FCC ID: 2ACRH-110024 Dabir Patient Support System

Instructions For Use CA-1001 (Controller Starter Kit) DA-101884 (Surgical Overlay) DA-303584 (MedSurg Bed Overlay) MC-303584 (MedSurg Bed Overlay-Micro) Patent Pending CA-9001 (Hose Assembly) CA-9002 (Power Cord) DOC# R01-0006-00004-AA Table of Contents 1 Introduction Important Before You Start 1.1 Safety Warnings 1.2 Labels and Descriptions 1.3 1.4 About this Manual 1.5 Indications of Use 1.6 Contraindications 1.7 About the Dabir System 1.8 How it Works Page #

3 3 4-6 7 7 7 8 8 2 Components of the Dabir Surfaces Overlay System 2.1 2.2 Pneumatic Controller, Hose Assembly, and Accessories Overlays 9 10 3 Setting up the System 3.1 3.2 Pneumatic Controller Pre-Assembly System Installation 4 Operating the Dabir System 5 Setting the Cycle Speed and Firmness Modes 5.1 5.2 Setting Overlay Firmness Setting Cycle Speed 6 Interrupting, Rapid Deate and Resuming Operation 7 Information Center: Error Codes and Alarms 8 Cleaning Procedures 9 Routine Maintenance 10 Troubleshooting 11 Specication Sheets 12 Limited Warranty 13 Contact Information 2 DOC# R01-0006-00004-AA 11 12-14 15 16 17 18 19-20 21 21 22 23-28 29-30 31 1.1 Important Before You Start

Please read entire manual carefully and completely before using. As with any device, failure to carefully read and follow all instructions and safety information prior to use may result in decreased product performance or failure. 1.2 Safety Warnings

It is the responsibility of the caregiver to ensure that the user can operate this product safely. Power OFF or STOP Pneumatic Controller for cardiac arrest events. The unit is not intended for use during CPR. (See Section 6)

Properly route and secure Power Cord and hoses to avoid trip hazard.

Maintain accessibility to Power Cord such that it can be easily unplugged. The Dabir System must be cleaned using the outlined guidelines within this manual. Cleaning conditions that do not reect the recommended cleaning process may result in irreparable damage.

Disconnect the Pneumatic Controller from the wall power source prior to cleaning and inspecting.

Do not immerse or allow liquid to enter any part of the Pneumatic Controller.

Keep DabirAIR Micropressure Overlay vent free and clear of liquids, contamination and debris to avoid over ination.

Do not operate the Pneumatic Controller in the presence of ammable liquids or gases.

Only use the DabirAIR Pneumatic Controller with manufacturer approved Overlays and Accessories to ensure proper system function. The DabirAIR Micropressure and DabirAIR Microclimate products are OVERLAYS, and are not intended to be used without an underlying support mattress or pad. Do not place the Pneumatic Controller in direct sunlight. The Pneumatic Controller must be stored and operated within designed operating conditions specied in this manual. Operating the Pneumatic Controller outside these ranges may cause damage to the device which could result in premature failure. The Pneumatic Controller must be used with specied operating wall currents. All other alternative power sources and currents may result in irreparable damage to the system and possible hazardous event to the patient or caregiver.

Equipment may be hazardous if misused. Modication of the device voids warranty and may compromise intended function. Service should be performed exclusively by the manufacturer or manufacturers representative. If Pneumatic Controller is damaged during the shipping process, please contact the manufacturer for appropriate action. If Pneumatic Controller is dropped during use with noticeable damage, please remove from service and contact the manufacturer for appropriate action. Do not transport or carry the Pneumatic Controller with an Overlay attached. This device requires the use of a shielded Power Cord for compliance with emissions limits. Do not operate device without manufacturer supplied Power Cord.

Do not use in an MRI environment. Do not block air intake ports on the bottom of the Pneumatic Controller or the exhaust vent under the handle. Turn Dabir System OFF during patient transfer and before patient positioning. Do not place Pneumatic Controller on top of loose articles which may block air intake ports.

It is the responsibility of the caregiver to adequately secure and protect the patient against patient falls. System must be at room temperature prior to operation. Allow Pneumatic Controller and Overlay to acclimate to room temperature for one hour prior to operation. WARNING: No modication of this equipment is allowed. 3 DOC# R01-0006-00004-AA 1.3 Labels and Descriptions The Symbols below appear on the Pneumatic Controller, Overlays, Hose Assembly, Accessories and/or packaging. Label Description Application UL Mark ANSI/AAMI ES60601-1 AMD 1 (2012), "Medical Electrical Equipment - Part 1:

General Requirements for Basic Safety and Essential Performance, Amendment 1. CAN/CSA-C22.2 No. 60601-1 (2014), "Medical Electrical Equipment - Part 1:

General Requirements for Basic Safety and Essential Performance Pneumatic Controller label UL Badge Indicates UL compliance on marketing, advertising, and packaging materials Pneumatic Controller label, Box labels, Overlay labels, Hose Assembly label NON STERILE Non-Sterile Indicates a medical device that has not been subjected to a sterilization process. Overlay labels & Overlay Box labels Instructions For Use Caution Alerts the reader of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the product or other property. This includes special care neces-

sary for the safe and eective use of the device and the care necessary to avoid damage to the device that may occur as a result of use or misuse. Manufacturer Indicates the medical device manufacturer. Box labels & Pneumatic Controller label Date of Manufacture Indicates the date when the medical device was manufactured. Box labels, Pneumatic Controller label, Hose Assembly label, Overlay labels YYYY-MM-DD Separate Collection Separate collection for electronic waste required. Box labels, Overlay Box labels, Overlay labels, Pneumatic Controller label, Hose Assembly label NOTE: Provides special information to make important instructions clearer. 4 DOC# R01-0006-00004-AA 1.3 Labels and Descriptions - Continued The Symbols below appear on the Pneumatic Controller, Overlays, Hose Assembly, Accessories and/or packaging. Label Description Application YYYY-MM-DD IP20 Follow instructions for use Debrillation-proof Type BF Applied Part Indicates a debrillation-proof type BF applied part complying with IEC 60601-1. Use-by Date Indicates the date after which the medical device is not to be used. Protected Against Solid Foreign Objects Of 12.5mm and greater. Not protected against liquid ingress. This Way Up Indicates a medical device that can be broken or damaged if not handled in a specic orientation. Pneumatic Controller label, Box labels, Overlay labels, Hose Assembly label Pneumatic Controller label Overlay Box labels & Overlay labels Pneumatic Controller label Pneumatic Controller Starter Kit Box label Keep Dry Indicates a medical device that needs to be protected from moisture. Box labels Fragile, Handle With Care Indicates a medical device that can be broken or damaged if not handled carefully. Pneumatic Controller Starter Kit Box label

%

kPA Humidity Limitation Indicates the range of humidity to which the medical device can be safely exposed. Box labels Atmospheric Pressure Limitation Indicates the range of atmospheric pressure to which the medical device can be safely exposed. Pneumatic Controller label &

Pneumatic Controller label XX C Temperature Limit Indicates the temperature limits to which the medical device can be safely exposed. Box labels & Pneumatic Controller label

%

kPA XX C DOC# R01-0006-00004-AA 5 1.3 Labels and Descriptions - Continued The Symbols below appear on the Pneumatic Controller, Overlays, Hose Assembly, Accessories and/or packaging. Label Description Application SN REF Serial Number Indicates the manufacturers serial number so that a specic medical device can be identied. Catalogue Number Indicates the manufacturers catalogue number so that the medical device can be identied. Box labels, Pneumatic Controller label, Serial ID labels, Overlay labels Box labels, Pneumatic Controller label, Hose Assembly label, Overlay labels LOT Batch Number Indicates the manufacturers batch code. Power Cord Box label Alternating Current Indicates that the equipment is suitable for alternating current only. Direct Current Indicates that the equipment is suitable for direct current only. ON (power) Indicates connection to the mains. Pneumatic Controller label, Controller Starter Kit label Hose Assembly label Pneumatic Controller label OFF (power) Indicates disconnection to the mains. Pneumatic Controller label Universal Serial Bus Pneumatic Controller label FCC Declaration of Conformity Certies that the electromagnetic interference from the device is under limits approved by the Federal Communications Commission Non-ionizing Electromagnetic Radiation Indicates equipment in the medical electri-

cal area that includes RF transmitters. Pneumatic Controller label Instructions For Use label 6 DOC# R01-0006-00004-AA 1.4 About this Manual This manual is your introduction to the Dabir Surfaces Patient Support System. Use it to initially set-up the DabirAIR Pneumatic Controller and Overlay. Keep it as a reference for day-to-day operation and as a guide for maintenance. 1.5 Indications of Use The Dabir Surface Patient Support System is indicated for:

Assisting in reducing pressure ulcer development when combined with a comprehensive pressure ulcer prevention plan. Reducing patient risk by minimizing impact of industry accepted causes of pressure ulcer formation. Use with patients weighing 50 to 400 lbs. 1.6 Contraindications Do not use the Dabir Surfaces Patient Support Systems for patients with unstable spinal fractures. 7 DOC# R01-0006-00004-AA 1.7 About the Dabir System The Dabir Surfaces Patient Support System is a low-prole, disposable, alternating pressure relief system with optional microclimate feature. d i u m M e L o w H i g h E S L C C Y E E P D d i u m M e L o w H i g h F I R M N E S S The system consists of:

DabirAIR Pneumatic Control Unit

- Easy Power Activation

- Smart Interconnect System

- Start/Stop Touch Operation

- Variable Cycle Speed Settings

- Variable Firmness Settings DabirAIR Micropressure Overlay

- Multi-Patient Use/Semi-Disposable

- Alternating Nodal Support

- Reduced Skin Shear

- Easy Wipe-Down Cleaning

- Covers with Standard Sheets DabirAIR Microclimate Overlay

- Multi-Patient Use/Semi-Disposable

- Alternating Nodal Support

- Reduced Skin Shear

- Removes Excess Heat/Moisture

- Easy Wipe-Down Cleaning

- Covers with Standard Sheets

1.8 How it Works Dabir Technology was developed on the principle of supporting a person on small, closely spaced areas of contact (Comfort Nodes) that dynamically alternate in height to relieve at-risk tissue against pressure ulcer formation. The aim is to preserve the circulatory components of arterial, venous and lymphatic blood ow in between these areas of contact. Skin Shear By shortening the distance between areas in contact, skin stretch during alternating support and immersion is reduced, thereby decreasing the risk of skin shear. Pressure The DabirAIR Micropressure Overlays achieve alternating support and relief utilizing independent rows of small comfort nodes that are intended to promote interstitial blood ow between areas of contact. Temperature & Moisture DabirAIR Microclimate Overlays provide Low-Air-Loss continuous airow to remove excess heat and moisture from the patients skin in areas of support. 8 DOC# R01-0006-00004-AA 2.1 Pneumatic Controller, Hose Assembly and Accessories DabirAIR Pneumatic Control Unit User Interface d i u m M e L o w H i g h E S L C C Y E E P D d i u m M e L o w H i g h F I R M N E S S Handle DabirAIR Hose Assembly Hose Assembly Connector (Female) Overlay Assembly Connector (Male) Hose Assembly Connector (Male) DabirAIR Accessories Low Medium High CYCLE SPEED Low Medium High FIRMNESS I nfor mation Center Hose Assembly Connector (Male) Power Cord 9 DOC# R01-0006-00004-AA 2.2 Overlays DabirAIR Micropressure Overlays Micropressure Overlay vent located here Overlay Assembly Connector (Male) DabirAIR Microclimate Overlays CAUTION: Keep Micropressure Overlay vent free and clear of liquids, contamination and debris to avoid over ination. Overlay Assembly Connector (Male) 10 DOC# R01-0006-00004-AA 3.1 Pneumatic Controller Pre-Assembly 1. Place Dabir Pneumatic Controller on a at, stable surface, free and clear of loose articles which could block the air intake. 2. 3. CAUTION: Do not block air intake ports on the bottom of the Pneumatic Control Unit or the exhaust vent under the handle. CAUTION: Do not position Pneumatic Controller on top of loose articles which may block air intake ports. Insert the Hose Assembly Connector (Male) into the receptacle of the Pneumatic Control Unit until fully seated (see image below). Insert the four (4) Attachment Screws into the Hose Assembly Connector (Male) and tighten with the provided Screwdriver. CAUTION: Do not over-tighten the Attachment Screws. CAUTION: Do not use petroleum based lubricants on the Hose Assembly Seals. Use of these lubricants may cause the seals to swell and/or leak. 4. Insert Power Cord as shown (see image below). Data Port for Factory Use Only Hose Assembly Connector (Male) 3 Attachment Screws (4) Low Medium High CYCLE SPEED Low Medium High FIRMNESS I nfor mation Center Pneumatic Controllor Power Cord 2 4 Hose Assembly Connector (Male) Data Port for Factory Use Only Power Cord Attach the Hose Assembly Connector

(Male) to the Pneumatic Controller using the four (4) phillips head Attachment Screws and Screwdriver provided. 11 DOC# R01-0006-00004-AA 3.2 System Installation Overlay Installation 1. Place Overlay at onto patient support surface, mattress or pad with THIS SIDE UP facing up. The hose routing position is preferred to be at the foot end. 2. CAUTION: Ensure there are no sharp objects between the Overlay and patient support surface, mattress or pad. Avoid placement near sharp or hot objects to avoid puncture. CAUTION: If Overlay is damaged or punctured in installation and/or usage, it must be replaced. Power ON the Pneumatic Controller and touch the cycle START/STOP key. Inspect the Overlay to insure that all nodes are properly inating and deating. If the Overlay nodes are not inating properly, inspect the Overlay and Hose Assembly routing to insure that there are no kinks restricting air ow. Cover Sheet Dabir Overlay Mattress Cover sheet to be placed above the Dabir Overlay.

(Not shown) Dabir Overlay

(Gray side down) Installation Cross Section 3. MedSurg Bed Installation CAUTION: Never place Overlay directly on bed frame. To assure proper function, the Overlay must be placed on top of a support mattress or pad. Place facility supplied, standard cover sheet over the top of the Overlay and tuck edges underneath the mattress or pad unless otherwise specied in manufacturers instructions. Overlay and sheet must be at and wrinkle free. CAUTION: It is recommended that no additional layers be added between the patient and Dabir Overlay. Additional layers may negativly impact performance. CAUTION: At the care-giver's discretion, Dabir Surgical Overlays (DA-101884) may be used without bedsheets for a single surgical procedure. NOTE: Latex is not used in the manufacture of this product. 12 DOC# R01-0006-00004-AA 3.2 System Installation - Continued Specic overlay usage details:

DabirAIR Micropressure Overlays DabirAIR Overlays are intended to provide alternating support relief with reduced skin shear. Additional layers such as moisture barriers, incontinence pads, etc. may be used, but should be kept to a single layer only. Additional bulk or non-stretch layers placed between the covering bottom sheet and patient should be avoided. DabirAIR Microclimate Overlays DabirAIR Microclimate Overlays operate under the same principle as the DabirAIR Micropressure Overlays described above, but require micro air ow between the patient and cover sheet to eectively remove excess heat and mois-

ture. Any additional layers added must be air permeable to assure proper performance. Placement of moisture barriers between the patient and cover sheet will impede air ow and reduce, or negate, Dabirs microclimate eectiveness. Pneumatic Controller and Hose Assembly Installation 1. Place Pneumatic Controller in a safe, out of the way location, approximately three (3) feet away from the bed or support surface, less than six (6) feet from a power outlet, and in a place where the user has easy access to the control panel for operation. 2. 3. CAUTION: To ensure proper device grounding, do not use an extension cord with this device. The Power Cord should be plugged directly into an acceptable wall power outlet. Route Power Cord and Hose Assembly such that it does not present a trip hazard. Using the supplied tie-straps, secure Hose Assembly to a xed or stable structure.

(See image below for recommended securing method.) CAUTION: If Pneumatic Controller is dropped during use with noticeable damage, please remove from service and contact the manufacturer for appropriate action. CAUTION: Ensure Hose Assembly is properly secured to prevent trip hazard and potential damage to the device. The Hose Assembly should not be bent, kinked or constrained in such a manner that might restrict air ow. CAUTION: Caregiver should not touch the patient and the Hose Assembly at the same time. Pneumatic Controller Tie-Strap Dabir Overlay (Gray side down) Tie-Strap CAUTION: Turn DabirAIR System OFF during patient transfer and/or before patient positioning. 13 DOC# R01-0006-00004-AA 3.2 System Installation - Continued 4. Connect Hose Assembly Connector (Female) to the Overlay Assembly Connector (Male). Orange Release Button Overlay Assembly Connector (Male) Hose Assembly Connector (Female) Hose / Overlay Connection:

Connection Procedure With the system powered OFF or STOPPED, insert the Overlay Assembly Connector (Male) into the Hose Assembly Connector (Female) (see gure above). An audible click can be heard once the connec-

tors are fully seated. Conrm connector seating with a slight pull. NOTE: The connectors must be assembled as shown in the gure below to ensure proper operation. The device will not function if a positive connection is not made. Orange Release Button Disconnection Procedure Depress orange button and pull to release Overlay Assembly Connector (Male). CAUTION: To avoid depressurization noise, this operation should only be performed with the Pneumatic Controller powered OFF or STOPPED. CAUTION: To avoid damage, do not over pull on connections or carry the Pneumatic Controller by the Hose Assembly. CAUTION: Do not use petroleum based lubricants on the Overlay Connector Seals. Use of these lubricants can cause the seals to swell and/or leak. 14 DOC# R01-0006-00004-AA 4 Operating the Dabir System Powering Pneumatic Controller ON 1. Plug the Pneumatic Controller Power Cord into an acceptable wall power outlet. CAUTION: To ensure proper device grounding, do not use an extension cord with this device. The Power Cord should be plugged directly into an acceptable wall power outlet. 2. Power Pneumatic Controller ON by depressing Main Toggle Switch. (see images below). CAUTION: Ensure Power Cord is clear of movable bed parts and placed to avoid a trip hazard or possible entrapment. CAUTION: Power OFF or STOP the Pneumatic Controller for cardiac arrest events. The unit is not intended for use during CPR. Main Toggle Switch Data Port

(Factory Use Only) Hose Assembly Connector (Male) Power Cord 15 DOC# R01-0006-00004-AA 5.1 Setting Cycle Speed 1. 2. Three (3) cycle speed options are available:

LOW MEDIUM HIGH

(Approx. 10 minutes Default Setting)

(Approx. 7.5 minutes)

(Approx. 5 minutes) Manually adjust cycle speed by touching the desired indicator key (see images below). NOTE: The Dabir Pneumatic Controller utilizes touch activated controls for added reliability, improved product durability and easier cleaning. Use of thick gloves may impact performance when operating the control. 3. Touch the START / STOP button to initiate the cycle. NOTE: The cycle speed and rmness can be changed independent of the START / STOP feature by simply touching the new desired setting. Low Low Medium Medium High High Low Low Medium Medium High High CYCLE SPEED CYCLE SPEED FIRMNESS FIRMNESS Information Information Center Center START/STOP key Cycle Speed Control keys Low Low Medium Medium High High Low Low Medium Medium High High Information Information Center Center CYCLE SPEED CYCLE SPEED FIRMNESS FIRMNESS Low Setting Low Low Medium Medium High High Low Low Medium Medium High High Information Information Center Center CYCLE SPEED CYCLE SPEED FIRMNESS FIRMNESS High Setting 16 DOC# R01-0006-00004-AA Low Low Medium Medium High High Low Low Medium Medium High High CYCLE SPEED CYCLE SPEED FIRMNESS FIRMNESS Medium Setting Information Information Center Center 5.2 Setting Overlay Firmness 1. 2. The Pneumatic Control Unit User Interface is equipped with three (3) dierent rmness settings:

LOW MEDIUM HIGH

(Default Setting) Manually adjust comfort by touching the desired rmness option on the User Interface (see images below). NOTE: Microclimate Overlays will only have one rmness setting. The LOW, MEDIUM and HIGH User Interface buttons all provide a LOW rmness when a Microclimate Overlay is connected. NOTE: The Dabir Pneumatic Controller utilizes touch activated controls for added reliability, improved product durability and easier cleaning. Use of thick gloves may impact performance when operating the control. 3. Touch the START/STOP key to initiate alternating cycles. NOTE: The cycle speed and rmness can be changed in mid-cycle by simply touching the key for the desired setting. CAUTION: To avoid bottoming out on the Overlay, the MED or HIGH rmness settings are recommended for patients with greater BMI. CAUTION: To avoid bottoming out on the Overlay, a MED or HIGH rmness setting is recommended when utilizing rmer base support surfaces, mattresses or pads. Low Low Medium Medium High High Low Low Medium Medium High High CYCLE SPEED CYCLE SPEED FIRMNESS FIRMNESS Information Information Center Center START/STOP key Firmness Control keys Low Low Medium Medium High High Low Low Medium Medium High High Information Information Center Center CYCLE SPEED CYCLE SPEED FIRMNESS FIRMNESS Low Setting Low Low Medium Medium High High Low Low Medium Medium High High Information Information Center Center CYCLE SPEED CYCLE SPEED FIRMNESS FIRMNESS High Setting Low Low Medium Medium High High Low Low Medium Medium High High Information Information Center Center CYCLE SPEED CYCLE SPEED FIRMNESS FIRMNESS Medium Setting 17 DOC# R01-0006-00004-AA 6 Interrupting, Rapid Deate and Resuming Operation Press the START/STOP key to pause or resume operation (see image below). NOTE: Unless unit is powered OFF, the Pneumatic Controller will remain at the previous settings when operation is resumed. To turn Pneumatic Controller o, toggle the main power switch to the OFF position. The Pneumatic Controller unit will return to default settings. CAUTION: Power OFF or STOP Pneumatic Controller for cardiac arrest events. The unit is not intended for use during CPR. Audible Tones and Visual Indicators:

The Dabir Pneumatic Controller utilizes soft audible tones, illuminated graphics and information displays to enhance the users operating experience. Low Low Low Low Medium Medium Medium Medium High High High High Low Low Low Low Medium Medium Medium Medium High High High High CYCLE SPEED CYCLE SPEED CYCLE SPEED CYCLE SPEED FIRMNESS FIRMNESS FIRMNESS FIRMNESS Information Information Information Information Center Center Center Center START/STOP key Low Low Medium Medium High High Low Low Medium Medium High High CYCLE SPEED CYCLE SPEED FIRMNESS FIRMNESS Information Information Center Center 18 DOC# R01-0006-00004-AA 7 Information Center: Error Codes and Alarms The User Interface panel includes an INFORMATION CENTER to aid users in diagnosing potential problems (see image below). Low Low Medium Medium High High Low Low Medium Medium High High CYCLE SPEED CYCLE SPEED FIRMNESS FIRMNESS Information Information Center Center START/STOP key Information Center area If the Pneumatic Controller detects a potential problem, one or more of the following three (3) text displays will illuminate with its associated feedback codes depending on the problem:

SERVICE UNIT CHECK CONNECTIONS REPLACE OVERLAY

(Potential Code: Continuous, Blinking, Audible Tone)

(Potential Code: Continuous, Blinking, Audible Tone)

(Potential Code: Continuous, Blinking, Audible Tone) Low Low Medium Medium High High Low Low Medium Medium High High CYCLE SPEED CYCLE SPEED FIRMNESS FIRMNESS Information Information Center Center Service Unit Check Connections Replace Overlay Error code will illuminate here NOTE: See the table on the following page for specic error code messages and required action. Error codes will automatically be cleared once the problem is resolved and operation is resumed by touching the START / STOP key. In the event that proper function cannot be resumed, please contact the manufacturer. 19 DOC# R01-0006-00004-AA 7 Information Center: Error Codes and Alarms - Continued Information Center Indicator Buzzer Meaning Check Connections Continuous Check Connections Flashing 2sec ON 2sec OFF Frequency: 2kHz 2sec ON after touching START/STOP button, then OFF continuous Frequency: 2kHz 2sec ON after touching START/STOP button, then OFF continuous The Pneumatic Controller is not properly communicating with the Overlay. Check the Hose Assembly to Overlay connection. Light will clear when proper connection is made and the unit will return to normal operation. If light does not clear, change the Overlay. If light still does not clear, contact the manufacturer or certied representative. The Pneumatic Controller is not properly communicating with the Hose Assembly. Check the Hose Assembly connection to the Pneumatic Controller. Power the unit OFF and wait 5 seconds using the main toggle switch. Power the unit ON again. If the light does not clear, please contact the manufacturer or certied representative. Replace Overlay Frequency: 2kHz Continuous 1sec ON 30sec OFF The Overlay has exceeded its usable life or its allowable shelf life and must be replaced. System will continue to run for 12hrs or until the unit is stopped or powered OFF. Replace Overlay Frequency: 2kHz Flashing 1sec ON 3sec OFF 2sec ON after 24hr mark, then OFF continuous The Overlay is within 24 hours of its usable life and within 36 hours of a forced shutdown by the Pneumatic Controller. Overlay must be replaced accordingly. The Pneumatic Controller did not achieve pressure set point upon startup. Power OFFusing the Main Toggle Switch. Check Overlay and Hose Assembly for possible leaks. Power the Pneumatic Controller back ON again. If problem persists, please contact the manufacturer or certied representative. The Pneumatic Controller has encountered a physical error. Power OFF using the Main Toggle Switch. Wait 5 seconds and power the Pneumatic Controller back ON again. If the problem persists, please contact the manufacturer or certied representative. Service Unit Frequency: 2kHz 3x - 0.5sec ON, 0.5sec OFF, then OFF continuous Frequency: 2kHz 3x - 0.5sec ON, 0.5sec OFF, then OFF continuous Flashing 2sec OFF 2sec ON Service Unit Continuous 20 DOC# R01-0006-00004-AA 8 Cleaning Procedures The cleaning procedures listed below are recommended by the manufacturer. Proper cleaning procedures should be adjusted according to specic healthcare facility policy. Aggressive cleaning measures could potentially damage system components. CAUTION: Turn Dabir System OFF during patient transfer and before patient positioning. CAUTION: If the Overlay is damaged in any way during cleaning, it must be replaced. CAUTION: Do not autoclave for cleaning. Cleaning the DabirAIR Controller and Hose Assembly Power OFF the Pneumatic Controller and disconnect the Power Cord from the wall outlet prior to clean-

ing. Clean by wiping with a moistened cloth using mild soap and water. Clean all exposed areas. Remove debris and allow the Pneumatic Controller to dry thoroughly. CAUTION: Do not saturate cloth or apply cleaning uids/liquids directly to the Pneumatic Controller or Hose Assembly to prevent uid ingress of this electronic device. Inspect air intakes and exhaust ports located on the bottom side of the Pneumatic Controller and Handle End-plate respectively to ensure they are not obstructed. Cleaning the DabirAIR Micropressure and Microclimate Overlays Disinfect by wiping down all areas with a hospital grade disinfecting cleaner and water, making sure to remove any organic debris. Be sure to dry the Overlay thoroughly before using with patients. Cleaner residue may eect the Overlay slip resistance. If this occurs, wipe the Overlay with a water moistened cloth to remove the residue. Dabir Overlays are compatible with the following disinfecting cleaners or equiva-

lent: Dispatch Hospital Cleaner Clorox, Virex 256 - Diversey, Isopropyl Alcohol. Ensure there are no sharp objects between the Overlay and patient support surface, mattress or pad. 9 Routine Maintenance The Dabir Surfaces Patient Support System It is recommended that the Pneumatic Controller be returned to the manufacturer for annual maintenance and performance check after every 12 months of use. Routinely check all electrical connections, the Power Cord and Hose Assembly for signs of wear or damage and replace if appli-

cable with manufactured certied replacement parts. For any non-serviceable damage noted, please contact the manufacturer or certied representative. Serial Number Labels The Pneumatic Controller serial number is located on the underside label. The Hose Assembly serial number is located on the Hose Assembly label. The Overlay serial number is located on the Overlay label. All serial numbers are in the following format: LSYYDDDXXXXT Please provide component serial numbers when requesting service. 21 DOC# R01-0006-00004-AA 10 Troubleshooting Repairs and Technical Support See Section 7: Information Center: Error Codes and Alarms for error codes and alarms. For non-error codes and alarms troubleshooting, see the table below. Problem Pneumatic Controller does not power ON. Pneumatic Controller powers ON but does not operate when START/STOP button is pressed. Abnormal noises and/or vibration coming from the Pneumatic Controller. Air leakage sounds Abnormal odors coming from the Pneumatic Controller. Potential Cause No electric supply Blown fuse Internal malfunction Connection issue or other malfunction Internal malfunction Hose connection issue or other leakage source Internal malfunction Remedy Conrm Power Cord is plugged into the Pneumatic Controller and the appropriate wall outlet. Contact manufacturer Contact manufacturer See Section 7, Page 19-20 Power OFF the Pneumatic Controller. Contact manufacturer. See Section 7, Page 19-20 Power OFF the Pneumatic Controller. Contact manufacturer. If fuse is blown - contact Dabir technical support for service (DO NOT REPLACE). How to reach us:

Dabir Surfaces maintains regular business hours from 9:00 a.m. to 5:00 p.m. Eastern time. Technical and Warranty Support support@dabir-surfaces.com Tel: +1 (885) 478-0694 22 DOC# R01-0006-00004-AA 11 Specication Sheets Controller Specications Model:

Supply Voltage:

Supply Frequency:

Power Input:

Size:

Weight:

Case Material:

Fuse Ratings:

Type of protection against electric shock:

Degree of protection from electrical shock:

Degree of protection from liquid ingress:

Mode of Operation:

Environment Conditions:

CA-1001 100-240 VAC 50-60 Hz 170VA Max 356 x 178 x 127 mm (14in. x 7in. x 5 in.) 3.95 kg (8.7 lb) Plastic 2A, 5x20mm, Fast Acting Class I Type BF IP20 Continuous Operation:

Storage and Transport:

10C to 35C (50F to 95F) 30-80% RH

-40C to 60C (-40F to 140F) 10-95% RH Maximum Operating Altitude: 3000m (9842 ft) No Latex is used in the manufacture of this product. Data subject to change. 23 DOC# R01-0006-00004-AA 11 Specication Sheets - Continued Accessory Specications Replacement Hose Assembly CA-9001 0.73kg (1.6lb) 5VDC 250mA Model:

Weight:

Input:

RF Transmitter Separate collection for electronic waste Replacement Power Cord Model:

Weight:

Length:

Wall Plug:

Controller Plug:

CA-9002 0.34 kg (0.75lb) 10'

NEMA 5-15P 3P Hospital Grade Green Dot IEC 60320-C13 No Latex is used in the manufacture of this product. Data subject to change. Model:

Application Overlay Models covered by this Installation Guide Length mm (in) 2134 (84) 2134 (84) 2134 (84) Width mm (in) 438 (17) 838 (33) 838 (33) Surgical Table MedSurg Bed MedSurg Bed DA-101884 DA-303584 MC-303584 Weight kg (lb) 1.54 kg (3.4) 2.95 kg (6.5) 2.95 kg (6.5) Microclimate Air Flow Usable Life N N Y 120 Hrs 720 Hrs 720 Hrs No Latex is used in the manufacture of this product. Data subject to change. 24 DOC# R01-0006-00004-AA 11 Specication Sheets - Continued Model CA-1001 Manufacturers Declaration Electromagnetic Immunity The Model CA-1001 system is intended for use in the electromagnetic environment specied below. The customer or the user of the Model CA-1001 system should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment/Guidance 6 kV contact Electrostatic discharge (ESD) IEC 61000-4-2 8 kV air Electrical fast 2 kV for power transient/burst supply lines IEC 61000-4-4 1 kV for input/output lines Surge 1 kV line(s) to line(s) IEC 61000-4-5 2 kV line(s) to earth

< 5% UT

(>95% dip in UT) for 0.5 cycle Voltage dips, 40% UT short

(60% dip in UT) interruptions for 5 cycles and voltage variations on power supply input lines Josh Floors should be wood, concrete, or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environ-

ment. If the user of the Model CA-1001 requires continued operation during power mains interruptions, it is recom-

mended that the Model CA-1001 be powered from an uninterruptible power supply or a battery. IEC 61000-4-11 70% UT

(30% dip in UT) for 25 cycles

< 5% UT

(>95% dip in UT) for 5 s NOTE: UT is the AC mains voltage prior to application of the test level. 25 DOC# R01-0006-00004-AA 11 Specication Sheets - Continued Model CA-1001 Manufacturers Declaration Electromagnetic Immunity The Model CA-1001 system is intended for use in the electromagnetic environment specied below. The customer or the user of the Model CA-1001 system should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment/Guidance Conducted RF 3 Vrms 3 V IEC 61000-4-6 150 kHz to 80 MHz Portable and mobile RF communications equipment should be used no closer to any part of the Model CA-1001, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Radiated RF 3 V/m 3 V/m Recommended separation distance IEC 61000-4-3 80 MHz to 2.6 GHz

=1.2

=1.2 80 MHz to 800 MHz

=2.3 800MHz to 2.3 GHz Where is the maximum output power rating for the transmitter in watts (W) according to the transmitter manufacturer and is the recommended separation distance in meters

(m). Field strengths from xed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects, and people. Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, and electromagnetic site survey should be considered. If the measured eld strength in the location in which the Model CA-1001 is used exceeds the applicable RF compliance level above, the Model CA-1001 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Model CA-1001. Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m. DOC# R01-0006-00004-AA 26 11 Specication Sheets - Continued Model CA-1001 Manufacturers Declaration Electromagnetic Emissions The Model CA-1001 system is intended for use in the electromagnetic environment specied below. The customer or the user of the Model CA-1001 system should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment/Guidance The Model CA-1001 uses RF energy only for its internal func-

tion. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Model CA-1001 is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Group 1 Class A Not applicable RF emissions CISPR 11z RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Not applicable Voltage uctuations/

icker emissions IEC 61000-3-3 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and Model CA-1001 The Model CA-1001 system is intended for use in the electromagnetic environment specied below. The customer or the user of the Model CA-1001 system should assure that it is used in such an environment. Rated Maximum Output Power of Transmitter

(W) Separation Distance According to Frequency of Transmitter(m) 150 kHz to 80 MHz d=1.2P 80 MHz to 800 MHz d=1.2P 800 MHz to 2.5 GHz d=2.3P 0.12 0.38 1.2 3.8 12

.12

.38 1.2 3.8 12 0.01 0.1 1 10 100 For transmitters radiated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects, and people. 0.23

.073 2.3 7.3 23 DOC# R01-0006-00004-AA 27 11 Specication Sheets - Continued Changes or modications not expressly approved by Dabir Surfaces, Inc. could void the user's authority to operate the equipment. This device complies with Part 15 of the FCC Rules and with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause inter-

ference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le prsent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorise aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radiolec-

trique subi, mme si le brouillage est susceptible d'en compromettre le fonctionnement. Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropi-

cally radiated power (e.i.r.p.) is not more than that necessary for successful communication. Conformment la rglementation d'Industrie Canada, le prsent metteur radio peut fonctionner avec une antenne d'un type et d'un gain maximal (ou infrieur) approuv pour l'metteur par Industrie Canada. Dans le but de rduire les risques de brouillage radiolectrique l'intention des autres utilisateurs, il faut choisir le type d'antenne et son gain de sorte que la puissance isotrope rayonne quivalente (p.i.r.e.) ne dpasse pas l'intensit ncessaire l'tablissement d'une communication satisfaisante. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be deter-

mined by turning the equipment o and on, the user is encouraged to try to correct the interference by one or more of the following measures:

- Reorient or relocate the receiving antenna.

- Increase the separation between the equipment and receiver.

- Connect the equipment into an outlet on a circuit dierent from that to which the receiver is connected.

- Consult the dealer or an experienced radio/TV technician for help. 28 DOC# R01-0006-00004-AA 12 Limited Warranty Dabir Surfaces, Inc. warrants that the product (Dabir Product) accompanied by this Limited Warranty, shall be free from defects in material and workmanship under normal use for a period of one (1) year. Except where prohibited by applicable law, this warranty is valid, beginning from date of original purchase, for the specic period associated with the Dabir Product purchased, and is nontransferable and is limited to the original, end user purchaser. This warranty gives you specic legal rights, and you may also have other rights which vary under local laws. Remedies Dabir Surfaces, Inc. entire liability and your exclusive remedy for any breach of warranty shall be, at Dabir Surfaces, Inc. option, (1) to replace the Dabir Product, or (2) to refund the price paid, provided that the Dabir Product is returned to a location as specied by Dabir Surfaces, Inc. with a copy of the sales receipt, or dated itemized receipt, from an authorized reseller, and with a return authorization number provided by Dabir Surfaces, Inc. Shipping and handling charges may apply except where prohibited by applicable law. Dabir Surfaces, Inc. may, at its option, use new or refurbished or used parts in good working condition to replace any hardware product. Any replacement Dabir Product will be warranted for the remainder of the original warranty period or thirty (30) days, whichever is longer or for any additional period of time that may be required in the end users jurisdiction. This warranty does not cover problems or damage resulting from (a) accident, abuse, misapplication, or any unauthorized repair, modication or disassembly; (b) improper operation or maintenance, usage not in accordance with product instructions or connection to improper voltage supply; or (c) use of consumables, such as replacement batteries, not supplied by Dabir Surfaces, Inc. except where such restriction is prohib-

ited by applicable law. How to Obtain Warranty Support Before submitting a warranty claim, you must contact Dabir technical support at:

support@dabir-surfaces.com or by calling (885) 478-0694 to verify the product failure and to receive a Return Material Authorization (RMA) number. Returns will not be accepted without an RMA number. The addresses and customer service contact information for the Dabir Product can be found in the documenta-

tion accompanying your Dabir Product and on the web at www.dabir-surfaces.com. You must include a copy of the sales receipt, or dated itemized receipt, from an authorized reseller, along with a return autho-

rization number provided by Dabir Surfaces, Inc. with your return. You must report any defect to Dabir Surfaces Inc. within the one (1) year period of the warranty. The following information must be marked on the outside of each carton and/or pallet:

- Shippers name and address:

- Dabir Surfaces Ship to address as listed below:

Dabir Surfaces, Inc. Attention: Repair Dept. / RMA #

7447 W. Wilson Harwood Heights, IL 60706 USA 29 DOC# R01-0006-00004-AA 12 Limited Warranty - Continued Limitation of Liability DABIR SURFACES, INC. SHALL NOT BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES WHATSOEVER, INCLUDING BUT NOT LIMITED TO LOSS OF PROFITS, REVENUE OR DATA (WHETH-

ER DIRECT OR INDIRECT) OR COMMERCIAL LOSS FOR BREACH OF ANY EXPRESS OR IMPLIED WARRANTY ON YOUR DABIR PRODUCT OR FOR ANY OTHER CLAIM, EVEN IF DABIR SURFACES, INC. HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IN ADDITION, TO THE EXTENT PERMITTED BY LAW, THE MAXIMUM LIABILITY OF DABIR SURFACES, INC. WITH RESPECT TO ANY DABIR PRODUCT FOR ANY CAUSE WHATSOEVER

(WHETHER BREACH OF CONTRACT OR WARRANTY, TORT OR OTHERWISE), IS LIMITED TO THE AMOUNT ACTUALLY PAID OR PAYABLE BY YOU FOR THE DABIR PRODUCT THAT GAVE RISE TO SUCH LIABILITY. THE FOREGOING LIMITATIONS SHALL APPLY EVEN IF THE PROVISIONS OF THIS AGREEMENT FAIL OF THEIR ESSENTIAL PURPOSE. Some jurisdictions do not allow the exclusion or limitation of special, indirect, incidental or consequential damages, so the above limitation or exclusion may not apply to you. THE WARRANTIES SET FORTH HEREIN ARE IN LIEU OF AND TO THE EXCLUSION OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTY AS TO THE MER-

CHANTABILITY OR FITNESS OF THE PRODUCT FOR A PARTICULAR PURPOSE OR AS TO ITS PERFORMANCE. Any statement, description or specication in Companys literature is for the sole purpose of identication of products sold by the Company and imparts no guarantee, warranty or undertaking by Company of any kind. Components and accessories not manufactured by Company are not included in this warranty and may be warranted separately by their respective manufacturers. Some jurisdictions may not permit this disclaimer so the above disclaimer may not apply to you. National Statutory Rights Consumers have legal rights under applicable national legislation governing the sale of consumer goods. Such rights are not aected by the warranties in this Limited Warranty. No Other Warranties No Dabir dealer, agent, or employee is authorized to make any modication, extension, or addition to this warranty. Registration You do not need to register the product for the Limited Warranty to be eective. Miscellaneous This limited warranty shall be governed by and construed in accordance with the laws of State of Illinois, United States of America, as if performed wholly within the state and without giving eect to the principles of conict of law. If any portion hereof is found to be void or unenforceable, the remaining provisions of this limited warranty shall remain in full force and eect. This Limited Warranty constitutes the entire limited warranty extended by Dabir Surfaces, Inc. with respect to Dabir Surface Patent Support System. 30 DOC# R01-0006-00004-AA 13 Contact Information P/N: R01-0006-00004 Revision: AA Print Date: MM/DD/YYYY Manufacturing 7447 West Wilson Ave Harwood Heights, IL 60706 USA Corporate Headquarters Dabir Surfaces, Inc. 24585 Evergreen Road Southeld, MI 48075 USA Tel: +1 (248) 796-0802 Fax: +1 (248) 354-6667 Sales sales@dabir-surfaces.com Technical and Warranty Support support@dabir-surfaces.com Tel: +1 (885) 478-0694 www.dabir-surfaces.com 31 DOC# R01-0006-00004-AA DOC# R01-0006-00004-AA