First Step TriCell User Manual Rev C April 2007

Rev C 04/07 First Step® TriCell® User Manual

TABLE OF CONTENTS INTRODUCTION... 1-1 Indications... 1-1 Contraindications... 1-1 Risks and Precautions... 1-1 Safety Information... 1-2 PREPARATION FOR USE... 2-1 Unboxing and Inspection... 2-1 Unit Setup... 2-2 PATIENT PLACEMENT... 3-1 Patient Transfer to the TriCell® Unit... 3-1 Ambulatory Patient Transfer... 3-1 Non-Ambulatory Patient Transfer... 3-1 Patient Transfer from the TriCell® Unit... 3-2 Ambulatory Patient Transfer... 3-2 Non-Ambulatory Patient Transfer... 3-2 Air Pressure Adjustment... 3-3 Completion of Patient Placement... 3-4 NURSING CARE... 4-1 CPR... 4-1 Patient Transport... 4-2 Patient Bathing... 4-2 Bedpan Placement... 4-3 Bedpan Removal... 4-3 Repositioning Patient Using Dri-Flo® Underpads... 4-4 Incontinence/Drainage... 4-4 Skin Care... 4-4 General Operation... 4-5 CARE AND CLEANING... 5-1 Daily Care and Cleaning of the TriCell® While in Use... 5-1 Weekly Care and Cleaning of the TriCell® While in Use... 5-1 Disassembly of Tricell® with Gore-Tex® Cover Sheet for Laundering and Cleaning... 5-2 Disassembly of Tricell® with Permanent Cover for Laundering and Cleaning... 5-3 Infection Control Procedures... 5-4 In-Home Cleaning (Single Patient Use)... 5-4 Infection Control Protocol... 5-4 Mixing Instructions for Cleaning Solutions... 5-4 Cleaning Procedure for Air Base and Underliner (Tricell® With Gore-Tex® Cover Sheet)... 5-4 Cleaning Procedure for Permanent Cover and Underliner (Tricell® With Permanent Cover)... 5-5 Rev C 04/07 First Step® TriCell® User Manual

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Cleaning Procedure for Therapy Control Unit, Hand Control, and Hoses... 5-5 Cleaning Procedure for Air Filter... 5-6 Laundering Procedure for Cushions, Cover Sheet and Tote Bag... 5-6 Assembly of the TriCell® with Gore-Tex® Cover Sheet after Laundering and Cleaning... 5-7 MAINTENANCE... 6-1 Preventive Maintenance... 6-1 Unscheduled Maintenance... 6-1 Air Filter Removal/Replacement... 6-2 TROUBLESHOOTING... 7-1 REPLACEMENT PARTS... 8-1 SPECIFICATIONS... 9-1 Specifications... 9-1 Symbols Used... 9-1 Miscellaneous... 9-2 EMC... 9-2 Classification... 9-3 Environmental Storage / Transit Conditions... 9-3 Environmental Operating Conditions... 9-3 Ground Continuity and Leakage Current Testing... 9-4 QUESTIONS AND INFORMATION... 10-1

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INTRODUCTION

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® MRS unit is comprised of an Underliner containing a 4” thick Foam 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 an 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 1/2" Static Foam Pad - May be used in place of the inflatable Air Base. • First Step® TriCell® Bolster Accessory • KCI Padded Side Rail Accessory

INDICATIONS 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:

• Prevention or treatment of skin breakdown

CONTRAINDICATIONS Patient conditions for which the application of pressure relieving therapy on the First Step® TriCell® Therapeutic Mattress Support System are contraindicated include:

• 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 caster steering and deflation of surface. Refer to Patient Transfer sections in the Patient Placement chapter of this manual.

• 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 related Safety Information (following section).

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• Patient Migration - As with all specialty bed products that are designed to reduce sheer 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 anaesthetic 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 open any electrical cover on Therapy Control Unit. Refer to Qualified Service Personnel.

SAFETY INFORMATION 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 - Caster brakes should always be locked once the bed is in position. Verify wheels are locked before any patient transfer to or from the bed. Bed Height - To minimize the risk of falls or injury, the bed should always be in the lowest possible 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. Rev C 04/07 Introduction

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Skin Care - Monitor skin conditions regularly, especially at bony prominences and areas where moisture or incontinence may occur or collect, and consider adjunct or alternative therapies for high acuity patients. Early intervention may be essential to preventing serious skin breakdown. 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 controls can cause corrosion, which may cause components to fail or operate erratically, possibly producing potential hazards to patient and caregivers. 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 wall-mounted outlet. Do not use extension cords or multiple outlet strips. Review and follow FDA’s Safety Information for Preventing Hospital Bed Fires (dated December 18, 2003) and other information referenced at: http://www.kci1.com/products/FDASafetyAlert. 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 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. 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. 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.

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PREPARATION FOR USE

Preparing the First Step® TriCell® Therapeutic Mattress Support System for use entails inspecting the unit for any damaged or unserviceable assemblies as well as performing the steps outlined in the Unboxing and Inspection procedure below. It is recommended that all sections of this manual be reviewed prior to product use. Carefully read the Contraindications, Safety Information and Risks and Precautions Sections in the Introduction chapter of this manual prior to placing a patient on the First Step® TriCell® Therapeutic Mattress Support System.

UNBOXING AND INSPECTION 1. Open shipping boxes. Do not use sharp instruments to open boxes. Damage to Tote Bag, mattress and hoses could result. 2. Inventory all items listed below:

• One Tote Bag containing one TriCell® mattress and Hose Set • Two Gore-Tex® Cover Sheets (not included if TriCell® unit has Permanent Cover) • One Therapy Control Unit • One Hand Control • One TriCell® User Manual • One Warranty Certificate 3. Remove and discard all packing materials. 4. Inspect all components for visible damage occurring from transport. Contact carrier and KCI Customer Service Department (1-800-275-4524) immediately if damage is observed.

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UNIT SETUP CAUTION Always use a standard healthcare bed frame with such safeguards and protocols as may be appropriate.

1. Level bed and lock brakes. Remove existing mattress from bed. 2. Install the TriCell® unit on bed frame:

• Open Tote Bag and remove the TriCell® unit. • Position the TriCell® unit on bed frame with Hose Set at patient left foot of bed, as shown at right.

Head of Bed

Air Mattress

Underliner

Hose Set

CAUTION Always ensure bed frame is properly sized. Ensure against any gaps that might entrap the patient’s head or body.

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3. Install Cover Sheet.

• Position Cover Sheet with “HEAD” label at head of bed. • Pull Cover Sheet over Air Mattress and Underliner, like a fitted sheet.

Cover Sheet

• Pull red CPR Emergency Deflation Strap through slot in Cover Sheet. Ensure strap is in plain view and is not twisted.

• Pull Hose Set through unsnapped opening in Cover Sheet at foot of bed.

• Snap Cover Sheet around Hose Set. NOTE: If installing the TriCell® unit with Permanent Cover, no Cover Sheet is used. Use standard bed linens.

4. Install Therapy Control Unit on Footboard:

• Extend Therapy Control Unit arms, as shown at right. • Hang Therapy Control Unit on Footboard. NOTE: If the arms cannot accommodate a large Footboard, a separate hanging bracket is available as an accessory, or the Therapy Control Unit may be placed on a clean floor. NOTE: Verify the air intake (located on the back face of the Therapy Control Unit) contains a clean Air Filter and is not blocked by a blanket or other object. The Therapy Control Unit has a thermal cutoff that will automatically deactivate the unit, after a period of time, if the air intake is blocked. 5. Connect Hoses to Therapy Control Unit:

• Position Hose Set Coupler with hoses stacked vertically and Quick Release Lever at the bottom, as shown at right.

Tab Hose Set Coupler Quick Release Lever

NOTE: Ensure Hose Set is not twisted.

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• Insert Tab of coupler into horizontal slot on right side of Therapy Control Unit, as shown at right.

• Pivot coupler downward, placing hose ends over air outlets, until bottom of coupler clicks into locked position, as shown at right.

• Press tab on Air Valve to ensure valve is open, as shown at right. Valve will “click” if it is closed.

• Insert Air Base Hose into valve, as shown at right. Valve will “click” when hose is locked into place.

Air Base Hose

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6. 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.

Hand Control Cable Receptacle

7. Press and release Power Button, located at top of Therapy Control Unit, until button is in raised “Off” position. 8. Plug Power Cord into a grounded wall outlet. NOTE: Verify power to this outlet is not controlled by a wall switch. 9. Adjust Air Flow Control Knobs for patient transfer as follows:

• Push Lock-Out Door Tab on front of Therapy Control Unit, as shown at right. Door will open, exposing Air Flow Control Knobs.

LockOut Door Tab

• For Non-Ambulatory Patients: • Turn all three Air Flow Control Knobs (Head, Seat, Foot) counterclockwise to maximum setting, as shown at right.

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• Press Power Button, as shown at right. Therapy Control Unit will activate and the TriCell® unit will inflate to provide a firm surface for patient transfer. NOTE: Cushions will inflate within approximately 10 seconds. Verify that the Air Base fully inflates within approximately 7 minutes.

Power Button

• For Ambulatory Patients, the TriCell® unit will be inflated after patient transfer. NOTE: Inspect all components for visible damage. Verify basic functionality and inspect all hoses, cords and other components for visible damage. Abort use and contact KCI Customer Service Department (1-800-275-4524) immediately if damage is observed.

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PATIENT PLACEMENT

It is recommended that all sections of this manual be reviewed prior to product use. Carefully read the Contraindications, Safety Information and Risks and Precautions Sections in the Introduction chapter of this manual prior to placing a patient on the First Step® TriCell® Therapeutic Mattress Support System.

PATIENT TRANSFER TO THE TRICELL® UNIT Ambulatory Patient Transfer 1. Press Power Button to deactivate Therapy Control Unit. Air Mattress will deflate. Air Base will remain inflated to provide a firm surface for patient support during transfer. NOTE: The Air Base can be deflated for patient transfer by pulling the CPR Emergency Deflation Strap. Install the Air Base Deflation Valve into the Air Base after base is deflated. 2. Adjust height of both surfaces to comfortable levels for patient transfer. 3. Lower side rails (when applicable). When decision has been made to use side rails (Refer to Risks and Precautions and Safety Information section in the Introduction chapter of this manual) 4. Lock castor wheel brakes and castor wheel steering on both surfaces. 5. Assist patient in ambulatory transfer, following all applicable safety rules and institution protocols. NOTE: To ensure patient comfort, it is recommended that ambulatory patients enter and exit a deflated TriCell® unit on the patient right side of the bed. 6. Center patient side-to-side on TriCell® surface. 7. Raise and lock side rails on both sides of bed, when decision has been made to use side rails (Refer to Risks and Precautions and Safety Information section in the Introduction chapter of this manual). 8. Press Power Switch to activate Therapy Control Unit and adjust air pressures. See Air Pressure Adjustment section below. 9. With air pressures set, verify patient comfort. 10. Lower bed height to lowest level appropriate for patient height.

Non-Ambulatory Patient Transfer 1. Note setting of all Air Flow Control Knobs. Turn knobs to full counterclockwise (maximum) position. Air pressures in all Cushions will increase to provide a firm surface for patient transfer. 2. Perform steps 2-7 from previous section (Ambulatory Patient Transfer). 3. Adjust Air Flow Control Knobs to setting prior to patient transfer. 4. Perform steps 9-10 from previous section (Ambulatory Patient Transfer).

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Patient Placement

PATIENT TRANSFER FROM THE TRICELL® UNIT Ambulatory Patient Transfer 1. Press Power Button to deactivate Therapy Control Unit. Air Mattress will deflate; Air Base will remain inflated to provide a firm surface for patient support during transfer. NOTE: The Air Base can be deflated for patient transfer by pulling the CPR Emergency Deflation Strap. Install the Air Base Deflation Valve into the Air Base after base is deflated. 2. Adjust height of bed to same level as surface to which patient is being transferred. 3. Lock castor wheel brakes and castor wheel steering on both surfaces. 4. Lower side rails, when decision has been made to use side rails (Refer to Risks and Precautions and Safety Information section in the Introduction chapter of this manual). 5. Transfer patient following all applicable safety rules and institution protocols. NOTE: To ensure patient comfort, it is recommended that ambulatory patients enter and exit a deflated TriCell® unit on the patient right side of the bed.

Non-Ambulatory Patient Transfer 1. Note setting of all Air Flow Control Knobs. Turn Knobs to full counterclockwise (maximum) position. Air pressures in all Cushions will increase to provide a firm surface for patient transfer. 2. Perform steps 2-5 from previous section (Ambulatory Patient Transfer).

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AIR PRESSURE ADJUSTMENT 1. Adjust green Air Flow (Seat) Knob to set overall mattress air pressures: 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. 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.

Air Flow (Seat) Control Knob

• Adjust knob to midrange setting “3”. • Allow time for all Cushions to respond to midrange setting.

• Verify proper air pressure adjustment using the following methods:

• Allow a 40% depression or “cradling” effect in Cushions where patient lies, as shown at right.

• Perform “hand check” by sliding hand flat between Air Mattress and Air Base. Verify 1 to 1 1/2 inches clearance beneath patient’s buttocks, as shown at right. 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.

Head Air Flow Control Knob

• Adjust setting to increase or decrease air flow to Seat Cushion, 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.

Foot Air Flow Control Knob

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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. 4. Verify all air pressure adjustments with patient in both sitting and side-lying positions. NOTE: It may be necessary to increase airflow to Seat Cushion to ensure proper air pressure when patient is sitting.

COMPLETION OF PATIENT PLACEMENT 1. Verify patient comfort. 2. Use FIRM/SOFT buttons on Hand Control to slightly modify air pressure within limits set in the Therapy Control Unit, as required. 3. Raise and lock side rails, when decision has been made to use side rails (Refer to Risks and Precautions and Safety Information section in the Introduction chapter of this manual).

Firm Button

Soft Button

On/Off Button

WARNING Serious injury or death can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restraints.

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CAUTION 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 side 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 http://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.

4. Adjust bed height to lowest level.

CAUTION 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. To minimize risks of injury from falls, the bed frame should always be in the lowest possible position when the patient is unattended.

5. Ensure all brakes are locked. 6. Close Lock-Out Door on Therapy Control Unit to prevent unintentional tampering with air flow settings. 7. Store Hand Control on handle of Therapy Control Unit, or within patient reach, if appropriate. NOTE: The Lock-Out feature on the Therapy Control Unit should be used at the staff’s discretion to ensure against unintentional and/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.

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NURSING CARE

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It is recommended that all sections of this manual be reviewed prior to product use. Carefully read the Contraindications, Risks and Precautions and Safety Information Sections in the Introduction chapter of this manual prior to performing nursing care for a patient on the First Step® TriCell® Therapeutic Mattress Support System.

CPR 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.

4. Level bed. 5. Lower side rails, when decision has been made to use side rails (Refer to Risks and Precautions and Safety Information section in the Introduction chapter of this manual). 6. Place back board under patient. 7. Begin CPR. NOTE: Patient’s body weight and CPR process will deflate Air Mattress and Air Base. Rev C 04/07 First Step® TriCell® User Manual

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