S5 Light Monitor Users Reference Manual April 2003

Intended purpose Datex-Ohmeda S/5 Light Monitor is intended for stationary and mobile monitoring of patient’s ECG, SpO2, non-invasive and invasive blood pressure, temperature, respiration and CO2 in hospitals and ambulances. When used outdoors, the monitor must be in the protective case. The monitor is intended for use by qualified medical personnel only. The S/5 Light Monitor is intended for patients with weight from 5 kg (11 lb.) up. Respiration monitoring is intended for patients three years old and up.

Classification according to IEC 60601-1 − − −

− −

CLASS I EQUIPMENT and INTERNALLY POWERED EQUIPMENT according to the type of protection against electrical shock. TYPE BF or CF equipment according to the degree of protection against electric shock is indicated with a symbol beside each patient connector. Degree of protection against harmful ingress of water as detailed in the IEC 60529: Monitor: IPX1, vertically falling water drops shall have no harmful effects (applicable when the monitor is in upright position, or tilted backwards). In the protective case IPX4, splash proof, when the case is closed properly, the monitor is intact and operates on battery power. Power adapter: IPX0, ordinary equipment. Power Adapter for Transport Vehicles: IPX1. 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.

Classification according to EU Medical Device Directive −

The monitor is classified as IIb.

Responsibility of the manufacturer Instrumentarium Corp. is responsible for the effects on safety, reliability and performance of the equipment only if: assembly, operations, extensions, readjustments, modifications, service and repairs are carried out by authorized personnel. − the electrical installation of the relevant room complies with appropriate requirements. − the equipment is used in accordance with this manual. The CO2 measuring option (N-LCM) is manufactured for Instrumentarium Corp. by Pryon Corp., 8500 S.W. Creekside Place, Beaverton, OR 97008-7107 USA. −

The Nellcor option (N-LNSAT) is manufactured for Instrumentarium Corp. by Mallinckrodt Inc., 675 McDonnell Boulevard, P.O. Box 5840, St. Louis, MO 63134 USA.

Trademarks ComWheel, Datex-Ohmeda AS/3, Datex-Ohmeda CS/3, Light, EarSat, FingerSat and Flexlite are trademarks of Instrumentarium Corp. © Instrumentarium Corp. All rights reserved.

General

Table of contents 1.

How to Use THIS MANUAL

1

Related documents ... 1 Symbols and abbreviations... 2 Symbols on the equipment ... 2 Symbols used in this manual... 4 Chapter symbols ... 4 Abbreviations ... 5 Conventions used in this manual ... 6

2.

SAFETY

7

Warnings ... 7 EXPLOSION HAZARD... 7 ELECTRICAL SHOCK HAZARD... 7 PATIENT SAFETY ... 8 Cautions... 9 BATTERY CAUTIONS ... 10

3.

Unpacking and Installation

11

Unpacking... 11 Placing ... 11 Electrical Power Adapter... 12 Charge batteries ... 13 Connecting to network ... 13 Configuration ... 13 Disposal ... 14

4.

Description

15

Parts of the monitor... 15 Rear panel... 16 Keys and controls... 17 ComWheel ... 17 Display... 18 Measurement connectors... 19

5.

Operation

20

Getting started... 20 During monitoring... 20 In-between patients... 20 At the end of the day ... 20 Using menus ... 21

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Datex-Ohmeda S/5 Light Monitor

6.

Batteries

22

Charging batteries... 22 Charging in the monitor ... 22 Removing batteries from the Battery Module ... 23 Battery alarms... 23 Storing and disposing of batteries... 23

7.

Cleaning

25

Dust filter ... 26 Monitor casing... 26 Pulse oximetry sensors ... 26 ECG cables, temperature probes, NIBP hose ... 26 NIBP cuff ... 27 Invasive pressure cables... 27 Airway accessories... 27 Adapters... 27 Mainstream CO2 sensor... 27

8.

ALARMS

29

Alarm categories... 29 Smart start alarms... 30 Silencing alarms ... 30 Silencing alarms for two minutes... 31 Turning audible alarms on and off ... 31 Alarm messages ... 32 Alarms setup and adjustments ... 32 Adjusting alarm limits... 32 Other settings ... 33 Automatic alarm recording... 33 Alarm tables... 34 Alarm sources... 34 Default limits... 34 Auto alarm limits ... 36

9.

MONITOR SETUP

38

Screen setup ... 38 Selecting waveforms... 38 Selecting numerical display fields ... 39 Setting time & date ... 40 Install/Service menu... 41 Default settings ... 41

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General

10.

TRENDS

45

Viewing graphic trends ... 46 Graphic trend pages... 46 Viewing numerical trend ... 48 Changing trend setup... 49 Erasing trend data... 49

11.

Patient Data

50

12.

Recording and Printing

52

Recording ... 52 Selecting the waveforms to be recorded... 52 Recording trends... 53 Other recorder settings... 53 Recorder paper replacement... 54 Printing... 54 Selecting the printer ... 54 Selecting the paper size ... 55 Printer installation... 55 Printer setup... 55

13.

Network and DataCard

56

Networking... 56 Patient view and multi view on the Datex-Ohmeda Central screen ... 56 Monitor-to-Monitor communication... 57 DataCard... 57 Inserting and removing the card ... 57 Collecting data... 58

14.

ECG

59

Monitoring ECG... 59 Applying electrodes ... 59 Patient preparation... 59 Placing electrodes ... 60 Electrode coding ... 60 Selecting trunk cable ... 61 What should happen when electrodes are applied ?... 61 Selecting ECG lead ... 61 ECG display... 61 Cascaded ECG... 62 ECG adjustments ... 62 ECG setup... 63 Setting heart rate alarm ... 64 iii

Datex-Ohmeda S/5 Light Monitor Pacemaker patients ... 64

15.

Respiration

65

Monitoring respiration... 65 Patient connections ... 65 Respiration setup ... 65 Limitations of measuring ... 66 Measuring principle... 67

16.

Pulse Oximetry

68

Monitoring pulse oximetry... 68 Selecting sensor... 69 Applying sensors... 69 What should happen when sensor is applied ?... 70 Pulse oximetry display... 70 Measuring limitations ... 70 Adjustments... 71 Setting SpO2 alarms ... 72 Measuring principle... 72 Alternative SpO2 measurement... 73 Nellcor sensors ... 73

17.

TEMPERATURE

74

Monitoring temperature ... 74 Temperature display ... 74 Temperature testing ... 74 Temperature setup... 75

18.

NON-INVASIVE BLOOD PRESSURE (NIBP)

76

Monitoring NIBP... 76 Display of NIBP measurement ... 77 Automatic NIBP double check... 78 Using NIBP functions ... 78 Starting/Stopping autocycle ... 79 Starting a manual measurement... 79 Canceling any measurement... 79 Starting a continuous measurement (STAT) ... 80 Using venous stasis... 80 NIBP adjustments ... 81 Calibration check... 81 NIBP alarms ... 82 Measuring principle... 82

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General

19.

INVASIVE BLOOD PRESSURE

83

Monitoring invasive pressures ... 83 Preparing pressure line... 83 Zeroing transducer... 84 Invasive pressure display... 85 Adjustments... 86 Labeling the invasive line... 86 Changing the scale ... 87 Other invasive pressure setup adjustments... 87 Invasive pressure alarms ... 88 Measuring principle ... 88

20.

Carbon Dioxide, CO 2

89

Monitoring mainstream CO2... 89 Display of CO2 measurement... 90 CO2 adjustments ... 91 Calibration check ... 91 Unit conversions ... 92 Measuring principle ... 92

21.

MAINTENANCE AND TROUBLESHOOTING

93

Maintenance... 93 Once a month ... 93 Once a year... 93 Checklist ... 93 General ... 93 ECG/Respiration... 94 Pulse oximetry ... 94 Temperature... 95 Non-invasive blood pressure NIBP... 95 Invasive blood pressure... 96 CO2 ... 96 Battery packs and Module ... 96 Alarm and information messages ... 97 ECG ... 97 Impedance respiration ... 98 Invasive blood pressure... 98 NIBP... 99 Temperature... 101 Pulse oximetry ... 101 CO2 ... 102 DataCard ... 103 v

Datex-Ohmeda S/5 Light Monitor Battery... 104 Recorder ... 104 Other messages... 105 Troubleshooting... 106

22.

GENERAL SPECIFICATIONS

107

Parameter specifications... 107 ECG... 107 Impedance respiration ... 107 Pulse oximetry (SpO2)/Pleth... 108 Temperature... 109 Non-invasive blood pressure... 109 Invasive blood pressure (F-LMP1 models only) ... 110 General... 111 Environmental conditions ... 112 Display... 112 Trends... 113 Alarms... 113 Light Monitor Battery Module (optional) (w/2 battery slots) ... 113 S/5 Light Monitor Backup Battery (optional)... 113 External Power Adapter ... 114 Power Adapter for transport vehicles (optional) ... 114 Option codes... 114 Nurse call and defibrillator synchronization signals ... 115

23.

Accessories

24.

INDEX

117 i

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General

1. HOW TO USE THIS MANUAL This manual describes how to use and maintain the Datex-Ohmeda S/5 Light Monitors F-LM1 and F-LMP1. The General section gives you information about safety aspects and installation. Get acquainted with them before using the monitor. The Basic Operation section helps you through the daily basic use of the monitor. The Detailed Operation section describes the monitor functions in detail. These chapters are necessary if you want to master all the features available in the monitor. The Troubleshooting/Specifications and Index sections help you find the information you need in various situations. NOTE: Before using your monitor, please read this manual. Pay special attention to WARNING and CAUTION statements.

Related documents S/5 Light Monitor Technical Reference Manual The Technical Reference Manual provides detailed technical descriptions and instructions for the service, maintenance procedures and troubleshooting.

Light Monitor Schematic Diagrams The Schematic Diagrams provide schematic diagrams and part layouts for the monitor.

Patient Monitor Supplies and Accessories The Patient Monitor Supplies and Accessories Catalogue provides information on all supplies and accessories available for the monitor.

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Datex-Ohmeda S/5 Light Monitor

Symbols and abbreviations Symbols on the equipment Attention, consult accompanying documents. on the rear panel indicates the warning:

Electric shock hazard. Do not open monitor frame. Refer servicing to qualified personnel. Do not touch any part of the monitor or patient connections during defibrillation procedure. Disconnect power supply before servicing.

on the rear panel dust filter indicates the reminder:

Check rear panel dust filter regularly, and clean at least once a month.

on the patient connector panel indicates the warnings and cautions:

Use only the specified cables and accessories.

on the external power adapter indicates the cautions:

For continued protection against fire hazard, replace only with same type and rating of fuse.

Ensure proper contact of the return electrode of the electrosurgery unit to your patient to avoid possible burns at ECG electrode or other probe sites. The output signals are not floating and must not be connected directly to a patient.

Make sure voltage selector is set according to local voltage. For indoor use only. For patient transport outdoors, use the monitor in its protective case and with battery power only. Do not immerse in liquid or allow any liquid to enter the interior.

on the battery unit indicates the warnings and cautions:

Do not put in fire. Do not short-circuit any terminals. Do not disassemble or mutilate. Use only with Battery Module or External Battery Charger. Discharge and charge batteries fully once a month to restore full capacity. Sealed NiCd battery must be recycled or disposed of properly. Discharge before disposing.

on the CO2 sensor:

Do not immerse the sensor in liquids or autoclave it.

2

General SpO2, CO2: Type BF (IEC-60601-1) protection against electrical shock, not defibrillation proof. NIBP: Type BF (IEC-60601-1) defibrillator-proof protection against electrical shock. Temperature: Type CF (IEC-60601-1) protection against electrical shock. ECG, Impedance Respiration, P1, P2: Type CF (IEC-60601-1) defibrillator-proof protection against electrical shock.

Ni-Cd

Battery packs contain heavy metal cadmium (chemical symbol Cd) and in case of disposal, must be separated from other waste according to local regulations. Battery packs contain Ni-Cd and they can be recycled.

Ni-Cd

IPX-class: IPX0 IPX1 IPX4

Degree of protection against harmful ingress of water as detailed in the IEC 60529: - ordinary equipment - vertically falling water drops shall have no harmful effects - splash proof Battery charging LEDs: LEDs are blinking while batteries are being charged and stay illuminated when batteries are fully charged and the monitor is connected to mains. The monitor is connected to the network (optional). The DataCard (option) is inserted. If symbol is blinking, the card is faulty or it is not inserted properly. A blinking heart next to the heart rate or pulse rate value indicates the beats detected. A lung next to the respiration rate value indicates that respiration rate is calculated from the impedance respiration measurement. Silence alarm indicator. When displayed on the upper left corner of the screen, indicates that all the alarms are silenced. When in the menu or digit fields, indicates that the alarm source has been turned off. Alternating current

3

Datex-Ohmeda S/5 Light Monitor Input voltage Output voltage Ethernet connectors Printer connector Sample gas outlet Do not immerse the sensor in liquids.

Symbols used in this manual Indicates the procedure for making adjustments (turn and press) in the menus. Submenu. Selecting a menu item with this symbol opens a new menu.

Chapter symbols General chapters

Measuring parameter chapters

General information

ECG

Operation

NIBP

Alarms

Pulse oximetry

Trends

Temperature

°C °F

4

General Recorder

Invasive pressure

Monitor setup

CO2

Networking and DataCard

Impedance respiration

Patient data

Abbreviations Blood pressure: Art CVP ICP Inv. Mean NIBP P PA S/D

arterial pressure central venous pressure intracranial pressure invasive mean of diastolic and systolic pressures non-invasive blood pressure blood pressure pulmonary arterial pressure systolic/diastolic

Temperature: Temp AirW Axil Blad Eso Myo Naso Rect Room Skin Temp Tymp Core Surf

temperature airway temperature axillary temperature bladder temperature esophageal temperature myocardial temperature nasopharyngeal temperature rectal temperature room temperature skin temperature temperature tympanic temperature central temperature surface temperature

5

Datex-Ohmeda S/5 Light Monitor Miscellaneous: Casc ECG EL HR LED Pleth P/N PR SpO2 MS SN, S/N

cascaded ECG waveform electrocardiography electroluminescence (display) heart rate light emitting diode plethysmograph waveform part number pulse rate oxygen saturation measured by pulse oximeter mainstream CO2 measurement serial number

Conventions used in this manual Names of the keys appear in bold typeface: Normal Screen. Selectable menu items appear in bold and italic typeface: Previous Menu. Informative messages displayed on the screen are enclosed in single quotes: ‘Please wait’.

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Safety

2. SAFETY Warnings WARNING

Indicates situations in which the user or the patient may be in danger of injury or death.

EXPLOSION HAZARD •

Do not use the monitor in presence of flammable anesthetics.

ELECTRICAL SHOCK HAZARD •

Do not remove cover. Refer servicing to qualified service personnel.

•

Use only hospital-grade grounded electrical outlets and power cord. Grounding reliability can only be achieved when the equipment is connected to a receptacle marked ‘hospital grade’.

•

Make sure that external equipment is hospital grade grounded before you connect it to the monitor. Do not connect any external equipment to the monitor, except that specified by Datex-Ohmeda.

•

When connecting external equipment to monitor, make sure that the whole combination complies with safety standard IEC 60601-1-1 for the medical electrical systems and with the requirements of local authorities. A non-medical electrical equipment connected to monitor shall be supplied from an extra separating transformer with a protectively grounded power outlet.

•

Before cleaning, disconnect the monitor from electrical outlet.

•

Do not immerse any part of the monitor in liquids or allow liquid to enter the interior.

•

Do not autoclave any part of the monitor with steam or ethylene oxide.

•

After cleaning, or if liquid has accidentally entered the interior of the monitor, make sure that every part of the monitor is dry before reconnecting it to the power supply.

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Datex-Ohmeda S/5 Light Monitor

PATIENT SAFETY •

Always make sure that necessary alarm limits are set and operative when you start monitoring.

•

When the alarms are suppressed, observe the patient frequently.

•

Connect only one patient to one monitor at a time.

•

Constant attention by a qualified professional is needed whenever a patient is under anesthesia or connected to a ventilator. Some equipment malfunctions may pass unnoticed in spite of the monitor alarm.

•

Do not use antistatic or electrically conductive breathing tubes. They may increase the risk of burns when electrosurgery unit is utilized.

•

Do not use the monitor during magnetic resonance imaging (MRI).

•

ECG, Impedance Respiration, InvBP: Ensure proper contact of the return electrode of the electrosurgery unit to your patient to avoid possible burns at sensor sites.

•

ECG, Impedance Respiration, InvBP: Make sure that no part of the patient connections touches any electrically conductive material including earth.

•

Impedance Respiration: In obstructive apnea, thoracic movements and impedance variations may continue.

•

NIBP: The monitor sets the inflation pressure automatically according to the first measurement. Reset the case to reset the inflation limit before measuring a new patient.

•

PATIENTS WITH PACEMAKERS OR ARRHYTHMIAS: Monitor may count the pacemaker pulses as heart beats during cardiac arrest, some arrhythmias, and with certain types of pacemakers particularly in ON R mode. Do not rely entirely upon rate meter alarms. Keep patients with pacemakers and arrhythmias under close surveillance.

•

PACEMAKER PATIENTS: The impedance respiration measurement may cause rate changes in Minute Ventilation Rate Responsive Pacemakers. Set the pacemaker rate responsive mode off or turn off the impedance respiration measurement on the monitor.

•

SpO2: A damaged sensor or a sensor soaked in liquid may cause burns during electrosurgery.

8

Safety •

SpO2: Change measuring site frequently. Change the sensor site and check skin and circulatory status every 2-4 hours with adults and every hour with small children.

•

The output signals are not floating and must not be connected directly to a patient.

•

Do not use delayed analog signals for defibrillator or intra-aortic balloon pump synchronization.

•

The monitor is intended for use by qualified medical personnel only.

•

InvBP: All invasive procedures involve risks to the patient. Use aseptic technique. Follow catheter manufacturer’s instructions.

•

InvBP: Use only defibrillator proof cables and transducers.

Cautions CAUTION

Indicates situations in which the unit or devices connected to it may be damaged. •

Use licensed patient cables and accessories only, see Patient Monitor supplies and accessories catalogue. Other cables and accessories may damage the system or interfere with measurement.

•

Before connecting the power cord, ensure that the input voltage selector is set correctly in the external power adapter.

•

Use the monitor outdoors with the battery power only.

•

Do not store the monitor beyond the specified temperature range.

•

Do not use hypochlorite, ammonia-, phenol- or acetone-based cleaners. They may damage the monitor.

•

Clean rear panel fan dust filter once a month or whenever needed.

•

Leave space around the monitor for ventilation to prevent the monitor from overheating.

•

Do not apply pressurized air to any outlet or tubing connected to the monitor. Pressure may destroy sensitive elements.

•

When used in moving vehicle, mount the monitor properly.

•

Dispose of the device and parts thereof in accordance with local regulations.

9

Datex-Ohmeda S/5 Light Monitor •

Vibrations during transport may disturb SpO2, ECG, impedance respiration and NIBP measurements.

•

CO2, SpO2: Do not apply force to sensors or sensor cables.

•

DataCards: Do not subject cards to excessive heat, bending, or magnetic fields.

•

InvBP: Mechanical shock to invasive blood pressure transducer may cause severe shifts in zero balance and calibration and produce erroneous readings.

•

Electromagnetic interference from radio-frequency transmitting devices in ambulances may affect the performance of this medical device.

BATTERY CAUTIONS •

Do not put in fire.

•

Do not short-circuit any terminals.

•

Do not use damaged or leaking batteries.

•

Do not disassemble or break the batteries.

•

Use only with Battery Module or External Battery Charger.

•

Charge and discharge batteries fully once a month to restore full capacity.

•

Sealed NiCd battery must be recycled or disposed of properly. Discharge before disposing.

10

Installation

3. UNPACKING AND INSTALLATION Unpacking The monitor is delivered in one box containing typically (as minimum): −

Datex-Ohmeda S/5 Light Monitor − Datex-Ohmeda S/5 Light Monitor Power Adapter with power cord or optional Power Adapter for Transport Vehicles − User’s Reference Manual Check that the contents correspond to your order and that all additional options you have ordered are included. If any of the items appears damaged or is missing, contact your sales person immediately.

Placing The monitor can be placed on a flat surface or hung with the handle from bed or wall rails. Make sure that the surface or rail holds up to at least 10 kg/22 lb.

Figure 3-1

Installation

A protective case is also available. If using the case, make sure that the monitor is always in a standing position to ensure proper ventilation. The monitor is splash-proof (IPX4) when it is in the protective case and all the openings of the case are closed properly. Make sure the monitor is intact and operates on battery power. When used outdoors, the monitor must be in the protective case. NOTE: The pocket in the protective case is not water-proof. Do not place items in the pocket that may be damaged by moisture. Universal mounting solutions are sold separately. Contact your local distributor. 11

Datex-Ohmeda S/5 Light Monitor

Electrical Power Adapter Use only the power cord and power adapter provided with the monitor. •

Set the voltage selector on the adapter to the right position (115V/230V) e.g. with a pen.

•

Connect the adapter cord to the connector on the rear panel.

•

Connect the power cord to the adapter and then plug onto the wall electrical outlet.

NOTE: To use the power adapter, it must be lying on a flat surface or hanging from the holder. Do not let any liquid enter the adapter. When external power supply is in use, a green led is lit.

Figure 3-2

WARNING

Placing Power Adapter

ELECTRICAL SHOCK HAZARD: Use only hospital grade grounded electrical outlets. CAUTION

Before connecting the power cord, ensure that the input voltage selector is set correctly in the power adapter.

In vehicles with 12 - 32 V power source, use the Power Adapter for Transport Vehicles, N-LPOWT. For information on how to install and use this adapter, refer to the instruction sheet provided with it, or contact your local distributor.

12