VQ OrthoCare Orthostim 4 User manual

Patient Manual
OrthoStim4 Rehabilitative Electrotherapy
from VQ OrthoCare
18011 Mitchell South, Irvine, CA 92614
Call 800.266.6969 Fax [phone]
www.vqorthocare.com
[email protected]
© 2010 VisionQuest Industries, Inc.
VQO021578REVA

VQ OrthoCare is not liable for any misuse or misunderstanding of the
OrthoStim4 product or operating manual. Please call your local
representative if any additional assistance is required regarding this
product and its operating instructions.
This patient manual is proprietary and confidential. No part of this document
may be reproduced or transmitted in any form or by any means, electronic
or mechanical, including photocopy, recording or information storage and
retrieval system, without permission in writing from VQ OrthoCare.
VQ OrthoCare warrants the OrthoStim4 to be free from electrical circuit
defects in workmanship and materials for a period of three (3) years upon
delivery to the customer. The case, cradle and belt clip are warranted to be
free from defects in workmanship and materials for one (1) year upon
delivery to the customer. VQ OrthoCare will repair or replace, at its
facilities, any OrthoStim4 unit found to have become defective within the
warranty period.
This warranty does not apply to accessories; specifically lead wires,
electrodes, batteries, tapes, gel, carrying case and AC Adapter, nor does it
apply to OrthoStim4 units that have been damaged due to misuse, or
repaired or altered by parties other than VQ OrthoCare at its facilities.
This warranty is in lieu of any other warranties expressed or implied.
No person or entity is authorized to bind VQ OrthoCare to any representa-
tion of warranty other than those specifically set forth herein.
Warranty
41

Letter to the Patient......................................................................2
System Components ...................................................................3
Precautions and Prescription Information..............................4
Controls and Features .................................................................6
Accessories....................................................................................8
Starting Your Treatment Sessions ...........................................10
Normal Running Screens..........................................................13
After Completing Your Treatment Sessions..........................17
Electrode Use and Care.............................................................18
Cradle/Modem............................................................................19
Care and Maintenance..............................................................22
Technical Data and Specifications .........................................26
Waveform Diagrams ..................................................................30
Troubleshooting .........................................................................37
Notes.............................................................................................39
Warranty.......................................................................................41
Table of Contents

2
Letter to the Patient
Your physician has selected the OrthoStim4 – a portable multi-modality
device that provides Interferential, Neuromuscular, Pulsed Direct Current
and High-Volt Pulsed Current Stimulation – as the most appropriate treat-
ment for your needs.
The OrthoStim4 electrical stimulator generates small pulses of current that
are delivered through lead wires to stimulating electrodes* placed on your
skin. These pulses pass through the skin and activate underlying nerves.
The OrthoStim4 activates sensory nerves at lower levels of stimulation,
producing a tingling sensation. Motor nerves are activated at higher levels
of stimulation, resulting in muscle contractions.
The OrthoStim4 system includes a cradle equipped with a modem that
enables your doctor or therapist and our technicians to conveniently admin-
ister setting changes to the device and keep your prescription information
up to date. As a patient, you may also take advantage of this technology to
make modifications to your settings, and to assist all of your healthcare
partners in providing the most personalized service possible.
In order to gain maximum benefit from your OrthoStim4 treatment, it is
important that you follow the therapy regimen prescribed by your physi-
cian or therapist. He or she is familiar with your specific requirements and
the technical specifications of the OrthoStim4, and will instruct you on the
proper mode of operation and correct degree of stimulation for your
individual treatment.
Please read the following sections carefully before using the OrthoStim4.
• Precautions and Prescription Information
• Controls and Features
• Starting Your Treatment Sessions
• Care and Maintenance
NOTE: The OrthoStim4 is not a substitute for full medical evaluation and
treatment. Always consult your physician or therapist if you have specific
questions or problems regarding the use of your OrthoStim4. The Ortho-
Stim4 should not be given to or used by any individual other than the
person for whom it is prescribed.
* For use only with stimulating electrodes, commonly referred to as “electrodes” throughout this manual

3
System Components
The OrthoStim4 multi-modality stimulation system is operated with:
(1) OrthoStim4 electrotherapy device
(1) package of non-sterile, reusable electrodes
(1) lead wire
(2) Power Packs
The OrthoStim4 system also includes:
(1) carrying case with removable shoulder pouch
(1) Patient Manual (this booklet)
(2) additional packages of non-sterile, reusable electrodes
(depending on your doctor’s protocol)
(8) adhesive remover towelettes
(4) additional Power Packs
(1) AC Adapter
(1) cradle with modem
(1) telephone cord with splitter
A
A
B
B
C
C
D
D
E
E
F
F
G
G
H
H
I

4
Precautions and Prescription Information
CAUTION: Federal law restricts this device to sale by, or on the order of,
a practitioner licensed by the law of the State in which he/she practices to
use or order the use of this device.
NOTE: Please read the following prescription information carefully before
using the OrthoStim4. If you have any questions regarding this information,
consult with your physician or therapist before proceeding.
Indications
The High Volt Pulsed Current Stimulation and Neuromuscular Electrical Stimulation
can be used in the following applications:
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increases local blood circulation
• Muscle re-education
• Maintaining and increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Interferential Stimulation can be used in the following applications:
• Relieves acute pain
• Relieves chronic pain
• Relaxation of muscle spasms
• Maintaining and increasing range of motion
• Increases local blood circulation
Pulsed Direct Current stimulation can be used in the following applications:
• Reduction of edema (under negative electrode)
• Relaxation of muscle spasm
• Increasing local blood circulation
• Retardation or prevention of disuse atrophy
• Muscle re-education
• Maintaining or increasing of range of motion
Contraindication
Stimulators should not be used on patients with cardiac demand pacemakers.
Warnings
• The long-term effects of chronic electrical stimulation are unknown.
• Stimulation should not be applied over the carotid sinus nerves, particularly in
patients with a known sensitivity to the carotid sinus reflex.
• Stimulation should not be applied over the neck or mouth; severe spasm of the
laryngeal and pharyngeal muscles may occur and the contractions may be strong
enough to close the airway or cause difficulty in breathing.

5
• Electrodes should not be placed on the chest in such a configuration that would
allow electrical current delivered by the device to flow through the chest because
it may cause a cardiac arrhythmia.
• Stimulation should not be applied transcerebrally.
• Stimulation should not be applied over swollen, infected, or inflamed areas or skin
eruptions, e.g. phlebitis, thrombophlebitis, varicose veins, etc.
• Stimulation should not be applie d over, or in proximity to, cancerous lesions.
• Due to the potential for causing skin burns, this device should only be used with
electrodes which limit the current density to 0.25W/cm2
• Stimulation should not be applied transthoracically in that the introduction of electrical
current may cause cardiac arrhythmias.
Precautions
• Safety of stimulators for use during pregnancy has not been established.
• Caution should be used for patients with suspected or diagnosed heart problems.
• Caution should be used for patients with suspected or diagnosed epilepsy.
• Caution should be used in the presence of the following:
- When there is a tendency to hemorrhage following acute trauma or fracture
- Following recent surgical procedures when muscle contraction may disrupt
the healing process
- Over the menstruating or pregnant uterus
- Over areas of the skin which lack normal sensation
• Some patients may experience skin irritation or hypersensitivity due to electrical
stimulation or electrical conductive medium. The irritation can usually be reduced
by using an alternative conductive medium or alternate electrode placement.
• Electrode placement and stimulation setting should be based on the guidance of
the prescribing practitioner.
• Keep out of the reach of children.
• Use only with the lead wires and electrodes recommended for use by
the manufacturer.
• Portable stimulators should not be used while driving, operating machinery, or
during any activity in which involuntary muscle contractions may put the user at
undue risk of injury.
• When the amplitude in the IF mode exceeds 40mA, electrical noise from the
device could interfere with other equipment operating in the nearby area.
• Do not trim electrodes as cut edges may affect even distribution of stimulation.
• Do not immerse electrodes in water.
Adverse Reactions
Skin irritation and burns beneath the electrodes have occasionally been reported
with the use of electrical stimulators. If you experience any symptoms of skin
irritation or any unusual reactions while using the OrthoStim4, discontinue use
immediately and contact VQ OrthoCare’s Patient Care Department at 800.452.7993
or consult your physician.

6
Controls and Features
Pressing the button turns on
the OrthoStim4 and performs a brief
system test. Once the OrthoStim4 is
turned on, pressing this button turns it off.
The button pauses treatment at any
time. Pressing this button again resumes treatment.
The (–) button has three functions. It can be
used to:
• Decrease the intensity of stimulation, either
in small increments through single presses
or by holding the button down to implement
a continuous decrease
• Move the cursor down in a selection list
• Rotate stimulation to the left in vector mode
The (+) button has three functions. It can be
used to:
• Increase the intensity of stimulation through
pressing and releasing the button
• Move the cursor up in a selection list
• Rotate stimulation to the right in vector mode
The (S) button has three functions. It can be
used to:
• Select items when options are provided
• Select channels in neuromuscular mode
• Access vector mode in interferential treatment
The (P) button has three functions. It can
be used to:
• Proceed to the next step, according
to directions on the screen
• Go to the Protocol screen
• Manually start a download when the
OrthoStim4 is in the cradle

7
Battery Indicator
A battery symbol in the upper left corner of
the screen will display the battery status.
When the battery is fully charged, the symbol
displays as black. When the battery power
is low, the symbol displays as white, and
starts to flash and the device will beep once
a minute. Replace the alkaline Power Packs as
soon as possible. When battery power is suf-
ficiently depleted, the device will shut
off automatically.
AC Adapter Indicator
When an AC Adapter is plugged into the
OrthoStim4, a plug symbol appears next to
the battery indicator. The AC Adapter bypasses
the Power Packs and supplies the power.
Full Replace

8
Accessories
Lead Wire
The lead wire connects the
OrthoStim4 to the electrodes.
When plugging the lead wire
into the OrthoStim4, make sure it is
pushed firmly into the socket, with the
strain relief pointing toward the bottom of
the OrthoStim4 (as shown). To remove the wire,
grip the connector close to the socket and pull
straight out.
Power Supply
The OrthoStim4 can be operated with two non-rechargeable alkaline
Power Packs, the AC Adapter, or by placing the OrthoStim4 in the cradle.
Power Packs
The unit should be turned off when switching from one power source to
the other. Additional Power Packs can be ordered from VQ OrthoCare’s
Patient Care Department by calling 800.452.7993.
Alkaline Power Packs (non-rechargeable)
Insert two alkaline Power Packs in the OrthoStim4
with the ribbon handle facing out. The plus symbol
should be aligned toward the top right of the Ortho-
Stim4 and the minus symbol toward the bottom left,
as indicated on the label. When the display indicates
low battery power, remove and properly dispose of.
Power Packs cannot be re-used or recharged.

9
AC Adapter
If the alkaline Power Packs are in the
OrthoStim4, the AC Adapter will
bypass the Power Packs and pro-
vide power. The alkaline Power
Packs are non-rechargeable.Use
only the AC Adapter provided, as
use of other products’ AC Adapt-
ers may damage the OrthoStim4.
Press the (PAUSE) button to pause
stimulation before connecting or disconnecting the AC Adapter.
Press (PAUSE) to resume treatment.
Cradle/Modem
The OrthoStim4 system includes a cradle
that contains a modem that enables the
download of updates and information to/
from the OrthoStim4 through a landline
telephone connection. The modem also
enables VQ OrthoCare to modify the
OrthoStim4 from a remote location per
physician specifications. The Cradle has
a plug receptor that will accept a regular
phone line (RJ11 plug) from any standard
home telephone. The Cradle/Modem will
initially be set up by a VQ OrthoCare
Patient Technician. For set-up informa-
tion, see page 20.

10
Starting Your Treatment Sessions
1. Insert two alkaline Power Packs into the OrthoStim4. Make sure each
is oriented according to the label on the battery pack and the battery
compartment, as the OrthoStim4 will only operate if the Power Packs
are inserted correctly. To use external power instead, plug the AC Adapter
into the OrthoStim4 or place the OrthoStim4 in the cradle.
[NOTE: If electrodes have been placed beneath a brace, cast or
bandages by your healthcare professional, skip to step 5.]
2. Prepare the skin. Electrode application sites must be clean, dry, un-
broken skin surfaces. To reduce the risk of skin irritation, observe the
following instructions for proper skin care before treatment.
Wash site of electrode placement with mild soap and water before
applying electrodes.
Rinse all soap off the skin before continuing.
Dry the skin thoroughly.
Trim excess body hair from electrode sites with scissors, being
careful not to cut (or break) the skin. DO NOT SHAVE THE SKIN
IMMEDIATELY PRIOR TO STIMULATION,because shaving will
create small cuts in the surface layer of skin.
CAUTION:
DO NOT apply lotions, oils or other ointments to the skin prior
to the application of electrodes, unless directed by your clinician or
a VQ OrthoCare representative. Topical agents may increase the risk
of skin irritation.
DO NOT clean the skin with anything other than soap and water.
Other cleaning agents may interfere with proper conduction of
electrical pulses.
In the event of skin irritation, discontinue use immediately and contact
VQ OrthoCare’s Patient Care Department at 800.452.7993 or consult
your physician or therapist.
3. Inspect each electrode and lead wire before application. Do not proceed
if there is any doubt about the integrity or proper function of any
electrode or lead wire. Connect the lead wire to the electrodes, making
sure there is no bare metal exposed at the connection points. Do not use
unnecessary force in connecting the electrodes to the lead wires. If they
do not fit, use a different set of electrodes and call VQ OrthoCare to re-

11
port the situation and receive a replacement set of electrodes.
Save the non-working electrodes for evaluation by VQ OrthoCare’s
Quality Assurance Department; DO NOT THROW THEM AWAY!
Select
Protocol
1
PAIN
40:00
(S) Select
6. Turn the OrthoStim4 on by pressing the (ON/OFF) button. The serial
number and compliance time will be displayed. After releasing the
(ON/OFF) button, the OrthoStim4 will start its self-test. When the
self-test is completed, you will see Select Protocol at the top of the
screen and a number 1flashing in the middle of the screen, along
with the length and purpose of treatment (e.g., pain; spasm).
4. Gently remove the electrodes from the plastic liner. Place the electrodes
on the sites prescribed by your physician or therapist and press them
firmly onto the skin. Electrodes should be placed at least one inch apart
from each other.
5. Insert the lead wire into the
OrthoStim4. For instructions,
see page 8.

12
Starting Your Treatment Sessions
(continued)
CAUTION: If using pain medication and/or other pain management
devices, exercise caution when increasing the amplitude of the
OrthoStim4.
CAUTION: When the device is used in environments where other
medical equipment is in use, the amplitude of Interferential (IF) should
not exceed 40mA or it may interfere with the operation of nearby
equipment.
7. Select the preset as directed by your physician or therapist by pressing
the (+) or (–) button until the number indicated for the protocol is shown
in the middle of the screen. Press (S) to select.
8. Increase the stimulation intensity level by repeatedly pressing and re-
leasing the (+) button. If your protocol involves multiple treatment types,
you will be asked to set the stimulation for each treatment before be-
ginning. Follow the prompts on the screen to set the intensity levels for
each segment of your protocol. The screen will then count down from 5
and treatment will start.

13
These are the screens that appear during most of your treatment time,
depending on the modality being used. Press the (+) or (–) button to change
stimulation intensity. For your safety, the keypad locks after 30 seconds of
inactivity. To unlock the keypad, press the (–) button and proceed to use
the (+) button to increase intensity. At any time, you can press the (PAUSE)
button to pause the treatment. Pressing the (PAUSE) button again will restart
the treatment. The intensity will slowly increase from zero back to its last
setting. If at any time you wish to discontinue treatment, press the (ON/OFF)
button and the device will shut down.
• The upper left corner of the screen displays the battery status and indicates
whether the AC Adapter is plugged into the device.
• The center top of the screen displays the protocol number you are using.
• The upper right corner displays the type of protocol currently running
(e.g. IF, NM, or HV).
• The middle of the screen displays the amplitude (intensity) of the
stimulation. Below the amplitude is a description of button functions.
If a button does not have a function, it will not appear on the list and
pressing the button will result in a beep.
• The bottom of the screen displays the time. Once treatment has started,
treatment time counts down in hours, minutes and seconds. If the
treatment is continuous, the timer will start at 00:00:00 and count up.
NOTE: It is normal for the OrthoStim4 to become warm during treatment.
INTERFERENTIAL treatment screen
Normal Running Screens
1IF
0mA
(P) Protocol
00:40:00
1IF
15mA
(S) Vector
(PAUSE) Pause
00:39:59
Before starting treatment While treatment is running
* If the time has an asterisk next to it, another treatment will follow the current one.

14
Before starting treatment, you have the option of returning to the protocol
screen by pressing (P) and selecting another protocol. Once treatment
has started, the (P) button does not return you to the protocol screen. [To
choose another protocol after treatment has started, decrease the amplitude
to 0 and press (P), or turn the device off, then on again.]
Vectoring
During an interferential (IF) treatment, the OrthoStim4 allows you to vector
the stimulation. Vectoring allows you to move the stimulation pattern so
that you feel more stimulation under the pair of electrodes where you have
the greatest pain. To access the vectoring option, press (S) during treatment.
The following screen will appear:
NOTE: As vectoring increases amplitude intensity levels, do not vector
stimulation if you have already set the amplitude to your maximum
comfort level.
VECTOR
(–) Left Right (+)
(P) Resume
Normal Running Screens (continued)

15
NEUROMUSCULAR treatment screen
If you are running a neuromuscular treatment, one of the following screens
will be displayed:
In the neuromuscular screen, there are two channels that must be set inde-
pendently. They are represented by gray and black wires on your lead wire.
Press the (S) button to move from one channel to another. Then press (+) or
(–) to increase or decrease the stimulation. The channel that is flashing will
be changed when (+) or (–) is pressed. If both channels are flashing, both
will be changed when (+) or (–) is pressed. If neither is flashing, press (–) to
unlock the keypad, then (S) to select one or both channels to adjust.
NOTE: Your OrthoStim4 may be programmed slightly different than shown
in the screen diagrams above. In NM (neuromuscular) mode, the screen
may read Red and Black instead of Gray and Black. In this case, the con-
trols work in the same way, but changing the black amplitude adjusts the
black-tipped leads/electrodes while changing the red amplitude adjusts the
red-tipped leads/electrodes.
When the treatment is programmed for time, the left screen shown above
will be displayed and will count down the time. When the treatment is
programmed for repetitions (such as exercise), the right screen shown
above will be displayed and will count repetitions up from zero.
1NM
4mA 6mA
Gray Black
(S) Ch Select
(PAUSE) Pause
00:19:59
1NM
4mA 6mA
Gray Black
(S) Ch Select
(PAUSE) Pause
2 reps
Normal Running Screens

16
PULSED Direct Current treatment screen
If you are running a Pulsed DC treatment, the following screen will be
displayed:
1HV
40V
(PAUSE) Pause
00:39:59
Normal Running Screens (continued)
HIGH-VOLT PULSED CURRENT treatment screen
If you are running a high-volt treatment, the following screen will be
displayed:
XPDC
4mA 6mA
Gray Black
(PAUSE) Pause
00:39:59

17
After Completing Your Treatment Sessions
1. The device will beep three times and read TREATMENT COMPLETE.
The device will then turn off.
2. Disconnect the lead wires from the electrodes. Remove the electrodes
from your skin. Place them on the plastic liner and place the plastic liner
in the resealable pouch.
XSL
SLEEP
00:29:59
Some protocols may include a SLEEP segment. During this segment, the
device does not provide stimulation, but the timer is counting down to
the next treatment. This function is used if a clinician wants to create a
protocol where the device treats for a specified amount of time, stops,
then treats again, without the patient having to turn the device on and off.
During the SLEEP segment, the screen will display the following:
SLEEP screen

18
NOTE: The electrodes supplied with this OrthoStim4 have been designed
and authorized specifically for use with this product and must not be
manipulated, cut, or altered in any way as this may affect the even
distribution of stimulation and/or its intensity beyond the recommended
0.25W per cm2 maximum.
NOTE: Do not place electrodes on cut, broken or irritated skin. If irri-
tation occurs, consult with your physician or therapist before changing
your placement sites.
To apply self-adhesive, reusable electrodes:
Attach the electrodes to the lead wires provided with the OrthoStim4.
Grasp an electrode by the edge and gently peel away the electrode
from its plastic liner.
Apply the electrodes to the affected area by firmly pressing the elec-
trode against the skin, checking all edges for proper adhesion. Your
physician or therapist will show you the application sites for treatment.
Always make sure electrodes are placed at least one inch apart from
each other.
To remove the electrodes:
 Grasp the electrode by the edge and gently remove it from the skin.
Return it to the plastic liner.
 Replace the electrodes on the plastic liner in the resealable
pouch provided.
CAUTION: Never remove the electrode by pulling on the wire, as this
may damage your electrode.
CAUTION: Be careful when using the OrthoStim4 during sleep, as
wires may tangle and become loose.
Electrode Use and Care
WARNING: This product should be used only under the direct super-
vision of a registered healthcare practitioner. Product use should be in
accordance with the directions and specifications of the stimulation
device. Improper use of this or any electrode may result in a patient burn.
Due to the potential for causing skin burns, devices must be limited to
0.25W per cm2. Electrodes should not be placed on the chest in such a
configuration that would allow electrical current delivered by the Ortho-
Stim4 to flow through the chest as it may cause cardiac arrhythmia.