Berg Inc
POLAR CARE series Cold Therapy Protocol Rev B March 2012
Therapy Protocol
2 Pages
Preview
Page 1
COLD THERAPY PROTOCOL Treatment Period Day: Through
Awake/ Asleep
Frequency / Duration
Inspect Skin Every:
Awake
Day:
Asleep
Day:
Awake
ELECTRICAL SAFETY
Like all electrical products, you must follow precautions to avoid electrocution, fire, burns, or other injuries. Supervise children and invalids near this product to ensure that these precautions are followed.
PRODUCT INSERT FOR POLAR CARE® GLACIER™ POLAR CARE KODIAK® POLAR CARE CUBE™
Keep electrical connections dry Even though the Polar Care unit is designed to hold and pump water, the electrical connections at the power outlet and from the power cord to the Polar Care unit are not waterproof and must be kept dry. • Do not handle the transformer 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.). • Do not use outdoors.
Breg, Inc.
If the electrical connections fall into water, do not touch any wet part of the product. Unplug only at dry electrical connections.
Through Day:
Asleep
Day:
Awake
Through Day:
Asleep
2885 Loker Ave. East Carlsbad, CA 92010 U.S.A. P: 800-321-0607 F: 800-329-2734 www.breg.com Breg is an Orthofix company
AW-1.00372 Rev B 0312
INFORMATION FOR PATIENTS & MEDICAL PROFESSIONALS USAGE TIPS 1. Use cubed or chunked ice for optimal performance. 2. If using a Breg Polar Care Cold Therapy unit with a detachable Cold Therapy Pad, it is possible to drain the pad between uses. To drain the pad between uses, hold the Cold Therapy Pad upright with the hose pointed toward the ground. Depress the black plunger and allow the water to drain out of the pad. 3. You may disconnect the Cold Therapy Pad from the unit without removing the pad from the affected area by depressing the silver tabs on the hose coupling and gently pulling the hoses apart. The Breg Polar Care Cold Therapy Pad and unit will seal itself and will not leak. Note: Some dripping during release is normal. 4. DO NOT RUN PUMP WITHOUT WATER! The pump in this unit is designed to run with water. Running the unit without water will cause permanent damage to the pump. Unplug unit before removing lid.
CLEANING, MAINTENANCE & SERVICE
After use, drain and dry pump with a soft cloth. Warm water and mild detergent may be used occasionally to clean the pump and tubes. There are no serviceable parts. Contact Breg Customer Care if replacement parts are needed.
Avoid flammables and oxidizers Do not use in places with flammable vapors or gasses (for example, flammable anesthetics), high oxygen concentrations, or other oxidizers (for example, nitrous oxide).
Pump not running Water not flowing to the pad Pad is not getting cold
Start the product Use only the transformer provided with the Breg Polar Care Cold Therapy unit, to meet the requirements of UL 60601-1. With dry hands, connect the transformer to the electrical connection located on the top of the cooler. Next, plug the transformer into an appropriate electrical outlet. The unit will automatically start running at this point. Unplug to stop the product when not in use Unplugging the Polar Care unit turns it off. Always unplug immediately after use. Never leave it plugged in while unattended. Electromagnetic Interference This Polar Care unit may cause electromagnetic or other interference with other electrical devices. To check whether the Polar Care unit is interfering with another device, unplug the Polar Care unit. If this corrects the problem, move the Polar Care unit or other device, or use an outlet on a different circuit.
Symbols used on the Polar Care Unit Symbol
1. Make sure the transformer is plugged into the wall outlet. 2. Confirm that the ice and water are filled to the indicated levels. 3. Make sure there are no kinks in the pad. 4. Gently pull on the blue tube to make sure the tube/pad junction is straight. 5. Remove the pad from the treatment site and fill it while the pad is lying flat; then reapply. 6. Confirm that the pad couplings are securely attached to the unit. Listen for the double clicks (Figure 1) to confirm the pad (fig. 1) couplings are securely attached. 7. Remove cap, which contains the foam filter, from the bottom of the pump (Figure 2) and clean out any debris. Replace cap ensuring the foam filter is in place. (fig. 2)
Grounded Use a grounded outlet Connect this product to a properly grounded Outlet outlet only.
Protect the power cord and transformer • Keep the cord and transformer away from heated surfaces. • Set up and use this equipment in a low traffic location away from children and pets. Never operate this product if it has a damaged cord, transformer, or plug. If the cord, transformer, or plug is damaged, unplug and contact Breg Customer Care, (800) 321-0607.
PRODUCT SPECIFICATIONS
TROUBLESHOOTING GUIDE
Leaks
Note: Some condensation on the lines, controller, and pads is unavoidable, especially in warmer climates. 1. If using a Breg Polar Care Cold Therapy unit with a detachable Cold Therapy Pad, and a leak exists (other than condensation on the lines) disconnect the pad couplings. Make sure the silver tabs on the couplings are depressed before reconnecting the pad to the pump hose; then confirm both sides of the coupling are properly clicked in. 2. If the coupling continues to leak or a leak is detected in the pad itself, stop using it and call Breg Customer Care at (800) 321-0607.
Description This is the safety alert symbol. It is used to alert you to potential personal injury hazards. Obey all safety messages that follow this symbol to avoid possible injury or death. Type B, applied part.
Class II Equipment
Physical and Electrical Specifications Unit Rated:
6Vdc, 600-1000mA
Electrical Specifications: Manufacturer: Hon-Kwang Model: D0660 Rated Input: 120V~, 60Hz
Output: 6Vdc, max. 600mA
Manufacturer: Group West Model: 18UR-06-1000 Rated Input: 100-240V~, 50-60Hz Output: 6Vdc, max. 1.0A Environmental Requirements: Temperature: 50°F to 100°F (10°C to 40°C) Operating Transport & Storage –40°F to 158°F (–40°C to 70°C) Humidity: 30 to 75% R.H. Operating Transport & Storage 10 to 100% R.H., non-condensing 700 hPa to 1060 hPa Atmospheric Pressure: Standards Compliance:
Designed to conform to applicable requirements of: UL 60601-1, CSA C22.2 / No. 601.1
Electrical Classifications:
Class II, Continuous Operation. Not suitable with flammable anesthetics.
DISPOSAL
Dispose of product according to local regulations.
WARRANTY
Breg, Inc. warrants that this product is free from defects in workmanship, materials, and fitness for use for 180 days from initial purchase under normal use for which it was intended if it has been properly used under direct supervision of a licensed health care practitioner. Breg, Inc.’s obligation under this warranty is limited to the replacement or repair of any defective part or parts of this product. All express or implied warranties, including the warranty of merchantability and fitness for a particular purpose, are limited to the actual warranty period set forth above. No other warranty, express or implied, is given and no affirmation of or by seller, by words or action, will constitute a warranty.
Product #:
Weight
Average Operating Range
10601, 10701
4.0 lbs (1.8kg) Empty 14.5 lbs (6.6kg) Filled
10901
5.0 lbs (2.3kg) Empty 19.7 lbs (8.9kg) Filled
At coldest setting (if applicable), average operating range of Polar Pad with Polar Dressing ≥ 45˚F (≥7.2˚C)
Polar Care® PRODUCT INSERT INFORMATION FOR MEDICAL PROFESSIONALS
Breg’s Polar Care Cold Therapy can be cold enough to seriously injure skin. Follow this information, the Operating Instructions (on the back and side of the unit), and the Cold Therapy Pad Fitting Instructions (provided with each Cold Therapy Pad).
GUIDELINES FOR USE
1. Screen Patients for Contraindications and Risk Factors
INDICATIONS FOR USE
The extended use of motorized cold therapy modalities, such as Breg’s Polar Care Cold Therapy, have been shown to have many beneficial effects following surgery. Motorized cold therapy has repeatedly been shown to decrease postoperative pain, swelling, inflammation, and narcotic use following a variety of surgical procedures, such as surgery to the shoulder, knee, and back. For a bibliography of extended use motorized cold therapy studies, contact Breg, Inc. at 800-321-0607.
2. Apply Insulation Barrier and Cold Therapy Pad
Always use an insulation barrier (such as Breg Polar Dressing, Webril, Kerlix, cast padding, elastic bandage) between the Cold Therapy Pad and skin. Do not let any part of the Pad touch skin. If a sterile dressing has been applied to the treatment site that does not completely cover the skin under the pad, use an additional insulation barrier. The Pad alone is too cold to be applied directly to the skin.
SAMPLE COLD THERAPY PROTOCOLS
The following protocols are examples of appropriate post-operative extended (>20 minute application) motorized cold therapy for patients with no risk factors. Therefore, these sample protocols would not apply to use on extremities, which may require extra precaution as described in Section 1. This is not a comprehensive list of treatment possibilities. Treatment protocols for extended motorized cold therapy may vary based upon specific patient conditions and health history, physician experience with cold therapy, and medical judgment. When used with a body part appropriate Cold Therapy Pad and an insulation barrier, the average operating temperature of the Breg Polar Care Cold Therapy System will automatically fall within these ranges.
Sample Protocol 1
All Breg Polar Care Cold Therapy products have the ability to deliver cold after ice replacement for approximately 6 to 8 hours. The duration of a cyclic application may vary depending upon the patient. If the patient does not experience pain relief, the physician may increase the duration of application. As the application duration is increased, the frequency of the skin inspections should increase.
Sample Protocol 2 Treatment Period
Frequency / Duration
Temp.
Skin Inspection
Day 1-3
While awake: Continuous
45° - 55° F
Inspect skin under pad every 1-2 hours
Day 4 to suture removal (Day 7-14)
While awake: As needed for pain control: Continuous for 1 hour intervals; not to exceed 12 hours/day
Periodically inspect Before prescribing cold therapy, always consider the patient’s medical Use only Breg Cold Therapy Pads. Other pads may be colder, increasing 45° - 55° F the skin under pad Treatment Frequency / Temp. Skin Inspection history, particularly any contraindications or risk factors. If not Period Duration the risk of skin injury. appropriately prescribed, motorized cold therapy can result in serious Inspect skin under While awake: Use only Breg Cold Therapy Pads designed for the body part being cold-induced injury, including full thickness skin necrosis. 45° - 55° F * pad every 1-2 hours Continuous treated. Multi-Use and Rectangle Pads may be used on shoulders, Day 1-3 CONTRAINDICATIONS knees, back, and hips. If the Cold Therapy Pad is placed on a body part Sample Protocol 3 While asleep: 45° - 55° F Upon waking Patients with any contraindications should not use Polar Care Continuous that it is not designed for, or if another brand of pad is used, the skin Treatment Frequency / can get too cold and be injured. Temp. Skin Inspection Period Duration While awake: History of cold injury, frostbite, Circulatory syndromes, Cyclic: Periodically inspect While awake: or adverse reactions to local including Raynaud’s disease, Do not cover the Cold Therapy Pad with dressing, wrapping, bracing or 45° - 55° F the skin under pad 1 hour on and Cyclic: Periodically inspect cold application. Buerger’s disease, peripheral casting that prevents the patient from checking the skin under the Pad. 45° - 55° F the skin under pad Day 4-10 1 hour off 1 hour on and Patients that are incoherent due vascular disease, vasospastic 1 hour off Day 1-3 to general anesthesia, sedation, disorders, sickle cell anemia, While asleep: 3. Provide Prescription and Instructions 45° 55° F Upon waking or coma. and hypercoagulable clotting While asleep: Continuous Breg Polar Care Cold Therapy units are classified by the FDA as Class II 45° - 55° F Upon waking Continuous Application areas with disorders. medical devices that must be prescribed by a physician or licensed While awake: compromised local circulation Local tissue infection. healthcare practitioner. A proper prescription for use must include: As needed for As needed for or potential wound healing Hand/wrist or feet/ankle pain control: • Frequency and duration of use (and breaks if applicable); pain control: Day 11 problems, including localized surgery with polyneuropathy. Periodically inspect Day 30 Periodically inspect Continuous for 45° - 55° F Continuous for • Frequency and instruction on skin inspections; 45° - 55° F the skin under pad the skin under pad and beyond compromise due to multiple Diabetic Polyneuropathy. and beyond 1 hour intervals; 1 hour intervals; • Treatment Period. surgical procedures. not to exceed not to exceed Use the Physician Prescription Form on the other side of this 12 hours/day 12 hours/day RISK FACTORS for Cold-Induced Injury document. This document should be given to the patient (or caregiver) *50° - 60° F for the ankle and wrist pads. upon discharge or transfer from the recovery room. Common operating Pathologic sensitivity to cold. local epinephrine use (such as temperatures for patients without risk factors for extended use (longer PATIENT DISCHARGE PROTOCOL Behaviors that negatively effect in local anesthetics). than 20 minutes) are 45° to 55° F (50° to 60° F for extremities). When Follow this protocol prior to discharging the patient from facility care to home use. circulation, including poor Medications that have a used with a body part appropriate Cold Therapy Pad and an insulation nutritional status, smoking and negative effect upon mental barrier, the average operating temperature of the Breg Polar Care Cold 1. Patient Screen. Screen the patient for any contraindications 5. Proper Pad Application. Instruct the patient that an tobacco use, excessive caffeine capacity. Therapy System will automatically fall within these ranges. and/or associated risk factors. If the patient has any insulation barrier must be between the Cold Therapy Pad and use, and excessive alcohol use. Excessive moisture at the contraindications, do not dispense Breg’s Polar Care Cold skin during use. No part of the Cold Therapy Pad should touch Patients with cold application application site due to A variety of extended use motorized cold therapy protocols Therapy to the patient. If the patient has any associated risk factors, the skin for any period of time. area desensitization due to local excessive bleeding, sweating, are reported in the literature. Treatment protocols vary based upon consult with the licensed healthcare practitioner to determine the anesthesia or regional nerve or condensation. specific patient conditions and health history, physician experience 6. Skin Inspection. Instruct the patient to inspect the skin blocks. appropriateness of application of Breg’s Polar Care Cold Therapy Diabetes. with motorized cold therapy application, and medical judgment. See receiving cold treatment per the practitioner’s instructions, Medications that have a to that patient. Hand/wrist or feet/ankle surgery. the Sample Cold Therapy Protocols to the right. typically every 1 to 2 hours. If dressing, wrapping, bracing, or negative effect on peripheral Cognitive disabilities. casting over the Cold Therapy Pad prevents the ability of the vascular circulation, including 2. Instructions For Use. Instruct the patient on how to Tell patients how to inspect skin under the Cold Therapy Pad Communication barriers. patient to regularly perform skin checks under the pad, do not beta adrenergic blockers and properly use Breg’s Polar Care Cold Therapy. Review the without compromising the sterile site and how often to do so. Young children and the elderly. dispense Breg’s Polar Care Cold Therapy to the patient. Operating Instructions affixed to the unit with each patient. Instruct patients to stop using Breg’s Polar Care Cold Therapy and contact you immediately if they experience any adverse reactions such If the risk of cold-induced injury outweighs the benefits of cold 7. Discontinue. Instruct the patient to stop using Breg’s Polar 3. Prescription. Instruct the patient regarding the licensed as: increased pain, burning, increased swelling, itching, blisters, therapy, do not prescribe Breg’s Polar Care Cold Therapy. If you Care Cold Therapy and contact their licensed health care healthcare practitioner’s prescribed protocol (frequency increased redness, discoloration, welts, or other changes in skin prescribe this product to patients with risk factors, consider taking practitioner immediately if they experience any adverse and duration of use and breaks if applicable), frequency and appearance. special measures to control the risk, such as: reactions such as: increased pain, burning, increased swelling, instruction on skin inspections, and treatment period. • Recommending more frequent skin checks. itching, blisters, increased redness, discoloration, welts, or other Review all product information with your patient. • Requiring more frequent follow-up examinations. 4. Potential For Injury. Inform the patient that improper use changes in skin appearance. Review the Information for Patients and Medical Professionals in this • Using a thicker insulation barrier between the pad and skin. can result in serious skin injury, including necrosis. Emphasize document, the Operating Instructions on the unit, and the Cold 8. Documentation. Give the patient this document with the • Prescribing shorter durations of application, less frequent the importance of following the prescribed protocol, proper pad Therapy Pad Fitting Instructions. Cold Therapy Protocol (on reverse side, top left) filled out. application, or eliminating nighttime application. application, and skin inspection.