ALPHA-STIM AID User manual

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Alpha-Stim® AID
Cranial electrotherapy stimulator
Owner’s Manual
LET NOTHING STOP YOU™

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Alpha-Stim® AID Owner’s Manual
Cranial Electrotherapy Stimulator for the
Treatment of Anxiety, Insomnia and Depression
© Copyright 2022 by Electromedical Products International, Inc. ALL RIGHTS RESERVED.
Alpha-Stim
®
is a registered trademark. Manufactured under U.S. patents 8,612,008; 8,457,765
and Worldwide Patents Pending.
IFU-CUS-002 REV G
Type BF Equipment. Internally
powered.
Consult operating instructions.
Read manual thoroughly
before using the device.
Text consists of a warning or
precaution relating to safety.
Read the text carefully and
use the equipment as
instructed to ensure safety.
Reference Number.
Serial Number.
CAUTION: Federal law
restricts this device to sale by
or on the order of a physician.
CE marking certifies that a
product has met consumer
safety, health or environmental
requirements.
Date of Manufacture.
Manufacturer.
Medical device.
Non-sterile.
Authorized Representative in
the European Community.
IP22
Protection against ingress of
solid foreign objects >12.5
mm and dripping water when
tilted at 15 degrees.
Single patient- multiple use.
Use-by-date.
Keep away from sunlight.
Do not use if package is
opened or damaged.
Waste electrical and electronic
equipment should not be
discarded together with
unseparated household
waste, but must be
collected separately.
Lot Number.
Medical Electrical Equipment
classified by Underwriters
Laboratories Inc. with respect
to electric shock, fire,
mechanical and other
specified hazards only in
accordance with UL-60601-1
and CAN/CSA C22.2
No.601.1.
Unique Device Identifier.
ONLY
USA

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Features .................................................................................................................................. 4
Installation of Batteries ..................................................................................................... 6
A Note to Health Care Practitioners ............................................................................ 7
Control Buttons ................................................................................................................... 8
LCD Display ........................................................................................................................... 9
Introduction ........................................................................................................................10
Description ..........................................................................................................................11
Electromedical Therapeutics. .........................................................................................12
Use the Alpha-Stim® AID with Confidence .............................................................13
Quick Guide ........................................................................................................................13
Cranial Electrotherapy Stimulation (CES) to Treat Anxiety, Insomnia
and/or Depression with Earclip Electrodes .......................................................14
What to Expect ..................................................................................................................16
Prescribing Information ..................................................................................................17
Technical Specifications .................................................................................................19
Storage and Cleaning .....................................................................................................20
Trouble Shooting ..............................................................................................................21
Service ..................................................................................................................................22
Notes on Disposal ............................................................................................................22
5 Year Limited Warranty ................................................................................................23
CONTENTS

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The Alpha-Stim® AID Device Package Contains:
- 1 set of Earclip Electrodes
- 1 50 ml bottle of Alpha-Stim® Conducting Solution
- 1 empty bottle for use with Alpha-Stim® Conducting Solution
- 256 Earclip Electrode Pads (EEPS™)
- Owner’s Manual
- Lanyard
- Storage case
- 2 AAA 1.5 volt lithium batteries
The Alpha-Stim® AID Kit Comes Complete and Ready to use with:
 Alpha-Stim® AID device – The Alpha-Stim® AID device is a battery powered
electrical device that produces low level electrical current to treat
anxiety, insomnia and depression. Device accessories connect to the
Alpha-Stim® AID to facilitate treatment. Part# 500
 Earclip Electrodes – Earclip Electrodes are accessories to the Alpha-Stim®
AID. The Earclip Electrodes transfer the current from the Alpha-Stim® AID
device to the patient through the earlobes. Part# 501
 Alpha-Stim® Conducting Solution is an accessory to the Alpha-Stim® AID
device. It is supplied as a liquid in a separate bottle. It is a proprietary mineral
salt solution that facilitates an efficient transfer of the Alpha-Stim® AID
current from the device to the electrodes and finally to the patient.
Alpha-Stim® Conducting Solution is applied to the Electrode Pads to ensure
the current is conducted properly. Part# SL50
 Electrode Pads – Earclip Electrode Pads (EEPS™) are also accessories for the
Alpha-Stim® AID device. They are felt-like pads made from polyester that
allow Alpha-Stim® Conducting Solution absorption to facilitate transfer of
current. The pads have an adhesive backing allowing them to stick to the
Earclip Electrodes. The adhesive does not contact the patient’s skin. The pads
are saturated with Alpha-Stim® Conducting Solution to ensure proper
current flow from the Alpha-Stim® device through to the Earclip Electrodes
and to the patient. Part# EEP
FEATURES

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 Owner’s manual – Describes what items come with the device and how to
use it. Includes a symbol table along with precautions, warnings and
contraindications. Device use is the same for the healthcare provider as it is
for use directly by the patient. Part# 503CUS
 Lanyard – The lanyard is an optional accessory for the Alpha-Stim® AID
device. It is a cloth cord to hold the Alpha-Stim® AID device around the neck
when in use, if desired. Part# 502
 Storage Case(s) – Alpha-Stim® AID comes in a hard case. An optional soft
case can be purchased separately. Part#s 504 & 505
 2 AAA batteries – The Alpha-Stim® AID is powered by lithium batteries which
are supplied in the initial order. They provide the energy source and are
placed inside the Alpha-Stim® AID before use. Batteries can be replaced with
off the shelf lithium batteries as needed. Part# 5300
Alpha-Stim® AID Features Include:
1. Full digital control for precision, consistency and reliability.
2. Earclip Electrodes.
3. Back lighting when any button is pressed.
4. Continuous circuit check when electrodes are in contact with skin.
5. Preset to 0.5 Hz.
6. 20, 40 or 60 minutes countdown cycles to auto-off.
7. Large timer display.
8. 0 – 500 microampere (µA) current control.
9. Current and treatment time may be locked to preset values
throughout entire treatment session.
10. Mute option.
11. Cumulative timer.
12. 30 minute auto-off when not in use.
13. Lanyard so AID can be worn around the neck.
14. Able to withstand electrostatic discharges of up to 15,000 volts.
15. Automatically and permanently disables itself should a single fault
develop within the device causing the current to exceed 700 µA.

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16. Battery strength indicator.
17. Earclip Electrode Pads (EEPS™) requires Alpha-Stim® Conducting
Solution (included).
18. 5 year limited warranty.
19. Protection against ingress of solid foreign objects >12.5 mm and
dripping water when tilted at 15 degrees.
20. Uses 2 AAA 1.5 volt batteries (included in the package but
not installed).
Inserting batteries
 Slide the cover of the battery case on the back
side of the device in the arrow direction.
 Insert the enclosed batteries according to
the symbols (+/-) into the base of the
battery case.
 Close the battery case again and push the
cover towards the device until it snaps
into position.
 When changing the batteries, only use 2 AAA
1.5-volt lithium batteries.
Danger of chemical burns! Leaking
battery acid may lead to chemical burns.
 Avoid contact between battery acid and skin,
eyes and mucous membranes.
 If battery acid comes in contact with any of these parts, rinse the
affected area with copious amounts of plain water immediately
and seek medical attention if necessary. Keep batteries out of
children’s reach. If a battery has been swallowed seek medical
attention immediately.
INSTALLATION OF BATTERIES

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 Do not disassemble, recharge, short circuit batteries or dispose of
them in fire. There is a risk of explosion.
 Remove batteries from the device if you do not use it for a
prolonged period.
 Do not dispose of used batteries in the household garbage, instead
dispose of them as special waste or at a battery collection point in a
specialist outlet.
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Thank you for recommending the Alpha-Stim® AID. This manual is written
for the person who will use the Alpha-Stim® AID, but your input will be
invaluable to your patient. Electromedical Products International, Inc. is
available to help serve the needs of your patients. New research is often
available that may have a direct bearing on a patient's specific disorder. Feel
free to write, call, fax, or email EPI for any reason at all. Also, check the
website regularly for new information. We welcome your input in the form
of testimonial letters or emails.
Electromedical Products International, Inc.
2201 Garrett Morris Parkway
Mineral Wells, TX 76067-9034 USA
Toll Free 1-800-FOR-PAIN
Outside of the USA [phone]
Fax [phone]
Email [email protected]
Web www.alpha-stim.com
A NOTE TO HEALTH CARE PRACTITIONERS

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1. On - Off
2. Timer. Waveform cycle starts when electrodes touch skin.
Countdown timers: select 20, 40 or 60 minutes.
3. Lock. Press 2 times within 5 seconds to lock or unlock settings
during treatment if desired.
4. or Current. Increases or decreases current. Increases at
50 microamperes (µA) per second when held down. Decreases at
100 µA per second. When the device is turned on, the current defaults
to 100 µA.
CONTROL BUTTONS