Quick Reference Guide
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Page 1
CPR
INTRODUCTION ®
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The First Step TriCell Therapeutic Mattress Support System is a mattress replacement system designed to provide pressure relief and low-air-loss therapy for the patient treated in multiple care ® settings. The TriCell unit is comprised of an Underliner containing a 4” thick Air Base, which is topped with a 6” thick Air Mattress. The Mattress is comprised of three individual Air Cushions zipped ® together. A soft GORE-TEX Cover Sheet fits over the Air Mattress, Air Base and Underliner. The Air Mattress and Air Base are inflated with a Therapy Control Unit and air pressure within the Head, Seat and Foot Cushions can be customized to the patient’s body weight and shape. Air pressures inside the Air Mattress may also be adjusted using an easy-to-use Hand Control. ®
Permanent Cover Option - The TriCell System is available with a permanent cover which zips onto the Underliner and is water-vapor impermeable. ®
Accessories - The following accessories are available for use with the TriCell system: · Air Supply Footboard Hanging Bracket - May be used to hang the Therapy Control Unit from the footboard if the Therapy Control Unit’s Hanging Arms cannot accommodate a large footboard. · 3 ½” Static Foam Pad - May be used in place of the inflatable Air Base. · First Step TriCell® Air Rail Accessory · KCI Padded Side Rail Accessory
1. Lift up on Quick Release Lever. 2. Swing hoses away from Therapy Control Unit. 3. Pull red CPR Emergency Deflation Strap, as shown at right.
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4. Level bed. 5. Lower Side Rails (if used). 6. Place back board under patient. 7. Begin CPR. NOTE: Patient’s body weight and CPR process will deflate Air Mattress and Air Base. 8. After CPR is performed and patient is clinically stable: · Close Air Base Deflation Valve on Air Base. · Connect Hose Set to Therapy Control Unit. · Ensure CPR Emergency Deflation Strap extends through slot in Cover Sheet, is in plain view and is not twisted. · Raise and Lock Side Rails.
INDICATIONS
I NT
ERTEK
CM
US
· Unstable vertebral fracture. · Unstable spinal cord injury · Cervical traction
RISKS AND PRECAUTIONS Transfer - Precautions should be taken during patient transfer including the locking of caster brakes and the deflation of inflatable surfaces. Refer to the Patient Placement section of this guide. Side Rails and Restraints - Use or non-use of restraints, including side rails, can be critical to patient safety. WARNING: Serious injury or death can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restraints. See Safety Information (following section). Patient Migration - As with all specialty bed products that are designed to reduce shear and pressure on the patient’s skin, the risk of gradual movement and/or sinking into hazardous positions of entrapment and/or inadvertent bed exit may be increased. Skeletal Traction or Unstable Fracture (if not contraindicated) - With skeletal traction, unstable pelvic fracture, or any other unstable fracture (to the extent not contraindicated), maintain physician directed angle of articulation and guard against risks of patient migration or inadvertent deflation of surface. Oxygen Use - DANGER: Risk of explosion if used in the presence of flammable anesthetics. Use of this product’s Therapy Control Unit in an oxygen-enriched environment may produce potential of fire hazard. This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. CAUTION: Position Therapy Control Unit only at foot end of bed when using Oxygen Administering Equipment. Electromagnetic Interference - Although this equipment conforms with the intent of the directive 89/336/EEC in relation to Electromagnetic Compatibility, all electrical equipment may produce interference. If interference is suspected, move equipment away from sensitive devices or contact the manufacturer. Shock Hazard - Electrical shock hazard, do not remove cover. Refer to Qualified Service Personnel.
NOVEMBER 2007
SPECIFICATIONS*
· Prevention or treatment of skin breakdown.
Patient conditions for which the application of pressure relieving therapy on the First Step TriCell® Therapeutic Mattress Support System are contraindicated include:
QUICK REFERENCE GUIDE P/N 212846 Rev D
The First Step TriCell® Therapeutic Mattress Support System is indicated for patients who would benefit from a pressure relief surface assisting in the early intervention of skin breakdown. The First Step TriCell® is indicated for:
CONTRAINDICATIONS
Therapeutic Mattress Support System
LIS T E D
Maximum Recommended Patient Weight (including accessories)... 300 lbs. Dimensions: Complete TriCell® System (inflated)... 80” L x 35" W x 10” H Air Base only (inflated)... 80” L x 35" W x 4” H Underliner only... 80” L x 35" W x 6” H Therapy Control Unit... 12” L x 7" W x 11” H Weight: Complete TriCell® System (includes Cushions, Air Base, Hose Set, Underliner, and Cover or Sheet Permanent Cover)...19 lb. Therapy Control Unit ... 11 lb. Hand Control...less than 1 lb. Electrical: Voltage ...120 VAC Frequency ...60 Hz. Ampere Rating...4 Amps Maximum Electrical Leakage ...17 Microamps Power Cord Length...16 ft. First Step® TriCell® is designed for use with 3-prong grounded outlets. ®
CAUTION: Federal law restricts this device to sale or rental by or on the order of a physician. *Specifications subject to change without notice.
QUESTIONS AND INFORMATION For additional information concerning the First Step® TriCell® Therapeutic Mattress Support System or its operation, contact your local KCI Representative or: KCI-USA Inc. San Antonio, Texas 78219 Call Toll Free 1-800-275-4524 FAX 1-800-275-3417 www.kci1.com GORE-TEX® is a registered trademark of W.L. Gore and Associates. All other trademarks designated herein are proprietary to KCI Licensing, Inc. (a US company), its affiliates and licensors. Trademarks designated with the "®" symbol are registered in at least one country (or jurisdiction) where this product/work is commercialized, but not necessarily all such countries. This product is protected by one or more of the following U.S. Patents: D344,735; 5,022,110; 5,168,589 and 5,594,963 and corresponding equivalents in other countries. Additional patents may be pending. Corresponding non-US patents may also apply. © 2007 KCI Licensing, Inc. All Rights Reserved 11/07 P/N 212846 Rev D
This guide is not intended as a guarantee or warranty. This guide is intended solely as a quick reference source and is not intended to be a comprehensive guide. For medical questions please consult a physician. For additional product information, call the Toll Free number in the Questions and Information section of this guide.
OPERATION PROCEDURES
PATIENT PLACEMENT
1. Adjust green Air Flow (Seat) Knob to set overall mattress air pressures.
1. Install the TriCell® unit on bed frame with Hose Set at patient left foot of bed.
NOTE: The green Air Flow (Seat) Knob controls overall air flow to all Cushions, so air flow to the Seat Cushion must be set first.
2. Install Cover Sheet. 3. Connect Hoses to Therapy Control Unit. 4. Insert Hand Control Cable into receptacle located on lower right side of Therapy Control Unit. NOTE: Hang Hand Control over handle of Therapy Control Unit when Hand Control is not in use.
After air pressures in the Head and Foot Cushions are set in Steps 2 and 3, future adjustment to the Air Flow (Seat) Knob or the Hand Control will adjust air pressures in all three cushions proportionately.
HEAD
ADJUST
AIRFLOW
Seat Air Flow Control Knob
(SEAT)
FEET
· Adjust knob to midrange setting “3”.
5. Plug Therapy Control Unit into wall outlet.
· Allow time for all Cushions to respond to midrange setting.
ADJUST
· Adjust setting to increase or decrease air flow to Seat Cushion,
6. Adjust Air Flow Control Knobs for patient transfer as follows: LockOut Door Tab
· Push Lock-Out Door Tab on front of Therapy Control Unit. Door will open, exposing Air Flow Control Knobs. · For Non-Ambulatory Patients: · Turn all three Air Flow Control Knobs counterclockwise to maximum setting.
HEAD
· Press Power Button to activate Therapy Control Unit and the TriCell® unit will inflate to provide a firm surface for patient transfer. · For Ambulatory Patients, the TriCell unit will be inflated after patient transfer.
SAFETY INFORMATION
AIR PRESSURE ADJUSTMENT
NOTE: Be familiar with all Indications, Contraindications, Risks and Precautions and Safety Information (and all other aspects of the User Manual) before placing patient.
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INTRODUCTION (CONT.)
as necessary, to achieve proper air pressure adjustment. 2. Adjust blue Head Air Flow Control Knob to set air pressure in Head Cushion. Allow a 40% depression at Head Cushion and use “hand check” under head and shoulders to verify air pressure adjustment. 3. Adjust red Foot Air Flow Control Knob to set air pressure in Foot Cushion. Allow a 40% depression at Foot Cushion and use “hand check” under heels to verify air pressure adjustment.
HEAD
Head Air Flow Control Knob
AIRFLOW
ADJUST
Air Flow Control Knobs
AIRFLOW
ADJUST
4. Verify all air pressure adjustments with patient in both sitting and side-lying positions.
(SEAT)
FEET
(SEAT)
7. Verify all caster brakes are locked.
FEET
8. Transfer patient following all applicable safety rules and institution protocols.
ADJUST
NOTE: It may be necessary to increase airflow to Seat Cushion to ensure proper air pressure when patient is sitting.
Foot Air Flow Control Knob
ADJUST
9. Center patient side-to-side on air mattress. 10. If decision has been made to use Side Rails (refer to Safety Information), ensure Side Rails are locked in their full upright position.
Q SHIFT CHECK
11. Verify proper air pressure setting for patient size: · Allow 40% depression or "cradling" effect in cushions where patient lies.
Verify proper air pressure setting for patient size:
· Perform "hand check" by sliding hand flat between air mattress and air base. Verify 1 to 1 ½ inches of clearance beneath patient's buttocks.
· Allow 40% depression or "cradling" effect in cushions where patient lies.
NOTE: Wait at least 7 minutes after the Therapy Control Unit is activated to ensure the air base is fully inflated before performing the “hand check.” NOTE: If patient is placed on the TriCell ® unit with Permanent Cover, do not use “hand check” method to verify air pressure adjustment. Unzipping the Permanent Cover may compromise infection control of the air base and air mattress. Use 40% depression method only. 12. Use FIRM/SOFT buttons on Hand Control to slightly modify air pressure within limits set in the Therapy Control Unit, as required.
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· Perform "hand check" by sliding hand flat between air mattress and air base. Verify 1 to 1 ½ inches clearance beneath patient's buttocks.
NOTE: If patient is placed on the TriCell ® unit with Permanent Cover, do not use “hand check” method to verify air pressure adjustment. Unzipping the Permanent Cover may compromise infection control of the air base and air mattress. Use 40% depression method only. · Use FIRM/SOFT buttons on Hand Control to slightly modify air pressure within limits set in the Therapy Control Unit, as required.
FRONT PAGE
Bed Frame - Always use a standard healthcare bed frame with safeguards or protocols that may be appropriate. It is recommended that Bed and Side Rails (if used) comply with the Hospital Bed System Dimensional and Assessment Guidance To Reduce Entrapment, March 2006 (see www.fda.gov/CDRH/Beds/Guidance/1537.PDF). Frame and Side Rails must be properly sized relative to the mattress to help minimize any gaps that might entrap a patient’s head or body. Brakes - To minimize risk of falls, caster brakes should always be locked once the bed is in position. Verify that wheels are locked before patient transfer to or from the bed. Bed Height - The bed should always be in the lowest practical position when the patient is unattended. Enter/Exit Bed - To ensure patient comfort, it is recommended that the ambulatory patient enter and exit a deflated unit on the patient right side. Side Rails/Patient Restraints - Whether and how to use Side Rails is a decision that should be based on each patient’s needs and should be made by the patient and the patient’s family, physician and caregivers, with facility protocols in mind. Caregivers should assess risks and benefits of Bed Rail/Restraint use (including entrapment and patient falls from bed) in conjunction with individual patient needs, and should discuss use or non-use with patient and/or family. Consider not only the clinical and other needs of the patient but also the risks of death or serious injury from falling out of bed and from patient entrapment in or around the Side Rails, restraints or other accessories. For a description of entrapment hazards, refer to FDA Safety Alert dated August 23, 1995, the JCAHO Sentinel Event Alert #27, dated September 6, 2002, and other information referenced at www.kci1.com/products/FDASafetyAlert. Consult a caregiver and carefully consider the use of bolsters, positioning aids, floor pads or KCI® Padded Side Rail Accessories, especially with confused, restless or agitated patients. It is recommended that Side Rails (if used) be locked in the full upright position when the patient is unattended. Make sure a capable patient knows how to get out of bed safely (and, if necessary, how to release the Side Rails) in case of fire or other emergency. Monitor patients frequently to guard against patient entrapment. CAUTION: To help prevent inadvertent bed exit or falls, manufacturer recommends using default air settings and ensuring the distance between top of Side Rails (if used) and top of mattress (without compression) is approximately 4.5 inches. Consider individual patient size, position (relative to the top of the side rail), and patient condition in assessing fall risk. Skin Care - Monitor skin conditions regularly and consider adjunct or alternative therapies for high acuity patients. Early intervention may be essential to preventing serious skin breakdown. Give extra attention to any possible pressure points and locations where moisture or incontinence may occur or collect. Fluids - Avoid spilling fluids on Therapy Control Unit. If spills do occur, clean fluids from bed and Therapy Control Unit, wearing rubber gloves to avoid any possibility of shock. Once fluid is removed, check operation of components in area of spill. NOTE: Fluids remaining on or inside controls can cause corrosion, which may cause components to fail or operate erratically, possibly producing hazards for patient and staff. Lock-Outs - The Lock-Out feature on the Therapy Control Unit should be used at the caregiver’s discretion to ensure against unintentional or unauthorized tampering with unit settings. In appropriate cases, the Hand Control may be unplugged or removed from patient’s reach to minimize patient adjustment of system settings. Avoid Fire Hazards - To minimize the risk of fire, connect the bed’s power cord directly into a wallmounted outlet. Do not use extension cords or multiple outlet strips. Review and follow FDA’s Safety Tips for Preventing Hospital Bed Fires (dated December 18, 2003) and other information referenced at www.kci1.com/products/FDASafetyAlert. Power Cord - Ensure power cord is kept free from all pinch points and moving parts and is not trapped under casters. Improper handling of the power cord can cause damage to the cord, which may possibly produce risk of fire or electric shock. No Smoking in Bed - Smoking in bed can be dangerous. To avoid the risk of fire, smoking in bed should never be allowed. Tobacco Smoke - If routine laundering and cleaning procedures as described in the Preventative ® Maintenance section of the Maintenance chapter in this First Step Tricell User Manual are not followed, tobacco smoke build-up may conceivably reduce the amount of air flow through the product. Severe air restrictions (whatever the source) may cause the Therapy Control Unit to overheat and automatically deactivate. Disposal - At the end of useful life, dispose of waste according to local requirements or contact the manufacturer for advice. General Protocols - Follow all applicable safety rules and institution protocols concerning patient and caregiver safety. -See also CONTRAINDICATIONS and RISKS AND PRECAUTIONS-