First Step All in ONE Quick Reference Guide Rev F Jan 2008

Do Not Duplicate Do Not Distribute

For Internal Use Only da 1/08

Preliminary Strictly Confidential

SMART SURFACE TECHNOLOGY™

INTRODUCTION ®

™®

KCI unique Smart Surface Technology™ controls the air pressure within the First Step All-InOne® mattress. The First Step All-In-One® unit senses mattress air pressure requirements for the patient without the need for defined height and weight information or caregiver intervention. The mattress adjusts itself in response to patient weight and movement for optimum patient comfort and therapeutic effect.

®

™

®

For additional details on Preparation for Use, Patient Transfer and Placement, Nursing Care, Care and Cleaning, Preventive Maintenance and Troubleshooting, please refer to the First Step All-In-One® User Manual, P/N 227688. The First Step All-In-One® (FSAIO) Mattress Replacement System (MRS) is a pressure-relieving surface designed to suspend the patient on a low-air-loss support surface, providing effective pressure relief and early intervention for patients with skin breakdown. The First Step All-In-One® surface is divided into three surfaces, Head, Body and Foot. The Therapy Control Unit consists of a variable speed blower and warmer for patient comfort.

HOSE CONNECT Hose connector with spring-loaded collar. Push hose on, connector will snap closed indicating proper connection. Pull back on collar to disconnect.

THERAPY LEVELS The First Step All-In-One® MRS provides three levels of therapy:

Therapy Level III

Home

Turning

Therapy Level I - Low-Air-Loss Surface, Pressure Relief, Instaflate®, Seat Deflate and Warming.

Pulsation Firmness

Therapy Level II - includes Therapy Level I with the addition of Pulsation. ?

INDICATIONS

Utilities

Seat Deflate

Status

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®

The First Step All-In-One product is indicated for patients who would benefit from a pressure relief surface assisting in the early intervention of skin breakdown and the treatment and prevention of pressure ulcers.

Hose connector has a Key and Slot to aid in proper alignment and connection.

CONTRAINDICATIONS

! Unstable Vertebral Fracture. ! Cervical Traction. RISKS and PRECAUTIONS ! Transfer – Precaution should be taken during patient transfer, including locking of caster wheels and deflation, if ambulatory use Seat Deflate feature, if non-ambulatory use Instaflate® feature. Refer to the Patient Transfer section in the Patient Placement chapter of the FSAIO User 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. ! Patient Migration – WARNING: 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. Position only at foot end of bed when using Oxygen Administering Equipment. 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. Also see SAFETY INFORMATION on reverse side.

C

SPECIFICATIONS* SSIFIE LA

D

Patient conditions for which the application of pressure relieving therapy on the First Step All-InOne® are contraindicated include: ! Unstable Spinal Cord Injuries.

JANUARY 2008

Nurse Assist

Warming

Therapy Level III - includes Therapy Level I and II with the addition of Turning and Nurse Assist.

Instaflate™

P/N 227544 Rev F

Maximum Recommended Patient Weight (including accessories)... 400 lbs. Dimensions:

QUICK REFERENCE GUIDE

R

C

US

MRS (Inflated) (Includes Foam and Envelope Base)... 35" W x 80” L x 8" D MRS (with foot extension)... 35" W x 84” L x 8" D Foam Base... 35" W x 80” L x 2" D Envelope Base... 35" W x 80” L x 2" D Therapy Control Unit... 16 1/4" W x 8" D x 10 1/2" H Weight: MRS (includes Cushions, Cover Sheet, Envelope Base/Hose,... 40 lbs. Therapy Control Unit... 15.9 lbs. Electrical Data... 115 VAC, 60 Hz, 7 A Power Cord... 16 ft. Hospital Grade *Specifications subject to change without notice. CAUTION: Federal law restricts this device to sale or rental by or on the order of a physician.

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QUESTIONS AND INFORMATION For additional information concerning the First Step All-In-One® please contact your local KCI representative or: KCI USA, Inc. San Antonio, Texas 78265-9508 Call Toll Free 1-800-275-4524 FAX 1-800-275-3417 www.kci1.com

® ®

All 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. The term GORE® Medical Fabric is a registered trademark of W.L. Gore Company. This product is protected by one or more of the following U.S. Patents: 5,022,110; 5,168,589 and 5,594,963 and corresponding equivalents in other countries. Additional patents may be pending. © 2008 KCI Licensing, Inc. All Rights Reserved 01/08 P/N 227544 Rev F

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, consult a physician. For additional product information please refer to the First Step All-In-One® User Manual or call the KCI number listed in the Questions and Information section of this guide.

Do Not Duplicate Do Not Distribute

For Internal Use Only da 1/08 ALARMS

Grasp CPR Deflation Strap and pull as shown at right. Mattress will begin to deflate. When CPR is activated two short beeps will sound every 30 seconds.

3.

Begin CPR. Patient's body weight and CPR process will deflate cushions.

4.

With CPR completed and patient clinically stable: ! Re-insert CPR Deflation Plug. !

Screen at right is displayed.

!

Return Side Rails, restraints and other accessories (if used, refer to Safety Information) to original position.

C P R

NOTE: When CPR strap is pulled, a signal is sent to the Therapy Control Unit shutting down blower and warmer (if in use). Level bed and lower Side Rails (if used).

NOTE: Be familiar with all Safety Information, Contraindications, Risks and Precautions (and all other aspects of this guide) before placing patient. 1. Remove existing mattress and install First Step All-In-One® (FSAIO ) Mattress Replacement System (MRS). & Position FSAIO mattress on bed frame with hose at patients left foot of bed. & Place Therapy Control Unit on foot board and connect Air Hose. & Install Breathable Gore™ Medical Fabric Cover Sheet. Use straps and buckles to secure sheet. Route Air Bolster air hose connectors through slots in cover sheet, connect to Air Bolster. NOTE: Only the cover sheet supplied with the FSAIO mattress should be used on this product. Cover Sheet must be on the mattress to ensure proper function of the FSAIO system. 2. Plug Therapy Control Unit into 115 VAC wall outlet. NOTE: Be sure power to this outlet is not controlled by a wall switch. 3. Press power switch to activate. On power up, the system will partially inflate cushions until patient is placed. 4. Ensure wheel brakes and steering are locked. 5. Transfer patient following all applicable safety rules and institution protocols. NOTE: Once a patient is placed, Smart Surface Technology™ will automatically sense patient presence and begin to inflate cushions as appropriate, targeting default air pressures for patient comfort and therapeutic effect. 6. Center patient side to side on FSAIO surface. Patients’ sacrum should be centered head to foot on body cushion. 7. Use Firmness button for individual adjustments to sectional pressures if desired. 8. Perform Hand-Check - Lift up cover sheet to expose body cushion, unzip body cushion from base. Slide hand between cushion and base to verify at least 1" to 1 1/2" clearance under patient’s sacrum. 9. Raise and lock Side Rails, if applicable. (Refer to Safety Information on Side Rail/Patient Restraints). 10. Lower bed height to lowest level. Verify patient comfort. 11. Use Warmer for a low level of comforting warmth. 12. Carefully re-review and follow all Safety Information, Risk and Precautions before leaving patient unattended.

HOME SCREEN TURNING Allows caregiver to begin turning therapy and adjust position and pause times. (Therapy Level III Option) CAUTION: Prior to turning, ensure that siderails are in their full upright and locked position. See Safety Information/Turning.

CPR

2.

SAFETY INFORMATION

PATIENT PLACEMENT

ALARM SEVERITY The number of "Beeps" an alarm sounds indicates the severity of the alarm. The severities are: One Beep - Notification, non repeating. Two Beeps - Low Priority, may or may not repeat. Three Beeps - Medium Priority, will repeat until alarm condition is remedied. THERAPY ALARMS TURNING: 1 short beep on activation. Side Rail Caution displayed. NURSE ASSIST: 1 short beep on activation, Side Rail Caution displayed. Time-out after 15 minutes with 2 beeps followed by 1 “Tick” each second for 15 seconds to allow for restart before actual time-out occurs. Screen displays “Nurse Assist On” when in operation and “Nurse Assist Off” when cancelled or timed-out. INSTAFLATE®: 1 short beep on activation. Time-out after 15 minutes with 2 beeps followed by 1 “Tick” each second for 15 seconds to allow for restart before actual time-out occurs. Screen displays “Instaflate® On” when in operation and “Instaflate® Off” when timed-out or cancelled. SEAT DEFLATE: 3 short beeps after (15 minutes) followed by 3 short beeps continuing every 30 seconds until cancelled or re-initialized. Screen displays “Seat Deflate On” when in operation and “Seat Deflate Off” when cancelled. CPR: 2 short beeps on activation repeated every 30 seconds. A “CPR Activated” screen is displayed. AIR HOSE DISCONNECT: Alarms 3 short beeps repeated every 30 seconds until reconnected. A visual alert screen is also displayed. Foam Base helps provide patient support in the event of an inadvertent hose disconnect and mattress deflation. SYSTEM ALARMS POWER RESUMPTION: After a power outage of 5 seconds or less any therapies running will resume at the point power was lost. For power outages of 5 second - 60 minutes, therapies running will default to Off. System will prompt the caregiver if therapies are to be resumed. For power outages of 60 minutes or greater, when power is restored the system will return to Home screen with no screen prompt to the caregiver. Therapies will not resume and will need to be reset at the home screen. P.O.S.T. FAILURE: "Power On System Test" failure will alarm 3 short beeps every 30 seconds until user interaction. GENERAL FAULT FAILURE: Alarms 3 short beeps every 30 seconds until user interaction. Contact KCI.

1.

Preliminary Strictly Confidential

Draft Copy

HT IG RA AY E ST AW AS LL UT B PU O OM FR

Pull

CPR Deflation Pull Strap CPR Mode TO RESTART THERAPIES 1) Ensure patient is clinically stable. 2) Ensure CPR Emergency Deflation Strap extends through slot in cover sheet. 3) Return Side Rails, restraints and other accessories (if used refer to Safety Tips) to original position. 4) Select Home.

?

Home

PULSATION Allows caregiver to select three levels of pulsation therapy and cycle times. (Therapy Level II Option) FIRMNESS Allows caregiver to adjust surface pressures in Head, Body and Foot cushions. WARMING Provides warmth for patient comfort.

Therapy Level III

Home

Turning Pulsation Firmness Warming

? WARNING!

Utilities

Instaflate™ Nurse Assist Seat Deflate Status

Review User Manual before using this product.

UTILITIES Provides system settings and selections.

STATUS Displays therapy status and current settings.

INSTAFLATE™ Creates a firm surface to assists in patient transfer and bathing. NURSE ASSIST Assists caregiver with care and cleaning by rotating patient right or left. (Therapy Level III Option) SEAT DEFLATE Assist patient transfer and bedpan placement by lowering pressure in body section. LOCK/UNLOCK Press and hold to Lock and Unlock Home screen.

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 risks of falls or injury, the bed should always be in the lowest practical position when the patient is unattended. Turning - CAUTION: Prior to engaging turn feature, ensure that bed frame has siderails and that all siderails are fully engaged in their full upright and locked position. 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, 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 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 staff’s discretion to ensure against unintentional and/or unauthorized tampering with unit settings. Avoid Fire Hazards - To minimize 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 Tips for Preventing Hospital Bed Fires (dated 12/18/03) and other information referenced at 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 Preventive ® Maintenance section of the Maintenance Chapter of the First Step All In One 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 cause) 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. General Protocols - Follow all applicable safety rules and institution protocols concerning patient and caregiver safety. Disposal - At the end of useful life, dispose of waste according to local requirements or contact the manufacturer for advice. There may be special requirements for disposal of batteries in this product. Air Bolsters - The use of Air Bolsters provide maximum patient stability. The patient tends to be more easily centered on the surface and cradled on each side by the Air Bolsters. Air Bolsters may provide additional support to the patient during Turning and Nurse Assist.

-See also CONTRAINDICATIONS and RISK AND PRECAUTIONS-

Do Not Duplicate Do Not Distribute

For Internal Use Only da 1/08 ALARMS

Grasp CPR Deflation Strap and pull as shown at right. Mattress will begin to deflate. When CPR is activated two short beeps will sound every 30 seconds.

3.

Begin CPR. Patient's body weight and CPR process will deflate cushions.

4.

With CPR completed and patient clinically stable: ! Re-insert CPR Deflation Plug. !

Screen at right is displayed.

!

Return Side Rails, restraints and other accessories (if used, refer to Safety Information) to original position.

C P R

NOTE: When CPR strap is pulled, a signal is sent to the Therapy Control Unit shutting down blower and warmer (if in use). Level bed and lower Side Rails (if used).

NOTE: Be familiar with all Safety Information, Contraindications, Risks and Precautions (and all other aspects of this guide) before placing patient. 1. Remove existing mattress and install First Step All-In-One® (FSAIO ) Mattress Replacement System (MRS). & Position FSAIO mattress on bed frame with hose at patients left foot of bed. & Place Therapy Control Unit on foot board and connect Air Hose. & Install Breathable Gore™ Medical Fabric Cover Sheet. Use straps and buckles to secure sheet. Route Air Bolster air hose connectors through slots in cover sheet, connect to Air Bolster. NOTE: Only the cover sheet supplied with the FSAIO mattress should be used on this product. Cover Sheet must be on the mattress to ensure proper function of the FSAIO system. 2. Plug Therapy Control Unit into 115 VAC wall outlet. NOTE: Be sure power to this outlet is not controlled by a wall switch. 3. Press power switch to activate. On power up, the system will partially inflate cushions until patient is placed. 4. Ensure wheel brakes and steering are locked. 5. Transfer patient following all applicable safety rules and institution protocols. NOTE: Once a patient is placed, Smart Surface Technology™ will automatically sense patient presence and begin to inflate cushions as appropriate, targeting default air pressures for patient comfort and therapeutic effect. 6. Center patient side to side on FSAIO surface. Patients’ sacrum should be centered head to foot on body cushion. 7. Use Firmness button for individual adjustments to sectional pressures if desired. 8. Perform Hand-Check - Lift up cover sheet to expose body cushion, unzip body cushion from base. Slide hand between cushion and base to verify at least 1" to 1 1/2" clearance under patient’s sacrum. 9. Raise and lock Side Rails, if applicable. (Refer to Safety Information on Side Rail/Patient Restraints). 10. Lower bed height to lowest level. Verify patient comfort. 11. Use Warmer for a low level of comforting warmth. 12. Carefully re-review and follow all Safety Information, Risk and Precautions before leaving patient unattended.

HOME SCREEN TURNING Allows caregiver to begin turning therapy and adjust position and pause times. (Therapy Level III Option) CAUTION: Prior to turning, ensure that siderails are in their full upright and locked position. See Safety Information/Turning.

CPR

2.

SAFETY INFORMATION

PATIENT PLACEMENT

ALARM SEVERITY The number of "Beeps" an alarm sounds indicates the severity of the alarm. The severities are: One Beep - Notification, non repeating. Two Beeps - Low Priority, may or may not repeat. Three Beeps - Medium Priority, will repeat until alarm condition is remedied. THERAPY ALARMS TURNING: 1 short beep on activation. Side Rail Caution displayed. NURSE ASSIST: 1 short beep on activation, Side Rail Caution displayed. Time-out after 15 minutes with 2 beeps followed by 1 “Tick” each second for 15 seconds to allow for restart before actual time-out occurs. Screen displays “Nurse Assist On” when in operation and “Nurse Assist Off” when cancelled or timed-out. INSTAFLATE®: 1 short beep on activation. Time-out after 15 minutes with 2 beeps followed by 1 “Tick” each second for 15 seconds to allow for restart before actual time-out occurs. Screen displays “Instaflate® On” when in operation and “Instaflate® Off” when timed-out or cancelled. SEAT DEFLATE: 3 short beeps after (15 minutes) followed by 3 short beeps continuing every 30 seconds until cancelled or re-initialized. Screen displays “Seat Deflate On” when in operation and “Seat Deflate Off” when cancelled. CPR: 2 short beeps on activation repeated every 30 seconds. A “CPR Activated” screen is displayed. AIR HOSE DISCONNECT: Alarms 3 short beeps repeated every 30 seconds until reconnected. A visual alert screen is also displayed. Foam Base helps provide patient support in the event of an inadvertent hose disconnect and mattress deflation. SYSTEM ALARMS POWER RESUMPTION: After a power outage of 5 seconds or less any therapies running will resume at the point power was lost. For power outages of 5 second - 60 minutes, therapies running will default to Off. System will prompt the caregiver if therapies are to be resumed. For power outages of 60 minutes or greater, when power is restored the system will return to Home screen with no screen prompt to the caregiver. Therapies will not resume and will need to be reset at the home screen. P.O.S.T. FAILURE: "Power On System Test" failure will alarm 3 short beeps every 30 seconds until user interaction. GENERAL FAULT FAILURE: Alarms 3 short beeps every 30 seconds until user interaction. Contact KCI.

1.

Preliminary Strictly Confidential

Draft Copy

HT IG RA AY E ST AW AS LL UT B PU O OM FR

Pull

CPR Deflation Pull Strap CPR Mode TO RESTART THERAPIES 1) Ensure patient is clinically stable. 2) Ensure CPR Emergency Deflation Strap extends through slot in cover sheet. 3) Return Side Rails, restraints and other accessories (if used refer to Safety Tips) to original position. 4) Select Home.

?

Home

PULSATION Allows caregiver to select three levels of pulsation therapy and cycle times. (Therapy Level II Option) FIRMNESS Allows caregiver to adjust surface pressures in Head, Body and Foot cushions. WARMING Provides warmth for patient comfort.

Therapy Level III

Home

Turning Pulsation Firmness Warming

? WARNING!

Utilities

Instaflate™ Nurse Assist Seat Deflate Status

Review User Manual before using this product.

UTILITIES Provides system settings and selections.

STATUS Displays therapy status and current settings.

INSTAFLATE™ Creates a firm surface to assists in patient transfer and bathing. NURSE ASSIST Assists caregiver with care and cleaning by rotating patient right or left. (Therapy Level III Option) SEAT DEFLATE Assist patient transfer and bedpan placement by lowering pressure in body section. LOCK/UNLOCK Press and hold to Lock and Unlock Home screen.

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 risks of falls or injury, the bed should always be in the lowest practical position when the patient is unattended. Turning - CAUTION: Prior to engaging turn feature, ensure that bed frame has siderails and that all siderails are fully engaged in their full upright and locked position. 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, 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 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 staff’s discretion to ensure against unintentional and/or unauthorized tampering with unit settings. Avoid Fire Hazards - To minimize 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 Tips for Preventing Hospital Bed Fires (dated 12/18/03) and other information referenced at 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 Preventive ® Maintenance section of the Maintenance Chapter of the First Step All In One 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 cause) 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. General Protocols - Follow all applicable safety rules and institution protocols concerning patient and caregiver safety. Disposal - At the end of useful life, dispose of waste according to local requirements or contact the manufacturer for advice. There may be special requirements for disposal of batteries in this product. Air Bolsters - The use of Air Bolsters provide maximum patient stability. The patient tends to be more easily centered on the surface and cradled on each side by the Air Bolsters. Air Bolsters may provide additional support to the patient during Turning and Nurse Assist.

-See also CONTRAINDICATIONS and RISK AND PRECAUTIONS-

Do Not Duplicate Do Not Distribute

For Internal Use Only da 1/08 ALARMS

Grasp CPR Deflation Strap and pull as shown at right. Mattress will begin to deflate. When CPR is activated two short beeps will sound every 30 seconds.

3.

Begin CPR. Patient's body weight and CPR process will deflate cushions.

4.

With CPR completed and patient clinically stable: ! Re-insert CPR Deflation Plug. !

Screen at right is displayed.

!

Return Side Rails, restraints and other accessories (if used, refer to Safety Information) to original position.

C P R

NOTE: When CPR strap is pulled, a signal is sent to the Therapy Control Unit shutting down blower and warmer (if in use). Level bed and lower Side Rails (if used).

NOTE: Be familiar with all Safety Information, Contraindications, Risks and Precautions (and all other aspects of this guide) before placing patient. 1. Remove existing mattress and install First Step All-In-One® (FSAIO ) Mattress Replacement System (MRS). & Position FSAIO mattress on bed frame with hose at patients left foot of bed. & Place Therapy Control Unit on foot board and connect Air Hose. & Install Breathable Gore™ Medical Fabric Cover Sheet. Use straps and buckles to secure sheet. Route Air Bolster air hose connectors through slots in cover sheet, connect to Air Bolster. NOTE: Only the cover sheet supplied with the FSAIO mattress should be used on this product. Cover Sheet must be on the mattress to ensure proper function of the FSAIO system. 2. Plug Therapy Control Unit into 115 VAC wall outlet. NOTE: Be sure power to this outlet is not controlled by a wall switch. 3. Press power switch to activate. On power up, the system will partially inflate cushions until patient is placed. 4. Ensure wheel brakes and steering are locked. 5. Transfer patient following all applicable safety rules and institution protocols. NOTE: Once a patient is placed, Smart Surface Technology™ will automatically sense patient presence and begin to inflate cushions as appropriate, targeting default air pressures for patient comfort and therapeutic effect. 6. Center patient side to side on FSAIO surface. Patients’ sacrum should be centered head to foot on body cushion. 7. Use Firmness button for individual adjustments to sectional pressures if desired. 8. Perform Hand-Check - Lift up cover sheet to expose body cushion, unzip body cushion from base. Slide hand between cushion and base to verify at least 1" to 1 1/2" clearance under patient’s sacrum. 9. Raise and lock Side Rails, if applicable. (Refer to Safety Information on Side Rail/Patient Restraints). 10. Lower bed height to lowest level. Verify patient comfort. 11. Use Warmer for a low level of comforting warmth. 12. Carefully re-review and follow all Safety Information, Risk and Precautions before leaving patient unattended.

HOME SCREEN TURNING Allows caregiver to begin turning therapy and adjust position and pause times. (Therapy Level III Option) CAUTION: Prior to turning, ensure that siderails are in their full upright and locked position. See Safety Information/Turning.

CPR

2.

SAFETY INFORMATION

PATIENT PLACEMENT

ALARM SEVERITY The number of "Beeps" an alarm sounds indicates the severity of the alarm. The severities are: One Beep - Notification, non repeating. Two Beeps - Low Priority, may or may not repeat. Three Beeps - Medium Priority, will repeat until alarm condition is remedied. THERAPY ALARMS TURNING: 1 short beep on activation. Side Rail Caution displayed. NURSE ASSIST: 1 short beep on activation, Side Rail Caution displayed. Time-out after 15 minutes with 2 beeps followed by 1 “Tick” each second for 15 seconds to allow for restart before actual time-out occurs. Screen displays “Nurse Assist On” when in operation and “Nurse Assist Off” when cancelled or timed-out. INSTAFLATE®: 1 short beep on activation. Time-out after 15 minutes with 2 beeps followed by 1 “Tick” each second for 15 seconds to allow for restart before actual time-out occurs. Screen displays “Instaflate® On” when in operation and “Instaflate® Off” when timed-out or cancelled. SEAT DEFLATE: 3 short beeps after (15 minutes) followed by 3 short beeps continuing every 30 seconds until cancelled or re-initialized. Screen displays “Seat Deflate On” when in operation and “Seat Deflate Off” when cancelled. CPR: 2 short beeps on activation repeated every 30 seconds. A “CPR Activated” screen is displayed. AIR HOSE DISCONNECT: Alarms 3 short beeps repeated every 30 seconds until reconnected. A visual alert screen is also displayed. Foam Base helps provide patient support in the event of an inadvertent hose disconnect and mattress deflation. SYSTEM ALARMS POWER RESUMPTION: After a power outage of 5 seconds or less any therapies running will resume at the point power was lost. For power outages of 5 second - 60 minutes, therapies running will default to Off. System will prompt the caregiver if therapies are to be resumed. For power outages of 60 minutes or greater, when power is restored the system will return to Home screen with no screen prompt to the caregiver. Therapies will not resume and will need to be reset at the home screen. P.O.S.T. FAILURE: "Power On System Test" failure will alarm 3 short beeps every 30 seconds until user interaction. GENERAL FAULT FAILURE: Alarms 3 short beeps every 30 seconds until user interaction. Contact KCI.

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Preliminary Strictly Confidential

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HT IG RA AY E ST AW AS LL UT B PU O OM FR

Pull

CPR Deflation Pull Strap CPR Mode TO RESTART THERAPIES 1) Ensure patient is clinically stable. 2) Ensure CPR Emergency Deflation Strap extends through slot in cover sheet. 3) Return Side Rails, restraints and other accessories (if used refer to Safety Tips) to original position. 4) Select Home.

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Home

PULSATION Allows caregiver to select three levels of pulsation therapy and cycle times. (Therapy Level II Option) FIRMNESS Allows caregiver to adjust surface pressures in Head, Body and Foot cushions. WARMING Provides warmth for patient comfort.

Therapy Level III

Home

Turning Pulsation Firmness Warming

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Utilities

Instaflate™ Nurse Assist Seat Deflate Status

Review User Manual before using this product.

UTILITIES Provides system settings and selections.

STATUS Displays therapy status and current settings.

INSTAFLATE™ Creates a firm surface to assists in patient transfer and bathing. NURSE ASSIST Assists caregiver with care and cleaning by rotating patient right or left. (Therapy Level III Option) SEAT DEFLATE Assist patient transfer and bedpan placement by lowering pressure in body section. LOCK/UNLOCK Press and hold to Lock and Unlock Home screen.

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 risks of falls or injury, the bed should always be in the lowest practical position when the patient is unattended. Turning - CAUTION: Prior to engaging turn feature, ensure that bed frame has siderails and that all siderails are fully engaged in their full upright and locked position. 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, 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 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 staff’s discretion to ensure against unintentional and/or unauthorized tampering with unit settings. Avoid Fire Hazards - To minimize 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 Tips for Preventing Hospital Bed Fires (dated 12/18/03) and other information referenced at 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 Preventive ® Maintenance section of the Maintenance Chapter of the First Step All In One 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 cause) 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. General Protocols - Follow all applicable safety rules and institution protocols concerning patient and caregiver safety. Disposal - At the end of useful life, dispose of waste according to local requirements or contact the manufacturer for advice. There may be special requirements for disposal of batteries in this product. Air Bolsters - The use of Air Bolsters provide maximum patient stability. The patient tends to be more easily centered on the surface and cradled on each side by the Air Bolsters. Air Bolsters may provide additional support to the patient during Turning and Nurse Assist.

-See also CONTRAINDICATIONS and RISK AND PRECAUTIONS-

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For Internal Use Only da 1/08

Preliminary Strictly Confidential

SMART SURFACE TECHNOLOGY™

INTRODUCTION ®

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KCI unique Smart Surface Technology™ controls the air pressure within the First Step All-InOne® mattress. The First Step All-In-One® unit senses mattress air pressure requirements for the patient without the need for defined height and weight information or caregiver intervention. The mattress adjusts itself in response to patient weight and movement for optimum patient comfort and therapeutic effect.

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For additional details on Preparation for Use, Patient Transfer and Placement, Nursing Care, Care and Cleaning, Preventive Maintenance and Troubleshooting, please refer to the First Step All-In-One® User Manual, P/N 227688. The First Step All-In-One® (FSAIO) Mattress Replacement System (MRS) is a pressure-relieving surface designed to suspend the patient on a low-air-loss support surface, providing effective pressure relief and early intervention for patients with skin breakdown. The First Step All-In-One® surface is divided into three surfaces, Head, Body and Foot. The Therapy Control Unit consists of a variable speed blower and warmer for patient comfort.

HOSE CONNECT Hose connector with spring-loaded collar. Push hose on, connector will snap closed indicating proper connection. Pull back on collar to disconnect.

THERAPY LEVELS The First Step All-In-One® MRS provides three levels of therapy:

Therapy Level III

Home

Turning

Therapy Level I - Low-Air-Loss Surface, Pressure Relief, Instaflate®, Seat Deflate and Warming.

Pulsation Firmness

Therapy Level II - includes Therapy Level I with the addition of Pulsation. ?

INDICATIONS

Utilities

Seat Deflate

Status

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The First Step All-In-One product is indicated for patients who would benefit from a pressure relief surface assisting in the early intervention of skin breakdown and the treatment and prevention of pressure ulcers.

Hose connector has a Key and Slot to aid in proper alignment and connection.

CONTRAINDICATIONS

! Unstable Vertebral Fracture. ! Cervical Traction. RISKS and PRECAUTIONS ! Transfer – Precaution should be taken during patient transfer, including locking of caster wheels and deflation, if ambulatory use Seat Deflate feature, if non-ambulatory use Instaflate® feature. Refer to the Patient Transfer section in the Patient Placement chapter of the FSAIO User 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. ! Patient Migration – WARNING: 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. Position only at foot end of bed when using Oxygen Administering Equipment. 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. Also see SAFETY INFORMATION on reverse side.

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SPECIFICATIONS* SSIFIE LA

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Patient conditions for which the application of pressure relieving therapy on the First Step All-InOne® are contraindicated include: ! Unstable Spinal Cord Injuries.

JANUARY 2008

Nurse Assist

Warming

Therapy Level III - includes Therapy Level I and II with the addition of Turning and Nurse Assist.

Instaflate™

P/N 227544 Rev F

Maximum Recommended Patient Weight (including accessories)... 400 lbs. Dimensions:

QUICK REFERENCE GUIDE

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MRS (Inflated) (Includes Foam and Envelope Base)... 35" W x 80” L x 8" D MRS (with foot extension)... 35" W x 84” L x 8" D Foam Base... 35" W x 80” L x 2" D Envelope Base... 35" W x 80” L x 2" D Therapy Control Unit... 16 1/4" W x 8" D x 10 1/2" H Weight: MRS (includes Cushions, Cover Sheet, Envelope Base/Hose,... 40 lbs. Therapy Control Unit... 15.9 lbs. Electrical Data... 115 VAC, 60 Hz, 7 A Power Cord... 16 ft. Hospital Grade *Specifications subject to change without notice. CAUTION: Federal law restricts this device to sale or rental by or on the order of a physician.

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QUESTIONS AND INFORMATION For additional information concerning the First Step All-In-One® please contact your local KCI representative or: KCI USA, Inc. San Antonio, Texas 78265-9508 Call Toll Free 1-800-275-4524 FAX 1-800-275-3417 www.kci1.com

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All 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. The term GORE® Medical Fabric is a registered trademark of W.L. Gore Company. This product is protected by one or more of the following U.S. Patents: 5,022,110; 5,168,589 and 5,594,963 and corresponding equivalents in other countries. Additional patents may be pending. © 2008 KCI Licensing, Inc. All Rights Reserved 01/08 P/N 227544 Rev F

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, consult a physician. For additional product information please refer to the First Step All-In-One® User Manual or call the KCI number listed in the Questions and Information section of this guide.