S5 Anesthesia Monitor Users Reference Manual May 2005

Datex-Ohmeda S/5 Anesthesia Monitor User's Reference Manual Related to software licenses L-ANE05 and L-ANE05A Monitoring functions

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Conformity according to the Council Directive 93/42/EEC concerning Medical Devices. CAUTION: U.S. Federal law restrict this device to sale by or on the order of a licensed medical practitioner. Outside the USA, check local laws for any restriction that may apply. All specifications are subject to change without notice. Document no. M1041785 30 May, 2005

GE Healthcare Finland Oy, Helsinki, Finland P.O. Box 900 FI-00031GE Tel: +358 10 39411 Fax: +358 9 146 3310 www.datex-ohmeda.com, www.gehealthcare.com © 2005 General Electric Company. All rights reserved.

Datex-Ohmeda, Inc. P.O. Box 7550 Madison, WI 53707-7550, USA Tel: +1-608-221-1551 Fax: +1-608-222-9147

Intended purpose (Indications for use) The Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE05 or L-ANE05A software is intended for multiparameter patient monitoring with optional patient care documentation. The S/5 Anesthesia Monitor with L-ANE05 and L-ANE05A 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. The S/5 Anesthesia Monitor with L-ANE05 and L-ANE05A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents. The S/5 Anesthesia Monitor with L-ANE05 and L-ANE05A software is also indicated for documenting patient care related information. The S/5 Anesthesia Monitor with L-ANE05 and L-ANE05A 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 B (F-CU5(P), F-CPU and N-AC: 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.

• Class B equipment is suitable for use in domestic establishments and in establishments 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."

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 Message-Digest Algorithm.

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 noninfringement. 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 About this manual 1 Safety precautions 2 System description 3 Monitoring basics 4 Interfacing 5 Alarms 6 Monitor setup 7 Trends and snapshots 8 Patient data management 9 Recording and printing 10 Cleaning and care 11 Troubleshooting 12 ECG 13 Pulse oximetry 14 Temperature 15 Invasive blood pressure 16 Impedance respiration 17 Cardiac output 18 Mixed venous oxygen saturation 19 Non-invasive blood pressure 20 Airway gases 21 Patient Spirometry 22 Gas exchange 23 Tonometry 24 Neuromuscular transmission 25 EEG and evoked potentials (EP) 26 Bispectral index (BIS) 27 Entropy Index

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Table of contents About this manual

About-1

Overview... About-1 Illustrations and names... About-1 Conventions used in this manual... About-1 Additional information... About-2 Installation and service... About-2 Clinical application... About-2 References... About-3

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About this manual

About this manual Overview This User’s Reference Manual describes the functions offered by the Datex-Ohmeda S/5 Anesthesia Monitor running the software license L-ANE05 or L-ANE05A. As the monitor setup may vary, some menus, displays and functions described may not be available in the monitor you are using. 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. The section gives instructions about setting up the system and making changes in the default settings.

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. All names used in examples and illustrations are fictitious.

Conventions used in this manual To help you find and interpret information easily, the manual uses consistent text formats: − Names of the hard keys on the Remote Controller, Command Bar and modules are written in the following way: Others. − Software terms that identify window parts or menu items are written in bold italic typeface: Lab Data. −

− − −

−

WARNING

This is a WARNING. −

CAUTION

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, file paths and text to be entered are written in the following way: comm.exe. Messages (alarm messages, informative messages) displayed on the screen are written inside single quotes: ‘Learning.’ 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 "iCentral User's Reference Manual: Alarms." Warnings are displayed in the following way:

Cautions are displayed in the following way:

This is a CAUTION.

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S/5 Anesthesia Monitor The following symbols are also used to distinguish procedures:

ECG

Press the menu key described.

Turn the ComWheel.

Push the ComWheel.

Additional information 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. 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.

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 reparations are allowed by authorized service personnel only. Section “Cleaning and care” describes cleaning and daily maintenance procedures.

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.

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About this manual

References 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.

IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 Medical electrical equipment Part 1: General requirements for safety CAN/CSA C22.2 No. 601.1-M90 + S1:1994 Medical Electrical Equipment - Part 1: General Requirements for Safety UL 60601-1:2003 Medical Electrical Equipment, Part 1: General Requirements for Safety (Replaces UL 2601-1) IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems IEC 60601-1-2:2001 Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility - Requirements and tests, 2nd edition IEC 60601-1-4:1996 Medical electrical equipment - Part 1: General requirements for safety 4. Collateral standard: Programmable electrical medical systems IEC 60601-2-10:1987 + Amd 1:2001 Medical electrical equipment Part 2: Particular requirements for the safety of nerve and muscle stimulators IEC 60601-2-25:1993 + Amd 1:1999 Medical electrical equipment Part 2-25: Particular requirements for the safety of electrocardiographs IEC 60601-2-26:2002 Medical electrical equipment. Part 2: Particular requirements for the safety of electroencephalographs IEC 60601-2-27:1994 Medical electrical equipment Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment EN 1041:1998 Information supplied by the manufacturer with medical devices ANSI/AAMI EC11:1991 Diagnostic electrocardiographic devices ANSI/AAMI EC13:2002 Cardiac monitors, heart rate meters, and alarms ANSI/AAMI EC57:1998 Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms IEC 60601-2-30:1999 Medical electrical equipment Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment EN 1060-1:1995 + Amd 1:2002 Non-invasive sphygmomanometers –Part 1: General requirements EN 1060-3:1997 Non-invasive sphygmomanometers –Part 3: Supplementary requirements for electromechanical blood pressure measuring systems ANSI/AAMI SP10:2002 Manual, electronic or automated sphygmomanometers IEC 60601-2-34:2000 Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment IEC 60601-2-40: 1998 Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment IEC 60601-2-49:2001 Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment ISO 9919:1992 Pulse oximeters for medical use - Requirements EN 865:1997 Medical electrical equipment - Pulse oximeters - Particular requirements ASTM F1415-92 Standard Specification for Pulse Oximeter ISO 7767:1997/EN 12598:1999 Oxygen monitors for monitoring patient breathing mixtures -Safety requirements ISO 9918:1993 Capnometers for use with humans - Requirements

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S/5 Anesthesia Monitor 27. EN 864:1996 Medical electrical equipment - Capnometers for use with humans - Particular requirements 28. ASTM F1456-01 Standard Specification for Minimum Performance and Safety Requirements for Capnometers 29. ISO 11196:1995 + Cor 1:1997 Anesthetic gas monitors 30. EN ISO 11196:1997 Anaesthetic gas monitors 31. EN 12470-4:2000 Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement

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Table of contents

Table of contents 1

Safety precautions

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Warnings... 1-1 Cautions... 1-2 ESD precautionary procedures... 1-2 ESD precautionary procedure training... 1-2 Points to note... 1-3 Disposal... 1-3

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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. • • • • •

To avoid explosion hazard, do not use the monitor in presence of flammable anesthetics. The monitor measures only non-flammable anesthetics. 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. Connect only one patient to the monitor at a time. Use only hospital-grade grounded power outlets and power cord. Some equipment malfunctions may not generate a monitor alarm. Always keep the patient under close surveillance.

• • • •

Never install the monitor or the displays so that they are above the patient.

• •

Do not touch the patient, table, instruments, modules or the monitor during defibrillation.

•

• • • • •

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. 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. 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” page 1-2. 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. 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. 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. 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. 1-1

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• • •

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. If the unit fails to respond as described, do not use the monitor until tested and repaired by authorized service personnel. The system is intended for use by qualified medical personnel only.

Cautions CAUTION

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

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

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 to 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.

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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 allowed cables, transducers, mounts and accessories for the system are listed in the “Supplies and Accessories” catalog delivered with the monitor.

•

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 2-39.

•

Service and repairs are allowed for authorized service personnel only.

•

Dispose of the whole device and parts of it in accordance with local environmental and waste disposal regulations.

Disposal

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