Pat
ch - Instr
uctions F
or Use
Hybr
esis Pat
ch Car
ton C
onten
ts:
• 6
Pa
tches
• 6
Saline
A
mpules
• 6
A
lcohol
Pr
eps
REF: 199589
READ THE H
YBRESIS C
ONTROLLER AND CHAR
GING STATION INSTR
UCTIONS FOR USE FOR ADDITIONAL
IMPORTANT INFORM
ATION.
• Single
use
only
• Non-st
erile
• Disposable
• S
tore
at
ambien
t temper
atur
e 15°
- 30°
C
(59°
- 86°
F)
• DO
N
OT e
xpose to
temper
atur
es abo
ve
50° C
(122°
F)
LATEX FREE
1
THEORY OF OPER
ATION
Iontophor
esis tr
ansports
char
ged w
ater
-soluble drugs
and
other
ionic
substanc
es acr
oss in
tact
skin.
Ion
tophor
esis technology
is
based
on
the
pr
inciple tha
t an
elec
tric
pot
ential
causes
charged
w
ater
-soluble drug
ions
in
solution
to
m
igr
ate
ac
cor
ding to
their
elec
trical
char
ges.
The
distribution
of
a
charged
ionic
drug
deliv
ered
by
ion
tophor
esis is
dependen
t upon
the
charge
of
the
ion,
the
siz
e of
the
ion
(molecular
w
eight),
the
str
ength and
dur
ation
of
the
electr
ical cur
ren
t applied
, the
composition
of
the
Pa
tch
and
numer
ous other
fac
tors
.
DESCRIPTION
The
Hybr
esis S
yste
m deliv
ers char
ged w
ater
-soluble drugs
and
other
ionic
substanc
es acr
oss
intac
t sk
in and
consists
of
thr
ee c
omponents:
a
Charging
Sta
tion, rechar
geable C
ontr
oller(s)
and disposable
Pa
tch(es).
The
Hybr
esis S
yste
m is
desig
ned to
pr
ovide
the
follo
wing thr
ee tr
eatmen
t options:
Hybresis T
rea
tment
The
Con
troller
deliv
ers cur
ren
t at
3mA
to
the
Pa
tch
fo
r thr
ee minut
es fo
r a
Sk
in C
onductivit
y
Enhancemen
t (SCE),
follo
wed
by
the
pa
tient w
earing
the
Pa
tch
fo
r appr
oxima
tely
one
to
two
hours, r
esulting in
a
40-80 mA
-minute
trea
tment r
espectiv
ely.
Standar
d Trea
tment
The
Con
troller
deliv
ers cur
ren
t at
2,
3
or 4
mA
to
the
Pa
tch
fo
r 10-20
minut
es, r
esulting in
a
40
mA-minut
e tr
eatmen
t. Fo
r an
80
mA
-minute
trea
tment,
repea
t the
tr
eatmen
t.
Pat
ch-O
nly Trea
tment
The
Patc
h deliv
ers low
lev
el cur
ren
t o
ver 2-4
hours
, resulting
in
an
appr
oxima
te
40-80
mA-minut
e tr
eatmen
t respec
tively
.
Warnings
•
Keep out of the reach of children.
•
Do not apply electrodes such that the current pathway crosses the heart or brain, as safety
has not been established.
•
Advise the patient to remove electrodes if any undue sensation of pain or burning occurs
during the treatment and to report discomfort to clinic.
•
To establish good contact between the electrodes and skin, excessive hair may be clipped,
but DO NOT SHAVE. Shaving may cause skin breaks that are not readily seen and can increase
the risk of adverse skin reactions.
•
Small pinhead size blisters may result in response to certain drugs. Contact physician if
problem persists longer than 24 hours.
•
On rare occasions, iontophoresis therapy can result in transient skin reactions such as rash,
inflammation and irritation. These skin reactions may be the result of individual sensitivity to
the ionic solution used, the condition of the skin at the onset of treatment, reaction to the
materials in the electrodes, or a poor connection between the electrode and the patient’s
skin. Advise the patient of this possibility before starting treatment. If a visible skin reaction
does occur, instruct the patient to discontinue the treatment and consult the prescribing
physician.
•
Care must be taken when operating this equipment adjacent to or stacked with other
equipment. Potential electromagnetic or other interference could occur to this or to the other
equipment. Care should be taken to minimize this interference by not using other equipment
in conjunction with it.
•
The system is not suitable for use in the presence of a flammable anaesthetic mixture with air or
with oxygen or nitrous oxide.
3
INDICATIONS
The Hybresis System is indicated for the administration of soluble salts or other drugs into the
body for medical purposes as an alternative to hypodermic injection.
CONTRAINDICATIONS
·
Cardiac pacemakers - Do not use on patients with pacemakers or other implanted devices.
·
Drug sensitivity – Do not use on patients with known sensitivity to the drug being
administered.
·
Pregnancy – Do not use on pregnant women. The safety of the system used during pregnancy
has not been established.
·
Scarring – Do not use on damaged skin, denuded skin or other recent scar tissue.
·
Skin sensitivity – Do not use on patients with known sensitivity to electrical current or to the
solution being administered.
·
Head treatment – Do not treat across either the temporal region or the orbital region.
2
STANDARD MODE TREATMENT
NOTE: While using the Controller, should an in-process iontophoresis treatment need to be
stopped or paused, DO NOT suddenly remove the Controller from the Patch without first
switching off the Controller. To stop or pause a treatment while the Controller is administering
iontophoresis, press the ON/OFF button and wait a few moments for the Controller to turn off.
1. Press the ON/OFF button on the Controller. The Green Hybresis Light will blink slowly.
2. Push the Standard Mode button on the Controller. The 2mA indicator light will blink slowly.
Each additional depression of the button will scroll to the next setting- 3mA or 4mA.
3. Attach the Controller to the Patch. The Patch connector (located at the center of the Patch)
plugs into the slot on the back of the Controller. Ensure that the Patch connector is fully and
securely engaged into the Controller- a click will be heard upon full engagement.
4. Position the patient so that there is no pressure on the Patch during treatment.
5. Press the START button to begin treatment. The Green mA Light will blink more rapidly,
then glow steadily.
6. To change the iontophoresis current setting while the Controller is administering a
treatment, press the Standard Mode button to re-select the desired setting. Within a few
moments, the Controller will automatically adjust to the new setting.
7. In 10-20 minutes
(see following table)
the Controller will sound a beep and the lights will
turn off, indicating the 40mA-minute treatment has been completed.
Standard Mode
40 mA-min
80 mA-min
2mA
20 minutes
Repeat steps 1-2 and 5-7
3mA
13 minutes
Repeat steps 1-2 and 5-7
4mA
10 minutes
Repeat steps 1-2 and 5-7
8. Remove the Controller from the Patch.
9. Remove and discard the Patch after the treatment has been completed. The Patch cannot
be reused.
9
Patch-Only Treatment
The Patch delivers low level current over 2-4 hours, resulting in an approximate 40-80
mA-minute treatment respectively.
HYBRESIS MODE TREATMENT
NOTE: While using the Controller, should an in-process iontophoresis treatment need to
be stopped or paused, DO NOT suddenly remove the Controller from the Patch without
first switching off the Controller. To stop a treatment while the Controller is administering
iontophoresis, press the ON/OFF button and wait a few moments for the Controller to turn off.
1. Push the ON button on the Controller. The Green Hybresis Light will blink slowly.
2. Attach the Controller to the Patch. The Patch connector (located at the center of the Patch)
plugs into the slot on the back of the Controller. Ensure that the Patch connector is fully and
securely engaged into the Controller- a click will be heard upon full engagement.
3. Position the patient so that there is no pressure on the Patch during treatment.
4. Press the START button to begin treatment. The green Hybresis Light will blink more rapidly,
then glow steadily.
5. After three minutes, the Controller will sound a beep and the lights will turn off
automatically. This indicates that the Skin Conductivity Enhancement (SCE) is completed.
6. Remove the Controller from the Patch. The Patch will now continue to deliver the remainder
of the iontophoresis treatment to the patient.
7. The average time to complete the dose is indicated in the following table. To prevent
excessive dosing, the Patch automatically switches off iontophoresis after the maximum
dose has been administered.
Hybresis Mode
40 mA-minutes
60 mA-minutes
80 mA-minutes
Wear Time
1 hour
1.5 hours
2 hours
8. Instruct the patient to remove and discard the Patch after a minimum of one to two hours
for a 40 to 80 mA-minute dose respectively.
9. Discard the Patch after treatment has been completed. The Patch cannot be reused.
8
Empi Inc.
599 Cardigan Road
St. Paul, MN 55126-4099 USA
651.415.9000
800.328.2536
360352 Rev. C, © 2008 Empi 9/08
Manufactured in the USA
This product may be protected by one or more of the following U.S. patents owned or licensed by Empi: 5,087,242; 5,413,628; 5,573,563; 6,761,977;
6,653,014.02 as well as foreign equivalents. Other patents pending.
PATCH-ONLY TREATMENT
1. The average time to complete a patch-only dose is indicated in the following table.
Patch
40 mA-minutes
60 mA-minutes
80 mA-minutes
Wear Time
2 hours
3 hours
4 hours
2. Instruct the patient to wear the Patch per the appropriate dose and time indicated in the
table as a minimum. To prevent excessive dosing, the Patch automatically switches off
iontophoresis after a maximum dose has been administered.
3. Remove and discard the Patch. The Patch cannot be reused.
10
Precautions
•
Consult directions for the use of the drug/compound before delivery. Some drugs/
compounds require a specific polarization for use. Observe the indications, contraindications,
warnings and precautions related to this issue.
•
Do not use electrodes that have been previously used.
•
Inspect the electrodes before use. Discard any electrode that shows signs of alteration or
damage, as these electrodes may not be safe for use.
•
The electrodes can be worn during normal activity. However, excessive motion where the
electrodes have been placed can cause poor contact between the skin and the electrode or
uneven distribution of current, resulting in greater risk of skin irritation.
•
A transient erythematous reaction, characterized by a uniform red pattern, can sometimes
occur directly under the electrodes. The redness usually disappears within a few hours after
treatment. Advise the patient of this possibility before starting treatment.
•
Use only saline ampule supplied for the return pad. For positive polarity (+), use only drugs
with Chloride (Cl-) counter ions. Use of tap water or any other solution may cause tattooing or
staining.
•
Handle the system with care. Do not immerse the system in fluids or allow it to be connected
with other electrical devices. Do not drop, abuse, or in any way exceed normal use. Do not
sterilize.
•
Do not operate this system in an environment where other devices are being used that
intentionally radiate electromagnetic energy in an unshielded manner. Portable and mobile
RF communications equipment can affect Medical Electrical Equipment.
4
a
company
DJOglobal.com
360352B Hybresis Map.indd 1
10/29/08 12:37:54 PM
205 Hwy 22 East
Clear Lake, SD 57226
651.415.9000
800.328.2536
360352 Rev. E © 2008, 2015 Empi, Inc.
Warnings
•
Keep out of the reach of children.
•
Do not apply electrodes such that the current pathway crosses the heart or brain, as safety
has not been established.
•
Advise the patient to remove electrodes if any undue sensation of pain or burning occurs
during the treatment and to report discomfort to clinic.
•
To establish good contact between the electrodes and skin, excessive hair may be clipped,
but DO NOT SHAVE. Shaving may cause skin breaks that are not readily seen and can increase
the risk of adverse skin reactions. Do not apply over broken or compromised skin (e.g.,
sunburns, cuts, or acne) due to increased risk of skin reaction.
•
Small pinhead size blisters may result in response to certain drugs. Contact physician if
problem persists longer than 24 hours.
•
On rare occasions, iontophoresis therapy can result in transient skin reactions such as rash,
inflammation and irritation. These skin reactions may be the result of individual sensitivity to
the ionic solution used, the condition of the skin at the onset of treatment, reaction to the
materials in the electrodes, or a poor connection between the electrode and the patient’s
skin. Advise the patient of this possibility before starting treatment. If a visible skin reaction
does occur, instruct the patient to discontinue the treatment and consult the prescribing
physician.
•
Care must be taken when operating this equipment adjacent to or stacked with other
equipment. Potential electromagnetic or other interference could occur to this or to the other
equipment. Care should be taken to minimize this interference by not using other equipment
in conjunction with it.
•
The system is not suitable for use in the presence of a flammable anaesthetic mixture with air
or with oxygen or nitrous oxide.
•
Do not wear electrode or controller during Magnetic Resonance Imaging (MRI) scans as this
may result in metal overheating and causing skin burns in the area of the patch.
Manufactured in the USA
