Cold Rush® Cold Therapy System

Cold Rush® Cold Therapy System
Instructions for use
Cold Rush®
Cold Therapy System
.....................................................................3
EN
FR
ES
Instructions for use.................................................5
Guide de fabrication................................................10
Instrucciones para el uso........................................16
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- Atención: 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.
• Attention - See operating instructions
• Meets IEC type B leakage current requirements
•
Class II Device
• Attention – Voir les instructions d'utilisation
• Conforme aux exigences de courant de fuite IEC de type B
•
Appareil de classe II
• Atención - Consulte las instrucciones de funcionamiento
• Cumple los requisitos IEC de tipo B para las fugas de corriente
•
Dispositivo de clase II
1
D
A
E
F
B
C
G
3
2
2
1
3
MAX
4
5
6a
6b
7
8
9
2
1
MAX
10
2
MAX
1
2
MAX
1
2
1
4
MAX
ENGLISH
Safety precautions
•
READ THE FOLLOWING INSTRUCTIONS CAREFULLY BEFORE
OPERATING THE COLD RUSH COLD THERAPY SYSTEM.
•
Correct temperature range for each patient’s skin should be
determined on an individual basis by a licensed healthcare
practitioner. Patients vary in sensitivity to cold. Periodically
monitor the temperature and appearance of the skin being treated
once steady flow of water through the pad is achieved.
•
The temperature at the surface of the skin may vary depending
upon the amount of dressing used and other factors beyond the
control of the manufacturer. Temperature and color of the skin, at
the treatment site, must be monitored by a licensed healthcare
practitioner.
•
Fill with water and ice only, do not overfill.
•
The Cold Rush Pad should never be applied directly to the patient’s
skin. Do not use the Cold Rush Cold Therapy System without first
applying an insulation barrier between the Cold Rush Pad and the
patient’s skin.
•
Unit is not suitable for use in the presence of flammable anesthetic
mixture with air, oxygen or nitrous oxide.
•
Follow local ordinances or regulations for proper disposal of
device, accessories and packaging.
•
Caution: Federal law requires this device to be sold by a physician
or by the order of a physician.
WARNING
READ THE FOLLOWING TREATMENT WARNING PROTOCOL
INSTRUCTIONS CAREFULLY BEFORE OPERATING THE COLD RUSH
COLD THERAPY SYSTEM.
•
The flow control knob should never be set at the maximum
settings (number “4” or “MAX”) for more than 30 minutes.
2
MAX
1
2
or
1
MAX
•
The Cold Rush pad should never be applied directly to the patient’s
skin. Do not use the Cold Rush Cold Therapy System without first
applying an insulation barrier between the Cold Rush pad and the
patient’s skin.
•
Patients should never utilize cold therapy while they are asleep or
unable to check their skin every 1-2 hours unless specifically
instructed to do so by the prescribing health care provider. If the
patient is instructed to utilize cold therapy while asleep or unable
to check their skin every 1-2 hours, turn the flow control knob
counterclockwise to the number “1” setting.
2
1
MAX
IMPORTANT WARNING!
Patients who fail to turn the flow control knob counterclockwise to the
number “1” setting when using cold therapy while asleep or unable to
check their skin every 1-2 hours can suffer cold-related injuries, including
full thickness skin necrosis.
5
•
•
When using while awake, patients must check their skin every 1-2
hours once steady flow of water through the pad is achieved. Turn
the flow control knob counterclockwise to increase the temperature
(warmer), and clockwise to decrease the temperature (colder).
When turning the unit on, turn the flow control knob clockwise to
the number “3” setting wait 10 minutes to allow the temperature to
stabilize before making any additional temperature adjustments.
2
1
•
MAX
The following patients should ALWAYS turn the flow control knob
counterclockwise to the number “1” setting when using cold
therapy
o Patients whose treatment area has been desensitized due to local
anesthesia or regional nerve blockers
o Patients taking prescribed medications that may negatively affect
peripheral vascular circulation, including beta adrenergic blockers
and local epinephrine use (such as in local anesthetics)
o Patients taking prescribed medications that negatively affect their
mental capacity or judgment
o Patients suffering from diabetes
o Patients who have recently undergone hand/wrist or foot/ankle
surgery
o Patients suffering from cognitive disabilities
o Young children and the elderly
•
•
•
•
•
•
•
•
•
•
Caution: Contact your healthcare provider immediately and
discontinue the use of your Cold Rush Cold Therapy Unit if you
experience any adverse reaction to the treatment area such as:
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.
Care should be taken during prolonged use for children, diabetics,
incapacitated patients and those with decreased skin sensitivity or
poor circulation.
A licensed healthcare practitioner must determine the correct
frequency and duration of treatment for each patient.
If prescribed by a licensed healthcare practitioner for home use,
the healthcare practitioner must provide each patient with training
for appropriate use and proper application of the Cold Rush Cold
Therapy System.
The health care practitioner must monitor the patient’s use of the
device to assure appropriate use and proper application of cold
therapy, including but not limited to application of an insulation
barrier between the patient’s skin and the Cold Rush Pad.
The product should never be left unattended when plugged in.
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 Cold Therapy
unit by pulling or tugging on the insulated hoses, as this may
cause damage to the unit and/or cause the hoses to disconnect.
Use handle when moving the Cold Rush Cold Therapy unit.
If you experience disturbance in any other electrical equipment
near the Cold Rush unit, please try to unplug it from the wall socket
to verify that it is not the source of disturbance.
ELECTRIC SHOCK HAZARD
•
Unplug unit before filling it with ice and water. To avoid danger of
electric shock be certain that hands are dry before inserting or
6
•
•
•
•
•
•
•
•
removing the power supply from wall socket.
Avoid getting water or ice on the flow control panel or power
adapter.
Always unplug this product immediately after each use.
Do not use 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.
Never operate this product if it has a damaged electrical cord or
plug, if it is not working properly, if it has been dropped or
damaged, or dropped into water. Return the product to your
healthcare provider for examination and repair.
Keep cord away from heated surfaces.
NOTE:
To create the safest operating conditions possible, Ossur has
designed the Cold Rush Cold Therapy System to operate on a 12
volt power supply, significantly reducing the chance of dangerous
electric shock. Great care should always be taken when using
electricity near water.
PRODUCT DEFINITIONS
•
The Cold Rush Cold Therapy System is designed for single patient
use only.
•
Use of Cold Rush Cold Therapy System is designed to reduce
localized pain and swelling following surgical procedures or
trauma.
LIST OF PARTS (Figure 1)
A. Cold Rush Cold Therapy System
B. Hose
C. Couplings
D. Flow Control Knob
E. DC Connector
F. 12V Power Supply
G. Cold Rush Pad (Sold Separately)
TECHNICAL SPECIFICATION
Do not use any other power supply other than the one provided with
the unit.
*Electrical - Power Supply
• Power Input: An external power supply for medical use.
• Input: 120V US, 230V EU
• Input frequency: 60Hz US, 50Hz EU
• Max output power: 12W
• Output Voltage: 12V
• Output Current: 1A
SAFETY STANDARDS
Cold Rush Cold Therapy System is tested and certified to comply with
the IEC60601-1 standard of electrical safety of medical devices and
IEC/EN60601-1-2, electromagnetic compatibility for medical electrical
devices. The company fulfills the requrements of ISO13485.
7
SETUP AND OPERATION
1. Ensure cold therapy unit is turned off, turn flow control knob
counter clockwise to the off position. Do not plug in to wall
socket. (Figure 2)
2. Fill reservoir with water to the indicated fill line. (Figure 3)
3. Add chopped or cubed ice to the reservoir up to the indicated fill
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
line. (Figure 4)
Attach the provided 12V power supply to DC power port, do not
plug into wall circuit (Figure 5).
Apply insulation barrier over the patient’s skin in the area to be
treated. (Figure 6a)
Apply Cold Rush Pad over insulation barrier. The Cold Rush Pad
should never be applied directly over the patient’s skin. (Figure 6b)
Connect Cold Rush pad to hose extending from the unit. To ensure
proper connection, push couplings together until they snap into
place. (Figure 7)
Plug the provided 12v power supply to wall socket (120V US, 230V
Europe). (Figure 8)
Turn flow control knob clockwise to the number "3" setting, this
will turn unit on. (Figure 9)
Wait 10 minutes to allow temperature to stabilize before adjusting
the temperature for comfort. (Figure 10)
•
Turn flow control knob counterclockwise to increase
temperature.
•
Turn flow control knob clockwise to decrease temperature.
To turn the cold therapy unit off, turn flow control knob
counterclockwise until it stops.
Always turn the cold therapy unit 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.
Drain all of the water out of the cold therapy unit after each use.
Follow directions 2-10 before each use.
MAINTENANCE
Do not try to repair your Cold Rush unit as this may create a user hazard
and will automatically void warranty. After talking with your healthcare
provider, to ensure you are following the operating instructions properly,
the unit shall be sent to Ossur for repairs or maintenance. No other
company or individual is allowed to service or repair the unit in any way.
CLEANING AND PROLONGED STORAGE
•
When you have finished all of your cold therapy treatments, prior
to prolonged storage, fill the unit with one gallon of water (or
enough so the water level is at the ice fill line.
•
Add 2 tablespoons of liquid bleach or 3 ounces of 3%
hydrogenated peroxide to the water and mix.
•
Connect hoses to the Cold Rush Pad, turn unit on to MAX setting.
•
Allow water mixture to circulate for 5 minutes.
•
Turn unit off and unplug the power supply.
•
Carefully drain the water mixture out of the unit and store in a cool
dark place leaving the lid slightly open. (Exposure to sunlight and
extreme heat may damage hoses and unit.)
•
When reusing the unit 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 2-10 before each use.
•
Before you use the unit, inspect hoses and new pad for any tears or
breaks. Contact your healthcare provider to obtain new Cold Rush
pad.
•
Clean or replace insulation barrier as recommended by your
healthcare practitioner.
ENVIRONMENTAL
•
Operating Temperature: +10°C to 40°C
•
Operating Humidity: 30% - 75% Relative Humidity
8
Was this manual useful for you? yes no
Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Download PDF

advertising