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Dynatron Dynatronics ibox User manual

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1Dynatron® ibox™ Operator’s Manual
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OPERATOR’S MANUAL
The Dynatron®ibox™, Iontophoresis System, is a non-invasive drug
delivery system designed as an alternative to hypodermic injections.
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CAUTION
Federal law restricts the Dynatron® ibox™ for sale by or on the order of a
physician, chiropractor, physical therapist, or dentist licensed by the law of the
state in which said person practices to use or order the use of this device.
WARNING
Risk of Burns and Fire: Do not use near conductive materials such as
metal bed parts, inner spring mattresses, and the like. Do not use near
highly ammable or combustible materials.
Danger - Explosion Hazard: Do not use in the presence of ammable
anesthetics.
Danger – Electrical Shock Hazard: Contact with other sources of
electricity may pose a risk of electric shock. Do not connect this deice
to any source of electricity.
IMPORTANT: Before treating a patient with the Dynatron®ibox™,
read the entire Operator’s Manual paying specic attention to
“Contraindications, Warnings, and Precautions.”
COMPLIANCE: The contents of this “Instructions For Use” manual are
exactly the same in both the printed and electronic forms.
INDICATIONS FOR USE: Dynatron® ibox™ Iontophoresis System is
intended to use a direct current to introduce ions of soluble salts or
other drugs into the body.
Dynatron® ibox™ Operator’s Manual
© Copyright 2016
Revised 5/14/2019
ALL RIGHTS RESERVED
Dynatronics Corporation
7030 Park Centre Drive Salt Lake City, Utah 84121
(801) 568-7000, (800) 874-6251
www.dynatronics.com / [email protected]
Inventory 5D00260 Rev. 2
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Table of Contents
The Dynatron®ibox™Iontophoresis Device..................... 5
Installation & Accessories ...................................5
Physical Features .........................................6
Error Messages ..........................................11
Dynatron® ibox™ Operating Instructions..................... 14
Default Treatments .......................................15
Custom Treatments.......................................16
Quick Reference: Single Phase Treatment Instructions............19
Quick Reference: Dual Phase Treatment Instructions .............20
Contraindications, Precautions, and Warnings ................. 21
Contraindications ........................................21
Warnings ...............................................22
Precautions .............................................23
Adverse Effects ..........................................23
Technical Information..................................... 24
Outputs................................................24
Treatment Timing ........................................24
Dimensions .............................................24
Environmental Conditions..................................24
Electromagnetic Emissions and Immunity .....................25
Batteries ...............................................29
Maintenance and Repair .................................. 30
Maintenance ............................................30
Returning a Device for Repair...............................30
Cleaning ..............................................31
Denition of Symbols and Labeling.......................... 32
Dynatron®ibox™Limited Warranty .......................... 33
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The Dynatron®ibox™
Iontophoresis Device
The Dynatron ibox has the ability to set polarity, dosage, and intensity
level while providing two delivery options: Single Phase (one drug) and
Dual Phase (two drugs of opposing polarities delivered from the same
iontophoresis electrode). In Dual Phase, the rst drug delivered via the
“active” electrode is the positive polarity drug followed by the negative
polarity drug.
Installation & Accessories
Unpacking
When you receive the device, unpack it and verify that all accessories are
present. Check for any possible damage, obvious or concealed. In case
of damage, immediately notify the carrier and take any steps necessary
to le a claim for the damage sustained. If possible, use the original
shipping carton if the device must be shipped for any reason. Improper
packaging of the device during transport can result in damage and will
invalidate the warranty.
Complete the warranty registration form and return it to Dynatronics
within 30 days of purchase. This is to insure that you are not billed
for services that are covered by the warranty policy. Warranty regis-
tration must include the device serial numbers.
Read the operating instructions in this manual carefully before
proceeding with a treatment.
The following are included with the Dynatron ibox:
Qty. Part No. Description
1 DIBOX2 Dynatron ibox Device
1 4H00390 Electrode Cables
2 9I0003 AA Alkaline Batteries 1.5 volt
1 5D00260 Dynatron ibox Operator’s Manual
1 910007 Carrying Case
REF
The Dynatron®ibox™Iontophoresis System is a non-invasive drug
delivery system designed as an alternative to hypodermic injections.
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Physical Features
The numbered features in the diagrams correspond to the numbered
descriptions on the following pages. Before administering treatment(s),
read the sections in this manual that provide specic instructions for
performing treatments, denitions of the available options, as well as
the contraindications warnings, and precautions.
1. POWER ON/OFF: The Dynatron ibox power is
controlled by a key located at the bottom-left of the
keypad and is shown by the international ON/OFF
power symbol.
Power ON: Press and hold the symbol until a beep
is heard, and the display illuminates. When rst
powered-on, the Dynatron ibox logo will be displayed
followed by the software version number. The initial
screen displayed after power-on allows the user to
choose between a default
treatment or a custom
treatment.
Power OFF: Press and hold
the ON/OFF key for about
two seconds. The display will
show the following message
prior to the device turning-off.
Front View
Selector Arrow Keys
Enter Key
Keypad
Display Window
Power On/Off
Case
Power-OFF Screen
Before operating the Dynatron®ibox™, acquaint yourself with the
physical and operational aspects of the device by reviewing the
instructions and illustrations within this manual.
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The Dynatron ibox power may be turned OFF before, during, or after
a treatment. Depressing the ON/OFF switch during a treatment
immediately ramps down the delivered current intensity to 0.5 mA.
2. DISPLAY WINDOW: The Dynatron ibox provides information to the
user through its Organic Light Emitting Diode (OLED) display window.
The display window will progress through a sequence of Polarity,
Dose, and Intensity during the setup phase of the treatment. During
the treatment phase, all three parameters will appear in the display
window.
Polarity: The display window allows the user three options for
polarity: Positive (+), Negative (-), and Dual Polarity (+/-). Positive
(+) delivers a positive current to the active electrode during a single
phase treatment. Negative (-) delivers a negative current to the active
electrode during a single phase treatment. Dual Polarity (+/-) delivers
a positive current to the active electrode rst, followed by a negative
current.
Dose: The display window shows a treatment dose as either a
single number during the setup stage or as a ratio of dose delivered
compared to the target dose in the treatment stage. The dose is
displayed in milliampere-minutes (mA-min) and is followed by a “+” or
“-” sign to indicate the polarity of the treatment. Below is an example
of a dose ratio displayed during a treatment.
6/40+
This gure indicates that 6 mA-min of dose has been delivered and
that the total target dose for the treatment is 40 mA-min. The (+)
indicates that this treatment has a positive polarity.
Time: The remaining time for a treatment is displayed in standard
time format using a colon to separate minutes from seconds as shown
below.
14:33
Time always counts down. Time is always calculated according to
the amount of dose to be delivered and the intensity of the current.
When a treatment is completed, time will be displayed as “00:00.”
Intensity: Intensity is the amount of current delivered to the
electrodes during a treatment. Intensity is displayed with two digits
separated by a decimal point and followed by the polarity of the
treatment as shown below. The units used are milliamperes (mA).
Current intensities can typically range from 0.5 to 4.0 mA.
3.8 mA+
3. KEYPAD: User control of the Dynatron
ibox is through interactions with the
keys on the keypad. All control is done
with single depressions of individual
keys. Some of the keys may be held
down to allow for successive increases
or decreases of certain parameters such
as dose and intensity without having
to press and release the key for each
change.
Note: If the Dynatron®ibox™is not actively delivering a treatment and
remains idle for 60 seconds, the device will automatically turn off.
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4. BATTERY COMPARTMENT COVER: Removal of this cover
allows access to the two AA Alkaline batteries for installation or
replacement. This cover is most easily removed by placing both
thumbs at the top of the compartment cover and pressing in and
pushing down on the cover at the same time.
See “BATTERIES” in the Technical Information section of this
manual for additional information on the
Dynatron ibox batteries.
5. OUTPUT JACK:
The output
jack allows for
connection of
the electrode
cable. The jack
only accepts an authorized
Dynatron ibox electrode
cable. The electrode
cable plug is “keyed” so
that it must be orientated
properly before insertion
into the jack.
6. BATTERIES: Two 1.5 Volt
AA Alkaline batteries are used
to power the Dynatron ibox.
They must be inserted into the
battery compartment as shown
with the correct orientation. Care
should be used when inserting the
batteries to avoid damage to the
device.
Case
Batteries
Battery Compartment Cover
Back and Battery Compartment Internal Views
The output jack
is located on the
top of the device.
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7. SELECTOR ARROW KEYS:
The selector arrow keys allow the user
to enter treatment parameters (polarity,
mode, and dose) for a treatment(s) and
control the current intensity of an
ongoing treatment. These keys also
allow treatments to be started either
normally, or start the treatment again
following the correction of a particular
electrode error code. Additionally,
they control the adjustment of default parameters during setup.
The “Up Arrow” key controls increasing of a particular parameter while
the “Down Arrow” key controls the decreasing of a parameter.
Holding down any of the selector arrow keys typically causes the
parameter in focus to increase or decrease its value in an accelerated
fashion.
8. ENTER KEY: The enter key causes a treatment
parameter, currently being modied by the user,
to be captured as part of a treatment setup.
After depressing of this key, the parameter
just modied will be captured and the next
treatment parameter to be dened will be displayed. After all
parameters have been entered, pressing the “Up Arrow” key starts the
treatment.
An enter key is not used during a treatment. However, depression of
an enter key when not delivering a treatment, will cause the treatment
setup process to begin. Finally, pressing the enter key just after
all parameters are dened for a treatment, but before starting the
treatment, will cause a return to the beginning of the treatment setup
process (polarity, dose and intensity denitions).
9. CASE: The Dynatron ibox is enclosed in a plastic case. This case
should not be opened by the user at any time. Clean the outer
surface of the case with a slightly damp or lightly moistened cloth.
Mild household cleaners work well on the case.
CAUTION
Do not use cleaners on the display window. Do not spray solutions
directly
on the device. First moisten the cloth and wipe off the device.
Solvents,
caustic solutions and harsh or abrasive cleaners must never be
used.
Top Side View
Output Jack
Case
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10. ELECTRODE CABLE: The electrode cable connects one of the
output channels to the “active” and “return” electrodes on a patient.
Two electrode cables are included with each device.
11. ELECTRODE CABLE PLUG: The “plug-end” of the electrode cable
is inserted into an Dynatron ibox channel jack connecting the device
output to the patient electrodes.
12. ACTIVE ELECTRODE CLIP:
The ACTIVE “clip-end” of the electrode cable is light gray. The clip
attaches to the active electrode on the patient and may be squeezed
in order to attach to the electrode more easily or it can be pushed
onto the electrode without squeezing.
13. RETURN ELECTRODE CLIP:
The RETURN “clip-end” of the electrode cable is dark gray in color.
The clip attaches to the return electrode on the patient and may be
squeezed in order to attach to the electrode more easily or it can be
pushed onto the electrode without squeezing.
Electrode Cable
Return Electrode Clip
(Dark Gray)
Active Electrode Clip
(Light Gray)
Electrode
Cable Plug
Electrode Cable