S5 FM Users Reference Manual June 2004

Datex-Ohmeda S/5 FM User's Reference Manual Related to software licenses L-FICU03 and L-FICU03A Monitoring functions

0537

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. M1017183-01 June, 2004

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

Datex-Ohmeda Division, Instrumentarium Corporation P.O. Box 900 FI-00031 DATEX-OHMEDA Tel: +358 10 39411 Fax: +358 9 146 3310 www.datex-ohmeda.com © 2004 General Electric Company. All rights reserved.

Intended purpose (Indications for use) The Datex-Ohmeda S/5 FM is intended for multiparameter patient monitoring. The S/5 FM with L-FICU03 or L-FICU03A software is indicated for monitoring of hemodynamics (including arrhythmia and ST-segment analysis) and respiratory status of all hospital patients. Impedance respiration measurement is indicated for patients three years old and up. NIBP and CO2 (using option N-FCREC or N-FC) measurements are indicated for patients weighing over 5 kg (11lb). The S/5 FM 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 IPX1 - degree of protection against harmful ingress of water. In accordance with EU Medical Device Directive The Datex-Ohmeda S/5 FM is classified as IIb. In accordance with CISPR 11: Group 1, Class B

• 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 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 Datex-Ohmeda Division, Instrumentarium Corporation 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 Datex-Ohmeda.

• 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®, and other trademarks S/5, D-lite, D-lite+, Pedi-lite, Pedi-lite+, D-fend, D-fend+, Mini Dfend, OxyTip+, MemCard, ComWheel, ComBar, EarSat, FingerSat, FlexSat, PatientO2, Patient Spirometry, Entropy and Tonometrics are property of Instrumentarium Corp. or its subsidiaries. All other product and company names are property of their respective owners.

End User License Agreement THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU, THE "PURCHASER," AND DATEX-OHMEDA (“D-O”). IF YOU DO NOT AGREE TO THE TERMS OF THIS AGREEMENT, PROMPTLY RETURN THE ENTIRE PACKAGE, INCLUDING ALL ACCESSORIES, IN THEIR ORIGINAL PACKAGE, WITH YOUR SALES RECEIPT TO D-O FOR A FULL REFUND. 1. Grant of License. In consideration of payment of the license fee, which is part of the price paid for this product, D-O grants to Purchaser a nonexclusive, nontransferable license, without right to sublicense, to use the copy of the incorporated software/firmware, and documentation in connection with Purchaser's use of the product for their labeled purpose and only when the instrument is used with authorized accessories and sensors. D-O reserves all rights not expressly granted to Purchaser. 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 D-O or its partners, and they do not pass to Purchaser. 3. Assignment. Purchaser shall not assign or transfer this License, in whole or in part, by operation of law or otherwise, without D-O's prior written consent. Any attempt without such consent, to assign any rights, duties or obligations hereunder shall be void. You may not transfer, assign, rent, lease, sell, or otherwise dispose of the software/firmware or the products on a temporary basis. 4. 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. 5. Use Restriction. As the Purchaser, 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 specifically permitted by local law. Your license to the software is not valid for use with any unauthorized data acquisition device. 6. Applicable Law and Jurisdiction 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 and the parties hereto irrevocably submit to the exclusive jurisdiction of the lower court of Helsinki, Finland.

Warranty This Product is sold by Datex-Ohmeda under the warranty set forth in the following paragraphs. Such warranty is extended only with respect to the purchase of this Product directly from Datex-Ohmeda or Datex-Ohmeda’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 Datex-Ohmeda or otherwise than in accordance with written instructions provided by Datex-Ohmeda, or altered by anyone other than Datex-Ohmeda, or if the Product has been subject to abuse, misuse, negligence, or accident. Datex-Ohmeda’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 Datex-Ohmeda’s option, a Product, which is telephonically reported to the nearest Datex-Ohmeda office or Datex-Ohmeda’s Authorized Dealers office and which, if so advised by Datex-Ohmeda, 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 Datex-Ohmeda office or Datex-Ohmeda’s Authorized Dealers office during normal business hours, transportation charges prepaid, and which, upon Datex-Ohmeda’s examination, is found not to conform to the above warranty. Datex-Ohmeda 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. DatexOhmeda 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 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 Non-invasive blood pressure 18 Airway gases Index

i

Table of contents

ii

About this manual

About this manual General This User’s Reference Manual describes the functions offered by the Datex-Ohmeda S/5 FM running the software license L-FICU03 or L-FICU03A. 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” 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 appearing throughout the manual. The new user of the monitor should begin with sections “Safety”, “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 “Monitor setup” section gives instructions about setting up the system and making changes in the default settings.

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 Board 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 "GE Datex-Ohmeda S/5 iCentral User's Reference Manual: Alarms." Warnings are displayed in the following way:

Cautions are displayed in the following way:

This is a CAUTION.

About-1

S/5 FM

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

ECG

Turn the ComWheel.

Push the ComWheel.

Additional information For more information about the GE Datex-Ohmeda S/5 iCentral, see the ”User’s Reference Manual” for this product. NOTE: Later in this manual the concept Central refers to both GE Datex-Ohmeda S/5 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 Datex-Ohmeda publications. Datex-Ohmeda produces application guides about CO2 monitoring, PCWP, ST segment analysis, impedance respiration, and so on.

About-2

About this manual

References 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.

12. 13. 14. 15. 16. 17. 18. 19. 20.

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 60601-2-25:1993 + Amd 1:1999 Medical electrical equipment Part 2-25: Particular requirements for the safety of electrocardiographs IEC 60601-2-27:1994 Medical electrical equipment Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment 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 60601-2-49:2001 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 EN 12470-4:2000 Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement

About-3

S/5 FM

About-4

Table of contents

Table of contents 1

Safety

1-1

Safety precautions... 1-1 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

i

Table of contents

ii

Safety

1 Safety 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. 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. Do not use the monitor without manufacturer approved mounting attached. 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 so that it is above the patient. 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. Do not touch the patient, table, instruments, modules or the monitor during defibrillation. 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 batteries, 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, batteries 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. Do not incinerate a battery or store at high temperatures as it will exlode. 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 modules, be careful not to drop them. Always support with one hand while pulling out with the other. If the integrity of the external protective earth conductor arrangement is in doubt, use the monitor with battery operation. 1-1

S/5 FM

• • • •

Vibrations during intrahospital transport may disturb SpO2, ECG, impedance respiration, InvBP and NIBP measurements. If liquid has accidentally entered the equipment, 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. After replacing a battery, always make sure to close the battery compartment by sliding the lid back to the right until it clicks. Other transmitting radio devices using the same radio frequency band (Industrial Scientific and Medical 2.45 GHz band) may degrade or disturb the wireless network communication.

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.

1-2

Safety

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.

•

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 2-31.

•

Service and reparations 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

1-3

S/5 FM

1-4

Table of contents

Table of contents 2

System description

2-1

Principles of functions... 2-1 System introduction... 2-1 Components... 2-3 Optional components... 2-4 Communication between monitors... 2-4 Monitor connections... 2-5 Module overview... 2-6 Patient Side Module E-PSM... 2-6 Patient Side Module E-PSMP... 2-7 Extension Module N-FC... 2-8 Extension Module N-FCREC... 2-9 Extension Module N-FREC... 2-9 General module description... 2-10 Inserting and removing a module... 2-10 Keyboards... 2-12 Command Board... 2-12 Side panel... 2-13 Remote Controller... 2-13 Batteries... 2-14 Battery indicators... 2-15 Replacing batteries... 2-16 Conditioning a battery... 2-17 Symbols and abbreviations... 2-17 Equipment safety symbols... 2-17 Other symbols... 2-18 Abbreviations...2-20 Performance... 2-31 Power supply... 2-31 Battery operation... 2-31 Environmental conditions... 2-31 Alarm behavior... 2-31 Hemodynamic modules E-PSM, E-PSMP... 2-31 Modules with CO2 measurement, N-FC and N-FCREC...2-34 Wireless Network Option, N-FMW...2-35 Modules with recorder, N-FREC and N-FCREC...2-36

i

Table of contents

ii

System description

2 System description Principles of functions The S/5 FM is a modular multiparameter patient monitor. The monitor is especially designed for monitoring in intensive care units. It can also be used during transportation within the hospital. The modular design makes the system flexible and easy to upgrade. In addition to patient parameter modularity and easy upgrades, the monitor can be upgraded to wireless networking. External devices can be interfaced to the monitor with interface modules.

System introduction The Datex-Ohmeda S/5 FM system may consist of the elements shown below.

1 2

3

4

Figure 2-1 (1) (2) (3) (4)

S/5 FM system

S/5 FM with module(s) Remote Controller, K-CREMCO Printer Other monitors in the network

NOTE: The allowed cables, batteries, transducers and accessories for the monitor are listed in the “Supplies and Accessories” catalog delivered with each monitor.

WARNING

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.

2-1