Priming InformationWhen using your RecoveryWrap System it is important to PRIME

This can be done by operating the RecoveryWrap Systemwith the new pad attached for at least 3 min set to

1. Press the Power Switch to the ON “ ” position. 2. Prime the unit: Adjust the Temperature Control Knob to a comfortable setting.

to continue.

RecoveryWrap SystemInstructions for Use

Please read these instructions completely and carefully before applying this product. Correct

application is important for proper function.

Control Unit

Pad

Tubing Set

Setting up the system is a simple three-step process. (1) The user

with ice and water, (2) then applies the RecoveryWrap Pad with an insulation barrier between the pad and skin, around the

attaches the control unit to the pad via the tubing set.

Warning NNO part of the pad should directly touch the skin. Once the control unit is turned on, cold water is passed through

then circulated through the pad, drawing heat from the body

through the tubing set to the control unit where it is re-cooled and then re-circulated back to the pad.

When using this system, please check the skin where the pad is applied periodically. Discontinue use if continued numbness, skin discoloration, blisters, etc. are present. Please refer to your health care professional prior to applying this system and/or using the system for extended periods of time.

Warning NO part of the pad should directly touch the skin.

Patient Discharge Instructions1. Assess Patient: Screen the patient for any contraindications and/or associated risk factors. If the patient has any contrain- dications, do NOT dispense the RecoveryWrap System for treat- ment. Consult a healthcare practitioner regarding the use of the RecoveryWrap System.2. Quick Guide: Refer to the quick guide for setup and directions to apply the pad correctly. Instruct the patient on how to properly use the RecoveryWrap System.

3. Protocol: Instruct the patient on the prescribed healthcare practi tioner protocol (frequency and duration of use). Instruct patient on periodic assesment of the skin area and the treatment period.4. Potential for Injury: Instruct patient that improper use can result in serious inury. Emphasize proper use, pad placement, skin inspection, and following the prescribed protocol. 5. Pad Application: DO NOT apply the RecoveryWrap Pad direct- ly to the skin. There should be a wound dressing or insulating material between the skin and the pad. NO part of the pad should directly touch the skin.6. Skin Inspection: Instruct the patient to visually inspect the skin per the healthcare practitioners instructions, typically every 1 to 2 hours. 7. Discontinue use of the RecoveryWrap System if you experience any adverse reactions such as: burning, increased pain, increas- ed swelling, increased redness, discoloration, itching, welts, blis- ters or any other changes to the skin appearance or condition. Contact your healthcare practitioner immediately.

Indications and ContraindicationsGeneral Indications for Cold TherapyThere are general indications for using cold therapy across the body and in various situations: • First aid after trauma • Relief of pain • Prevention or reduction of swelling of traumatic origin

Cold is preferred during treatment of acute injury, sub-acute

Contraindications for Cold TherapyUsers should be aware of situations where cold therapy may

-wise contraindicated for use.

• Cold Uticaria • Cryoglobulinemia • Raynaud’s Syndrome • Proximal cold hemoglobinuria • Vasospastic disease • Cold hypersensitivity • Peripheral neuropathy (as in some cases in diabetes) • Compromised local circulationUsers should take caution in applying cold therapy over open sores and abrasions. At a minimum these areas should be cleaned and bandaged.

Directions For Use:1. Unlock and remove lid by rotating handle away from the vertical position.

1 2 3

OFF

ON

OFF

ON

switch

OFF

ON

40˚F70˚F

5. Replace lid onto the unit- make sure to line up the cutout with the notch on the lid.6. Lock lid onto the unit by returning the handle to the vertical position.7. Connect BLUE connector hose to the unit by aligning the white dots and pressing into the slot.8. Connect BLUE connector hose (opposite end) to the cold therapy pad by aligning the white dots and pressing together.9. Attach the power cord to the unit.10. Turn unit on with the green button on the top of the lid.11. Adjust temp control knob to the image showing 3

12. Allow unit to PRIME for 3 minutes- additional ICE/WATER may need to be added after this process – Turn unit OFF before removing the lid to add ICE/WATER to the unit.13. Over a dressing or moisture barrier apply the pad to the

directly to the skin.14. Adjust the temp knob based on physician recommendation.

pad.

Patient Use Tips1. Use cubed ice for best performance.2. You may disconnect the RecoveryWrap pad from the unit

blue tabs on the hose coupling and gently pulling the hose from the connector. The pad will seal itself and will not leak.3. Do NOT run the unit without water in the container. The pump is designed to run WITH water. Unplug the unit before removing the lid from the water container.

1851 East Paradise Road Suite ATracy, CA 95304

Phone: 1.866.592.0488www.topshelforthopedics.com

02419 Rev A

WarrantyTop Shelf Orthopedics guarantees the RecoveryWrap System free from defects in material and workmanship for a period of 6 months from the date of purchase except as noted below. This warranty extends only to the original retail purchaser.

This Top Shelf Orthopedics product warranty does not cover damage caused by misuse or abuse; accident; the attachment of any unauthorized accessory; alteration to the product; or any other conditions whatsoever that are beyond the control ofTop Shelf Orthopedics.

Note: For single patient use only.

Cleaning the Control UnitTo clean your RecoveryWrap System, please follow these simple steps:1. Remove electrical cord, fold down handle, and remove top assembly.

fresh, room temperature water.3. Replace top assembly, electrical cord, and raise handle to lock.4. Turn system ON for 10 minutes with setting on maximum COLD.5. Repeat these actions periodically.

RecoveryWrap

Size (approximately) 8”diameter x 11.8”H (20.3cm x 30.0cm)

Weight (dry) 5 lbs . (2.27 kg)

Fluid Tether 8 . (2.4m)

Type Manual user control

Range 40°F to 70°F (4.4°C to 21.1°C)

Operating Period 2-6 hours typica l con nuous use

Reservoir Capacity 1.1 ga l lons (4.1 l i ters )

Reservoir Fluid Ice water

Flow Rate (through Vital Wrap) 5.5 gph (21 lph)

Maximum Pressure 18 ps i

Voltage 1 V C

Max Power 18W

Leakage Current Under 300µA

Classi cation Class I I Equipment

Type of Equipment Type BF

Atmospheric Pressure 525 to 795 mmHg

Humidity 30% to 70% rela ve non-condens ing

Temperature 10°C to 40°C

Atmospheric Pressure 179 to 760 mmHg

Humidity 10% to 95%

Temperature 0°C and +50°C

EN60601-1-2(2007)

Regulatory

Operating Environment

Transport & Storage Environment

Regulatory Approvals

Physical

Control System

Thermal System

Circulating System

Electrical System

20 A , 60HZ

LeaksNOTE: Some condensation(wetness) on the lines and pads is unavoidable, especially in warmer climates.1. If during the use of a pad you experience a leak (other than

condensation) disconnect the pad coupling from the hose by depressing the blue tabs. Reconnect the pad to the hose

2. If the coupling continues to leak or the leak is demonstrated in the pad itself, STOP using the unit. Contact customer service.

Cleaning the RecoveryWrap Pad: The RecoveryWrap pad can be washed in cold water using gently cycle in a conventional laundry machine.*Top Shelf Orthopedics recommends a maximum of three machine washes per Recovery wrap.

The Caution or Warning symbol precedes an operationalstep that could damage the instrument if the user does not take certain precautions. Cautions or Warnings are located in the main text, are preceded by a Caution or Warning statement and are accompanied by this symbol in the left margin.

Caution: Risk of electric shock.

“OFF” (only for a part of EQUIPMENT)

“ON” (only for a part of EQUIPMENT)

Safety Symbols And Warnings

DANGER –To reduce the risk of electric shock:1. Always unplug this appliance from the electrical outlet immediately after using and before cleaning. 2. DO NOT use while bathing or in a shower.3. DO NOT place or store appliance where it can fall or be pulled into a tub or sink. DO NOT place in or drop into water or other liquid.4. DO NOT reach for a products that has fallen into water. Unplug immediately.

Periodically check skin where pad is applied for skin discoloration, numbness, blisters, etc., which can indicate a poten-tial burn. If detected, discontinue use and consult a physician. An appliance should never be left unattended when plugged in. Unplug from outlet when not in use, and before

Close supervision is necessary when this appliance is used by, on, or near children, invalids, or disabled persons. This appliance should not be used by or on children without parental supervision.

Use this appliance only for its intended use as described in this manual. DO NOT use attachments not recommended by the manufacturer.

Never operate this appliance if it has a damaged cord or plug, if it is not working properly, if it has been dropped or damaged, or dropped into water.

Warnings1. Ensure the top of the appliance is properly installed and the handle is fully engaged prior to carrying the appliance.2. DO NOT carry this appliance by supply cord or use cord as a handle.3. Keep the cord away from heated surfaces.4. Never operate the appliance without the Fluid Canister, the Top Assembly, the Tubing Set, and the pad completely connected.

5. Never operate the appliance with any foreign objects in the Fluid Canister.6. Never drop or insert any object into any opening.

remove plug from outlet.8. Use cooling surfaces carefully. Do not use over insensitive skin areas or in the presence of poor circulation on an incapacitated person may be dangerous. Consult your physician.

NO part of the pad should directly touch the skin.