Breg Polar Care Wave User manual

INSTRUCTIONS FOR USE
INSTRUCCIONES DE USO
MODE D’EMPLOI
ISTRUZIONI PER L’USO
GEBRAUCHSANWEISUNG
GEBRUIKSAANWIJZING
ANVÄNDARINSTRUKTIONER
BRUKSANVISNING
KÄYTTÖOHJEET
BRUGSANVISNING
INSTRUKCJA UŻYTKOWANIA
ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ
HASZNÁLATI UTASÍTÁS
E/U authorized
representative
MDSS GmbH
Schigraben 41
D-30175 Hannover
Germany
UK Responsible Person
Joint Operations Ltd
11 Interface Business Park
Royal Wootton Bassett
Wiltshire
England
SN4 8SY
2797 0086
Breg, Inc.
2382 Faraday Avenue, Suite 300
Carlsbad, CA 92008 USA
Toll Free Tel: [phone]
Local: [phone]
Fax: [phone]
www.breg.com
© 2023 Breg, Inc. All rights reserved.
Polar Care Wave is a registered trademark
of Breg, Inc.
AW-1.04509 Rev A 07/23
MX

Table of Contents
Indications/Contraindications..........................................................2
SymbolsKey............................................................................4
PolarCare WaveDescription.............................................................5
Warnings...............................................................................6
Cautions................................................................................9
OperatingInstructions..................................................................10
Cleaning..............................................................................15
Storage...............................................................................16
Product Part Numbers /Warranty.....................................................17
Troubleshooting Guide.................................................................18
Product Specications (Electrical, Environmental, Performance, and Physical)...........20
ElectricalSafety.......................................................................22
Discharge Reminders for Healthcare Professionals......................................23
Cold CompressionProtocol.............................................................24
INSTRUCTIONS FOR USE
CAUTION: United States Federal Law restricts this device to sale by or on the order of a
medical professional.
The Polar Care Wave and cold compression pads are intended for single patient use only,
dispensed with a prescription.
For questions or product inquiries, contact Breg Customer Care at 1-800-321-0607
or [phone].

2 3
CONTRAINDICATIONS
INDICATIONS / CONTRAINDICATIONS
INDICATIONS FOR USE
The Polar Care Wave System is intended to treat post-surgical and acute injuries to reduce edema, swelling,
and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed
healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.
CONTRAINDICATIONS
The patient should NOT use the Polar Care Wave System if the patient is suspected of or observed to have
any of the following pre-existing conditions:
Cold and Compression Therapy:
•Signicant vascular impairment in the
affected region (e.g., from prior frostbite,
arteriosclerosis, arterial insufciency, diabetes,
vascular dysregulation, or other vascular
ischemic disease).
•Current clinical signs of inammatory
phlebitis, venous ulcers, or cellulitis.
•Any signicant risk factors or current clinical
signs of embolism (e.g., pulmonary embolus,
pulmonary edema, cerebral infarction, atrial
brillation, endocarditis, myocardial infarction,
or atheromatous embolic plaque).
•A condition in which increased venous or
lymphatic return is not desired in the affected
extremity (e.g., lymphedema after breast
cancer or other local carcinoma and/or
carcinoma metastasis in the affected extremity).
•Hypertension, cardiac failure, extreme low
blood pressure, or decompensated cardiac
insufciency.
•Localized unstable skin condition (e.g.,
dermatitis, vein ligation, gangrene, or recent
skin graft) in the affected region.
•Had recent toe surgery in the affected region.
Compression Therapy:
•Current clinical signs in the affected region
of signicant peripheral edema (e.g., deep
vein thrombosis, chronic venous insufciency,
acute compartment syndrome, systemic
venous hypertension, congestive heart failure,
cirrhosis/liver failure, renal failure).
•An acute, unstable (untreated) fracture in the
affected region.
•Any active local or systemic infection.
•Obtunded or with diabetes mellitus, multiple
sclerosis, poor circulation, spinal cord injuries,
and rheumatoid arthritis.
•Areas of skin breakdown or damage
(damaged or at-risk skin) producing uneven
heat conduction across the skin (e.g., open
wound, scar tissue, burn or skin graft). Any
open wound must be dressed prior to use of
the Polar Care Wave System.
•Presumptive evidence of congestive heart failure
•Pre-existing DVT condition
•Deep acute venal thrombosis
(Phlebothrombosis)
•Inammatory phlebitis process
Compression Therapy (continued from page 2):
•Episodes of pulmonary embolism
•Pulmonary edema
•Acute inammation of the veins
(Thrombophlebitis)
•Decompensated cardiac insufciency
•Arterial dysregulation
•Erysipelas
•Carcinoma and carcinoma metastasis in the
affected extremity
•Decompensated hypertonia
•Acute inammatory skin diseases or infection
•Venous or arterial occlusive disease
•Medical situations where increased venous or
lymphatic return is undesirable
•Poor peripheral circulation
•Severe arteriosclerosis, or active infection
Cold Therapy:
•Known hematological dyscrasias that
predispose to thrombosis (e.g., paroxysmal
cold hemoglobinuria, cryoglobulinemia, sickle-
cell disease, serum cold agglutinins).
•Tissues inamed as a result of recent injury or
exacerbation of chronic inammatory condition.
•Compromised local circulation or neurologic
impairment (including paralysis or localized
compromise due to multiple surgical procedures
or diabetes) in the affected region.
•Cognition or communication impairments that
prevent them from giving accurate and timely
feedback.
•Raynaud’s disease or cold hypersensitivity
(cold urticaria).
•Decompensated hypertonia in the affected
region.
•Raynaud’s phenomenon or other vasospastic
conditions.
•Cold allergy
•Cold agglutinin disorders like paroxysmal cold
hemoglobinuria
•Buergers disease
•Chilblains
•Cryoglobulinemia
•Sickle cell anemia
•Diabetes
•Hypersensitivity to cold
•History of cold injury
•Severe cardiovascular disease, anesthetic
skin, hypercoagulation disorders, poor
circulation, extremities sensitive to pain,
extremely low blood pressure that are
incapacitated, decreased skin sensitivity,
vein ligation or recent skin grafts, or
pheochromocytoma.
Contraindications continued through page 3.
CONTRAINDICATIONS

4 5
SYMBOLS KEY
POLAR CARE WAVE DESCRIPTION
The Polar Care Wave is a motorized cold therapy and intermittent compression device. Motorized cold therapy
and compression have repeatedly been shown to decrease postoperative pain, swelling, inammation, and
narcotic use following a variety of surgical procedures, such as surgery to the shoulder, knee, and back.
The Polar Care Wave unit consists of a container, tubing, lid with pumps, power supply, and a cold compression
pad. The cold compression pad is applied to the patient’s injured area which delivers cold and intermittent
compression therapy. The unit delivers cold therapy by circulating water from the container through the tubing
into the cold compression pad. The compression therapy is delivered by the unit’s air pump, which inates and
deates air into the cold compression pad providing gentle squeezing of the pad around the affected area. The
cold and compression therapies can be used in conjunction with each other or independently of each other, if
preferred or prescribed by a licensed healthcare professional. Breg offers a family of cold compression pads to
meet treatment needs (see page 12 for the full cold compressioncold compression pad options).
The Polar Care Wave can be used and operated by a patient or caretaker in a home or clinical setting.
These items are included:
POLAR CARE WAVE DESCRIPTION
SYMBOLS KEY
Label
Symbols Description
This is the safety alert symbol. It is used to alert of potential personal injury hazards.
Obey all safety messages that follow this symbol to avoid possible injury or death.
Type BF, applied part
Class II Equipment
Refer to instructions for use
IP22 Ingress Protection Marking of IP22: Protection against solid foreign objects of 12.5mm
and greater and against vertically falling water drops when tilted up to 15°.
Disposal of product according to local regulations.
Breg logo
Lid Lock/Unlock
Single Patient multiple use
Lid to container alignment
Keypad Symbols Description
Colder setting
Cold setting
Regular compression setting
Low compression setting
On/off button Knee Y Adapter Power Adapter
Cold compression Pad
(may be sold separately)
Knee Pad shown, for other
pad images see page 12.
Breg Ice Bags
Power Supply
Wave Unit
Lid
Container
Tubing
COLD COMPRESSION
WARNINGS
Accessories (sold separately):

6 7
WARNINGS
The Polar Care Wave can be cold enough to cause serious injury, including full skin necrosis. Follow and
carefully read the instructions for use and the cold compression pad tting instructions (printed on each cold
compression pad) prior to use.
WARNING
General Warnings
Cognitive risk factors
Patients with any of the following cognitive risk factors should only use Polar
Care Wave under direct supervision of a medical professional or caretaker. If
patient has any of the cognitive risk factors below, medical
professional or caretaker should provide skin checks:
•Children under 18 years old and elderly
•Cognitive disabilities
•Communication barriers
•Use of medications that have a negative effect upon mental capacity
•Visually impaired
Discuss treatment
with your licensed
healthcare
professional
Ask your healthcare professional about potential adverse reactions and cold-induced
injuries. Certain medical conditions make cold-induced injury more likely.
Use only as
prescribed
Do not use this device if you did not receive or do not understand the
instructions. Use only according to your healthcare professional’s instructions
regarding the frequency, duration, and settings of cold and compression
application and length of breaks between uses, how and when to inspect the
skin, and total length of treatment.
United States Federal law restricts this device to sale by or on the order of a
healthcare professional. The Polar Care Wave and cold compression pads are
intended for single patient, multiple use only. Dispensed with a prescription.
The prescription must include:
•The frequency, duration, and settings of the cold and compression
application
•Length of breaks between uses
•How and when to inspect the skin
•Total length of treatment
Warnings continued through page 9. Warnings continued through page 9.
WARNINGS
WARNINGS
General Warnings
Inspect skin regularly
Patients vary in sensitivity to cold, regularly inspect the skin under the cold
compression pad (by lifting the edge) as prescribed, typically every 1 to 2
hours. Do not use the Polar Care Wave unit if skins checks are inhibited by a
barrier.
Stop using and consult your healthcare professional immediately if you
experience any adverse reactions, such as: increased pain, burning, increased
swelling, itching, blisters, increased redness, discoloration, welts, irritation and
other changes in skin appearance, or any other reaction identied by your
healthcare professional.
General safety
•Keep tubing and cords away from the neck to avoid risk of strangulation.
•If a leak or a steady stream of water is owing from any part of the unit,
tubing or cold compression pad, discontinue use and contact Breg Customer
Care. Excess moisture could result in a slip hazard or unwanted moisture at
an injury site.
•Do not modify, service, or perform unspecied maintenance on this equipment
or accessories. Only use parts and accessories designed for the Polar Care Wave.
•Do not attempt to sterilize Polar Care Wave or cold compression pads by
any means.
•Set up and use this equipment in a location away from unsupervised
children and pets.
•Do not operate the unit in a heavy dust/lint environment, excessive dust/
lint may cause clogging. Do not leave the unit in direct sunlight, UV light
may damage or discolor the unit.
•Device not intended for use with numbing agents.
NOTICE TO USERS
If any serious incident has occurred in relation to the device, report to Breg and the competent authority
of the Member State in which the user and/or patient is established.
WARNINGS

8 9
WARNINGS
Warnings continued through page 9.
WARNINGS / CAUTIONS
General Warnings
Cold compression
pad
•Regularly check the therapy area.
•Cold compression pads are non-sterile. Patients should take caution in applying
cold compression pads over open wounds or breached skin. At a minimum,
these areas should be cleaned and bandaged.
•Cold compression pad should be inspected for cleanliness for each
treatment. If the pad is dirty, clean as indicated in the cleaning section on
page 15.
•Check for moisture on the cold compression pad before placing on the
skin. Remove any moisture before use.
•Ensure the therapy wrap is applied correctly before initiating any therapy.
Do not wrap the cold compression pads as to restrict blood ow or uid
ow within the cold compression pad.
•Do not apply any casting or restrictive devices over the cold compression
pad and tubing set as this may prevent proper operation and restrict skin
checks.
•The Polar Care Wave and cold compression pads are intended for single
patient, multiple use only. Re-use of single patient use pads may lead to risk
of infection.
Cold Therapy Warnings
Cold risk If the risk of cold-induced injury outweighs the benets of cold therapy, do not
prescribe Polar Care Wave.
Clinical risk factors
If the patient has any of the following clinical risk factors, use of Polar Care Wave
may result in serious cold-induced injury, including full thickness skin necrosis:
•Pathologic sensitivity to cold
•Behaviors that negatively affect circulation, including poor nutritional status,
smoking and tobacco use, excessive caffeine use, and excessive alcohol use
•Cold application area desensitization due to local anesthesia or regional
nerve blocks
•Diabetes
•Hand/wrist or feet/ankle surgery
•Taking medications that have a negative effect on peripheral vascular
circulation, including beta adrenergic blockers and local epinephrine use
(such as in local anesthetics)
WARNINGS WARNINGS
Cold Therapy Warnings
Cold risk mitigation
If you prescribe this product to patients with risk factors, consider taking special
measures to control the risk, such as:
•Recommending more frequent skin checks. If patient has cognitive risk
factors, healthcare professional or caretaker should provide skin checks
•Requiring more frequent follow-up examinations
•Adding an insulation barrier between the cold compression pad and skin
•Prescribing shorter durations of application, less frequent application, or
eliminating nighttime application
•Prescribe the warmer temperature setting (smaller snowake/"cold" setting)
Application site Excessive moisture at the application site due to excessive bleeding, sweating,
or condensation may increase the risk of serious cold-induced injury, including
full thickness skin necrosis.
Compression Therapy Warnings
Compression risk If the risk of injury outweighs the benets of compression therapy, do not
prescribe Polar Care Wave.
Clinical risk factors
Patients with any of the following compression risk factors should consult with a
healthcare professional prior to use:
•Neuropathies or tissue viability problems (i.e. diabetes, arterial or venous
insufciencies.)
•Patients positioned in the supine lithotomy position for extended lengths
•Poor circulation
Compression risk
mitigation Immediately stop compression therapy if you experience any sense of discomfort,
numbness or tingling of the limb and consult your healthcare professional.
CAUTIONS
•Do not walk with tubing connected to the cold compression pads. It is a trip hazard.
•If the unit is damaged or cracked, discontinue use and contact Breg Customer Care.
•Do not use hot water in this unit. It may be unsafe or damage the unit since it has not been designed
or tested with use of hot water.
•Do not use any other uids besides water or recommended cleaning agents on page 15 with the
Polar Care Wave. Doing so will damage the unit.
•Do not run cold therapy without water. Using cold therapy without water can cause permanent
damage to the water pump.

10 11
OPERATING INSTRUCTIONS
OPERATING INSTRUCTIONS
Setup with Water and Ice:
Set up and operate unit on a at surface so the unit does not tip over.

Unlock handle by rotating handle to the front of the unit.
Remove lid and ll container with water to indicated water
ll line.

Fill to lines on label inside container. Use cubed ice for optimal
performance.
Only use ice and water or four (4) Breg Ice Bags and water with
this unit (see page 11 for Setup with Breg Ice Bag Accessories).
CAUTION: Do not overll the unit with ice and water.
Appropriate levels are indicated by the ice/water label in the
container. Overlling the unit can cause water to spill out or
prevent the lid from closing properly.
FIRST ADD WATER
SECOND ADD ICE
Place lid on container using align stickers.
COLD COMPRESSION
Lock by rotating the handle to the upright or back position
according to image on handle.
Every 6-8 hours or as needed, pour out enough water to return water level to original water ll
line and re-ll ice to ice line.
Continue to Power Supply instructions on page 11.
OPERATING INSTRUCTIONS
OPERATING INSTRUCTIONS
Setup with Breg Ice Bag Accessories and Water:
Remove four (4) empty Breg Ice Bags from the packaging. Only
use Breg Ice Bags that come with the Polar Care Wave.
Fill the four (4) Breg Ice Bags with water to ll line. Do not over ll.
Freeze Breg Ice Bags in freezer. Dry Breg Ice Bag exterior before
placing in freezer.
Set up and operate unit on a at surface so the unit does not tip over.
Unlock handle by rotating handle to the front of the unit.
Remove lid and add water to ll line in container.
COLD COMPRESSION
FIRST ADD WATER
SECOND ADD ICE BAGS

Place all four (4) Breg Ice Bags into the corners of the container
as shown.
Only use ice and water or four (4) Breg Ice Bags and water with
this unit.
Replace lid and lock by rotating the handle to the upright or back position.

Replace four (4) melted Breg Ice Bags with four (4) frozen Breg Ice Bags every 4-5 hours or as
needed. While using the Breg Ice Bags, cubed ice may also be added to the container up to the
ice ll line to optimize the colder setting.
Power Supply:
Plug power supply into the wall and other end
of cord into lid.

12 13
OPERATING INSTRUCTIONS
OPERATING INSTRUCTIONS
OPERATING INSTRUCTIONS
Cold compression Pad Application:
(Make sure Breg logo and pad instructions are facing out, away from the injury site)
Standard / Large Knee Pad
100281 Rev G
G
GUPDATED ARTWORK FOR BREG BRANDING 24 APR 15 MZ
C00017
REF
LOT
Made in China
US Patents Pending
Breg, Inc.
2885 Loker Ave. East
Carlsbad, CA 92010 U.S.A.
P: 800-321-0607
760-795-5440
www.breg.com
c2015 Breg, Inc.
All rights reserved
12548
Hip Pad
Shoulder Pad
C00004
1a
1b
2b
2a
FUpdate artwork for Breg branding
Simplified artwork
Clarified arrows
21 APR 2015 MZ
F
100235 Rev F
REF
LOT
Made in China
US Patents Pending
Breg, Inc.
2885 Loker Ave. East
Carlsbad, CA 92010 U.S.A.
P: 800-321-0607
760-795-5440
www.breg.com
c2015 Breg, Inc.
All rights reserved
12548
Back Pad
100436 Rev C
C
CUPDATED ARTWORK FOR BREG BRANDING 24 APR 15 MZ
C00020
REF
LOT
Made in China
US Patents Pending
Breg, Inc.
2885 Loker Ave. East
Carlsbad, CA 92010 U.S.A.
P: 800-321-0607
760-795-5440
www.breg.com
c2015 Breg, Inc.
All rights reserved
12548
Foot / Ankle Pad
100437 Rev C
C
CUPDATED ARTWORK FOR BREG BRANDING 24 APR 15 MZ
REF
LOT
Made in China
US Patents Pending
Breg, Inc.
2885 Loker Ave. East
Carlsbad, CA 92010 U.S.A.
P: 800-321-0607
760-795-5440
www.breg.com
c2015 Breg, Inc.
All rights reserved
C00005
12548
Universal Pad
(use for knee or shoulder)
F
FUpdated for Breg Branding 21 APR 2015 MZ
12548
1a 2a
2b
1a
1b
1b
2a
2b
C00016
100242 Rev F
REF
LOT
Made in China
US Patents Pending
Breg, Inc.
2885 Loker Ave. East
Carlsbad, CA 92010 U.S.A.
P: 800-321-0607
760-795-5440
www.breg.com
c2015 Breg, Inc.
All rights reserved
OPERATING INSTRUCTIONS
Connecting and Disconnecting Cold compression Pad to Unit:
Line up the Breg logos on the
tubing and pad connectors.
Knee Pad Shown
COLD COMPRESSION
Squeeze down gently on the
blue clips.
Push connectors together until
they make a “click” sound.

Disconnect the cold compression pad from the unit by pressing the blue clips and gently pulling
the connectors apart.
The Breg Polar Care cold compression pad may be disconnected from the unit while it's running
and connectors will seal, preventing water from owing out of tubing. Note: Some dripping during
release is normal.
Power Adapter:
First, take the power supply and appropriate plug adapter from the
packaging.
Then with the power supply plugs folded in vertically (shown on
left), align the power supply and plug adapter (shown on right).
Make sure locking notch is on top, otherwise invert the plug
adapter.
Finally, slide the adapter down gently until it is fully recessed down
to the power supply.

14 15
OPERATING INSTRUCTIONS
CLEANING
OPERATING INSTRUCTIONS
Keypad Key:
Press to cycle compression
between regular, low, and off
Press to cycle cold between
colder, cold, and off
COLD COMPRESSION
Press to turn on/off
Colder
Cold
Regular
Low
Operating the Unit:

Press the on/off button to turn the unit on. It will illuminate.
Upon initial start-up, the unit will default to colder and regular settings for cold and compression
therapy, respectively.
If the unit was previously in use, it will default to the last settings selected when the unit was
turned off.
Press the cold button to cycle between colder, cold, and off.
Press the compression button to cycle between regular, low, and off.
Press the on/off button to turn the unit off. All lights will turn off.
•Cold and compression therapies may be used at the same time or independently.
•If the on/off button continuously ashes, refer to troubleshooting guide on page 18.
•If the on/off button is on and both therapies are off for more than 15 minutes, the unit will
automatically shut off.
•Some condensation on the tube and cold compression pad is possible, especially in warmer
climates.
CLEANING
WARNING: Do not apply cold compression pad to patient during the cleaning procedure.
Exposure to cleaning agent may cause injury.
CAUTION: Do not apply a direct stream of any liquid onto the unit's lid, submerge the unit, or allow any
liquid to pool on the top of the lid. The unit's lid contains all of the unit's electronics.
Clean as necessary or if soiled or debris is present in the unit. If using well water, more frequent cleanings
may be required.
Polar Care Wave – Exterior Surfaces
(container, lid, tubing, cold compression pad, and y-adapter)
Cleaning agents for
home setting:
•Mild soap
•Water
Cleaning agents for
clinical setting:
•Use only mild soap and water on cold compression pad
•Disposable disinfection wipes
•Quaternary ammonium
Procedure: •Follow the manufacturer’s instructions and precautions for the cleaning
agent you select.
•Use selected cleaner and a soft cloth to wipe surfaces of container, lid,
tubing, connectors, and cold compression pad.
•Wipe dry.
Polar Care Wave – Internal Components
(pump system, internal tubing, inside of cold compression pad and y-adapter)
Cleaning agents: •Bleach
•Water
Procedure: •Connect cold compression pad to unit.
•Fill the unit with cold tap water to the ice line and add 1/2 teaspoon of
bleach.
•Do not add ice.
•Run the cold therapy for at least 10 minutes.
•Roll the cold compression pad while still connected and squeeze the water
back into the container.
•Disconnect the cold compression pad, pour the water out of the unit, and
wipe dry.

16 17
STORAGE
PRODUCT PART #'S / WARRANTY
STORAGE
Storing the Unit:
Remove water from the cold compression pad by rolling the pad up while still connected and squeezing
the water back into the unit. Disconnect cold compression pad.
Pour out water from unit and wipe dry.
Coil tubing as shown and secure using
straps.
Do not store with water. Refer to page 20 for environmental storage requirements.
PRODUCT PART NUMBERS
Product # Description
100716-000 PC Wave INTL
C00003 Breg Cold Compression Pad, Knee L
C00004 Breg Cold Compression Pad, Shoulder
C00005 Breg Cold Compression Pad, Foot/Ankle
C00013 Breg Cold Compression Pad, Hip
C00016 Breg Cold Compression Pad, Universal
C00017 Breg Cold Compression Pad, Knee
C00020 Breg Cold Compression Pad, Back
C00015 Breg Carrying Bag
100576-000 PC Wave Knee Y Adapter
100582-000 Breg Ice Bags
100717-000 International PC Wave Replacement Power Supply
100718-000 Power Supply Adapter Kit, INTL
WARRANTY
Breg, Inc. warrants that this product is free from defects in workmanship and materials, and t for use for
180 days from initial purchase under normal use for which it was intended.
Breg, Inc.’s obligation under this warranty is limited to the replacement or repair of any defective part or parts
of this product. All expressed or implied warranties, including the warranty of merchantability and tness for a
particular purpose, are limited to the actual warranty period set forth above. No other warranty, expressed or
implied, is given and no afrmation of or by seller, by words or action, will constitute a warranty.

18 19
TROUBLESHOOTING GUIDE
TROUBLESHOOTING GUIDE
TROUBLESHOOTING GUIDE
Problem Possible Solutions
On/off button
flashing notification
•Restart the Unit
○Turn unit off by either pressing the on/off button or by disconnecting
and reconnecting power supply from the unit or from the wall.
○Press on/off button to turn unit back on.
○Press cold or compression therapy buttons (if required) to start desired
therapies.
•If compression therapy does not function after pressing compression button
(cold compression pad doesn’t appear to be inating or compression
therapy setting light is not on), see Compression Therapy troubleshooting
sections on page 19.
•If cold therapy does not function after pressing cold button, see Cold
Therapy troubleshooting section on page 19.
On/off button isn’t
responding
•Conrm power outlet is working and power supply is fully inserted in the
outlet.
•Conrm that power supply plug is fully inserted into the unit lid.
•Conrm the correct Polar Care Wave power supply is connected (see page 20).
Condensation •Wrap material loosely over cold compression pad and tubing to minimize
air exposure.
•Protect the wound site by using a sterile dressing with waterproof barrier.
Acceptable barriers include an undercast bandage similar to Webril™
(ARTG 371503), a gauze bandage similar to Kerlix™ (ARTG 186369) or
a tubular bandage.
Note: Some condensation on the tube and cold compression pad is possible,
especially in warmer climates. Place a cloth layer under the container to protect
items under the unit.
Unit is leaking from
blue connectors
•Disconnect blue tabs on the cold compression pad connector.
•Check that the Breg logos on the blue connectors are lined up correctly and
reconnect.
If the problem continues, please contact Breg Customer Care at 1-800-321-0607
or [phone] for assistance.
Problem Possible Solutions
Cold therapy: water
not
flowing to
cold compression
pad or pad not cold
•Conrm on/off button is illuminated and a cold therapy "colder" or
"cold" setting light is on to indicate that cold therapy is functioning.
•Check that blue connectors between cold compression pad and tubing are
fully engaged with Breg logos lined up. Disconnect blue connectors and
reconnect if needed.
•Allow 10 minutes for cold compression pad temperature to stabilize.
•Conrm unit has both ice and water to appropriate levels.
•While using the Breg Ice Bags, cubed ice may also be added to the
container up to the ice ll line to optimize the colder setting.
•Elevating the unit to the same or higher elevation than the cold compression
pad may increase water ow to the cold compression pad.
•Check that tubing and cold compression pad are not kinked.
•Remove cold compression pad and lay it at. Allow cold compression pad to
ll with water and then reapply.
Compression
therapy:
cold compression
pad not compressing
or filling with air
Note: During compression therapy operation, it is normal for the compression to
inate and deate continuously. The duration of each ination-deation cycle is
approximately 1 to 2 minutes.
•Conrm on/off button is illuminated and a compression therapy "regular" or
"low" setting light is on to indicate that compression therapy is functioning.
•Check that blue connectors between cold compression pad and tubing are
fully engaged with Breg logos lined up. Disconnect blue connectors and
reconnect if needed.
•Tighten cold compression pad.
•Check that tubing and cold compression pad are not kinked.
•Remove cold compression pad and lay it at. Check if the cold compression
pad is inating with air and then reapply.
Compression
therapy:
cold compression
pad not deflating
properly
•Check that blue connectors between cold compression pad and tubing are
fully engaged with Breg logos lined up.
•Disconnect blue connectors, deate pad by rolling to remove air, and
reconnecting blue connectors if needed.
If the problem continues, please contact Breg Customer Care at 1-800-321-0607
or [phone] for assistance.
TROUBLESHOOTING GUIDE

20 21
PRODUCT SPECIFICATIONS
PRODUCT SPECIFICATIONS
PRODUCT SPECIFICATIONS
Electrical Specications (Also see Electromagnetic Immunity Test Table on page 21)
Unit Rated: 12VDC, 1A
Power supply is specified as part of ME Equipment
Manufacturer: HDP Model: HDP12-MD12010C Output: 12VDC, max. 1.0A
Back up supply: FRIWO Model: FW8000M/12 Output: 12VDC, max. 1.0A
Rated Input: 100-240VAC, 50-60Hz
Standards Compliance: Designed to conform to applicable requirements of: EN 60601-1,
Edition 3.1 and 60601-1-2, 4th Edition
Electrical Classifications: Class II, Continuous Operation. Not suitable with ammable
anesthetics. Group 1, Class B.
Environmental Requirements
Transport & Storage:
Operating:
–25°C to 5°C, and
5°C to 35°C at a relative humidity of 10% to 90%, non-condensing;
>35°C to 70°C at a water vapor pressure up to 50 hPa
5°C to 40°C (41°F to 104°F )15-90% RH non-condensing,
700 hPa to 1060 hPa
Indoor use only up to 2000m altitude
There is no warm up time required from when the Wave is stored at
the minimum storage temperature and when the product is used.
Performance Specications
Expected Service Life: 1 year from date of rst use (unit and accessories).
Average operating temperature of a Polar
Care Wave cold compression pad:
≥45°F at the colder setting
≥50°F at the cold setting
Note: The Foot/Ankle pad at the cold setting may operate at temperatures above 60°F which only
provides a cooling sensation.
Average peak compression pressure of the
cold compression pad:
50 mmHg at the regular setting
25 mmHg at the low setting
Physical Specications
Weight: 5 lbs (2.3 kg) Empty, 16 lbs (7.3 kg) Filled
Electromagnetic Immunity Test Table
Immunity Test Basic EMC Standard IEC 60601 Test Level (Home Healthcare)
Electrostatic discharge (ESD) IEC 61000-4-2 +/- 8 kV contact
+/- 2kV, +/-4kV, +/-8 kV, +/- 15kV air
Radiated RF EM elds IEC 61000-4-3 10V/m
80 MHz - 2.7 GHz
80% AM at 1 kHz
Proximity elds from RF wireless
communications equipment
IEC 61000-4-3 Reference IEC 60601-1-2 table 9
Rated power frequency
magnetic elds
IEC 61000-4-8 30 A/m 50Hz or 60Hz
Electrical fast transients/bursts IEC 61000-4-4 +/- 2 kV for power supply lines
100 kHz repetition frequency
Surge IEC 61000-4-5 +/- 0.5 kV, +/- 1 kV line-to-line
+/- 0.5 kV, +/- 1 kV, +/- 2 kV line-to-ground
Conducted disturbances induced
by RF elds
IEC 61000-4-6 3V
0.15MHz - 80 MHz
6V in ISM and amateur radio bands between
0.15 MHz and 80 MHz
80% AM at 1 kHz
Voltage dips IEC 61000-4-11 0% UT 0.5 cycle
At 0, 45, 90, 135, 180, 225, 270, and
315 degrees
0% UT: 1 cycle
70% UT: 25/30 cycles
Single phase: at 0 degrees
Voltage interruptions IEC 61000-4-11 0% UT: 250/300 cycles
Note: UT is the mains voltage prior to application of the test level
PRODUCT SPECIFICATIONS

22 23
ELECTRICAL SAFETY
DISCHARGE REMINDERS
ELECTRICAL SAFETY
Flammables
•When using or cleaning the Polar Care Wave, avoid ammables and oxidizers.
Do not use in places with ammable vapors or gases (e.g., ammable
anesthetics), high oxygen concentrations, or other oxidizers (e.g., nitrous oxide).
Keep electrical
components dry
and free of debris
•Even though the Polar Care unit is designed to hold and pump water, the
electrical components of the unit and power supply must be kept dry.
•Do not handle the power supply or electrical cord with wet hands.
•Always keep the unit in a place where the connections will not fall into water
(e.g., a tub, sink, etc.).
•If the electrical connections fall into water, do not touch any part of the product.
•Unplug only at dry electrical connections.
Power supply •Use only the power supply provided with the Breg Polar Care Wave unit.
Model number is listed in Electrical Specication section on page 20.
•Keep the cord and power supply away from heated surfaces.
•Never operate this product if it has a damaged cord, power supply, or plug,
which could result in electric shock.
•If the cord, power supply, or plug is damaged, unplug and contact Breg
Customer Care.
Electromagnetic
interference and
emissions
•This Polar Care Wave unit may cause electromagnetic or other interference with
other electrical devices. Avoid using the Polar Care Wave unit adjacent to or
stacked on other equipment because it could result in improper operation of the
unit or the other equipment.
•Portable RF communications equipment should be used no closer than 12
inches (30 cm) to any part of the Polar Care Wave unit, doing so may result
in product performance degradation.
•Using accessories or a power supply other than those provided could result in
increased electromagnetic emissions or decreased electromagnetic immunity
of the unit and can result in unit malfunction.
Disposal
This product contains electrical components and can not be discarded in standard waste.
Dispose of product according to local regulations.
DISCHARGE REMINDERS FOR HEALTHCARE PROFESSIONALS
Follow these reminders prior to discharging the patient from facility care to home use.
1. Patient Screen. Screen the patient for any contraindications and/or applicable warnings. If the
patient has any contraindications (see Contraindications), do not dispense Breg’s Polar Care
Wave to the patient. If any of the warnings apply to the patient (see Warnings), determine the
appropriateness of application of Breg’s Polar Care to that patient.
2. Instructions For Use. Instruct the patient on how to properly use Breg’s Polar Care Wave. Review the
Operating Instructions in this document and afxed to the unit with each patient.
3. Prescription. Instruct the patient regarding the healthcare professional’s prescribed protocol: frequency,
compression level, temperature level and duration of use, length of breaks between uses, how and
when to inspect the skin, and total length of treatment. A protocol template is included in this document
(see page 24) to ll in and provide to the patient. The duration of application, temperature and
compression level may vary depending upon the patient. If the patient does not experience pain relief,
the physician may increase the duration of application and/or adjust temperature and compression
levels. As the application duration is increased, the frequency of the skin inspections should increase
(see Warnings). Instruct the patient to take breaks by turning off the unit for a specied period of time.
4. Potential For Injury. Inform the patient that improper use can result in serious skin injury, including
full thickness skin necrosis. Emphasize the importance of following the prescribed protocol, proper
cold compression pad application, and skin inspection.
5. Proper Cold compression Pad Application. Instruct the patient to use only the Breg Polar Care Wave
cold compression pad designed for the body part being treated; other pads may not connect or may
be colder, increasing the risk of serious cold-induced injury, including full thickness skin necrosis. Do
not use the Polar Care Wave unit if skin checks are inhibited by a barrier.
6. Skin Inspection. Instruct the patient to inspect the skin receiving treatment per the practitioner’s
instructions, typically every 1 to 2 hours. Do not use the Polar Care Wave unit if skin checks are
inhibited by a barrier.
7. Discontinue. Instruct the patient to stop using Breg Polar Care Wave and consult his/her healthcare
professional immediately if he/she experiences any adverse reactions, such as: increased pain,
burning, increased swelling, itching, blisters, increased redness, discoloration, welts, or other
changes in skin appearance.
8. Documentation. Provide the patient a prescription. The prescription must include:
•The frequency, duration, and settings of the cold and compression application
•Length of breaks between uses
•How and when to inspect the skin
•Total length of treatment

24 25
PROTOCOL
Cold Compression Protocol*
Treatment
Period
Cold Frequency/Duration/
Setting(s)
Compression Frequency/
Duration/Setting(s)
Skin Inspection Frequency/
Breaks Between Use
Week 1
Weeks 2-4
Week 4+
*To be completed by a licensed healthcare professional.
Discuss treatment with your licensed healthcare professional
Ask your healthcare professional about potential adverse reactions and cold-induced injuries. Certain
medical conditions make cold- induced injury more likely.
Use only as prescribed
Do not use this device if you did not receive or do not understand the instructions. Use only according
to your healthcare professional’s instructions regarding the frequency, duration, and settings of cold and
compression application and length of breaks between uses, how and when to inspect the skin, and
total length of treatment.
United States Federal law restricts this device to sale by or on the order of a healthcare professional.
The Polar Care Wave and cold compression pads are intended for single patient, multiple use only.
Dispensed with a prescription. The prescription must include:
•The frequency, duration, and settings of the cold and compression application
•Length of breaks between uses
•How and when to inspect the skin
•Total length of treatment
Inspect skin regularly
Patients vary in sensitivity to cold, regularly inspect the skin under the cold compression pad (by lifting the
edge) as prescribed, typically every 1 to 2 hours. Do not use the Polar Care Wave unit if skins checks are
inhibited by a barrier.
Stop using and consult your healthcare professional immediately if you experience any adverse reactions, such
as: increased pain, burning, increased swelling, itching, blisters, increased redness, discoloration, welts, irritation
and other changes in skin appearance, or any other reaction identied by your healthcare professional.
Contact information
Breg Customer Care 1-800-321-0607 or [phone].

INSTRUCCIONES DE USO

Índice
Indicaciones y contraindicaciones ...................................................2
Clave de símbolos.................................................................4
Descripción del dispositivo Polar Care Wave..........................................5
Advertencias ......................................................................6
Precauciones......................................................................9
Instrucciones de operación ....................................................... 10
Limpieza ....................................................................... 15
Almacenamiento ................................................................ 16
Números de partes del producto / Garantía ....................................... 17
Guía de solución de problemas ................................................... 18
Especicaciones del producto (eléctricas, rendimiento, ambientales y de físicas) ...... 20
Seguridad eléctrica .............................................................. 22
Recordatorios del alta médica para profesionales de la salud ........................ 23
Protocolo de compresión fría ..................................................... 24
INSTRUCCIONES DE USO
PRECAUCIÓN: La Ley Federal de los Estados Unidos restringe la venta de este
dispositivo y solo puede hacerla un profesional de salud o con la orden de este.
Las almohadillas del dispositivo Polar Care Wave y compresión fría están diseñadas para
uso exclusivo de un solo paciente y se surten con receta médica.
Si tiene preguntas o consultas sobre el producto, póngase en contacto con Atención al
cliente de Breg en el 1-800-321-0607 o [phone].

2 3
CONTRAINDICACIONES
INDICACIONES Y CONTRAINDICACIONES
INDICACIONES PARA EL USO
El sistema Polar Care Wave está diseñado para tratar lesiones posoperatorias y agudas para reducir el edema,
la inamación y el dolor cuando se indiquen frío y compresión. Está diseñado para usarse por parte de
profesionales de la salud registrados o por indicación de estos en hospitales, clínicas ambulatorias, instalaciones de
entrenamiento deportivo o el hogar.
CONTRAINDICACIONES
El paciente NO debe usar el sistema Polar Care Wave si se sospecha o se observa que tiene alguna de las
siguientes condiciones preexistentes:
Terapia de frío y compresión:
•Deterioro vascular signicativo en la región
afectada (por ejemplo, por congelación previa,
arteriosclerosis, insuciencia arterial, diabetes,
desregulación vascular u otra enfermedad
isquémica vascular).
•Signos clínicos actuales de ebitis inamatoria,
úlceras venosas o celulitis.
•Cualquier factor de riesgo importante o signos
clínicos actuales de embolia (por ejemplo,
embolia pulmonar, edema pulmonar, infarto
cerebral, brilación auricular, endocarditis, infarto
de miocardio o placa embólica ateromatosa).
•Una condición en la que no se desea un aumento
del retorno venoso o linfático en la extremidad
afectada (por ejemplo, linfedema después del
cáncer de mama u otro carcinoma local y/o
metástasis en la extremidad afectada).
•Hipertensión, insuciencia cardíaca, presión
arterial extremadamente baja o insuciencia
cardíaca descompensada.
•Afección localizada inestable de la piel (por
ejemplo, dermatitis, ligadura de venas, gangrena
o injerto cutáneo reciente) en la región afectada.
•Tuvo una cirugía reciente del dedo del pie en la
región afectada.
Terapia de compresión:
•Signos clínicos actuales en la región afectada
de edema periférico signicativo (por ejemplo,
trombosis venosa profunda, insuciencia venosa
crónica, síndrome compartimental agudo,
hipertensión venosa sistémica, insuciencia
cardíaca congestiva, cirrosis/insuciencia
hepática o insuciencia renal).
•Una fractura aguda, inestable (sin tratar) en la
región afectada.
•Cualquier infección local o sistémica activa.
•Aturdimiento o con diabetes mellitus, esclerosis
múltiple, mala circulación, lesiones de la médula
espinal y artritis reumatoide.
•Áreas de ruptura o daño de la piel (piel dañada o
en riesgo) que produce una conducción de calor
desigual a través de la piel (por ejemplo, herida
abierta, tejido cicatricial, quemadura o injerto de
piel). Cualquier herida abierta debe cubrirse antes
de usar el sistema Polar Care Wave.
•Prueba presuntiva de falla cardíaca congestiva.
•Condición de trombosis venosa profunda
preexistente.
•Trombosis venosa aguda profunda
(ebotrombosis).
•Proceso de ebitis inamatoria.
Terapia de compresión (continúa de la página 2):
•Episodios de embolia pulmonar
•Edema pulmonar
•Inamación aguda de las venas
(tromboebitis)
•Insuciencia cardiaca descompensada
•Desregulación arterial
•Erisipelas
•Carcinoma y metástasis de carcinoma en la
extremidad afectada
•Hipertonía descompensada
•Enfermedades inamatorias agudas de la piel o
infección
•Enfermedad oclusiva venosa o arterial
•Situaciones médicas en las que no es deseable
un aumento del retorno venoso o linfático
•Mala circulación periférica
•Arterioesclerosis severa o infección activa
Terapia de frío:
•Discrasias hematológicas conocidas que
predisponen a la trombosis (por ejemplo,
hemoglobinuria paroxística por frío,
crioglobulinemia, enfermedad de células
falciformes, aglutininas frías en suero).
•Inamación tisular como resultado de una
lesión reciente o exacerbación de una condición
inamatoria crónica.
•Circulación local comprometida o deterioro
neurológico (incluyendo parálisis o
compromiso localizado debido a múltiples
procedimientos quirúrgicos o diabetes) en la
región afectada.
•Deterioros de la cognición o la comunicación
que impidan dar comentarios precisos y
oportunos.
•Enfermedad de Raynaud o hipersensibilidad al
frío (urticaria por frío).
•Distonía descompensada en la región afectada.
•Fenómeno de Raynaud u otras condiciones
vasoespásticas.
•Alergia al frío
•Trastornos de aglutinina fría como hemoglobinuria
paroxística por frío
•Enfermedad de Buergers
•Sabañones
•Crioglobulinemia
•Anemia falciforme
•Diabetes
•Hipersensibilidad al frío
•Historial de lesiones por frío
•Enfermedad cardiovascular grave, anestesia
cutánea, trastornos de la hipercoagulación, mala
circulación, extremidades sensibles al dolor,
presión arterial extremadamente baja que está
incapacitada, disminución de la sensibilidad de
la piel, ligadura de venas o injertos cutáneos
recientes o feocromocitoma.
Contraindicaciones continúa hasta la página 3.
CONTRAINDICACIONES

4 5
CLAVE DE LOS SÍMBOLOS
DESCRIPCIÓN DEL DISPOSITIVO POLAR CARE WAVE
El Polar Care Wave es un dispositivo motorizado para terapia fría y compresión intermitente. Se ha demostrado
repetidamente que la terapia fría y las compresiones motorizadas disminuyen el dolor postoperatorio, la hinchazón,
la inamación y el uso de narcóticos después de una diversidad de procedimientos quirúrgicos, como la cirugía del
hombro, la rodilla y la columna.
El dispositivo Polar Care Wave consta de un recipiente, un tubo exible, una tapa con bombas, una fuente de
alimentación y una almohadilla de compresión fría. La almohadilla de compresión fría se aplica en la zona
lesionada del paciente, para suministrarle una terapia de compresión fría e intermitente. La unidad suministra la
terapia fría haciendo circular el agua del recipiente a través del tubo exible hasta la almohadilla de compresión
fría. La terapia de compresión es administrada por la bomba neumática de la unidad, la cual ina y desina
con aire la almohadilla de compresión fría, para lograr así un apriete suave con la almohadilla enrollada
alrededor de la zona afectada. Las terapias frías y de compresión pueden ser aplicadas de manera combinada o
independientemente una de la otra, si así lo preere o lo receta un profesional de salud autorizado. Breg ofrece
una familia de almohadillas de compresión fría para satisfacer las necesidades de tratamiento (consulte la página
12 para conocer las opciones completas de almohadillas de compresión fría).
La unidad Polar Care Wave puede ser utilizada y accionada por un paciente o cuidador en un hogar o en un entorno clínico.
Se incluyen estos componentes:
DESCRIPCIÓN DEL DISPOSITIVO POLAR CARE WAVE
CLAVE DE LOS SÍMBOLOS
Símbolos de
etiquetas Descripción
Este es el símbolo de alerta de seguridad. Se utiliza para alertar de posibles riesgos de
lesiones personales. Obedezca todos los mensajes de seguridad que siguen a este símbolo
para evitar posibles lesiones o la muerte.
Tipo BF, parte aplicada
Equipo Clase II
Consulte las instrucciones de uso
IP22 Marca de protección contra ingreso de objetos extraños IP22: Protección contra objetos
extraños sólidos de 12.5 mm y mayores, y contra gotas de agua que caen verticalmente con
una inclinación de hasta 15°.
Desechar el producto en conformidad con las regulaciones locales.
Logotipo de Breg
Bloqueo y desbloqueo de tapa
Varios usos en un solo paciente
Alineación de tapa con el contenedor
Símbolos del teclado Descripción
Ajuste más frío
Ajuste frío
Ajuste de compresión regular
Ajuste de compresión baja
Botón de encendido y apagado Adaptador en Y de rodilla
Almohadilla de compresión fría
(puede venderse por separado)
Se muestra la almohadilla para la rodilla, para ver
imágenes de otras almohadillas, consulte la página 12.
Bolsas de hielo Breg
Fuente de alimentación
Unidad Wave
Tapa
Recipiente
Tubo exible
COLD COMPRESSION
Accesorios (se venden por separado):
Power Adapter

6 7
ADVERTENCIAS
El dispositivo Polar Care Wave puede ser sucientemente frío para causar lesiones graves, incluso necrosis
de la piel de grosor total. Siga y lea detenidamente las instrucciones de uso y las instrucciones de uso de la
almohadilla de compresión fría (impresas en cada almohadilla de compresión fría) antes del uso.
ADVERTENCIA
Advertencias generales
Factores de riesgo
cognitivo
Los pacientes con cualquiera de los siguientes factores de riesgo cognitivo solo deben
utilizar el dispositivo Polar Care Wave bajo la supervisión directa de un profesional
de salud o cuidador. Si el paciente tiene alguno de los factores de riesgo
cognitivo que se indican a continuación, el profesional de salud o
cuidador debe realizar controles cutáneos:
•Niños menores de 18 años y ancianos
•Discapacidades cognitivas
•Barreras de comunicación
•Uso de medicamentos que tienen un efecto negativo en la capacidad mental
•Discapacidad visual
Comente el
tratamiento con su
profesional de salud
autorizado
Pregúntele a su profesional de salud acerca de posibles reacciones adversas y lesiones
inducidas por el frío. Ciertas condiciones médicas aumentan la probabilidad de causar
lesiones inducidas por el frío.
Use el producto
únicamente de la
manera indicada
No use este dispositivo si no recibió o si no entiende las instrucciones. Use solo de
acuerdo con las instrucciones de su profesional de salud en cuanto a la frecuencia,
la duración y la preparación de la aplicación de frío y compresión y la duración de
las pausas entre usos, cómo y cuándo inspeccionar la piel y la duración total del
tratamiento.
La Ley Federal de los Estados Unidos restringe la venta de este dispositivo y solo
puede hacerla un profesional de salud o con la orden de este. Los productos de Polar
Care Wave y las almohadillas de compresión en frío son para usar en un solo paciente
y para varios usos y se surten con receta médica. La receta debe incluir:
•La frecuencia, la duración y la preparación de la aplicación de frío y compresión
•La duración de las pausas entre usos
•Cómo y cuándo inspeccionar la piel
•La duración total del tratamiento
Advertencias continúa hasta la página 9. Advertencias continúa hasta la página 9.
ADVERTENCIAS
ADVERTENCIAS
Advertencias generales
Inspeccione la piel con
regularidad
La sensibilidad al frío varía en los pacientes; inspeccione periódicamente la piel
debajo de la almohadilla de compresión fría (levantando el borde) según se indique o
generalmente cada 1 o 2 horas. No utilice la unidad Polar Care Wave si los chequeos
de la piel están inhibidos por alguna barrera.
Deje de usar el dispositivo y contacte a su profesional de salud inmediatamente si
experimenta cualquier reacción adversa, como: aumento del dolor, ardor, aumento
de la hinchazón, picazón, ampollas, aumento del enrojecimiento, decoloración,
ronchas, irritación y otros cambios en la apariencia de la piel, o cualquier otra reacción
identicada por su profesional de salud.
Seguridad en general
•Mantenga los tubos exibles y los cables eléctricos lejos del cuello para evitar el
riesgo de estrangulación.
•Si ocurre una fuga o si uye un chorro constante de agua desde cualquier parte
de la unidad, tubo exible o almohadilla de compresión fría, interrumpa el uso
y comuníquese con el servicio de Atención al Cliente de Breg. El exceso de
humedad podría ocasionar un peligro de resbaladuras o humedad no deseada
en el sitio de la lesión.
•No modique, repare ni realice mantenimiento no especicado en este equipo o
accesorios. Utilice únicamente piezas y accesorios diseñados para el dispositivo
Polar Care Wave.
•No intente esterilizar por ningún medio la unidad Polar Care Wave o las
almohadillas de compresión fría.
•Instale y use este equipo en un lugar alejado de niños y mascotas sin
supervisión.
•No opere la unidad en un ambiente con mucho polvo o pelusa, ya que el
exceso de polvo o pelusa puede causar obstrucciones. No deje la unidad
expuesta a la luz solar directa, ya que la luz ultravioleta puede dañar o
decolorar la unidad.
•El dispositivo no está diseñado para usarse con agentes anestésicos.
AVISO PARA LOS USUARIOS
Si se produce un incidente grave debido a este dispositivo, informe a Breg y a la autoridad competente
del Estado miembro donde esté establecido el usuario o el paciente.
ADVERTENCIAS

8 9
ADVERTENCIAS
Advertencias continúa hasta la página 9.
ADVERTENCIAS Y PRECAUCIONES
Advertencias generales
Almohadilla de
compresión fría
•Verique periódicamente la zona de terapia.
•Las almohadillas de compresión fría no son estériles. Los pacientes deben tener
cuidado al aplicar almohadillas de compresión fría sobre heridas abiertas o
abrasiones de la piel. Como mínimo, estas áreas se deben limpiar y vendar.
•Se debe vericar la limpieza de las almohadillas de compresión fría para cada
tratamiento. Si la almohadilla está sucia, límpiela según se indica en la sección
Limpieza en la página 15.
•Antes de colocar la almohadilla de compresión fría sobre la piel, revise la
presencia de humedad. Elimine cualquier humedad antes de usar.
•Antes de aplicar cualquier terapia, asegúrese de que la envoltura de la terapia
se aplique correctamente. No envuelva las almohadillas de compresión fría de
forma que se restrinja el ujo sanguíneo o el uido dentro de la almohadilla de
compresión fría.
•No aplique ningún yeso o dispositivo de restricción sobre el conjunto de
almohadilla de compresión fría y tubos exibles, ya que esto puede impedir el
funcionamiento adecuado y restringir las inspecciones cutáneas.
•Los productos de Polar Care Wave y las almohadillas de compresión en frío son para
usar en un solo paciente y para varios usos. Usar más de una vez las almohadillas
puede ocasionar un riesgo de infección.
Advertencias sobre la terapia de frío
Riesgo por el frío Si el riesgo de sufrir lesiones inducidas por el frío supera los benecios de la terapia
fría, no recete el dispositivo Polar Care Wave.
Factores de riesgo
clínico
Si el paciente tiene cualquiera de los siguientes factores de riesgo clínicos, el uso de
Polar Care Wave puede dar origen a graves lesiones inducidas por el frío, incluyendo
necrosis cutánea de grosor total:
•Sensibilidad patológica al frío
•Comportamientos que afectan negativamente la circulación, incluido un estado
nutricional deciente, el tabaquismo y el consumo de tabaco, el uso excesivo de
cafeína y el uso excesivo de alcohol
•Desensibilización del área de aplicación del frío debido a anestesia local o bloqueos
nerviosos regionales
•Diabetes
•Cirugía de mano/muñeca o pie/tobillo
•Tomar medicamentos que tienen un efecto negativo en la circulación vascular
periférica, incluidos los betabloqueadores adrenérgicos y el uso local de epinefrina
(como en la anestesia local)
ADVERTENCIAS ADVERTENCIAS
Advertencias sobre la terapia de frío
Mitigación del riesgo
por el frío
Si receta este producto a pacientes con factores de riesgo, considere tomar medidas
especiales para controlar ese riesgo, tales como:
•Recomendar inspecciones más frecuentes de la piel. Si el paciente tiene factores de
riesgo cognitivo, el profesional médico o cuidador debe realizar inspecciones cutáneas
•Indicar exámenes de seguimiento más frecuentes
•Agregar una barrera de aislamiento entre la almohadilla de compresión fría y la piel
•Indicar duraciones de aplicación más cortas, menos frecuentes, o eliminar las
aplicaciones nocturnas
•Prescribir ajustes de temperaturas más cálidas (copo de nieve más pequeño /
ajuste “cold” (frío))
Sitio de aplicación
La humedad excesiva en el sitio de aplicación debida a sangrado excesivo, sudoración
o condensación puede aumentar el riesgo de lesiones graves inducidas por el frío,
incluyendo necrosis cutánea de grosor total.
Advertencias sobre la terapia de compresión
Riesgo de compresión Si el riesgo de sufrir lesiones supera los benecios de la terapia de compresión, no
recete el dispositivo Polar Care Wave.
Factores de riesgo
clínico
Los pacientes con cualquiera de los siguientes factores de riesgo por compresión
deberán consultar con un profesional de salud antes de usar el dispositivo:
•Neuropatías o problemas de viabilidad del tejido (es decir, diabetes,
insuciencia arterial o venosa).
•Pacientes colocados en posición de litotomía supina durante períodos prolongados
•Mala circulación
Mitigación del riesgo
por compresión
Suspenda inmediatamente la terapia de compresión si observa cualquier sensación
de incomodidad, entumecimiento u hormigueo de la extremidad y consulte a su
profesional de salud.
PRECAUCIONES
•No camine con el tubo exible conectado a las almohadillas de compresión fría. Esto constituye un riesgo de tropiezo.
•Si la unidad está dañada o agrietada, suspenda el uso y comuníquese con el servicio de Atención al Cliente de Breg.
•No use agua caliente en esta unidad. Puede ser peligroso o causar daños a la unidad dado que no está
diseñada ni ha sido probada para el uso con agua caliente.
•No use ningún otro líquido excepto agua o los agentes de limpieza recomendados en la página 15 con la
unidad Polar Care Wave. Hacerlo puede dañar la unidad.
•No realice la terapia fría sin agua. Utilizar la terapia fría sin agua puede causar daños permanentes a la
bomba de agua.