GE S5 Owners Manual
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Introduction3 Document no. M1187317-009 1 Introduction The Datex-Ohmeda 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 interfac ed to the monitor with interface modules. NOTE: Your system may not include all these components. Consult your local representative for the available components. Figure 1 S/5 FM with N-FCREC (1) and E-PSM (2) modules 1.0.1 Compatibility S/5 FM is compatible with: S/5 L-FICU04/A S/5 L-FICU06/A Patient Side Modules, S/5 E-PSM and E-PSMP xx Extension Module S/5 F-FC x x Extension Modules, S/5 N-FCREC, and N-FREC xx Device Interfacing Solution S/5 N-DISxxx, rev. 01 and later xx S/5 Network and iCentral x x Wireless LAN is available with WLAN option F-FMW xx 2 1
Datex-Ohmeda S/5 FM 4 Document no. M1187317-009 1.1 Symbols 1.1.1 Symbols on transport packaging 1.1.2 Symbols on equipment The contents of the transport package are fragile and must be handled with care. Indicates the correct upright position of the transport package. The transport package must be kept in a dry environment. Indicates the temperature limitations within which the transport package should be stored. This package can be recycled. This battery contains lead and can be recycled. Dangerous voltage. The separate collection symbol is affixed to a battery, or its packaging, to advise you that the battery must be recycled or disposed of in accordance with local or country laws. The letters below the separate collection symbol indicate whether certain elements (Pb=Lead, Cd=Cadmium, Hg=Mercury) are contained in the battery. To minimize potential effects on the environment and human health, it is important that all marked batteries that you remove from the product are properly recycled or disposed. For information on how the battery may be safely removed from the device, please consult the technical or service manual, or equipment instructions. Information on the potential effects on the environment and human health of the substances used in batteries is available at this url: http://www.gehealthcare.com/euen/weee-recycling/index.html Pb Pb/Cd/Hg
Introduction5 Document no. M1187317-009 1.1.3 Equipment safety symbols - Attention, consult accompanying documents. - When displayed next to the HR value, indicates that the pacer is set on R. - On the N-FC(REC) module indicates that the airway gases should be calibrated every 6 months in normal use and every two months in continuous use to ensure that the measurement accuracy remains within specifications. - On the E-PSM(P) module: WARNING Protection against cardiac defibrillator discharge is due in part to the accessories for pulse oximetry (SpO 2), temperature (T) and invasive pressure (P) measurement. - On the rear or bottom panel: WARNING Electric shock hazard. Do not open the cover or the back. Refer servicing to qualified service personnel. WARNING Do not touch the monitor during defibrillation procedure. WARNING Disconnect from the power supply before servicing. WARNING When using the monitor with mounting attached, make sure that the mounting is manufacturer approved. CAUTION For continued protection against fire hazard, replace the fuse only with one of th e same type and rating. CAUTION Lithium battery on the CP U board. Dispose of the battery in accordance with local environmental and waste disposal regulations. - On top of the monitor beside the battery cover: WARNING Use manufacturer recommended batteries only. Dispose of the batteries in accordance with local environmental and waste disposal regulations. Type BF (IEC 60601-1) protection against electric shock. Type BF (IEC 60601-1) defibrillator-proo f protection against electric shock. Type CF (IEC 60601-1) protection against electric shock.
Datex-Ohmeda S/5 FM 6 Document no. M1187317-009 1.1.4 Other symbols Type CF (IEC 60601-1) defibrillator-proof protection against electric shock. When displayed in the upper left corner of the screen, indicates that the alarms are silenced. When displayed in the menu or digit fields, indicates that the alarm source has been turned off or alarm does not meet the alarm-specific activation criteria. ESD warning symbol for electrostatic sensitive devices. 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 section “1.2.2. ESD precautionary procedures ”. Symbol for non-ionizing electromagnetic radiation. Interference may occur in the vicinity of equipment marked with this symbol. Equipotentiality. Monitor can be co nnected to potential equalization conductor. Alternating current Fuse. Replace the fuse only with one of the same type and rating. SN, S/NSerial Number Submenu. Selecting an alternative marked with this symbol in a menu opens a new menu. Battery operation and remaining capacity. The height of the green bar indicates the charging level. Battery (A) charging (white bar) Battery (A) failure Both batteries have failed B BA B B
Introduction7 Document no. M1187317-009 Battery (A) is missing In the front panel: mains or external DC power. (External DC power for future use.) The monitor is connected to the Datex-Ohmeda Network (Local Area Network, LAN). The monitor is connected to the Datex-Ohmeda S/5 Network (Wireless Local Area Network, WLAN). Data Card (green) or Menu Card (white) is inserted. WLAN signal strength. The number of segments corresponds to the signal strength: four segments indicate strong signal, one segment weak signal. When connection to access point is being searched, the segments scroll from zero to four and back. Ethernet connector A blinking heart next to the heart rate or pulse rate value indicates the beats detected. A lung next to the respiration rate va lue indicates that respiration rate is calculated from the impedance respiration measurement. Gas inlet Gas outlet Do not reuse. Use by. Indicates the last use day. B
Datex-Ohmeda S/5 FM 8 Document no. M1187317-009 Date of manufacturer Manufacturer name and address Does not contain Latex. Do not immerse the sensor in liquids. IPX class: IPX0 IPX1 IPX2 IPX3 IPX4 IPX7 IPX8 Degree of protection against harmful ingress of water as detailed in the IEC 60529: - Ordinary equipment - Protection against vertically falling water drops. - Protection against vertically fallin g water drops when enclosure tilted up to 15 °. - Protected against spraying water. - Protected against splashing water. - Protected against the effects of temporary immersion in water. - Protected against the effects of continuous immersion in water. This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.
Introduction9 Document no. M1187317-009 1.2 Safety The following list contains general warnings an d cautions you should know before installing, maintaining or servicing the system. Warnings and cautions specific to the use of the system can be found in the User’s Guide and User’s Reference Manual. 1.2.1 Safety precautions Warnings WARNING A WARNING indicates a situation in whic h the user or the patient may be in danger of injury or death. •The device is not able to withstand unpacked drops from a height of 1 m. If the device is dropped, please service the device before taking it back into use. Power connection •Always check that the power cord and plug are intact and undamaged. •Do not use the power cord delivered with this product for any other product or purpose. •Use only hospital-grade grounded power outlets and power cord. Do not remove the grounding pin from the power plug. •Use only an intact and undamaged power cord. Replace the power cord if it is cracked, frayed, broken or otherwise damaged. •All system devices must be connected to the same power supply circuit. •Do not apply tension to the power cord otherwise the cord may get damaged. •Do not use an additional multiple socket outlet , extension cord or adapters of any kind. •Before starting to use the system, ensure that the whole combination complies with the international standard IEC 60601-1-1 and with th e requirements of the local authorities. Do not connect any external devices to the system other than those specif ied. •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. •To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Installation •Do not incinerate a battery or store at high temperatures as it will explode. •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. •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 section “ 1.2.2. ESD precautionary procedures.” •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.
Datex-Ohmeda S/5 FM 10 Document no. M1187317-009 •Do not use the monitor in high electromagnetic fields (for example, during MRI.) •A printer or computer must be supplied from an additional transformer providing at least basic isolation (isolating or separating transformer). •If you accidentally drop the monitor, modules or frames, have them checked by authorized service personnel prior to clinical use. •To avoid explosion hazard, do not use the mo nitor in presence of flammable anesthetics. •Do not touch the patient, table, instruments, modules or the monitor during defibrillation. •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. External connection •Do not connect any external devices to the monitor other than those specified. Explosion hazard •To avoid explosion hazard do not use th e monitor in the presence of flammable anesthetics. •Do not incinerate a battery or store at high temperatures as it will explode. Patient safety •Do not perform any testing or maintenance on the monitor while it is being used on a patient. •PACEMAKER PATIENTS: The impedance respiration measurement may cause rate changes in Minute Ventilation Rate Respon sive Pacemakers. In this case, set the pacemaker rate responsive mode off or turn the monitor impedance respiration measurement off. •Never install the monitor so that it is above the patient . •When using the monitor with mounting attached, make sure that the mounting is manufacturer approved. •Operation of the monitor outside the specified values may cause inaccurate results. Autoclaving and sterilizing • Do not autoclave any part of the system wi th steam or sterilize with ethylene oxide. Cleaning and service •Only trained personnel with proper tools and test equipment should perform the tests and repairs described in this manual. Unauthorized service may void the monitor warranty. •Always unplug the monitor before cleaning or service. After cleaning or service ensure that every part of the monitor is dry before reconnecting it to the power supply. •Do not touch any exposed wire or conductive surface while any cover is removed and the monitor is energized. The voltages present can cause injury or death. •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 section “ 1.2.2. ESD precautionary procedures”. •NOTE! The monitor is always internally powered when the batteries are connected.
Introduction11 Document no. M1187317-009 •Electrostatic discharge through the PC bo ards may damage the components. Before handling PC boards, wear a grounded antistatic wristband. Handle all PC boards by their non-conductive edges and use antistatic containers when transporting them. •Do not break or bypass the patient isolation barrier when testing PC boards. •Always perform an electrical safety check an d a leakage current test on the monitor after service. •Handle the water trap and its contents as yo u would any body fluid. Infectious hazard may be present. •Do not immerse any part of the device in any liq uid, or allow liquid to enter the monitor or modules. •If liquid has accidentally entered the system or its parts, disconnect the power cord from the power supply, remove the batteries from the monitor and have the equipment serviced by authorized service personnel. •Since calibration gas contains anesthetic agents, always ensure sufficient ventilation of the room during calibration. Accessories •Use only accessories, includin g mounts, and batteries, and def ibrillator-proof cables and invasive pressure transducers approved by GE Healthcare. For a list of approved supplies and accessories, see the “Supplies and Accessories” catalog. Other cables, batteries, transducers and accessories may cause a safety hazard, damage the equipment or the 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 oxim etry (SpO2), temperature (T) and invasive pressure (P) measurement.) •Single-use products are not designed to be reused. Reuse may cause a risk of cross-contamination, affect the measurement accuracy and/or system performance, or cause a malfunction as a result of the product being physically damaged due to cleaning, disinfection, re-sterilization and/or reuse. Special components Special components are used in th ese monitors that are vital to assure reliability and safety. GE Healthcare assumes no respon sibility for damage, if replacement components not approved by GE Healthcare are used. Batteries The Lithium Ion batteries are recyclable. Follow your local recycling guidelines. Refresh the batteries completely every six months. To replace the batteries safely, please refer to the service instructions in this manual. •Do not short-circuit th e battery terminals, this may prod uce a very high current, which will damage the battery. •Do not dispose of the battery into open flam e, nor put the battery near fire, as it may explode. •Do not dismantle the battery. •After replacing a battery, always make sure to close the battery compartment by sliding the lid back to the right until it clicks. See also section “Symbols”.
Datex-Ohmeda S/5 FM 12 Document no. M1187317-009 Storage and transport Do not store or transport the monitor outside the specified temperature, pressure and humidity ranges: Temperature -20...+60 °C/-4...140 °F Atmospheric pressure 670...1060 hPa/500...800 mmHg/670...1060 mbar Relative humidity 10...90% noncondensing Disposal •Dispose of the whole device, parts of it and its packing material and manuals in accordance with local environmental and waste disposal regulations. •Dispose the calibration gas container in acco rdance with local environmental and waste disposal regulations. Cautions CAUTION A CAUTION indicates a condition that may lead to equipment damage or malfunction. Installation •Leave space for air circulation to pr event the monitor from overheating. •Before connecting the power cord to the 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. Before use •Allow two minutes for warm-up and note any error messages or deviations from normal operation. Fuse replacement Replace a fuse only with one of the same type and rating. Cleaning and service •Do not use hypochlorite-, acetone-, phenol- or ammonia -based cleaners, abrasive material or harsh chemicals as they may damage the surfaces of the device. •Do not use abrasive cleaning compounds, instruments, brushes or rough-surface materials. •Do not apply pressurized air to any outlet or tubing connected to the monitor. Special components • Lithium battery on the CPU board. Dispose of the battery in accordance with local environmental and waste disposal regulations.