Donjoy IceMan CLEAR3 User manual

IceMan®CLEAR3
IceMan® CLASSIC &
IceMan®CLASSIC3
Cold Therapy Units
Instructions for Use

1
English ............................................... 
Español...............................................17
Français . .............................................33
TABLE OF CONTENTS

2
When to use the IceMan®
The intended use of the IceMan® CLEAR, IceMan® CLASSIC, and
IceMan® CLASSICis for the temporary reduction of swelling and pain
after surgery or injury. This is a non-sterile prescription device for single
patient use to provide localized external application of cold therapy. This
device may not be used for any other purpose.
INDICATIONS FOR USE
THIS DEVICE CAN BE COLD ENOUGH TO CAUSE SERIOUS INJURY.
SERIOUS ADVERSE REACTIONS AND SAFETY HAZARDS MAY OC-
CUR WHEN USING THIS DEVICE.
The intended user should be a licensed medical professional, the patient,
the patient’s caretaker, or a family member providing assistance. The
user should be able to:
· Read, understand and be physically capable to perform all the direc-
tions, warnings and cautions provided in the information for use.
INTENDED USER PROFILE
The DonJoy® IceMan® devices provide cold therapy by flowing cold wa-
ter, from an ice bath through an applied therapy pad.
OPERATING PRINCIPLE

2 3
When not to use the IceMan® DO NOT use this device on patients with
Raynaud’s phenomenon or other vasospastic conditions; Buerger’s dis-
ease; cold allergy or hypersensitivity; cryoglobulinemia; paroxysmal cold
hemoglobinuria or other cold agglutinin disorders; pheochromocytoma;
sickle cell anemia or history of cold injury.
Limit the use of the IceMan® with these patients Limit the use of this
device with patients who are unresponsive, incapacitated, have altered
mental status or altered pain perception. Post-surgical patients under se-
dation or on analgesics or anesthetics, as well as patients taking hypnotics,
anxiolytics, or antidepressants, must be monitored frequently during use
of this device. These patients may not be able to perceive pain, burning,
numbness, tingling or decreased sensation and may be susceptible to in-
jury. Discontinue cold therapy immediately at the first sign of cold injury.
CONTRAINDICATIONS
LIMITATIONS ON SPECIAL PATIENT POPULATIONS

4
WARNINGS & PRECAUTIONS
WARNING
• THIS DEVICE CAN BE COLD ENOUGH TO CAUSE SERIOUS INJURY.
SERIOUS ADVERSE REACTIONS AND SAFETY HAZARDS MAY OC-
CUR WHEN USING THIS DEVICE.
• Read and understand all warnings and Instructions for Use
before using this device.
• For IceMan® CLEARor IceMan® CLASSIC(WITHOUT ther-
mometer and temperature control) DO NOT use this device
without a prescription from a physician. Rx only. Your prescrip-
tion must state how long and how often the device should be
used and the length of breaks between uses. DO NOT use this
device if a prescription has not been provided to you or if you
do not understand the prescription. Use of this device without
a prescription or failure to follow the prescription may result in
serious injury, including tissue necrosis.
• For IceMan® CLASSIC (WITH thermometer and tempera-
ture control) DO NOT use this device without a prescrip-
tion from a physician. Rx only. Your prescription must state a
temperature, how long and how often the device should be
used and the length of breaks between uses. DO NOT use this
device if a prescription has not been provided to you or if you
do not understand the prescription. Use of this device without
a prescription or failure to follow the prescription may result in
serious injury, including tissue necrosis.
• This device can be cold enough to cause serious injury, including
tissue necrosis. You must be able to check your skin condition un-
der the cold pad frequently (at least every hour). DO NOT use
this device if you cannot check your skin condition frequently
(at least every hour). Check for increased pain, burning, numb-
ness, tingling, increased redness, discoloration, itching, increased
swelling, blisters, irritation or other changes in skin condition
under the cold pad or around the treatment area. If you experi-
ence any of these conditions, immediately discontinue use of
this device and contact your physician.
• This device is intended only for single patient use. Secondary
use can cause serious injury, including infection.
• Application of the cold pads directly on the skin may result in
serious injury, including tissue necrosis. DO NOT let any part
of the cold pad touch your skin. ALWAYS use with a barrier
between your skin and the cold pad.

4 5
PRECAUTIONS
When to exercise special care when prescribing the IceMan®
Exercise special care prescribing this device for the following patients:
those with arthritic conditions; peripheral vascular disease; children
under the age of ; those with decreased skin sensitivity; poor circula-
tion, or compromised local circulation; hypercoagulation disorders;
diabetes or neuropathies.
WARNINGS & PRECAUTIONS (con’t)
• The barrier between your skin and the cold pad may develop
moisture during use, which may create colder temperatures on
the skin. Temperatures that are too cold may result in serious
injury, including tissue necrosis. ALWAYS check for moisture on
the barrier between your skin and the cold pad. If moisture is pres-
ent on the barrier, immediately discontinue use of this device.
• Poor connections between hoses may cause leaking, which may
result in serious injury, including infection and tissue necrosis. AL-
WAYS listen for a “snap” or “click” when connecting the IceMan®
cold therapy unit hose to the cold pad hose. Use only IceMan®
cold pads.
• Use of the IceMan® with wet hands or in a wet location may
result in electrical shock and serious injury. DO NOT handle
transformer or power cord with wet hands or in a wet location.
The power supply unit is the mains power disconnect. Do not
position the equipment to make access to the disconnect dif-
ficult. Only connect equipment to the power supply provided for
this product.
• DO NOT use the IceMan® near flammable anesthetics or oxygen
enriched environment, which may result in explosion and serious
injury.
• Keep power cord, hose, small parts, and packaging materials
away from children and animals. These items pose a risk for suf-
focation or strangulation.
• It could be unsafe to use accessories, detachable parts and
materials, or interconnect to other equipment not described in
these instructions, or otherwise modify the equipment.
• Care must be taken when operating this device adjacent to
other equipment. Potential electromagnetic or other interfer-
ence could occur to this or other equipment. Try to minimize this
interference by not using other electronic equipment in conjunc-
tion with this device.
• To avoid the risk of electrical shock, do not disassemble the
IceMan®. If device is not functioning properly, please contact
DonJoy product support.

6
Directions for use of the IceMan®
• A physician must prescribe treatment to be rendered by this device,
which must state a temperature (for the IceMan® CLASSIC), how long
and how often the device should be used and the length of breaks
between uses. You must follow the individual prescription provided to
you by your physician.
• Thisdevicecanbecoldenoughtocauseseriousinjury,includingtissue
necrosis. You must be able to check your skin condition under the cold
pad. DO NOT use if you cannot check your skin condition frequently
(at least every hour). People are sensitive to cold in diverse ways and
may react differently to cold treatment.
• Checkforincreasedpain,burning,numbness,tingling,increased
redness, discoloration, itching, increased swelling, blisters, irritation
or other changes in skin condition under the cold pad or around the
treatment area. If you experience any of these conditions, immediately
discontinue use of this device and contact your physician.
• Informyourphysicianifanyofthefollowingapplytoyou:arthritic
conditions; peripheral vascular disease; under the age of ; decreased
skin sensitivity; poor circulation or compromised local circulation;
hypercoagulation disorders; diabetes or neuropathies.
• Checkformoistureonthebarrierbetweenyourskinandcoldpad.If
moisture is present on the barrier, immediately discontinue use of this
device.
• DonotcastorbandageoverIceMan®coldpads.
• UseonlyapprovedIceMan®coldtherapypadswiththeIceMan®units.
• ToensureareliableconnectionbetweentheIceMan®andIceMan®
cold pad, “snap” or “click” hoses together into place so that the fit is
tight and snug. Monitor hose connections during use.
• Thisdeviceisintendedforsinglepatientuse.
•Follow all precautions necessary to avoid electrical shock, fire, burns, or
other personal injury from electrical power by using the device indoors,
with dry hands, and in a dry location. Keep all electrical connections
away from water.
• Neverusethisdeviceifthepowercordorplugisdamaged.
• The IceMan® is non-sterile and is not intended to be sterilized. Do not
attempt to sterilize the unit by any means.
• Rxonly.
PATIENT INFORMATION

6 7
Add ice to fill line inside the device.
Add cold water to fill line.
a. CLEARLid – Place lid on the device
making sure the lip inserts into the groove.
Then press the lid down to close and secure.
b. CLASSIC and CLASSICLid – With the
handle down, place lid on device making sure
the label is facing up. Secure the lid by raising
the handle, which will enage the lid locking
mechanism.
Connect the IceMan® hose to the cold pad
hose. To ensure a reliable connection, “snap”
or “click” hoses together into place so that
the fit is tight and snug.
To turn the device on, insert cord into con-
nection on the back of the device and plug
power supply into the wall outlet. (To turn
o the device unplug it.) WARNING! When
applying the cold pad, DO NOT let any part
of the cold pad touch your skin. Always use
with a barrier between your skin and the cold
pad. Apply cold pad to patient. Refer to ap-
plication instructions provided with cold pad.
Check for moisture on the barrier between
the patient’s skin and cold pad. If moisture is
present on the barrier, immediately discon-
tinue use of this device.
For IceMan® CLASSIC
Set temperature control on the hand console
starting at the white dot. Allow  minutes
after the cold pad is placed on the patient for
the temperature to stabilize. Then adjust the
temperature to the range prescribed by the
physician.
DO NOT use if you do not have a prescription.
1
2
3
4
5
OPERATING INSTRUCTIONS
6
10
minimum cold
maximum cold
a b

8
• Unplug the power supply from the electrical outlet.
• TO AVOID DANGER OF ELECTRICAL SHOCK, DO NOT UNPLUG
THE POWER SUPPLY WITH WET HANDS.
• Disconnect pad from hose.
• Draincoolerandwipedry.
• Drainpadbyholdingsothatthehoseishangingdownward.
• Pressinthebuttonsattheendofthehoseandallowallwaterto
drain out of the pad.
• Ifcleaningisnecessary:wipedowndeviceandhandwashpadsand
wraps with mild soap and warm water. Air dry.
ENVIRONMENTAL & SERVICE LIMITS
• Operating Temperature Range: ⁰C  ⁰C
• OperatingRelativeHumidityRange:%  %
• StorageandTransportationTemperature:-⁰C  ⁰C
• StorageandTransportationRelativeHumidityRange:upto %
• AtmosphericPressureRange: hPa -  hPa
• ShelfLife: Years
• ServiceLife:OperatingHours
POWER SUPPLY
• ToorderareplacementpowersupplycontactDJOGlobalCustomer
Support.
• DonJoy®IceMan®CLASSIC&CLEARPower Supply: DJO P/N 
• DonJoy®IceMan®CLASSICPower Supply:DJO P/N 
STORAGE & CLEANING INSTRUCTIONS
DJO, LLC will repair or replace all or part of the unit and its accessories for
material or workmanship defects for a period of six months from the date
of sale.
WARRANTY

8 9
Manufacturer Rx Only Type BF Equip-
ment
Temperature
Limits
Attention / Read
Manual
Class II Equip-
ment Cold Temperature Warning Sign
Mode of Operation – Continuous Operation
External Electrical Power Source – Class II Equipment
Degree of Protection Against Electric Shock – Type BF Equipment
International Protection Marking Code which indicates that the
device has been tested to Standard IEC  for ingress protec-
tion.
SAFETY CLASSIFICATIONS
Blue – Action Required by User
Yellow – Proceed With Caution
Orange – Warning
LEGEND / SYMBOL DESCRIPTION
Safety Mark HumidityLimits Atmospheric
Pressure Limits
This device must
be separated from
household waste
and recycled as
electronic waste
CUS
60601

10
Pump will not turn on
• Check all electrical connections and make sure the wall plug has power.
Cold pad will not cool down/Cold pad pressure is low
• Make sure trapped air is out of cold pad once power is applied.
• Make sure cooler is filled with ice and water.
• Check all hose connections and make sure cold pad is wrapped properly to
allow water to flow.
No water flow
• Check water level. Add water if necessary.
• Check and clean filter cap located under pump assembly.
• Cold pad and hose are wrapped too tightly or the hose is kinked. Unwrap
and rewrap the cold pad with cold therapy unit running, making sure water is
circulating freely throughout the cold pad and the hose is not kinked.
• Make sure connection between the cold therapy unit hose and cold pad hose
is properly connected.
Water leak at connector
• Connector between cold therapy unit hose and cold pad hose is not properly
connected. Stop machine, disconnect hose, and reconnect hose listening for
a “snap” or “click”, and restart the unit.
• Check barrier to ensure it is dry. Replace with dry barrier, if it is wet.
• Check o-rings.
TROUBLESHOOTING
FormoredetailspleasereferDJOGlobalwebsite:djoglobal.com
Contact manufacturer if assistance is needed in setting up, using or
maintaining the equipment or to report unexpected operation or events.
For product support call + or +.
WEBSITE
PRODUCT SUPPORT

10 11
Contact DJO Global product support at the above number or visit www.djo-
global.com for information and availability of any of the following accessories:
• Cold Pads*
• Cold Wraps*
• Dressings*
* Sterile options available.
ACCESSORIES

12
Iceman has been tested and found to comply with the electromagnetic
compatibility (EMC) limits for medical devices to IEC . These
limits are designed to provide reasonable protection against harmful
interference in a typical medical installation.
Caution: Medical electrical equipment requires special precautions
regarding EMC and must be installed and operated according to these
instructions. It is possible that high levels of radiated or conducted
radio-frequency electromagnetic interference (EMI) from portable and
mobile RF communications equipment or other strong or nearby
radio-frequency sources, could result in performance disruption of the
system. Evidence of disruption may include equipment ceasing to
operate, or other incorrect functioning. If this occurs, survey the site of
disruption, and take the following actions to eliminate the source(s).
• Turnequipment in the vicinity o and on to isolate disruptive
equipment.
• Relocateorreorientinterferingequipment.
• Increasedistancebetweeninterferingequipmentandyoursystem.
• Manageuseoffrequenciesclosetothesystemfrequencies.
• RemovedevicesthatarehighlysusceptibletoEMI.
• Lowerpowerfrom internal sources within the facility control (such as
paging systems).
• Labeldevices susceptible to EMI.
• EducateclinicalstafftorecognizepotentialEMI-relatedproblems.
• EliminateorreduceEMIwithtechnicalsolutions(suchasshielding).
• Restrictuseof personal communicators (cell phones, computers) in
areas with devices susceptible to EMI.
• Sharerelevant EMI information with others, particularly when
evaluating new equipment purchases which may generate EMI.
• Purchasemedicaldevices that comply with IEC  EMC
Standards (V/meter EMI immunity, limit interference level to .
V/meter).
ELECTROMAGNETIC COMPATIBILITY EMC
COMPLIANCE STATEMENTS

12 13
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
Iceman is intended for use in the electromagnetic environment specified below. The
customer or the user of Iceman should assure that it is used in such an environment.
Emissions Tests Compliance Electromagnetic Environment
Guidance
RF Emissions CISPR  Group  Iceman uses RF energy only for its
internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
RF Emissions CISPR  Class B Iceman is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes.
Harmonic Emissions
IEC 
Class A
Voltage Fluctuations
IEC 
Complies
ELECTROMAGNETIC COMPATIBILITY (EMC)
TABLES – RF EMISSIONS CLASS B

14
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Iceman is intended for use in the electromagnetic environment specified below. The
customer or the user of Iceman should assure that it is used in such an environment.
Immunity Test IEC  Test
Level
Compliance
Level
Electromagnetic
Environment
Guidance
Electrostatic
Discharge (ESD)
IEC 
± kV contact
± kV air
± kV contact
± kV air
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material,
the relative humidity
should be at least
%.
Electrical Fast
Transient/Burst
IEC 
± kVfor power
supply lines ± KV
for input/
output lines
± kVfor power
supply lines ± kV
for input/
output lines
Mains power quality
should be that of a
typical commercial
or hospital
environment.
Surge
IEC 
±1 KV differential
mode ± kV
common mode
± kV differential
mode ± kV
common mode
Mains power quality
should be that of a
typical commercial
or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 
Voltage dips of
>% for . cycles
% for  cycles
% for cycles
>% for 
cycles (s)
Voltage dips of
>% for . cycles
% for  cycles
% for cycles
>% for  cycles
(s)
Mains power quality
should be that of a
typical commercial
or hospital
environment. If the
user of the Cold
Therapy Unit
requires continued
operation during
power mains
interruptions, it is
recommended that
Iceman be powered
from an
uninterrupted power
supply or a battery.
Power Frequency
(50/60Hz)
Magnetic Fields
IEC 
Inductive loop at
 Hz and  Hz,
to  amps (rms)
per meter
Inductive loop at
 Hz and  Hz,
to  amps (rms)
per meter
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial
or hospital
environment.
NOTE: UTis the ac mains voltage prior to application of the test level.
ELECTROMAGNETIC COMPATIBILITY (EMC)
TABLES – RF EMISSIONS CLASS B (con’t)

14 15
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Iceman is intended for use in the electromagnetic environment specified below. The
customer or the user of Iceman should assure that it is used in such an environment.
Immunity
Test
IEC 
Test Level
Compliance
Level Electromagnetic
Environment Guidance
Conducted RF
IEC 
 kHz - 
MHz at 
Vrms
 kHz %
amplitude
modulated
 kHz - 
MHz at 
Vrms
 kHz %
amplitude
modulated
Portable and mobile RF
communications equipment should
be used no closer to any part of the
Cold Therapy Unit, including cables,
than the recommended separation
distance calculated from the
equation applicable to the frequency
of the transmitter.
Recommended separation
distance:
d = [3.5/V1]√P  KHz to  MHz
d = [3.5/E1]√P  MHz to  MHz
d = [/E1]√P  MHz to . GHz
where Pis the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manu-facturer and dis
the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,ashould
be less than the compliance level in
each frequency range.b
Interference may occur in the
vicinity of equipment marked with
the following symbol:
Radiated RF
IEC 
Radiation
field strength
of  V/m
from  
 MHz
(% AM 
kHz)
Radiation
field strength
of  V/m from
  
MHz
(% AM 
kHz)
NOTE 1: At  MHz and  MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which Iceman is used exceeds
the applicable RF compliance level above, Iceman should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the Cold Therapy Unit.
bOver the frequency range  kHz to  MHz, field strengths should be less than [V1] V/m.
ELECTROMAGNETIC COMPATIBILITY (EMC)
TABLES – RF EMISSIONS CLASS B (con’t)

16
Recommended separation distances between portable and mobile RF
communications equipment and the Cold Therapy Unit
Iceman is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of Iceman can help
prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and
Iceman as recommended below,according to the maximum output power of the
communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of
transmitter
m
 KHz to  MHz
d = [./V1]√P
 MHz to 
MHz
d = [./E1]√P
 MHz to ,
GHz
d = [/E1]√P
, , , ,
, , , ,
 , , ,
 , , ,
   
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer. NOTE 1: At  MHz and  MHz, the separation distance for the
higher frequency range applies. NOTE 2: These guidelines may not apply in all
situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
ELECTROMAGNETIC COMPATIBILITY (EMC)
TABLES – RF EMISSIONS CLASS B (con’t)

IceMan®CLEAR3
IceMan® CLASSIC &
IceMan®CLASSIC3
Unidades de terapia en frío
Instrucciones de uso

18
Cuándo utilizar IceMan®
El uso previsto de las unidades IceMan® CLEAR, IceMan® CLASSIC e
IceMan® CLASSICes para la reducción temporal de la inflamación y el
dolor después de una cirugía o una lesión. Éste es un dispositivo no estéril
de venta bajo receta para el uso en un solo paciente, para la aplicación
externa de terapia en frío. El dispositivo no puede usarse para ningún
otro fin.
INDICACIONES DE USO
ESTE DISPOSITIVO PUEDE ESTAR LO SUFICIENTEMENTE FRÍO COMO PARA
CAUSAR LESIONES GRAVES. PUEDEN PRODUCIRSE REACCIONES ADVER-
SAS GRAVES Y PELIGROS DE SEGURIDAD DURANTE SU USO.
El usuario previsto debe ser un profesional médico autorizado, el
paciente, el cuidador del paciente, o un familiar que proporciona
asistencia. El usuario debe poder:
· Leer, comprender y ser físicamente capaz de seguir todas las instruc-
ciones, advertencias y precauciones proporcionadas en la información
de uso.
PERFIL DEL USUARIO PREVISTO
Los dispositivos DonJoy® IceMan® ofrecen terapia en frío al hacer fluir
agua fría desde un baño de hielo a través de una almohadilla de terapia
aplicada.
PRINCIPIO DE FUNCIONAMIENTO

18 19
Cuándo no utilizar IceMan®
NO utilice este dispositivo en pacientes que padezcan la enfermedad de
Raynaud u otras afecciones vasoespásticas; la enfermedad de Buerger;
alergia o hipersensibilidad al frío; crioglobulinemia; hemoglobinuria pa-
roxística por frío u otros trastornos de crioaglutininas; feocromocitoma;
anemia de hematíes falciformes o antecedentes de lesiones por el frío.
Limite el uso de IceMan® con estos pacientes
Limite el uso de este dispositivo en pacientes que no respondan, sean
discapacitados o que tengan las facultades mentales o la percepción del
dolor alteradas. Los pacientes postquirúrgicos que se encuentren bajo el
efecto de la sedación, analgésicos o anestésicos, además de los pacientes
que consuman hipnóticos, ansiolíticos o antidepresivos deben supervi-
sarse frecuentemente durante el uso de este dispositivo. Es posible que
estos pacientes no puedan percibir el dolor, las quemaduras, el entu-
mecimiento, el hormigueo o la disminución de sensibilidad y pueden ser
susceptibles a lesiones. Interrumpa la terapia en frío inmediatamente al
presentarse el primer signo de lesión por frío.
CONTRAINDICACIONES:
LIMITACIONES EN GRUPOS DE PACIENTES ESPECIALES