GE S5 Owners Manual
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Appendix B ElectroMagnetic CompatibilityB-3(4) Document no. M1187317-009 Table 3 Guidance and manufacturer’s declaration – electromagnetic immunity Guidance and manufacturer’s decl aration – electromagnetic immunity The S/5 FM is intended for use in the electromagnetic envi ronment specified below. The customer or the user of the S/5 FM should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the S/5 FM, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms 3 Vrms 150 kHz to 80 MHz 1 Vrms (1 Radiated RF IEC 61000-4-33 V/m 80 MHz to 2.5 GHz 3 V/m where P is the maximum output power rating of the transmitter in watts (W) a ccording to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may oc cur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations . Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. aField strengths from fixed transmitters, such as base stat ions for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcas t and TV broadcast cannot be predicated theoretically with accuracy. To assess the electromagnetic environmen t due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the S/5 FM is used exceeds the applicable RF compliance level above, the S/5 FM should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the S/5 FM. bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m or 1 V/m (1. (1 For impedance RESP measurement d 1.2P = d 3.5P = d 1.2P = d 2.3P = 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Datex-Ohmeda S/5 FM B-4(4) Document no. M1187317-009 Table 4 Recommended separation distances between portable and mobile RF communications equipment and the S/5 FM (1 For impedance RESP measurement. Recommended separation distances between portable and mobile RF communications equipment and the S/5 FM. The S/5 FM is intended for use in an electromagneti c environment in which radiated RF disturbances are controlled. The customer or the user of the S/5 FM can help prevent electromagnetic interference by maintaining a minimum distance between portabl e and mobile RF communications equipment (transmitters) and the S/5 FM as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz (1 80 MHz to 800 MHz 800 MHz to 2.5 GHz 0.01 0.12 0.35 (10.12 0.23 0.1 0.38 1.1 (10.38 0.73 11 .2 3.5 (11.2 2.3 10 3.8 11 (13.8 7.3 100 12 35 (112 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rati ng of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not app ly in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. d 1.2P = d 3.5P = d 1.2P =d 2.3P =
Appendix C, Channel Mask Selections for S/5 FMC-1(2) Document no. M1187317-009 APPENDIX C: Channel Mask Selections for S/5 FM NOTE: The selections are country specific. Make sure that you are using the correct selection. Selection Allowed BandDS Channels 07FF 2.400 - 2.4835 01 - 11 1FFF 2.400 - 2.4835 01 - 13 1C00 2.4465 - 2.4835 11 - 13 00F0 2.418 - 2.457 05-08
Datex-Ohmeda S/5 FM C-2(2) Document no. M1187317-009
Datex-Ohmeda S/5 TM FM Planned Maintenance Instructions Conformity according to the Council Directive 93/42/EEC concerning Medical Devices amended by 2007/47/EC CAUTION: U.S. Federal law rest ricts 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. Document number M1187318-003 2 February, 2010 GE Healthcare Finland Oy Kuortaneenkatu 2 FI-00510 Helsinki, Finland Tel: +358 10 39411 Fax: +358 9 1463310 www.gehealthcare.com Copyright © 2010 General Electric Com pany. All rights reserved.
Table of contentsi Document no. M1187318-003 Table of contents 1 Planned maintenance instructions 1 1.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1.2 Recommended tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1.2.1 Hemodynamic patient simulators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1.3 Recommended parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1.4 Planned maintenance parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1.4.1 PM parts for Airway Module, N-FC(REC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1.4.2 PM parts for S/5 FM frame, F-FM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2 Planned maintenance check list5 2.1 Visual inspection/preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 2.1.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 2.1.2 Extension module, N-F(C)(REC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 2.1.3 Recorder unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 2.1.4 E-PSM(P) Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 2.2 Functional inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 2.2.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 2.2.2 Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 2.2.3 Keyboard(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 2.2.4 N-FC(REC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 2.2.5 Multiparameter Hemodynamic Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 2.2.6 Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 2.2.7 Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 2.2.8 Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 2.2.9 Wireless Network Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 2.2.10 Device Interfacing Solution , N-DISxxx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 2.2.11 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Appendix A: Planned maintenance ch eck form, Datex-Ohmeda S/5 FM A-1
Planned maintenance instructions1 Document no. M1187318-003 1 Planned maintenance instructions 1.1 Introduction These instructions include procedures for planned maintenance (PM) for the Datex-Ohmeda S/5 FM. The Planned maintenance should be performed once a year. These instructions include “Planned maintenance check form, Datex-Ohmeda S/5 FM” which may be used when performing the procedures. The symbol in the instructions means that the procedure performed should be signed in the check form. The procedures should be performed in ascending order, bypassing those that are not applicable for a particular monitor. If you need further information on how to per form a certain planned maintenance procedure, please refer to the corresponding slot in the Technical Reference Manual. All menu selections related to the Datex-Oh meda monitors are written in the following typeface: e.g. Parameters - Gas Unit As you enter the service menus, you need following passwords: Monitor Setup - Install/Service (password 16-4-34) - Service (password 26-23-8) In case you evaluate the measurement accuracy with a patient simulator, add the simulator’s accuracy specification to the one for the monitor. WARNING Handle the water trap and its conten ts as you would any body fluid. Infectious hazard may be present. WARNING Only trained personnel with appropriate equipment should perform the tests and repairs outlined in this section. Unauthorized se rvice may void warranty of the unit. WARNING Wear a grounded antistatic wris tband when handling PC boards. Electrostatic discharge may dama ge components on the board. WARNING Failure on the part of all responsible individuals, hospitals or institutions, employing the use of this device, to implement the recommended maintenance schedule may cause equipment failure. The manufacturer does not, in any manner, assume th e responsibility for performing the recommended mainte nance schedule, unless an equipment maintenance agreement exists. The so le responsibility rests with the individuals, hospitals, or institut ions utilizing the device.
Datex-Ohmeda S/5 FM 2 Document no. M1187318-003 1.2 Recommended tools NOTE: Use only properly maintained, calibrated and traceable measurement equipment for the specified calibrations and adjustments to ensure accuracy. NOTE: * Ensure that the calibration gas and regulator are functioning properly before calibration. Perform annual maintenance on the regulator as required. For more information see section “Adjustments and calibrations” in N-FC(REC) slot. For product(s) Tool Order No. N-FC(REC) Flowmeter Calibration gas (CO2, 5%, 4 cans per package)755580 Regulator 755534-HEL* CO2 sampling line 3 m/10 ft 733163 Sampling line, 6 m/20 ft 73306 Hemodynamic modules E-PSM(P) Adult NIBP cuff hose with cuff ID 2021285-001 Adult NIBP cuff 2753E Infant cuff hose without cuff ID 414874-001 InvBP transducer 70077-001 Pressure manometer Multi-Link ECG accessories, IEC E-PSM(P) - Multi-link 3-leadwire set 412682-003 - Multi-link 5-leadwire set 412681-003 - Multi-link 5-leadwire set, C2-C6 416467-004 or Multi-Link ECG accessories, AHA E-PSM(P) - Multi-link 3-leadwire set 412682-001 - Multi-link 5-leadwire set 4162681-001 - Multi-link 5-leadwire set, V2-V6 416467-003 E-PSM(P) SpO 2 finger probe OXY-F-UN SpO 2 Interconnect Cable OXY-ES3 Temperature test set 884515-HEL Monitor / Modules MemCard – Menu MemCard – Data Torx screwdrivers; T8, T10