Xprezzon (91393) Security Manual

P/N 070-2924-00 Rev. A | www.spacelabshealthcare.com August 2020

O P E R A T I O N S M A N U A L
 Xprezzon (91393) Security Manual

©2020 Spacelabs Healthcare

All rights reserved. Contents of this publication may not be reproduced in any form without the written permission
of Spacelabs Healthcare. Products of Spacelabs Healthcare are covered by U.S. and foreign patents and/or
pending patents. Printed in U.S.A. Specifications and price change privileges are reserved.
Spacelabs Healthcare considers itself responsible for the effects on safety, reliability and performance of the
equipment only if:

• assembly operations, re-adjustments, modifications or repairs are carried out by persons authorized by
Spacelabs Healthcare, and
• the electrical installation of the relevant room complies with the requirements of the standard in force, and
• the equipment is used in accordance with the operations manual.
In the event of a serious incident, notify Spacelabs and the competent authority of the EU Member State.
Spacelabs Healthcare will make available, on request, such circuit diagrams, component part lists, descriptions,
calibration instructions or other information which will assist appropriately qualified technical personnel to repair
those parts of the equipment which are classified by Spacelabs Healthcare as field repairable.
Spacelabs Healthcare is committed to providing comprehensive customer support beginning with your initial
inquiry through purchase, training, and service for the life of your Spacelabs Healthcare equipment.

CORPORATE OFFICES

Corporate Headquarters

Spacelabs Healthcare, Inc.

35301 SE Center Street
Snoqualmie, WA 98065
U.S.A.
Telephone: (1) 800 287 7108
Telephone: (1) 425 396 3300

Authorized EC Representative

MediMark® Europe. 11 rue E. Zola 38100

Grenoble. France

Please refer to https://www.spacelabshealthcare.com/about-us/patents-trademarks for a full listing of Spacelabs Healthcare

trademarks. Other brands and product names used herein are trademarks of their respective owners.

• Rx Only U.S. Federal law restricts the devices documented herein to sale by or on the order of
a physician.
• Before use, carefully read the instructions, including all warnings and cautions.

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 Table of Contents

1 About This Manual

Overview................................................................................................................ 1-1
Conventions used in this manual........................................................................... 1-1
2 Xprezzon Security
Xprezzon (91393) Description ............................................................................... 2-1
System Details .................................................................................................. 2-2
Network ............................................................................................................. 2-2
Data Classification ............................................................................................ 2-2
Security and Privacy Controls for the Xprezzon Monitor ....................................... 2-3
User Authentication and Authorization .......................................................... 2-3
Device Group Roles .......................................................................................... 2-5
How to set up password for group roles:........................................................ 2-5
How to distribute password for group roles: ................................................... 2-5
Protection of Data in Transit ......................................................................... 2-5
Wired Connectivity ............................................................................................ 2-6
Remote Access ................................................................................................. 2-6
Internal Systems Connections ..................................................................... 2-7
Protection of Data at Rest ............................................................................ 2-7
Audit Event Logging ..................................................................................... 2-7
Time Stamps ................................................................................................ 2-8
Manually set the date and time ...................................................................... 2-9
Secure Configuration Baseline ..................................................................... 2-9
Spacelabs customers can make changes to the following security features:2-10
Ports, Protocols and Services ......................................................................... 2-11
Bug Reporting and Cybersecurity Product Updates .................................... 2-12
Security Bugs/Defect Identification and Reporting .......................................... 2-12
Antivirus ...................................................................................................... 2-12
Incident Response ...................................................................................... 2-13
3 Appendix G — Symbols

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 Xprezzon (91393) Security Manual

About This Manual

Overview
This manual provides instructions on how to use specific security features of
the Xprezzon®.
This manual has questions from the Manufacturer Disclosure Statement for
Medical Device Security (MDS2) form and the answers are specifically about
the Xprezzon bedside monitor. The sections that are not from the MDS2 are
noted.

Read this manual before use and pay attention to all warnings
and cautions.

Conventions used in this manual

Certain conventions are used throughout this manual for consistency and to
aid in the search for information about the Xprezzon bedside monitor.
• Non-blue italicized typeface are references to information outside this
manual. They indicate references to other manuals or information which
is available in another form, as identified by a title or a part number.
• Bold typeface indicates text labels, phrases, or titles that show on an
LCD or display which are part of a Spacelabs Healthcare software
application.
• A non-bold term with Leading Capital Letters identifies the formal name
of an icon, control, or view. These items do not include text as part of
their identification, such as Home Screen, Patient View, or Setup
Window.

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 Xprezzon (91393) Security Manual About This Manual

• Numbered steps are presented to accomplish a task. Some steps

conclude in a step result—unnumbered indented text. For an example of
task steps, refer to How to set up password for group roles: on page 2-5.
• Warnings and cautions are included before pertinent content to alert you
to important information on the use of the monitor Notes are placed after
pertinent content. An example of each follows.

Warnings indicate potentially harmful conditions that can lead to injury

or death.

Cautions indicate conditions that can lead to damage to or

malfunction of the device.

Note:
Notes alert the user to relevant facts and conditions.

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 Xprezzon (91393) Security Manual

Xprezzon Security

Xprezzon (91393) Description

The Spacelabs Xprezzon monitor is a high acuity modular monitor which
connects to the command module at the bedside to display and process
patient parameters (vitals) such as electrocardiogram (ECG), oxygen
saturation (SPO2), non-invasive blood pressure (NIBP), invasive blood
pressure, and invasive temperature.

Figure 2-1: Xprezzon

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 Xprezzon (91393) Security Manual Xprezzon Security

System Details

Component: Details:

Hardware XPREZZON

Software version 3.08.00

OS version VxWorks 6.6

Network

Connectivity: Capable:

Wired Yes

Wireless No

Internet Ready No

Bluetooth No

Remote Access No

Data Classification

Process/
Data Type Transmit Store
Display

Electronic Personal Health Information (ePHI) Yes Yes Yes

Xprezzon stores up to 96 hours of patient data, including trends and features

remote viewing, Alarm Watch, and four user-selectable main screen formats,
including large numerics. Xprezzon comes standard with two module slots
and is expandable with the optional 90499 two-slot module housing to
support additional Spacelabs specialty parameter modules, such as BISx,
Multigas, Capnography, and SvO2/ScvO2. When deployed with the
Spacelabs Xhibit® Central Station and Intesys® Clinical Suite, Xprezzon
offers enterprise connectivity to the hospital EMR, ECG management
systems, paging systems, and remote access solutions.

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Security and Privacy Controls for the Xprezzon

Monitor
Spacelabs provides its customers with capabilities to configure the Xprezzon
to meet their own security policies and requirements. The areas of
responsibilities are shown below:

Area of responsibility
Security feature
Customer

Authentication and Authorization ✔

Protection of Data in Transit ✔

Remote Access N/A

Internal System Connection ✔

Protection of Data at Rest N/A

Audit Event Logging ✔

Time Stamps N/A

Secure Configuration Baseline ✔

Bug Reporting and Cybersecurity Product ✔

Updates

Antivirus N/A

Incident Response ✔

User Authentication and Authorization

Ability of the device to authenticate users and to determine the authorization
of users.

# Questions Responses

Does the device support user/operator-specific Yes, see

1
username(s) and password(s) for at least one user? below*

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# Questions Responses

Does the device support unique user/operator specific

2 No
IDs and passwords for multiple user?

Can the device be configured to authenticate users

3 through an external authentication service (example: No
MS Active Directory, NDS, LDAP, etc)?

Can the device be configured to lock out a user after a

4 N/A
certain number of unsuccessful logon attempts?

Can default passwords be changed at/prior to

5 Yes
installation?

6 Are any shared user IDs used in this system? Yes

Can the device be configured to enforce creation user

7 account passwords that meet established complexity No
rules?

Can the device be configured so that account

8 No
passwords expire periodically?

Can the device prevent access to unauthorized users Yes, see

9
through user login requirements or other mechanism? below*

Can users be assigned different privilege level within

Yes, see
10 an application based on ‘roles’ (example: guest,
below*
regular users, power users, administrators, etc)?

Can the device owner/operator obtain unrestricted

11 administrative privileges (example: access operating No
system or application via local root or admin account)?

*The device provides bedside monitoring information to healthcare staff and

is intended to be operated in Kiosk mode, in an always on/functional mode -
healthcare workers do not have to log on to get access to the monitor
information. All elevated permissions functions (used to setup or configure
the device) are not accessible in the unauthenticated Kiosk interface, but can
be accessed via shared accounts for clinical, biomed, and service personnel.
The password for the clinical and biomed accounts can be controlled by the
Healthcare Organization.

Note:
• Operating System (OS): OS level user accounts are not applicable
on this device. This device has an embedded operating system
which does not allow for usernames/passwords.
• Database: This device has no direct communication with Intesys
Clinical Suite (ICS) and no user accounts.

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Device Group Roles

Level Type Use

Users can admit patients and view vitals

0 Kiosk
No password

Users can change some configuration

items related to clinical settings. Refer to
1 Clinical Operations Manual, 070-070-2112-04 Rev
E)
Change default password

Users can set device wide settings as well

as change passwords for Biomed (Level 2)
Biomed/Clinical and/or Clinical (Level 1). Refer to Systems
2
Engineers Administration Guide, 070-2380-03 Rev R.
Change default password

Users can change licensure on the bedside

Service – Spacelabs monitor. Refer to the Xprezzon Service
3 Field Service Manual, 070-2155-06 Rev D.
Engineers (FSEs) This is configured by Spacelabs Field
Service Engineers (FSEs)

How to set up password for group roles:

• It is recommended that the default password be change prior to use.
Each role can only change the password for that respective role and the
roles below it.
For example: a BIOMED user can change both a CLINICAL user and
BIOMED user password, but not a SERVICE user password. The
instructions for doing so are below:
Once logged into the role for the password that requires changing,
touch Change Password at the bottom of the screen and follow the
prompts to change the password.

How to distribute password for group roles:

1 Distribution of passwords is left up to the customer.
2 The customer should follow the best practices implemented in its
individual organization.

Protection of Data in Transit

The ability of the device to ensure the confidentiality and integrity of
transmitted data

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# Questions Responses

Can PII/ePHI data be transmitted only via a point-to-point

1 No
dedicated cable?

Is PII/ePHI data encrypted prior to transmission via a

2 No
network?

Is PII/ePHI data transmission restricted to a fixed list of

3 Yes
network destinations?

Does the device support any mechanism intended to

4 Yes
ensure data is not modified during transmission?

Wired Connectivity
Xprezzon monitors use the IEEE 802.3 standard for communications. This
device is not capable of encrypting data transmissions.

Note:
It is recommended that this device be placed on a separate VLAN for
medical devices to limit network communication.

Remote Access

# Questions Responses

1 Can the device be serviced remotely? No

Can the device restrict remote access to/from

2 specified devices or users or network locations Not Applicable
(specific IP addresses)?

Can the device be configured to require the local user

3 Not Applicable
to accept or initiate remote access?

Note:
Remote Service is not available for this device.

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Internal Systems Connections

The questions in this section are not included on the MDS2 form.
Xprezzon bedside monitors can communicate with Xhibit Central Stations, so
that nurses have multiple people watching over the patients and their vital
signs. Xprezzon bedside monitors can communicate with the ICS Monitor
Loader to send the data to the database and even to the hospital’s electronic
medical records database.

# Questions Responses

1 Can this device connect to other Spacelabs products? Yes

Can this device connect to other non-Spacelabs

2 No
products?

Protection of Data at Rest

The device ability to ensure unauthorized access does not compromise the
integrity and confidentiality of data stored on the device.

# Questions Responses

1 Can the device encrypt data at rest? No

Are the device components maintaining PII/ePHI data

2 Yes
physically secure (i.e. cannot be remove without tool?

Does the device ensure the integrity of stored data with

3 Yes
implicit or explicit error detection/correction technology?

This device cannot be encrypted during normal operations. The bedside

monitor must be connected for the data to be viewable. Once a patient has
been discharged from the Xprezzon monitor, that patient information will be
removed from the device.

Audit Event Logging

The ability to reliably audit activity on the device is explained in section,
Device Group Roles on page 2-5.

# Questions Responses

1 Can the device create an audit trail? No

Indicate which of the following events are recorded

2
in the audit log:

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# Questions Responses

2a Login/Logout Not Applicable

2b Display/presentation of data Not Applicable

2c Creation/modification/deletion of data Not Applicable

2d Import/export of data from removable media Not Applicable

Receipt/transmission of data to/from external

2e Not Applicable
(example network) connection

2f Remote service activity (Remote Access) Not Applicable

2g Other events Not Applicable

Indicate what information is used to identify events

3
recorded in the audit log

3a User ID Not Applicable

3b Date/Time Not Applicable

4 Can the device send event logs to a SEIM Not Applicable

This device is capable of capturing patient vitals and trends; however, this
device has no system event logging capabilities.

Time Stamps
The questions below are not included on the MDS2 form.

# Questions Responses

Does the medical device use an internal clock for time

1 Yes
stamps?

Can the time stamps be mapped to Coordinated

2 Yes
Universal Time (UTC) or Greenwich Mean Time (GMT)?

If Intesys® Clinical Suite (ICS) has been purchased, all monitors will receive
their time from the Monitor Loader component of ICS. This can be configured
in the monitor itself. This process is done on the Monitor Loader component
and will be discussed elsewhere (refer to 070-2922-00, ICS Security
Manual).
If the monitors will not be connected to an ICS server, the date and time will
have to be manually updated. The process is as follows:

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Manually set the date and time

1 Log onto the BIOMED role on the device.
2 Click on the Time/Date Tab in the Biomed Privileged Access Menu.

Figure 2-2 Time/Date Tab

3 Touch the field that requires change.

4 Touch Clear on the keypad below the Time and Date fields.
5 Use the on-screen keypad to enter numbers.
6 Touch Enter.
7 The numbers selected will be entered in the field.
8 After any changes to the time, date, or selected to change the time
display, touch Update to refresh the monitor.

Secure Configuration Baseline

The ability to configure/re-configure device security capabilities to meet user
needs.

# Questions Responses

Can the device owner/operator/admin reconfigure

1 Yes
product security features/capabilities?

Spacelabs customers are responsible for following their own Change Control
Processes. Spacelab devices do not have the ability to auto-detect changes
in configuration. Spacelabs recommends that after the device has been
customized to the customer’s requirements, a document should be created
detailing that baseline. This baseline document can then be used for the
device configuration testing.

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Spacelabs customers can make changes to the

following security features:
• BIOMED and CLINICIAN role password. Refer to Device Group Roles
on page 2-5.
Security configuration (Recommended)
• Passwords: Spacelabs recommend that the default passwords be
changed for the BIOMED and CLINICAL user roles. Spacelabs
recommends using the industry best practices on password complexity
and rotations.
• Network Security – Spacelabs recommends that Spacelabs devices be
placed on its own separate VLAN behind the customers Firewall.
• This device is not internet ready and does not require access to the
internet.
• This device has DNS services configured but have no internet
configuration and do not interact with the internet. DNSSEC is not
required.
This device does not come configured for an IDS nor IPS. If the customer
wishes, the customer can configure its respective IDS/IPS system to capture
activity on its device.

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Ports, Protocols and Services

See table below:

Data
Ports Protocol Service Purpose Source Destination
Exchanged

Other
51374 and Spacelabs
specific monitors,
offsets above ICS Monitor
Patient
UDP Transport of Monitor loader
physiological
[Port Multicast – physiological (91390, (92810),
Monitoring data
numbers Spacelabs waveforms and 91393, Xhibit
(waveforms,
calculated proprietary configurations 91389) Central
alarms, etc.)
and set Station and
during XC4
configuration] (96102,
96501)

Configuration
of Spacelabs
TCP –
Communications plug-in Configuration Configuration
6105, 6106 Spacelabs Monitor
(Genie) modules (e.g. PC settings
proprietary
Command
Module)

Monitor Monitor
TCP – Sharing
Communications (91390, (91390, Configuration
6105, 6106 Spacelabs monitor
(Genie) 91393, 91393, settings
proprietary settings
91389) 91389)

TCP – Communication Monitor Customer

Spacelabs Desktop
Citrix ICA with Citrix (91390, Citrix
1494 DNA client – remote
Spacelabs Metaframe 91393, Metaframe
communication access
DNA client servers 91389) servers

Communication Monitor Customer

Spacelabs DNA Location of
TCP-http with Citrix (91390, Citrix
80, 443 client – browse server (IP
and https Metaframe 91393, Metaframe
for services address)
servers 91389) servers

Communication Monitor Customer

Spacelabs DNA Desktop
TCP-Citrix with Citrix (91390, Citrix
1023-65534 client – remote
ICA Metaframe 91393, Metaframe
communication access
servers 91389) servers

Communication Monitor Customer

Spacelabs DNA
UDP-Citrix with Citrix (91390, Citrix
1604 – browse for
ICA Metaframe 91393, Metaframe
services
servers 91389) servers

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Bug Reporting and Cybersecurity Product Updates

The ability of on-site service staff, remote service staff or authorized
customer staff to install/upgrade device security patches. The ability to report
security bugs or product defects.

# Questions Responses

Can relevant OS and device security patches be applied

1 Yes
to the device as they become available?

Can security patches or other software be installed

2 No
remotely?

3 Can product security bugs be reported? Yes

Security Bugs/Defect Identification and Reporting

• Internal Spacelabs testing teams identified defects are forwarded to
Spacelabs Research and Development for investigation, analysis, and
remediations.
• Customer identified defects are reported to Spacelabs by calling
Spacelabs Global Technical Support (GTS) via phone (800-522-7025),
via email ([email protected]) or via the Internet link (https://
www.spacelabshealthcare.com/support/feedback-submission/)

Complaint management: Once a defect/complaint is received by Spacelabs, the GTS team will work
with the customer to remedy the defect or issue reported. If GTS is unable to
remedy the customer's issue, it will be escalated to "higher level escalation
teams" who work on the defect/complaint in conjunction with Spacelabs
Research and Development. The customer will be involved on an as needed
basis.
Patch Updates and Process: Spacelabs customer will need to contact Spacelabs to schedule time for a
Spacelabs FSE to come to the site to update the device.

Antivirus
The ability of the device to effectively prevent, detect and remove malicious
software (such as malware, virus, etc…)

# Questions Responses

1 Does the device support the use of anti-virus software? No

Can the user independently re-configure anti-virus

2 N/A
settings?

Does notification of virus/malware detection occur in the

3 N/A
device interface?

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# Questions Responses

Can only manufacturer-authorized persons repair

4 N/A
systems when virus or malware has been detected?

Can the device owner install or update anti-virus

5 No
software?

Can the device owner/operator (technically/physically)

6 update virus definitions on manufacturer-install anti-virus N/A
software?

Note:
This device does not support antivirus software.

Incident Response

# Questions Responses

Does the manufacturer provide support to investigate

1 Yes
security incidents involving the device?

Customer can report security incidents by calling into Spacelabs Global

Technical Support (GTS):
• Via phone at 800-522-7025;
• Via email at [email protected]; and/or
• Via the internet at https://www.spacelabshealthcare.com/support/
feedback-submission/
Once the incident is received, Spacelabs will investigate and prioritize
appropriately.

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Appendix G — Symbols

The following list of international and safety symbols describes all symbols
used on Spacelabs Healthcare products. No one product contains every
symbol.

Note:
Graphic elements of certain keys and symbols may vary between
product lines.

HELP Key

?
HELP (Explain Prior Screen) Key

MONITOR SETUP Key

REMOTE Key

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TRENDS Key

RECORD Key

SPECIAL FUNCTIONS Key

NORMAL SCREEN Key

SAVE Key

No Network Connection

Network Connection

Do Not Connect to Network

No Connection to Intesys® Clinical Suite (ICS)

Compression

Magnifying Glass

File Cabinet

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List of Rooms

Printer

Service Message

PREVIOUS MENU Key

HOME Key

Arrows

STANDBY Key
Power ON/OFF Key

ENTER Key

Delete
x

Nurse Alert Interface

ALARM SUSPEND/TONE RESET Key

ALARMS Key

Alarm, General

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Alarm Reset

Alarm Audio ON

Alarm Audio OFF

Alarm Audio Paused

Alarm Indicator.
On the display, the color of the symbol designates the priority of the alarm:
• cyan = low
• yellow = medium
• red = high
On monitor hardware, this symbol indicates Alarm Output.

Alarms Paused

Alarm OFF or equipment has no alarm system

Parameter below measurement range

---
Parameter above measurement range
+++
Parameter measurement indeterminate
???
Indicator — Remote Control

Normal Screen

Clock/Time Setting Key

Slow Run

Activate Recorder for Graphics

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Reset

START (NIBP) Key

Power Indicator LED

Activate Telemetry Recorder

Output (Non-terminated)

Data Input/Output

Input

No Output (Terminated)

Indicator — Local Control

Indicator — Out of Paper

Recorder Paper

Menu Keys

Waveform/Parameter Keys

1
Return to Prior Menu
2
3 1
2
3

1
Monitor Setup
2 Select Program Options
3

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1
Set Initial Conditions Menu
2 A
3

1
Access Special Function Menu
2 B
3

1
Return Unit to Monitor Mode
2
3

Keypad

Serial Port 1
1

Serial Port 2
2

Serial Port

Auto Mode (NIBP)

External Marker Push Button Connection

Arterial Pulse

Gas Exhaust

Video Output

Television; Video Display

Video Output, Primary

1
Video Output, Secondary

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Enlarge, Zoom

Input/Output

PCMCIA Card

Touchscreen, External

Universal Serial Bus

SDLC Port
SDLC

Hard Drive

Antenna

Electrocardiograph or Defibrillator Synchronization

Foot Switch

Audio Output, Speaker

Event

Gas Sampling Port

Gas Return Port

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Battery
Replace only with the appropriate battery.

Battery Status

Battery
Replace only with the appropriate battery.

Low Battery

Replace only with the appropriate battery.

(+ / - signs may be reversed)

Check battery switch on bottom of unit.

Battery off. Shipping and service mode.

Battery on. Regular operating mode.

All batteries should be disposed of properly to protect the environment. Lithium

batteries should be fully discharged before disposal. Batteries such as lead-acid (Pb)
and nickel-cadmium (Ni-Cd) must be recycled. Please follow your internal procedures
and or local (provincial) laws regarding disposal or recycling.

This symbol indicates that the waste of electrical and electronic equipment must not
be disposed as unsorted municipal waste and must be collected separately. Please
contact an authorized representative of the manufacturer for information concerning
the decommissioning of your equipment.

Caution - hazardous voltages. To reduce risk of electric shock, do not remove the
cover or back. Refer servicing to a qualified field service engineer (U.S.A.).
DANGER - High Voltage (International)

Protective Earth Ground

Replace Fuse Only as Marked

Power supply jack polarity.

(+ / - signs may be reversed)

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Alternating Current

Both Direct and Alternating Current

Functional Earth Ground

Fuse

Equipotentiality Terminal

Direct Current

Input Power. Use only Spacelabs Power Supply.

AC/DC Input

Loop Filter

Audio Output, Speaker

IEC 60601-1 Type B equipment. The unit displaying this symbol contains an adequate
degree of protection against electric shock.

IEC 60601-1 Type BF equipment which is defibrillator-proof. The unit displaying this
symbol is an F-type isolated (floating) patient-applied part which contains an adequate
degree of protection against electric shock, and is defibrillator-proof.

IEC 60601-1 Type BF equipment. The unit displaying this symbol is an F-type isolated
(floating) patient-applied part providing an adequate degree of protection against
electric shock.

IEC 60601-1 Type CF equipment. The unit displaying this symbol is an F-type isolated
(floating) patient-applied part providing a high degree of protection against electric
shock, and is defibrillator-proof.

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 Xprezzon (91393) Security Manual Appendix G — Symbols

IEC 60601-1 Type CF equipment. The unit displaying this symbol is an F-type isolated
(floating) patient-applied part providing a high degree of protection against electric
shock.

IEC 60601-1 Class II equipment, double-isolated. The unit displaying this symbol does
not require a grounded outlet.

Warning: Do not modify this equipment without authorization of the manufacturer.

Operates on Non-Harmonized Radio Frequencies in Europe

Adult Noninvasive Blood Pressure (NIBP)

Fetal Monitor Connection (Analog)

Fetal Monitor Connection RS-232 (Digital)

Physiological Monitor Connection RS-232 (Digital)

Noninvasive Blood Pressure (NIBP), Neonate

Symbol Set, Adult/Pediatric Cuff Sizes

Symbol Set, Neonatal Cuff Sizes

NIBP Cuff, Neonatal 1

NIBP Cuff, Neonatal 2

NIBP Cuff, Neonatal 3

NIBP Cuff, Neonatal 4

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NIBP Cuff, Neonatal 5

NIBP Cuff, Single Hose

NIBP Cuff, Dual Hose

NIBP Cuff, Surface Applied to Patient

THIS SIDE TO PATIENT

NIBP Cuff, Child Size (12 to 19 cm)

CHILD

NIBP Cuff, Child Size, Long (12 to 19 cm)

CHILD, LONG

NIBP Cuff, Small Adult Size, Long (17 to 25 cm)

SMALL ADULT, LONG

NIBP Cuff, Small Adult Size (17 to 25 cm)

SMALL ADULT

NIBP Cuff, Adult Size, Long (23 to 33 cm)

ADULT, LONG

NIBP Cuff, Large Adult Size, Long (31 to 40 cm)

LARGE ADULT, LONG

NIBP Cuff, Large Adult Size (31 to 40 cm)

LARGE ADULT

NIBP Cuff, Adult Size (23 to 33 cm)

ADULT

NIBP Cuff, Infant Size (8 to 13 cm)

INFANT

NIBP Cuff, Neonatal 1 Size (3 to 6 cm)

NEONATAL 1

NIBP Cuff, Neonatal 2 Size (4 to 8 cm)

NEONATAL 2

NIBP Cuff, Neonatal 3 Size (6 to 11 cm)

NEONATAL 3

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 Xprezzon (91393) Security Manual Appendix G — Symbols

NIBP Cuff, Neonatal 4 Size (7 to 13 cm)

NEONATAL 4

NIBP Cuff, Neonatal 5 Size (8 to 15 cm)

NEONATAL 5

NIBP Cuff, Thigh Size (38-50 cm)

THIGH

NIBP Cuff, Nylon Material

NYLON

NIBP Cuff, Soft Material

SOFT

NIBP Cuff, Vinyl Material

VINYL

Quantity
QTY

Place Artery Symbol and Arrow over Brachial or Femoral Artery

ARTERY

eIFU = electronic Instructions for Use (CD-ROM or website) is available

Consult Instructions For Use

Follow Instructions For Use

Warning—Potential danger to patient or user

(consult accompanying documents)

Caution—Potential damage to equipment

(consult accompanying documents)

Note Note

Keep Dry

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Indoor Use Only

12,200 m
Altitude Limit

Temperature Range

Fragile, handle with care

Handle with Care

This Way Up

Up Arrow

Down Arrow

Humidity Limit

Humidity limitation

Atmospheric pressure limitation

Open Padlock

Closed Padlock

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 Xprezzon (91393) Security Manual Appendix G — Symbols

PVC-Free (Polyvinyl Chloride)

PVC

Do Not Reuse; Single Use Only

2
Single patient - multiple use

Reusable

Drip-Proof
IPX1

Unit can withstand accidental immersion in one meter of water for up to 30 minutes
IPX7

Catalog Number or Order Number

Medical Device
MD

Use by date [YYYY-MM-DD]

Recycle

Non Sterile

NON
STERILE

Latex Free – Not made with natural rubber latex

Contains latex

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Does not contain phthalates

Contains or presence of phthalates, such as DEHP

Date of Manufacture

Manufacturer

Radio transmitting device; elevated levels of non-ionizing radiation

A CE mark certifies that a product has met EU health, safety, and environmental
requirements, which ensure consumer safety.

XXXX is the European Notified Body number. 0123 is the number for TÜV SÜD
XXXX Product Service GmbH, München, Germany.

Canadian Standards Association Approved

Does not contain hazardous substances — Europe

Does not contain hazardous substances — China

Batch Code

Nellcor Oxisensor II Compatible

NE
2

Novametrix Compatible
NV
X

Spacelabs TruLink Compatible

Nellcor OxiMax Compatible

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 Xprezzon (91393) Security Manual Appendix G — Symbols

Spacelabs Compatible

UL certified for use in the United States and Canada

UL recognized component in Canada and United States

Nellcor OxiMax Compatible

Masimo SET Compatible

ABBREVIATIONS USED AS SYMBOLS ARE SHOWN BELOW.

1 - 32 Access Codes 1 Through 32

AIR Air

A Amperes

ANT 1 Diversity Antenna System 1

ANT 2 Diversity Antenna System 2

Arr1 Arrhythmia Net 1

ArrNet2 Arrhythmia Net 2

avDO 2 Arterial/Venous Oxygen Difference

CaO 2 Arterial Oxygen

CH EEG, EMG, or ECG Channel

ch EEG Channels - CH1, CH2, CH3, CH4
EMG Channel - CH5

cmH 2 O Centimeters of Water

C.O. Cardiac Output

CO

CvO 2 Venous Oxygen

CO2 Carbon Dioxide

CO 2

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DIA Diastolic
dia

ECG Electrocardiogram
ecg

EEG Electroencephalogram
eeg

EMG Electromyogram
emg

ESIS Electrosurgical Interference Suppression

EXT External

FECG Fetal Electrocardiogram

FHR1 Fetal Heart Rate, Channel 1

FHR2 Fetal Heart Rate, Channel 2

GND Ground
gnd

Hz Hertz

Hgb Hemoglobin

HLO High-Level Output

hlo

Multiview Multi-Lead Electrocardiogram

N2O Nitrous Oxide

NIBP Noninvasive Blood Pressure

nibp

O 2 AV Oxygen Availability

O2 Oxygen

PaO 2 Partial Pressure of Arterial Oxygen

PRESS Pressure
press
PRS

PvO 2 Partial Pressure of Mixed Venous Oxygen

Ref. Oxygen reference gas port

RESP Respiration
resp

SDLC Synchronous Data Link Control

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 Xprezzon (91393) Security Manual Appendix G — Symbols

Serial number
SN

Option

SVO2 Mixed Venous Oxygen Saturation

SvO2
SvO 2

SYS Systolic
sys

T1 Temperature 1
T2 Temperature 2
T3 Temperature 3
T4 Temperature 4

TEMP Temperature
temp

UA Uterine Activity or Umbilical Artery

UV Umbilical Venous

VAC Vacuum Connection

VO 2 Oxygen Consumption

V Volts

W Watts

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