B30 Patient Monitor User Manual Rev C July 2009

B30 Patient Monitor User's Guide Related to software L-DICU08 0459 All specifications are subject to change without notice. Document no. 2039822-002 C 7th July 2009

GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI USA Zip: 53223 Tel: 1 414 355 5000 (outside US) 800 558 5102 (US only) Fax: 1 414 355 3790 www.gehealthcare.com

Copyright © 2009 General Electric Company. All rights reserved.

GE Healthcare 3F Building 1, GE Technology Park 1 Huatuo Road Shanghai PRC 201203 Tel: +86 21 3877 7888 Fax: +86 21 3877 7451

About this guide This User's Guide describes the features and functions offered by the B30 monitor. Descriptions refer to the software L-DICU08. This manual is an integral part of the product and describes its intended use. Keep it always close to the equipment. Observance of the manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. If you are a new user of the monitor, we suggest you begin with sections "Safety precautions", "System introduction" and "Monitoring basics." The following conventions are used: − Names of the hard keys on the Command Board and modules are written in the following way: ECG. − Menu items are written in bold italic typeface: ECG Setup. − Menu access is described from top to bottom. For example, the selection of the Screen Setup menu item and the Waveform Fields menu item would be shown as Screen Setup - Waveform Fields. − Messages (alarm messages, informative messages) displayed on the screen are written inside single quotes: 'Learning.' − When referring to different sections in this manual, section names are enclosed in double quotes: "Cleaning and care." − In this manual, the word "select" means choosing and confirming.

Related documentation − Clinical aspects, basic methods of measurement and technical background: B30 Patient Monitor User's Reference Manual

− Installation, technical solutions and servicing: B30 Patient Monitor Technical Reference Manual

− Options and selections of the software: B30 Patient Monitor Default Configuration Worksheet

− Compatible supplies and accessories: B30 Patient Monitor Supplies and Accessories

− Other devices closely related to the monitor: iCentral User's Reference Manual

Trademarks Dash, Datex, Ohmeda, S/5, D-fend, D-fend+, Mini D-fend, OxyTip+, ComBar, ComWheel, EarSat, FingerSat, FlexSat are trademarks of GE Healthcare. All other product and company names are property of their respective owners.

Product availability Some of the products mentioned in this manual may not be available in all countries. Please, consult your local representative for the availability.

Intended purpose (Indications for use)

Classifications

The B30 patient monitor is intended for multiparameter patient monitoring. The B30 monitor is indicated for continuous monitoring of hemodynamic parameters (including arrhythmia and ST segment analysis) and respiratory status and creation of limit alarms. The B30 monitor is intended for all hospital patients and all hospital departments including intra-hospital transport but excluding harsh physical environment like MRI.

In accordance with IEC 60601-1: − Class I and internally powered equipment - the type of

The Patient side module E-PSM(P)W 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, oscillometric NIBP (sys/dia/mean), temperature, SpO2 (including monitoring during conditions of clinical patient motion), and invasive blood pressure. Impedance respiration measurement is indicated for patients ages three years and up. The NIBP measurement is indicated for patients who weight 5kg (11 lb) or up.The E-PSM(P)W is intended for all hospital departments including intra-hospital transport but excluding harsh physical environment like MRI. The extension module N-F(C)(REC) (option N-FCREC, or N-FC) is indicated for monitoring of CO2 and respiration rate of all hospital patients. CO2 measurements are indicated for patients who weight over 5 kg (11 lb). The B30 monitor and N-F(C)(REC) Extension Module and E-PSM(P)W Patient Side Module are indicated for use by qualified medical personnel only.

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 is 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. − Portable Monitor

In accordance with IEC 60529: − IPX1 - degree of protection against harmful ingress of water. In accordance with EU Medical Device Directive: IIb In accordance with CISPR 11: Group 1 Class B; see page 3 of this User's Guide.

Responsibility of the manufacturer GE Medical Systems Information Technologies, Inc. is responsible for the safety, reliability and performance of the equipment only if: − Assembly, extensions, readjustments, modifications, service and repairs are carried out by personnel authorized by GE. − Electrical installation complies with appropriate requirements. − The equipment is used in accordance with this User's Guide.

Contents Safety precautions... 1

Pulse oximetry...63

Symbols... 5

Non-invasive blood pressure (NIBP)...67

System introduction... 9

Invasive blood pressure...71

Monitor introduction...11

Airway gas (CO2)...75

Monitoring basics...23

Troubleshooting...79

Setting up the monitor before use...25

Messages...81

Entering and loading patient data...31

Abbreviations...85

Starting and ending...33

Performance...91

Screen setup...35

Electromagnetic Compatibility...97

Alarms...37

End User License Agreement... 103

Printing and recording...41

Warranty... 105

Trends...45 Cleaning and care...47 ECG and ST...53 Impedance respiration...59 Temperature...61

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Safety precautions These precautions refer to the entire system. Warnings and cautions specific to parts of the system can be found in the relevant section.

Warnings

A WARNING indicates a situation in which the user or the patient may be in danger of injury or death. • • • • • • • • • • • •

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. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Do not use an additional multiple socket outlet or extension cord. 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. If you accidentally drop the monitor or modules, have them checked by authorized service personnel prior to clinical use. Vibrations during intrahospital transport may disturb SpO2, ECG, impedance respiration, NIBP and InvBP measurements. Some equipment malfunctions may not generate a monitor alarm. Always keep the patient under close surveillance. To avoid explosion hazard, do not use the monitor in presence of flammable anesthetics. 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.

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Do not touch the patient, table, instruments, modules or the monitor during defibrillation. If the integrity of the external protective earth conductor arrangement is in doubt, use the monitor with battery operation. When detaching modules, be careful not to drop them. Always support with one hand while pulling out with the other. Use only approved accessories, batteries, mounts 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, 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 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 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. Connecting electrical equipment together or using the same extension cord for more than one device may cause their leakage currents to exceed the limits specified in relevant safety

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standards. Always make sure that the combination complies with the international safety standard IEC 60601-1-1 for medical electrical systems and with the requirements of local authorities. 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. See "Safety precautions: ESD precautionary procedures" in the"User's Reference Manual" for details. Other equipment may interfere with the system, even if that other equipment complies with CISPR emission requirements. If liquid has accidentally entered the system or its parts, 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. Before cleaning, disconnect the monitor from the power supply. Use only an intact power cord. Replace the power cord if it is cracked, frayed, broken or otherwise damaged. Do not apply tension to the power cord otherwise the cord may get damaged. The power cord may only be connected to a three-wire, grounded, hospital grade receptacle. NOTE: The monitor is always internally powered when the batteries are connected. The B30 is always energized by the internal batteries. A short circuit may cause internal damage. Do not touch any exposed wiring or conductive surface inside, this may cause an electric shock. Make sure that the Pole Mount for PSMW is always used in vertical position to prevent water from entering the E-PSM(P)W module.

Cautions

A CAUTION indicates a situation in which the unit or devices connected to it may be damaged. • • • • • • • • • • • •

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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. Leave space for circulation of air to prevent the monitor from overheating. Refresh the batteries completely every six months (see "Cleaning and care"). Do not store or use the monitor outside the temperature and humidity ranges specified in the "Performance" section of this manual. After replacing a battery, always make sure that you close the battery compartment by sliding the lid back to the right until it clicks. Perform regular functional testing of each of the parameters and accessories. The monitor display is fragile. Ensure that it is not placed near a heat source or exposed to mechanical shocks, pressure, moisture or direct sunlight. Do not immerse any part of the device in liquids or allow liquid to enter the interior. Do not autoclave any part of the system with steam or sterilize with ethylene oxide. Do not apply pressurized air to any outlet or tubing connected to the monitor. Pressure may destroy sensitive elements. Before use, allow two minutes for warm-up and note any error messages or deviations from normal operation. Do not short-circuit the battery terminals, this may produce a very high current, which will damage the battery.

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Do not store or transport the monitor outside the specified temperature, pressure and humidity ranges.

Disposal •

Dispose of the whole device, parts of it, its packing material and this manual in accordance with local environmental and waste disposal regulations.

Points to note •

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This manual is intended for clinical professionals. Clinical professionals are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring of critically ill patients. Medical electrical equipment needs special precautions regarding electromagnetic compatibility and needs to be installed and put into service according to the electromagnetic compatibility 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, accessories and mounts 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 the "Performance" section. Service and repairs are allowed for authorized service personnel only. CISPR 11 classification: 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.

For your notes:

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Symbols − Attention, consult accompanying documents. − On the modules or frames indicates that modules with identical measurements should not be used in the same monitor. If such modules have been inserted, remove the module that has been most recently connected. You can also remove both modules and reconnect the new module after five second. − On the E-PSM(P)W module indicates that protection against cardiac defibrillator discharge is due in part to the accessories for pulse oximetry (SpO2), temperature (T) and invasive pressure (P) measurement. − On the N-F(C)(REC) module indicates that airway gases should be calibrated every six months in normal use and every two months in continuous use. − On top of the monitor beside the battery cover: Use manufacturer recommended batteries only. Follow the regional regulations for disposal.

− On the rear panel this symbol indicates the

following warnings and cautions: −Electric shock hazard. Do not open the cover or the back. Refer servicing to qualified personnel. −For continued protection against fire hazard, replace the fuse only with one of the same type and rating. −Disconnect from the power supply before servicing. −Do not touch the monitor during defibrillation. −Do not use the monitor without manufacturer approved mounting attached.

Type BF (IEC 60601-1) protection against electric shock Type BF (IEC 60601-1) defibrillator-proof protection against electric shock Type CF (IEC 60601-1) protection against electric shock 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.

Battery (A) missing

In the front panel: mains/external DC power

Equipotentiality. Monitor can be connected to potential equalization conductor.

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. See "Safety precautions: ESD precautionary procedures" in the "User's Reference Manual" for details.

Alternating current Fuse. Replace the fuse only with one of the same type and rating In the front panel: battery

A B

B

Symbol for non-ionizing electromagnetic radiation. Interference may occur in the vicinity of equipment marked with this symbol.

Battery operation and remaining capacity. The height of the green bar indicates the charging level.

SN,S/N

Serial number Submenu. Selecting a menu item with this symbol opens a new menu.

Battery (A) charging (white bar)

The monitor is connected to Network.

B

Battery (A) failure

A blinking heart next to the heart rate or pulse rate value indicates the beats detected.

Both batteries failed

A lung next to the respiration rate value indicates that respiration rate is calculated from the impedance respiration measurement.

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7 Date of manufacture

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. 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. 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 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/weeerecycling/index.html This product consists of devices that may contain mercury, which must be recycled or disposed of in accordance with local, state, or country laws. (Within this system, the backlight lamps in the monitor display contain mercury).

For your notes:

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System introduction (1) B30 monitor with modules (2) Printer (3) Other monitors in the network NOTE: You cannot view other monitors on the B30 monitor with L-DICU08 software. NOTE: The monitor display is fragile. Ensure that it is not placed near a heat source or exposed to mechanical shocks, pressure, moisture, or direct sunlight. NOTE: Your system may not include all these components. Consult your local representative for the available components.

Optional components Optional components for the B30 monitor are: • Patient Side Modules E-PSMW and E-PSMPW • Extension Modules N-FREC, N-FCREC and N-FC For details regarding modules, see section "Measurement modules." The monitor provides places for one E-PSM(P)W and/or one N-Fx module.

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Alarms If the monitor is connected to the network, the alarm limits can also be changed using the Central if this feature has been enabled in the Central configuration. If the monitor is connected to the network, the bedside alarms can also be silenced using the Central if this feature has been enabled in the Central configuration. For more information on alarms, see “Alarms“ on page 37.

WARNING: Connect only one patient to the monitor at a time.

WARNING: Never install the monitor so that it is above the patient.

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.

WARNING: Do not use the monitor without manufacturer approved mounting attached. WARNING: Always make sure that the audio alarm volume level is adequate in your care environment. WARNING: Before starting to use the system, ensure that the whole combination complies with the international standard IEC 60601-1-1 and the requirements of the local authorities. Do not connect any external devices to the system other than those specified.

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Monitor introduction 1

2

3 4

5

12 6 11 10

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WARNING: If you accidentally drop the monitor or modules, have them checked by authorized service personnel prior to clinical use.

(1) Battery compartment, see below (2) Transportation handle (3) Alarm light, see page 39 (4) Alarm LEDs, see page 37 (5) Side panel keys, see page 14 (6) The ComWheel (7) Command Board keys, see page 13 (8) Guide rail for GCX mounting (9) Mains power and battery LEDs, see page 15 (10) ON/standby key (11) Defibrillator & IABP synchronization connector (marked with X5) (12) Measurement modules, see page 19

Rear panel connections 1

5

(1) Battery compartment (2) Slot for infusion pole mount (3) Module connector (marked with X4) (4) Guide rail for GCX mounting (5) Receptacle for power cord (6) Fuse holder (7) Serial port (marked with X9) (8) Network ID connector (marked with X8) (9) Connector for future use (marked with X7) (10) Accessory: multi I/O adapter (with connectors 7 - 9 above) (11) Network connector (12) Equipotential connector

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6 3

11 9

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4

12

13

Command Board keys

1

2

10

3

4

Admit/ Discharge

Pt.Data & Trends

Monitor Setup

Print/ Record

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(1) ON/standby key (2) Mains power ON (lit) or OFF (dark): indicates mains or external DC power (3) For admitting or discharging a patient; for selecting user modes (4) For viewing trends and alarm history (5) For activating parameter specific menus. NOTE: All modules do not measure all of these parameters. For more information, see page 19

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ECG

NIBP

Invasive Pressures

Airway Gas

Others

Normal Screen

7 (6) For returning the Normal Screen view to the screen (7) For activating pulse oximetry, impedance respiration and temperature setup menus (8) For printing and recording different trends and waveforms (9) For setting up the monitor and for activating the Help menu (10) Battery operation LEDs, see page 15

Side panel keys Silence Alarms Alarms Setup

1

Alarm LED indicators: see page 37

2

For silencing the alarms, see page 40

3

For activating the Alarms Setup menu

4

For zeroing the invasive pressure channels, see page 71 NOTE: Functional with the E-PSMPW module only.

5

For starting the NIBP autocycling, see page 68

6

For starting or stopping the NIBP manual cycling, see page 68

7

For starting or stopping local recording, see page 41 NOTE: Functional with the N-FREC and N-FCREC modules only.

Invasive Pressures

Zero ALL

NIBP

Start Cancel

Recorder

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Batteries The B30 monitor allow to use two lithium-ion batteries at most, located in the battery compartment. They can be charged separately, and screen symbols and monitor frame LEDs indicate their charging level and possible failure, see table on the right. You can also check the battery status through Monitor Setup - Battery Setup. If you wish to have the battery charge visible at all times, select it in one of the digit fields: Monitor Setup - Screen Setup - Digit Fields Battery. You can now see how much charging time is left for each battery separately both in numbers and as symbols, and the total charging time in numbers. NOTE: Always use the B30 monitor with battery inserted. Otherwise all trend data and temporary settings are lost if the power cable is detached from the mains. NOTE: When the monitor is battery powered, the green battery LED is on. When the monitor is mains powered, the green mains LED is on. See also sections "Conditioning the batteries" and "Messages." NOTE: When useable batteries are installed, if the monitor loses AC power, it automatically switches to battery power without interruption of operation.

Battery indicators Screen

A B

A

Explanation

B

B

B

Front panel battery LEDs

Green lit Monitor is battery Orange dark powered. Batteries are fully charged; the size of the green bar indicates the charging level. Green lit Monitor is battery Orange dark powered. Battery A is empty, battery B charge is ok. Green lit Monitor is battery powered. Battery A failure, Orange flashing battery B is full.

NOTE: If both batteries fail, the green battery LED is dark. Monitor is mains powered. Green dark Battery A is being charged Orange lit (white bar), battery B is already charged. no symbol

Monitor is mains powered. 'No battery backup' message on screen. Batteries have failed or they are not inserted.

Green dark Orange flashing