Dräger Area User manual

Area Control Unit
For central gas supply systems
Supplement
WARNING
To ensure the proper assembly of this medical device,
read and comply with the corresponding assembly
instructions and this supplement. To ensure the
proper use of this medical device, read and comply
with the corresponding instructions for use and this
supplement.
Area Control Unit

2 Supplement | Area Control Unit
This page has been left blank intentionally.

Supplement | Area Control Unit 3
Contents
Area Control UnitFor centra l gas supply syst ems
Contents
1Supplement to the instructions for use and to the assembly
instructions .............................................................................................. 5
2Information about this document ........................................................... 6
2.1 Typographical conventions ............................................................. 6
2.2 Illustrations...................................................................................... 6
2.3 Trademarks..................................................................................... 6
3Safety-related information....................................................................... 8
3.1 Intended use ................................................................................... 8
3.2 Environment of use......................................................................... 8
3.3 User group requirements ................................................................8
3.4 Information on safety instructions and precautionary statements... 9
3.5 Safety instructions .......................................................................... 9
4Overview ................................................................................................... 11
4.1 Area control unit with digital display................................................ 11
4.2 External view of the area control unit with digital display................ 12
4.3 Layout of an area control unit with digital display ........................... 13
4.4 Abbreviations .................................................................................. 14
4.5 Symbols .......................................................................................... 14
5Operating concept.................................................................................... 15
5.1 Digital display.................................................................................. 15
5.2 Display elements ............................................................................ 15
5.3 Display status ................................................................................. 15
6Operation .................................................................................................. 17
6.1 Alarms............................................................................................. 17
7Reprocessing............................................................................................ 19
7.1 Safety information........................................................................... 19
7.2 Information on reprocessing ........................................................... 19
7.3 Classifications for reprocessing ...................................................... 19
7.4 Validated reprocessing procedures ................................................ 20
7.5 Other agents and reprocessing procedures ................................... 21
8Disposal .................................................................................................... 23
8.1 Disposing of the product ................................................................. 23
9Technical data .......................................................................................... 24
9.1 Ambient conditions ......................................................................... 24
9.2 Electronic operating specifications ................................................. 24
9.3 Measurement displays.................................................................... 25
9.4 Classification................................................................................... 25
9.5 EMC declaration ............................................................................. 25

4 Supplement | Area Control Unit
Contents
10 Final assembly.......................................................................................... 27
10.1 Safety information........................................................................... 27
10.2 Layout of the live electrical components......................................... 27
10.3 Cabling work ................................................................................... 32
10.4 Mounting the warning sign on the partition plate ............................ 34
11 Acceptance and handover....................................................................... 35
12 Order list ................................................................................................... 36
13 Password .................................................................................................. 37
13.1 User password for Area Control Unit .............................................. 37
13.2 Information on the user password .................................................. 37

Supplement | Area Control Unit 5
Supplement to the instructions for use and to the assembly instructions
1 Supplement to the instructions for use and to
the assembly instructions
WARNING
►To ensure the proper assembly of this medical device, read and comply with the
corresponding assembly instructions and this supplement. To ensure the proper
use of this medical device, read and comply with the corresponding instructions
for use and this supplement.
Add this supplement to the instructions for use and the assembly instructions of
the device.
This supplement is an update to the information contained in the following chapters
of the instructions for use and the assembly instructions.
Instructions for use Part number Edition
Area Control Unit 9038611 1 – 2005-01 and higher
Assembly instructions Part number Edition
Area Control Unit 9038612 1 – 2005-01 and higher

6 Supplement | Area Control Unit
Information about this document
2 Information about this document
2.1 Typographical conventions
2.2 Illustrations
Illustrations of products and screen content in this document may differ from the
actual products depending on configuration and design.
2.3 Trademarks
2.3.1 Trademarks owned by Dräger
The following web page provides a list of the countries in which the trademarks are
registered: www.draeger.com/trademarks
Text Texts in bold or italic script indicate screen texts. Bold, italicized text indi-
cates texts that are displayed on the screen.
1. Numbers with a period indicate the individual steps within a process
sequence. The numbering for each new process sequence starts once
more at number 1.
a. Lower-case letters with a period indicate secondary process steps. The let-
tering for each new higher-level process step starts once more with the let-
ter a.
●This bullet point identifies individual process steps without a specific
sequence.
►In safety instructions and warning notices, this triangle indicates ways to
avoid the hazard.
(1) Numbers in parentheses refer to elements in illustrations.
1Numbers in illustrations denote elements referred to in the text.
– Dashes indicate listings.
> The greater-than symbol indicates the navigation path in a dialog.
This symbol indicates information that will facilitate the use of the product.
This arrow indicates the result of a process step.
✓This check mark indicates the result of a sequence of process steps.
Trademark
VoluCount®

Supplement | Area Control Unit 7
Information about this document
2.3.2 Trademarks owned by third-party manufacturers
Trademark Trademark owner
Dismozon®BODE Chemie
acryl-des®
Schülke & Mayr
Mikrozid®
Perform®
Actichlor®
Ecolab USA
Incidin®
Oxycide®
BruTab 6S®Brulin
Dispatch®Clorox
Klorsept®Medentech
Descogen®
Antiseptica
Oxygenon®
SteriMax®Aseptix
Cleanisept®Dr. Schumacher

8 Supplement | Area Control Unit
Safety-related information
3 Safety-related information
3.1 Intended use
The distribution system for medical gases and vacuum (Medical Distribution
System) is used for distributing and monitoring gases and vacuum for medical
applications.
3.1.1 Component description
As a component of the distribution system for medical gases and vacuum, the area
control unit is used for the continuous monitoring of pressures and volume flows of
medical gases and vacuum.
3.2 Environment of use
Do not operate the area control unit in an environment that is subject to explosion
hazard.
Set up the area control units indoors only.
3.3 User group requirements
The term "user group" describes the personnel responsible who have been
assigned by the operating organization to perform a particular task on a product.
3.3.1 Duties of the operating organization
The operating organization must ensure the following:
– Every user group has the required qualifications (e.g., has undergone specialist
training or acquired specialist knowledge through experience).
– Every user group has been trained to perform the task.
– Every user group has read and understood the relevant chapters in this
document.
3.3.2 User groups
Clinical users
This user group operates the product in accordance with the intended use.
Users have medical specialist knowledge in the application of the product.
Reprocessing personnel
This user group carries out the necessary activities to reprocess the product.
Reprocessing personnel has specialist knowledge in the reprocessing of medical
devices.
Service personnel
This user group installs the product and performs the service activities.
Service personnel has specialist knowledge in electrical and mechanical
engineering and experience in the servicing of medical devices.

Supplement | Area Control Unit 9
Safety-related information
Where product specific knowledge or tools are required, the service activities must
be performed by specialized service personnel. The specialized service personnel
was trained by Dräger for these service activities on this product.
3.4 Information on safety instructions and precautionary
statements
Safety instructions and precautionary statements warn of risks and give instructions
for the safe use of the product. Failure to observe them may lead to personal injury
or property damage.
3.4.1 Safety instructions
This document contains sections with safety instructions which warn of risks. The
type of risk and the consequences of non-compliance are described in each safety
instruction.
3.4.2 Precautionary statements
Precautionary statements relate to action steps and warn of risks that may arise
when performing the action steps. Precautionary statements precede the action
steps.
The following warning signs and signal words indicate precautionary statements
and differentiate the possible consequences of non-compliance.
3.5 Safety instructions
3.5.1 Assembly instructions
Non-compliance with the installation instructions in this supplement and the
corresponding assembly instructions may lead to personal injury and property
damage.
►Observe all information specified in the assembly instructions.
►Keep the assembly instructions accessible to personnel working with and on the
equipment.
►Observe the assembly instructions of all products which are used in combination
with this product.
►All information on the assembly and disassembly of the product provided in the
assembly instructions must be observed for the correct installation of the
product.
►This product must only be used in accordance with the intended use stated in
the instructions for use.
►During installation or service, the product must be disconnected from the power
supply.
Warning sign Signal word Consequences of non-compliance
WARNING May result in death or serious injury.
CAUTION May result in moderate or minor injury.
NOTICE May result in property damage.

10 Supplement | Area Control Unit
Safety-related information
3.5.2 Instructions for use
Non-compliance with the information given in this supplement and the
corresponding instructions for use may lead to personal injury and property
damage.
►Observe the instructions for use.
►This product must only be used in accordance with its intended use.
►Keep the instructions for use accessible to personnel working with and on the
equipment.
►Observe the instructions for use of all products which are used in combination
with this product.
The instructions for use do not contain any information on the following topics:
– Risks that are obvious to users
– Consequences of obvious improper use of the product
– Potential adverse effects on patients with one or several medical conditions
3.5.3 Electromagnetic compatibility (EMC)
Electrostatic discharge
When handling components carrying the ESD warning symbol, observe the
required protective measures against electrostatic discharges. Failure to observe
these may lead to malfunction and put the patient at risk.
To prevent malfunctions, observe the following measures and train the relevant
personnel:
►Observe the ESD protective measures, for example:
– Wear antistatic clothing and shoes.
– Use electrically insulating and antistatic gloves.
– Touch a potential equalization pin when connecting the equipment.

Supplement | Area Control Unit 11
Overview
4 Overview
4.1 Area control unit with digital display
By default, the area control unit is delivered with a display unit (pressure gauge and
LEDs). The display unit is supplemented by a digital display. The digital display is
integrated into the door and equipped with a door opening alarm.
The following information is displayed on the backlit color touchscreen of the digital
display.
– The numerical values of the current pressures of all monitored gases
– The visualization of pressure alarms
– The numerical values of the current volume flows of all monitored gases
Display options for the monitored gases
–AIR, additional supply circuits if required (AIR (1), AIR (2), AIR (3))
–AIR800
–O2additional supply circuits if required (O2(1), O2(2), O2(3))
–CO2
–N2O
–N2O+O2(mixture of nitrous oxide and oxygen)
–VAC

12 Supplement | Area Control Unit
Overview
4.2 External view of the area control unit with digital
display
49722
No. Designation
1Display unit (pressure gauge, gas type, alarms)
2Digital display
3Emergency access button
32
1

Supplement | Area Control Unit 13
Overview
4.3 Layout of an area control unit with digital display
Illustration (example)
47547
No. Designation
1Interfaces to the Dräger Alarm Management System (Alarm System Inter-
face)
2Volume flow measurement (VoluCount)
3Interface to an external monitoring system (relay modules for dry contacts)
4Transmission of door opening alarms to the Dräger Alarm Management Sys-
tem (Analog Input Module)
5Power supply unit, 230 V AC, 24 V DC, 0.5 A for door opening alarm
6Power supply unit, 230 V AC, 12 V DC, 1.5 A
7Terminal blocks
17
3
6
2
4 5

14 Supplement | Area Control Unit
Overview
4.4 Abbreviations
4.5 Symbols
Abbreviation Explanation
Air (800, Instr.) Compressed air for operating surgical tools
Air (Medical) Medical compressed air
CO2Carbon dioxide
GMDN Global Medical Device Nomenclature
Global Medical Device Nomenclature
LON Local Operating Network
N2O Nitrous oxide
O2Oxygen
UMDNS Universal Medical Device Nomenclature System
Nomenclature for medical devices
VAC Vacuum
Symbol Explanation
Observe the instructions for use
Manufacturer
Date of manufacture
Part number
WEEE marking
AC voltage
Connection to protective grounding
ESD label, follow the information on electromagnetic compati-
bility.
Dangerous voltage
Configuration, system settings
Door opening alarm muted
Door opening alarm enabled
Door open alarm triggered

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Operating concept
5 Operating concept
5.1 Digital display
This section describes the display elements and the respective status during
operation and in the event of an alarm.
5.2 Display elements
During operation, the digital display of the area control unit shows the following
information for all monitored gases.
5.3 Display status
5.3.1 Displayed values
The current pressure values displayed on the pressure gauge and the lights for
the operating status always have priority over the information shown on the digital
display.
The displayed values are the current measured values and are displayed in
different colors.
50280
No. Explanation
1Gas type
2Operating pressure of the corresponding type of gas
3Volume flow rate of the corresponding type of gas
4Configuration control element (only for DrägerService)
5Operating status display element
6Door opening alarm control and display element
2
5
1
3
64
Status: OK

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Operating concept
Cumulated measured values of the volume flow are displayed on the VoluCount
display unit.
5.3.2 Status bar
The status bar provides information on the general status and the status of the door
opening alarm. Furthermore, specialized service personnel can use the symbol
to configure the area control unit.
5.3.2.1 Symbols
Touching the buttons will open the corresponding dialogs and allow functions to be
enabled.
5.3.2.2 Status display
The status display shows the operating status of the area control unit.
Color Symbol Explanation
Blue The measured pressure is within the tolerance.
Red
Flashing
The measured pressure is above the tolerance
>20 % for medical gases and
>–0.34 bar for vacuum.
Red
Flashing
The measured pressure is below the tolerance
<20 % for medical gases and
<–0.34 bar for vacuum.
Gray No measuring device for monitoring the volume flow of the
relevant gas is installed.
Blue The digital display is not receiving any valid data.
---
---
50361
Status: OK
Symbol Explanation
Configuration menu
Door opening alarm muted
Door opening alarm enabled
Door open alarm triggered
Operating status Explanation
Status: OK No active alarms.
Status: Alarm There is at least one active alarm.
Status: COM error The digital display is not receiving any valid data.

Supplement | Area Control Unit 17
Operation
6 Operation
WARNING
Risk if assembly is not performed properly
An improperly mounted device may compromise the safety of patient care and
endanger the user. Before the device is handed over to the operator, the proper
functioning of the system must be proven by the acceptance test. This verifies
compliance with national regulations.
►The equipment must be approved before commissioning the system and after
installing the components.
►If the test fails, the medical devices must not be put into service.
6.1 Alarms
6.1.1 Door opening alarm
When the door is opened or unlocked, the integrated door contact triggers the door
opening alarm. The alarm comprises a visual and an audible alarm signal.
When the area control unit is connected to an external monitoring system or the
Dräger Alarm Management System, the alarm signals of the door opening alarm
are transmitted to that system.
Display
The door opening alarm has the following display notifications:
Muting the door opening alarm
When it becomes necessary to open the door for operational purposes, the door
opening alarm can be temporarily muted. The alarm silence function will disable the
acoustic alarm signals and the transmission of the alarm.
1. Touch the button .
2. Enter the user password. For further information see: "Password", page 37.
3. Confirm the information on the screen.
✓The door opening alarm is muted.
The alarm can also be muted when the door is already opened.
In case of an active pressure alarm, the acoustic alarm signal of the door
opening alarm is automatically disabled.
Symbol Explanation
Door opening alarm muted
Door opening alarm enabled
Flashing
Door open alarm triggered

18 Supplement | Area Control Unit
Operation
Enabling the door opening alarm
60 seconds after closing the door, the door opening alarm will be enabled
automatically. Alternatively, it can be enabled manually as described below.
1. Touch the button .
2. Enter the user password. For further information see: "User password for Area
Control Unit", page 37.
3. Confirm the information on the screen.
✓The door opening alarm is enabled.

Supplement | Area Control Unit 19
Reprocessing
7 Reprocessing
7.1 Safety information
WARNING
Risk due to inappropriately reprocessed products
Reusable products must be reprocessed, otherwise there is an increased risk of
infection.
►Follow the infection prevention policies and reprocessing regulations of the
health-care facility.
►Follow the national infection prevention policies and reprocessing regulations.
►Use validated procedures for reprocessing.
►Reprocess products before using them the first time.
►Follow the manufacturer's instructions for cleaning agents, disinfectants, and
reprocessing devices.
►The reprocessing instructions in this chapter are available to the reprocessing
personnel.
►Reprocessing must be carried out exclusively by the defined user groups.
WARNING
Risk due to penetrating liquid
Penetrating liquid may cause the following:
– Damage to the device
– Device malfunctions
►Ensure that no liquid penetrates the device.
►Use validated procedures for reprocessing.
7.2 Information on reprocessing
Follow the national infection prevention policies and reprocessing regulations.
Follow the infection prevention policies and reprocessing regulations of the health-
care facility (e.g., concerning the reprocessing cycles).
7.3 Classifications for reprocessing
7.3.1 Classification of medical devices
The classification depends on the intended use of the medical device. The risk of
infection transmission through the application of the product to the patient without
proper reprocessing is the basis of the Spaulding classification.
Classification Explanation
Non-critical Components that come into contact only with skin that is
intact
Semi-critical Components that carry breathing gas or come into contact
with mucous membranes or pathologically altered skin
Critical Components that penetrate skin or mucous membranes or
come into contact with blood

20 Supplement | Area Control Unit
Reprocessing
7.3.2 Classification of device-specific components
The following classification is a recommendation from Dräger.
Non-critical
–Surface
7.4 Validated reprocessing procedures
7.4.1 Overview of the reprocessing procedures of the components
7.4.2 Surface disinfection with cleaning
Components:
–Surfaces
Prerequisites:
– The surface disinfectant has been prepared in accordance with the
manufacturer's instructions.
– The manufacturer's instructions, e.g., regarding shelf life or application
conditions, are observed.
– An uncontaminated, lint-free cloth soaked in surface disinfectant is used for the
cleaning surface disinfection.
Cleaning
1. Wipe off obvious soiling with a disposable cloth soaked in surface disinfectant.
Dispose of the cloth.
2. Wipe all surfaces. After that, there must no longer be any soiling visible.
Surface disinfection
3. Wipe cleaned surfaces again to visibly wet all surfaces to be disinfected with
surface disinfectant.
4. Wait for the surface disinfectant contact time.
5. At the end of the contact time, moisten a new, uncontaminated and lint-free cloth
with water (at least drinking water quality).
6. Wipe all surfaces until no remains of the surface disinfectant, such as foam
residues or streaks, are visible.
7. Wait until the surfaces are dry.
8. Check the surfaces for visible damage and, if necessary, replace the product.
Components Surface disinfection
with cleaning
Description of the procedure
Surface Yes (see "Surface disinfection with
cleaning", page 20)
Surface disinfec-
tant
Manufacturer Concentration Contact time
Dismozon plus BODE Chemie 1.6 % 15 min
Oxycide Ecolab USA 2.3 % 5 min