DJO Donjoy IceMan CLEAR3 User manual
ICEMAN® CLEAR3
& ICEMAN® CLASSIC3
COLD THERAPY UNITS
UNIDADES DE TERAPIA
EN FRÍO
UNITÉS DE CRYOTHÉRAPIE
ENGLISH
BEFORE USING THE DEVICE, PLEASE READ THE
FOLLOWING INSTRUCTIONS COMPLETELY AND
CAREFULLY. CORRECT APPLICATION IS VITAL TO THE
PROPER FUNCTIONING OF THE DEVICE.
NOTICE: WHILE EVERY EFFORT HAS BEEN MADE IN
STATE-OF-THE-ART TECHNIQUES TO OBTAIN THE MAXIMUM
COMPATIBILITY OF FUNCTION, STRENGTH, DURABILITY AND
COMFORT, THERE IS NO GUARANTEE THAT INJURY WILL BE
PREVENTED THROUGH THE USE OF THIS PRODUCT.
1
4
5
2
3B
3A
13-4446 REV F - 2021/02/11©2021 DJO, LLC
INTENDED USER PROFILE:
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
directions, warnings and cautions provided in the information
for use.
OPERATING PRINCIPLE: The DonJoy® IceMan® devices
provide cold therapy by flowing cold water, from an ice bath
through an applied therapy pad.
INTENDED USE/INDICATIONS: The intended use of the
IceMan® CLEAR, and IceMan® CLASSICis 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.
CONTRAINDICATIONS: DO NOT use this device on
patients with Raynaud’s phenomenon or other vasospastic
conditions; Buerger’s disease; 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 this device with patients who are
unresponsive, incapacitated, have altered mental status or
altered pain perception. Post-surgical patients under sedation
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 injury. Discontinue cold
therapy immediately at the first sign of cold injury.
WARNING:
• THIS DEVICE CAN BE COLD ENOUGH TO CAUSE
SERIOUS INJURY. SERIOUS ADVERSE REACTIONS
AND SAFETY HAZARDS MAY OCCUR WHEN USING
THIS DEVICE.
• Read and understand all warnings and Instructions for
Use before using this device.
• For IceMan® CLEARor IceMan® CLASSIC
DO NOT use this device without a prescription from a
physician. Rx only. Your prescription 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.
• 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 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, 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.
• 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.
• 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 present 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. ALWAYS 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 difficult. 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 suffocation 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
interference could occur to this or other equipment.
Try to minimize this interference by not using other
electronic equipment in conjunction 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.
PRECAUTIONS: 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 circulation, or
compromised local circulation; hypercoagulation disorders;
diabetes or neuropathies.
DIRECTIONS FOR USE:
• A physician must prescribe treatment to be rendered by
this device, which must state 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.
OPERATING INSTRUCTIONS:
. Add ice to fill line inside the device. (Figure 1)
. Add cold water to fill line. (Figure 2)
. CLEARLid – Place lid on the device making sure the lip
inserts into the groove. Then press the lid down to close
and secure. (Figure 3A)
CLASSICLid – 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.
(Figure 3B)
. 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.
(Figure 4)
. To turn the device on, insert cord into connection on the
back of the device and plug power supply into the wall
outlet. (Figure 5) (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 application 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 discontinue use of this device.
STORAGE & CLEANING INSTRUCTIONS: Please view the
complete User Manual on the DJO Global website for details.
ENVIRONMENTAL & SERVICE LIMITS: Please view the
complete User Manual on the DJO Global website for details.
POWER SUPPLY:
•To order a replacement power supply contact DJO Global
Customer Support.
•DonJoy® IceMan® CLEARPower Supply:DJO P/N
•DonJoy® IceMan® CLASSICPower Supply: DJO P/N
WARRANTY: 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.
SAFETY CLASSIFICATIONS:
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 protection.
LEGEND / SYMBOL DESCRIPTION:
(Blue)
Attention /
Read Manual Type BF
Equipment
Class II
Equipment Temperature
Limits
(Yellow)
Cold
Temperature
CUS
60601 Safety Mark
(Yellow)
Warning Sign Humidity Limits
Manufacturer Atmospheric
Pressure Limits
Rx Only
This device must
be separated from
household waste
and recycled as
electronic waste
Blue – Action Required by User
Yellow – Proceed With Caution
Orange – Warning
TROUBLESHOOTING:
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.
WEBSITE: For more details please refer DJO Global website
www.djoglobal.com
PRODUCT SUPPORT: 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
+.
ACCESSORIES: Please view the complete User Manual on the
DJO Global website for details.
COMPLIANCE STATEMENTS:
ELECTROMAGNETIC COMPATIBILITY EMC
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 off 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) TABLES – RF
EMISSIONS CLASS B
Please view the complete User Manual on the DJO Global
website for details.
CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY
OR ON THE ORDER OF A LICENSED HEALTH CARE PROFESSIONAL.
DJ
O, LLC
1430 Decision Street
Vista, CA
DJOglobal.com
ICEMAN® CLEAR3
& ICEMAN® CLASSIC3
COLD THERAPY UNITS
UNIDADES DE TERAPIA
EN FRÍO
UNITÉS DE CRYOTHÉRAPIE
ENGLISH
BEFORE USING THE DEVICE, PLEASE READ THE
FOLLOWING INSTRUCTIONS COMPLETELY AND
CAREFULLY. CORRECT APPLICATION IS VITAL TO THE
PROPER FUNCTIONING OF THE DEVICE.
NOTICE: WHILE EVERY EFFORT HAS BEEN MADE IN
STATE-OF-THE-ART TECHNIQUES TO OBTAIN THE MAXIMUM
COMPATIBILITY OF FUNCTION, STRENGTH, DURABILITY AND
COMFORT, THERE IS NO GUARANTEE THAT INJURY WILL BE
PREVENTED THROUGH THE USE OF THIS PRODUCT.
1
4
5
2
3B
3A
13-4446 REV F - 2021/02/11©2021 DJO, LLC
INTENDED USER PROFILE:
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
directions, warnings and cautions provided in the information
for use.
OPERATING PRINCIPLE: The DonJoy® IceMan® devices
provide cold therapy by flowing cold water, from an ice bath
through an applied therapy pad.
INTENDED USE/INDICATIONS: The intended use of the
IceMan® CLEAR, and IceMan® CLASSICis 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.
CONTRAINDICATIONS: DO NOT use this device on
patients with Raynaud’s phenomenon or other vasospastic
conditions; Buerger’s disease; 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 this device with patients who are
unresponsive, incapacitated, have altered mental status or
altered pain perception. Post-surgical patients under sedation
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 injury. Discontinue cold
therapy immediately at the first sign of cold injury.
WARNING:
• THIS DEVICE CAN BE COLD ENOUGH TO CAUSE
SERIOUS INJURY. SERIOUS ADVERSE REACTIONS
AND SAFETY HAZARDS MAY OCCUR WHEN USING
THIS DEVICE.
• Read and understand all warnings and Instructions for
Use before using this device.
• For IceMan® CLEARor IceMan® CLASSIC
DO NOT use this device without a prescription from a
physician. Rx only. Your prescription 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.
• 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 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, 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.
• 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.
• 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 present 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. ALWAYS 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 difficult. 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 suffocation 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
interference could occur to this or other equipment.
Try to minimize this interference by not using other
electronic equipment in conjunction 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.
PRECAUTIONS: 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 circulation, or
compromised local circulation; hypercoagulation disorders;
diabetes or neuropathies.
DIRECTIONS FOR USE:
• A physician must prescribe treatment to be rendered by
this device, which must state 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.
OPERATING INSTRUCTIONS:
. Add ice to fill line inside the device. (Figure 1)
. Add cold water to fill line. (Figure 2)
. CLEARLid – Place lid on the device making sure the lip
inserts into the groove. Then press the lid down to close
and secure. (Figure 3A)
CLASSICLid – 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.
(Figure 3B)
. 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.
(Figure 4)
. To turn the device on, insert cord into connection on the
back of the device and plug power supply into the wall
outlet. (Figure 5) (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 application 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 discontinue use of this device.
STORAGE & CLEANING INSTRUCTIONS: Please view the
complete User Manual on the DJO Global website for details.
ENVIRONMENTAL & SERVICE LIMITS: Please view the
complete User Manual on the DJO Global website for details.
POWER SUPPLY:
•To order a replacement power supply contact DJO Global
Customer Support.
•DonJoy® IceMan® CLEARPower Supply:DJO P/N
•DonJoy® IceMan® CLASSICPower Supply: DJO P/N
WARRANTY: 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.
SAFETY CLASSIFICATIONS:
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 protection.
LEGEND / SYMBOL DESCRIPTION:
(Blue)
Attention /
Read Manual Type BF
Equipment
Class II
Equipment Temperature
Limits
(Yellow)
Cold
Temperature
CUS
60601 Safety Mark
(Yellow)
Warning Sign Humidity Limits
Manufacturer Atmospheric
Pressure Limits
Rx Only
This device must
be separated from
household waste
and recycled as
electronic waste
Blue – Action Required by User
Yellow – Proceed With Caution
Orange – Warning
TROUBLESHOOTING:
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.
WEBSITE: For more details please refer DJO Global website
www.djoglobal.com
PRODUCT SUPPORT: 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
+.
ACCESSORIES: Please view the complete User Manual on the
DJO Global website for details.
COMPLIANCE STATEMENTS:
ELECTROMAGNETIC COMPATIBILITY EMC
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 off 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) TABLES – RF
EMISSIONS CLASS B
Please view the complete User Manual on the DJO Global
website for details.
CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY
OR ON THE ORDER OF A LICENSED HEALTH CARE PROFESSIONAL.
DJ
O, LLC
1430 Decision Street
Vista, CA
DJOglobal.com
ICEMAN® CLEAR3
& ICEMAN® CLASSIC3
COLD THERAPY UNITS
UNIDADES DE TERAPIA
EN FRÍO
UNITÉS DE CRYOTHÉRAPIE
ENGLISH
BEFORE USING THE DEVICE, PLEASE READ THE
FOLLOWING INSTRUCTIONS COMPLETELY AND
CAREFULLY. CORRECT APPLICATION IS VITAL TO THE
PROPER FUNCTIONING OF THE DEVICE.
NOTICE: WHILE EVERY EFFORT HAS BEEN MADE IN
STATE-OF-THE-ART TECHNIQUES TO OBTAIN THE MAXIMUM
COMPATIBILITY OF FUNCTION, STRENGTH, DURABILITY AND
COMFORT, THERE IS NO GUARANTEE THAT INJURY WILL BE
PREVENTED THROUGH THE USE OF THIS PRODUCT.
1
4
5
2
3B
3A
13-4446 REV F - 2021/02/11©2021 DJO, LLC
INTENDED USER PROFILE:
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
directions, warnings and cautions provided in the information
for use.
OPERATING PRINCIPLE: The DonJoy® IceMan® devices
provide cold therapy by flowing cold water, from an ice bath
through an applied therapy pad.
INTENDED USE/INDICATIONS: The intended use of the
IceMan® CLEAR, and IceMan® CLASSICis 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.
CONTRAINDICATIONS: DO NOT use this device on
patients with Raynaud’s phenomenon or other vasospastic
conditions; Buerger’s disease; 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 this device with patients who are
unresponsive, incapacitated, have altered mental status or
altered pain perception. Post-surgical patients under sedation
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 injury. Discontinue cold
therapy immediately at the first sign of cold injury.
WARNING:
• THIS DEVICE CAN BE COLD ENOUGH TO CAUSE
SERIOUS INJURY. SERIOUS ADVERSE REACTIONS
AND SAFETY HAZARDS MAY OCCUR WHEN USING
THIS DEVICE.
• Read and understand all warnings and Instructions for
Use before using this device.
• For IceMan® CLEARor IceMan® CLASSIC
DO NOT use this device without a prescription from a
physician. Rx only. Your prescription 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.
• 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 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, 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.
• 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.
• 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 present 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. ALWAYS 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 difficult. 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 suffocation 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
interference could occur to this or other equipment.
Try to minimize this interference by not using other
electronic equipment in conjunction 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.
PRECAUTIONS: 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 circulation, or
compromised local circulation; hypercoagulation disorders;
diabetes or neuropathies.
DIRECTIONS FOR USE:
• A physician must prescribe treatment to be rendered by
this device, which must state 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.
OPERATING INSTRUCTIONS:
. Add ice to fill line inside the device. (Figure 1)
. Add cold water to fill line. (Figure 2)
. CLEARLid – Place lid on the device making sure the lip
inserts into the groove. Then press the lid down to close
and secure. (Figure 3A)
CLASSICLid – 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.
(Figure 3B)
. 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.
(Figure 4)
. To turn the device on, insert cord into connection on the
back of the device and plug power supply into the wall
outlet. (Figure 5) (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 application 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 discontinue use of this device.
STORAGE & CLEANING INSTRUCTIONS: Please view the
complete User Manual on the DJO Global website for details.
ENVIRONMENTAL & SERVICE LIMITS: Please view the
complete User Manual on the DJO Global website for details.
POWER SUPPLY:
•To order a replacement power supply contact DJO Global
Customer Support.
•DonJoy® IceMan® CLEARPower Supply:DJO P/N
•DonJoy® IceMan® CLASSICPower Supply: DJO P/N
WARRANTY: 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.
SAFETY CLASSIFICATIONS:
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 protection.
LEGEND / SYMBOL DESCRIPTION:
(Blue)
Attention /
Read Manual Type BF
Equipment
Class II
Equipment Temperature
Limits
(Yellow)
Cold
Temperature
CUS
60601 Safety Mark
(Yellow)
Warning Sign Humidity Limits
Manufacturer Atmospheric
Pressure Limits
Rx Only
This device must
be separated from
household waste
and recycled as
electronic waste
Blue – Action Required by User
Yellow – Proceed With Caution
Orange – Warning
TROUBLESHOOTING:
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.
WEBSITE: For more details please refer DJO Global website
www.djoglobal.com
PRODUCT SUPPORT: 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
+.
ACCESSORIES: Please view the complete User Manual on the
DJO Global website for details.
COMPLIANCE STATEMENTS:
ELECTROMAGNETIC COMPATIBILITY EMC
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 off 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) TABLES – RF
EMISSIONS CLASS B
Please view the complete User Manual on the DJO Global
website for details.
CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY
OR ON THE ORDER OF A LICENSED HEALTH CARE PROFESSIONAL.
DJ
O, LLC
1430 Decision Street
Vista, CA
DJOglobal.com
ICEMAN® CLEAR3
& ICEMAN® CLASSIC3
COLD THERAPY UNITS
UNIDADES DE TERAPIA
EN FRÍO
UNITÉS DE CRYOTHÉRAPIE
ENGLISH
BEFORE USING THE DEVICE, PLEASE READ THE
FOLLOWING INSTRUCTIONS COMPLETELY AND
CAREFULLY. CORRECT APPLICATION IS VITAL TO THE
PROPER FUNCTIONING OF THE DEVICE.
NOTICE: WHILE EVERY EFFORT HAS BEEN MADE IN
STATE-OF-THE-ART TECHNIQUES TO OBTAIN THE MAXIMUM
COMPATIBILITY OF FUNCTION, STRENGTH, DURABILITY AND
COMFORT, THERE IS NO GUARANTEE THAT INJURY WILL BE
PREVENTED THROUGH THE USE OF THIS PRODUCT.
1
4
5
2
3B
3A
13-4446 REV F - 2021/02/11©2021 DJO, LLC
INTENDED USER PROFILE:
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
directions, warnings and cautions provided in the information
for use.
OPERATING PRINCIPLE: The DonJoy® IceMan® devices
provide cold therapy by flowing cold water, from an ice bath
through an applied therapy pad.
INTENDED USE/INDICATIONS: The intended use of the
IceMan® CLEAR, and IceMan® CLASSICis 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.
CONTRAINDICATIONS: DO NOT use this device on
patients with Raynaud’s phenomenon or other vasospastic
conditions; Buerger’s disease; 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 this device with patients who are
unresponsive, incapacitated, have altered mental status or
altered pain perception. Post-surgical patients under sedation
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 injury. Discontinue cold
therapy immediately at the first sign of cold injury.
WARNING:
• THIS DEVICE CAN BE COLD ENOUGH TO CAUSE
SERIOUS INJURY. SERIOUS ADVERSE REACTIONS
AND SAFETY HAZARDS MAY OCCUR WHEN USING
THIS DEVICE.
• Read and understand all warnings and Instructions for
Use before using this device.
• For IceMan® CLEARor IceMan® CLASSIC
DO NOT use this device without a prescription from a
physician. Rx only. Your prescription 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.
• 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 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, 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.
• 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.
• 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 present 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. ALWAYS 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 difficult. 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 suffocation 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
interference could occur to this or other equipment.
Try to minimize this interference by not using other
electronic equipment in conjunction 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.
PRECAUTIONS: 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 circulation, or
compromised local circulation; hypercoagulation disorders;
diabetes or neuropathies.
DIRECTIONS FOR USE:
• A physician must prescribe treatment to be rendered by
this device, which must state 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.
OPERATING INSTRUCTIONS:
. Add ice to fill line inside the device. (Figure 1)
. Add cold water to fill line. (Figure 2)
. CLEARLid – Place lid on the device making sure the lip
inserts into the groove. Then press the lid down to close
and secure. (Figure 3A)
CLASSICLid – 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.
(Figure 3B)
. 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.
(Figure 4)
. To turn the device on, insert cord into connection on the
back of the device and plug power supply into the wall
outlet. (Figure 5) (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 application 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 discontinue use of this device.
STORAGE & CLEANING INSTRUCTIONS: Please view the
complete User Manual on the DJO Global website for details.
ENVIRONMENTAL & SERVICE LIMITS: Please view the
complete User Manual on the DJO Global website for details.
POWER SUPPLY:
•To order a replacement power supply contact DJO Global
Customer Support.
•DonJoy® IceMan® CLEARPower Supply:DJO P/N
•DonJoy® IceMan® CLASSICPower Supply: DJO P/N
WARRANTY: 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.
SAFETY CLASSIFICATIONS:
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 protection.
LEGEND / SYMBOL DESCRIPTION:
(Blue)
Attention /
Read Manual Type BF
Equipment
Class II
Equipment Temperature
Limits
(Yellow)
Cold
Temperature
CUS
60601 Safety Mark
(Yellow)
Warning Sign Humidity Limits
Manufacturer Atmospheric
Pressure Limits
Rx Only
This device must
be separated from
household waste
and recycled as
electronic waste
Blue – Action Required by User
Yellow – Proceed With Caution
Orange – Warning
TROUBLESHOOTING:
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.
WEBSITE: For more details please refer DJO Global website
www.djoglobal.com
PRODUCT SUPPORT: 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
+.
ACCESSORIES: Please view the complete User Manual on the
DJO Global website for details.
COMPLIANCE STATEMENTS:
ELECTROMAGNETIC COMPATIBILITY EMC
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 off 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) TABLES – RF
EMISSIONS CLASS B
Please view the complete User Manual on the DJO Global
website for details.
CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY
OR ON THE ORDER OF A LICENSED HEALTH CARE PROFESSIONAL.
DJ
O, LLC
1430 Decision Street
Vista, CA
DJOglobal.com
ICEMAN® CLEAR3
& ICEMAN® CLASSIC3
COLD THERAPY UNITS
UNIDADES DE TERAPIA
EN FRÍO
UNITÉS DE CRYOTHÉRAPIE
ENGLISH
BEFORE USING THE DEVICE, PLEASE READ THE
FOLLOWING INSTRUCTIONS COMPLETELY AND
CAREFULLY. CORRECT APPLICATION IS VITAL TO THE
PROPER FUNCTIONING OF THE DEVICE.
NOTICE: WHILE EVERY EFFORT HAS BEEN MADE IN
STATE-OF-THE-ART TECHNIQUES TO OBTAIN THE MAXIMUM
COMPATIBILITY OF FUNCTION, STRENGTH, DURABILITY AND
COMFORT, THERE IS NO GUARANTEE THAT INJURY WILL BE
PREVENTED THROUGH THE USE OF THIS PRODUCT.
1
4
5
2
3B
3A
13-4446 REV F - 2021/02/11©2021 DJO, LLC
INTENDED USER PROFILE:
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
directions, warnings and cautions provided in the information
for use.
OPERATING PRINCIPLE: The DonJoy® IceMan® devices
provide cold therapy by flowing cold water, from an ice bath
through an applied therapy pad.
INTENDED USE/INDICATIONS: The intended use of the
IceMan® CLEAR, and IceMan® CLASSICis 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.
CONTRAINDICATIONS: DO NOT use this device on
patients with Raynaud’s phenomenon or other vasospastic
conditions; Buerger’s disease; 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 this device with patients who are
unresponsive, incapacitated, have altered mental status or
altered pain perception. Post-surgical patients under sedation
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 injury. Discontinue cold
therapy immediately at the first sign of cold injury.
WARNING:
• THIS DEVICE CAN BE COLD ENOUGH TO CAUSE
SERIOUS INJURY. SERIOUS ADVERSE REACTIONS
AND SAFETY HAZARDS MAY OCCUR WHEN USING
THIS DEVICE.
• Read and understand all warnings and Instructions for
Use before using this device.
• For IceMan® CLEARor IceMan® CLASSIC
DO NOT use this device without a prescription from a
physician. Rx only. Your prescription 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.
• 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 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, 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.
• 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.
• 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 present 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. ALWAYS 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 difficult. 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 suffocation 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
interference could occur to this or other equipment.
Try to minimize this interference by not using other
electronic equipment in conjunction 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.
PRECAUTIONS: 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 circulation, or
compromised local circulation; hypercoagulation disorders;
diabetes or neuropathies.
DIRECTIONS FOR USE:
• A physician must prescribe treatment to be rendered by
this device, which must state 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.
OPERATING INSTRUCTIONS:
. Add ice to fill line inside the device. (Figure 1)
. Add cold water to fill line. (Figure 2)
. CLEARLid – Place lid on the device making sure the lip
inserts into the groove. Then press the lid down to close
and secure. (Figure 3A)
CLASSICLid – 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.
(Figure 3B)
. 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.
(Figure 4)
. To turn the device on, insert cord into connection on the
back of the device and plug power supply into the wall
outlet. (Figure 5) (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 application 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 discontinue use of this device.
STORAGE & CLEANING INSTRUCTIONS: Please view the
complete User Manual on the DJO Global website for details.
ENVIRONMENTAL & SERVICE LIMITS: Please view the
complete User Manual on the DJO Global website for details.
POWER SUPPLY:
•To order a replacement power supply contact DJO Global
Customer Support.
•DonJoy® IceMan® CLEARPower Supply:DJO P/N
•DonJoy® IceMan® CLASSICPower Supply: DJO P/N
WARRANTY: 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.
SAFETY CLASSIFICATIONS:
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 protection.
LEGEND / SYMBOL DESCRIPTION:
(Blue)
Attention /
Read Manual Type BF
Equipment
Class II
Equipment Temperature
Limits
(Yellow)
Cold
Temperature
CUS
60601 Safety Mark
(Yellow)
Warning Sign Humidity Limits
Manufacturer Atmospheric
Pressure Limits
Rx Only
This device must
be separated from
household waste
and recycled as
electronic waste
Blue – Action Required by User
Yellow – Proceed With Caution
Orange – Warning
TROUBLESHOOTING:
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.
WEBSITE: For more details please refer DJO Global website
www.djoglobal.com
PRODUCT SUPPORT: 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
+.
ACCESSORIES: Please view the complete User Manual on the
DJO Global website for details.
COMPLIANCE STATEMENTS:
ELECTROMAGNETIC COMPATIBILITY EMC
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 off 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) TABLES – RF
EMISSIONS CLASS B
Please view the complete User Manual on the DJO Global
website for details.
CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY
OR ON THE ORDER OF A LICENSED HEALTH CARE PROFESSIONAL.
DJ
O, LLC
1430 Decision Street
Vista, CA
DJOglobal.com
ICEMAN® CLEAR3
& ICEMAN® CLASSIC3
COLD THERAPY UNITS
UNIDADES DE TERAPIA
EN FRÍO
UNITÉS DE CRYOTHÉRAPIE
ENGLISH
BEFORE USING THE DEVICE, PLEASE READ THE
FOLLOWING INSTRUCTIONS COMPLETELY AND
CAREFULLY. CORRECT APPLICATION IS VITAL TO THE
PROPER FUNCTIONING OF THE DEVICE.
NOTICE: WHILE EVERY EFFORT HAS BEEN MADE IN
STATE-OF-THE-ART TECHNIQUES TO OBTAIN THE MAXIMUM
COMPATIBILITY OF FUNCTION, STRENGTH, DURABILITY AND
COMFORT, THERE IS NO GUARANTEE THAT INJURY WILL BE
PREVENTED THROUGH THE USE OF THIS PRODUCT.
1
4
5
2
3B
3A
13-4446 REV F - 2021/02/11©2021 DJO, LLC
INTENDED USER PROFILE:
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
directions, warnings and cautions provided in the information
for use.
OPERATING PRINCIPLE: The DonJoy® IceMan® devices
provide cold therapy by flowing cold water, from an ice bath
through an applied therapy pad.
INTENDED USE/INDICATIONS: The intended use of the
IceMan® CLEAR, and IceMan® CLASSICis 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.
CONTRAINDICATIONS: DO NOT use this device on
patients with Raynaud’s phenomenon or other vasospastic
conditions; Buerger’s disease; 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 this device with patients who are
unresponsive, incapacitated, have altered mental status or
altered pain perception. Post-surgical patients under sedation
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 injury. Discontinue cold
therapy immediately at the first sign of cold injury.
WARNING:
• THIS DEVICE CAN BE COLD ENOUGH TO CAUSE
SERIOUS INJURY. SERIOUS ADVERSE REACTIONS
AND SAFETY HAZARDS MAY OCCUR WHEN USING
THIS DEVICE.
• Read and understand all warnings and Instructions for
Use before using this device.
• For IceMan® CLEARor IceMan® CLASSIC
DO NOT use this device without a prescription from a
physician. Rx only. Your prescription 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.
• 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 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, 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.
• 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.
• 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 present 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. ALWAYS 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 difficult. 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 suffocation 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
interference could occur to this or other equipment.
Try to minimize this interference by not using other
electronic equipment in conjunction 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.
PRECAUTIONS: 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 circulation, or
compromised local circulation; hypercoagulation disorders;
diabetes or neuropathies.
DIRECTIONS FOR USE:
• A physician must prescribe treatment to be rendered by
this device, which must state 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.
OPERATING INSTRUCTIONS:
. Add ice to fill line inside the device. (Figure 1)
. Add cold water to fill line. (Figure 2)
. CLEARLid – Place lid on the device making sure the lip
inserts into the groove. Then press the lid down to close
and secure. (Figure 3A)
CLASSICLid – 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.
(Figure 3B)
. 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.
(Figure 4)
. To turn the device on, insert cord into connection on the
back of the device and plug power supply into the wall
outlet. (Figure 5) (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 application 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 discontinue use of this device.
STORAGE & CLEANING INSTRUCTIONS: Please view the
complete User Manual on the DJO Global website for details.
ENVIRONMENTAL & SERVICE LIMITS: Please view the
complete User Manual on the DJO Global website for details.
POWER SUPPLY:
•To order a replacement power supply contact DJO Global
Customer Support.
•DonJoy® IceMan® CLEARPower Supply:DJO P/N
•DonJoy® IceMan® CLASSICPower Supply: DJO P/N
WARRANTY: 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.
SAFETY CLASSIFICATIONS:
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 protection.
LEGEND / SYMBOL DESCRIPTION:
(Blue)
Attention /
Read Manual Type BF
Equipment
Class II
Equipment Temperature
Limits
(Yellow)
Cold
Temperature
CUS
60601 Safety Mark
(Yellow)
Warning Sign Humidity Limits
Manufacturer Atmospheric
Pressure Limits
Rx Only
This device must
be separated from
household waste
and recycled as
electronic waste
Blue – Action Required by User
Yellow – Proceed With Caution
Orange – Warning
TROUBLESHOOTING:
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.
WEBSITE: For more details please refer DJO Global website
www.djoglobal.com
PRODUCT SUPPORT: 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
+.
ACCESSORIES: Please view the complete User Manual on the
DJO Global website for details.
COMPLIANCE STATEMENTS:
ELECTROMAGNETIC COMPATIBILITY EMC
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 off 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) TABLES – RF
EMISSIONS CLASS B
Please view the complete User Manual on the DJO Global
website for details.
CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY
OR ON THE ORDER OF A LICENSED HEALTH CARE PROFESSIONAL.
DJ
O, LLC
1430 Decision Street
Vista, CA
DJOglobal.com
ICEMAN® CLEAR3
& ICEMAN® CLASSIC3
COLD THERAPY UNITS
UNIDADES DE TERAPIA
EN FRÍO
UNITÉS DE CRYOTHÉRAPIE
ENGLISH
BEFORE USING THE DEVICE, PLEASE READ THE
FOLLOWING INSTRUCTIONS COMPLETELY AND
CAREFULLY. CORRECT APPLICATION IS VITAL TO THE
PROPER FUNCTIONING OF THE DEVICE.
NOTICE: WHILE EVERY EFFORT HAS BEEN MADE IN
STATE-OF-THE-ART TECHNIQUES TO OBTAIN THE MAXIMUM
COMPATIBILITY OF FUNCTION, STRENGTH, DURABILITY AND
COMFORT, THERE IS NO GUARANTEE THAT INJURY WILL BE
PREVENTED THROUGH THE USE OF THIS PRODUCT.
1
4
5
2
3B
3A
13-4446 REV F - 2021/02/11©2021 DJO, LLC
INTENDED USER PROFILE:
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
directions, warnings and cautions provided in the information
for use.
OPERATING PRINCIPLE: The DonJoy® IceMan® devices
provide cold therapy by flowing cold water, from an ice bath
through an applied therapy pad.
INTENDED USE/INDICATIONS: The intended use of the
IceMan® CLEAR, and IceMan® CLASSICis 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.
CONTRAINDICATIONS: DO NOT use this device on
patients with Raynaud’s phenomenon or other vasospastic
conditions; Buerger’s disease; 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 this device with patients who are
unresponsive, incapacitated, have altered mental status or
altered pain perception. Post-surgical patients under sedation
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 injury. Discontinue cold
therapy immediately at the first sign of cold injury.
WARNING:
• THIS DEVICE CAN BE COLD ENOUGH TO CAUSE
SERIOUS INJURY. SERIOUS ADVERSE REACTIONS
AND SAFETY HAZARDS MAY OCCUR WHEN USING
THIS DEVICE.
• Read and understand all warnings and Instructions for
Use before using this device.
• For IceMan® CLEARor IceMan® CLASSIC
DO NOT use this device without a prescription from a
physician. Rx only. Your prescription 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.
• 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 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, 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.
• 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.
• 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 present 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. ALWAYS 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 difficult. 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 suffocation 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
interference could occur to this or other equipment.
Try to minimize this interference by not using other
electronic equipment in conjunction 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.
PRECAUTIONS: 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 circulation, or
compromised local circulation; hypercoagulation disorders;
diabetes or neuropathies.
DIRECTIONS FOR USE:
• A physician must prescribe treatment to be rendered by
this device, which must state 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.
OPERATING INSTRUCTIONS:
. Add ice to fill line inside the device. (Figure 1)
. Add cold water to fill line. (Figure 2)
. CLEARLid – Place lid on the device making sure the lip
inserts into the groove. Then press the lid down to close
and secure. (Figure 3A)
CLASSICLid – 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.
(Figure 3B)
. 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.
(Figure 4)
. To turn the device on, insert cord into connection on the
back of the device and plug power supply into the wall
outlet. (Figure 5) (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 application 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 discontinue use of this device.
STORAGE & CLEANING INSTRUCTIONS: Please view the
complete User Manual on the DJO Global website for details.
ENVIRONMENTAL & SERVICE LIMITS: Please view the
complete User Manual on the DJO Global website for details.
POWER SUPPLY:
•To order a replacement power supply contact DJO Global
Customer Support.
•DonJoy® IceMan® CLEARPower Supply:DJO P/N
•DonJoy® IceMan® CLASSICPower Supply: DJO P/N
WARRANTY: 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.
SAFETY CLASSIFICATIONS:
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 protection.
LEGEND / SYMBOL DESCRIPTION:
(Blue)
Attention /
Read Manual Type BF
Equipment
Class II
Equipment Temperature
Limits
(Yellow)
Cold
Temperature
CUS
60601 Safety Mark
(Yellow)
Warning Sign Humidity Limits
Manufacturer Atmospheric
Pressure Limits
Rx Only
This device must
be separated from
household waste
and recycled as
electronic waste
Blue – Action Required by User
Yellow – Proceed With Caution
Orange – Warning
TROUBLESHOOTING:
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.
WEBSITE: For more details please refer DJO Global website
www.djoglobal.com
PRODUCT SUPPORT: 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
+.
ACCESSORIES: Please view the complete User Manual on the
DJO Global website for details.
COMPLIANCE STATEMENTS:
ELECTROMAGNETIC COMPATIBILITY EMC
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 off 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) TABLES – RF
EMISSIONS CLASS B
Please view the complete User Manual on the DJO Global
website for details.
CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY
OR ON THE ORDER OF A LICENSED HEALTH CARE PROFESSIONAL.
DJ
O, LLC
1430 Decision Street
Vista, CA
DJOglobal.com
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