GE S5 Owners Manual
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GE Healthcare Datex-Ohmeda S/5 FM Technical Reference Manual Conformity according to the Council Directive 93/42/EEC concerning Medical Devices amended by 2007/47/EC CAUTION: U.S. Federal law restricts this device to sale by or on the order of a li censed medical practitioner. Outside the USA, check local laws for any restriction that may apply. All specifications subject to change without notice. Order code M1181261 3rd edition 10 Febru ary, 2012 GE Healthcare Finland Oy Kuortaneenkatu 2 FI-00510 Helsinki, Finland Tel: +358 10 39411 Fax: +358 9 1463310 www.gehealthcare.com Copyright 2010, 2012 General Electric Company. All rights reserved.
Indications for use The S/5 FM with L-FICU06 and L-FICU06A and N-FCREC Module are intended for multiparameter patient monitoring. The S/5 FM with L-FICU06 or L-FICU06A software is indicated for monitoring of hemodynamics (including arrhythmia and ST-segment analysis) and respiratory status of all hospital patients. Extension module N-FCREC (option N-FCREC or N-FC) is indicated for monitoring CO2 and respiration rate of all hospital patients. CO2 measurements are indicated for patients weighing over 5kg (11lbs). The S/5 FM Monitor and N-F(C)(REC) Extension Module are indicated for use by qualified medical personnel only. The Datex-Ohmeda S/5 PSM module (consisting of E-PSM, E-PSMP and E-INTPSM Modules) and accessories is intended for monitoring hemodynamic parameters of hospitalized patients. The Datex-Ohmeda S/5 PSM module (consisting of E-PSM, E-PSMP and E-INTPSM Modules) and accessories are indicated for monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG (including ST-segment and arrhythmia), Impedance respiration, NIBP, Temperature, SpO2 (inc luding monitoring during conditions of clinical patient motion), and invasive blood pressure. Impedance Respiration measurement is in dicated for patients ages 3 and up. The NIBP measurement is indicated for pa tients who weigh 5 kg (11 lbs.) and up. The device is indicated for use by qualified medical personnel only. NOTE: E-INTPSM Module is not in use with the S/5 FM. 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 A • Group 1 contains all ISM (Industrial, scientific and medical) equipment in which there is intentionally generated and/or used conductively coupled ra dio-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 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, modificati ons, 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 “Users Guide.” Trademarks S/5, D-lite, D-lite+, Pedi-lite, Pedi-lite+, Mini D- fend, D-fend, D-fend+, MemCard, ComBar, ComWheel, EarSat, FingerSat, FlexSat, PatientO2, Entropy and Patient Spirometry are trademarks of GE Healthcare Finland Oy. Datex, Ohmeda, and OxyTip+ are trademarks of GE Healthcare Finland Oy and Datex-Ohmeda, Inc. All other product and company names are property of their respective owners. Product availability Some of the products mentioned in this manu al may not be available in all countries. Please, consult your local representative for the availability.
Master Table of Contents1 Document no. M1187317-009 Datex-Ohmeda S/5 FM Technical Reference Manual, Order code: M1181261 3rd edition Part I, General Service Guide Part II, Product Service Guide Document No. Updated Description M1187317-009 Introduction, Syst em description, Installation, Interfacing, Functional check, General troubleshooting 1 M1187318-003 Planned Main tenance Instructions2 Document No. Updated Description M1187329-003 S/5 FM Service Menu 1 M1187335-004 Frame for FM 2 M1215098-002 Patient Side Module, E-PSM, E-PSMP 3 M1187338-003 S/5 Extension Module for FM, N-FC, N-FCREC, N-FREC 4 M1187342-004 S/5 Remote Controller, K-REMCO, K-CREMCO 5 M1187344-003 Device Inte rfacing Solution, N-DIS6 M1187346-007 S/5 FM Spare Parts 7
Table of contentsi Document no. M1187317-009 Table of contents Table of contents i Table of figures iii List of tables iv About this manual1 1Introduction 3 1.0.1 Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1.1 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1.1.1 Symbols on transport packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1.1.2 Symbols on equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1.1.3 Equipment safety symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 1.1.4 Other symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 1.2 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1.2.1 Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1.2.2 ESD precautionary procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 2 System description14 2.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 2.2 Bus structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 2.3 Distributed processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 2.4 Module communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 2.5 Software loading. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 2.6 Parameter modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 3 System installation 18 3.1 Unpacking instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 3.2 Choosing location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 3.3 Mounting the S/5 FM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 3.3.1 E-PSM(P) Mounting Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 3.3.2 Monitor connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 3.3.3 Connection to mains . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 3.3.4 Connection to Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 3.3.5 Connection to Wireless Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 3.3.6 Inserting and removing the parameter modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 3.3.7 Downloading Monitor Software F-FM(W)-00 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 3.3.8 Downloading Monitor Software, F-FM(W)-01 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 3.3.9 Performing Factory Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 3.3.10 Installing the Datex-Oh meda Wireless Network Upgrade, U-FMW (F-FM-00) . . . . . . 25 3.3.11 Installing the Datex-Ohmeda Wireless Network Service Option, N-FMWS (F-FM-00) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 3.3.12 Installing the S/5 Wireless Network Upgrade, U-FMW-01 . . . . . . . . . . . . . . . . . . . . . . . . 28 3.4 Remote Controller, K-CREMCO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 3.5 Visual indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 3.6 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Datex-Ohmeda S/5 FM ii Document no. M1187317-009 4Interfacing32 4.1 Interfacing external bedside devices via Device Interfacing Solutions, N-DISxxx . . . . . . . . . 32 4.1.1 Device Interfacing Solution components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 4.1.2 Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 4.1.3 Mounting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 4.1.4 Selecting the external device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 4.1.5 Functional check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 4.1.6 Selecting the parameter data source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 5 4.2 Interfacing printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 4.2.1 Setting S/5 FM interface for printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 4.2.2 Connection to serial printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 4.2.3 Connection to parallel printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 4.2.4 Installing the Serial-to-Parallel Converter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 4.2.5 Connection to printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 4.3 Interfacing computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 4.4 Output signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 4.4.1 Digital outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 4.4.2 Analog outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 5 Functional check 40 5.1 Recommended tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 5.2 Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 5.3 Functional inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 5.3.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 5.3.2 Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 5.3.3 Keyboard(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 5.3.4 Frame unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 5.3.5 Extension Module with CO 2 measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 5.3.6 Multiparameter Hemodynamic Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 5.3.7 Data Card and Menu Card function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 5 5.3.8 Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 5.3.9 Network connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 5.3.10 Wireless Network Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 5.3.11 Device Interfacing Solution, N-DISxxx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 5.3.12 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 6 General troubleshooting 47 Appendix A: Functional check form, Datex-Ohmeda S/5 FM A-1 Appendix B: ElectroMagnetic Compatibility B-1 Appendix C: Channel Mask Selections for S/5 FM C-1
Table of figuresiii Document no. M1187317-009 Table of f igures Figure 1 S/5 FM with N-FCREC (1) and E-PSM (2) modules .......................................................................................................... 3 Figure 2 General bus structure of S/5 FM ....................................................................................... .................................................14 Figure 3 Principle of UPI section operation ..................................................................................... .................................................15 Figure 4 General structure of param eter modules with patient isolation .......................................................... ...............17 Figure 5 E-PSM(P) mounting accessories .......................................................................................... ................................................19 Figure 6 S/5 FM front panel ..................................................................................................... ................................................................20 Figure 7 Rear panel connections ................................................................................................. .........................................................21 Figure 8 Connection cables and LED indicators ................................................................................... .........................................33 Figure 9 An example of interfacing external devices with Device Interfacing Solution..............................................34 Figure 10 Connecting S/5 FM monito r to printer, converter model PI130-R2 ........................................................ ............37 Figure 11 S/5 FM general troubleshooting fl owchart ....................................................................................................................47
Datex-Ohmeda S/5 FM iv Document no. M1187317-009 List of tables Table 1 DIS modules and interfaced devices............................................................................................................. 32 Table 2 NET ID connector, X8 on Multi I/O adapt er ............................................................................................... 38 Table 3 Defib & IABP sync connector, X5 .. .................................................................................................................. 38 Table 4 Patient simulators’ compatibility with ea ch hemodynamic module.............................................. 41 Table 5 Adapter cables for hemody namic patient simulators .......................................................................... 42 Table 6 Guidance and manufacturer’s declaration – electromagnetic emissions ................................ B-1 Table 7 Guidance and manufacturer’s declaration – electromagnetic immunity ................................. B-2 Table 8 Guidance and manufacturer’s declaration – electromagnetic immunity ................................. B-3 Table 9 Recommended separation distances between portable and mobile RF communications equipment and the S/5 FM .. ................................................................................ B-4
1 Document no. M1187317-009 About this manual Intended audience This Technical reference manual is meant for service representatives and technical personnel who install, configure, maintain, ad minister, troubleshoot or repair Datex-Ohmeda S/5 FM. Notes to the reader As the monitor setup may vary, some functions described may not be available in the monitor you are using. •The order code for the entire printed manual is M1181261. The manual includes Technical Reference Manual Slots and every slot has an individual document number. •Part I gives the reader an overview of the S/5 FM. It contains the information needed to install, interface and troubleshoot the moni tors. Instructions for functional check and planned maintenance are also included. Read the manual through and make sure that you understand the procedures described before th e installation of the monitor. To avoid risks concerning safety or health, strictly observe the warning indications. If you need any assistance concerning the installation, please do not hesitate to contact your authorized distributor. •Part II contains detailed descriptions of each component of the S/5 FM, such as frame unit, parameter modules Remote Controller and Device Interfacing Solution. Service check for each product, service menus and all the spare parts information for the Monitor is included. The manufacturer reserves the right to change product specifications without prior notice. Although the information in this manual is believed to be accurate and reliable, the manufacturer assumes no responsibility for its use. Installation and service are allowed by authorized service personnel only. GE Healthcare Finland Oy (GE) assumes no responsibility for the use or re liability of its software in equipment that is not furnished by GE. Ordering manuals A paper copy of this manual will be provi ded upon request. Contact your local GE representative and request the part number on the cover page of the manual. Related documentation S/5 FM Monitor For instructions for daily use including cleaning and daily maintenance, clinical aspects and basic methods of measurement see: S/5 FM Monitor, User’s Guide S/5 FM Monitor, User’s Reference Manual For more information about the iCentral, S/5 Arrhythmia Workstation and anesthesia record keeping solution, see the “Technical Reference Manuals” and ”User’s Reference Manuals” for these products.” Software options and default settings are describ ed in the “Default Configuration Worksheet” delivered with each monitor. Available accessories are described in the “Supplies and Accessories” catalog.
Datex-Ohmeda S/5 FM 2 Document no. M1187317-009 Conventions used To help you find and interpret information easily, the manual uses consistent text formats: Hard KeysNames of the hard keys on the Remote Controller, Command Board, side panel 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: ECG Setup. Menu access is described from top to bott om. 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 . ‘Messages’ Messages (alarm messages, informative messages) displayed on the screen are written inside single quotes: ‘Please wait’. “Sections” 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 Users Reference Manual: Alarms. Hypertext links Hypertext links on PDF versions are written in blue color. WARNING Warnings are written in the following way: WARNING This is a WARNING. CAUTION Cautions are written in the following way: CAUTION This is a CAUTION. NOTE Notes are written in the following way: NOTE: This is a NOTE. In this manual, the word “select” means choosing and confirming. Illustrations and names All illustrations in this manual are only exampl es, 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. Sign the check form after performing the procedure.