Dabir Surfaces DabirAIR CA-1001 User manual

Instrucons For Use
CA-9001 (Hose Assembly)
CA-9002 (Power Cord)
CA-1001 (Controller Starter Kit)
DA-101884 (Surgical Overlay)
DA-303584 (MedSurg Bed Overlay)
MC-303584 (MedSurg Bed Overlay-Micro)
Patent Pending DOC# R01-0006-00004-AA

1 Introducon Page #
1.1 Important Before You Start 3
1.2 Safety Warnings 3
1.3 Labels and Descripons 4-6
1.4 About this Manual 7
1.5 Indicaons of Use 7
1.6 Contraindicaons 7
1.7 About the Dabir System 8
1.8 How it Works 8
2 Components of the Dabir Surfaces Overlay System
2.1 Pneumac Controller, Hose Assembly, and Accessories 9
2.2 Overlays 10
3 Seng up the System
3.1 Pneumac Controller Pre-Assembly 11
3.2 System Installaon 12-14
4 Operang the Dabir System 15
5 Seng the Cycle Speed and Firmness Modes
5.1 Seng Cycle Speed 16
5.2 Seng Overlay Firmness 17
6 Interrupng, Rapid Deflate and Resuming Operaon 18
7 Informaon Center: Error Codes and Alarms 19-20
8 Cleaning Procedures 21
9 Roune Maintenance 21
10 Troubleshoong 22
11 Specificaon Sheets 23-28
12 Limited Warranty 29-30
13 Contact Informaon 31
Table of Contents
2
DOC# R01-0006-00004-AA

1.1 Important Before You Start
• Please read enre manual carefully and completely before using.
• As with any device, failure to carefully read and follow all instrucons and safety informaon
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”
Pneumac Controller for cardiac arrest
events. The unit is not intended for use during CPR. (See Secon 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 condions that do not reflect
the recommended cleaning process may result in irreparable
damage.
• Disconnect the Pneumac Controller from the wall power source
prior to cleaning and inspecng.
• Do not immerse or allow liquid to enter any part
of the
Pneumac Controller .
• Keep DabirAIR Micropressure Overlay vent free and clear of liquids,
contaminaon and debris to avoid over inflaon.
• Do not operate the Pneumac Controller in the presence
of flammable liquids or gases.
• Only use the DabirAIR
Pneumac Controller with manufacturer
approved Overlays and Accessories to ensure proper system
funcon.
• The DabirAIR Micropressure and DabirAIR Microclimate
products are OVERLAYS, and are not intended to be used
without an underlying support maress or pad.
• Do not block air intake ports on the boom of the
Pneumac
Controller or the exhaust vent under the handle.
• Do not place Pneumac Controller on top of loose arcles which may
block air intake ports.
• System must be at room temperature prior to operaon. Allow
Pneumac Controller and Overlay to acclimate to room temperature
for one hour prior to operaon.
3
WARNING: No modificaon of this
equipment is allowed.
DOC# R01-0006-00004-AA
• Do not place the Pneumac Controller in direct sunlight.
• The Pneumac Controller must be stored and operated within
designed operang condions specified in this manual.
Operang the Pneumac Controller outside these
ranges may cause damage to the device which could
result in premature failure.
• The Pneumac Controller must be used with specified operang
wall currents. All other alternave power sources
and currents may result in irreparable damage to
the system and possible hazardous event to the
paent or caregiver.
• Equipment may be hazardous if misused.
• Modificaon of the device voids warranty and
may compromise intended funcon. Service should
be performed exclusively by the manufacturer or
manufacturer’s representave.
• If Pneumac Controller is damaged during the shipping process,
please contact the manufacturer for appropriate acon.
• If Pneumac Controller is dropped during use with noceable
damage, please remove from service and contact the manufacturer
for appropriate acon.
• Do not transport or carry the Pneumac Controller with an
Overlay aached.
• 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.
• Turn Dabir System “OFF” during paent transfer and
before paent posioning.
• It is the responsibility of the caregiver to adequately secure and
protect the paent against paent falls.

• Do not place the Pneumac Controller in direct sunlight.
• The Pneumac Controller must be stored and operated within
designed operang condions specified in this manual.
Operang the Pneumac Controller outside these
ranges may cause damage to the device which could
result in premature failure.
• The Pneumac Controller must be used with specified operang
wall currents. All other alternave power sources
and currents may result in irreparable damage to
the system and possible hazardous event to the
paent or caregiver.
• Equipment may be hazardous if misused.
• Modificaon of the device voids warranty and
may compromise intended funcon. Service should
be performed exclusively by the manufacturer or
manufacturer’s representave.
• If Pneumac Controller is damaged during the shipping process,
please contact the manufacturer for appropriate acon.
• If Pneumac Controller is dropped during use with noceable
damage, please remove from service and contact the manufacturer
for appropriate acon.
• Do not transport or carry the Pneumac Controller with an
Overlay aached.
• 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.
• Turn Dabir System “OFF” during paent transfer and
before paent posioning.
• It is the responsibility of the caregiver to adequately secure and
protect the paent against paent falls.
4
1.3 Labels and Descripons
UL Mark
ANSI/AAMI ES60601-1 AMD 1 (2012), "Medical
Electrical Equipment - Part 1:
General Requirements for Basic Safety and
Essenal Performance, Amendment 1.
CAN/CSA-C22.2 No. 60601-1 (2014), "Medical
Electrical Equipment - Part 1:
General Requirements for Basic Safety and
Essenal Performance
Label Descripon Applicaon
Pneumac Controller label
The Symbols below appear on the Pneumac Controller, Overlays, Hose Assembly,
Accessories and/or packaging.
NON
STERILE
Non-Sterile
Indicates a medical device that has not been
subjected to a sterilizaon process. Overlay labels & Overlay Box labels
Instrucons For Use
Cauon
Alerts the reader of a potenally hazardous
situaon which, if not avoided, may result in
minor or moderate injury to the user or
paent or damage to the product or other
property. This includes special care neces-
sary for the safe and effecve use of the
device and the care necessary to avoid
damage to the device that may occur as a
result of use or misuse.
Separate Collecon
Separate collecon for electronic waste
required.
Box labels, Overlay Box labels,
Overlay labels, Pneumac Controller
label, Hose Assembly label
Date of Manufacture
Indicates the date when the medical device
was manufactured.
Box labels, Pneumac Controller
label, Hose Assembly label,
Overlay labels
YYYY-MM-DD
Manufacturer
Indicates the medical device manufacturer.
Box labels & Pneumac
Controller label
UL Badge
Indicates UL compliance on markeng,
adversing, and packaging materials
Pneumac Controller label, Box
labels, Overlay labels, Hose
Assembly label
DOC# R01-0006-00004-AA
NOTE: Provides special informaon to make important instrucons clearer.

XX° C
Temperature Limit
Indicates the temperature limits to which the
medical device can be safely exposed.
Box labels & Pneumac
Controller label
Pneumac Controller label
Defibrillaon-proof Type BF Applied Part
Indicates a defibrillaon-proof type BF
applied part complying with IEC 60601-1.
YYYY-MM-DD
IP20 Protected Against Solid Foreign Objects
Of 12.5mm Ø and greater. Not protected
against liquid ingress.
Pneumac Controller label
%
%
1.3 Labels and Descripons - Connued
Follow instrucons for use
Label Descripon Applicaon
Pneumac Controller label, Box
labels, Overlay labels, Hose
Assembly label
Use-by Date
Indicates the date aer which the medical
device is not to be used.
Keep Dry
Indicates a medical device that needs to be
protected from moisture.
Fragile, Handle With Care
Indicates a medical device that can be broken
or damaged if not handled carefully.
Humidity Limitaon
Indicates the range of humidity to which the
medical device can be safely exposed.
Atmospheric Pressure Limitaon
Indicates the range of atmospheric pressure
to which the medical device can be safely
exposed.
Overlay Box labels & Overlay labels
Box labels
Pneumac Controller Starter Kit
Box label
Box labels
Pneumac Controller label &
Pneumac Controller label
kPA
kPA
This Way Up
Indicates a medical device that can be
broken or damaged if not handled in a
specific orientaon.
Pneumac Controller Starter Kit
Box label
DOC# R01-0006-00004-AA
The Symbols below appear on the Pneumac Controller, Overlays, Hose Assembly,
Accessories and/or packaging.
5
XX° C

6
1.3 Labels and Descripons - Connued
Label Descripon Applicaon
Serial Number
Indicates the manufacturer’s serial
number so that a specific medical device
can be idenfied.
Box labels, Pneumac Controller
label, Serial ID labels, Overlay labels
Box labels, Pneumac Controller
label, Hose Assembly label, Overlay
labels
SN
REF
LOT
Alternang Current
Indicates that the equipment is suitable for
alternang current only.
Catalogue Number
Indicates the manufacturer’s catalogue
number so that the medical device can be
idenfied.
Batch Number
Indicates the manufacturer’s batch code.
Direct Current
Indicates that the equipment is suitable for
direct current only.
“ON” (power)
Indicates connecon to the mains.
“OFF” (power)
Indicates disconnecon to the mains.
Universal Serial Bus
Power Cord Box label
FCC Declaraon of Conformity
Cerfies that the electromagnec interference
from the device is under limits approved by
the Federal Communicaons Commission
Pneumac Controller label,
Controller Starter Kit label
Hose Assembly label
Pneumac Controller label
Pneumac Controller label
Pneumac Controller label
Pneumac Controller label
Non-ionizing Electromagnec Radiaon
Indicates equipment in the medical electri-
cal area that includes RF transmiers.
Instrucons For Use label
DOC# R01-0006-00004-AA
The Symbols below appear on the Pneumac Controller, Overlays, Hose Assembly,
Accessories and/or packaging.

1.4 About this Manual
This manual is your introducon to the Dabir Surfaces Paent Support System. Use it to inially
set-up the DabirAIR Pneumac Controller and Overlay. Keep it as a reference for day-to-day
operaon and as a guide for maintenance.
1.5 Indicaons of Use
The Dabir Surface Paent Support System is indicated for:
• Assisng in reducing pressure ulcer development when combined with a
comprehensive pressure ulcer prevenon plan.
• Reducing paent risk by minimizing impact of industry accepted causes of
pressure ulcer formaon.
• Use with paents weighing 50 to 400 lbs.
1.6 Contraindicaons
• Do not use the Dabir Surfaces Paent Support Systems for paents with
unstable spinal fractures.
7
DOC# R01-0006-00004-AA

1.7 About the Dabir System
The Dabir Surfaces Paent Support System is a low-profile, disposable, alternang pressure relief
system with oponal microclimate feature.
The system consists of:
• DabirAIR Pneumac Control Unit
- Easy Power Acvaon
- Smart Interconnect System
- Start/Stop Touch Operaon
- Variable Cycle Speed Sengs
- Variable Firmness Sengs
• DabirAIR Micropressure Overlay
- Mul-Paent Use/Semi-Disposable
- Alternang Nodal Support
- Reduced Skin Shear
- Easy Wipe-Down Cleaning
- Covers with Standard Sheets
• DabirAIR Microclimate Overlay
- Mul-Paent Use/Semi-Disposable
- Alternang 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 supporng a person on small, closely spaced areas of
contact (Comfort Nodes) that dynamically alternate in height to relieve at-risk ssue against pressure ulcer
formaon. The aim is to preserve the circulatory components of arterial, venous and lymphac blood flow
in between these areas of contact.
Skin Shear
By shortening the distance between areas in contact, skin stretch during alternang support and immersion
is reduced, thereby decreasing the risk of skin shear.
Pressure
The DabirAIR Micropressure Overlays achieve alternang support and relief ulizing
independent rows of small comfort nodes that are intended to promote intersal blood flow between
areas of contact.
Temperature & Moisture
DabirAIR Microclimate Overlays provide Low-Air-Loss connuous airflow to remove excess heat and
moisture from the paent’s skin in areas of support.
Low Medium High
CYCLESPEED
Low Medium High
FIRMNESS
8
DOC# R01-0006-00004-AA

2.1 Pneumac Controller, Hose Assembly and Accessories
DabirAIR Pneumac Control Unit
Low Medium High
CYCLE SPEED
Low Medium High
FIRMNESS
DabirAIR Accessories
9
DabirAIR Hose Assembly
Handle
User
Interface
Low Medium High
CYCLE SPEED
Low Medium High
FIRMNESS
Information
Center
Hose Assembly
Connector (Female)
Overlay Assembly
Connector (Male)
Power Cord
Hose Assembly
Connector (Male)
Hose Assembly
Connector (Male)
DOC# R01-0006-00004-AA

2.2 Overlays
DabirAIR Micropressure Overlays
DabirAIR Microclimate Overlays
10
Overlay Assembly
Connector (Male)
Overlay Assembly
Connector (Male)
DOC# R01-0006-00004-AA
Micropressure
Overlay vent
located here
CAUTION: Keep Micropressure
Overlay vent free and clear of liquids,
contaminaon and debris to avoid
over inflaon.