Cranial Stimulator Instruction Manual
Federal Law (USA) restricts this device to sale by, or on the order of an M.D.. D.O.. or a O.C. licensed In the State In which he practices.
TABLE OF CONTENTS
1.0 Introduction
2.0 Contraindications
3.0 Warnings
4.0 Precautions
5.0 Adverse Reactions
6.0 Federal Labeling
7.0 Theory of Operation
8.0 Indications for Use of the SBL500-B
9.0 Device Controls
10.0 Skin Preparation
11.0 Application of the Device
12.0 Battery Replacement
13.0 Troubleshooting
14.0 Device Specification
15.0 Limited Warranty
1.0 INTRODUCTION
The Fisher-Wallace Cranial Stimulator (Zero DC] Model £ SBL202-B is a portable battery powered pulse generator used to reduce the symptoms of Depression, Anxiety, and Insomnia.
The Fisher-Wallace Cranial Stimulator (Zero DC).delivers an electrical stimulus which is conducted by the electrical cables to either water/wet sponges (supplied with the device) or self adhesive electrically conducting contacts to the tissue to which they are applied. Frequently, the Fisher-Wallace Cranial Stimulator (Zero DC I contacts can be applied from the skin over the spinal column at the base of the neck to various parts of the head and face. The contacts can also be placed on the head in a transcranial application, with one contact anterior to the top tip of the right ear and the other contact anterior to the top tip of the left ear.
2.0 Contraindications
Patients having cardiac pacemakers of the demand or sensing type should be aware that actions of the pacemakers may be inhibited or otherwise interfered with by this Cranial Electrotherapy Stimulator.
a. This device should not be used around the Carotid sinus.
b. Patients with known or suspected heart disease should not be stimulated.
c. Patients who react poorly to the idea of electrical stimulation of any kind should not use this device.
d. Patients whose skin is irritated around either electrode site should discontinue the use of this device.
e. This device must not be used until the physician has established the etiology of the Pain through a differential diagnosis. This device must be used only for the purpose for which a physician has prescribed. This device must only be used by the person for whom the prescription has been written.
3. Warnings
a. The safety of CES devices or use during pregnancy or delivery has not been established.
b. CES devices should be used only under the continued supervision of a physician.
c. CES is a symptomatic treatment and as such suppresses the symptoms of Depression, Anxiety, and Insomnia which would otherwise serve as a stimulus to see a Physician.
d. The user must keep the device out of reach of children.
e. Electronic monitoring equipment (such as ECG monitors, ECG alarms) may not operate properly when CES stimulation is in use.
4.0 Precautions
a. Isolated cases of skin irritation may occur at the site of electrode placement following long term application.
b. Effectiveness is dependent upon patient selection and patient compliance.
5.0 Adverse Reactions
a. There may be skin irritation with people who have sensitive skin. Proceed cautiously with short time exposures to prove skin viability.
b. Electrode burns can occur if the sponge deteriorates and contact is made between the skin and the metal contact behind the sponge.
6.0 Federal Labeling
Federal Law (USA) restricts this device to sale by, or on the order of an M.D., D.O. or D.C., licensed in the state in which they practice.
7.0 Theory of Operation
a. The Fisher-Wallace Cranial stimulator (Zero DC) is an electronic signal generator which has been shown to reduce the symptoms of Depression, Anxiety, and Insomnia. The Fisher-Wallace Cranial Stimulator [Zero Del provides electrical connection from the signal generator through wire cables to the skin contacting method (either water/wet sponges (supplied with the device) or appropriate self adhesive electrically conductive contacts).
b. The electronic waveform of the Fisher-Wallace Cranial Stimulator I Zero DC) contains a 15,000 hi 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 5OOHz changes the “on” time series of 15,000hz carrier pulses (750 pulses in SO milliseconds) into 25 smaller bursts of 15 pulses each of the 15,000hz carrier signal (375 pulses in the same 50mil1liseconds). (Waveform sketches are appended hereto.) The subject device is a bipolar version of a CES 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.
c. The pulse period for the basis carrier waveform of 15,000Hz is 66.7 microseconds (5O% 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 (5O% 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 constant current 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).
g. A 9 volt alkaline battery is supplied, (non rechargeable)
8.0 Indications for Use of the SBL500-B
The Model SBL500-B device is an electronic signal generator which is indicated for the symptomatic relief of anxiety, depression, and insomnia.
9.0 Device Controls
The Fisher-Wallace Cranial Stimulator Model SBL500-B has only one knob which encompasses both the on/off switch for turning the device on or off as well as the intensity control for adjusting the level of current which is delivered to the tissue.
a. There are two electrode lead receptacles. The color of the receptacles are the same (green) since the polarity is shifting automatically every major burst, there is no concern for polarity.
b. There is a red LED indicator which flashes for the total time (ten [10) Minutes, set at the factory) when the device is turned on, no matter what the intensity.
c. There are four (4) amber LED indicators which flash according to the intensity:
INTENSITY (Peak ma) £ OF Flashing INDICATORS
1 — 1
2 — 2
3 — 3
4 — 4
d. Low Battery is indicated by the non indication of the “on” lite when the on/off switch is turned into the “on” position.
10.0 Skin Preparation
Good skin care is important in minimizing any skin irritations that may be encountered with the active use of the electrodes. Prepare the skin before using the Fisher-Wallace Cranial Stimulator [Zero DC] by:
10.1 Thoroughly washing the skin sites where the electrodes will be placed with a mild soap and water solution to remove non-conducting skin oils.
10.2 Rinsing the area with warm water and drying thoroughly.
11.0 Application of the Device
11.1 Electrode Preparation
Place the Cellulose Sponge into the electrode receptacle in such a way that the edge of the receptacle fits into the slit depression in the side of the Sponge. This procedure should be done with the Sponge very wet and pliable. Connect the Electrode Receptacle to the Cable using the snap fastener connection. Insert the other end of the Cable via the plug into the Receptacle on the Fisher-Wallace Cranial stimulator [Zero DC].
11.2 Setting Device Controls
While holding the device in the hand with the Receptacles in the upper right side, rotate the intensity knob toward your body (Counterclockwise) using the right thumb. Be sure the device starts from the off position (Listen for and feel the click when the device is turned to the “off” position.). To start the stimulation, rotate the intensity knob clockwise (Away from the body), listen for and feel the click when the device goes from the “off” position to the “on” position. Continue clockwise rotation, increasing the intensity until the patient feels a sensation (Itching, pins & needles, warmth or mosquito bite, or “light” flicker when it is used on the head). Then turn the intensity knob (Reducing) counterclockwise until the sensation disappears. If the patient feels the perception again, turn it down again. The patient does not have to feel the sensation in order for benefit to be derived. In fact, many people do not feel the sensation and yet, they get benefit, nonetheless.
11.3 Electrode Placement
11.3.1 Cranial Placement
For reducing the symptoms of Depression, Anxiety, or Sleeping Problems, place one contact on the head, anterior to the tip of the right ear and the other contact on the head, anterior to the tip of the left ear. Treatment time is ten (10) to twenty (20) minutes. Sponge contacts must be wet but not dripping.
11.3.2 Cranial Placement (Alternate 1)
For reducing the symptoms of Depression, Anxiety, or Sleeping Problems, place one contact on the Frontalis Midline and the other contact at the Occiput midline or bilateral contacts on the bilateral Mastoid Process Areas (piggyback contacts arranged on the instrument). Treatment is ten (10) to twenty (20) minutes.
12.0 Battery Replacement
In order to replace the battery, remove battery compartment cover by sliding the cover into the open position and detach the nine (9) volt battery from the battery clip and replace with another alkaline nine (9) volt battery. A rechargeable battery may be used. It must match the mechanical configuration and be a standard nine (9) volt battery.
13.0 Trouble Shooting
If the “on” LED lamp does not illuminate when the on switch is turned on, replace the nine (9) volt battery and turn the device on again. If it still does not illuminate, return the device for repair. If the “on” LED lamp does go on but the intensity lamps do not illuminate, be sure the sponges are clean and wet; touch sponges together and raise the intensity; replace the wires in the output receptacles with a paper clip rebent to short circuit the receptacles. If the intensity lamps still do not illuminate, return the device for repair.
14.0 Device Specification
PARAMETER NOMINAL VALUE +/-10%
Output Amplitude into 1.000 Ohms 4.0 volts Pk.
Rate 15/500/15.000 hz
Pulse Width 33 microseconds
Maximum Charge per Pulse .13 microcoulombs
On Time per Burst SO milliseconds
Off Time per Burst 16.7milliseconds
Waveform: Assymmetrica1 bipolar square wave with double modulation. This waveform contains 25 bursts of 15 pulses each. Each pulse is 33.3 microsecond duration in a pulse period of 66.7 microseconds.
Power Source: 9 volt Alkaline Battery
Contact dimension: Approx.l.75“diam
Power Density:
Load Impedance (Ohms) Power Density (Watts/sq. in.)
200 .0013
1,000 .0067
10,000 .0667
- Note: This device can not be connected to the power line
Device Type Nominal Time Minutes Minimum Time Min.:Sec. Maximum Time Min.:Sec.
SBL500-B 20 17:17 19:06
-B4 40 34:35 38:13
-B6 60 51:52 57:19
15.0 Limited Warranty
Fisher-Wallace Laboratories, LLC warrants each new Fisher-Wallace Cranial Stimulator (Zero DC) (exclusive of batteries) to be free from defects in materials and workmanship for a period of 18 months and accessories (not including disposables) for a period of 90 days following the delivery of the Fisher-Wallace Cranial Stimulator to the original purchaser. The obligation of Fisher-Wallace Laboratories, LLC 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 Laboratories, LLC satisfaction, shall have become defective during the warranty period, and which shall have been returned to Fisher-Wallace Laboratories, LLC 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 Cranial 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 Cranial Stimulator (Zero DC I which has been repaired, tampered with or altered by someone other than a duly authorized Fisher-Wallace Laboratories, LLC representative, 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 (user) and does not extend to any transferee, assignee or subsequent purchaser or user of the Fisher-Wallace Cranial Stimulator.
THIS WARRANTY IS THE SOLE AND EXCLUSIVE WARRANTY MADE OR WHICH MAY BE DEEMED TO HAVE BEEN MADE BY FISHER-WALLACE LABORATORIES, LLC 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, LLC TO ANY WARRANTY, GUARANTEE OR REPRESENTATION EXCEPT AS SPECIFICALLY SET FORTH HEREIN.