Efficia CM Series

Rack and Modules
for Efficia CM Series

Patient Monitors
Release C.00
English
In
Instructions for Use

Rack and Modules
for Efficia CM Series Patient Monitors
English
Notice
Proprietary Information
This document contains proprietary information, which is protected by copyright.
Copyright
Copyright © 2019 Koninklijke Philips N.V.
All Rights Reserved
Trademark Acknowledgements
This software is based in part on the work of the FLTK project (http://www.fltk.org).
Microstream™, FilterLine™ and CapnoLine™ are trademarks of a Medtronic company.
Oridion Medical 1987 Ltd. is a Medtronic company.
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810 USA
(978) 687-1501
Document Number
453564622841 Rev C
Warranty Disclaimer
The information contained in this document is subject to change without notice. Philips
Medical Systems makes no warranty of any kind with regard to this material, including,
but not limited to, the implied warranties or merchantability and fitness for a particular
purpose. Philips Medical Systems shall not be liable for errors contained herein or for
incidental or consequential damages in connection with the furnishing, performance, or
use of this material.
Printing History
New editions of this document incorporate all material updated since the previous
edition. Update packages may be issued between editions and contain replacement and
additional pages to be merged by a revision date at the bottom of the page. Pages that
are rearranged due to changes on a previous page are not considered revised.
The documentation printing date and part number indicate its current edition. The
printing date changes when a new edition is printed. (Minor corrections and updates that
are incorporated at reprint do not cause the date to change.) The document part number
changes when extensive technical changes are incorporated.
Third Edition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . September 2019
ii Rack and Modules Instructions for Use

Conventions
This section describes the conventions used in this guide.
Text Formatting
The following typographical conventions are used in this guide:
Typeface Usage Example
Bold System keys Press the Main Screen key.
Special User interface text Open the System Menu.

bold
Italic Variables, document <product name>-<hardware

titles configuration>-<software version>.cfg
Efficia Rack Instructions for Use
Decimal Points
Because the Efficia monitors use a period (.) to indicate a decimal point in decimal
numbers (for example, 10.0), all decimal numbers in this guide use a period as a decimal
point. Commas are not used as decimal points.
Notes, Cautions, and Warnings

This guide uses the following conventions for Notes, Cautions, and Warnings.
Note: A Note calls attention to an important point in the text.
Caution A Caution calls attention to a condition or possible situation that could damage or
destroy the product or the user’s work.
Warning A Warning calls attention to a condition or possible situation that could cause injury to the
user and/or patient.
Rack and Modules Instructions for Use iii

Explanation of Symbols
This section explains the symbols that appear on the rack and its packaging.
Product labels have been redesigned to include UDI information, as required by USA
regulation. The UDI label contains a device identifier (DI) and a production identifier (PI).
The identifiers are machine and human readable.
• The Device Identifier (DI) is a unique GSI GTIN-12 number that has been registered
with the US FDA.
• The Production Identifier (PI) is a combination of Lot or Batch Number,
Manufacturing Dates, Serial Number and/or Expiration Date, as applicable for the device.
Note: See the Efficia CM Series Instructions for Use for symbols that appear on your monitor.
Documentation Safety Sign

The following safety sign advises you to read the Instructions for Use.
Sign Description Standard/Reference

Follow Instructions for Use ISO 7010* M002
(Blue safety sign)
iv Rack and Modules Instructions for Use

Packaging Symbols
The following symbols appear on the Efficia Rack packaging.
Symbol Name Standard/Reference
Keep upright International Air Transport

Association, 405B
Fragile, handle with care ISO 15223-1** 5.3.1
Stacking limit by number ISO 7000** 2403
1014 hPA
Atmospheric pressure range for transport ISO 15223-1* 5.3.9
max
and storage
708 hPA
min
90% Relative humidity range (non-condensing) ISO 15223-1* 5.3.8

for transport and storage
15%
Ambient temperature range (non- ISO 15223-1* 5.3.5

40°C
max condensing) for transport and storage
-20°C
min
Keep dry ISO 15223-1* 5.3.4
CE mark: Product meets the requirements European Council Directive

of 93/42/EEC for Medical Devices 93/42/EEC of 14 June
distributed in the European Economic Area concerning Medical devices,
(EEA). Annex XII***
Recycling Universal Recycling Symbol
* ISO 7000 Graphical symbols for use on equipment - Registered symbols

** ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labeling and information to be
supplied - Part 1: General requirements
***The CE Mark does not apply to the BIS Module.
Rack and Modules Instructions for Use v

Measurement Module Symbols
The following symbols appear on the Efficia Modules.
Gas input connector ISO 7000-0794***

(for the Gas module, the symbol is on the
Gas water trap)
Gas output connector ISO 7000-0795
Defibrillator Proof Type CF applied part on IEC 60417* 5336

Gas and CO2 modules
Defibrillator Proof. Type BF Equipment. IEC 60417-5334

Displayed on the BIS patient cables.
Caution ISO 15223-1** 5.4.4
BIS™ BIS™ module marking NA
IBP IBP module marking NA
IBP Zero Button NA
Microstream™ CO2 module marking NA
GAS Gas module marking NA
Gas module eject button. NA
Gas module water trap rotation indicator. NA
* IEC 60417 Graphical symbols for use on equipment

** ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labeling and information to be
*** ISO 7000 Graphical symbols for use on equipment - Registered symbols
vi Rack and Modules Instructions for Use

Rear Panel Label Symbols
The following symbols appear on the rear panel label of the Rack.
Catalog number ISO 15223-1* 5.1.6
Manufacturer’s name and address ISO 15223-1* 5.1.1
ICES-001 Canadian ISM requirement International Erosion Control

Systems
Compliance with WEEE standard Waste Electrical and Electronic
Equip. directive 2012/19/EU,
Article 14.4
Authorized EU Representative ISO 15223-1* 5.1.2

EC REP
Date of manufacture ISO 15223-1* 5.1.3
2019-02-08
Unique Device Identification (UDI) barcode NA

UDI
Rx Only Prescription Use Only (US Federal Law) 21 CFR 801.109(b)(1) Prescription
Devices
Ingress protection against vertically falling IEC 60529, Ed. 2.2 Degrees of
IPX1 water drops protection provided by
enclosures (IP Code), section 6
SGS mark SGS North America Listed Mark
CE mark CE0123: Product meets the European Council Directive 93/

requirements of 93/42/EEC for Medical 42/EEC of 14 June concerning
0123 Devices distributed in the European Medical devices, Annex XII.
Economic Area (EEA).
The radio device used in the
Efficia CM10, CM12, CM100,
CM120, and CM150 monitors is
in compliance with the essential
requirements and other relevant
provisions of Directive 2014/53/
EU (Radio Equipment Directive).
Serial number ISO 15223-1* 5.1.7
Part number for label NA

PN
* ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labeling and information to be
Rack and Modules Instructions for Use vii

GMDN code Global Medical Device Nomenclature NA
33586
Power USB Port mark USB Implementors Forum, Inc.
standard icon.
* ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labeling and information to be
Regulatory and Safety Specifications

Do not dispose of this product (or any part of it) in industrial or domestic waste. The
system may contain hazardous substances that can cause serious environmental
pollution. The system also contains privacy sensitive information. Philips recommends
that you contact your Philips Service Organization before disposing of this product.
To avoid contaminating or infecting personnel, the environment, or other equipment,
disinfect and decontaminate the monitor before disposing of it in accordance with your
country’s laws. For more information, see the resources listed in the Efficia CM Series
Patient Monitors, Instructions for Use.
Declaration
The Efficia CM10, CM12, CM100, CM120, and CM150 monitors are Class IIb medical
devices and comply with the requirements of the Council Directive 93/42/EEC of 14
0123June 1993 concerning medical devices and carry CE-marking accordingly.
Note: The CE Mark does not apply to the BIS Module.
Authorized EU Representative
Philips Medizin Systeme Böblingen GmbH
EC REP Hewlett-Packard Str. 2
71034 Böblingen
Germany
Australian Sponsor
Philips Electronics Australia Ltd.
65 Epping Road, North Ryde, NSW
Australia 2113
Rx Only
Caution United States Federal Law restricts this device to sale by or on the order of a physician.
viii Rack and Modules Instructions for Use

Contents
1. Overview
Intended Use/Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Efficia CM Series Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Using the Philips InCenter Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Navigation Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
2. Basic Operation
The Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
The Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Battery Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Testing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Mounting the Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Using the Efficia Rack and Modules Safely. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Module Conflicts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Ingress of Liquids Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
3. Monitoring Invasive Blood Pressure
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Preparing to use the Dual IBP measurement module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Zeroing the Transducers on the Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Troubleshooting the Zero . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Selecting a Pressure Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Resolving Conflicts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Dual IBP Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
4. Monitoring Carbon Dioxide
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Preparing to use the CO2 measurement module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
CO2 Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Carbon Dioxide Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
5. Monitoring Bispectral Index (BIS™)
Intended Use/Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
BIS Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
How BIS monitoring works . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Measurement Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Preparing to use the BIS module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Sensor Application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Changing BIS Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Changing the Sweep Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Changing the Waveform Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Changing Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
BIS Display Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
BIS Impedance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
BIS Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Replace the PIC (Patient Interface Cable) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
BIS Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
6. Monitoring Anesthetic and Respiratory Gases
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Gas Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Measurement Principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Gas Waveform Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Table of Contents
Efficia CM Series Rack and Modules Instructions for Use 1
Preparing to use the Gas measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Removing Exhaust Gases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Gas Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Configuring Waveform Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Changing the Sweep (Waveform) Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Changing the Waveform Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Configuring Apnea Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Changing measurement units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Configuring Gas Measurement Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
Gas Mixtures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
Gas Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Measurement Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Gas Measurement Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
7. Care and Cleaning
General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Cleaning and Disinfecting the Monitor, Rack and Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Reprocessing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Approved Cleaning Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Cleaning and Disinfecting the Cables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
8. Accessories List
IBP Module Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
CO2 Module Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Sidestream CO2 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
BIS™ Module Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Gas Module Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Miscellaneous Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
9. Specifications
Rack and Plug-in Module Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Safety Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Electrical and Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Measurement Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Interface Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Rack Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Alarm Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Physiological Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Technical Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
CO2 Microstream™ Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16
CO2 Response Time for Infant/Neonatal Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-18
IBP Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-18
BIS Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19
Gas Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-21
Measurement Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-21
Gas Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-21
Measurement system of endtidal values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-22
Influence of respiratory rate and I:E ratio on the accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-22
Quantitative effects of interfering gases and vapors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-22
Profile Settings for Rack Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23
A. Electromagnetic Compatibility
Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Reducing Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Restrictions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Emissions and Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Guidance and Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Table of Contents
2 Efficia CM Series Rack and Modules Instructions for Use
Efficia CM Series Instructions for Use 3
4 Efficia CM Series Instructions for Use
1
Overview
This chapter provides a brief overview of the Efficia rack.

The Efficia rack works as an interface for connecting plug-in modules with the Efficia CM
Series patient monitor. With these modules, you can expand measurement parameters,
in accordance with the module connected.
The rack is connected to the monitor’s interface PoweredUSB™, which provides power
and a communications channel.
Efficia modules Efficia modules
Efficia rack
Figure 1-1 Patient Monitor, Rack and Modules
Warning Before each use, inspect the rack, modules and accessories for deterioration or damage.
Replace any damaged equipment or report it to your technical support team.
Caution Read this entire manual carefully before using the monitor and rack in a clinical setting.
Notes
• This document includes information on functions and features which may not be available
on all Efficia CM Series patient monitors or may be available only in selected regions. For
information specific to your region, please contact your local Philips representative.
• The exterior surfaces of the Efficia rack are not manufactured of natural rubber latex.
Overview
Efficia CM Series Rack and Modules Instructions for Use 1-1
Intended Use/Indications for Use

The Efficia rack works with the Efficia CM12, CM120 and CM150 patient monitors and is
indicated for use by healthcare professionals whenever there is a need for monitoring the
physiological parameters of patients. Intended for monitoring, analysis, recording and
alarming of multiple physiological parameters.
The Efficia rack connects to the following Efficia modules:
• Dual IBP
• BISx and BISx4
• Multi-Gas with O2 and dual agent automatic identification.
• Multi-Gas without O2 and with manual agent identification.
• CO2 (Oridion Microstream™)
The Efficia rack and modules require Efficia CM Series patient monitors running software
version C.00 or above. If the Software Version displayed in the System Menu is not C.00
or above, contact your system administrator.
The Efficia modules should be used in healthcare environments for the patient types
listed below. Additionally, the monitors and modules may be used in transport situations
within a healthcare facility.
Patient Types
Module/Parameter
Adult Pediatric Neonatal
Module 1: BIS  
(BISx or BISx4)
Module 2: Dual IBP   
Module 3: Multi-Gas with O2 and   

dual agent auto detection.
Module 3: Multi-Gas without O2   

and detects one agent.
Module 4: CO2 (Oridion   

Microstream™)
For more information about the Efficia Series patient monitors (CM10, CM12, CM100,
CM120 and CM150), refer to the Efficia Series Instructions for Use (PN 453564622811).
Normal operating conditions include electromagnetic interference, which is deemed a
typical characteristic of the clinical environment.
Cautions • Keep these Instructions for Use accessible to all users.

• Users should use the patient monitor and optional modules for the intended use
and observe all WARNING and CAUTION statements throughout this book.
• The patient monitor, rack and modules should be used by qualified personnel.
• Do not tamper or unnecessarily modify this device or accessories.
Overview
1-2 Efficia CM Series Rack and Modules Instructions for Use
Contraindications
Contraindications
The Efficia rack and modules are not for transport outside the healthcare facility.
Efficia CM Series Documentation

Efficia documentation includes:
• Efficia CM Series Patient Monitors Instructions for Use: Provides information for day
to day operation of the Efficia CM Series monitors. Also includes safety information,
monitor specifications, and a list of compatible accessories.
• Efficia CM Series Patient Monitors Quick Card: Provides brief descriptions of
commonly used functions.
• Efficia CM Series Patient Monitors Data Export Guide: Provides detailed
information about the syntax and structure of the HL7 messages that are exported
from the monitors.
• Efficia CM Series Patient Monitors Network Configuration Guide: Provides
instructions for configuring your monitor to connect to a network using a wired LAN
connection, a wireless LAN connection, or an RS-232 serial adapter.
• Efficia CM Series Patient Monitors Service Guide: Provides information about
maintenance, troubleshooting, and performance verification testing of the monitor.
• Efficia CM Series Patient Monitors Installation and Configuration Guide: Provides
instructions for unpacking, installing, and connecting all hardware. Includes initial
testing and configuration procedures. Also includes instructions for returning the
monitor.
• Efficia Rack Instructions for Use: Provides information for day to day operation of
the Efficia Rack.
• Efficia Rack Installation and Configuration Guide: Provides instructions for
unpacking, installing, and connecting all hardware and modules. Includes
instructions for returning the rack and modules.
• Efficia Rack Service and Repair Guide: Provides information about maintenance,
troubleshooting, and performance verification testing of the rack and modules.
The Efficia CM Series documentation CD contains PDF versions of the above mentioned
documents.
Notes
• For information about purchasing additional copies of the Efficia CM Series Patient
Monitors documentation or Rack documentation, contact the Philips Customer Care
Center.
• Graphical Trends include measurements reported by Efficia modules. See the Efficia CM
Series Patient Monitors Instructions for Use, “Viewing Trend Data” for more information.
Overview
Using the Philips InCenter Site
Using the Philips InCenter Site

The Philips InCenter site provides frequent updates to all Efficia CM Series product
documentation and product software.
The Philips InCenter site requires an active registration and password. To register, go to
the InCenter site at: https://incenter.medical.philips.com and click on the Need help? link
on the main page (located under the Email address and password fields). On the
following page, under Software Updates (upper left corner of the page), click the Click
here for Efficia CM patient monitor account registration link. The Efficia InCenter
Registration page appears. Complete all of the information fields on the page to receive a
temporary password for the InCenter site and instructions for logging in.
Registration for the InCenter site requires the serial number of at least one Efficia CM
Series patient monitor in active use at your facility. The serial number is found on the
product identification label. The product identification label is located on the rear panel
of the monitor.
Serial Number
UDI
1/
Figure 1-2 Product Identification Label
About Adobe Acrobat Versions

Adobe Acrobat Reader version 9.0 or higher must be installed on the PC that is used to
access the Philips InCenter site. Previous versions of Acrobat Reader are not compatible
with the Philips InCenter site, and attempting to access InCenter with a previous version
of Acrobat Reader will result in error messages when opening documents. Uninstall all
previous versions of Acrobat Reader, and then proceed for a free install of Acrobat
Reader at: www.adobe.com.
Any version of Adobe Acrobat Professional or Acrobat Elements are also not compatible
with the Philips InCenter site, and error messages will appear when opening documents
with these applications. Acrobat Reader 9.0 or higher must be installed in addition to
Acrobat Professional or Acrobat Elements.
Follow this procedure when accessing documents on the Philips InCenter site.
To access documents on the Philips InCenter site:
1. Exit Acrobat Professional or Acrobat Elements (if open).

2. Start Acrobat Reader.
3. Open Internet Explorer, and go to the Philips InCenter site. Keep Acrobat Reader 9.0
open the entire time while accessing the InCenter site.
Overview
Navigation Controls
Navigation Controls
Navigation on the Efficia CM Series patient monitors can be done using a touch screen or
a navigation wheel. The touch screen feature is standard on the CM100, CM120, and
CM150 models and is optional on the CM10 and CM12 models. All Efficia CM Series
patient monitors include a navigation wheel. The following table describes how to use
the navigation controls on all models.
Note: If the touch screen feature becomes disabled, the navigation wheel can still be used to
operate the monitor.
.
Screen
Action Description
Type
Select Touch Touch a button, menu, or list item on the touch screen to select it.
Non-touch Rotate the wheel to highlight an item and then press the wheel to select
it.
Press Touch Press a front panel key or press the wheel.
Non-touch Press a front panel key or press the wheel.
Enter data Touch Touch the item to display the numeric keypad or the keyboard. Touch
using the the values, and then touch OK to close the keypad or keyboard.
keyboard
Non-touch Press the wheel to display a keyboard. Rotate the wheel to highlight the
text or value, and then press the wheel to select the value. Select OK to
close the keyboard.
Select or Touch Touch a check box to select or clear it.

clear
check Non-touch Rotate the wheel to highlight a check box and press the wheel to select
boxes or clear a check box.
Scroll Touch Touch a scroll bar arrow to scroll through the list one segment at a time.
Touch and hold the arrow to quickly scroll through the list. (You can also
use the wheel to scroll and select items in the list.)
A scroll bar to the right of the list indicates the current location in the list.
Touch an item to select it.
Non-touch Rotate the wheel to highlight a list and then press the wheel.
To scroll through the list, rotate the wheel.
To select items in the list, press the wheel.
A scroll bar to the right of the list indicates the current location in the list.
Overview
Navigation Controls
Overview
2
Basic Operation
This chapter describes how to begin using the Efficia rack with the Efficia CM Series
monitors.
For information on using the Efficia CM Series monitors, see the Efficia CM Series
Instructions for Use.
The Front Panel

The following picture displays the module slots, buttons and the power indicator on the
Efficia rack.
Efficia Rack Front Panel
module eject buttons
power
Indicator
Figure 2-1 Efficia Rack Front Panel
The rack has four (4) plug-in slots and four (4) ejection buttons for removing plug-in
modules. The Gas module occupies two slots in the Rack.
An LED displays rack power and status. A green light on the Power indicator means that
the rack is powered and communicating with the monitor. A blue light means that the
rack is powered but has no communication with the monitor.
Basic Operation
The Rear Panel
The Rear Panel

The following illustration shows the back of the Efficia rack.
Efficia Rack Rear Panel
PoweredUSB™
mounting
cable socket holes
Figure 2-2 Efficia Rack Rear Panel

To connect the rack to the patient monitor, plug one end of the system cable into the
back of the monitor and the other end into the back of the rack.
Battery Power
Running the monitor with the rack on battery power:
When the remaining battery capacity is lower than a certain value (see below), a warning
will be displayed when the rack is connected.
If your monitor is running on 3-cell (single or dual) battery power only (without AC), the
monitor will turn off the rack. If a 9-cell battery is used, the rack operation can be
enabled. The Gas module can be used as long as the battery capacity is over 3900mAh.
A battery extreme low alarm is displayed when the monitor is running on battery power,
with the rack connected (with or without modules inserted), and with a battery capacity
lower than 600mAh for 10” monitor, 800mAh for 12” monitor, or 900mAh for 15” monitor.
Testing Alarms
When you switch the monitor on, a self test is started. You must check that the alarms
lamps light, one after the other, and that you hear a single tone. This indicates that the
visible and audible alarm indicators are functioning correctly. For further testing of
individual measurement alarms, perform the measurement on yourself (for example
SpO2 or CO2) or use a simulator. Adjust alarm limits and check that appropriate alarm
behavior is observed.
Silencing Technical Alarms

For most technical alarms, after pressing the alarm silence key, audio indication will end
but background flashing and the alarm message remains displayed until the alarm
condition is cleared.
Basic Operation
The Rear Panel
For the following Rack and Module technical alarms, after pressing the alarm silence key,
all sound, alarm message and background flashing will end, and the alarm will be
dismissed:
• BIS Device Disconnected • Rack Disconnected

• BIS Sensor Disconnected • Module Disconnected: <Module Name>
• BIS Sensor Invalid
• BIS SQI Under 50%
• BIS L SQI Under 50%
• BIS R SQI Under 50%
• BIS SQI Too Low
• BIS L SQI Too Low
• BIS R SQI Too Low
• Check BIS Sensor
• BIS Sensor Error, Detach/Reattach
To learn more about Efficia alarms, see Chapter 3 of the Efficia CM Series Patient Monitor
Mounting the Rack

The Rack can be mounted using a variety of mounting accessories, including:
• Roll Stand (Philips PN 989803199711)
• Wall Mount Kit (989803198311), which is used with the Efficia Wall Mount (Philips PN
989803195571)
• Bed Post/Rail Clamp (Philips PN 989803199711)
For information about mounting the rack on the roll stand or wall mount, see the
Instructions for Use that comes with the mounting hardware.
Basic Operation
Using the Efficia Rack and Modules Safely

Modules are inserted into the rack with the front of the module facing out. To insert a
module, gently push the module into the rack slot until you hear the module click into
place.
Module Conflicts
When you connect a module to the rack, if the module conflicts with any of the active
measurements (label conflict, duplicate measurements, etc), the Module Configuration
menu will open automatically. If there is already a window open, the menu will be closed
and the module configuration menu opened. Exceptions include:
• If the Admin/Edit/Discharge Patient Menu is opened or

• If the Date/Time Menu is opened (only when the Date/Time Menu is opened
automatically after a cold start) or
• If the monitor is in Diagnostics mode or
• If the Software Upgrade Menu is open.
Ingress of Liquids Standard

The Efficia CM Series monitor, rack and plug-in modules meet the Ingress of Liquids
Standard IEC 60529, Level IPX1. Patient contact materials comply with ISO 10993.
The Multi-gas CO2 Connections and dual IBP patient applied parts for use with
the Efficia CM patient monitors and rack are classified as type CF, which
specifies their degree of protection against electrical shock. The BIS patient
applied parts are classified as type BF. All are rated as defibrillator proof.
See the Efficia CM Series Instructions for Use for the complete list of
certifications.
The Efficia CM Series monitor, rack and plug-in modules are suitable in the presence of
electrosurgery.
The monitor and its accessories must be tested by qualified service personnel at regular
intervals to ensure that performance has not been degraded by aging or environmental
conditions. Periodic performance verification tests can be performed, as described in the
Efficia CM Service Guide.
Rack and module replacements may only be made by qualified service personnel.
Warnings Risk of injury or health hazard:

• Explosion Hazard. Equipment not suitable for use in the presence of a flammable
anesthetic mixture with air or oxygen or nitrous oxide. Oxygen concentrations must be
<25% and partial pressure <27.5 kPa when no other oxidants are present.
• To prevent or minimize burns caused by a defective neutral electrode connection, use
caution when handling electrodes, transducers, and cables in the presence of high-
frequency surgical equipment. Verify that the equipment is working correctly before
each use.
• Do not open the patient monitor or attempt to change the battery. Incorrect battery
replacement may cause overheating, fire or explosion. If you suspect a problem with
parts within the monitor, contact your technical support team or Philips
representative.
Basic Operation
Cautions • Properly secure the monitor and rack when in use to avoid injury to patient and staff.
• Properly insert and latch the plug-in modules to avoid injury to patient and staff.
• Route patient cabling to reduce the possibility of tripping, entanglement or
strangulation of the patient, caregiver, or service personnel. To reduce this risk, Philips
recommends the use of the cable management kit. For more information, see the
Efficia CM Series Patient Monitors Instructions for Use.
• Do not place the monitor or rack in a position where the patient or staff could
inadvertently cause it to fall and be damaged. If the monitor and/or rack are wall
mounted, do not pull down on the monitor or rack.
• If your monitor and/or rack are mounted on a roll stand, use the handle on the roll
stand to move the monitor and rack. Do not use the monitor handle to move the
monitor and rack; doing so, creates stress on the mounting bracket and could cause
the monitor to fall off the roll stand or tip over.
• Disconnect the power cord from the power source before moving the monitor and
rack. Do not pull the power cord to disconnect.
Basic Operation
Basic Operation
3
Monitoring Invasive Blood
Pressure
Note: This chapter is used in conjunction with the IBP chapter in the Efficia CM Series Instructions
for Use.
Like the internal IBP measurement on the Efficia CM monitor, the Dual IBP measurement
module for the Efficia rack, measures the following types of IBP:
• Arterial Blood Pressure - ABP • Non-specific Pressure — P
• Arterial Blood Pressure (alternative) - ART • Pulmonary Artery Pressure — PAP
• Aortic Pressure - Ao • Right Atrial Pressure — RAP
• Central Venous Pressure - CVP • Umbilical Arterial Pressure — UAP
• Intracranial Pressure — ICP • Umbilical Venous Pressure — UVP
• Left atrial Pressure — LAP
IBP module Efficia rack

Figure 3-1 Efficia Rack with IBP Module
The Dual IBP measurement module is a single slot module with two (2) IBP channel
connectors that plug into any slots on the Efficia rack. The module has two (2) buttons
which perform the zero function for each channel.
Note: All exterior surfaces of the Dual IBP measurement module and its accessories are latex-free.
Monitoring Invasive Blood Pressure

Intended Use
Intended Use
The Dual IBP measurement module is intended for use under the direct supervision of a
licensed healthcare practitioner or by personnel trained in its proper use. The module is
used in the Efficia rack to monitor IBP in Adult, Pediatric and Neonatal patients within a
hospital or medical facility.
Preparing to use the Dual IBP measurement module

The Efficia CM Series patient monitor can be configured with two internal IBP channels.
The Dual IBP measurement module also comes with two external IBP channels. You can
use whatever channel you want, provided you follow the rules below:
• The internal and external IBP channels work in pairs. You cannot enable or disable
one channel without affecting the other Dual IBP channel.
• You can use a second Dual IBP measurement module in the rack, but you will have
to turn off the two internal IBP measurements because you can only have four (4)
active channels at a time.
• At any time, there cannot be two active channels using the same label. For more
information, see “Resolving Conflicts” on page 3-6.
Step
1 Follow the instructions in the Efficia CM Series, Instructions for Use to setup
transducers and purge air from the lines.
2 Insert the IBP measurement module into any open slot in the rack.
3 Press the Rack button on the monitor.
4 Select the check box for IBP under Rack Parameters.
5 The IBP channels on the module have default labels of CVP and P. If you
would like to change the labels, choose a label from the Top and Bottom
drop down menus.
To configure the label parameters, see “Selecting a Pressure Type”
6 Select X to close the window.
Zeroing the Transducers on the Module

The monitor requires a valid zero to ensure accurate pressure readings. To do this, you
must zero the transducer and the pressure measurement. Zero the transducer in
accordance with your hospital policy as follows:
• At least once a day
• When you use a new transducer or tubing
• When you reconnect the transducer cable to the monitor
• If you suspect that the pressure readings are incorrect
There are two ways to zero the pressure measurement when using the Dual IBP
measurement module. From the module itself, or from the IBP waveform on the Efficia
monitor.
To zero the pressure measurement from the Dual IBP measurement module:
Step
1 Turn the zero reference stopcock “off” to the patient and remove the non
vented cap for the side port which opens the zero reference stopcock to air.
Note: The air-fluid interface of the zero reference stopcock should be at or near
the right atrial (mid-axillary) level.
2 Hold the Zero button down until you see the text <pressure> Zero - In
Progress on the waveform.
The Zero button for the top channel is directly below the channel and the
Zero button for the bottom channel is directly above the channel.
Figure 3-2 Zero button on IBP Module

If the waveform is not on the screen and you press the zero button, the
following message will be displayed, <pressure> Zero - to initiate the zero,
first assign the corresponding waveform to the screen.
When the waveform is on the screen, if you press and release the button
before the correct time (2 seconds), an error beep will sound and the
following message will be displayed on the waveform pane: To zero IBP,
press and hold zero button for 2 seconds. The message is removed after a
few seconds.
3 The text on the waveform will change to <pressure> Zero - Complete when
finished. Turn the zero reference stopcock “off” to the side port. Replace the
nonvented cap
To zero the pressure measurement from the Efficia monitor:
Step
1 Turn the zero reference stopcock “off” to the patient and remove the non
vented cap for the side port which opens the zero reference stopcock to air.
Note: The air-fluid interface of the zero reference stopcock should be at or near
the right atrial (mid-axillary) level.
2 Select the <pressure> waveform.

The <pressure> Waveform Menu opens.

3 Select the <pressure> Zero button.

A tone sounds to indicate that the zero has started and the message
<pressure> Zero - In Progress appears in the waveform pane.
4 Look in the waveform pane for the message, <pressure> Zero - Complete,
turn the zero reference stopcock “off” to the side port. Replace the non-
vented cap.
Troubleshooting the Zero

If the zero is unsuccessful, an error message appears in the waveform pane. The
following table lists the error messages and the corrective actions to take.
Message Corrective Action
Unable to Zero - Noisy Check the transducer connection and try again.
Signal Make sure the stopcock is off the patient and
open to air.
Unable to Zero - No Make sure that the transducer is connected and

Transducer try again. If this fails, exchange the adapter cable
and try again. If this fails, exchange the
transducer.
Unable to Zero - Make sure the stopcock is off the patient and
Pulsatile Pressure open to air and try again.
Unable to Zero - Timed Try selecting the <Pressure> Zero button again. If
Out this fails, replace the transducer and adapter
cable, and contact your service personnel.
Unable to Zero - Make sure that the stopcock is open to

Excessive Offset atmosphere, not to the patient, and the stopcock
is vented. Then try again. If this fails, the hardware
may be faulty. Replace the adapter cable and try
again. If it fails, replace the transducer and try
again. If it still fails, contact your service
personnel.

Selecting a Pressure Type
Selecting a Pressure Type

When you select an IBP pressure type, the monitor uses the alarm limits for the selected
pressure and changes the color of the associated numeric values and waveform.
Note: The IBP Label options can be updated in both the numeric IBP Menu and the IBP Waveform
Menu. Changes in one menu apply to the setting in the other menu.
To select an IBP pressure type for each channel on the Dual IBP measurement module:
Step
1 Select the IBP waveform channel on the monitor.
2 In the selected waveform drop down, if you would like to change

the label, choose a value from the waveform drop down menu.
Note: When you select a label for one IBP channel, you cannot select
the same label in any other IBP channels.
Select one of the following options:
• ABP
• CVP
• ART
• Ao
• ICP
• LAP
• P
• PAP
• RAP
• UAP
• UVP
Note: CVP unit can be configured independently of other IBP units,
except when CVP is overlapped with another IBP channel.In that
situation, if CVP and the other pressures are configured with different
units, when the overlapped waveform or digit is assigned to the layout,
the CVP unit is changed to the unit configured for other IBP pressures.
3 The upper and lower limits available will depend on the label
selected. Sys (mmHg), Dia (mmHg), and/or Mean (mmHg) are
displayed.
Select upper and lower limits for the Sys, Dia and/or Mean.
4 Select the parameter pane for IBP. Select the alarm symbol to
turn alarms off for the label. A red X will appear over the alarm
symbol. To turn the alarm back on, select the alarm symbol again.
5 Close the menu.

Resolving Conflicts
Resolving Conflicts
Label conflicts occur when two IBP channel labels are the same. When an external IBP
module is connected, it’s labels are compared with the labels of the active modules. If the
default Dual IBP module labels are available, the module is automatically activated. If
one or both labels are equal to one of the current active labels, the module is connected,
but not activated.
Conflicting labels or labels already in use appear in red along with a message instructing
you to resolve the conflict.
Figure 3-3 IBP measurement labels

If the conflict is solved by a change in the label that is conflicting, the module will be
enabled automatically (provided there are not four IBP labels enabled already).
Step
1 Press the rack button The icon is red because of the conflict.
2 Press the IBP label in conflict in the Top or Bottom drop down menu for the
rack module, or the internal monitor label.
3 Select the label drop down and chose another IBP pressure measurement.
Labels in use are red. Close the window.
4 If the conflicts are resolved, then the module will be enabled automatically
and the Rack button will return to a white outline color (shown in black here
for readability.
Alarm Limits
See the Efficia CM Series Instructions for Use for information about alarm limits when
measuring IBP.

Dual IBP Safety Information

The Dual IBP module is suitable in the presence of electrosurgery.
Warnings Risk of performance degradation:

• Measurement accuracy may decrease temporarily while performing electro-surgery or
defibrillation. The recovery time is less than 10 seconds. This does not affect patient or
equipment safety.
• The monitor and its accessories must be tested by qualified service personnel at
regular intervals to ensure that performance has not been degraded by aging or
environmental conditions. Periodic performance verification tests can be performed,
as described in the Efficia CM Service Guide.
Risk of injury or health hazard:
anaesthetic mixture with air or oxygen or nitrous oxide. Oxygen concentrations must
be <25% and partial pressure <27.5 kPa when no other oxidants are present.
each use.
• To avoid injury, place the medical device on a secure and level platform. Do not place
the rack module, cables, hoses and/or sample line on the ground. Do not place anything
on top of the medical device.
Risk of Electrical Shock:
• Do not attempt to disconnect the power cord with wet hands. Make certain that your
hands are clean and dry before touching the power cord.
• Do not remove monitor covers during operation or while power is connected in the
monitor.
Risk of Connecting External Equipment:
• When connecting external equipment (e.g. data capture computer), the system
leakage current must be checked and must be less than the IEC 60601-1 Clause 16
limit.
• The use of accessory equipment not complying with the equivalent safety
requirements of this equipment may lead to a reduced level of safety of the resulting
system. Consideration relating to the choice shall include:
• Use of the accessory in the patient vicinity.
• Evidence that the safety certification of the accessory has been performed in
accordance to the appropriate IEC 60601-1 harmonized national standard.
Risk of Environmental Hazards:
• Within the U.S.A., a hospital-grade outlet with proper grounding is required. The power
receptacle must be a three-wire grounded outlet. Never adapt the three-prong plug
from the monitor to fit a two-slot outlet. If the outlet has only two slots, make sure
that it is replaced with a three-slot grounded outlet before attempting to operate the
monitor.
• Whenever an event such as spillage of blood or solution occurs, re-test ground
leakage current before further use.
• Leakage current must be checked by a qualified biomedical engineering technician
whenever instrument case is opened.

Risk of electromagnetic interference:

• Do not use the monitor and gas measurement module during magnetic resonance
imaging (MRI) scanning. Induced current could potentially cause burns. The monitor
may affect the MRI image, the MRI unit may affect the accuracy of the monitor’s
measurements and the magnetic force could accelerate devices towards the MRI
magnet.
• Operation of this device may affect or be affected by other equipment in the vicinity
due to electromagnetic interference (EMI). If this occurs:
• Increase separation between devices
• Re-orient device cabling
• Plug devices into separate outlet circuit branches
• WARNING: MR-unsafe!
• Do not expose the device to a magnetic resonance (MR) environment.
• The device may present a risk of projectile injury due to the presence of
ferromagnetic materials which can be attracted by the MR magnet core.
• Thermal injury and burns may occur due to the metal components of the device
which can heat during MR scanning.
• The device may generate artifacts in the MR image.
• The device may not function properly due to the strong magnetic and radio
frequency fields generated by the MR scanner.
• Refer to Chapter , “Electromagnetic Compatibility” for specifications.

4
Monitoring Carbon Dioxide
The Efficia CM patient monitor uses the Oridion Microstream™ CO2 method to measure
carbon dioxide (CO2). Measurements can be obtained using the internal CO2 connection
or from the Efficia CO2 measurement module, or from the Gas module.
The CO2 module works exactly the same way as described in the Efficia CM Series
Instructions for Use, Monitoring Carbon Dioxide-Microstream chapter.
Note: You can only use one CO2 measurement method at a time. Manually disable the internal CO2
to use the CO2 measurement module.
Caution Before use, carefully read the Microstream™ etCO2 sampling lines Directions for Use.
The CO2 measurement module is a single slot module that can plug into any slot on the
Efficia rack.
Efficia rack
CO2 module
Figure 4-1 Efficia Rack and CO2 Module
Note: The CO2 measurement module and its accessories are not made with natural rubber latex.

Intended Use
Intended Use
The CO2 measurement module is intended for use under the direct supervision of a
licensed healthcare practitioner or by personnel trained in its proper use. The module is
used in the Efficia rack to monitor carbon dioxide in Adult, Pediatric and Neonatal
patients within a hospital or medical facility.
Preparing to use the CO2 measurement module

The patient monitor can be configured to use internal CO2 or external CO2 from either the
Gas or CO2 module. If your monitor is configured for internal CO2, but you prefer to use
either the Gas module or CO2 module, you will notice that the Rack button will be red
and a message will be displayed indicating that only one CO2 must be selected, as
displayed in the following screenshot.
Modules Configuration X
Monitor Parameters
CO2
IBP1 IBP2
IBP ABP PAP
Rack Parameters
GAS Rack
button
GAS Red
Top Bottom indicates
IBP a conflict
CVP P
BIS
Only one CO2 can be enabled at a time. The CO2 connected to the patient should
be selected.
Figure 4-2 Modules Configuration
To use the Gas or CO2 module, clear the check mark for the internal CO2 and then select
the check box for the Gas or CO2 module. The internal CO2 button text will remain red to
indicate that one of the existing measurements cannot be enabled. And the message
“Only one CO2 can be enabled at a time. The CO2 connected to the patient should be
selected” is displayed.
Note: If your monitor is configured for internal CO2 and you remove the Gas or CO2 module from the
rack, the internal CO2 is not automatically enabled. You must select it as described above.

Setup
Setup
To use the CO2 module:
Step
1 Insert the CO2 module into the rack.
2 Press the rack button on the monitor.
3 Select the CO2 check box under Rack Parameters.

The following reminder message is displayed if the monitor has internal
CO2, “Only one CO2 can be enabled at a time. The CO2 connected to the
patient should be selected”. Users will not be able to select the CO2
checkbox if the internal CO2 measurement is checked, so the first step is to
uncheck the internal CO2 then check the CO2 module.
4 Attach the Luer connector to the CO2 input connector by pushing the socket
cover down and screwing the connector into place.
Screw the sampling line connector clockwise into the CO2 input connector
until it can no longer be turned, to ensure that it is connected securely to
the module. This will ensure that gas does not leak from the connection
point and that measurement accuracy is not compromised.
Note: During warm up, the numeric values may or may not be displayed
depending on the temperature status informed by the module.
5 Check that the sampling line is not kinked. Kinked tubing may cause
inaccurate CO2 sampling or affect O2 delivery to the patient.
6 Check that CO2 values appear on the monitor display.

If you see a “CO2 Purging” alarm message, this indicates that the sample
line is occluded. The module will try to clear the occlusion, but if it persists,
the CO2 Purging alarm is cleared, and the “CO2 Occlusion” alarm is
triggered instead. The pump is turned off until you remove the FilterLine™
and connect a new one (or the same).
Replace the sampling line according to hospital protocol or when a blockage is indicated
by the device. Excessive patient secretions or a buildup of liquids in the airway tubing
may occlude the sampling line, requiring more frequent replacement.
The CO2 module contains an intake connector and an exhaust connector.

Setup
The exhaust connector needs to be connected to a scavenging system or can be

returned to the anesthesia machine.
Input connector
Exhaust connector
CO2 module
Figure 4-3 CO2 module
The FilterLine™ Recognition Safeguard (FRS) enables the module to detect the presence
of the FilterLine™ at startup and in normal operation. The pump does not draw in gas
from the input port when a FilterLine™ is not connected. While in normal operating mode,
the "FRS Lock" detection time is no longer than 1 second.
Disconnect the FilterLine™ sampling line during suctioning and nebulizing therapies.
Notes
• When the system performs an auto zero, the following occurs:
• The CO2 Auto Zero message appears in the message area.
• A question mark (-?-) appears in the CO2 numeric pane to indicate that CO2
measurements are suspended during the Auto Zero period.
• The CO2 waveform goes to zero to indicate that CO2 measurements are suspended
during the Auto Zero period.
• The flow is irreversible.
• During nebulization or suction for Intubated patients, in order to avoid moisture buildup
and sampling line occlusion, the user should use the Standby mode or remove the sampling
line luer connector from the monitor.
• When the Caution message Blockage!! appears on the screen, indicating that the
FilterLine™ which is attached to the handheld monitor is blocked, the monitor's CO2 pump
will stop pumping the patient's breath into the monitor for testing. Follow the instructions
that appear in the Troubleshooting section of this manual: First disconnect and reconnect
the FilterLine™. If the message still appears, disconnect and replace the FilterLine™. Once a
working FilterLine™ is attached to the monitor, the pump will automatically resume
operation.
• Sampling lines with H in their names include a moisture reduction component (Nafion®* or
its equivalent) for use in higher humidity environments where long duration use of CO2
sampling is required.
• Sampling lines are recommended for use with oxygen provided at up to 5l/min. At higher
levels of oxygen provision, dilution of CO2 readings may occur, leading to lower CO2 values.

Carbon Dioxide Safety Information
CO2 Configuration
For information about changing the CO2 settings or configuring the CO2 waveform, see
the Efficia CM Series Instructions for Use.

The Carbon Dioxide module is suitable in the presence of electro-surgery.

• To ensure CO2 measurement accuracy, ask your system administrator to calibrate the
CO2 module as soon as the CO2 Calibration Needed technical alarm appears. Also
check the patient’s vital signs by alternate means and make sure the monitor is
functioning correctly.
• If calibration does not take place as instructed in the Service documentation, provided
to your system administration, the monitor may be out of calibration. A monitor that is
out of calibration may provide inaccurate results. Contact your system administrator/
biomedical engineer.
• Do not cut or remove any part of the sampling line. Cutting the sampling line could
lead to inaccurate readings.
each use.
the rack module, cables, hoses and/or sample line on the ground. Do not place
anything on top of the medical device.
• Carefully route the sampling line to reduce the possibility of patient entanglement or
strangulation.
• When using a sampling line for intubated patients with a closed suction system, do
not place the airway adapter between the suction catheter and endotracheal tube.
This is to ensure that the airway adapter does not interfere with the functioning of the
suction catheter.
• Loose or damaged connections may compromise ventilation or cause an inaccurate
measurement of respiratory gases. Securely connect all components and check
connections for leaks according to standard clinical procedures.
• To minimize the risk of injury or contamination due to the reuse of a single-use device,
all accessories are for single patient use.
• Check CO2 and O2 tubing regularly during use to ensure that no kinks are present.
Kinked tubing may cause inaccurate CO2 sampling or affect O2 delivery to the patient.


monitor.
limit.
system.
Consideration relating to the choice shall include:
receptacle must be a three-wire grounded outlet. Never adapt the three- prong plug
monitor.
may affect the MRI image, the MRI unit may affect the accuracy of the monitor's
magnet.
• The device may not function properly due to the strong magnetic and radio frequency
fields generated by the MR scanner.

Cautions • Only use Microstream™ etCO2 sampling lines to ensure the monitor functions
properly.
• Microstream™ etCO2 sampling lines are designed for single patient use, and are not to
be reprocessed. Do not attempt to clean, disinfect, sterilize or flush any part of the
sampling line as this can cause damage to the monitor.
• Use of a CO2 sampling line with H in its name (indicating that it is for use in humidified
environments) during MRI scanning may cause interference. These sampling lines
include CapnoLine™ H/Long, CapnoLine™ H O2, Smart CapnoLine™ H/Long, Smart
CapnoLine™ H O2, and Smart CapnoLine™ H Plus O2/Long. The use of non H sampling
lines is advised.
• CO2 sampling lines used with the monitor are marked with the upper limit of oxygen
that may be provided with the sampling line. At levels of oxygen provision higher than
those marked on the sampling line packaging, dilution of CO2 readings may occur,
leading to lower CO2 values.
• Ensure that tubing is not stretched during use.
• Dispose of sampling lines according to standard operating procedures or local
regulations for the disposal of contaminated medical waste.
• When monitoring with capnography during sedation, please note that sedation may
cause hypo-ventilation and CO2 waveform distortion or disappearance. Waveform
attenuation or disappearance is an indicator that the status of the patient's airway
should be assessed.
• When monitoring patients during upper endoscopy, partial blockage of the oral airway
due to endoscope positioning may cause periods of low readings and rounded
waveforms. The occurrence will be more pronounced with high oxygen delivery levels.
• If CO2 insufflation is performed during CO2 monitoring, the etCO2 values will
accordingly rise very significantly and this may result in device alarms and abnormally
high waveforms until the CO2 is evacuated from the patient.
• Entry of dust or fluids into the CO2 intake of the Microstream™ CO2 will cause
blockage of the narrow channels. When a FilterLine is not inserted, the Microstream™
CO2 has no protection from fluid or dust entry. A spring-loaded door covers the input
connector when a FilterLine is not inserted.


5
Monitoring Bispectral Index
(BIS™)
The Bispectral Index (BIS) module enables anesthesia professionals to access processed
EEG information as a measure of the effect of certain anesthetics during patient care.
The BIS Index, one of the output parameters, may be used as an aid in monitoring the
effects of certain anesthetic agents; and its usage with certain anesthetic agents may be
associated with a reduction in primary anesthetic use and a reduction in emergence and
recovery time.
Use of the BIS Index for monitoring to help guide anesthetic administration may be
associated with the reduction of incidence of awareness with recall in adults during
general anesthesia and sedation.
BIS is a complex monitoring technology intended for use as an adjunct to clinical

judgment and training. Clinical judgment should always be used when interpreting BIS in
conjunction with other available clinical signs. Reliance on BIS alone for intraoperative
anesthetic management is not recommended. As with any monitored parameter, artifacts
and poor signal quality may lead to inappropriate BIS values. Potential artifacts may be
caused by poor skin contact (high impedance), muscle activity or rigidity, head and body
motion, sustained eye movements, improper sensor placement and unusual or excessive
electrical interference. BIS values should also be interpreted cautiously with certain
anesthetic combinations, such as those relying primarily on either ketamine or nitrous
oxide/narcotics to produce unconsciousness. Due to limited clinical experience in the
following applications, BIS values should be interpreted cautiously in patients with
known neurological disorders and those taking other psychoactive medications.
Note: The BIS education site, www.biseducation.com, offers relevant information and published
articles on the clinical use of BIS. In addition, there is a “Monitoring Consciousness Using the
Bispectral Index during Anesthesia” Clinician's Pocket Guide available on the website and
through your local Covidien Representative. For more information, please contact Covidien at
(800) 442-2051. If you require additional information on the use of BIS, please contact
Covidien at 800-442-8655 or 617-559-7655 if calling from outside of the USA.
Monitoring Bispectral Index (BIS™)

The BIS measurement module is a single slot module that fits into any of the four slot
positions available in the Efficia rack.
The person responsible for installation, maintenance and use of the equipment should
make sure that this is working properly and in compliance with the procedures and
restrictions of use listed in this manual (e.g. environmental radiation, flammable gases,
temperature and humidity). The person responsible should also make sure that all users
and operators of the equipment are trained in their use and maintenance, and that they
have access to this manual.
Efficia rack
BIS module
Figure 5-1 Efficia Rack and BIS Module
Note: All exterior surfaces of the BIS measurement module and its accessories are latex-free.

BIS is intended for use under the direct supervision of a licensed healthcare practitioner
or by personnel trained in its proper use. The system, and all its associated parameters, is
intended for use on adult and pediatric patients within a hospital or medical facility
providing patient care to monitor the state of the brain by data acquisition of EEG signals.
BIS is a complex monitoring technology intended for use as an adjunct to clinical
judgment and training.
The BIS module is suitable in the presence of electrosurgery.
Warning The Efficia CMS200 Central Station (revision B.01 or below) does not support waveforms
and parameter values from the Efficia CM Series C.00 Gas or BIS modules. For Gas or BIS
waveforms and parameter values, refer to the patient monitor and not the CMS Central
Station.

BIS Terminology
The BIS module is recommended to monitor the level of consciousness or sedation of the
patient in various situations:
• Neuromuscular blockade
• Mechanical ventilation
• Procedures to bedside
• Patients in the ICU
• Surgical procedures
• Academic research or clinics
The parameters calculated by BIS aim to provide objectively the level of sedation/
awareness of the patient and assist the physician in the administration of sedatives. BIS
has been shown to be strongly correlated to common scales of measurement of
sedation.
BIS Terminology
The following terms will be used throughout this chapter. See page 5-5 for measurement
ranges associated with each term.
• Bispectral Index (BIS)
Range = 0 – 100
The Bispectral Index is a continuous processed EEG parameter that correlates
to the patient’s level of hypnosis, where 100 = awake and 0 = flat line EEG. BIS
was designed to correlate with “hypnotic” clinical endpoints (sedation, lack of
awareness, and memory) and to track changes in the effects of anesthetics on
the brain.
• Electromyography (EMG)
The EMG frequency range contains power from muscle activity (i.e.,
electromyography or “EMG”) as well as power from other high-frequency artifacts.
When the EMG indicator bar is low, it indicates that EMG activity is low. BIS
monitoring conditions are optimal when the bar is empty.
1 bar represents power in the 30-38 range

2 bars represents power in the 39-47 range
3 bars represents power in the 48-55 range
4 bars represents power greater than 55
• Signal Quality Index (SQI)

The Signal Quality Index is a measure of the signal quality for the EEG channel
source and is calculated based on impedance data, artifact, and other variables.
Signal quality is optimal when all five bars of the SQI icon are green. When signal
quality is too low to accurately calculate a BIS value, the BIS value and other trend
variables that are adversely affected by artifact will not be displayed on the screen.
• Suppression Ratio (SR)
The Suppression Ratio (SR) is a calculated parameter designed to indicate when an
isoelectric (flat line) condition may exist. Suppression ratio is the percentage of time
over the last 63-second period that the signal is considered to be in the suppressed
state. For example, an SR of 11 indicates isoelectric over 11% of time during the last
63 second review.

How BIS monitoring works
• Spectral Edge Frequency (SEF)

The Spectral Edge Frequency (SEF) is the frequency at which 95% of the total
power lies below it and 5% lies above it.
• Total Power (TP)
A measure of the absolute total power in the frequency range from 0.5 to 30.0 Hz.
The value is in dB with respect to 0.0001 V2
• Burst Count (BC)
When a BIS Extended Sensor is in use, the Burst Count (BC) is displayed above the
EEG waveform display. The BC is an alternative method of quantifying suppression,
reported as the number of EEG bursts per minute. The system defines a “burst” as a
short period of EEG activity, preceded and followed by periods of inactivity. When
the signal quality is low or when the Suppression Ratio is less than 5, the Burst
Count is not displayed.
• Patient Interface Cable (PIC)
This cable is the connection between the electrodes and the BISx or BISx4 module.

A sensor placed on the patient’s forehead transmits EEG signals to the BIS module. The
BIS module filters the data, analyzes it for artifact and processes it using digital signal
techniques, then sends the data to the monitor for display. The purpose of processing the
EEG waveform data is to extract characteristic features from the complex signal in order
to provide easier pattern recognition of changes over time during the recording.
BIS Range and Clinical State

100 Awake
Responds to the voice normally.
80 Light/Moderate Sedation
May respond to loud commands
or mild prodding/shaking.
BIS
Index 60 General anesthesia
Range Low probability of explicit recall.
Unresponsive to verbal stimulus.
40 Deep hypnotic state
20 Burst suppression
0 Flat Line EEG

Figure 5-2 BIS Range Guidelines
BIS measurements are displayed in both a waveform pane and a numeric pane. When
using a Quatro, Extended or Pediatric sensor, EEG (BIS)/EEG2 (BIS) waveforms and BIS/
SQI1/SEF/EMG2/SR/TP parameters are available.
When using an Extended Sensor, the BC parameter is also available.

With the Bilateral Sensor, EEG (BIS), EEG2 (BIS), EEG3(BIS) and EEG4(BIS) waveforms
and BIS R/SQI R/SEF R/EMG* R/SR R/TP R/BC R and BIS L/SQI L/SEF L/EMG* L/SR L/
TP L/BC L parameters are also available.
Waveform pane Numeric pane
Figure 5-3 Efficia Waveform and Numeric panes

*EMG values are displayed in a bar graph format. The numeric value is not displayed on the main
screen.
Above and below the waveform, lines are drawn to mark the maximum and minimum
levels. These scale lines are not at the absolute edge of the waveform region, but at
about the +/- 75% levels from the center. The actual scale is displayed with each line.
Waveforms for EEG and EEG2 are drawn in yellow, and waveforms for EEG3 and EEG4
are drawn in magenta. Messages related to Impedance Check, Ground Check, Simulator
and Device/Sensor Disconnection are shown in the waveform pane.
Measurement Ranges
The following table lists the BIS measurement ranges:
Measurement Range
Bispectral Index (BIS) 0 to 100
Electromyography (EMG) 25 to 100 dB
Signal Quality Index (SQI) 0 to 100%
Suppression ratio (SR) 0 to 100%
Spectral Edge Frequency (SEF) 0.5 to 30.0 Hz
Total Power (TP) 40 to 100 dB
Burst Count (BC), Extended sensor only 0 to 30
When using the bilateral sensor, each parameter will have a R and L value for the right
and left side of the brain, with the above ranges.
1. SQI
is also represented by a graphic icon. The SQI level indicator has 5 segments, each representing 20%.
No segments: SQI = 0%
1 segment: SQI between 1% and 14%
2 segments: SQI between 15% and 35%
2. The EMG bar graph is made of 4 segments, and the segments are filled according to the EMG value :
No segments: EMG below 30 dB

1 segment: EMG between 30 and 38 dB
2 segments: EMG between 39 and 47 dB
3 segments: EMG between 48 and 55 dB
4 segments: EMG above 55 dB

Preparing to use the BIS module
Components
Verify that you have all necessary components. For a BIS measurement you will need:
• Efficia Monitor and Rack Monitor Interface Cable
• BIS Measurement Module Patient Interface Cable

(PIC)
• Covidien BISx or BISx4 Device
• BIS Sensor
The Efficia Patient Monitor supports the following BIS devices and sensors:
BISx™ BISx4™
Device
• Quatro (4 electrode, adult) • Quatro (4 electrode, adult)

• Extended (ICU) • Extended (ICU)
Sensors • Pediatric (age 4 and up) • Pediatric (age 4 and up)
• Bilateral (detects hemispheric dif-
ferences in brain)
Figure 5-4 BIS DSC Devices and Sensors

BISx is a 2 channel device (BIS LoC 2 Channel) monitoring one side of the head.
BISx4 is a 4 channel device (BIS LoC 4 Channel) monitoring bilaterally, when using the
bilateral sensor.
Figure 5-5 Sensors

Setup
Follow the steps below to setup the BIS module with the patient monitor to begin taking
measurements.
Step
1 Insert the BIS module into the rack.
2 Select any of the Select Waveform options.
3 Select one of the EEG (BIS) waveforms. Close window.
Note: The message “BIS Device Disconnected” is displayed on the

waveform because the Covidien BISx or BISx4 has not been
connected yet. After attaching the BIS device, you may see the
error “BIS Sensor Disconnected” if the sensor strip has not been
connected to the device.
4 Connect the BIS device to the BIS module. Then attach the BIS Sensor to the
patient. See “Sensor Application” below.
When the sensor properly adheres to the skin, the BIS number pane should look similar
to the following image:
BIS SR % SQI %
100
30
91 EMG
10
SEF Hz TP dB
24.5 57
66
If one or more of the electrodes are not adhered to the skin properly, the BIS number
pane will show which electrodes are problematic. In the example below, Electrode 4 is
displayed as NOK, which means Not OK. The electrode impedance is not within the
acceptable range. Press the edges of the sensor to ensure adhesion and then press each
circle for 5 seconds to ensure proper contact. Check all connections. If the problem
persists, remove sensor, clean skin thoroughly, and reapply sensor or apply new sensor
in accordance with instructions on the sensor packaging.
BIS - Impedance Test

Electrode 1: OK - 1kohm
Electrode 4: NOK - 35kohm
The electrodes with impedance within the acceptable range are displayed as OK and
include the kiloohms (kohm) resistance unit of measurement.
Note: For bilateral sensors, Electrode 5 and Electrode 6 will also be displayed.
.

Sensor Application
Sensor Application
Step
1 If you are using the Extended Sensor, using a ballpoint pen, record the date
and time of application on the sensor.
2 Wipe skin with alcohol, and dry.
3 Apply sensor on forehead as follows:

• Circle #1: Center of forehead, approximately 2 inches (5 cm) above nose.
• Circle #4: Directly above and parallel to eyebrow.
• Circle #3: On the temple area between corner of eye and hairline.
4 Press edges of sensor to ensure adhesion.

• Circle all four elements/circles to seal in gel.
5 Press each circle for five seconds to ensure

proper contact.
• Use fingertip
• Press circles one at a time
• Press firmly
6 Insert sensor tab into patient interface cable until fully engaged.
7 If you are using the Extended Sensor, replace the sensor within 24 hours.
When disconnecting sensor, press release button on patient interface cable.
Changing BIS Settings

Changing the Sweep Speed
Step
1 Select any waveform.

The waveform menu appears.
2 Select Sweep Speed from the Select Sweep Speed menu.
3 Select a sweep speed option. Available options are:

• 6.25 mm/s
• 12.5 mm/s
• 25.0 mm/s
• 50.0 mm/s

Changing BIS Settings
Changing the Waveform Scale

If the displayed waveform is too small or is clipped, use the Scale menu option to adjust
the size of the waveform.
Step
1 Select any waveform. The waveform menu appears.
2 Select the EEG (BIS) waveform from the Select Waveform menu.
3 Select a scale option. Available options are:
• ± 50.0 µV
• ± 75.0 µV
• ± 100.0 µV
• ± 200.0 µV
• ± 500.0 µV
• ± 750.0 µV
• ± 1000.0 µV
Changing Filters
Step
1 Select any waveform. The waveform menu appears.
2 Select the EEG (BIS) waveform from the Select Waveform menu.
3 Select the Filters box.
Note: If the Filters option is not selected, the configuration will be set to
High Pass 0.25 Hz, Low Pass - no filter, and Notch - no filter.
4 Select the Filters tab.

5 Select the High Pass. Available options are:
• 0.25 Hz
• 1 Hz
• 2 Hz
6 Select Low Pass. Options are:
• No Filter
• 30 Hz
• 50 Hz
• 70 Hz
7 Select Notch. Options are:
• No Filter
• 50 Hz
• 60 Hz
• 50 Hz and 60 Hz
8 When the Filter options have been selected, close the window.

BIS Display Information
BIS Display Information

The BIS number pane displays the measurement parameters calculated using the EEG.
All items are shown in yellow. If you are using a bilateral sensor, the BIS L (left) pane will
be yellow and the BIS R (right) pane will be magenta.
The BIS number pane displays up to five parameters at a time. To see Burst Count (BC),
you will need to use an Extended Sensor. If you are using the Bilateral Sensor, you will
also see “BC L” and “BC R”.
Note — If the SQI is less than 15%, the BIS value will show -?-, a low priority technical
alarm is triggered.
The BIS Menu displays information specific to the BIS module. To display the BIS Menu,
press the BIS Number Pane. The following options are available on the General Tab:
Menu Item Options
Alarm Icon Press icon to turn the alarm on or off.
Upper and Lower alarm limits Use the up and down arrow to select alarm limits
for the BIS module.
Parameters TP (Total Power)

BC (Burst Count)
Burst Count is not available when using a Quatro
or Pediatric Sensor.
Auto Check Impedance See “BIS Impedance” on page 5-11.
Bispectra Smoothing Rate The following choices of smoothing rates are

available (over which the BIS value is averaged):
10, 15 and 30 seconds.
10 Seconds provides increased responsiveness to
state changes, such as induction or awakening.
And 30 seconds provides a smoother trend with
decreased variability and sensitivity to artifact.
This is the default setting.
The Sensor tab includes the option to Start Sensor Verification, displays results of the
latest Impedance Test and also displays data read from the sensor (name, channels, lot
code, use by date).
BIS Impedance
BIS Impedance
The BIS module checks electrode impedance levels continuously during a procedure by
utilizing a 128 Hz test signal. Occasionally this signal may interfere with other equipment.
If this becomes a problem, you may turn off the continuous impedance checking (see
below). Impedance levels will still be tested at startup, but once they pass, they will not
be tested again until a new case is begun, or a manual impedance check is initiated.
The following screen shots show the Impedance Test results for a 4-Electrode Sensor
and a Bilateral Sensor:
4-Electrode Sensor
Bilateral Sensor
Figure 5-6 Sensor Checking Examples
Notes
• Even when Auto Check Impedance is unchecked, an impedance check is executed when a
sensor is connected.
• Positive impedance measurements may interfere with EEG monitoring.
• During ground impedance checks, the EEG signal is disconnected and therefore normal
BIS monitoring cannot take place if the BIS Device stays in the GROUND state.
To turn continuous impedance checking off, select the BIS numeric pane.
Step
1 Open the BIS numeric pane.
2 Clear the selection for Auto Check Impedance

BIS Alarm Messages
To perform a manual Impedance test.
Step
1 Open the BIS numeric pane.
2 Select the Sensor tab
3 Select Sensor Verification, Start

Results from the latest impedance check are displayed on the Sensor tab. If
“No Record” is displayed, an impedance check has not been previously
performed.
Since the first impedance test of a sensor is mandatory and cannot be
canceled, the Cancel button is not displayed for the first test.
BIS Alarm Messages

Refer to Chapter 9, “Specifications,” for the Technical and Physiological alarms.
Maintenance
The BIS module is designed so that no periodic adjustment or calibration is required.
Suggested routine maintenance includes: periodic checking of cable integrity, and
checking leakage current.
Replace the PIC (Patient Interface Cable)

The Patient Interface Cable (also known as the PIC cable) is considered a consumable
part of the system and is expected to wear out due to normal usage. The internal wires
and/or connector contacts may fail with fatigue over time or become contaminated with
foreign material. This is an expected occurrence, as it is with any equipment that utilizes
lead wires or patient connection cables. Therefore, it is recommended that the PIC cable
be tested on a periodic basis and replaced if it has been in service for more than two
years.
The PIC cable date of manufacture is printed on each cable and is located on a white
label wrapped around the PIC cable. The manufacturing date code is identified in one of
the following methods:
“PIC+ mmddyy” (month, day, year)

“PIC+ mm/dd/yy” (month, day, year)
“nnnnnnwwyy” (where ww is week and yy is year)
Replacing the PIC cable is an important routine maintenance action which will improve
the reliability of the BIS monitoring system.
Instructions on replacing the PIC cable are included in the Medtronic Instructions for Use,
should replacement be necessary.

BIS Safety Information

The BIS module is suitable in the presence of electro-surgery.
The CE Mark does not apply to the BIS Module.
Warnings Risk of Explosion:

• Explosion Hazard: Do not use the BIS module in a flammable atmosphere or where
concentrations of flammable anesthetics may occur. Equipment not suitable for use in
the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide.
Oxygen concentrations must be <25% and partial pressure <27.5 kPa when no other
oxidants are present.
Risk of Injury or Health Hazard:
• Be sure the monitor is mounted securely in place to avoid personal or patient injury.
• Due to elevated surface temperature, do not place BISX™ in prolonged direct contact
with patient’s skin, as it may cause discomfort.
each use.
• To reduce the hazard of burns during use of brain-stimulating devices (e.g.,
transcranial electrical motor evoked potential), place stimulating electrodes as far as
possible from the BIS sensor and make certain that sensor is placed according to
package instructions.
• To reduce the hazard of burns during use of high-frequency surgical equipment, the
sensor or electrodes should not be located between the surgical site and the electro-
surgical unit return electrode.
• The sensor must not be located between defibrillator pads when a defibrillator is used
on a patient connected to the BIS module. The BIS module provides protection for the
operator and patient during cardiac defibrillation. This protection is achieved via the
isolation barrier within the BISx.
• To minimize the risk of patient strangulation, the patient interface cable (PIC) must be
carefully placed and secured.
• Universal precautions shall be observed to prevent contact with blood or other
potentially infectious materials. Place contaminated materials in regulated waste
container.
• Do not mix disinfecting solutions (e.g., bleach and ammonia), as hazardous gases may
result.
Risk of performance degradation:
equipment safety.
Risk of Electrode Placement:
• The conductive parts of electrodes or sensor and connectors should not contact other
conductive parts, including earth.


monitor.
limit.
• When you are connecting the electrodes or the patient cable, make sure that the
connectors never come into contact with other conductive parts, or with earth. In
particular, ensure that all of the ECG electrodes are attached to the patient to prevent
them from contacting conductive parts or earth.
Risk of Electromagnetic Interference:
• Do not use the monitor during magnetic resonance imaging (MRI) scanning. Induced
current could potentially cause burns. The monitor may affect the MRI image, and the
MRI unit may affect the accuracy of the monitor’s measurements.

Cautions • Read this entire manual carefully before using the monitor in a clinical setting. Do not
autoclave the BISX™ or patient monitor. Autoclaving will seriously damage both
components.
• Do not open BISX for any reason. The seal to prevent liquids from entering the BISX
may be damaged if opened.
• Service or repairs must be performed only by qualified biomedical technicians.
• The BIS module has been designed to operate with a BIS sensor. The sensor is a
silver/silver chloride electrode array that utilizes Covidien’s patented Zipprep®
technology and uses a proprietary connector. Use of other electrodes is not
recommended.
• Continuous impedance checking may need to be disabled if the 1 nanoampere 128 Hz
impedance check signal interferes with other equipment (e.g., evoked potential
monitors).
• Considerations when using Electro-Convulsive Therapy (ECT) equipment during BIS
monitoring: Place ECT electrodes as far as possible from the BIS sensor to minimize
the effect of interference. Certain ECT equipment may interfere with the proper
function of the BIS monitoring system. Check for compatibility of equipment during
patient setup.
• The BIS module contains an internal Lithium ion battery. The battery must be removed
by a qualified service technician and disposed of or recycled in accordance with the
national laws of the country.
• Avoid liquid ingress to the Patient Interface Cable. Contact of fluids with the PIC
sensor connector can interfere with PIC performance. Service or repairs must be
performed only by qualified biomedical technicians.
• The BIS module complies with the electromagnetic compatibility requirements of IEC
60601-2-26, except where superseded by specifications in Covidien documentation
ENG080-0615 and 070-0069, 10-OE-7113_SS and 030-0033.
Operation of this device may affect or be affected by other equipment in the vicinity
• Refer to “Electromagnetic Compatibility” on page A-1 for specifications.
• Do not disconnect the BIS module during the software update.
• When connecting or disconnecting the BIS module, take care not to touch the
exposed contacts of either connector. Damage due to electrostatic discharge may
result.
• Using accessories other than those specified may result in increased electromagnetic
emissions or decreased electromagnetic immunity of the BIS module.
• The BIS module should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the BIS module should be observed to verify
normal operation in the configuration in which it will be used.


6
Monitoring Anesthetic and
Respiratory Gases
The Anesthetic and Respiratory Gas module samples and analyzes breathing gas from
adult, pediatric, and neonatal patients in anesthesia applications. It measures the
concentrations of carbon dioxide (CO2), nitrous oxide (N2O), and anesthetic agents
(Desflurane, Enflurane, Halothane, lsoflurane, Sevoflurane) in a mixture of these gases.
As an option, it also measures the oxygen (O2) concentration in the mixture.
The Gas module provides the concentration values as well as derived values and related
status information to the Efficia patient monitor.
Note:
The water trap
must be vertical
to ensure water
remains on the
bottom of the
trap.
Efficia rack
Gas module
Figure 6-1 Efficia Rack and Gas Module
The Gas measurement module is a dual slot module, fitting into any two of the four slot
positions available in the Efficia rack. The module has an exhaust connector and a
rotatory mechanism for the water trap so that the trap will stay vertical (90 degree
position) if the rack is mounted sideways.
Warnings • The Gas module works with the Efficia Series of patient monitors and is intended for
use by qualified healthcare professionals whenever there is a need for monitoring the
physiological parameters of patients.
• Do not base therapy solely on individual measured values. The most reliable method
of patient monitoring requires correct operation of the monitor and close observation
of the patient.
• Do not use the Gas measurement module in flammable environments i.e.: anesthetic
mixture with air, with oxygen or nitrous oxides.
• Proper use of the Gas measurement module and all accessories will help to prevent
inaccurate measurements and damage to the monitor. Read these Instructions for Use
and those of specified accessories thoroughly before using the measurement module.
Monitoring Anesthetic and Respiratory Gases

Intended Use
Notes
• The Gas measurement module and its accessories are not made with natural rubber latex.
• Both the water trap and exhaust connector are type CF for the Gas module with O2 and
dual agent auto detection and without O2 and without agent auto detection.
Intended Use
The Anesthetic and Respiratory Gas module is intended for use under the direct
supervision of a licensed healthcare practitioner or by personnel trained in its proper use.
The module is used in the Efficia rack. It samples and analyzes breathing gas from adult,
pediatric, and neonatal patients in anesthesia applications, within a hospital or medical
facility. It measures the concentrations of CO2, O2, N2O, and anesthetic agents in a
mixture of these gases, as described above.
Warning The Efficia CMS200 Central Station (revision B.01 or below) does not support waveforms
and parameter values from the Efficia CM Series C.00 Gas or BIS modules. For Gas or BIS
waveforms and parameter values, refer to the patient monitor and not the CMS Central
Station.
Caution Read this entire manual carefully before using the monitor and rack in a clinical setting.
Gas Measurements
There are two types of Gas modules available:
1. With O2 (Dual Agent Automatic Identification): Consists of an O2 sensor which
automatically measures the concentration of O2 and anesthetic gas automatic for
identification and measurement of up to two anesthetic agents from one gas mixture.
The first anesthetic detected is displayed as AGT and the second anesthetic detected
is displayed as AGT2.
2. Without O2 (Manual, Single Agent Identification): Consists of anesthetic gas for
identification and measurement of one anesthetic agent from one gas mixture. You
can select which one gas agent will be measured.
Note: During the transition between anesthetic agents, if the anesthetic agent is not identified, it
will display AGT or AGT2.

Gas Measurements
The following anesthetic agents are supported:

• Halothane
• Isoflurane
• Sevoflurane
• Enflurane
• Desflurane
The sum of the partial MACs are displayed in a parameter called MACt. This parameter
can be configured in a gas number pane through the Parameters section of the Gas
Menu.
The MACt value is calculated as follows:
MACt = MAC AGT + MAC AGT2 + MAC N2O
The installation and setup instructions for both types of Gas modules are the same.
MAC values are uncorrected. In order to calculate the MAC value the standard 1.0 MAC
concentrations of anesthetic agents and nitrous oxide are required. The following table
lists the concentrations (according to the ISO 80601-2-55:2011 standard). The values are
based on the assumptions that the patient is 40 years old.
MAC
Anesthetic agent (in oxygen)
% volume fraction
Halothane 0,77
Enflurane 1,7
Isoflurane 1,15
Desflurane 6,0
Sevoflurane 2,1
Nitrous oxide 1051

1. MAC nitrous oxide can only be reached in a hyperbaric chamber.
For the MACt calculation, the following must be considered:

• If N2O is invalid (-?-), MACt is invalid.
• If no anesthetic agent is detected, etAGT1/etAGT2 shows -?-, but MACt may be calcu-
lated and is equal to N2O.
• If more than 2 agents are used (mixture) then MACt is invalid.
• For all Gas modules, if any of the anesthetic agents is out of range (overflow), the
MACt will be invalid (-?-).
• If any of the anesthetic agents are in transition between agents (calculate), MACt is
invalid.
• For modules without anesthetic agent identification, if the anesthetic agent is invalid,
MACt is invalid.

Measurement Principle
Measurement Principle
A sample line is connected between the Y-piece at the patient side and a water trap as
the input port of the Gas module. A pump draws the gas being measured through the
whole system.
The water trap prevents water and other fluids from passing into the gas analyzer and
causing contamination and/or internal occlusions. It has a water reservoir in which fluids
are collected and two water separation filters. The gas flows to the internal components
of the Gas module. The flow rate is set to 200 ml/min and is supervised. The gas output
port needs to be connected to a scavenging system or can be returned to the anesthesia
machine.
The Gas measurement module has an automated cyclical zeroing once a day (in error-
free operation) as well as automated barometric pressure compensation.
Figure 6-2 Side-stream gas measurement schematic

Gas module venting (internal fan) ensures that the oxygen concentration stays below 25
Vol% at a leak flow of 220mL/min oxygen into its case. A fan rotation error can be
detected.
Warning To avoid influence on the gas measurement and prevent damage to the water trap and
measuring system, do not spray the O-rings in the water trap housing with silicone spray.
Note: The water trap is for multi-patient use and must be replaced after a service life of four weeks
at the latest, during this time it can be emptied and reused as often as required. Regularly
check the level of fluid in the water trap and empty as required.

Gas Waveform Menu
Gas Waveform Menu

Use the Waveform Menu to:
• Change the speed of the Gas measurement waveform
• Change the scale of the Gas measurement waveform
• Select the corresponding measurement unit, CO2, N2O or anesthetic.
For information on other settings in the Gas measurement waveform menu, see the
appropriate section in this chapter.
To open the Gas measurement Waveform Menu:
• Select any Gas waveform on the screen. The selected Gas Waveform Menu
appears, and the current settings are displayed.
The Gas measurement module has the following waveforms:
• O2
• CO2
• N2O
• AGT.xxx1
• AGT2.xxx2
The available waveforms depend on the measurement module being used. Modules with
the dual agent measurement (AGT and AGT2) can identify up to two anesthetics being
used at the same time and differentiate them in waveforms and number panes. Modules
with single agent detection or without agent identification use only the field AGT.
The waveform type selected will be displayed at the top-left corner of the waveform
pane. The waveform labels and color depends on the selected waveform and the
detected anesthetics.
Anesthetic Label Color
O2 O2 Green
CO2 CO2 Yellow
N2O N2O Blue
Halothane HAL Red
Sevoflurane SEV Yellow
Isoflurane ISO Dark Purple
Enflurane ENF Orange
Desflurane DES Blue
AGT AGT White
AGT2 AGT2 White
1. xxx will be replaced by the name of the anesthetic being used.

2. xxx will be replaced by the name of the anesthetic being used.

Preparing to use the Gas measurement
Preparing to use the Gas measurement
Components
Verify that you have all necessary components. For a Gas measurement you will need:
• Efficia Monitor and Rack
• Gas Measurement Module
• Sample Line
WaterLock Gas Sample Line
Removing Exhaust Gases
Exhaust connector
Figure 6-3 Gas Module
Warning To prevent the risk of inaccurate gas measurement values or exposing bystanders to
anesthetic gases, always connect the gas exhaust of the monitor and measurement
module and the anesthesia machine to the scavenging system. Do not return the gases to
the breathing system.
Notes
• The flow of gas is irreversible.
• Avoid negligent placement of device components, such as the sampling line, cables, etc.

Removing Exhaust Gases
The Anesthetic and Respiratory Gas module is a diverting respiratory gas monitor /
sidestream monitor, that transports a portion of respiratory gases from the sampling site
through the sampling tube (sample line) to the sensor, which is remote from the sampling
site.
The diverted sample gas leaving the module through its gas exhaust must be treated
properly. Two solutions are possible:
1. Wasting the diverted sample gas to a scavenging system. A hose is connected to the
gas exhaust of the module. The other side of the hose is then inserted into a gas
scavenging system (e.g. waste anesthetic gas disposal outlet or vacuum outlet).
2. Returning the sample gas to the breathing system of the anesthesia machine
(especially desired for low-flow and minimal-flow anesthesia applications). A sample
gas return set is connected between the gas exhaust of the module and the
anesthesia machine before the CO2 absorber. The sample gas return set must
incorporate a microbial filter.
The hoses connected to the gas exhaust of the Anesthetic and Respiratory Gas module
shall not generate significant pneumatic resistance, otherwise the pump of the module
may fail.
Warnings • Place the Gas module at least 25 cm (10 inches) away from any ignition sources, such
as electrosurgery and laser surgery.
• Do not use the monitor or modules in areas where oxygen concentrations exceed
25%, or where combustible or explosive gas mixtures are likely to occur.
• Do not use the monitor or modules if oxygen leakage is suspected in the medical
device or in its vicinity.

Gas Setup
Gas Setup
Step
1 Insert the Gas module into the rack.

When the module is connected, and before the warm up starts, the module
starts the fan at max speed for a few seconds to exhaust any residual gas
from inside the module. During that period, the user will not be able to
select Gas waveforms or numeric panes.
The Gas module will warm up for the first five minutes after it has been
plugged-in. During this initialization and warm-up period, gases may not be
fully identified and the module will appear in a state of reduced accuracy.
As soon as the parameters reach reduced accuracy, the values (except
awRR) will be displayed followed by a question mark. This state is displayed
on the menu as “warming” in the selected gas waveform.
Notes
• As the water trap serves as a separator for fluids (condensated
water, eventually mucus) and germs from the sample gas, it
eventually becomes filled and must be emptied and also
replaced every four weeks at the latest, even if undamaged, due
to hygienic aspects.
• Always keep the water trap installed, especially during cleaning
and disinfection.

Gas Setup
Step
2 Connect the sample line to the water trap on the front of the Gas module.
Connect the other end of the sample line to the patient’s breathing circuit.
Make sure that the sample line is not kinked.
Warnings
• Check the sample line for kinks or ruptures. Replace it, if damaged. (The
sample line should be replaced with each new patient, even if
undamaged).
• Be sure to place the sample line and cables correctly.
• Make sure that you do not accidentally connect the luer connector of the
gas sample line to an infusion link or any other links in the patient
vicinity.
• Inspect the water trap on the water trap holder for damage (cracks, etc.).
Replace the water trap, if damaged or part of a scheduled maintenance.
• Check the water trap holder for damage. Carefully check the rubber O-
rings located on the grommets of the water trap holder for visible
damage. If damaged, replace the water trap holder. After replacing,
perform a leakage test on the pneumatics.
• A new bacterial filter should be used on the sample line for each new
patient.
• Do not apply excessive pressure (e.g., syringe, or compressed air) to the
inlet, exhaust port, or the water trap.
3 Press the Rack button on the monitor.
4 If your monitor is configured for internal CO2, but you want to use the Gas
module, you will need to clear the check mark for the internal CO2 or any
connected CO2 module. Select the check box next to Gas under Rack
Parameters. A check mark will appear.
Note: Only one CO2 can be enabled at a time. The CO2 or Gas module
connected to the patient should be selected if there is another CO2
module (or the internal CO2) present.
5 Close the Modules Configuration window and return to the main menu.
Waveforms for CO2, O2 and N2O will appear with a message saying the
sensor is heating.

Configuring Waveform Settings
Changing the Sweep (Waveform) Speed

The Sweep Speed determines the speed at which the waveform is drawn across the
screen. Options are:
• 3.125 mm/s
• 6.25 mm/s
• 12.5 mm/s
• 25.0 mm/s
To change the Gas waveform speed:
Step
1 Open the waveform menu.
2 Select the Sweep Speed menu item.
3 Select a speed option.
4 Close the menu.
Changing the Waveform Size

If the displayed Gas waveform is too small or is clipped, use the Scale menu item to
adjust the size of the waveform. Options are:
Anesthetic Scale Options Scale Options Scale Options
O2 • 0—25%
• 0—50%
• 0—100%
N20 • 0—25% OR • 0.0—0.2 MAC

• 0—50% • 0.0—0.5 MAC
• 0—100% • 0.0—1.0 MAC
CO2 • 0.0—50.0 mmHg OR • 0.0—6.6% OR • 0.0— 6.7 kPa

• 0.0—75.0 mmHg • 0.0—9.9% • 0.0— 10.0 kPa
• 0.0—100.0 mmHg • 0.0—13.2% • 0.0— 13.3 kPa
AGT / AGT2 • 0—2% OR • 0.0—0.5 MAC

• 0—5% • 0.0—1.0 MAC
• 0—10% • 0.0—2.0 MAC
• 0—20% • 0.0—5.0 MAC

Configuring Apnea Alarms

The Apnea alarm time defines the length of time between breaths before generating the
Apnea alarm. For example, if the Apnea Alarm time is set to 20 seconds, and the monitor
does not detect a breath for more than 20 seconds, the monitor sounds an Apnea alarm.
Apnea options are:
• 20 seconds
• 25 seconds
• 30 seconds
• 35 seconds
• 40 seconds
• 45 seconds
• 50 seconds
• 55 seconds
• 60 seconds
Step
1 Open the waveform menu.
2 Select the Apnea Time field.
3 Select the Apnea time.
4 Close the window.
Note: The apnea algorithm starts after 4 breaths are taken by the patient.
Changing measurement units

Depending on what type of measurement you select, will determine which Units you
have available to select. The following table show which units are available for each
measurement type.
Measurement Unit
O2 %
CO2 mmHg,%, kPa
N2O %, MAC
AGT %, MAC
AGT2 %, MAC

Configuring Gas Measurement Alarms

Gas measurement alarms are divided into two groups, each one with its own adjustment
allowing its alarms to be activated or deactivated.
1. General audible alarms (configured from the General tab) are:
awRR, etO2, inO2, etCO2, and imCO2
2. Anesthetic audible alarms (configured from the Anesthetics tab) are:
etN2O, inN2O1, etHAL, inHAL, etSEV, inSEV, etENF, inENF, etISO, inISO, etDES, and
inDES
The alarm limits and measurement values are displayed as configured by the user in the
Gas menu.
Notes
• The anesthetic values and their limits always have one digit after the decimal point.
• The N2O values and their limits are whole numbers when the selected unit is “%” and has
one digit after the decimal point when the selected unit is “Mac”.
• The CO2 values and their limits are whole numbers when the selected unit is “mmHg” and
has one digit after the decimal point when the selected unit is “%” or “kPa”.
• The O2 and awRR values and their limits are always whole numbers.
The patient monitor displays the waveforms on the left side of the screen and numeric
panes on the right side of the screen. Two Gas waveforms can be displayed on the
numeric pane, Gas Page 1 and Gas Page 2.
When the first Gas waveform is selected, the Gas Page 1 pane is added to the right of the
screen. When a second waveform is assigned to the screen, the Gas Page 2 pane is
added to the screen.
Gas Page 1
Gas Page 2
Note: the waveforms above have been compressed.
Above and below the Gas waveform are lines which mark the minimum and maximum
levels. These scale lines are not at the absolute edge of the waveform region, but at
1. The
physiological alarm “inO2 Low” cannot be disabled.

about the +/- 75% levels from the center. The actual scale is displayed with each line and
drawn in white. The scale is configurable in the related waveform configuration dialog.
To view and/or change the default alarm limits for the Gas measurement module, select
the numeric pane on the right side of the screen that corresponds with the waveform you
are measuring to display the Gas Menu. The General tab of the Gas Menu includes the
following selections and default limits:
Measurement Options
awRR (rpm) Upper 30

Lower 8
etCO2 (mmHg) 60
25
imCO2 (mmHg) 4
etO2 (%) 100

10
inO2 (%) 100

18
Apnea Time Default is 20 seconds
CO2 Unit mmHg,%, kPa
Gas On/Standby On
Off
See “Gas Standby Mode”
on page 6-15
O2 Compensation 41—60%
(available only for modules
without O2)
There are between three and five parameter selection boxes. Select one parameter for
each box. These parameters will be displayed on the numeric pane on the main screen of
the patient monitor.
Parameter Selections
• awRR
• imCO2 (inspired minimum CO2)
• etCO2 (end tidal carbon dioxide)
• inN2O
• etN2O (end tidal nitrous oxide concentration)
• inO2
• etO2 (end tidal oxygen concentration)
• inAGT (inspired agent)*
• etAGT (expired agent)*
• MACt
*If using the dual agent module, there will be inAGT2 and etAGT2 also.

Gas Mixtures
Parameter selections are displayed on the numeric pane:
The Anesthetics tab of the Gas Menu includes all of the available anesthetic alarm limits
and defaults. If the Anesthetic Agent selected is ENF, the applicable alarm limits will be
etENF and inENF. If the Anesthetic Agent is DES, the applicable alarm limits will be etDES
and inDES.
For the modules without agent identification, the user needs to select the anesthetic
agent used. The default selection is HAL. If the wrong gas is selected, this can confuse
the user and lead to misinterpretation.
etHAL (MAC) etSEV (MAC) etENF (MAC) etISO (MAC) etDES (MAC)
2.1 2.4 1.9 2.2 1.7
0.0 0.0 0.0 0.0 0.0
inN2O (MAC) inHAL (MAC) inSEV (MAC) inENF (MAC) inISO (MAC) inDES (MAC)
0.8 2.6 2.9 2.4 2.6 2.5
0.0 0.0 0.0 0.0 0.0
Notes
• The MAC values for each anesthetic agent are extracted from the 80601-2-55 standard.
• Alarm limits in MAC are calculated based on a healthy 40-year-old adult male patient.
Gas Mixtures
When a mixture of gases is identified by the Gas module, there will be a technical alarm.
The following table displays the Agent Type, Mixture, Alarm Priority and Alarm Message.
Alarm
Module Type No Agents MACt Value Alarm Message
Priority
Dual Agent module 2 MAC >= 3 Medium Anesthetic Mixture: High MAC
Dual Agent module 2 MAC < 3 Low Anesthetic Mixture: Low MAC
Dual Agent module 3 or more -?- Low Anesthetic Mixture
Single Agent 2 or more -?- Low Anesthetic Mixture

module

Accessories
Gas Standby Mode

The Gas Menu provides an option to turn the Gas module On or to put it on Standby.
When the module is on Standby, the pump is turned off, however the fan remains on and
keeps the components warm, thus when you exit standby mode, the measurement is
available almost instantly.
When the Efficia monitor is put in suspended mode, the Gas module is put in standby
mode automatically, and when the monitor leaves suspended mode, the Gas module
returns to operating mode.
The low priority, visual-only alarm, “Gas Alarms Suppressed” will be displayed when the
Gas module is turned on or leaves standby mode. The alarm means that the Gas
module’s physiological alarms (high/low and apnea) are suppressed until breathing
activity is detected. To confirm breathing activity, the monitor waits until 4 breath cycles
are detected. This is to prevent alarms before the patient is actually connected to the
monitor.
Accessories
See “Gas Module Accessories” on page 8-4
Note — The Gas measurement module and its accessories are not made with natural rubber latex.
Measurement Troubleshooting
Numerous factors can influence the accuracy of the Gas measurement output values:
sampling tube erroneously connected, sample flow reversed, kinked sampling tube, etc.
Problems that can occur:
• No gas measurement data
• Small amount of blood extracted from the patient.
Follow your institution’s policies and protocols for performing Gas measurements.
Warning Philips recommends cleaning and disinfecting the monitor and module before
maintenance is performed, or if the equipment is returned for repair. Turn the monitor off
before you begin cleaning and disinfecting.

Maintenance
Maintenance
The biomed at your hospital should be perform regular inspection and service of the
monitor and gas module. Philips recommends that for repairs and complex maintenance,
these should be performed by experts and/or the manufacturer.
Authentic parts should be used for all repairs. Refer to the Service and Repair Guide for
the Rack and Modules and also the Installation and Configuration Guide.
Gas Measurement Safety Information

The Gas module is suitable in the presence of electrosurgery.

equipment safety.
• Do not use the Gas measurement module in flammable environments i.e.: anesthetic
mixture with air, with oxygen or nitrous oxides. Do not use in the presence of
explosive anesthetic agents such as alcohol, ether, cyclopropane or spray them into
the device.
the rack module, cables, hoses and/or sample line on the ground. Do not place anything
on top of the medical device.
• The sample gas must not be wasted to the ambient air. Contamination of the ambient
air with sample gas causes a health hazard to the personnel in the operating room
and leads to inaccurate measurement values when used for zeroing purposes.
• During a cardiopulmonary bypass, disconnect the sample line and seal the Luer Lock
connector on the Y-piece or switch the gas analyzer to standby mode.
each use.
• Do not operate the Gas measurement module without the water trap. Always use the
water trap to avoid cross-infection of patients, exposing patient to contaminated
breathing gas, and damages to the gas measurement module. Contaminated liquid in
the water trap could be exposed to the user while draining the removable water trap
or touching the water trap or device surface.

• Used sample lines may be infectious due to the breathing gases that passed through
them. Foreign particles, pathogenic germs and bacterial contamination can occur if
the sample lines are not replaced. Sampling lines are not reusable and must be
replaced after each patient unless a bacterial filter is in place between sample line
and patient. Observe the replacement intervals of the water trap.
• Serious contamination hazards can occur with used sampling lines, HMEs, water traps
and using a contaminated module and require appropriate disposal. See your
biomedical engineer for appropriate action.
• Ensure proper ventilation of the place where the monitor and Gas module are located.
When anesthetic gases are improperly vented in a room and prolonged exposure of
the users to such mixtures with concentrations above the commonly accepted values,
could lead to minor injury (dizziness and reduced accountability).
• Do not expose the gas analyzer to excessive heat or sunlight as this could lead to
overheating of the instrument and result in injuries.
• Avoid any restriction or blockage of air flow as this could cause overheating of the gas
analyzer and result in injuries.

monitor.
limit.
receptacle must be a three-wire grounded outlet. Never adapt the three-prong plug
monitor.
• When you are connecting the electrodes or the patient cable, make sure that the
connectors never come into contact with other conductive parts, or with earth. In
particular, ensure that all of the ECG electrodes are attached to the patient to prevent
them from contacting conductive parts or earth.
may affect the MRI image, the MRI unit may affect the accuracy of the monitor’s
magnet.

Risk of inaccurate Gas measurement:
• To prevent the risk of inaccurate gas measurement values or exposing bystanders to
anesthetic gases, always connect the gas exhaust of the monitor and measurement
module and the anesthesia machine to the scavenging system. Do not return the
gases to the breathing system.
• Using the Gas module in environments that do not meet recommended temperature,
humidity and altitude environments can cause condensation inside the device.
• To avoid temporary influence on the gas measurement and prevent damage to the
water trap and measuring system, do not use nebulizers/aerosols in the breathing
system, when the medical device is connected. Disconnect the sample line
temporarily when using nebulizers in the breathing system.
• When selecting the anesthetic agent manually, be sure to select the correct label for
the agent that you will be using in the operating room. Selecting the wrong agent will
cause erroneous readings.
• In addition to the warnings mentioned above, the following conditions may also cause
inaccurate or no measurement data:
• Exposing the device to excessive heat or direct sunlight.
• Operating the device without a water trap
• During a system restart no measurement data will be collected.

7
Care and Cleaning
To clean or disinfect your Efficia rack and measurement modules, use only the approved
cleaning agents listed in this chapter.
For information on how to clean or disinfect accessories, see the instructions for use
provided with the accessory.
General Guidelines
Keep the rack, modules, cables, and accessories free of dust and dirt. Periodically inspect
vents for dust and clean the vents if necessary. After you clean and disinfect the
modules, check them carefully and do not use it if you see signs of deterioration or
damage.
If you need to return any equipment to Philips, clean and disinfect it first.
Cautions • It is the responsibility of the hospital to determine the appropriate cleaning protocol
for each care unit.
• Do not use unapproved cleaning or disinfecting agents. Even small quantities of some
cleaning agents will damage the monitor.
• Do not use abrasive cleaners or strong solvents such as acetone or acetone-based
compounds. The warranty does not cover damage caused by using unapproved
substances.
• Follow these general precautions:
• Always dilute cleaning agents according to the manufacturer’s instructions or
use the lowest possible concentration.
• Do not allow liquid to enter the monitor case or modules. Do not immerse any
part of the equipment in liquid.
• Do not pour liquid onto the system. If you spill liquid on the exterior of the monitor,
use a clean cloth to dry the monitor. If you believe the liquid may have gotten inside
the monitor, contact your technical support team, who can verify the performance and
safety of the unit.
• Do not use abrasive material (such as steel wool or silver polish).
• Do not autoclave, steam sterilize, or ultrasonically clean the monitor or cables.
• Do not use bleach on the electrical contacts or connectors.
Care and Cleaning

Cleaning and Disinfecting the Monitor, Rack and Modules
Cleaning and Disinfecting the Monitor, Rack and Modules

To clean and disinfect the Efficia Monitor, Rack and Modules:
Step
1 Dampen a soft cloth with any of the following solutions:

• Isopropyl alcohol (70% solution in water)
• Mild soap and water
• Sodium hypochlorite (chlorine bleach, 10% solution in
water)
• Quaternary ammonium chloride compounds (<1%)
• Hydrogen peroxide (<5%) with phosphoric acid (<5%)
• Peracetic acid (<1%) with Hydrogen peroxide (<1%)
• Sodium dichloroisocyanurate solid (48% before dilution)
• Ethylene glycol monobutyl ether (1% – 5%) with
isopropanol (17%)
• n-Alkyl dimethyl benzyl ammonium chloride (8.1%) before
dilution with didecyl dimethyl ammonium chloride (8.7%)
before dilution
• Diethylene glycol butyl ether (5 – 10% by weight)
• Sodium dodecylbenzenesulfonate solid (20% before
dilutions)
2 Wring any excess moisture from the cloth and wipe the
monitor at room temperature.
Reprocessing
Follow the above mentioned instructions for care and cleaning of your rack and modules.
For information on cleaning and reprocessing any accessories, see the Instructions for
Use that ships with the accessory.
Approved Cleaning Agents

The following cleaners have been tested and are approved for cleaning the Efficia rack
and measurement modules.
Caution Only use the approved cleaners. The use of unapproved cleaners will cause damage to
the rack and modules and void the warranty.
• Dismozon Plus
• Descogen Liquid RFU
• Descospet Pur
• Biguacid Liquid (Also known as Big Spray “new”)
Care and Cleaning
Cleaning and Disinfecting the Cables
Cautions • Do not use alcohol to clean the cables. Alcohol can cause the cables to become brittle
and fail.
• Do not immerse or autoclave the cable.
• Do not use ultrasonic cleaners on the cable.
• Do not clean electrical contacts or connectors with bleach.
• For information on cleaning accessories, see the Instructions for Use that ships with
the accessory.
To clean the cables:
Step
1 Dampen a soft cloth with alcohol-free hand soap.
2 Wring any excess moisture from the cloth before cleaning and
gently clean the cables.
3 Clean the areas again with a damp cloth moistened with water
only.
To disinfect the cables:
Step
1 Dampen a soft cloth with sodium hypochlorite (chlorine

bleach), 3% solution in water.
Caution: Sodium hypochlorite may discolor the cable.
2 Wring any excess moisture from the cloth and gently clean the
cables.
3 Clean the areas again with a damp cloth moistened with water
only.
Care and Cleaning

Care and Cleaning

IBP Module Accessories
8
Accessories List
This chapter lists accessories that are compatible with the Efficia rack. Not all accessories
are available in all countries.
Warning Use only approved accessories with the Efficia CM patient monitor, rack and modules. The
use of unapproved accessories can diminish performance or safety. For a list of
accessories compatible with the Efficia CM patient monitors see, Efficia CM Series
Note: The accessory list is subject to change. For the latest information on supported accessories,
contact your authorized Philips representative or refer to www.healthcare.philips.com.
IBP Module Accessories
Reusable Transducers
Description Part Number
Reusable pressure transducer 5V/V/mmHg CPJ840J6

sensitivity
Single use sterile domes (50/case) CPJ84022
Accessories List
CO2 Module Accessories
Note: Accessories specified below do not allow for a connection to the output port
back to the patient.
Sidestream CO2 Accessories
Intubated FilterLineTM Sampling Lines
Patient Category Description Part Number
Adult/Pediatric FilterLine™ set M1920A
Adult/Pediatric FilterLine™ H set M1921A
Infant/Neonatal FilterLine™ H set M1923A
Adult/Pediatric VitaLine H set 989803159571
Infant/Neonatal VitaLine H set 989803159581
Adult/Pediatric FilterLine™ set, long 989803160241
Adult/Pediatric FilterLine™ H set, long 989803160251
Infant/Neonatal FilterLine™ H set, long 989803160261
Accessories List
Non-Intubated Oral/Nasal FilterLineTM Sampling Lines
Patient Category Description Part Number
Adult/Intermediate Smart CapnoLine™ M2526A
Pediatric Smart CapnoLine™ M2524A
Adult/Intermediate Smart CapnoLine™ O2, oral-nasal cannula M2522A
Pediatric Smart CapnoLine™ O2, oral-nasal cannula M2520A
Adult Smart CapnoLine™ O2, oral-nasal cannula, long 989803160281
Pediatric Smart CapnoLine™ O2, oral-nasal cannula, long 989803160271
Adult Smart CapnoLine™ plus, long 989803160301
Adult Smart CapnoLine™ H O2, oral-nasal 989803177951
Adult Smart CapnoLine™ H O2, oral-nasal, long 989803177961
Pediatric Smart CapnoLine™ H O2,oral-nasal 989803177971
Pediatric Smart CapnoLine™ H O2, oral-nasal, long 989803177981
Adult1 Smart CapnoLine™ Guard 989803178031
Adult1 Smart CapnoLine™ Guard O2 989803178041
Adult1 Smart CapnoLine™ Guard O2, long 989803178051

1. For any patient that requires and can tolerate a 60 Fr Bite Block, as recommended by the attending physician.
Non-Intubated Nasal FilterLine™ Sampling Lines
Patient
Category
Adult CapnoLine™ H O2, nasal M4680A
Pediatric CapnoLine™ H O2, nasal M4681A
Infant/Neonatal CapnoLine™ H O2, nasal 989803178001
Adult NIV Line M4686A
Pediatric NIV Line M4687A
Infant/Neonatal CapnoLine™, nasal 989803178021
Adult CapnoLine™ H, nasal M4689A
Infant/Neonatal CapnoLine™ H, nasal M4691A
Infant/Neonatal CapnoLine™ H, nasal, long 989803178011
Adult CapnoLine™ O2 989803179101
Pediatric CapnoLine™ O2 989803179121
Adult CapnoLine™ O2, long 989803179111
Accessories List
BIS™ Module Accessories
BIS™ Module Accessories

To re-order BIS™ sensors, contact Covidien. BIS sensors are not available from Philips.
Gas Module Accessories
8633902 863383
CM120 CM12
Water Trap 989803191081 X X
Gas Sample Line, 2.6M M1658A X X
Elbow Airway Adapter 13902A x x
Straight Airway Adapter M1612A x x
Gas Exhaust Return Line M1655B x x
Gas Exhaust Return Filter M1656B x x
Miscellaneous Accessories
Cable management kit 989803148841
Cable hook kit 989803195551
Lithium ion battery, 3-cell battery pack 989803189981
Lithium ion battery, 9-cell battery pack 989803194541
Roll stand 989803176601
Roll stand mounting kit 989803195541
Recorder paper (5 rolls) 989803136891
Serial interface adapter 989803159601
Wall mount, 10-inch 989803195571
Accessories List
9
Specifications
Rack and Plug-in Module Specifications
Parameter Specification
Rack Size
Dimensions 148mm (H) x 223mm (W) x 162mm (D) including the

rubber feet
Weight < 1.5 kg (without the aluminum support)
Physical Characteristics
Slots The rack has four (4) plug-in slots
Ejection Buttons The rack has four (4) ejection buttons to remove a plug-in
from a slot
Dual IBP module
Dimensions ื 105mm (H) x 50.5mm (W) x 121mm (D)
Weight < 270g

CO2 module
Weight < 380g
BISx4 module
Weight < 250g
Gas module (without Dräger Water-Trap)
Dimensions ื 105mm (H) x 102.5mm (W) x 131.5mm (D)
Weight < 1.25kg
Specifications
Safety Standards
Safety Standards
Applicable Standards
IEC 60601-1:2005/A1:2012 IEC 60601-2-27:2011

IEC 60601-1-2:2014 IEC 80601-2-30:2018
EN 60601-1-2:2015 IEC 60601-2-34:2011
IEC 60601-1-6:2013 IEC 80601-2-49:2018
IEC 62366:2007/A1:2014 ISO 80601-2-55:2018
IEC 60601-1-8:2006/A1:2012 ISO 80601-2-56:2017
IEC 62304:2006/A1:2015 ISO 80601-2-61:2017
IEC 60601-2-26:2012
Protection Class Class I, internally powered equipment, per IEC 60601-1
Degree of Protection The Multi-gas CO2 Connections and dual IBP are Type
CF defibrillator-proof: per IEC 60601-1
The BIS module is Type BF defibrillator-proof.
IPX1 Ingress protection against vertically falling water
drops
Mode of Operation Continuous
Protection Against Hazards Equipment is not suitable for use in the presence of a
of Ignition of Flammable flammable anesthetic mixture with air or oxygen or
Anesthetic Mixtures nitrous oxide, per IEC 60601-1.
Electrical and Environmental Specifications

The monitor might not meet performance specifications if stored or used outside the
specified temperature, humidity, and altitude ranges.
Power Sources
Power Supply One PoweredUSB cable connection to the monitor for

power and data.
The cable is available in:
• 1.0 m
• 1.8 m
Specifications
Battery Run Time With the monitor connected to the rack and with one fully
(Monitoring ECG, SpO2 and charged 9 cell battery.
15 minute NBP interval > 1 hour for CM12, CM120, and CM150 monitors.
measurements, 25°C, LCD
screen brightness at 6)
With the monitor connected to the rack and with two fully
charged 9 cell batteries.
> 3 hours for CM12, CM120 and CM150 monitors.
See “Rack Power” on page 9-6 for more information.
Mechanical Shock The monitor, rack and modules operate after exposure to
the following mechanical shock standards.
Operating:
• Half-sine waveform, Peak Acceleration 50g’s.
• Velocity of < 55 in/sec
• Pulse duration < 3 ms, one impact on each of six
faces.
Non-Operating Survival:
• Trapezoidal waveform, acceleration >= 30g
• Faired Acceleration velocity change = 742 cm/s +/-
5%
• One impact on each of six faces.
Test conditions include:

• Peak Acceleration: 150 m/s2 (15.3g)
• Duration: 11 ms
• Pulse shape: half sine
• Number of shocks: 3 shocks per direction per axis (18
total)
Mechanical Vibration Test conditions include:

• Frequency range: 10 Hz to 2000 Hz
• Resolution: 10 Hz
• Acceleration amplitude:
10 Hz to 100 Hz 1.0 (m/s2)2/Hz.
100 Hz to 200 Hz -3 dB/octave
200 Hz to 2000 Hz 0.5 (m/s2)2/Hz
• Duration: 10 min per each perpendicular axis (3 total)
Rack to monitor Interface 9-15V

Supply Voltage range The maximum current draw through rack is 3.6A while
Gas, dual IBP and BIS modules are inserted.
Thermal
Operating Monitor, rack, and modules:

Temperature1 • 10oC to 40oC (50o F to 104o F)
Specifications
Storage Monitor, rack, and modules:
Temperature2 • -20oC to 50oC (-4o F to 122o F)
Monitor with recorder paper
• -20oC to 40oC (-4o F to 104o F)
Dräger OEM Gas module:
• -20oC to 75oC (-4o F to 167o F)
Covidien BISx4 patient cable:
• -40oC to 70oC (-40o F to 158o F)
Oridion Microstream™ CO2:
• -40oC to 70oC (-40o F to 158o F)
Transport -20oC to 40oC (-4o F to 104o F)

Temperature
Humidity
Operating Humidity3 Monitor, rack, and modules:

• 15% to 90% RH, without paper non-condensing
Storage Humidity 15% to 90% RH, non-condensing
Transport Humidity 15% to 90% RH, non-condensing
Atmospheric Pressure
Operating Monitor, rack, and modules:

Atmospheric • 0 m to 3,000 m (0 ft to 9,842 ft) above sea level
Pressure4 • 1,013 mbar to 701 mbar (101 kPa to 70 kPa)
Storage Atmospheric Monitor, rack, and modules:

Pressure • 0 m to 3,000 m (0 ft to 9,842 ft) above sea level
• 1,013 mbar to 701 mbar (101 kPa to 70 kPa)
Transport 701 hPA to 1013 hPA

Atmospheric Pressure
Electromagnetic The monitor, rack and modules meet the IEC 60601-1-2:2014,
Compatibility 4th Edition Standard.
Meets IEC Class A emission levels
1. Composite test range: 10° C to 40° C

2. Composite test range: -20° C to 50° C without paper
3. Composite test range: 15% to 90% without paper non-condensing
4. Composite tested 1013 - 701 mbar, 0 - 3000 meters, 0 - 9842 feet above sea level.
Specifications
Measurement Connectors
Measurement Connectors
IBP module Dual IBP has 2 channel connectors

Type CF, defibrillator proof
Gas module Rotary mechanism for the water trap to enable

plug-in use in 90 degree position
Exhaust connector
Type CF for module with O2 and dual agent auto
detection and without O2 and dual agent auto
detection.
BIS module Philips 12 pin circular connector (no insulation in

the module)
Type BF
CO2 module Oridion input/output connector

Type CF, defibrillator proof
Interface Specifications
Connector BIS: 12 pin circular, not insulated
Specifications
Rack Power
Rack Power
When running on batteries, the connection of previously disconnected modules is not
always possible. When the rack detects that module will not be able to be powered
without affecting the monitor, the slot is turned off. The module will be displayed as
malfunction.
If the monitor is powered by at least one 9-cell battery (1

x9 cell or 2 x9 cell or 1 x 3cell and 1x9 cell) and not
plugged into AC Power, the rack works normally while the
charge of the highest charged 9-cell battery is above
50%.
For the monitor running on battery power (without AC):

• Disable rack operation if only a 3-cell battery (single
or dual) is installed.
• Enable rack operation while a 9-cell battery is
installed.
Rack Power • Enable Gas module operation as long as the battery
capacity is over 3900mAh.
For a monitor running on battery power, with a battery
capacity lower than:
• 800mAh for 12" monitor
• 900mAh for 15" monitor
When the monitor is connected to the rack (with or
without modules), a battery extreme low alarm will result.
The modules and rack are not being powered on due to
insufficient power availability.
If the battery goes below 50% while a Gas module is

connected, the module is disconnected and the rack
keeps working normally. An alarm is triggered to inform
the user: GAS Unavailable - Low Battery.
If the user tries to connect the Gas module while the

battery is below 50%, and not connected to AC power, it
will be rejected. An alarm is triggered to inform the user:
Rack power with Gas GAS Unavailable - Low Battery.
module
If a user connects a Gas module to an AC powered
monitor while the battery is below 50%, the rack and Gas
modules will work normally.
For information about enabling rack operation with a 9-

cell battery, using the Gas module, see “For the monitor
running on battery power (without AC):” referenced
above.
Specifications
Alarm Specifications
The following section describes all physiological and technical alarms used with the
Efficia rack and the measurement modules.
For more information about Efficia CM Series alarm limits and defaults, see the Efficia CM
Series Instructions for Use.
Physiological Alarms
The following table lists all physiological alarm messages and provides a description of
each alarm.
Alarm Message Priority Cause

BIS Alarms
BIS High Medium High BIS limit violated
BIS Low Medium Low BIS limit violated
BIS L High Medium High BIS L limit violated
BIS L Low Medium Low BIS L limit violated
BIS R High Medium High BIS R limit violated
BIS R Low Medium Low BIS R limit violated
Gas Module
inO2<18% High Inspired O2 is lower than 18% violated
inO2 High Medium High inspired O2 limits violated
inO2 Low Medium Low inspired O2 limits violated
etO2 High Medium High expired O2 limits violated
etO2 Low Medium Low expired O2 limits violated
imCO2 High Medium High inspired CO2 limits violated
etCO2 High Medium High expired CO2 limits violated
etCO2 Low Medium Low expired CO2 limits violated
inN2O High Medium High inspired N2O limits violated
inHAL High Medium High inspired HAL limits violated
inHAL Low Medium Low inspired HAL limits violated
etHAL High Medium High expired HAL limits violated
etHAL Low Low Low expired HAL limits violated
inENF High Medium High inspired ENF limit violated
inENF Low Medium Low inspired ENF formats violated
etENF High Medium High expired ENF limits violated
Specifications

etENF Low Medium Low expired ENF limits violated
inISO High Medium High inspired ISO limits violated
inISO Low Medium Low inspired ISO limits violated
etISO High Medium High expired ISO limits violated
etISO Low Medium Low expired ISO limits violated
inSEV High Medium High inspired SEV limits violated
inSEV Low Medium Low inspired SEV limits violated
etSEV High Medium High expired SEV limits violated
etSEV Low Medium Low expired SEV limits violated
inDES High Medium High inspired DES limits violated
inDES Low Medium Low inspired DES limits violated
etDES High Medium High expired DES limits violated
etDES Low Medium Low expired DES limits violated
Gas awRR Apnea High Apnea time exceeded
Anesthetic Mixture: Medium A mixture of anesthetic gases were detected, the

High MAC gases were identified and the total MAC of the
mixture is equal to or greater than three.
IBP Module
ABP(s) High Medium High Systolic ABP blood pressure limits violated
ABP(d) High Medium High Diastolic ABP blood pressure limits violated
ABP(m) High Medium High Mean ABP blood pressure limits violated
ABP(s) Low Medium Low Systolic ABP blood pressure limits violated
ABP(d) Low Medium Low Diastolic ABP blood pressure limits violated
ABP(m) Low Medium Low mean ABP blood pressure limits violated
CVP(m) High Medium High mean CVP pressure limits violated
CVP(m) Low Medium Low mean CVP pressure limits violated
PAP(s) High Medium High Systolic PAP pressure limits violated
PAP(d) High Medium High Diastolic PAP pressure limits violated
PAP(m) High Medium High Mean PAP pressure limits violated
PAP(s) Low Medium Low Systolic PAP pressure limits violated
PAP(d) Low Medium Low Diastolic PAP pressure limits violated
PAP(m) Low Medium Low Mean PAP pressure limits violated
ICP(m) High Medium High mean ICP pressure limits violated
ICP(m) Low Medium Low mean ICP pressure limits violated
Specifications

ART(s) High Medium High Systolic ART pressure limits violated
ART(d) High Medium High Diastolic ART pressure limits violated
ART(m) High Medium High Mean ART pressure limits violated
ART(s) Low Medium Low Systolic ART pressure limits violated
ART(d) Low Medium Low Diastolic ART pressure limits violated
ART(m) Low Medium Low Mean ART pressure limits violated
P(s) High Medium High Systolic P pressure limits violated
P(d) High Medium High Diastolic P pressure limits violated
P(m) High Medium High Mean P pressure limits violated
P(s) Low Medium Low Systolic P pressure limits violated
P(d) Low Medium Low Diastolic P pressure limits violated
P(m) Low Medium Low Mean P pressure limits violated
Ao(s) High Medium High Systolic Ao pressure limits violated
Ao(d) High Medium High Diastolic Ao pressure limits violated
Ao(m) High Medium High Mean Ao pressure limits violated
Ao(s) Low Medium Low Systolic Ao pressure limits violated
Ao(d) Low Medium Low Diastolic Ao pressure limits violated
Ao(m) Low Medium Low Mean Ao pressure limits violated
UAP(s) High Medium High Systolic UAP pressure limits violated
UAP(d) High Medium High Diastolic UAP pressure limits violated
UAP(m) High Medium High Mean UAP pressure limits violated
UAP(s) Low Medium Low Systolic UAP pressure limits violated
UAP(d) Low Medium Low Diastolic UAP pressure limits violated
UAP(m) Low Medium Low Mean UAP pressure limits violated
LAP(m) High Medium High mean LAP pressure limits violated
LAP(m) Low Medium Low mean LAP pressure limits violated
RAP(m) High Medium High mean RAP pressure limits violated
RAP(m) Low Medium Low mean RAP pressure limits violated
UVP(m) High Medium High mean UVP pressure limits violated
UVP(m) Low Medium Low mean UVP pressure limits violated
Specifications
Technical Alarms
The following table lists all technical alarm messages and provides a description of each
alarm. The alarms are grouped by module.

Rack
Module unsupported (slot 1) Low An unsupported module has been

Module unsupported (slot 2) connected to the Rack.
Module unsupported (slot 3)
Module unsupported (slot 4)
Module malfunction (slot 1) Low An Efficia module is connected to

Module malfunction (slot 2) the Rack and isn’t working
properly (it has a power or a
Module malfunction (slot 3)
communication problem.)
Module malfunction (slot 4)
For example, if the Gas module is
turned on and the temperature
probe is defective, the module will
shut down and the Module
Malfunction alarm will be triggered
and reported in the error log.
Contact your biomed for service.
Module Incompatible (slot 1) Low A module connected has a

Module Incompatible (slot 2) software version incompatible with
the monitor software version.
Module Incompatible (slot 3)
Module Incompatible (slot 4)
Rack Incompatible Low The Rack software version is not

compatible with the monitor
software version.
Rack Disconnected Low The Rack has been disconnected.
Module Disconnected: IBP Low An IBP module has been

disconnected.
Module Disconnected: BIS Low An BIS module has been

disconnected.
Module Disconnected: GAS Low An Gas module has been

disconnected.
Module Disconnected: CO2 Low An etCO2 module has been

disconnected.
Module Malfunction (Gas) Low Module Gas power fault. The

module connected to the Rack
isn’t working properly or there has
been a communication problem.
Module Malfunction: CO2 Low Module CO2 power fault. The

module connected to the Rack
isn’t working properly or there has
been a communication problem.
Rack Malfunction Low The Rack is not responsive or it

has a software corruption.
Specifications

BIS Module
BIS Device Disconnected Low BIS Device is disconnected from

the BIS module or defective BIS
module/cable.
BIS Device Source Error Low BIS Device internal isolated source
is defective or dysfunctional.
Check BIS Sensor Low BIS sensor is incorrectly connected

to BIS Device or defective BIS
Device/Sensor or Sensor is
improperly positioned on patient’s
forehead.
When this alarm message is
triggered, an impedance test is
automatically run.
BIS Sensor Disconnected Low BIS sensor is not connected to the

BISx or BISx4 device.
BIS Sensor Invalid Low A defective, incorrect or

unsupported sensor has been
connected to the BIS Device.
BIS Sensor Validity Expired Low Sensor validity date has expired.
BIS SQI Under 50% Low Signal Quality Index is below 50%
BIS L SQI Under 50%, when using Low Signal Quality Index for BIS L
bilateral sensor. sensor is below 50%
BIS R SQI Under 50%, when using Low Signal Quality Index for BIS R
bilateral sensor. sensor is below 50%
BIS SQI Too Low Low BIS signal quality is too low so the
BIS value cannot be precisely
calculated or too much artifact
interference or sensor may be
incorrectly positioned on the
patient’s forehead.
BIS L SQI Too Low, when using Low BIS signal quality is too low so the
bilateral sensor. BIS value cannot be precisely
BIS R SQI Too Low, when using Low BIS signal quality is too low so the
bilateral sensor. BIS value cannot be precisely
BIS Sensor Error, Detach/ Low BIS sensor shows a hardware error.
Reattach
Specifications

Too Many Uses - Replace BIS Low BIS sensor has been used too
Sensor many times - recommend replace
sensor.
BIS Device Not Responsive Low BIS Device is not responding.
BIS Device Malfunction Low BIS Device is malfunctioning.
BIS Device Overcharge Low BIS Device is in overcharge state.
BIS Artifact Low (visual only) Artifacts detected in EEG signal.
BIS Isoelectric EEG Low No EEG activity has been detected

for the last 63 seconds or no brain
activity. Also possible the sensor
simulator is connected to the BIS
Device or a defective sensor.
BIS Sensor Error, Detach/ Low BIS sensor shows a hardware error.
Reattach
GAS Module
Gas Unavailable - Low Battery Low Remaining Battery capacity is not

sufficient to power Gas module
properly. The Gas module is
disconnected.
Gas Sample Line Blocked High Obstruction of sampling tube.
Gas Check Water Trap/sample High Sampling tube disconnected,

line sampling tube incompatible, filter
filled with water, filter with
disconnected reservoir or filter
with obstructed reservoir.
Gas AGT1 Out of Range Medium AGT concentration is too high to

be measured.
Gas AGT2 Out of Range Medium AGT2 concentration is too high to

(for modules with dual agent be measured.
measurement)
Gas Malfunction1 High At least one component in the

module is inoperative.
Gas Timeout High No messages sent to the module

were validated in the last second.
Gas Fan Error Low Internal fan isn’t working at the

configured speed.
Gas High Temperature Medium The internal temperature is too

high (above 50o Celsius).
Anesthetic Mixture Medium A mixture of anesthetic gases were

detected and these gases haven’t
been identified.
Gas Reduced Accuracy Low (visual only) The accuracy of the gas
measurements is reduced.
Specifications

Anesthetic Mixture: Low MAC Low A mixture of anesthetic gases were
detected, the gases were
identified and the total MAC of the
mixture is less than three.
Gas Alarms Suppressed Low The physiological alarms are

(visual only) suppressed until the breath
activity is detected. To confirm
breath activity, the monitor waits
until 4 breath cycles are detected.
IBP Module
ABP Equip Malfunc1 Low IBP A/D cannot be configured

Ao Equip Malfunc 1 correctly during power-up, reset,
or if the configuration of the
ART Equip Malfunc1
module is not successful.
CVP Equip Malfunc1
ICP Equip Malfunc1
LAP Equip Malfunc1
P Equip Malfunc1
PAP Equip Malfunc1
RAP Equip Malfunc1
UAP Equip Malfunc1
UVP Equip Malfunc1
ABP Out of Range Low IBP pressure is over range.

Ao Out of Range
ART Out of Range
CVP Out of Range
ICP Out of Range
LAP Out of Range
P Out of Range
PAP Out of Range
RAP Out of Range
UAP Out of Range
UVP Out of Range
ABP No Transducer Medium The electrical connection is

Ao No Transducer broken.
ART No Transducer
CVP No Transducer
ICP No Transducer
LAP No Transducer
P No Transducer
PAP No Transducer
RAP No Transducer
UAP No Transducer
UVP No Transducer
Specifications

ABP Non-pulsatile High IBP pressure goes from wave to
Ao Non-pulsatile static and stays as static for 4
seconds.
ART Non-pulsatile
P Non-pulsatile
PAP Non-pulsatile
UAP Non-pulsatile
ABP Calibration Needed Low Module isn’t calibrated.

Ao Calibration Needed
ART Calibration Needed
CVP Calibration Needed
ICP Calibration Needed
LAP Calibration Needed
P Calibration Needed
PAP Calibration Needed
RAP Calibration Needed
UAP Calibration Needed
UVP Calibration Needed
CO2 Module
CO2 Equip Malfunc Low CO2 Equipment Malfunction.

Configuration for CO2 module is
not successful. Check error log for
details.
CO2 Out of Range Low CO2 value over range
CO2 Auto Zero Low SFM in Progress
CO2 Occlusion Low The CO2 sample line or exhaust

tube is blocked.
CO2 No Tubing High Filter Line not connected.
CO2 Calibration Needed Low CO2 module shall be calibrated

after 1200 operating hours, then
once a year or after 4000
operating hours, whichever comes
first.
Consult the Efficia Rack Service &
Repair Guide for calibration
instructions.
CO2 Sensor Malfunc Low CO2 Sensor Malfunction. Check

error log for details.
CO2 Out of Range Low CO2 value over-range (150 mmHg

or 20.0 kPa)
CO2 No Sensor High CO2 Sensor is not connected.
Specifications

CO2 Check Airway Adapter High CO2 Adapter is not plugged in
correctly or has been removed.
There is an optical blockage on the
windows of the airway adapter.
May also be caused by a failure to
perform a zero when the adapter
type is changed.
To clear, clean the airway adapter
if mucus or moisture is seen. If the
adapter is clean, perform a zero.
CO2 Sensor Over Temp Low CO2 Sensor temperature is greater

than 40° C.
CO2 Equip Malfunc Low CO2 Equipment Malfunction or if

the module configuration is not
successful. Check error log for
details.
CO2 Purging Low The CO2 filter line is being purged

to remove an occlusion in the line
or airway adapter. If the occlusion
is removed, the message
disappears.
1. Also displayed in the Error log
Specifications
CO2 Microstream™ Specifications

Capnography is a non-invasive method for monitoring the level of carbon dioxide in
exhaled breath (etCO2) to assess a patient’s ventilatory status. Microstream™
capnography modules use Microstream™ non-dispersive infrared (NDIR) spectroscopy.
Infrared spectroscopy is used to measure the concentration of molecules that absorb
infrared light. Because the absorption is proportional to the concentration of the
absorbing molecule, the concentration can be determined by comparing its absorption to
that of a known standard. The Microstream™ etCO2 sampling lines deliver a sample of
the inhaled and exhaled gases from the ventilator circuit or directly from the patient at 50
ml/min sampling flow rate. Moisture and patient secretions are extracted from the
sample, while maintaining the shape of the CO2 waveform.
The capnography module is intended to provide professionally-trained healthcare
providers with continuous, non-invasive measurement and monitoring of carbon dioxide
concentration of the expired and inspired breath and respiration rate. It is intended for
use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, and
intra-hospital transport.
Measurement Range 0 mmHg – 150 mmHg
Unit of measure Options include: mmHg, kPa or cmH20
Module operates with 0 to 700 ppm

ambient CO2 levels
Data Sample Rate Waveform sampling, 20 samples per second
Flow Rate 50 ml/min –7.5 + 15 ml/min, flow measured by volume.

If the module cannot hold the flow within the specified range, the module will
stop measuring, enter Failure Mode, and set the appropriate status bits
etCO2 and imCO2 1 mmHg

Displayed Resolution
Power Up Time1 Maximum 10 seconds
Initialization Time The time between powering up the monitor and presenting the first reading is
typically 30 seconds; maximum 3 minutes
CO2 Response Time The total response time for adults/pediatrics is approximately 3.9 seconds, for
10% to 90% changes in CO2 concentration. Calculated as follows:
Delay time + Rise time + System response time
CO2 Delay time: 2.7 seconds (typical)
CO2 Rise time: 0.2 seconds (typical)
Monitor response time: 1.0 second
The maximum CO2 response time (with a standard-length FilterLine™) is 5.3
seconds (typical).
Note:
• Adult/Pediatric Long FilterLines and Long Smart CapnoLines have a
maximum CO2 response time of 6.9 seconds (typical).
• For information on CO2 response time for infant/neonatal patients, see
“CO2 Response Time for Infant/Neonatal Accessories” on page 9-18.
Specifications
Calibration Interval • First calibration at 1,200 hours of use or after one year, whichever
comes sooner.
• After the first calibration, once a year or after 4,000 hours,
whichever comes sooner.
Auto Zero Interval Once per hour (typical)
Leak Tightness < 250 mBar/min when a 30% vacuum is invoked on the flow system.
CO2 Accuracy 0 mmHg – 38 mmHg: ±2 mmHg

39 mmHg – 99 mmHg: ± (5% of reading + 0.08 for every 1 mmHg above 38
mmHg)
100 mmHg – 150 mmHg: ± (5% of reading + 0.08 for every 1 mmHg above 38
mmHg)
As soon as a CO2 reading is presented, the measurement is accurate to the
above specifications.
Note:
• Accuracy applies for breath rates up to 80 bpm. For breath rates above 80
bpm, accuracy is ±4 mmHg or ±12% of reading, whichever is greater for
etCO2 values greater than 18 mmHg. To achieve the specified accuracies for
breath rates above 60 bpm, use the FilterLine™ H set for infant/neonatal
patients.
• The accuracy specification is maintained to an additional 4% of the
expected reading in the presence of interfering gases.
Drift of Measurement The periodic auto zero function compensates for drifts between components,
Accuracy changes in ambient temperature, and barometric conditions. This automatic
process eliminates variances that might otherwise cause measurement drift.
Therefore, the module does not exhibit drift.
Respiration Rate Range 0 rpm to 150 rpm
Respiration Test Method Breaths are simulated for use in respiration rate measurement with a system
which uses a tank of N2 (representing no CO2 for inhalation) and a tank of CO2
(of the % CO2 required for the particular test). A control board, which is triggered
by a computer, uses solenoids to switch the module input between the 2 tanks
of gas, creating a gas CO2 square wave. This system can create simulated
breaths over the full required range of specified respiration rates.
Respiration Rate Accuracy ±1 rpm in the range of 0 rpm – 70 rpm

±2 rpm in the range of 71 rpm – 120 rpm
±3 rpm in the range of 121 rpm – 150 rpm
Automatic Barometric The monitor is equipped with automatic barometric pressure compensation.
Pressure
Effects of Cyclical Will operate within specifications with over-pressure and under-pressure from a
Pressure ventilation system as follows:
• Over-pressure: +100 cmH2O
• Under-pressure: –20 cmH2O
Note: With high over pressures close to the upper limit, the module may enter
into a blockage mode in order to safeguard the module from damage.
The US Patents for the microMediCO2 module are listed at: www.covidien.com/patents
1. The time before CO2 measurements are available includes power-up time and initialization time.
2. CO2 conforms to ISO 80601-2-55.
Specifications
CO2 Response Time for Infant/Neonatal Accessories
CO2 Response Time for Infant/Neonatal Accessories
Total
Delay
Rise Time System
Part Number Description Time
(typical) Time
(typical)
(typical)
989803159581 VitaLine H Set intubated circuit 240 ms 5.3 s 6.5 s
989803160261 FilterLine™ H Set Long intubated 240 ms 3.0 s 7.2 s

circuit
989803178001 CapnoLine™ H O2 non-intubated Up to 310 ms Up to 5.9 s 7.2 s

dual-purpose circuit
989803178011 CapnoLine™ H Long non- Up to 320 ms Up to 5.9 s 7.2 s

intubated single-purpose circuit
989803178021 Nasal FilterLine™ non-intubated Up to 250 ms Up to 4.0 s 5.3 s

ventilation single-purpose circuit (standard length)
M1923A FilterLine™ H Set intubated circuit 180 ms 2.7 s 3.9 s
M4691A CapnoLine™ H non-intubated Up to 250 ms Up to 4.0 s 5.3 s

single-purpose circuit
IBP Specifications
Measurement Range -40 mmHg – 360 mmHg
Input Sensitivity 5m V/V/mmHg
Zero Static Offsets Up to ± 200 mmHg with ± 1 mmHg accuracy
Transducer Load Impedance Memscap Load impedance: 200 to 2000 Ohms

Memscap Output impedance: < 3000 Ohms
Transcap Load impedance: 300 to 700 Ohms
Transcap Output impedance: 300 to 1,000 Ohms
Overall Accuracy (including transducer) ± 4% of reading or ± 4 mmHg, whichever is greater
Volume displacement of CPJ840J6 0.2 mm3/100 mmHg
Warmup time of equipment and transducer < 15 seconds.
Specifications
BIS Specifications
BIS Specifications
The BIS measurement module is designed to monitor the hypnotic state of the brain
based on acquisition and processing of EEG signals. The BIS module processes raw EEG
signals to produce a single number, called the Bispectral Index™, or BIS, which correlates
with the patient's level of hypnosis.
The Efficia CM Series patient monitor when in use with the BIS module, will display:
• The current BIS number
• Trend graphs of processed EEG parameters
• Raw EEG waveforms in real time
• Various signal quality indicators (EMG, SQI)
• Suppression Ratio (if requested by the user)
• Burst Count number (when a BIS Extended Use Sensor is in use)
• Alarm Indicator and Messages
The module performs self-tests to ensure that it is functioning properly and that
impedance levels of patient sensors are within acceptable limits.
Measurement
Parameter Resolution
Ranges
Bispectral Index (BIS) 0 to 100 1%
Electromyography (EMG) 30 to 80 dB 1 dB
Signal Quality Index (SQI) 0 to 100% 1%
Suppression ratio (SR) 0 to 100% 1%
Spectral Edge Frequency (SEF) 0.5 to 30.0 Hz 0.1 Hz
Total Power (TP) 40 to 100 dB 1 dB
Burst count (BC) 0 to 30 1
When using a bilateral sensor, each parameter will have an R and L value for Right and
Left side of the brain, with above ranges and resolution.
.
EEG Trace Scale • ± 50 V
• ± 75 V
• ± 100 V
• ± 200 V
• ± 500 V
• ± 750 V
• ± 1000 V
Specifications
BIS Specifications
EEG Sweep Speeds • 6.25 mm/s
• 12.5 mm/s
• 25.0 mm/s
• 50.0 mm/s
Signal Bandwidth 0.25 Hz to 100 Hz (-3 dB) +/- 10%
Input Signal Information Input signals in the range of ±0,5 mV, varying at a rate to 12 mV/s,
shall be reproduced on the output with an error of  ±20 % of the
nominal value of the output or ±10 V, whichever is greater.
EEG Waveform Noise <0.3 V RMS (2.0 V peak-to-peak); 0.25 Hz to 50 Hz
Voltage information With a dc. offset voltage in the range of ±300 V and differential
input signal voltages of ± 0.5 mV that vary at rates up to 12 mV/s,
when applied to any LEAD WIRE, the time varying output signal
amplitude shall not change by more than ± 10% over the specified
range of dc. offset.
Common Mode Rejection 110 dB at 50/60 Hz to earth ground
(Isolation Mode)
Sensor Ground Check A periodic sensor ground check is performed every 10 minutes and
has a typical duration of < 5 seconds
Host Cable Power +5VDC +/- 5%, 500mA
Requirements
Protocol RS232/TTL
Specifications
Gas Specifications
Gas Specifications
The Gas measurement module samples gas from the breathing gas of pediatric patients
and adults. It continuously measures the concentration of CO2, N20 and anesthetic
agents in breathing gas as well as the 02 concentration (optional).
Measurement Ranges
Measurement Rise Time

Gas Type Accuracy
Range (t10...90)
O2 0 to 100 Vol% (only ± (2.5 Vol% 2.5% rel.) <500 ms (only Dual
Dual Module version) (only Dual Module Module version)
version)
CO2 0 to 13.6 Vol% ± (0.43 Vol% 8% rel.) <350ms
N2O 0 to 100 Vol% ± (2 Vol% 8% rel.) <350ms
Halothane 0 to 8.5 Vol% ± (0.2 Vol% 15% rel.) <450ms
Isoflurane 0 to 8.5 Vol% ± (0.2 Vol% 15% rel.) <450ms
Enflurane 0 to 10 Vol% ± (0.2 Vol% 15% rel.) <450ms
Servoflurane 0 to 10 Vol% ± (0.2 Vol% 15% rel.) <450ms
Desflurane 0 to 20 Vol% ± (0.2 Vol% 15% rel.) <450ms
Gas Measurements
Method Sidestream gas measurement
Infrared measurement: CO2, N2O, anesthetic agents
Paramagnetic measurement: O2
Gas unit of measure Options include: % and MAC
CO2 unit of measure Options include: mmHg, %, or kPA
Barometric pressure compensation Automated compensation
Gas sampling rate 200 mL/min ±20 mL/min
Gas sampling delay <5 seconds
Drift compensation (zeroing) Automated cyclical zeroing, once per day (in error-free
operation), latest 35 min. after last start-up
Zeroing duration <20s
Automatic detection1 (only Dual Primary gas: at least at 0.3 Vol%

Module version) Secondary gas: at least at 0.4 Vol%
Respiratory rate
Specifications
Quantitative effects of interfering gases and vapors
• Range 0 to 100 /min
• Accuracy 0 to 60 /min: ±1 /min

> 60 /min: not specified
• Resolution 1 /min
Water Trap lifetime 4 weeks
Time from startup to reach <450s

specified accuracy
1. With desflurane concentration greater than 4 Vol%, mixture detection occurs at the latest when the concentration
of the second anesthetic gas rises above 10% of the desflurane concentration.
Measurement system of endtidal values

The response time of the measuring system and gas sampling rate influence the gas
measurement. The accuracies specified in the technical data only apply to endtidal
values at a maximum respiratory rate of 75 /min and an I:E ratio of 1:2.
Influence of respiratory rate and I:E ratio on the accuracy

The influence of respiratory rate and I:E on the accuracy has been determined for the
measured gas concentrations in a simulated breathing system with step changes in
concentration.
Quantitative effects of interfering gases and vapors

Use the following table to view the cross sensitivity values for specified gas or vapor
levels in volume fraction.
Gas Level in % volume fraction

Gas or Vapor <0.2 Vol% volatile agent, <1.0 Vol% O2
CO2, and N20
Water Vapor Sample gas saturated with Sample gas saturated with
humidity at 37°C humidity at 37°C
Ethanol 0.3% 0.3%
Isopropanol 1.0% 1.0%
Acetone 0.1% 0.1%
Methane 0.1% 0.1%
Xenon Not for use with Xenon
Helium Not for use with Helium
Metered dose inhaler Not for use with metered dose inhaler propellants
propellants
Specifications
Profile Settings for Rack Modules

Profiles are predefined monitor configurations that can be used for different monitoring
situations. The monitor ships with the following three default profiles:
• Operating Room (OR)
• General Ward (GW)
• Intensive Care Unit (ICU)
See the Efficia CM Series Instructions for Use for more details about Profile Settings used
in the monitor. The following table lists the contents in profiles and their default
configurations for Rack modules:
Parameter GW ICU OR
Gas Gas Page 1 Pane displayed parameters Dual Module: Dual Module: Dual Module:
etCO2, inO2, etCO2, inO2, etCO2, inO2,
inN2O, inAGT1, inN2O, inAGT1, inAGT1
awRR awRR Single Module:
Single Module: Single Module: etCO2, awRR,
etCO2, awRR, etCO2, awRR, inAGT1
inN2O, inAGT1 inN2O, inAGT1
Gas Page 2 Pane displayed parameters Dual Module: Dual Module: Dual Module:
imCO2, etCO2, imCO2, etCO2, imCO2, inN2O,
etN2O, etAGT1, etN2O, etAGT1, awRR
awRR awRR Single Module:
Single Module: Single Module: imCO2, inN2O,
imCO2, awRR, imCO2, awRR, awRR, (or
etN2O, etAGT1, etN2O, etAGT1, inAGT2 for
awRR (or awRR (or double agent
etAGT2 for etAGT2 for modules)
double agent double agent
modules) modules)
CO2 Pressure Units mmHg mmHg mmHg
AGT Concentration Units % % %
Fan ON ON ON
Apnea Time 20 seconds 20 seconds 20 seconds
O2 Compensation 41-60% 41-60% 41-60%
Anesthetic Agent1 HAL HAL HAL
CO2 Sweep Speed 6.25 mm/s 6.25 mm/s 6.25 mm/s
CO2 Scale 0-25% 0-25% 0-25%
O2 Sweep Speed 6.25 mm/s 6.25 mm/s 6.25 mm/s
O2 Scale 0-25.0% 0-25% 0-25%
N2O Sweep Speed 6.25 mm/s 6.25 mm/s 6.25 mm/s
N2O Scale 0-25.0% 0-25.0% 0-25.0%
AGT2 Sweep Speed 6.25 mm/s 6.25 mm/s 6.25 mm/s
Specifications
Parameter GW ICU OR
AGT2 Scale 0-2.0% 0-2.0% 0-2.0%
General Audible Alarms Yes Yes Yes
Anesthetics’ Audible Alarms Yes Yes Yes
Gas On/Standby On On On
BIS EEG Sweep Speed 6.25 mm/s 6.25 mm/s 6.25 mm/s
BIS Scale -50 to 50 V -50 to 50 V -50 to 50 V
BIS Alarm Audible (Adult) Yes Yes Yes
BIS Alarm Audible (Pediatric) Yes Yes Yes
BIS Alarm Audible (Neonatal) Yes Yes Yes
BIS High Pass Filter 2 Hz 2 Hz 2 Hz
BIS Low Pass Filter 70 Hz 70 Hz 70 Hz
BIS Notch Filter 50 & 60 Hz 50 & 60 Hz 50 & 60 Hz
BIS Bispectra Smoothing Rate 30 seconds 30 seconds 30 seconds
BIS Impedance Check Yes Yes Yes
BIS Pane displayed parameters BIS, SR, SEF, BIS, SR, SEF, BIS, SR, SQI
SQI, TP SQI, TP
BIS L Pane displayed parameters BIS L, SR L, SEF BIS L, SR L, SEF BIS L, SR L, SQI
*Visible only with a bilateral sensor L, SQI L, TP L L, SQI L, TP L L
BIS R Pane displayed parameters BIS R, SR R, SEF BIS R, SR R, SEF BIS R, SR R, SQI
*Visible only with a bilateral sensor R, SQI R, TP R R, SQI R, TP R R
1. Available on Gas modules without AGT identification.

2. AGT Sweep Speed and Scale apply to all anesthetic agents, independently of the anesthetic agent detected.
Specifications
A4
Electromagnetic
Compatibility
This appendix lists the tests and compliance levels that make the Efficia CM patient
monitors suitable for use in the specified electromagnetic environment according to
IEC 60601-1-2:2014, 4th Edition Standard.

Medical electrical equipment can either generate or receive electromagnetic interference.
This product has been evaluated for electromagnetic compatibility (EMC) with the
appropriate accessories according to IEC 60601-1-2:2014, the international standard for
EMC for medical electrical equipment. This IEC standard has been adopted in the
European Union as the European Norm, EN 60601-1-2:2015.
Radio frequency (RF) interference from nearby transmitting devices can degrade
performance of the product. Electromagnetic compatibility with surrounding devices
should be assessed prior to using the product.
Fixed, portable, and mobile radio frequency communications equipment can also affect
the performance of medical equipment. See your service provider for assistance with the
minimum recommended separation distance between RF communications equipment
and the product.
The cables, sensors/transducers, and other accessories for which compliance is claimed
are listed in this manual.
Warnings • Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
• The Efficia CM patient monitors should not be used adjacent to or stacked with
other equipment. This should be avoided because it could result in improper
operation. If adjacent or stacked use is necessary, the monitor should be observed
to verify normal operation in the configuration in which it is used.
Reducing Electromagnetic Interference

The Efficia CM patient monitors and associated accessories can be susceptible to
interference from other RF energy sources and continuous, repetitive, power line bursts.
Examples of other sources of RF interference are other medical electrical devices, cellular
products, information technology equipment, and radio/television transmission. If
interference is encountered, as demonstrated by artifact on the ECG or dramatic
variations in physiological parameter measurement values, attempt to locate the source.
Assess the following:
Electromagnetic Compatibility
Efficia CM Series Rack and Modules Instructions for Use A-1
• Is the interference due to misplaced or poorly applied electrodes or sensors? If so, re-
apply electrodes and sensors correctly according to directions in the product’s
• Is the interference intermittent or constant?
• Does the interference occur only in certain locations?
• Does the interference occur only when in close proximity to certain medical electrical
equipment?
• Do parameter measurement values change dramatically when the AC line cord is
unplugged?
Once the source is located, attempt to attenuate the interference by distancing the
product from the source as much as possible. If assistance is needed, contact your
technical support team.
Restrictions for Use

Artifact on ECG and other physiological waveforms caused by electromagnetic
interference should be evaluated by a physician or physician authorized personnel to
determine if it will negatively impact patient diagnosis or treatment.
Emissions and Immunity

The Efficia CM patient monitors are designed and evaluated to comply with the
emissions and immunity requirements of international and national EMC standards. For
detailed information regarding declaration and guidance, see Table A-1 through Table A-
3.
The EMC standards state that manufacturers of patient-coupled equipment must specify
immunity levels for their systems. See Table A-2 to Table A-6 for this detailed immunity
information.
Immunity is defined in the standard as the ability of a system to perform without

degradation in the presence of an electromagnetic disturbance. Degradation in system
performance is a qualitative assessment which can be subjective.
Caution should, therefore, be taken in comparing immunity levels of different devices.

The criteria used for degradation is not specified by the standard and can vary with the
manufacturer.
A-2 Efficia CM Series Rack and Modules Instructions for Use
Guidance and Manufacturer’s Declaration
The Efficia CM patient monitors are intended for use in the electromagnetic environment
specified in the following tables. The customer or the user of the product should verify
that it is used in such an environment.
Table A-1
Emissions Test Compliance Electromagnetic Environment Guidance
RF emissions Group 1 Efficia CM Patient Monitors may contain an internal radio which
CISPR 11 emits RF energy. Including these radio modules, total RF
emissions are very low and not likely to cause any interference
in nearby electronic equipment.
RF emissions Class A The Efficia CM monitors are suitable for use in a Hospital
CISPR 11 Environment, whose power is not directly connected to the
public low-voltage power supply network.
Harmonic emissions Class A
IEC 61000-3-2
Voltage fluctuations/ Complies

flicker emissions
IEC 61000-3-3
Note — The EMISSIONS characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11
class B is normally required) this equipment might not offer adequate protection to radio-
frequency communication services. The user might need to take mitigation measures, such as
relocating or re-orienting the equipment.
Table A-2 Enclosure Port

Immunity Test Compliance
Immunity Test Electromagnetic Environment — Guidance
Level Level
Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, concrete, or ceramic

discharge (ESD) ±2, ±4,±8, ±15 kV air ±2, ±4,±8, ±15 kV air tile. If floors are covered with synthetic
IEC 61000-4-2 material, the relative humidity should be at
least 30%.
Radiated RF 3 V/m 3 V/m Typical Hospital Environment

Electromagnetic 80 MHz - 2.7 GHz 80 MHz - 2.7 GHz
Field
IEC 61000-4-3
Proximity fields Refer to Table A-3 Refer to Table A-3 Typical Hospital Environment
from RF wireless
communications
equipment
IEC 61000-4-3
Power frequency 30 A/m 30 A/m Typical Hospital Environment

magnetic field 50 Hz or 60 Hz 50 Hz or 60 Hz
IEC 61000-4-8
Table A-3 Proximity fields from RF wireless communications equipment
Test IMMUNITY
Band a) Modulation b) Distance
Frequency Service a) Modulation b) TEST LEVEL
(MHz) (W) (m)
(MHz) (V/m)
385 380 – 390 TETRA 400 Pulse 1,8 0,3 27

modulation b)
18 Hz
450 430 – 470 GMRS 460, FM c) 2 0,3 28

FRS 460 ± 5 kHz
deviation
1 kHz sine
710 704 – 787 LTE Band 13,17 Pulse 0,2 0,3 9

modulation b)
745 217 Hz
780
810 800 – 960 GSM 800/900, Pulse 2 0,3 28

TETRA 800, modulation b)
870 iDEN 820, 18 Hz
930 CDMA 850,
LTE Band 5
1720 1 700 – GSM 1800; Pulse 2 0,3 28

1 990 CDMA 1900; modulation b)
1845
GSM 1900; 217 Hz
1970 DECT;
LTE Band 1, 3,
4, 25; UMTS
2450 2 400 – Bluetooth, Pulse 2 0,3 28

2 570 WLAN, modulation b)
802.11 b/g/n, 217 Hz
RFID 2450,
LTE Band 7
5240 5 100 – WLAN 802.11 Pulse 0,2 0,3 9

5 800 a/n modulation b)
5500
217 Hz
5785
Warning Portable RF communications equipment (including peripherals such as antenna cables

and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the Efficia CM patient monitors, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
Notes
If necessary to achieve the Immunity Test Level, the distance between the
transmitting antenna and the Efficia CM patient monitors may be reduced to 1 m.
The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the up link frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) Asan alternative to FM modulation, 50% pulse modulation at 18 Hz may be
used because while it does not represent actual modulation, it would be worst
case
Table A-4 Input A.C. Power Port
Electromagnetic
Immunity Test Immunity Test Level Compliance Level
Environment - Guidance
Electrical fast transient/ ± 2 kV ± 2 kV Typical Hospital

burst Environment
100 kHz repetition 100 kHz repetition
IEC 61000-4-4 frequency frequency
Surge ± 0.5 kV, ±1 kV ± 0.5 kV, ±1 kV

Line to line
IEC 61000-4-5
Surge ± 0.5 kV, ±1 kV, ±2 kV ± 0.5 kV, ±1 kV, ±2 kV

Line to ground
IEC 61000-4-5
Conducted disturbances 3V 3V
induced by RF fields 0.15 MHz – 80 MHz 0.15 MHz – 80 MHz
IEC 61000-4-6 6 V in ISM and amateur 6 V in ISM and amateur
radio bands between radio bands between
0.15 MHz and 80 MHz 0.15 MHz and 80 MHz
Voltage dips, short 0% UT; 0,5 cycle 0% UT; 0,5 cycle

interruptions and voltage At 0°, 45°, 90°, 135°, 180°, At 0°, 45°, 90°, 135°, 180°,
variations on power 225°, 270° and 315° 225°, 270° and 315°
supply input lines
0% UT; 1 cycle and 70% 0% UT; 1 cycle and 70%
IEC 61000-4-11 UT; 25/30 cycles Single UT; 25/30 cycles Single
phase: at 0° phase: at 0°
Voltage interruptions 0 % UT; 250/300 cycle 0 % UT; 250/300 cycle

IEC 61000-4-11
Note: UT is the AC mains voltage prior to application of the test level.
Table A-5 Signal Input/Output Port
Electromagnetic
Electrostatic ±8 kV contact ±8 kV contact Floors should be

discharge (ESD) ±2, ±4, ±8, ±15 kV air ±2, ±4, ±8, ±15 kV air wood, concrete, or
ceramic tile. If floors
IEC 61000-4-2 are covered with
synthetic material,
the relative humidity
should be at least
30%.
Electrical fast ± 1 kV ± 1 kV Typical Hospital

transient/burst Environment
IEC 61000-4-4
Conducted 3 V, 0.15 MHz – 80 3 V, 0.15 MHz – 80 Typical Hospital

disturbances MHz MHz Environment
induced by RF fields
IEC 61000-4-6 6 V in ISM and 6 V in ISM and
amateur radio bands amateur radio bands
between between
0.15 MHz and 80 0.15 MHz and 80
MHz MHz
Table A-6 Patient Coupling Port
Electromagnetic
Electrostatic ±8 kV contact ±8 kV contact Floors should be wood,

discharge (ESD) ±2, ±4, ±8, ±15 kV air ±2, ±4, ±8, ±15 kV air concrete, or ceramic
tile. If floors are
IEC 61000-4-2
covered with synthetic
material, the relative
humidity should be at
least 30%.
Conducted 3 V, 0.15 MHz – 80 MHz 3 V, 0.15 MHz – 80 MHz Typical Hospital

disturbances Environment
induced by RF fields 6 V in ISM and amateur 6 V in ISM and amateur
IEC 61000-4-6 radio bands between radio bands between
0.15 MHz and 80 MHz 0.15 MHz and 80 MHz
© 2019 Koninklijke Philips N.V.
All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means, electronic, mechanical or otherwise, is prohibited
without the prior written consent of the copyright owner.
Printed in China
453564622841, Revision C
*453564622841*
*C*

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Rack and Modules

for Efficia CM Series

Instructions for Use

Instructions for Use

Third Edition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . September 2019

ii Rack and Modules Instructions for Use

This section describes the conventions used in this guide.

Typeface Usage Example

Bold System keys Press the Main Screen key.

Special User interface text Open the System Menu.

Italic Variables, document <product name>-<hardware

Notes, Cautions, and Warnings

Note: A Note calls attention to an important point in the text.

Rack and Modules Instructions for Use iii

Documentation Safety Sign

Sign Description Standard/Reference

iv Rack and Modules Instructions for Use

Symbol Name Standard/Reference

Keep upright International Air Transport

Fragile, handle with care ISO 15223-1** 5.3.1

Stacking limit by number ISO 7000** 2403

90% Relative humidity range (non-condensing) ISO 15223-1* 5.3.8

Ambient temperature range (non- ISO 15223-1* 5.3.5

Keep dry ISO 15223-1* 5.3.4

CE mark: Product meets the requirements European Council Directive

Recycling Universal Recycling Symbol

* ISO 7000 Graphical symbols for use on equipment - Registered symbols

Rack and Modules Instructions for Use v

Symbol Name Standard/Reference

Gas input connector ISO 7000-0794***

Gas output connector ISO 7000-0795

Defibrillator Proof Type CF applied part on IEC 60417* 5336

Defibrillator Proof. Type BF Equipment. IEC 60417-5334

Caution ISO 15223-1** 5.4.4

BIS™ BIS™ module marking NA

IBP IBP module marking NA

IBP Zero Button NA

Microstream™ CO2 module marking NA

GAS Gas module marking NA

Gas module eject button. NA

Gas module water trap rotation indicator. NA

* IEC 60417 Graphical symbols for use on equipment

vi Rack and Modules Instructions for Use

Manufacturer’s name and address ISO 15223-1* 5.1.1

ICES-001 Canadian ISM requirement International Erosion Control

Authorized EU Representative ISO 15223-1* 5.1.2

Unique Device Identification (UDI) barcode NA

CE mark CE0123: Product meets the European Council Directive 93/

Part number for label NA

Rack and Modules Instructions for Use vii

Regulatory and Safety Specifications

Note: The CE Mark does not apply to the BIS Module.

viii Rack and Modules Instructions for Use

This chapter provides a brief overview of the Efficia rack.

Efficia modules Efficia modules

Figure 1-1 Patient Monitor, Rack and Modules

Intended Use/Indications for Use

Module 2: Dual IBP   