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Infinity Centralstation Wide vg30

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0% found this document useful (0 votes)
19 views62 pages

Infinity Centralstation Wide vg30

Uploaded by

Pedro Marquez
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Supplement

Infinity CentralStation Wide

WARNING Infinity CentralStation Wide


For a full understanding of the
performance characteristics of this VG3.0
device, the user should carefully read
this supplement and the related
instructions for use before use of the
device.
Supplement for Infinity CentralStation Wide

Contents

Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Supplement overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

For your safety and that of your patients. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8


Mandatory reporting of adverse events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
General safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Functional safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Security recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Connections to IT networks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Information about connecting to an IT network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Device symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Infinity CentralStation reboot or restart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Default minimum alarm volume when an M300/M300+ is offline . . . . . . . . . . . . . . . . . . . . . . . 16
Alarm tones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Telemetry defaults > Alarms > Device settings page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Optical alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Report handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Trends/Data > Trends graph and Trends table pages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
System setup > Recorders/Reports page. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Previewing reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Adding the hospital name to report headers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Adding a logo to report headers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Specifying the output destination for reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
System setup > Scheduled reports page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Configuring printers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Parameter order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Main screen layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34


Password protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Customized viewport layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Main screen bottom channel access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Parameter box alarming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Moving an M300/M300+ patient from one room (viewport) to a different room (viewport) . . . . 39

Supplement – Infinity CentralStation Wide – VG3.0 3


Supplement for Infinity CentralStation Wide

VentCentral Setup screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

ECG Calipers tool. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41


Calipers - Measure page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
ICS speakers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
ICS battery indicator icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Canvys touchscreen and widescreen displays. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Mouse movement with dual-display configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Gen 4 Central Processing Unit (CPU) Upgrade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
RAID disk error message (CPU Gen 4 only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Additional language support. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Corrections to the IFU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Information on reprocessing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Classifications for reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Reprocessing list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Reprocessing procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

4 Supplement – Infinity CentralStation Wide – VG3.0


Supplement for Infinity CentralStation Wide

Trademarks

– Infinity®
is a trademark of Dräger.
– Masimo®
is a trademark of Masimo corporation.
– Nellcor®
is a trademark of a Medtronic company.
– Dismozon®
is a trademark of BODE Chemie.
– Buraton®
– Perform®
– Mikrozid®
– acryl-des®
are trademarks of Schülke & Mayr.
– Actichlor®
is a trademark of Ecolab.
– Oxycide®
is a trademark of Ecolab USA.
– BruTab 6S®
is a trademark of Brulin.
– Descogen®
is a trademark of Antiseptica.
– Klorsept®
is a trademark of Medentech.
– Virkon®
is a trademark of DuPont.
– Dispatch®
is a trademark of Clorox.

Supplement – Infinity CentralStation Wide – VG3.0 5


Supplement for Infinity CentralStation Wide

Abbreviations

In the Instructions for use Infinity CentralStation Wide SW VG1.n and Infinity M300, the following
information is added to the section “Abbreviations”:
For any abbreviations of parameters originating from source monitors, see the corresponding instruc-
tions for use.

6 Supplement – Infinity CentralStation Wide – VG3.0


Supplement for Infinity CentralStation Wide

Supplement overview

This supplement contains the instructions for use for Infinity CentralStation Wide VG3.0. Combine this
supplement with the Instructions for use Infinity CentralStation Wide SW VG1.n and Infinity M300 to form
the complete set of instructions for use.
Infinity CentralStation (ICS) VG3.0 includes the following enhancements:
– Mandatory reporting of adverse events
– Infinity CentralStation reboot or restart
– Alarms
– Default minimum alarm volume when an M300/M300+ is offline
– Selecting alarm tone patterns
– Report handling
– Graphical and Tabular trend reports
– Previewing reports
– Adding the hospital name to report headers
– Adding a logo to report headers
– Specifying the output destination for reports (for printing and exporting)
– Scheduled reports
– Selecting patients for scheduled reports
– Configuring printers
– VentCentral Setup screen (default ventilator parameter settings)
– Hardware
– ICS speakers (external USB speaker support)
– ICS battery indicator icon
– Canvys touchscreen and widescreen displays (HDMI capable display)
– Mouse movement with dual-display configurations
– Gen 4 CPU upgrade
– Additional language support
For a list of open-source software (OSS) and the respective licenses, see Open Source License
Agreement at:
[Link]

Supplement – Infinity CentralStation Wide – VG3.0 7


Supplement for Infinity CentralStation Wide

For your safety and that of your patients

Mandatory reporting of adverse events

Serious adverse events with this product must be reported to Dräger and the responsible authorities.

General safety information

The following WARNING, CAUTION, and NOTE statements apply to general operation of the medical
device.
See the Instructions for use Infinity CentralStation Wide SW VG1.n and Infinity M300 for additional safety
information.

WARNING
Risk exists that waveforms and parameter boxes are disassociated during Main Screen Layout.
User may be unaware of disassociating a waveform from a parameter box during Main Screen
Layout.
User can choose a default list of waveforms and parameter boxes that are associated.

WARNING
Risk of incorrect use.
Instructions for use must be kept accessible for the user.

WARNING
Dräger recommends using the ICS only as a remote monitoring device, and the bedside monitor
for primary diagnosis.

WARNING
Any modification of this device or use other than that specified within this document may cause
interference with other equipment or result in injury to the patient or user, including electric
shock, burns, or death.

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Supplement for Infinity CentralStation Wide

WARNING
Risk of patient removal from the Main screen.
Changing settings on the Main Screen Layout dialog could remove previously assigned beds.
A confirmation popup informs the user that the layout of at least one bed that is currently
assigned to the Main Screen has been changed.

CAUTION
The Infinity CentralStation (ICS) does not have virus protection software and therefore relies on the
firewall of your institution to prevent access to infected files. While setting up IT applications to access
web sites, evaluate each web site with regard to possible virus infection.
Dräger recommends that users implement a firewall and install antivirus software to protect their devices
from potential cybersecurity threats.

CAUTION
Risk of user misinterpreting patient information.
User may be unaware that alarms for arterial systolic and diastolic invasive pressures are disabled while
in ECMO (Extracorporeal membrane oxygenation) mode.
See the source device instructions for use, for details regarding device-specific modes related to alarms.

NOTE
User misinterprets the meaning of a label.
The meaning of the label may be unclear.
See the source device instructions for use, for any abbreviations of parameters originating from the
source device.

NOTE
User may misinterpret patient status.
The Bedview waveform and parameter box layout always follows the source bedside monitor and may
differ from the Main Screen layout when a Parameter order template is in use.

Functional safety

The essential performance of a patient monitor is to provide a clinician with meaningful parameter values
and alarm annunciation when the established parameter limits have been exceeded, or the ability to
provide values is compromised. Risks associated with use of the monitor in light of these essential
performance functions have been evaluated and mitigations implemented so that the residual risk is as
low as reasonably practicable, provided routine maintenance and service recommendations are followed
throughout the life of the product.

Supplement – Infinity CentralStation Wide – VG3.0 9


Supplement for Infinity CentralStation Wide

Security recommendations

Dräger makes the following security recommendations:


– Physical security of the patient monitors is recommended and is the responsibility of the operating
organization.
– Physical security of the telecommunications closet is recommended and is the responsibility of the
operating organization.
– Dräger recommends that operating organizations restrict physical access to unused ethernet ports on
the ICS.
– Dräger recommends that operating organizations restrict physical access to unused USB and serial
ports on the ICS.
– Dräger relies on the medical device isolation mechanism of the VLANs and the proper configuration,
implementation, and use of the operating organization's security measures to prevent the introduction
of malware onto the Infinity network.

10 Supplement – Infinity CentralStation Wide – VG3.0


Supplement for Infinity CentralStation Wide

Connections to IT networks

In an IT network, data can be exchanged by means of wired or wireless technologies. An IT network can
be any data interface (e.g., RS232, LAN, USB, printer interface) that is described in standards and
conventions.
During operation, this device can exchange information with other devices by means of IT networks and
supports the following functions:
– Display of waveforms and parameter data
– Signaling of alarms
– Recording, storing, and printing
– Remote control (e.g., alarm management)
– Bed view by remote access
– Access to saved patient data
– Transfer of device settings and patient data
Connecting this device to a network that incorporates other devices or making subsequent changes to that
network can lead to new risks for patients, users, and third parties. Before the device is connected to the
network or the network is changed, these risks must be identified, analyzed, and evaluated, and
appropriate measures taken.
Examples of subsequent changes to the network:
– Changing the network configuration
– Removing devices from the network
– Adding new devices to the network
– Performing upgrades or updates on devices that are connected to the network

Information about connecting to an IT network

Prerequisites

This device may be connected to the network by service personnel. The IT representative of the
hospital must be consulted in advance.
The following documents must be observed:
– Accompanying documents of this device
– Descriptions of the network

Supplement – Infinity CentralStation Wide – VG3.0 11


Supplement for Infinity CentralStation Wide

– Description of the network-based alarm systems


Dräger recommends complying with IEC 80001-1 (risk management for IT networks with medical
devices).

LAN networks

– LAN networks are usually configured in a star topology. Individual devices can be combined into
groups by means of layer-n-switches. Other data traffic is decoupled by means of separate VLAN
networks. Configure the network settings of the device in accordance with these instructions for
use and the network specifications.
– Specifications for LAN connections are described in the following standards:
Wired networks: IEEE˽802.3
Wireless networks: IEEE˽802.11 (b, g, n)
– If the device is used with a layer-2-switch or a layer-3-switch, the port settings must be configured
on the network switch. Before the device is shipped, Dräger can configure the network settings of
the device so that they are compatible with the specifications of the operating organization.
– This device exchanges data with other medical devices over the LAN network. The network must
support the following transmissions and protocols:
– TCP/IP
– Unicast (static or dynamic addressing with the ARP or RARP network protocols)
– Multicast
– Broadcast
– IGMP (version 2)

This device can join or leave an IP multicast group by using the IGMP network protocol.

VLAN networks

If data is being exchanged within a single physical network and a clinical information system is used, an
independent VLAN network must be set up for the clinical information system. Additionally, at least one of
the following independent VLAN networks must be set up:
– Network for medical devices for intra-hospital use
– Network for portable patient monitors

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Consequences of using an unsuitable network

If the network does not meet the requirements, hazardous situations can result. The following situations
can occur with this device:
– Due to unsafe distributed alarm system:
– Alarms are not transmitted.
– Alarms or data are delayed.
– False alarms are indicated.
– During an interruption of the network connection:
– Alarms are not transmitted.
– Suppressed alarms or alarm tones are not reactivated, but remain suppressed.
– Without firewall and antivirus software:
– Data are not protected.
– Device settings are changed.
– The device generates false alarms or no alarms.
– Data are sent incomplete, sent to the wrong device, or not sent at all.
– Patient data are intercepted, falsified, or damaged.
– Data have incorrect time stamps.
– An overload of the device due to very high network loads (e.g., caused by denial-of-service attacks)
can lead to deactivation of the interface. The interface will only be available again after the device has
been restarted. In rare cases, a warm boot may take place and may occur repeatedly.

Requirements for the electrical characteristics of connected devices and networks

The LAN interfaces and the serial interfaces are only suitable for the connection of devices or networks
that have a rated voltage of at most 24 V DC on the network side and that meet the requirements of one
of the following standards:
– IEC 60950-1: Ungrounded SELV circuits
– IEC 60601-1 (as of 2nd edition): Touchable secondary circuits

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Supplement for Infinity CentralStation Wide

Device symbols

The following table lists additional Dräger hardware device symbols.

Symbol Description
Not made with natural rubber latex

Not made with natural


rubber latex

Eurasian conformity mark

Unique Device Identifier, barcode

China RoHS mark

Acceptable storage temperatures

Acceptable humidity range

Acceptable atmospheric pressure range

Lot/batch number

Safety certification mark

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Infinity CentralStation reboot or restart

When the ICS must be rebooted or restarted, Dräger recommends that patients connected to monitors
are to be supervised by clinical personnel during the reboot or restart process.

NOTE
A restart will automatically close and reopen only the Infinity CentralStation application. A reboot, or
manual power cycling, will power cycle the Infinity CentralStation computer and restart all applications
and processes.

The ICS is the primary monitoring device for the M300/M300+. If M300/M300+ monitoring devices are
monitored on only one ICS, they will not be actively monitored during a reboot or restart. When monitoring
devices are offline, the ICS cannot capture full-disclosure data. This results in data gaps. While offline,
monitoring devices continue to capture trends in their local database. If a reboot or restart is necessary,
Dräger recommends moving all monitoring devices to a secondary ICS temporarily to ensure continued
patient monitoring during the downtime. Once the original ICS is back online:
– The ICS automatically resumes patient monitoring and backfills trends saved in the local database of
all monitoring devices.
– The M300/M300+ devices can be safely moved back to the original ICS to continue monitoring. When
moving M300/M300+ devices back to the original ICS, a Question dialog appears to confirm the move.
Once confirmed, the devices are moved back to the original ICS and removed from the secondary one.
Restarting the ICS application, instead of rebooting or manually power cycling the ICS computer, is a
much faster method and thus recommended.
To restart the ICS application:
1 Select System setup from the Main screen menu bar.
2 Select the Biomed tab.
3 Enter the password, and click OK.
4 Select the System console tab.
5 Type restartcentral in the console window, and press Enter.

NOTE
Rebooting or manually power cycling the ICS computer should be considered a final course of action.

Supplement – Infinity CentralStation Wide – VG3.0 15


Supplement for Infinity CentralStation Wide

Alarms

Default minimum alarm volume when an M300/M300+ is offline

On the Telemetry defaults > Alarms > Device settings tab, the Minimum selectable alarm volume if
offline [%] selection settings are 10, 20, 30, 40, 50 (default), 60, 70, 80, 90, or 100. The factory default is
50%.

Alarm tones

Alarm tones (IEC fast and IEC slow) can be set to use either cardiac-type sound (default) or ventilation-
type sound.

Telemetry defaults > Alarms > Device settings page

Users select ICS alarm tone patterns individually by alarm grade (low, medium, and high). Alarms for a
given alarm grade sound at the ICS using the selected alarm tone pattern. Select alarm tone patterns
using the Alarm pattern option on the System setup > Alarms page. Available alarm tone pattern
selections for non-telemetry beds include:
– Infinity
– IEC fast Cardiac (default)
– IEC slow Cardiac
– IEC fast Other
– IEC slow Other
Use the Telemetry defaults > Alarms > Device settings page to select M300/M300+ alarm tone
patterns. Available M300/M300+ alarm tone pattern selections include:
– Infinity
– IEC fast
– IEC slow

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Optical alarms

Message banners for optical alarm signals can be read by the user from distances of up to 1 meter
(approximately 3.3 feet) from the Infinity CentralStation display. Flashing parameter field signals are
intended to be recognized by the user from distances of up to 4 meters (approximately 13 feet).
Alarm functionality should be verified by generating a high-priority, medium-priority, and low-priority alarm
condition and confirming optical alarm signals and acoustic alarm signals at the Infinity CentralStation.

Configuring the alarm settings of the patient

The following settings can be accessed from the BedView Alarms > Device settings page:
– For patient monitors:
– Volume for external device alarm
– For M300/M300+ telemetry:
– Volume for M300/M300+ speaker alarm
– Selectable for M300/M300+ VGn only:
- Priority for SpO2 sensor off alarm
- Priority for ECG leads off alarm
- Priority for critical battery alarm

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Supplement for Infinity CentralStation Wide

Alarm volume range

Alarm priority level Minimum alarm volume Maximum alarm volume


High 39 – 55 dB 64 – 81 dB
Medium 42 – 52 dB 67 – 79 dB
Low 41 – 54 dB 65 – 79 dB

System setup > Alarms page

Selection Settings Description


External device On, Off (default) The ICS can be configured to annunciate
alarm audio acoustic alarm signals from external devices.
The alarm message from an external device
always appears on the main screen.
ICS speakers Go to System setup > Indicates the type of speaker selected — USB
Alarms. One of the following or Analog and if the internal speaker is on or
settings is displayed: off.
– USB
– Internal speaker on or
Internal speaker off
– Analog

Note: This field is read only.


Speaker selection is done at
installation and may be
changed by contacting
DrägerService.

Visual surveillance alarm signals

CAUTION
With a Delta/DeltaXL patient monitor, if a low-priority alarm occurs while a medium or high-priority alarm
is audio paused (silenced), the surveillance alarm message and banner are temporarily removed until
the audio pause times out.

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Report handling

Trends/Data > Trends graph and Trends table pages

The Trends/Data dialog window lets users generate and print patient trend reports in either a graphical
trend format or a tabular trend format. Users can generate the following trend reports containing all
parameters in the current report setup for a patient:
– A Graphical trend report that displays stored trend data based on a trends graph. It is compiled using
settings from the Trends/Data > Trends graph page and the Trends graph setup page.
– A Tabular trend report that displays stored trend data based on a trends table. It is compiled using
settings from the Trends/Data > Trends table page and the Trends table setup page. For more
information on Tabular trend report settings and formatting, see “Tabular trend report settings” and
“Tabular trend report formatting” below.
For a complete description of the Trends graph page and Trends table page, their functions, how to
access them, and how to customize their content, see the Instructions for use Infinity CentralStation Wide
SW VG1.n and Infinity M300.
Users can manually generate, preview, and print trend reports from the Trends graph page and the
Trends table page, respectively. For more information about previewing reports, see "Previewing reports"
on page 22.
Users can also schedule trend reports for automatic generation from the System setup > Scheduled
reports page. For more information about the Scheduled reports page, see "System setup > Scheduled
reports page" on page 27.

Tabular trend report settings

The Tabular trend report is a multi-parameter report containing all trended parameters in the full disclosure
database. Unless otherwise specified, the following settings match those on the Trends table page:
– Selected Trend table parameters, their display order, and their data values at each time interval.
– Initial time interval between the trend table columns, which is 1, 5, 10, 15 (default), 30, or 60 minutes.
– Report duration, which is 2, 4, 8, 12, or 24 hours.
– Report start time is the interval column time minus the duration.
– Initial end time is the interval closest in time to the current anchored cursor time. Users can also select
the report end time using the cursor location.

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Tabular trend report formatting

The Tabular trend report includes the following row and column formatting:
– Report header, which includes the report title, hospital name, patient name and ID, date of birth, care
unit and bed labels, admission date, type of implant, report start and end times, and report generation
time.
– Separate parameter and units-of-measure columns.
– Up to nine time interval columns on a page labeled in HH:MM:SS format.
When the number of intervals exceeds the maximum number of columns on a page, the additional
intervals appear in labeled columns below the previous set of interval columns.
– Report footer, which includes a comments area for handwritten comments, signature area, signature
date area, and page number.
The Tabular trend report appears in a horizontal format, and prints with a landscape orientation. Be sure
to send Tabular trend reports to a printer that is capable of printing in landscape mode.

System setup > Recorders/Reports page

The System setup > Recorders/Reports page provides additional configuration settings for:
– Previewing reports,
– Adding the hospital name and logo or other image to reports, and
– Specifying the output destination for generated reports.

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The following illustration shows the System setup > Recorders/Reports page.

Recorders/Reports
System
setup

Configure
Default report
printer destination
Preview Off
reports On

Report Configure
hospital report logo
name

Undo Apply

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Previewing reports

The Preview reports option on the System setup > Recorders/Reports page lets users enable report
preview for available reports from the Trends/Data dialog window. Use the On button to enable report
preview, and the Off button to disable it.
Available reports include:
– Graphical trend report
– Tabular trend report
– Full disclosure report
– Events report

NOTE
The Preview reports option setting becomes the default in BedView.

To enable print preview:


1 Press the System setup... button on the main screen.
The System setup page appears.
2 Go to the Recorders/Reports tab.
3 Next to Preview reports, click the On button.
4 Click Apply.
To preview a report for a patient:
1 With Preview reports enabled, select the patient’s viewport on the main screen.
2 Press the Trends/Data button.
The Trends/Data dialog window opens.
3 On any Trends/Data tab, press the Reports... button.
4 Select the desired report and duration.
The ICS generates a preview of the selected report.
To print a report from the preview, click . If Export manual reports: in the Configure report
destination dialog is enabled, the user is also prompted to export the report to a file. For more information,
see "Specifying the output destination for reports" on page 24.

Adding the hospital name to report headers

The Report hospital name option on the System setup > Recorders/Reports page lets the user display
a hospital name in the header of reports.

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To display the hospital name on reports:


1 Press the System setup... button on the main screen.
The System setup page appears.
2 Go to the Recorders/Reports tab.
3 Enter the hospital name in the Report hospital name field.
4 Click Apply.

Adding a logo to report headers

The Configure report logo button on the System setup > Recorders/Reports page displays the
Configure report logo dialog. This dialog lets users select a JPG file, from a USB drive, that contains a
logo or other image to display in the header of reports.

NOTE
Include a logo in the header of any report type, except for Rest ECG reports.

The following illustration shows the Configure report logo dialog.

Configure
report logo

Available
report logo <Select a file>
files

Delete current
report logo

Delete

Cancel Apply

JPG images should have an aspect ratio of 2:1 (twice as wide as high), as they are scaled to
approximately 400 x 200 pixels in report headers.

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To display a logo or other image in the header of printed reports:


1 Press the System setup... button on the main screen.
The System setup page appears.
2 Go to the Recorders/Reports tab.
3 Click the Configure report logo button.
The Configure report logo dialog opens.
4 Select a JPG file from the <Select a file> drop-down list, which displays the list of available files found
on the USB drive. If a USB drive is not installed in the USB port, this option is grayed out.
A preview of the selected image (in an approximate size) appears in the dialog.
5 Click Apply.
The JPG file is copied to the system and the image is displayed in the header of reports.
To delete the currently selected image (as shown in the preview):
– Click the Delete button for the Delete current report logo option.
The JPG file is deleted from the system, and the image no longer appears in report headers.

Specifying the output destination for reports

The Configure report destination button on the System setup > Recorders/Reports page displays the
Configure report destination dialog. This dialog lets users specify the output destination for scheduled
reports and manually generated reports, including Rest ECG reports. Report destinations include printer,
file location, or both.

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The following illustration shows the Configure report destination dialog.

Configure
report
destination

Printer USB

Export

Export manual
reports: Export
destination:

Export Rest
ECG report:

On Off Cancel Apply

The following table lists the available settings on the Configure report destination dialog. Your selection
takes effect upon selection of the Apply button.

Selection Settings Description


Printer check box Sends scheduled reports to the default printer, if
defined on the System setup >
Recorders/Reports page. At least one printer
must be configured for printing reports. Other-
wise, this option is grayed out.
USB check box Sends scheduled reports, manually generated
reports, and Rest ECG reports to the root folder
of a USB drive installed in the USB port. The
folder path is displayed in Export destination.
Export check box Sends scheduled reports, manually generated
reports, and Rest ECG reports to the /mnt/fdex-
port folder on a mounted file share configured
by specialized service personnel. The folder
path is displayed in Export destination.

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Selection Settings Description


Export manual reports: On, Off (default) Enables the export of manually generated
reports to the Export destination location.
Choose On to enable the export of these
reports, and Off to disable it.
Export Rest ECG report: On, Off (default) Enables the export of Rest ECG reports to the
Export destination location. Choose On to
enable the export of these reports, and Off to
disable it.

NOTE
Either the USB check box or the Export check box must be selected before the user can enable the
Export manual reports and Export Rest ECG report options.

To enable the automatic export of reports, and specify the output destination for reports:
1 Press the System setup... button on the main screen.
The System setup page appears.
2 Go to the Recorders/Reports page.
3 Click the Configure report destination button.
The Configure report destination dialog opens.
4 Specify the output destination settings.
5 Click Apply.
Based on the specified settings, reports are automatically:
– Sent to the default printer (if the printer is defined and the Printer check box is selected), and
– Saved to a USB drive, or
– Exported to a mounted file share.

Clinical log entries

A patient name is required to print a report. A patient ID is required to export a report to a file location; it
is not required to print a report.
A clinical log entry is created whenever a PDF report is:
– Printed or saved to a file location,
– Not printed because the patient name is missing, or
– Not saved because the patient ID is missing.

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System setup > Scheduled reports page

The System setup > Scheduled reports page lets users enable and configure the automatic generation
of reports for one or more patients monitored within the shift reporting time. Scheduled reports can include
one or more of the following reports:
– Shift report
– Patient status report
– Graphical trend report
– Tabular trend report
Users can generate scheduled reports for patients individually or in collated sets. They can also
automatically print or save an electronic copy of these reports by configuring an output destination for
reports. These reports can be used for medical review or stored with a patient's other paper or electronic
medical records. For more information, see "Specifying the output destination for reports" on page 24.

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The following illustration shows the System setup > Scheduled reports page.

Scheduled reports

System
setup

On
Scheduled
Off
reports
All
Included Selected
patients

Collate
reports
Report start
time
Report
frequency

Included
reports:

Interval

Undo Apply

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The following table lists the available settings on the Scheduled reports page. Your selection takes effect
upon selection of the Apply button.

Selection Settings Description


Scheduled On, Off (default) Enables the generation of scheduled reports.
reports Choose On to enable scheduled reports. Choose
Off to disable scheduled reports.
Included patients All (default), Selected The patients to include in the scheduled reports.
Choose All to include all patients listed on the
Trends/Data (census) page that are assigned to
the local ICS. The listed patients are preselected
and cannot be modified. They include patients
who were monitored during the time covered by
the report, even if they were not actively
monitored at the time the report was generated.
Choose Selected to include one or more patients
listed on the Trends/Data (census) page. For
more information, see "Selecting patients for
scheduled reports" on page 30.
Collate reports On, Off (default) Enables the collation of selected reports for each
patient. That is, specifies how selected reports for
each patient are assembled. Choose On to com-
bine all selected reports for each patient into one
file. In this case, the label "collated" is added to
the file name. Choose Off to separate selected
reports for each patient into individual files.
Report start time 1 minute to 24 hours The initial report start time (in hours and minutes).
(default is 08:00)
Report frequency 2, 4, 8 (default), 12, or 24 The frequency at which reports are generated
hours after the report start time. This is also the report
duration.
Included reports: Available reports include: The reports to include in the set of scheduled
reports for each patient.
– Shift report
– Patient status report
– Graphical trend report
– Tabular trend report
Interval 1, 5, 10, 15 (default), 30, or The interval between trend columns in Tabular
60 minutes trend reports, when included in the set of sched-
uled reports.

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Selecting patients for scheduled reports

The Trends/Data (census) page displays a table containing all available patients with a disclosure record
in either the ICS's own monitoring unit(s), or in one or more configured monitoring units.
Users can select one or more patients from this table to include in the scheduled reports generated as
defined on the System setup > Scheduled reports page. Selected patients can be active or inactive, and
must be assigned to the local ICS.
The following illustration shows a fragment of the Trends/Data (census) page.

Trends/Data

Status Central Station

Scheduled reports

To select one or more patients:


1 Press the Trends/Data button on the main screen.
The Trends/Data (census) page appears.
2 Select patients by clicking in the table cell in the Scheduled reports column.
A check mark appears for each patient selected. To clear the check mark, click in the cell again.

NOTE
The Status column indicates whether the patient is active or inactive. The Central Station column iden-
tifies the ICS to which each patient is assigned.

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Configuring printers

Users can configure up to two printers, independently, in the Printer setup section of the Biomed >
Configure central > General settings page. In addition to setting the printer names and IP addresses,
users can also select the paper tray and paper size for each printer.
The following illustration shows the Printer setup section of the Biomed > Configure central > General
settings page.

Biomed Configure central

General
settings

Printer
setup

Printer IP address Paper tray Paper size

The Printer setup section includes the following additional settings:


– The Paper tray drop-down list, which lets users select:
– A paper tray from the printer’s available paper trays, or
– Auto (default), which automatically selects the paper tray for the selected paper size.
– The Paper size drop-down list, which lets users select either of the following paper sizes:
– Letter (default), which measures 215.9 mm x 279.4 mm (or 8.5 in x 11.0 in).
– A4, which measures 210 mm x 297 mm (or 8.27 in x 11.69 in).

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Parameter order

The following illustration shows the Parameter order dialog, which lets the user configure the order of
parameters and how they display on the Main screen.
To access the Parameter order dialog:
1 Select System setup... on the main menu bar.
2 Select the Parameter order tab.
3 Next to Template, in the pull-down box, select from 25 predefined templates.
4 In the Name field, enter a name for the template you selected in step “3”.
5 Next to Display mode, select:
– Auto – Unavailable waveforms and parameters from the source device will not be displayed.
– Manual – Unavailable waveforms and parameters from the source device will display blank.
Only the first 11 parameters from the source device are available for display. Only the first
11 parameters from the source device are available for display
6 Under Rearrange parameter order, use the up and down arrows to organize the waveforms under
Waveform, and parameters under Parameter box. Multiple parameter boxes can be selected and
moved at one time, using drag and drop functionality.
7 Click Apply to save the selections.

NOTE
Only named templates are available in the Main screen layout tab or in the customize layout dialog.

NOTE
If a template is active on the Main screen, the template name can be modified but cannot be deleted.

NOTE
Select the System default button to reset to the factory default settings.

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General Recorders/Reports Parameter Biomed


settings Main screen order
layout Rearrange
Alarms
parameter order

System setup X

General Alarms Recorders/ Main screen Parameter


Parameter
settings Reports layout order
order Biomed
Template

Template Template 1

Name
Only named templates are available in the Main screen
Name ICCU layout tab or in the customize layout dialog.

Unavailable waveforms and parameters from the source


Auto Auto Manual device will display blank.
Display mode
Only the first 11 parameters from the source device
are available for display.

Display Rearrange parameter order


mode Waveform Parameter box
ECG1 HR+SpO2+NIBP
Manual
ECG2 ST1, ST2, ST3
System
SpO2 SpO2+PLS(PI) default

ART ART
System
RRi RRi
default
CVP CVP

PA PA

LA LA

RV RV

CO2 CO2

Paw Paw

Flow Flow

Undo Apply

Undo Apply

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Main screen layout

The following illustration shows the Main screen layout dialog, where the user can configure up to four
screen layout views.
To access the Main screen layout dialog:
1 Select System setup... on the Main screen.
2 Select the Main screen layout tab.
3 Next to Select layout, choose Layout 1.

NOTE
The button with the (*) indicates the layout Name currently in use and displayed.

4 In the Name field, enter a custom name to help you identify the layout.
5 Next to Split screen, select On to enable a split screen or select Off to default to a full screen setup.
6 Configure the following options for both Left side and Right side when using Split screen mode, and
for Full screen when Split screen is Off.
– Under Beds, select the number of beds to monitor in the pull-down box (the number of beds may
vary depending on license options).
– Under Parameters, select the number of parameters to display. The number of parameters
allowed is based on the number of beds being monitored.

WARNING
Modifying layouts in the Main screen layout tab can remove a previously assigned bed.

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Alarms Main screen layout Biomed


General Recorders/Reports Parameter order
settings

System setup X

General Alarms Recorders/ Main screen Parameter


settings Reports layout order Biomed

Select Layout 1
layout Layout 2

Select layout Layout 1* Layout 2 Layout 3 Layout 4 Layout 3


Layout 4
Name Layout 1
Name * Layout 1 is in use
On
Off
Split screen Split screen On Off
Parameters

Bed Bed Parameters Parameter order Bottom Bottom


Left side 4 4 ICU Waveform
Left side
Right side Right side 2 4 ICCU Parameters

Parameter
order

Layout and bed assignments

Bed17 Remove Bed09 Remove

Bed21 Remove

Bed22 Remove Bed15 Remove

Bed03 Remove

Undo Apply

Undo Apply

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Beds Parameters
1-2 Up to 8
3-4 Up to 4
5-6 Up to 3
7-8 Up to 2

– Under Parameter order select a pre-configured template or select Follow bed (refers to the order
of the waveform and parameters as displayed and sent by the bedside monitor).
– Under Bottom, select Waveform or Parameters. Selecting Parameters displays a total of 3
parameter boxes in the lower channel for Split screen, or a total of 4 parameter boxes for Full
screen.
7 Select Apply at the bottom of the screen to save the current configuration, or select Undo to cancel
changes.
8 Repeat steps “3” to “7” to customize Layout 2, Layout 3, and Layout 4.
9 To activate a layout that you created, select Layouts... from the main menu bar.
10 In the Layouts dialog, select the desired layout, and click Apply.

Password protection

To allow access to the Main screen layout tab without a password, perform the following steps.
1 Select System setup... on the main menu bar.
2 Select the Biomed tab.
3 Select the Passwords tab.
4 Select Off next to Main screen layout password.
5 Select Apply.

Customized viewport layout

1 Select Main screen on the main menu bar.


2 Select the menu icon for the patient bed that you want to customize

NOTE
The triangle indicates that the patient viewport is customized.

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3 Select Change patient parameters to display the Customize layout for: dialog for the selected bed.

Layout default
Customize layout for: Bed 3 X
Choose
Parameter template
layout
Layout Choose
Parameter layout default template
Customize Customize

Template N/A

Template
Rearrange
Rearrange parameter order parameter order
Waveform Parameter box
ECG1 HR+ARR+PVC/min

ECG2 ST1, ST2, ST3

SpO2 SpO2 %+PLS+PI

[No waveform] CO

[No waveform] SpO2*+PLS*+SpO2

[No waveform] Temp basic

GP2 GP2

Cancel

Cancel Apply Apply

4 Select Customize and arrange the desired order of parameter boxes.


5 Select Apply.
en

NOTE
A change in the parameter order template does not affect the Customized layout.

NOTE
The Customized layout remains until the patient is removed from the Viewport.

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Main screen bottom channel access

1 Select Main screen on the main menu bar.


2 Select the menu icon for the patient bed that you want to customize

NOTE
The triangle indicates that the patient viewport is customized

3 When the bottom row is currently set to waveform, and you want to change it to parameters, select
Parameters:

or if the bottom row is currently to set to parameters, and you want to change it to waveform, select
Waveform:

NOTE
A change in the parameter order template does not affect the customized bottom channel.

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Parameter box alarming

In the parameter box (p-box) on the main screen, only the portion of the box that is associated with the
alarmed parameter (or parameters) flashes, quickly showing which parameter (or parameters) needs
attention.
In addition to the flashing alarm parameters, a yellow alarm message banner flashes for medium alarms
and a red alarm message banner flashes for high alarms. A solid cyan appears for low alarms.
Parameters alarm separately in grouped parameter boxes when parameters are from different devices.
Multi-parameter boxes which contain parameters from one device cause the entire parameter box to
alarm.

NOTE
Only parameters with medium (yellow) and high (red) alarms will flash.

Moving an M300/M300+ patient from one room (viewport) to a different


room (viewport)

A new Question dialog displays when an M300/M300+ patient is moved to a new room (viewport). For
viewports on the same ICS, the dialog contains the following buttons:
– Cancel
– Move – moves the M300/M300+ patient to the new viewport, and then discharges the patient from
the original viewport.
– Admit – discharges the M300/M300+ patient from the original viewport and admits them as a new
patient to the new viewport.

NOTE
For patients on different ICS systems, the Question dialog contains only a Cancel button and a Move
button.

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VentCentral Setup screen

The default settings on the VentCentral Setup screen are the current settings on the corresponding bed.
Users can save up to 12 trend ventilator parameters on the VentCentral screen. The default is up to 3
ventilator parameters active at the bedside.

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ECG Calipers tool

The ECG Calipers tool enables users to measure, store, calculate, review, and document time-based
interval measurements and averages using stored ECG waveform data.

Calipers - Measure page

The following Caliper measurement features are available on the Calipers page:

A B
C
F

D E

A Lead button – Selects the lead to provide measurements.


B Size button – Selects the size of the waveform.
C – Zooms in or out of a particular waveform.
D Add row button – Creates a new row to contain a new set of measurements. Only one lead can be
measured at a time (in one row).
E Delete row button – Deletes the current measurement row.
F HR (RR) column – Displays the heart rate in bpm. The calculation is: HR (RR) = (60*1000)/RR with
RR interval in milliseconds.

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Hardware

ICS speakers

The ICS supports external USB speakers. Dräger-approved external USB speakers include the Edifier
R19U speaker (which includes AUX/USB input).

NOTE
For an analog speaker, the user must connect to the analog port for sound, and the USB port for power.
For a USB speaker, the user connects to the USB port.

If a connected USB speaker becomes disconnected, the following alarm message and symbol appear in
the ICS main screen and remain until the speaker is reconnected:

USB speakers disconnected! Audio off


The Warning under “ICS CPU precautions” in Instructions for use Infinity CentralStation Wide SW VG1.n
and Infinity M300, reads as follows:

WARNING
The Infinity CentralStation (ICS) CPU and its display(s) must always remain on and functional,
and the external speakers must always remain connected and powered on. Never press any of
the On/Off buttons to turn the CPU or the display(s) off. Contact your technical personnel for
assistance in properly shutting down the ICS.

The two tables titled “ICS alarm tones” and “M300 speaker alarm tones” in the Alarms chapter in the
Instructions for use Infinity CentralStation Wide SW VG1.n and Infinity M300 provide specifications for
external speakers to implement audible alarm notification, including periodic checks.

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ICS battery indicator icon

Following are additional indications of the ICS battery indicator icon for the M300/M300+:
– The battery icon turns red when the battery runtime indicator shows only a single bar.
– The battery icon is framed in red when the battery runtime indicator shows no bars.
– The battery icon turns white when the battery runtime indicator shows more than a single bar or the
device is charging. This applies only to the M300.

Canvys touchscreen and widescreen displays

ICS supports the following displays:


– Canvys 21.5 inch touchscreen display. See “Canvys 21.5-inch touchscreen display” for specification
information.
– Canvys 21.5 inch widescreen display. See “Canvys 21.5-inch widescreen display” for specification
information.

NOTE
This display is capable of operating from an HDMI input from the ICS.

WARNING
All changes or modifications to the device hardware or software must only be done by Dräger
authorized service personnel, otherwise patient safety may be negatively impacted. Any
unauthorized change could decrease patient safety, could void the user's authority to operate the
equipment, and will void the warranty.

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Canvys 21.5-inch touchscreen display

Touchscreen display
Type 54.7 cm (21.5 in) diagonal LCD
TFT active matrix LCD, Anti-glare
Touch technology Projected Capacitive
Active display area (h x w) 476.64 x 268.11 mm (18.77 x 10.56 in)
Native resolution 1680 x 1050 or 1920 x 1080
Response time 16 ms
Viewing angle (H x V) 178° / 178°
Trolley Tilt base
Electrical specifications
Power consumption 22 watts (max.)
Power input 100 to 240 VAC, 50/60 Hz
Environmental specifications
Temperature range Operating: 5 °C to 40 °C (41 °F to 104 °F)
Storage: -10 °C to 60 °C (14 °F to 140 °F)
Relative Humidity Operating: 90 % at max. +50 °C (122 °F)
(non-condensing) Storage: 90 % at max. +50 °C (122 °F)
Physical specifications
Size (H x W x D) 378 x 525.3 x 180 mm (14.88 x 20.68 x 7.08 in)
Weight 7.2 kg (15.87 lbs)
Chassis color White

Canvys 21.5-inch widescreen display

Widescreen display
Type 54.7 cm (21.5 in) diagonal LCD
TFT active matrix LCD, Anti-glare
Active display area (h x w) 476.64 x 268.11 mm (18.77 x 10.56 in)
Native resolution 1680 x 1050 or 1920 x 1080
Response time 16 ms
Viewing angle (H x V) 178° / 178°
Trolley Tilt base
Electrical specifications
Power consumption 23.6 watts (max.)
Power input 100 to 240 VAC, 50/60 Hz
Environmental specifications

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Widescreen display
Temperature range Operating: 5 °C to 40 °C (41 °F to 104 °F)
Storage: -10 °C to 60 °C (14 °F to 140 °F)
Relative Humidity Operating: 90 % at max. +50 °C (122 °F)
(non-condensing) Storage: 90 % at max. +50 °C (122 °F)
Physical specifications
Size (H x W x D) 378 x 525.3 x 180 mm (14.88 x 20.68 x 7.09 in)
Weight 7.2 kg (15.87 lbs)
Chassis color White

Mouse movement with dual-display configurations

In dual-display configurations, users can position a second display relative to the primary display with the
following position options: Right of, Left of, Above, or Below. Users can move the mouse horizontally or
vertically between the displays, based on their relative position.
ICS supports the use of a universal Black Box KVM box Extender that includes:

Part Number Quantity Description


ACR1020A-T 1 Agility Dual Head Sender
RMK2004 1 Transmitter Rack Mount Kit
ACR1020A-R 1 Agility Dual Head Receiver
ACR1X-VESA 2 Mount Bracket for Single/Dual Head Receivers
LGB1110A 1 Black Box L2+ Ethernet Switch
EJG9300L 1 3.5mm Audio Y-Cable
AVSP-DVI1X2 2 1 x 2 DVI-D Splitter with Audio & HDCP
EVNDVI02-0003 2 DVI-D Cable 0.9m
EVNDVI02-0006 2 DVI-D Cable 1.8m

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Gen 4 Central Processing Unit (CPU) Upgrade

The ICS includes a Gen 4 CPU (MS32504).

Gen 4 CPU specifications

The following table describes the Gen 4 CPU specifications.

Infinity CentralStation
Display specifications
Display size 54.7 cm (21.5 in) diagonal or larger wide screen
Resolution 1680 x 1050 or 1920 x 1080 (native resolution)
User controls
Input device controls USB/PS/2-compatible keyboard and USB/PS/2-compatible
optical mouse included in country-specific kit. Optional Dräger
supplied touchscreen is also supported.
Central Processing Unit (Gen 4 CPU: MS32504)
Processor Intel® Processor
Storage – 8 GB RAM, DVD-RW/CD-RW
– 1x 1TB HD (standard)
– 1x 1TB HD (optional for RAID DB)
– 1x 128GB SSD (standard)
– 1x 128GB SSD (optional for RAID OS)
Disk array SATA with optional RAID1 mirror
Software updates DVD-ROM (optical drive)
Connections – 6 USB ports (1 in front, 5 in rear)
– 2 RJ45 LAN connections
– 1 DVI graphics connection
– 2 DisplayPort connectors
– 1 VGA DB 15
– 2 PS/2 ports for keyboard/mouse
– IEC C14 power input connector
– 1x3 audio jack connectors (line-in, line-out, microphone)
Network connectivity – Infinity Network
Video output Dual DisplayPort graphics output 1680 x 1050 (minimum) at 60
Hz
Audio output Dräger-supplied external speakers (analog or USB) plus an
internal speaker as backup.
Input current rating 4.5A (RMS) FOR 115 VAC/2.0A (RMS) FOR 230 VAC

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Infinity CentralStation
Electrical specifications
Power consumption (typical) 30 watts
BTU output 116 BTU/hour
External sound level/fan noise < 46 dB(A) at a 1 meter radius
Maximum patients per CPU Up to 64 beds total:
– 32 patients on the main screen
– up to 32 patients in Surveillance mode (not including M300)
Environmental specifications
Temperature range Operating: 5 °C to 40 °C (41 °F to 104 °F)
Storage: -20 °C to 60 °C (-4 °F to 140 °F)
Altitude/Atmospheric pressure Operating: 700 to 1100 hPa
Storage: 500 to 1100 hPa
Humidity (non-condensing) Operating: 10 % to 95 %
Storage: 10 % to 95 %
Mode of operation Continuous
Acoustic noise < 46 dB(A) at 1 meter
Physical specifications
Size (H x W x D) 90 x 325 x 330 mm (3.54 x 12.8 x 12.99 in)
Weight 4.6 kg (10.1 lbs)
Chassis color Black

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Gen 4 CPU figure

The following figure shows the front and back of the Gen 4 CPU.

Front

A
B

G D Back
E F

H I J K L

Front Back
A DVD drive D USB port
B On/Off E VGA Display port
C USB F Two LAN Connectors
G Two Display ports
H DVI Display port
I Four USBs ports
J Microphone port
K Sound Out
L Sound In

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RAID disk error message (CPU Gen 4 only)

For an ICS with an optional RAID, when a disk error or failure occurs in one of the drives in a mirrored set,
one of the following messages displays in the ICS Main Screen status message area.

RAID failure on DB drive


RAID failure on OS drive
When there are dual screens, the warning message displays on both screens.

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Additional language support

The Language settings on the Biomed > Configure central > Country tab include the following additional
languages:
– Finnish (missing from the IFU)
– Lithuanian (newly supported)
– Serbian (newly supported)

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Corrections to the IFU

In the Instructions for use Infinity CentralStation Wide SW VG1.n and Infinity M300:
– The section “Selected events” is corrected as follows:
Depending on the number of events selected, the Selected event report section may consist of up to
six pages, with four waveform strips per page. For an event to appear in the Shift report, the symbol
corresponding to that event must be selected so that a check mark appears.
– The following alarm settings information is added to the section “Latching and non-latching alarm”:
Certain special modes on the bedside monitor (such as OR mode, ECMO mode, Pressures paused,
and Pressures off) might affect alarm settings. See the Instructions for use for the specific device.
– The following note is added to the section “Rest ECG report”:

NOTE
The Rest ECG report displays leads in sequential format.

– The following information is added to the section “Selecting different waveforms (manual waveform
configuration)”:
If the user docks a different monitor or discharges the patient and admits a different patient, that
viewport changes back to Auto mode. For a new patient, the user can manually change waveforms
again.
– The description of External device alarm audio in the System setup > Alarms page is updated. See
“System setup > Alarms page” for more information.

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Limitations

Alternate speed feature

The R-50 “Alternate speed” feature is not supported for IACS or M300/M300+ monitors.

Changing layouts

NOTE
When changing layouts, all recordings are canceled (even if the bed is assigned in both layouts).

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Reprocessing

Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Observe before disassembly . . . . . . . . . . . . . . 54

Information on reprocessing. . . . . . . . . . . . . 54
Safety information. . . . . . . . . . . . . . . . . . . . . . . 54

Classifications for reprocessing. . . . . . . . . . 55


Classification of medical devices . . . . . . . . . . . 55
Classification of device-specific components . . 56

Reprocessing list . . . . . . . . . . . . . . . . . . . . . . 57

Reprocessing procedures . . . . . . . . . . . . . . . 57
Validated reprocessing procedures . . . . . . . . . 57
Disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Surface disinfection with cleaning . . . . . . . . . . 58

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Disassembly

Observe before disassembly

1 Switch off the device and all devices connected to it.


2 Disconnect the mains plugs.

Information on reprocessing

Instructions for reprocessing are based on internationally accepted guidelines, e.g., standard ISO 17664.

Safety information

WARNING
Risk due to inappropriately reprocessed products.
Reusable products must be reprocessed, otherwise there is an increased risk of infection.
– Observe the hygiene regulations and reprocessing regulations of the healthcare facility.
– Observe national hygiene regulations and reprocessing regulations.
– Use validated procedures for reprocessing.
– Reprocess reusable products after every use.
– Observe the manufacturer's instructions for cleaning agents, disinfectants, and reprocessing
devices.

CAUTION
Risk due to faulty products
Signs of wear, e.g., cracks, deformation, discoloration, or peeling, may occur with reprocessed products.
Check the products for signs of wear and replace them if necessary.

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Classifications for reprocessing

Classification of medical devices

Medical devices and their components are classified according to the way they are used and the resulting
risk.

Classification Explanation
Non-critical Components that come only into contact with skin that is intact
Semi-critical (A, B) Components that carry breathing gas or come into contact with mucous
membranes or pathologically altered skin
Critical (A, B, C) Components that penetrate skin or mucous membranes or come into contact with
blood

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Classification of device-specific components

Observe the instructions for use for the components.


The following classification is a recommendation from Dräger.

Non-critical
– Infinity CentralStation Wide

Semi-critical A
– None

Semi-critical B
– None

Critical
– None

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Reprocessing list

Components Surface disin- Manual clean- Machine Steam steril- Special repro-
fection with ing followed cleaning with ization cessing mea-
cleaning by disinfec- thermal disin- sures
tion by im- fection
mersion
Infinity Yes N/A N/A N/A N/A
CentralStation Wide

Reprocessing procedures

Validated reprocessing procedures

At the time of product-specific validation, the following reprocessing procedures showed good material
compatibility and effectiveness:

Procedure Agent Manufacturer Concen- Contact Tempera-


tration time ture
Surface disinfection with Dismozon pur Bode Chemie 1.5 % 15 min N/A
cleaning Dismozon plus Bode Chemie 1.6 % 15 min N/A

The effectiveness of the listed reprocessing procedures has been validated by independent laboratories
that are certified to the standard ISO 17025.

Disinfectants

Use disinfectants that are nationally approved and are suitable for the particular reprocessing procedure.

Surface disinfectant
At the time of the test, the surface disinfectants listed in the following table showed good material
compatibility. They can be used in addition to the surface disinfectants listed in the section Validated
reprocessing procedures.
The manufacturers of the surface disinfectants have verified at least the following spectra of activity:
– Bactericidal
– Yeasticidal
– Virucidal or virucidal against enveloped viruses
Observe the specifications of the surface disinfectant manufacturers.

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Other surface disinfectants are used at one's own risk.

Class of active ingredient Surface disinfectant Manufacturer


Chlorine-releasing agents Actichlor plus Ecolab
BruTab 6S Brulin
Clorox Professional Disinfecting Clorox
Bleach Cleaner
Dispatch Hospital Cleaner Disin-
fectant Towels with Bleach
Klorsept 17 Medentech
Oxygen-releasing agents Descogen Liquid Antiseptica
Descogen Liquid r.f.u.
Dismozon plus Bode Chemie
Dismozon pur
Oxycide Ecolab USA
Perform Schülke & Mayr
Virkon DuPont
1)
Quaternary ammonium com- Mikrozid sensitive liquid Schülke & Mayr
pounds Mikrozid sensitive wipes 1)

Mikrozid alcohol free liquid1)


Mikrozid alcohol free wipes1)
acryl-des1)
Aldehydes Buraton 10 F Schülke & Mayr
1) Virucidal against enveloped viruses

Dräger states that oxygen-releasing agents and chlorine-releasing agents may cause color change in
some materials. Color change does not indicate that the product is not functioning correctly.

Surface disinfection with cleaning

WARNING
Risk due to penetrating liquid
Penetrating liquid may cause the following:
– Damage to the device
– Electric shock
– Device malfunctions
Ensure that no liquid penetrates the device.

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1 Remove soiling immediately. Use a cloth dampened with disinfectant to remove soiling.
2 Perform surface disinfection.
3 After the product has been exposed to the disinfectant for the specified contact time, remove residual
disinfectant.
4 Wipe with a cloth dampened with water (at least drinking-water quality). Allow the product to dry.
5 Check the product for visible soiling. Repeat steps 1 to 5 if necessary.
6 Check the product for visible damage and replace if necessary.

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This page has been left blank intentionally.

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This supplement only applies to
Infinity CentralStation Wide
VG3.0
with the Serial No.:
If no Serial No. has been filled in by Dräger,
these Instructions for Use are provided for
general information only and are not intended for
use with any specific machine or unit.
This document is provided for customer informa-
tion only, and will not be updated or exchanged
without customer request.

In Europe, Middle East, Africa, Latin


America, Asia Pacific distributed by
Draeger Medical Systems, Inc.
Drägerwerk AG & Co. KGaA
3135 Quarry Road
Moislinger Allee 53 – 55
Telford, PA 18969-1042
23542 Lübeck
U.S.A.
Germany
(215) 721-5400
+49 451 8 82-0
(800) 4DRAGER
FAX +49 451 8 82-20 80
(800 437-2437) [Link]
FAX (215) 723-5935
[Link]

3707181 – RI 00 en
© Drägerwerk AG & Co. KGaA
Edition: 1 – 2019-12
Dräger reserves the right to make modifications
to the equipment without prior notice.

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