S5 Anesthesia Monitor Users Reference Manual 1st edition April 2009

Intended purpose (Indications for use) The Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 or L-ANE07A software is intended for multiparameter patient monitoring with optional patient care documentation. The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy (State Entropy and Response Entropy) and neurophysiological status of all hospital patients. When the BIS module is used with the S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A, it is intended for use by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical faculty providing patient care to monitor the state of the brain by data acquisition of EEG signals. The Bispectral index (BIS), a processed EEG variable, and one component of the BIS module, may be used in adults as an aid in monitoring the effects of certain anesthetic agents. The Bispectral index is a complex technology, intended for use only as an adjunct to clinical judgement and training. In addition, the clinical utility, risk/ benefit, and application of BIS have not undergone full evaluation in pediatric population. The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is also indicated for documenting patient care related information. The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for use by qualified medical personnel only.

Classifications In accordance with IEC 60601-1 Class I and internally powered equipment – the type of protection against electric shock. Type BF or CF equipment. The degree of protection against electric shock is indicated by a symbol on each parameter module. Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Continuous operation according to the mode of operation. In accordance with IEC 60529 IPX0 - the degree of protection against harmful ingress of water. In accordance with EU Medical Device Directive The Datex-Ohmeda S/5 Anesthesia Monitor is classified as IIb. In accordance with CISPR 11: Group 1, Class A:

• Group 1 contains all ISM (Industrial, scientific and medical) equipment in which there is intentionally generated and/or used conductively coupled radio-frequency energy which is necessary for the internal functioning of the equipment itself.

• Class A equipment is suitable for use in all establishments other than domestic and those directly connected to a low voltage power supply network which supplies buildings used for domestic purposes.

Responsibility of the manufacturer GE Healthcare Finland Oy (GE) is responsible for the effects on safety, reliability and performance of the equipment only if:

• Assembly, extensions, readjustments, modifications, servicing and repairs are carried out by personnel authorized by GE.

• The electrical installation of the monitor room complies with appropriate requirements. • The equipment is used in accordance with the "User's Guide."

Product availability Some of the products mentioned in this manual may not be available in all countries. Please, consult your local representative for the availability.

Trademarks Datex, Ohmeda, S/5, D-lite, D-lite+, Pedi-lite, Pedi-lite+, D-fend, D-fend+, Mini D-fend, OxyTip+, MemCard, ComWheel, ComBar, EarSat, FingerSat, FlexSat, PatientO2, Patient Spirometry, Entropy and Tonometrics are trademarks of GE Healthcare Finland Oy. All other product and company names are property of their respective owners. A portion of the Entropy software is derived from the RSA Data Security, Inc. MD5 MessageDigest Algorithm. Masimo SET is a licensed trademark of Masimo Corporation.

Product availability Some of the products mentioned in this manual may not be available in all countries. Please, consult your local representative for the availability.

End User License Agreement THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU, THE "LICENSEE," AND GE HEALTHCARE FINLAND OY (“GE”). IF YOU DO NOT AGREE TO ALL THE TERMS OF THIS AGREEMENT, PROMPTLY RETURN THE ENTIRE PACKAGE, INCLUDING ALL ACCESSORIES, IN THEIR ORIGINAL PACKAGE, WITH YOUR SALES RECEIPT TO GE FOR A FULL REFUND. 1. Grant of License. GE grants to Licensee a nonexclusive, nontransferable, restricted license, without right to sublicense, to use the copy of the incorporated software/firmware("Software"), and manuals and documentation related to the Software in connection with Licensee's use of the product for their labeled purpose and only when the instrument is used with authorized accessories and sensors, in accordance with this End User License Agreement ("Software License"). GE reserves all rights not expressly granted to Licensee. 2. Ownership of Software/Firmware. Title to, ownership of, and all rights and interests in, any software and/or firmware and the documentation, and all copies thereof, remain at all times vested in GE or its partners, and they do not pass to Licensee. 3. Assignment. The rights and obligations of the Licensee under this Software License are personal. Accordingly, neither this Software License nor any of such rights and obligations are assignable or transferable by merger or by operation of law or otherwise without the prior written consent of GE. You may not rent, lease, sell, or otherwise dispose of the software/ firmware or the products on a temporary basis. GE may assign this Software License and/or any rights of Licensor hereunder, to any affiliate, or to any purchaser of substantially all of the assets used by GE in the performance of this Software License. 4. Limitation of liability. Other than the attached limited warranty, the Software is being licensed to Licensee "as is," without warranty of any kind, express or implied, including without limitation the warranties of merchantability, fitness for a particular purpose, functionality, use or performance of the Software and compatibility with particular computer systems, computer peripherals or other software packages, title or non-infringement. Some jurisdictions do not allow the disclaimer of implied warranties, so the above disclaimer may not apply to Licensee, in which case the duration of any such implied warranties is limited to the longer of (i) minimum required by law or (ii) thirty (30) days from the date the Software is received by Licensee.

In no case, including without limitation any breach of a fundamental term or a fundamental breach of this Software license, shall GE be liable for any damages, including but not limited to indirect, exemplary, special, consequential or incidental damages of any kind (including without limitation lost profits), even if GE has been advised of the possibility of such damages. These provisions hereof shall apply to the full extent permitted by law. 5. Copy Restrictions. The software/firmware and the accompanying written materials are copyrighted. Unauthorized copying of the software, including software that has been modified, merged, or included with other software, or other written materials is expressly forbidden. You may be held legally responsible for any copyright infringement that is caused or incurred by your failure to abide by the terms of this license. 6. Use Restriction. As the Licensee, you may physically transfer the products from one location to another provided that the software/firmware is not copied. You may not electronically transfer the software/firmware from the products to any other device. You may not disclose, publish, translate, release or distribute copies of the software/firmware to others. You may not modify, adapt, translate, reverse engineer, decompile, disassemble, or create derivative works based on the software/firmware, unless and to the extent specifically permitted by local law. Your license to the software is not valid for use with any unauthorized data acquisition device. When information of the internal structure of the Software is necessary in order to obtain interoperability of the Software with other software programs, Licensee shall immediately contact GE. The Software contains proprietary and confidential information of GE and its suppliers and is considered by GE and its suppliers to constitute valuable trade secrets. Licensee will hold the Software in confidence and shall protect the Software with at least the same degree of care with which Licensee protects its own similar confidential information but in no event less than a reasonable standard of care. Licensee agrees that its officers and employees shall protect the confidentiality of the Software and all confidential and non-public information relating thereto and shall not disclose such information to any third party. This obligation of confidentiality shall survive the termination of the Software License. Licensee agrees to comply with all applicable export and re-export restrictions and regulations imposed by the government of the United States or of the country to which the Software is shipped to Licensee. Licensee shall not commit any act or omission, which will result in a breach of any such export requirements. Licensee shall defend, indemnify and hold GE and all GE's suppliers harmless from any claims arising out of Licensee's violation of such export control laws. Upon termination by GE or its suppliers of this Software License, Licensee shall (as advised by GE) immediately destroy the Software and all copies thereof or return the same to GE and within two (2) business days thereafter certify to GE in writing that in accordance with instructions from GE or its suppliers, all copies of the Software have been either destroyed or returned to GE, whether same is in tangible or intangible form and Licensee shall further certify that all use thereof is and shall remain terminated. 7. Applicable Law , Settlement of Disputes. This Software License is construed, governed by and interpreted in accordance with the laws of Finland, excluding the UN Convention on Contracts for the International Sale of Goods. Disputes arising from or in connection with this Software License are to be settled by arbitration by one arbitrator. The arbitrator shall be appointed by the Board of Arbitration of the Central Chamber of Commerce of Finland and the Rules of the said Board are to be followed in the arbitration proceedings. The arbitration shall be held in Helsinki, Finland, in the English language. Notwithstanding the foregoing, GE and its suppliers shall have the right, but not the obligation, to undertake legal proceedings in a court of Licensee's domicile, principal place of business or other appropriate court to: (i) settle any issue or dispute arising out of or relating to monies due by Licensee to GE; (ii) protect or enforce any patent, trademark, copyright or other intellectual property right, confidential information or trade secrets; or (iii) proceed with litigation commenced by a third party. Judgment upon the award rendered may be entered in any Court having jurisdiction or application may be made to such Court for a juridical acceptance of the award and an order of enforcement, as the case

may be. Where arbitration would not be allowed as the method of settlement of disputes as a part of this Software License due to reasons relating to indispositive legislation valid in some jurisdictions, the parties hereto irrevocably submit to the exclusive jurisdiction of the lower court of Helsinki, Finland. 8. No waiver. The failure of GE to enforce any provision of this Software License shall not be considered a waiver of any subsequent breach of that provision or as a waiver of any other provision hereof. 9. Amendments. This Software License may be modified only by a written instrument expressly agreed to by the parties hereto.

Warranty This Product is sold by GE Healthcare Finland Oy (“GE”) under the warranty set forth in the following paragraphs. Such warranty is extended only with respect to the purchase of this Product directly from GE or GE’s Authorized Dealers as new merchandise and is extended to the Buyer thereof, other than for the purpose of resale. For a period of twelve (12) months from the date of original delivery to Buyer, this Product, other than expandable parts, is warranted against functional defects in materials and workmanship and to conform to the description of the Product contained in this manual and accompanying labels and/or inserts, provided that the same is properly operated under the conditions of normal use, that regular periodic maintenance and service is performed and that the replacements and repairs are made in accordance with the instructions provided, using genuine parts and performed by a trained person. The foregoing warranty shall not apply if the Product has been repaired by anyone other than GE or otherwise than in accordance with written instructions provided by GE, or altered by anyone other than GE, or if the Product has been subject to abuse, misuse, negligence, or accident. GE’s sole and exclusive obligation and Buyer’s sole and exclusive remedy under the above warranty is limited to repairing or replacing, free of charge, at GE’s option, a Product, which is telephonically reported to the nearest GE office or GE’s Authorized Dealers office and which, if so advised by GE, is thereafter returned with a statement of observed deficiency, not later than seven (7) days after the expiration date of the applicable warranty, to the GE office or GE’s Authorized Dealers office during normal business hours, transportation charges prepaid, and which, upon GE’s examination, is found not to conform to the above warranty. GE shall not be otherwise liable for any damages including but not limited to incidental damages, consequential damages, or special damages. There are no express or implied warranties, which extend beyond the warranty hereinabove set forth. GE makes no warranty of merchantability or fitness for particular purpose with respect to the product or parts thereof.

Table of contents

Table of contents 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

Safety precautions System description Monitoring basics Interfacing Alarms Monitor setup Trends and snapshots Patient data management Printing and recording Cleaning and care Troubleshooting ECG Pulse oximetry Temperature Invasive blood pressure Impedance respiration Cardiac output Mixed venous oxygen saturation Non-invasive blood pressure Airway gases Patient Spirometry Gas exchange Neuromuscular transmission EEG and evoked potentials (EP) Bispectral index (BIS) Entropy

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Table of contents

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Table of contents

Table of contents About this manual

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Intended audience... About-1 Overview... About-1 Illustrations and names... About-1 Conventions used in this manual... About-2 Related documentation... About-2 Installation and service... About-3 Clinical application... About-3 References... About-3

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About this manual

About this manual Intended audience This manual is intended for clinical professionals. Clinical professionals are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring critically ill patients.

Overview This User’s Reference Manual describes the functions offered by the Datex-Ohmeda S/5 Anesthesia Monitor running the software license L-ANE07 or L-ANE07A. As the monitor setup may vary, some menus, displays and functions described may not be available in the monitor you are using. This manual is an integral part of the product and describes its intended use. Keep it always close to the equipment. Observance of the manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. NOTE: Before using your monitor, please read the “User’s Guide Part I and Part II” or this manual thoroughly. This User’s Reference Manual gives you more specific information about the clinical and technical aspects. Pay special attention to WARNING and CAUTION statements. The new user of the monitor should begin with sections “Safety precautions”, “System description” and “Monitoring basics.” These sections describe the system and the basic operation of the monitor. The measurement sections describe the measurement technique, setup and how to adjust displays and menus for patient monitoring and special views. Section “Monitor setup” gives instructions about setting up the system and making changes in the default settings. Section “Cleaning and care” describes cleaning and daily maintenance procedures.

Illustrations and names All illustrations in this manual are only examples, and may not necessarily reflect your system settings or data displayed in your system. If a particular selection is not available in your system, the selection is shown grayed in the menu. All names used in examples and illustrations are fictitious.

About-1

S/5 Anesthesia Monitor

Conventions used in this manual To help you find and interpret information easily, the manual uses consistent text formats:

Hard keys

Names of the hard keys on the Remote Controller, Command Bar and modules are written in the following way: Others.

Menu items

Software terms that identify window parts or menu items are written in bold italic: Lab Data.

Menu access

Menu access is described from top to bottom. For example, the selection of the Monitor Setup hard key, the Screen 1 Setup menu item and the Waveform Fields menu item would be shown as Monitor Setup - Screen 1 Setup - Waveform Fields.

File names etc.

File names, file paths and text to be entered are written in the following way: comm.exe.

Messages

Messages (alarm messages, informative messages) displayed on the screen are written inside single quotes: ‘Please wait.’

References

When referring to different sections in this manual or to other manuals, manual names and section names are enclosed in double quotes: See section “Cleaning and care”. Please refer to "Technical Reference Manual: Installation."

WARNING CAUTION

This is a WARNING. This is a CAUTION.

NOTE

This is a NOTE.

The following symbols are also used to distinguish procedures: Press the menu key described. ECG

Turn the ComWheel.

Push the ComWheel.

Related documentation Software options and default settings are described in the “Default Configuration Worksheet” delivered with each monitor. Available accessories are described in the “Supplies and Accessories” catalog delivered with each monitor.

About-2

About this manual

For more information about the iCentral, S/5 Arrhythmia Workstation and anesthesia record keeping solution, see the “User’s Reference Manuals” for these products. NOTE: Later in this manual the concept Central refers to both iCentral and Datex-Ohmeda S/5 Central.

Installation and service A separate “Technical Reference Manual” describes installation, interfacing, connectors, service, maintenance and reparation procedures of the monitor. Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the “Technical Reference Manual” by qualified personnel. Service and repairs are allowed for authorized service personnel only.

Clinical application Detailed information on clinical applications can be found in several publications. Application guides are produced about patient spirometry, CO2 monitoring, PCWP, cardiac output, ST segment analysis, impedance respiration, and so on.

References 1.

IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 / EN 60601-1:1990 + Amdt. 1:1993 + Amdt. 2:1995 + A13:1996 + Corr1:1995 Medical electrical equipment Part 1: General requirements for safety

2.

CAN/CSA C22.2 No. 601.1-M90 + S1:1994 + Amd2: 998 Medical Electrical Equipment - Part 1: General Requirements for Safety

3.

UL 60601-1:2003 Medical Electrical Equipment, Part 1: General Requirements for Safety

4.

IEC 60601-1-1:2000 / EN 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

5.

IEC 60601-1-2:2001 + A1:2004 / EN 60601-1-2:2001 + A1: 2006 Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests, 2nd edition

6.

IEC 60601-1-4:2000 / EN 60601-1-4:2000 Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems

7.

IEC 60601-1-8:2006 Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: Alarm systems - General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

8.

IEC 60601-2-10:1987 + Amd 1:2001 / EN 60601-2-10:2000 + Amd 1:2001 Medical electrical equipment Part 2: Particular requirements for the safety of nerve and muscle stimulators

9.

IEC 60601-2-26:2002 / EN 60601-2-26:2003 Medical electrical equipment. Part 2: Particular requirements for the safety of electroencephalographs

10.

IEC 60601-2-27:1994 / EN 60601-2-27:1994 Medical electrical equipment Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment

11.

EN 1041:1998 Information supplied by the manufacturer with medical devices

12.

ANSI/AAMI EC11:1991/(R)2001/(R)2007 Diagnostic electrocardiographic devices

13.

ANSI/AAMI EC13:2002 / (R)2007 Cardiac monitors, heart rate meters, and alarms

About-3

S/5 Anesthesia Monitor

About-4

14.

ANSI/AAMI EC57:1998 / (R)2003 Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms

15.

IEC 60601-2-30:1999 / EN 60601-2-30:2000 Medical electrical equipment Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment

16.

EN 1060-1:1995 Non-invasive sphygmomanometers -Part 1: General requirements for electromechanical blood pressure measuring systems

17.

EN 1060-3:1997 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electromechanical blood pressure measuring systems

18.

ANSI/AAMI SP10:2002 + A1:2003 + A2:2006 Manual, electronic or automated sphygmomanometers

19.

IEC 60601-2-34:2000 / EN 60601-2-34:2000 Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment

20.

IEC 60601-2-40:1998 / EN 60601-2-40:1998 Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment

21.

IEC 60601-2-49:2001 / EN 60601-2-49:2001 Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment

22.

ISO 9919:2005 / EN ISO 9919:2005 Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeters equipment for medical use

23.

ANSI/ISO 21647:2004 / EN ISO 21647:2004 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors

24.

EN 12470-4:2000 Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement

Table of contents

Table of contents 1

Safety precautions

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Warnings... 1-1 Cautions... 1-3 ESD precautionary procedures... 1-3 ESD precautionary procedure training... 1-3 Points to note... 1-3 Disposal... 1-4

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Safety precautions

1 Safety precautions The following list contains all the general warnings and cautions you should know before starting to use the system. Warnings and cautions specific to parts of the system can be found in the relevant section.

Warnings WARNING

A WARNING indicates a situation in which the user or the patient may be in danger of injury or death.

• •

Connect only one patient to the monitor at a time.

• • •

Use only hospital-grade grounded power outlets and power cord.

• • •

Do not use an additional multiple socket outlet, extension cord or adapter of any kind.

•

PACEMAKER PATIENTS. Rate meters may continue to count the pacemaker during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. Keep pacemaker patients under close surveillance. See this manual for disclosure of the pacemaker pulse rejection capability of this instrument.

•

To avoid explosion hazard, do not use the monitor in presence of flammable anesthetics. The monitor measures only non-flammable anesthetics.

• •

Do not use the monitor in high electromagnetic fields (for example, during MRI).

• • • •

Do not connect any external devices to the system other than those specified.

•

If you accidentally drop the monitor, modules or frames, have them checked by authorized service personnel prior to clinical use.

•

The user may only perform maintenance procedures specifically described in this manual.

Before starting to use the system, ensure that the whole combination complies with the international standard IEC 60601-1-1 and with the requirements of the local authorities. All system devices must be connected to the same power supply circuit. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Always check that the power cord and plug are intact and undamaged. Some equipment malfunctions may not generate a monitor alarm. Always keep the patient under close surveillance.

Keep the monitor horizontal when the Compact Airway Module is used. Tilting the monitor may cause erroneous results in the Compact Airway Module’s readings and damage the module. Do not touch the patient, table, instruments, modules or the monitor during defibrillation. Do not under any circumstances remove the grounding conductor from the power plug. After transferring or reinstalling the monitor, always check that it is properly connected and all parts are securely attached. Pay special attention to this in case of stacked mounting.

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S/5 Anesthesia Monitor

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Use only approved accessories, including mounts, and defibrillator-proof cables and invasive pressure transducers. For a list of approved supplies and accessories, see the "Supplies and Accessories" catalog delivered with the monitor. Other cables, transducers and accessories may cause a safety hazard, damage the equipment or system, result in increased emissions or decreased immunity of the equipment or system or interfere with the measurement. Protection against cardiac defibrillator discharge is due in part to the accessories for pulse oximetry (SpO2), temperature (T) and invasive pressure (P) measurement.

•

Single-use accessories are not designed to be re-used. Re-use may cause a risk of contamination and affect the measurement accuracy.

•

Pins of connectors identified with the ESD warning symbol should not be touched. Connections should not be made to these connectors unless ESD precautionary procedures are used. For details, see “ESD precautionary procedures” on page 1-3.

•

If liquid has accidentally entered the system or its parts, disconnect the power cord from the power supply and have the equipment serviced by authorized service personnel.

• •

Do not autoclave any part of the system with steam or sterilize with ethylene oxide.

•

If the unit fails to respond as described, do not use the monitor until tested and repaired by authorized service personnel.

• • • • •

Do not use the monitor without manufacturer approved mounting attached.

•

When detaching Patient Side Modules, be careful not to drop them. Always support with one hand while pulling out with the other.

•

Always unplug the monitor before cleaning. After cleaning, ensure that every part of the monitor is dry before reconnecting it to the power supply.

• • •

Carefully route patient cabling to avoid patient discomfort and entanglement.

The unit is not able to withstand unpacked drops from a height of 1 m without damaging module latches. If the device is dropped, please service the device before taking it back into use.

Do not use the power cord delivered with this product for any other product or purpose. Do not apply mechanical tension to the power cord, otherwise it may be damaged. Never install the monitor or the displays so that they are above the patient. The monitor or its components should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the monitor and its components should be observed to verify normal operation in the configuration in which it will be used.

The system is intended for use by qualified medical personnel only. Operation of the monitor outside the specified values may cause inaccurate results.

Safety precautions

Cautions CAUTION

A CAUTION indicates a situation in which the unit or the devices connected to it may be damaged.

•

Before connecting the power cord to a power supply, check that the local voltage and frequency correspond with the rating stated on the device plate.

• • •

Turn off the power before making any rear panel connections.

•

Ensure that the plug-in modules are properly oriented (that is, the module release latch is facing downward) before insertion.

Leave space for air circulation to prevent the monitor from overheating. Do not store or use the monitor outside the temperature and humidity ranges specified in “Performance” in section “System description” of this manual.

ESD precautionary procedures •

To avoid electrostatic charges to build up, it is recommended to store, maintain and use the equipment at a relative humidity of 30% or greater. Floors should be covered by ESD dissipative carpets or similar. Non-synthetic clothing should be used when working with the component.

•

To prevent applying a possible electrostatic discharge to the ESD sensitive parts of the equipment, one should touch the metallic frame of the component or a large metal object located close to the equipment. When working with the equipment and specifically when the ESD sensitive parts of the equipment may be touched, a grounded wrist strap intended for use with ESD sensitive equipment should be worn. Refer documentation provided with the wrist straps for details of proper use.

ESD precautionary procedure training • It is recommended that all potential users receive an explanation of the ESD warning symbol and training in ESD precautionary procedures.

•

The minimum content of an ESD precautionary procedure training should include an introduction to the physics of electrostatic charge, the voltage levels that can occur in normal practice and the damage that can be done to electronic components if they are touched by an operator who is electrostatically charged. Further, an explanation should be given of methods to prevent build-up of electrostatic charge and how and why to discharge one’s body to earth or to the frame of the equipment or bond oneself by means of a wrist strap to the equipment or the earth prior to making a connection.

Points to note •

Medical electrical equipment needs special precautions regarding electromagnetic compatibility, EMC, and needs to be installed and put into service according to the EMC information provided in the "Technical Reference Manual" by qualified personnel.

•

Portable and mobile RF communications equipment can affect the medical electrical equipment.

•

The equipment is suitable for use in the presence of electrosurgery. Please notice the possible limitations in the parameter sections and in “Performance” on page 2-36.

• •

Service and repairs are allowed for authorized service personnel only. Please pay attention to any additional information that may accompany the displays, including safety statements and cleaning instructions. 1-3

S/5 Anesthesia Monitor

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CISPR 11 Classification: Group 1, Class A: −

Group 1 contains all ISM (industrial, scientific and medical) equipment in which there is intentionally generated and/or used conductively coupled radio-frequency energy which is necessary for the internal functioning of the equipment itself.

−

Class A equipment is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies building used for domestic purposes.

Disposal • •

1-4

Dispose of the whole device, parts of it, its packing material and manuals in accordance with local environmental and waste disposal regulations. Dispose of the calibration gas container in accordance with local environmental and waste disposal regulations.

Table of contents

Table of contents 2

System description

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Overview... 2-1 System introduction... 2-2 Central Units... 2-4 8-module Central Unit F-CU8... 2-4 Rear of the Central Unit F-CU8... 2-5 5-module Central Units... 2-5 Rear of the frame unit F-CU5(P)... 2-7 Central Processor Unit, F-CPU, and Power Unit, N-AC... 2-7 Extension frame for Central Unit F-CU8... 2-8 Displays... 2-9 15” LCD display D-FPD15, M1138310...2-10 12” LCD display, D-LCC12A...2-11 19” LCD display, M1063774...2-12 Module overview...2-13 Measurement modules...2-13 Other modules...2-14 Avoiding identical modules...2-14 Plug-in modules...2-15 Inserting a plug-in module...2-15 Removing a plug-in module...2-16 Patient Side Modules E-PSM and E-PSMP...2-16 Inserting a Patient Side Module in the 5-module frame unit...2-17 Removing a Patient Side Module from the 5-module frame unit...2-17 Connecting the E-PSM(P) module to F-CU8 Central Unit...2-18 Keyboards...2-19 Command Bar...2-19 Remote Controller...2-19 Anesthesia record keeping solution keyboard...2-20 Symbols and abbreviations...2-21 Equipment safety symbols...2-21 Other symbols...2-22 Abbreviations...2-25 Performance...2-36 Monitor...2-36 Power supply...2-36 Environmental conditions...2-36 Alarm behavior...2-36 Alarm sound pressure range...2-36 Hemodynamic modules E-PRESTN, E-RESTN, E-PRETN; Patient Side Modules E-PSM and E-PSMP...2-37 Invasive Pressure Modules, E-P, E-PP and E-PT...2-41 Cardiac Output Modules, E-COP and E-COPSv...2-41 Nellcor Compatible Saturation Module, E-NSATX...2-42 Masimo Compatible Saturation Module, E-MASIMO...2-43 i