FW Fisher Wallace Stimulator User manual

!
PL$1003!Rev.!A!
1
THE FISHER WALLACE STIMULATOR FOR THE TREATMENT OF PAIN ON THE BODY
INSTRUCTION MANUAL.Call us with any questions: (800) 692 - 4380
1.0 INTRODUCTION
The Fisher Wallace Stimulator is a portable, battery-powered device which has been cleared by the FDA for
symptomatic relief of chronic pain, post-traumatic acute pain and post-surgical pain when used on the body. The
device is also cleared by the FDA for the treatment of depression, anxiety and insomnia. Although the device
poses no significant risks to health, patients should be monitored by their physician at least once every three
months while using the device; more frequent monitoring is recommended. Do not attempt to reduce or cease
use of other medication without first consulting your doctor.
The device delivers a micro-electrical stimulus (1-4 mA) that is carried by electrical cables to wet sponges (supplied
with the device) that are applied to the skin. When treating site-specific pain on the body, the electrodes are
placed on the body. As clearly illustrated in this manual on pages 6-12, the red wire electrode is typically placed at
the rear base of the neck and the black wire electrode is placed on the pain site (with the exception of gastro pain
treatment). The electrodes are secured to the body with Velcro body straps, which are included in the kit.
Read section 10.0 APPLICATION OF THE DEVICE ON THE BODY for instructions for use, as well
as the Treatment Diagrams on pages 6-12 for guidance regarding the treatment of Back Pain, Shoulder
Pain, Gastro Pain, Elbow Pain, Phantom Limb Pain, Arthritic Pain and Neck Pain.
Please email us at [e-mail] or call us at (800) 692 - 4380 with any questions.
2.0 CONTRAINDICATIONS
The device is contraindicated for use in patients who have demand or sensing type cardiac pacemakers.
3.0 WARNINGS
Keep the device out of the reach of children. Electronic monitoring equipment (such as ECG monitors, ECG
alarms) may not operate properly when CES stimulation is in use. High Frequency surgical equipment may not be
used when CES stimulation is in use. Do not operate the CES stimulator in close proximity to short-wave or
microwave therapy equipment.
This device is not suitable for use with oxygen or in the presence of a flammable anesthetic mixture with air or
oxygen, or with nitrous oxide.
4.0 PRECAUTIONS
This device should not be used on the throat or neck, except the rear base of the neck as indicated in the diagrams
for treating pain (see the Chronic Pain Instruction Manual). This device should not be used on the eyes. This
device should not be used on or near areas of the body, including the head, that contain implanted devices, such as
stimulators, stents, and active or inactive implants such as deep brain stimulators and vagus nerve stimulators.
Patients should avoid using the device near areas of the body where there is embedded shrapnel or metal plates.
There is no danger in using the device if you have dental fillings.
Do not allow water to enter this device. The Fisher Wallace Stimulator should not be exposed to environmental
conditions where the system may get wet.
5.0 ADVERSE REACTIONS (VERY RARE)
Skin irritation may occur at the site of sponge electrode placement, especially if the sponges deteriorate (sponges
should be replaced EVERY TWO WEEKS) or if contact is made between the skin and the metal part of the
sponge receptacle, or if the sponges are not thoroughly wet before each use. A mild headache or dizziness may
occur, and should cease after you stop using the device. Such reactions are very rare.

!
PL$1003!Rev.!A!
2
6.0 FEDERAL LABELING
Federal Law (USA) states that this device must only be purchased by or under the order of a health care
practitioner, licensed in the state in which he/she practices.
7.0 INDICATIONS FOR USE
The Fisher Wallace Stimulator is a portable battery powered pulse generator that may be used for symptomatic
relief of chronic pain, post-traumatic acute pain and post-surgical pain. Your physician will prescribe the
appropriate duration to utilize the Fisher Wallace Stimulator. Please refer to the enclosed diagrams regarding
electrode placement and standard treatment durations. Typically, patients should use the device on the body
two to three times a day for twenty to forty minutes per treatment session, at Level #3 or #4.
8.0 DEVICE CONTROLS
The Fisher Wallace Stimulator has only one knob that encompasses both the ON/OFF switch for turning the
device ON or OFF as well as adjusting the level of current.
There is a green LED indicator light that flashes when the device is turned ON.
There are four (4) yellow LED indicator lights that flash according to the intensity of stimulation. Level #2 is
typically used when the sponge electrodes are placed on the head, and level #3 and #4 are typically used when the
sponge electrodes are placed on the body.
Both the green and yellow lights flicker when lit – this is normal.
9.0 SKIN PREPARATION
Good skin care is important in minimizing any skin irritation, which may be encountered with the active use of the
electrodes. Thoroughly wash the skin sites where the electrodes will be placed.
10.0 APPLICATION OF THE DEVICE ON THE BODY
To treat pain on a particular area of the body, such as the lower back or elbow, apply the red-lead sponge
electrodes to the rear base of the neck (except when treating gastro pain) and the black-lead electrode to the pain
area. Use the Velcro straps to hold the electrodes in place. Refer to the body diagrams below on pages 6-12 for
electrode placement and application. If you have any questions, please call or email us.
10.1 Electrode Preparation
New headsets come with new sponges (dehydrated yellow disks) already installed in the white sponge receptacles.
The sponges will expand when submerged in water. You may wet the sponges separately or while they are in the
plastic receptacles. The entire plastic sponge receptacle, including the wire, may be dunked into water. The wet
sponges should fit into the white receptacles in such a way that the edge of the receptacles overlaps the sides of the
sponges.
Snap the red and black wires onto the receptacles and then connect the other ends of the wires into the stimulator.
Black and red colors should be matched.
After use, sponges will dry more quickly if removed from the receptacles and allowed to dry by themselves.
SPONGES SHOULD BE REPLACED EVERY 2-4 WEEKS FOR OPTIMAL PERFORMANCE.
Replacement sponges may be purchased on www.FisherWallace.com.
10.2 Electrode Placement
Please refer to the diagrams on pages 6-12 regarding electrode placement and standard treatment
durations.

!
PL$1003!Rev.!A!
3
Make sure the sponges are wet. Use the enclosed Velcro body straps to secure the red wire electrode to the rear
base of the neck (see below) and the black wire electrode to the area of the body that is experiencing pain as
indicated in the diagrams.
Below is an example of how to use the Velcro body straps to secure the sponge electrodes. You may use other
kinds of straps if you prefer, as long as the sponge electrodes are secure:
Velcro Strap on base of neck Red Wire sponge electrode tucked
beneath strap, wet sponge against skin
Velcro Strap on elbow Black Wire sponge electrode tucked
beneath strap, wet sponge against skin
10.3 Treatment Duration
When used on the body, the device may be used 2-3 times a day, for 20-40 minutes per treatment session.
The device will turn off automatically after 20 minutes. To reactivate the device for another 20 minutes,
turn the dial clockwise to the OFF position until you hear an audible click, and then turn the device back
on.
10.5 Device cleaning
The device and headset should be thoroughly cleaned every two weeks. To clean the device, remove the
black and red wires from the base unit, remove the old sponges from the sponge electrodes, dampen a cloth or
paper towel with alcohol and clean the inside and outside of the plastic electrode receptacles in a circular motion.
Insert a new pair of sponges and dispose of used sponges. To clean the base unit, dampen a cloth or a paper towel

!
PL$1003!Rev.!A!
4
with alcohol and wipe down the base unit.
Once clean, reinsert the wires into the base unit, matching the wire colors to the circles on the base unit. Now you
can continue to use the device.
11.0 BATTERY REPLACEMENT
In order to replace the battery, remove the battery compartment cover on the back of the device by sliding the
cover into the open position. Use only high quality AA batteries.
12.0 TROUBLE SHOOTING
If your device turns off before the 20 minutes are up, or when the device is set down on a table or lightly
jarred or tapped, re-insert the batteries. Sometimes the batteries will misalign with the metal receptors in the
battery compartment and as a result, the device will turn off when lightly jarred or tapped.
If the green “ON” light does not illuminate when the device is turned ON, first turn the device completely OFF
by rotating the dial clockwise until you hear a click, then try turning the device ON again. Replace the batteries
with fresh ones if you still have trouble.
If the yellow indicator lights (1-4) do not illuminate, be sure the sponges are new, clean and thoroughly
wet. The hair / skin beneath the sponge electrodes must also be sufficiently wet. People with thick hair
may have more difficulty wetting the hair enough to cause the electrodes to conduct. Some people with
small heads will require a tighter headband to make the electrodes work properly – adequate pressure is
needed against the electrodes by the headband.
To test if the electrodes are working, press the two sponge electrodes together (like an “Oreo cookie”), turn the
device ON (green light flashing), and, while continuing to squeeze the sponge electrodes together, continue dialing
up (counterclockwise) until you see the yellow lights illuminate.
If the yellow lights illuminate when you test them but not when you have them in use on your head or body, then
the wetness of the sponges / hair / skin is insufficient or the tightness of the headband or strap holding the
electrodes in place may be insufficient. Make sure the headband or strap provides a snug fit. If the headband or
strap is not pressing the electrodes firmly enough, adequate conductivity may not occur. Press the wet electrodes
firmly while the device is on and see if this causes the yellow lights to illuminate. If they illuminate, you will need a
smaller headband or to tighten the strap.
If your device beeps throughout the treatment session, or fails to beep at the end of the session, replace
the batteries.
If, after trying the above suggestions, you are still having trouble with your device, call us at [phone] or
email us at [email protected]. If we cannot fix your problem over the phone, we will repair or replace your
device.
If you are required to return your device for repair or replacement, you will be responsible for shipping it to us.
We will repair or replace the device for free if it is still under warranty, and ground ship it back to you at no cost.
If you would like the repaired or replaced device shipped overnight to you, you will be charged $58.95 for
expedited shipping. In-person drop offs by customers are not accepted at our administrative offices in New York
City.
13.0 THEORY OF OPERATION
The electronic waveform contains a 15,000Hz square wave carrier which is rectified, varying from zero to a maximum of 4
milliamperes. The first modulating signal of 15Hz provides an "ON" time of 50 milliseconds and an "OFF " time of 16.7
milliseconds. The second modulating signal of 500Hz changes the "ON" time series of 15,000Hz carrier pulses (750 pulses in
50 milliseconds) into 25 smaller bursts of 15 pulses each of the 15,000Hz carrier signal 375 pulses in the same 50 milliseconds.
The subject device is a bipolar version of a TENS device, wherein the first major burst of energy (50 milliseconds is positive
[above the zero axis], followed by a 16.7 millisecond "OFF " time, is then followed by a second major burst of energy (50
milliseconds is negative [below the axis]) followed by a 16.7 millisecond "OFF " time. Thus, the consecutive positive burst and
OFF time is followed by an equal and opposite negative burst and OFF time, balancing the direct current component to zero.

!
PL$1003!Rev.!A!
5
c.) The pulse period for the basis carrier waveform of 15,000Hz is 66.7 microseconds (50% duty cycle). d.) The pulse period
for the 1st Modulator of 15Hz is 66.7 milliseconds (75% duty cycle). e.) The pulse period for the 2nd Modulator of 500Hz is 2
milliseconds (50% duty cycle). f.) The output voltage is variable from zero to 40 volts and then voltage limited, first positive
and then negative. Therefore, load impedances of up to 10,000 ohms will be able to have a constant current of up to 4
milliamperes. However, beyond 10,000 ohms, the constant current is limited inversely with the load, (ie: A patient with a 10,000
ohm impedance will be able to receive a maximum of 2 milliamperes).
14.0 DEVICE SPECIFICATIONS
PARAMETER NOMINAL VALUE
Output Amplitude (milliamperes) 0-4 mA
Rate 15/500/15.000 Hz
Pulse Width 33 microseconds
Maximum Charge per Pulse 0.13 microcoulombs
On Time per Burst 50 milliseconds
Off Time per Burst 16.7 millisecon
Operating temperature range: 41 to 95°F (5 to 35°C)
Storage/transport temperature range: -4 to 140ºF (-20 to 60ºC)
Operating humidity range: 10% to 80% relative humidity, non-condensing
Storage/transport humidity range: 10% to 90% relative humidity, non-condensing
These output parameters are valid for an impedance load range of 0-700 Ω
Fisher Wallace Laboratories, LLC
515 Madison Ave., FL 22
New York, NY 10022 USA
Telephone (800) 692 - 4380
Fax [phone]
Email [e-mail]
Web www.fisherwallace.com
Authorized Representative (MDD 93/42/EEC)
Methodize Europe
Drieblad 11
NL-2811EG Reeuwijk
The Netherlands
Telephone [phone]l
Class II Medical Consult instructions Type BF Applied Part
Electrical Equipment for use This stimulator is
internally powered only
Separate collection for electrical and electronic equipment per EC Directive 2002/96/EC. – Waste
Electrical and Electronic Equipment (WEEE)
15.0 LIMITED 1-YEAR WARRANTY
Fisher Wallace Laboratories warrants each new Fisher Wallace Stimulator (exclusive of batteries) to be free from defects in
materials and workmanship for a period of one (1) year following the delivery of the device to the original purchaser. The
obligation of Fisher Wallace Laboratories under this warranty is expressly limited solely and exclusively to the repair or
replacement of the unit or any parts thereof, which to Fisher Wallace’s satisfaction, shall have become defective during the
0120$

!
PL$1003!Rev.!A!
6
warranty period, and which shall have been returned to Fisher-Wallace Laboratories within 30 days after the discovery of the
defect by the original purchaser. This warranty does not extend to any liability for medical or dental expenses, or for any other
direct, indirect or consequential damages caused by the failure, defect or malfunction of the Fisher Wallace Stimulator, except
as herein provided, whether such damage claim shall be based on contract, tort, breach of warranty, or otherwise. This warranty
shall not apply to any Fisher Wallace Stimulator which has been repaired, tampered with or altered by someone other than a
Fisher Wallace Laboratories representative or technician, or which has been subjected to negligence, accident, mishandling or
which has not been used in accordance with the enclosed instructions or for the stated purposes. This warranty is expressly
limited solely to the original purchaser and does not extend to any transferee, assignee or subsequent purchaser or user of the
Fisher Wallace Stimulator. This warranty does not cover accessories, like electrodes, which are warrantied for a 60 day period.
THIS WARRANTY IS THE SOLE AND EXCLUSIVE WARRANTY MADE OR WHICH MAY BE DEEMED TO
HAVE BEEN MADE BY FISHER WALLACE LABORATORIES AND IS EXPRESSLY IN LIEU OF ANY AND ALL
OTHER WARRANTIES, EITHER EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. NO PERSON OR ENTITY HAS ANY
AUTHORITY TO BIND FISHER WALLACE LABORATORIES TO ANY WARRANTY, GUARANTEE OR
REPRESENTATION EXCEPT AS SPECIFICALLY SET FORTH HEREIN.
16.0 30-DAY GUARANTEE
If the device is undamaged and does not successfully treat the purchaser’s symptoms within thirty (30) days after it is delivered
to the purchaser, the device may be returned for a refund. Shipping charges and extra accessories, such as the purchase of
extra sponges, extra headbands or extra straps, will not be reimbursed. We issue full refunds for the entire amount of all
purchased (not rented) devices in the form of a check, 4-6 weeks from the date we receive a return. Please obtain delivery
confirmation.
Please click on the Customer Service menu tab on our website for instructions regarding servicing and returns.

!
PL$1003!Rev.!A!
7
Yellow Light Indicator/ Amperage Level: 3 or 4

!
PL$1003!Rev.!A!
8
Yellow Light Indicator/ Amperage Level: 3 or 4

!
PL$1003!Rev.!A!
9
Yellow Light Indicator / Amperage Level: 3 or 4

!
PL$1003!Rev.!A!
10
Yellow Light Indicator/ Amperage Level: 3 or 4

!
PL$1003!Rev.!A!
11
Yellow Light Indicator/ Amperage Level: 3 or 4

!
PL$1003!Rev.!A!
12
Yellow Light Indicator/ Amperage Level: 3 or 4
IF NECK PAIN RADIATES TO BOTH SIDES OF THE UPPER BACK, USE THE BLACK LEAD
SEPARATELY ON EACH SIDE FOR 10-20 MINUTES.

!
PL$1003!Rev.!A!
13
Yellow Light Indicator/ Amperage Level: 3 or 4
!