arcticice clear CTU2C 200228 Cold Therapy System User Manual

arcticice clear CTU2C 200228 Cold Therapy System

INDICATIONS FOR USE

THIS DEVICE CAN BE COLD ENOUGH TO CAUSE SERIOUS INJURY. SERIOUS ADVERSE REACTIONS AND SAFETY HAZARDS MAY OCCUR DURING USE.
The ARCTIC ICE System is intended to treat post-surgical and acute in juries to reduce edema, swelling, and pain where cold is indicated.
When to use the ARCTIC ICE
The intended use of the ARCTIC ICE is for the temporary reduction of swelling and pain after surgery or injury. This is a non-sterile
device for Single patient use to provide localized external application of cold therapy. This device may not be used for any other purpose.

CONTRAINDICATIONS

When not to use the ARCTIC ICE DO NOT use this device on patients with Raynaud’s phenomenon or other vasospastic conditions; Buerger’s disease; cold allergy or hypersensitivity; cryoglobulinemia; paroxys mal cold hemoglobinuria or other cold agglutinin disorders; pheochro mocytoma; sickle cell anemia or history of cold injury.

LIMITATIONS ON SPECIAL PATIENT POPULATIONS

Limit the use of the ARCTIC ICE with these patients:
Limit the use of this device with patients who are unresponsive, incapacitated, have altered mental status or altered pain perception. Post- surgical patients under sedation or on analgesics or anesthetics, as well as patients taking hypnotics, anxiolytics, or antidepressants, must be monitored frequently during use of this device. These patients may not be able to perceive pain, burning, numbness, tingling or decreased sensation and may be susceptible to injury. Discontinue cold therapy immediately at the first sign of cold injury.

OPERATION INSTRUCTIONS

1. Add ice to the fill line inside the device’s transparent ice bucket.

2. Add cold water to the fill line.

3. Place the device lid on the ice bucket, making sure the lip aligns into the groove. Then press front of the lid down to close and secure.

4. Connect the ARCTIC ICE Pad with the ARCTIC ICE device using the Extension Tube. To ensure a reliable connection, “snap” or “click” hoses together into place so that the fit is tight and snug. Then connect the therapy pad to the extension hose. Note: If using a pad other then the one included you may need to change couplings. A set of blue couplings is provided.

5. Plug power supply into the device power socket, Plug the adapter into the wall Outlet.

6. Menu setting.

7. Power on the device.
   The LCD screen will light up and a short beep will indicate that the device is ready for setup and use.

8. To select or modify the device setting, press and hold the “Mode” (M)  button for two seconds.
   A. Flow Rate setting: when the “LPM” tag is flashing on the screen, press the “Up” or “Down” arrow button to adjust the flow rate of the treatment;
   B. Treatment Time setting: Pressing the “Mode”(M)  button again will transition the setting screen from Flow Rate setting to Treatment Time setting. When the “Mins” tag is flashing, press the “Up” or “Down”  arrow button to adjust the treatment time desired;
   C. Press the “Mode”(M)  button again to exit the device setting. You can abort device setting at any time during the operation by pressing the “Start/Pause” button.

9. .In standby mode, press the “Start/Pause”  button to start the pump treatment, The screen will display the flow rate selected and the current temperature estimate inside the ice bucket. The treatment timer count down is also shown on the screen.

10. During the treatment, you can press the “Start/Pause”  button at any time to pause the treatment.

11. Regardless of the mode, the device is in, temperature monitoring is always effective. Real-time device temperature is displayed on the screen.
    NOTE: The information on treatment parameters such as time, velocity and temperature, are only intended for reference and cannot be used for measurement or diagnosis purposes.

12. Alarms: The ARCTIC ICE device has two alarms:
    A. Temperature Alarm: when the actual temperature of the treatment solution has risen above 15°C (59°F), the screen Temperature Alarm will be on, with the on-screen thermometer displaying full bars at the highest temperature flashing constantly and a repeating 3-beat beep every
    15 seconds. The device will not stop the treatment when the Temperature Alarm is active. To stop the Temperature Alarm, simply press the Start/Pause ( ) button once
    B. Treatment Time alarm: When the scheduled treatment time is up, the Treatment Time alarm will be on, with an alarm clock sign ( )
    flashing on the screen and a repeating 3-beat beep every 15 seconds. To stop the Treatment Time Alarm, press the Start/Pause ( ) button to restart a new therapy session, or simply power off the device from the back panel of the Control Unit.

13. Keep pad at the same level position with the machine during use.

14. After using this device, turn off the power switch and pull the adapter out of the outlet. Separate the garment and the extension tubing. Cl ear the water in the ice bucket to the sink and wipe the device clean.

PRODUCT SPECIFICATIONS

1. Dimensions
   Device Size: 30cm length x 30cm width x 28cm height (excluding ca rrying case) / 12” length x 12” width x 11” height (excluding carrying case)
   Ice Bucket Maximum Volume: 6L

2. Weight
   3.1kg / 6.85 lbs

3. Flow rate
   MAX 2L/min

4. Adapter
   AC Input: 100~240 Volts,
   AC 50-60Hz, 500mA MAX
   Output: 12 VDC 1.0 A.
   Adapter Type: Switching Power Adaptor
   Adapter Model: UES12LCP-120100SPA

5. Mode
   Timed: 30, 45, 60, 90 min

6. Therapy Time
   MAX 90 minutes

7. Power
   100~240 Volts, AC 50-60Hz, 500mA MAX

STORAGE AND TRANSPORTATION

• Unplug the power supply from the electrical outlet.
• TO AVOID THE DANGER OF ELECTRICAL SHOCK, DO NOT UNPLUG UG THE POWER SUPPLY WITH WET HANDS.
• Disconnect garment from the hose.
• Drain the ice bucket and wipe dry.
• Drain the garment by holding so that the hose is hanging downward.
• Press in the buttons at the end of the hose and allow all water to drain out of the garment.

Storage & Transportation Temperature Conditions: -25°C ~ 70°C (-13 °F ~ 158°F)
Storage & Transportation Relative Humidity: 10% – 90% non-condensing

Caution

Do not keep in extreme hot or cold temperatures (above 50°C /120°F or below 0°C/ 33°F).
Do not leave in a hot or freezing car. Do not leave the Control Unit in direct sunlight. The UV light may damage or discolor the Control Unit.

NOMINAL OPERATING ENVIRONMENT

• Ambient Temperature: 4°C ~ 40°C (39°F ~ 104°F)
• Relative Humidity: 15% ~ 90%
• Atmosphere Pressure: 800-1060hPa
• Altitude: < 2000m

POWER SUPPLY

Domestic Power Supply: 100~240 Volts, AC 50-60Hz, 500mA MAX

WARRANTY

The manufacturer will repair or replace all or part of the unit and its accessories for material or workmanship defects for a period of 1 year from the date of sale.

WARNINGS & PRECAUTIONS

• WARNINGS: THIS DEVICE CAN BE COLD ENOUGH TO CAUSE SE SERIOUS INJURY. SERIOUS ADVERSE REACTIONS AND SAFETY

• HAZARDS MAY OCCUR WHEN USING THIS DEVICE.

• WARNING! Read and understand all warnings and Instructions for Use before using this device.

• WARNING! The adapter plug is the only part of the device that is separated from the power supply. The power switch is only for device control.

• WARNING: Use of accessories, detachable parts, and materials not described in the Instructions for Use can create unknown new risks, hence these should be avoided.

• WARNING: Precautions to be taken in the event of changes in the performance of the system: Read the instructions carefully.
  if you encounter any abnormal behavior of the device, turn off the device and contact your customer support team.

• WARNING! This device can be cold enough to cause serious injury, including tissue necrosis. You must be able to check your skin condition under the cold garment frequently (at least every hour) DO NOT use this device if you cannot check your skin condition frequently (at least every hour). Check for increased pain, burning, numbness, tingling, increased redness, discoloration, itching, increased swelling, blisters, irritation or other changes in skin condition under the cold garment or around the treatment area If you experience any of these conditions, immediately discontinue use of this device and contact your physician.

• WARNING! This device is intended only for single patient use. Secondary use can cause serious injury, including infection.

• WARNING! Application of the cold garments directly on the skin may result in serious injury, including tissue necrosis. DO NOT let any part of the cold garment touch your skin. ALWAYS use with a barrier between your skin and the cold garment.

• WARNING! The barrier between your skin and the cold garment may develop moisture during use, which may create colder temperatures on the skin. Temperatures that are too cold may result in serious injury, including tissue necrosis. ALWAYS check for moisture on the barrier between your skin and the cold garment. If moisture is present on the barrier, immediately discontinue use of this device.

• WARNING! Poor connections between hoses may cause leaking, which may result in serious injury, including infection and tissue
  necrosis. ALWAYS listen for a “snap” or “click” when connecting the ARCTIC ICE cold therapy unit hose to the cold garment hose.

• WARNING! Use of the ARCTIC ICE with wet hands or in a wet location may result in electrical shock and serious injury. DO NOT handle the transformer or power cord with wet hands or in a wet location.

• WARNING: After using the ARCTIC ICE, please wipe clean. Stay away from children and pets or pests. Avoid hurting them and polluting devices.

• WARNING: When using the ARCTIC ICE, make the extension tube straight to avoid the strangulation

CLEANING METHOD

1. The Ice Bucket can be washed by water.
2. The Control unit, Extension Tube, and Garment can be rubbed clean by a wet rag.
3. After treatment, the ice water in the tank can be poured directly into the sink.

TROUBLESHOOTING

The pump will not turn on

• Check all electrical connections and make sure the wall plug has power.
• Cold Garment will not cool down
• Make sure trapped air is out of cold garment once power is applied.
• Check all hose connections and make sure the cold garment is wrapped properly to allow water to flow Cold garment pressure is low
• Check water level. Add water if necessary.
• Make sure trapped air is out of the cold garment.
• Check water level. Add water if necessary.
• Cold garment and hose are wrapped too tightly or the hose is kinked. Unwrap and rewrap the cold garment with the cold therapy unit running, making sure water is circulating freely throughout the cold garment and the hose is not kinked.
• Make sure the connection between the cold therapy unit hose and cold garment hose is properly connected.

Water leak at the connector

• The connector between cold therapy unit hose and cold garment hose is not properly connected. Stop the machine, disconnect hose, and reconnect hose listening for a “snap” or “click”, and restart the unit.
• Check the barrier to ensure it is dry. Replace with dry barrier, if it is wet.

Water leak at cold garment

• Faulty cold garment, replace.
• Check the barrier to ensure it is dry. Replace with dry barrier, if it is wet.

Magnetic or Electromagnetic Interference

• Reorient or relocate the device. Increase the separation between the equipment. Plug the power supply into an outlet on a circuit different from that to which the Other device(s) are connected.
• Keep clear of the connector ports and power supplier ports to prevent the accumulation of lint or dust. Avoid prolonged exposure to the device from direct sunlight.

PRODUCT SUPPORT

No product maintenance should be performed by the user.
If your ARCTIC ICE System requires maintenance, please contact Customer Service.
The expected service life of the equipment: the expected service life of parts and accessories shipped with the equipment when used properly is 1 year.

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