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Directions for Use
PN-025838 – Rev A

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Summary of Contents for Top shelf Orthopedics SIERRA COLD

  • Page 1 Directions for Use PN-025838 – Rev A...
  • Page 2: Table Of Contents

    Storage and Transportation............... hospitals, outpatient clinics, athletic training or home settings. Nominal Operation Environment............. The intended use of Sierra Cold Therapy System is for the temporary reduction Power Supply....................of swelling and pain after surgery or injury. This is a non-sterile prescription device for single patient use to provide localized external application of cold Warranty......................
  • Page 3: Operating Instructions

    Then add ice to and skin. DO NOT place the indicated line. DO NOT overfill the pad directly on the with ice. DO NOT run Sierra Cold skin as this may lead to Therapy System without water. a cold injury.
  • Page 4: Quick Start Instructions

    Take the #1 strap and wrap around the torso underneath the axilla or armpit and attach 4. After use of the Sierra Cold Therapy System, unplug the AC Adapter to the pad using the hook and loop. Next, take strap #2 and wrap from the unit and wall.
  • Page 5: Product Specifications

    Pad Application (continued) 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 automobile. Do not leave the lid with LCD display in direct sunlight. A Multi-use pad is also available and may be used for other areas of The UV light may damage or discolor the LCD display.
  • Page 6: Warnings And Precautions

    WARNING! DO NOT exceed the maximum fill level when adding water and/or ice into the unit. WARNING! Use of the Sierra Cold Therapy System with wet hands or in a wet location may result in electrical shock and serious injury. DO NOT WARNING! DO NOT use this device without a prescription from a handle transformer or power cord with wet hands or in a wet location.
  • Page 7: Patient Information

    Keep electrical connections dry and free of debris. Even though cold therapy pad to the device. Any operation not intended for the the Sierra Cold Therapy System is designed to hold and pump water, patient to operate should be clearly defined by the health the electrical connections at the power outlet and from the power cord practitioner.
  • Page 8: Safety Classification

    Safety Classifications Troubleshooting Error Alarm and code displays: Mode of operation is timed sessions of 20, 40 or 60 minutes with • If the unit is beeping an alarm and an error code E1 shows on the automatic shutoff unit display. This indicates there is not enough water in the cooler to function properly.
  • Page 9: Disposal

    No product maintenance should be performed by the user. If your then restart the unit. Sierra Cold Therapy System requires maintenance, please contact • Check the barrier between the pad and your skin for dryness. your health practitioner or customer support at (866) 592-0488.
  • Page 10: Symbol Interpretation

    Symbol Interpretation Electromagnetic Compatibility Information essential for proper use shall be indicated by using the corresponding symbols. The following symbols Warning: may be seen on the device and labeling. • Do not use near active HF surgical equipment and the RF shielded room of an ME system for magnetic Symbol Title resonance imaging, where the intensity of EM...
  • Page 11 Electromagnetic Compatibility (continued) Guidance and manufacturers declaration – Guidance and manufacturers declaration – electromagnetic immunity electromagnetic emission The device is intended for use in the electromagnetic environment <5% U <5% U specified below. The customer or the user of the device should (>95% dip in U (>95% dip in UT) assure that it is used in such an environment.
  • Page 12 Electromagnetic Compatibility (continued) Recommended separation distances between portable and mobile RFcommunications 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 interfer- ence by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output...
  • Page 13 Top Shelf Orthopedics Tracy, CA 95304 PH: (866) 592-0488 FAX: (209) 834-8832 PN-025838 – Rev A...

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