
the device and human skin
Battery 2 X1.5V AAA Battery
(Type LR6)
Battery Low Detect 2.2V±0.1V
Weight / Size 45g / 12 x 3 x 1.5cm
Flexi TENS Inst US 2009. x7:Layout 1 10/6/09 11:09 Page 12

12
Flexi TENS Inst US 2009. x7:Layout 1 10/6/09 11:09 Page 13

13
Flexi TENS Inst US 2009. x7:Layout 1 10/6/09 11:09 Page 14

14
Guarantee
Your TENS machine is guaranteed for a period of 5 years against
manufacturer’s defects. Please record purchase details in the
space provided below for your record purposes.
The guarantee does not include leads, electrodes or battery
Name of product: Flexi TENS
Date of purchase:
Invoice number:
Flexi TENS Inst US 2009. x7:Layout 1 10/6/09 11:09 Page 15

Body Clock Health Care Ltd
108 George Lane
South Woodford
London E18 1AD
England
Tel (+44) (0)20 8532 9595
Fax (+44) (0)20 8532 9551
www.bodyclock.net
e-mail [email protected]
ISO 9001:2008 ISO 13485:2003
Medical De ices Directi e 93/42/EEC Annex V
0120
June 2009 (3)
Flexi TENS Inst US 2009. x7:Layout 1 10/6/09 11:09 Page 16