Össur COLD RUSH COMPACT Instructions For Use Manual

Marca: Össur

Modelo: COLD RUSH COMPACT

Tipo: Instructions For Use Manual

Instructions for Use

COLD RUSH® COMPACT

FIGURES 3

EN | Instructions for Use 5

FR | Notice d’utilisation 16

ES | Instrucciones para el uso 29































EN - Caution: This product has been

designed and tested based on single

patient usage and is not recommended

for multiple patient use. If any

problems occur with the use of this

product, immediately contact your

medical professional.

FR- Attention: Ce produit a été conçu et

testé pour être utilisé par un patient

unique et n'est pas préconisé pour être

utilisé par plusieurs patients. En cas de problème lors de l'utilisation de ce

produit, contactez immédiatement un professionnel de santé.

ES- Precaución: Este producto se ha diseñado y probado para su uso en un

paciente único y no se recomienda para el uso de varios pacientes. En caso de

que surja algún problema con el uso este producto, póngase inmediatamente

en contacto con su profesional médico.

 - See operating instructions

Meets IEC type BF leakage current requirements

Protected against solid foreign objects of .mmØ and

greater. Protected against vertically falling water drops.

Class II Device

 – Voir les instructions d'utilisation

Conforme aux exigences de courant de fuite IEC de type BF

Protégé contre les corps solides étrangers de diamètre

supérieur ou égal à .mm.

Protégé contre les chutes verticales de gouttes d'eau.

Appareil de classe II

 - Consulte las instrucciones de funcionamiento

Cumple requisitos de con los fuga de corriente de equipos de

tipo BF según el IEC

Protegido contra objetos sólidos mayores o iguales a ,

mm de diámetro. Protegido contra la caída vertical de gotas

de agua.

Dispositivo de clase II

IP21



ENGLISH

INSTRUCTIONS FOR PATIENTS AND MEDICAL PROFESSIONALS

Patients and Medical Professionals should carefully read all of the

following instructions and warnings before operating the Cold Rush

Compact Cold Therapy System.

INTENDED USE AND INDICATIONS

• Provides cold therapy

• Indications requiring the application of cold therapy to a joint or limb

such as post-surgical, trauma pain, and swelling

CONTRAINDICATIONS

The Cold Rush Compact Cold Therapy Device should not be used on

patients with the following conditions:

• History of cold-related injury or adverse reactions to cold therapy;

• Unconsciousness or incoherence due to general anesthesia, sedation

or coma;

• Impairment of circulation or potential impairment of healing in the

treatment area, including infection;

• Circulatory disease, including Reynaud’s disease, Burger’s disease,

peripheral vascular disease, vasospastic disorders, sickle cell anemia,

or hypercoagulable clotting disorders; or

• Polyneuropathy or other nerve damage.

WARNING: RX ONLY

This device should only be used with a prescription from a physician that

includes the following treatment information: () the number of days or

weeks that the treatment should last and () the length and frequency of

product use (and breaks) during treatment. DO NOT USE THIS DEVICE

IF YOU DO NOT HAVE A PRESCRIPTION FROM YOUR PHYSICIAN

THAT INCLUDES ALL SUCH TREATMENT INFORMATION.

A blank treatment protocol to be filled out by your healthcare provider is

provided on top of the Cold Rush Compact Cold Therapy Device.

WARNING: POSSIBLE COLDRELATED INJURIES

This device reduces the temperature of the skin and tissue. If not used

properly and in accordance with the prescribed instructions from your

physician, this device can cause serious injury, including frostbite, tissue

necrosis and nerve damage.

WARNING: SKIN INSPECTION AND ADVERSE REACTIONS

You or your healthcare provider must check your skin at least every –

hours during use of this device, regardless of whether you are asleep or

awake, for any change in skin condition, including for any increase in

pain, burning, blistering, itching, increased swelling, discoloration of the

skin, increased redness, welts or any other changes in the appearance of

the skin. If you experience any of these reactions, you should immediately

discontinue use of your Cold Rush Compact Cold Therapy Device and

contact your healthcare provider. Any dressing, casting, bracing or

wrapping must not interfere with your ability to check your skin

condition. If you are unable to check your skin condition for any reason,

do not use the Cold Rush Compact Cold Therapy Device.

WARNING: NO DIRECT CONTACT WITH SKIN; INSULATION

BARRIER REQUIRED

The Cold Rush Pad should never make direct contact with the skin. The

Cold Rush pad operating temperature is too cold to be placed directly on

the skin. An insulation barrier between the pad and the skin should be

used at all times without exception so as to prevent the skin from

becoming too cold. Failure to use an insulation barrier between the pad

and the skin can lead to a cold-related injury.

WARNING: USE ONLY ÖSSUR COLD RUSH PADS

Competitive brand cold therapy pads should not be used with the Cold

Rush Compact Cold Therapy Device as the temperature may become too

cold when using competitive pad and the pads may not otherwise

function properly, causing injury. Only Össur Cold Rush Pads should be

used with the Cold Rush Compact Cold Therapy Device.

WARNING: NO MOISTURE IN INSULATION BARRIER

If the moisture is present in the insulation barrier, the skin may become

colder than intended. The insulation barrier should be inspected regularly

to check for moisture caused by bleeding, sweating or condensation. If

moisture is found on the insulation barrier between the pad and the skin,

immediately discontinue use of the Cold Rush until the moisture is

removed and a fresh barrier is placed between the pad and the skin.

RISK FACTORS

Physicians should carefully consider the following conditions or factors

before before prescribing the Cold Rush Compact Cold Therapy Device:

• Sensitivity to cold;

• General impaired circulation;

• Use of medications that may negatively affect peripheral vascular

circulation, including beta adrenergic blockers and local epinephrine

use (such as local anesthetics);

• Poor nutrition, smoking, tobacco use, excessive use of caffeine or

alcohol and any other behavior negatively affecting circulation;

• Desensitization of the treatment area due to local anesthesia or

regional nerve blockers;

• Cognitive impairment and use of medications that have a negative

effect upon mental capacity or judgment;

• Moisture at the application site due to excessive bleeding, sweating or

condensation;

• Diabetes;

• Use of product on hand, wrist, foot or ankle; and

• Young children and elderly.

DEVICE PARTS IDENTIFICATION Figure 

. Cold Rush Compact Cold Therapy System

. Hose

. Couplings

. DC Connector V Power Supply

. V Power Supply

. Cold Rush Pad (Sold Separately)

APPLICATION/OPERATION

. Do NOT plug unit into wall socket until steps – are completed.

. Fill reservoir with water to the indicated fill line (Figure ).

Warning: water level should not exceed the reference mark on the

sticker inside the bucket to avoid risk of overflow when closing the

cover.

. Add chopped or cubed ice to the reservoir up to the indicated fill line

(Figure ).

Warning: Make sure the ice level does not exceed the reference mark

on the sticker. Failure to comply will cause device overflow when

closing the lid.

. Close the reservoir. With handle in the open position, press lid firmly

onto unit making certain that the lid is in full contact with the vessel

and the seal is engaged, then pull handle into the locked position

(Figure )

. Attach the provided V power supply to DC power port, but do not

plug into wall (Figure ).

. Apply insulation barrier (not included) over the patient’s skin in the

area to be treated (Figure ).

. Connect Cold Rush pad to hose extending from the device. To ensure

proper connection, push couplings together until they snap into place

(Figure ).

. Apply Cold Rush Pad over insulation barrier. The Cold Rush Pad

should never be applied directly over the patient’s skin (Figure ).

. Plug the provided V power supply to wall socket (Figure ).

. To turn off the cold therapy device, unplug the power supply unit from

wall socket.

. Always turn the cold therapy device off before disconnecting the Cold

Rush Pad or any hoses. To disconnect the hoses, press the release

tabs on the coupling and pull the connectors apart.

. To open lid, press handle down to disengage lid seal, then lift to

remove (Figure )

. Drain all of the water out of the cold therapy device after each use.

. Follow directions – before each use.

TROUBLESHOOTING

Pump will not turn on

Ensure that the power supply connector properly inserted in to port on

unit and that the wall plug has power.

Pad will not get cold

Visually inspect pad to see if water is flowing.

If water is flowing: check pad for pockets of trapped air. Gently massage

the pad to help remove the trapped air. Once water flow appears to

moving freely through the pad, resume usage

If no water is flowing, make certain the unit is properly filled. Refer to

filling instructions.

Check the hose connection to ensure that the coupling is fully engaged.

Check to ensure that the hose is not kinked or pinched by any object.

Water leaking at connector

Unplug device, disconnect hose, visually inspect to ensure coupling

connectors are in the open position and then reconnect hose. Snap or

clicking sound indicates proper connection (Figure  & ).

Leaking

Note: certain conditions such as hot or humid climates may cause

condensation to develop on unit and or pads.

Leaking Pad -Remove pad, towel dry and then visually inspect pad. If a

leak is detected, then the pad will need to be replaced. See warranty

regarding pad replacement.

Leaking Unit – visually inspect to determine the location of the leak. Refer

to limited warranty for damaged replacement requirements. If no leak is

detected, it may be condensation.

HEALTHCARE PROVIDER RESPONSIBILITIES

• The prescribing physician must determine () the number of days or

weeks that the treatment should last and () the length and frequency

of product use (and breaks) during treatment. All such information

should be included in the patient's prescription.

• Appropriate training must be provided by the healthcare provider, in

the proper application, use and operation and care of the Cold Rush

Compact Cold Therapy System.

• The healthcare provider must monitor the patient’s use of the device

to assure compliance with the prescribed protocol, appropriate use,

proper application and operation of the Cold Rush Compact Cold

Therapy System, including but not limited to application and

maintenance of an insulation barrier between the patient’s skin and

the Cold Rush Pad.

Treatment

Time Period

Frequency and

Duration of Use

Inspect

Skin Every

Day

ADDITIONAL WARNINGS

• The Cold Rush Compact Cold Therapy Device should never be left

unattended when plugged in.

• Do not place the tubes or the power cord where your or other’s feet

can get entangled, causing a fall.

• Never drop or insert any object into any opening or hose.

• Do not operate where aerosol (spray) products are being used or

where oxygen is being administered.

• Do not attempt to drag or reposition the Cold Rush Compact Cold

Therapy Device by pulling or tugging on the insulated hoses, as this

may cause damage to the device and/or cause the hoses to

disconnect. Use handle when moving the Cold Rush Compact Cold

Therapy Device.

• Do not place the tubes or the power cord by the top of your bed

where they could twist around your neck while you are sleeping.

• The pump in Cold Rush Compact Cold Therapy Device is designed to

run with water. Running the device without water will cause

Through

permanent damage to the pump.

• A wireless communications equipment such as wireless home

network devices, mobile phones, cordless telephones and their base

stations, walkie-talkies can affect the Cold Rush Compact Cold

Therapy Device and should be kept at least a distance . m away

from the Cold Rush Compact Device.

SAFETY STANDARDS

Cold Rush Compact Cold Therapy System is tested and certified to

comply with the IEC- standard of electrical safety of medical

devices and IEC/EN--, electromagnetic compatibility for medical

electrical devices. IEC --, requirements for medical electrical

equipment and medical electrical systems used in the home healthcare

environment. The company fulfills the requirements of ISO.

ELECTRIC SHOCK HAZARD

To create the safest operating conditions possible, Össur has designed

the Cold Rush Compact Cold Therapy System to operate on a  volt

power supply, significantly reducing the chance of dangerous electric

shock. Avoid use near any water source.

• Only use the power supply provided with the device.

• Unplug device before filling it with ice and water.

• To avoid danger of electric shock be certain that hands are dry before

inserting or removing the power supply from wall socket.

• Avoid getting water or ice on the power adapter.

• Always unplug this product immediately after each use.

• Never use Cold Rush Compact Cold Therapy device while bathing.

• Do not place or store product where it can fall or be pulled into a tub

or sink.

• Do not place in or drop into water or other liquid.

• Do not reach for a product that has fallen into water. Unplug

immediately.

• Keep cord & device away from heated surfaces.

• Never operate this product if:

– The device has a damaged electrical cord or plug;

– The device has been dropped or damaged;

– The has been dropped into water; or

– The device is not working properly.

• If any of the above have occurred, immediately discontinue use of the

Cold Rush Compact Cold Therapy Device and return the product to

your healthcare provider for examination and repair.

TECHNICAL SPECIFICATION: ELECTRICAL  POWER SUPPLY

• Model no: UESWU-SPA

• Input:  V US

• Input frequency:  Hz US

• Output power:  W

• Output Voltage:  V

• Output Current: . A

MAINTENANCE

Do not attempt to repair your Cold Rush Compact Device as this may

create a user hazard and will automatically void the warranty.

CLEANING AND PROLONGED STORAGE

• When you have finished all of your cold therapy treatments, prior to

prolonged storage, fill the device so the water level is at the ice fill

line.

• Add  tablespoons of liquid bleach or  ounces of % hydrogen

peroxide to the water and mix.

• Connect hoses to the Cold Rush Pad, plug in the device to start.

• Allow water mixture to circulate for  minutes.

• To turn device off, unplug power supply.

• Carefully drain the water mixture out of the device and store in a dry,

cool, and dark place leaving the lid slightly open. (Exposure to

sunlight and extreme heat may damage hoses and device.)

• When reusing the device after storage, fill the reservoir with clean

water and turn the pump on to circulate the water through the hoses

and flush the remaining water mixture out of the system (use old pad

for this procedure, discard the pad after cleaning is completed).

• Dispose water and refill the reservoir with fresh ice and water

combination to begin cold therapy treatment. Follow operating

instructions – before each use.

• Before you use the device, inspect hoses and new pad for any tears or

breaks. Contact your healthcare provider to purchase new Cold Rush

Pad.

• Clean or replace insulation barrier as recommended by your

healthcare practitioner.

ENVIRONMENTAL

• Operating Temperature: + °C (+ °F) to  °C ( °F)

• Operating Humidity: % - % Relative Humidity

• Operating Atmospheric Pressure: – h Pa

• Shipping and Storage Temperature: - °C (- °F) to  °C ( °F)

• Shipping and Storage Humidity: % - % Relative Humidity,

non- condensing

• Shipping and Storage Atmospheric Pressure: – h Pa

DISPOSAL

Follow local ordinance or regulations for proper disposal of device,

accessories, and packaging.

ACCESSORIES

The following accessories are available for your Cold Rush Compact Cold

Therapy System at an additional charge. To order, contact your healthcare

provider.

• Cold Rush Ankle Pad

• Cold Rush Hip Pad Left

• Cold Rush Hip Pad Right

• Cold Rush Knee Pad

• Cold Rush Lumbar Pad

• Cold Rush Rectangular Pad Small

• Cold Rush Shoulder Pad Small

• Cold Rush Shoulder Pad Large

• Cold Rush Universal Pad

• Insulation barrier used for testing thermal properties of the system is

a single layer of -ply Seal-In Sock, Össur product numbers (K-,

K-, K-, K-).

LIMITED WARRANTY

Össur warrants, to the original purchaser, that this product is free from

defects in materials and workmanship for  months from initial purchase.

This warranty does not apply if this product:  was not purchased from

Össur or its authorized dealer  has been altered in any way; or  has not

been used in accordance with Össur’s Instructions For Use (IFU). This

Limited Warranty does not cover damage due to accidents, neglect,

misuse, or operation beyond capacity, parts damaged by improper

installation, substitution of parts not approved by Össur, or any other

alteration or repair by others that, in Össur’s judgment, materially or

adversely affects the product or part. This product expected service life is

 months from the date of first use.

For complete warranty guidelines please visit www.ossur.com

ELECTROMAGNETIC COMPATIBILITY PRECAUTIONS

The Cold Rush Compact Cold Therapy System needs special precautions

regarding electromagnetic compatibility (EMC). Specifically it

needs to be installed and put into service according to the EMC

information provided as follows:

• The Cold Rush Compact Cold Therapy System should not be used

adjacent to or stacked with other equipment. In case adjacent or

stacked use is necessary, the Cold Rush Compact Cold Therapy

System should be observed to verify normal operation in the

configuration in which it will be used.

• The Cold Rush Compact Cold Therapy System may be susceptible to

electromagnetic interference from portable and mobile RF

communications devices such as mobile (cellular) telephones.

• The Cold Rush Compact Cold Therapy System may be interfered with

by other equipment, even if that other equipment complies with cispr

emission requirements.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The device is intended for use in the electromagnetic environment specified

below. The customer or user of device should assure that it is used in such an

environment.

Emissions Test Compliance

Electromagnetic Environment –

Guidance

RF Emissions CISPR  Group  The device uses RF energy only for

its internal function. Therefore, its

RF emissions are low and are not

likely to cause any interference in

nearby electronic equipment.

RF Emissions CISPR  Class B The device is suitable for use in all

establishments, including domestic

establishments and those directly

connected to the public low voltage

power supply network that supplies

buildings used for domestic

purposes.

Harmonics Emissions

IEC --

Class B

Voltage Fluctuations/

Flicker Emissions

vIEC --

Complies

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The device is intended for use in the electromagnetic environment specified below. The customer or user of device should assure that it is used in such an environment.

Immunity Test IEC  Test Level Compliance Level Electromagnetic Environment – Guidance

Electrostatic Discharge (ESD)

IEC --

± kV contact

± kV air

± kV contact

± kV air

Floors should be wood, concrete, or ceramic

tile. If floors are covered with synthetic

material, the relative humidity should be at

least %.

Electrical fast transient/burst

IEC --

± kV for power supply lines

± kV for input/output lines

± kV for power supply lines

± kV for input/output lines

Mains power quality should be that of a

typical commercial or hospital environment.

Surge IEC -- ± kV line(s) to line(s)

± kV line(s) to earth

± kV line(s) to line(s)

± kV line(s) to earth

Mains power quality should be that of a

typical commercial or hospital environment.

Voltage dips, Short

interruptions and voltage

variations on power supply

lines IEC --

< % UT (> % dip in UT) for . cycle.

 % UT ( % dip in UT) for  cycles.

 % UT ( % dip in UT) for  cycles.

< % UT (>% dip in UT) for  s.

< % UT (> % dip in UT) for . cycle.

 % UT ( % dip in UT) for  cycles.

 % UT ( % dip in UT) for  cycles.

< % UT (>% dip in UT) for  s.

Mains power quality should be that of a

typical commercial or hospital environment.

If the user of the device requires continued

operation during power mains interruptions,

it is recommended that the device be

powered from an uninterruptible power

supply or a battery.

Power frequency (/ Hz)

magnetic field

IEC --

 A/m  A/m Power frequency magnetic fields should be at

levels characteristic of a typical location in a

typical commercial or hospital environment.

Note: UT is the a.c. mains voltage prior to application of the test level.

Recommended separation distances between portable and mobile RF

communications equipment and the device.

The device is intended for use in an electromagnetic environment in which

radiated RF disturbances are controlled. The customer or the user of the device

can help prevent electromagnetic interference by maintaining a minimum

distance between portable and mobile RF communications equipment

(transmitters) and the device as recommended below, according to the

maximum output power of the communications equipment.

Rated maximum

output power of

transmitter

Separation distance according to frequency of

transmitter

 kHz to

 MHz

d=,√P

 MHz to

 MHz

d=,√P

 MHz to ,

GHz

d=,√P

, , , ,

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

 , , ,

   

For transmitters rated at a maximum output power not listed above, the

recommended separation distance d in meters (m) can be estimated using the

equation applicable to the frequency of the transmitter, where P is the maximum

output power rating of the transmitter in watts (W) according to the transmitter

manufacturer.

NOTE  At  MHz and  MHz, the separation distance for

the higher frequency range applies.

NOTE  These guidelines may not apply in all situations.

Electromagnetic propagation is affected by absorption

and reflection from structures, objects and people.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The device is intended for use in the electromagnetic environment specified below. The customer or user of device should assure that it is used in such an environment.

Immunity Test IEC  Test Level Compliance Level Electromagnetic Environment – Guidance

Electrostatic Discharge (ESD)

IEC --

± kV contact

± kV air

± kV contact

± kV air

Floors should be wood, concrete, or ceramic

tile. If floors are covered with synthetic

material, the relative humidity should be at

least %.

Electrical fast transient/burst

IEC --

± kV for power supply lines

± kV for input/output lines

± kV for power supply lines

± kV for input/output lines

Mains power quality should be that of a

typical commercial or hospital environment.

Surge IEC -- ± kV line(s) to line(s)

± kV line(s) to earth

± kV line(s) to line(s)

± kV line(s) to earth

Mains power quality should be that of a

typical commercial or hospital environment.

Voltage dips, Short

interruptions and voltage

variations on power supply

lines IEC --

< % UT (> % dip in UT) for . cycle.

 % UT ( % dip in UT) for  cycles.

 % UT ( % dip in UT) for  cycles.

< % UT (>% dip in UT) for  s.

< % UT (> % dip in UT) for . cycle.

 % UT ( % dip in UT) for  cycles.

 % UT ( % dip in UT) for  cycles.

< % UT (>% dip in UT) for  s.

Mains power quality should be that of a

typical commercial or hospital environment.

If the user of the device requires continued

operation during power mains interruptions,

it is recommended that the device be

powered from an uninterruptible power

supply or a battery.

Power frequency (/ Hz)

magnetic field

IEC --

 A/m  A/m Power frequency magnetic fields should be at

levels characteristic of a typical location in a

typical commercial or hospital environment.

Note: UT is the a.c. mains voltage prior to application of the test level.

Recommended separation distances between portable and mobile RF

communications equipment and the device.

The device is intended for use in an electromagnetic environment in which

radiated RF disturbances are controlled. The customer or the user of the device

can help prevent electromagnetic interference by maintaining a minimum

distance between portable and mobile RF communications equipment

(transmitters) and the device as recommended below, according to the

maximum output power of the communications equipment.

Rated maximum

output power of

transmitter

Separation distance according to frequency of

transmitter

 kHz to

 MHz

d=,√P

 MHz to

 MHz

d=,√P

 MHz to ,

GHz

d=,√P

, , , ,

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

 , , ,

   

For transmitters rated at a maximum output power not listed above, the

recommended separation distance d in meters (m) can be estimated using the

equation applicable to the frequency of the transmitter, where P is the maximum

output power rating of the transmitter in watts (W) according to the transmitter

manufacturer.

NOTE  At  MHz and  MHz, the separation distance for

the higher frequency range applies.

NOTE  These guidelines may not apply in all situations.

Electromagnetic propagation is affected by absorption

and reflection from structures, objects and people.

SAVE THESE INSTRUCTION

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The device is intended for use in the electromagnetic environment specified below.

The customer or user of the device should assure that it is used in such an environment.

Immunity Test IEC  Test Level Compliance Level

Electromagnetic Environment – Guidance

Portable and mobile RF communications equipment should be used no closer to any

part of the device, including cables, than the recommended separatvion distance

calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

Conducted RF IEC --  Vrms,  kHz to  MHz  Vrms

d=.√P

Radiated RF IEC --  V/m,  MHz to . GHz  V/m

d=.√P  MHz to  MHz

d=.√P  MHz to . GHz

where “P” is the maximum output power rating of the transmitter in watts (W)

according to the transmitter manufacturer and d is the recommended separation

distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site

survey*, should be less than the compliance level in each frequency range**.

Interference may occur in the vicinity of

equipment marked with the following symbol:

Note 

At  MHz and  MHz, the higher frequency range applies.

Note 

These guidelines may not apply in situations. Electromagnetic propagation is

affected by absorption and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/

cordless) telephones and land mobile radios, amateur radio, AM and FM radio

broadcast and TV broadcast cannot be predicted theoretically with accuracy. To

assess the electromagnetic environment due to fixed RF transmitters, an

electromagnetic site survey should be considered. If the measured field strength in

the location in which the device is used exceeds the applicable RF compliance level

above, the device should be observed to verify normal operation. If abnormal

performance is observed, additional measures may be necessary, such as

re-orienting or relocating the device.

Over the frequency range  kHz to  MHz, field strengths should be less than

 V/m.