Toshiba Cardiocap 5 Technical Manual

Datex-Ohmeda Cardiocap™/5

Technical Reference Manual

Document Number M1031914

edition

2 9 May 2007

Datex-Ohmeda, Inc.

P.O. Box 7550, Madison WI 53707-7550, USA Tel. +1-608-221-1551 Fax +1-608-222-9147

GE Healthcare Finland Oy

Helsinki, Finland

P.O. Box 900

FI-00031 GE

Tel. +358 10 39411 Fax +358 9 146 3310

www.gehealthcare.com

NOTICE

Intended use

The Datex-Ohmeda Cardiocap/5 and accessories are indicated for indoor monitoring of hemodynamic (ECG, impedance respiration, NIBP, temperature, SpO rate, anesthetic agent, and agent identification), ventilatory (airway pressure, volume, and flow), and relaxation status (NMT) of all hospital patients.

With the N-XOSAT option, monitoring of arterial oxygen saturation includes monitoring hospital patients during conditions of clinical patient motion.

Cardiocap/5 is indicated for patients weighing 5 kg (11 lb.) or more.

Impedance respiration measurement is indicated for patients ages 3 years and older.

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

, and invasive pressure), respiratory (CO2, O2, N2O, respiration

CAUTION: US Federal law restricts this device to sale by or on the order of a licensed medical practitioner. Outside the USA, check local laws for any restriction that may apply.

Classifications

IEC 60601-1:

• Type of protection against electric shock: Class I equipment.

• Degree of protection against electric shock (indicated by a symbol on the panel beside each connector):

Type BF applied part or Type CF applied part.

• The equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with

oxygen or nitrous oxide.

• Mode of operation: Continuous.

• CISPR 11: Group 1, c lass A

IEC 60529 (degree of protection against harmful ingress of water): IPX1

EU Medical Device Directive: IIb

Responsibility of the manufacturer

GE Healthcare Finland Oy (GE) is responsible for the safety, reliability and performance of the equipment only if:

• Assembly, operation, 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 the Cardiocap/5 User’s Guide and serviced and maintained in

accordance with the Cardiocap/5 Technical Reference Manual.

GE Healthcare assumes no responsibility for the use or reliability of its software on equipment that is not furnished by GE Healthcare.

Trademarks

Datex®, Ohmeda®, and other trademarks (Cardiocap/5, AS/3, CS/3, S/5, S/5 Light, D-lite, Pedi-lite, D-fend, D-fend+, MemCard, ComWheel, EarSat, FlexSat, OxyTip, Patient O GE Healthcare Finland Oy.

Nellcor® is a registered trademark of Mallinckrodt Inc.

All other product and company names are the property of their respective owners.

, and Patient Spirometry) are trademarks of

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.

Cardiocap/5 Technical Reference Manual

Part I – General Service Guide

Overview

Monitor Structure

Safety Precautions

Product Specifications

Installation and Functional Check

Installation

Interfacing

Functional Check

Functional Check Form

Planned Maintenance

Planned Maintenance Instructions

Planned Maintenance Form

Troubleshooting

Messages

Troubleshooting Charts

Part II – Product Service Guide

Frames and Software

Hemodynamic Frame (F-MX)

Hemodynamic with Airway Gases Frame (F-MXG)

Anesthesia and Critical Care Software

Measurement Parameters

Parameter Unit (NESTPR)

Invasive Pressures and Second Temperature Option (N-XP)

Nellcor Pulse Oximetry Option (N-XNSAT)

Datex-Ohmeda Enhanced Pulse Oximetry Option (N-XOSAT)

Airway Gas Options (N-XC, N-XCO, N-XCAiO)

Patient Spirometry Option (N-XV)

NeuroMuscular Transmission Option (N-XNMT)

Service Procedures

Repair and Replacement

Checks, Adjustments, and Calibration

Service Menus

Spare Parts 9

Chapter 1. Overview

1.1 About this manual ................................................................ 1-1

Related documentation............................................................................... 1-1

1.2 Cardiocap/5 models and features ......................................... 1-2

1.2.1 Options for hemodynamic model (F-MX)....................................................... 1-2

1.2.2 Options for hemodynamic model with airway gas measurement (F-MXG)......... 1-2

1.2.3 Data collection and management options (for F-MX and F-MXG)..................... 1-2

1.3 Monitor structure ................................................................. 1-3

1.3.1 Measurement parameter units..................................................................... 1-3

NESTPR unit ............................................................................................... 1-3

PVX unit for Patient Spirometry (N-XV option)................................................. 1-4

CAiO unit (N-XC, N-XCO, and N-XCAiO options).............................................. 1-4

Datex-Ohmeda enhanced pulse oximetry (N-XOSAT option)............................ 1-4

Nellcor® compatible pulse oximetry (N-XNSAT option)................................... 1-4

NeuroMuscular Transmission (N-XNMT option) .............................................. 1-4

1.3.2 Communication.......................................................................................... 1-4

1.3.3 CPU board.................................................................................................. 1-4

Distributed processing................................................................................. 1-5

1.3.4 Display ...................................................................................................... 1-5

1.3.5 I/O board................................................................................................... 1-5

1.3.6 DC/DC board ............................................................................................. 1-5

1.3.7 AC/DC unit................................................................................................. 1-5

1.3.8 Recorder (N-XREC option)............................................................................ 1-5

Contents

1.4 Symbol definitions................................................................ 1-6

Symbols on equipment................................................................................ 1-6

Symbols on screens ....................................................................................1-7

Symbols on transport packaging ..................................................................1-7

1.5 Safety precautions ............................................................... 1-8

1.5.1 Warnings.................................................................................................... 1-8

Installation ................................................................................................. 1-8

Power connection ....................................................................................... 1-8

External connection..................................................................................... 1-8

Electrical shock hazard................................................................................ 1-9

Fuse replacement ....................................................................................... 1-9

Explosion hazard......................................................................................... 1-9

Patient safety.............................................................................................. 1-9

Temperature probes .................................................................................... 1-9

Cleaning and service ................................................................................... 1-9

Accessories.............................................................................................. 1-10

1.5.2 Cautions ..................................................................................................1-10

General.................................................................................................... 1-10

Installation............................................................................................... 1-10

Before use................................................................................................ 1-10

Cardiocap/5 Technical Reference Manual

Airway gas measurement ........................................................................... 1-10

Autoclaving and sterilizing..........................................................................1-10

Cleaning and service .................................................................................1-10

Batteries...................................................................................................1-11

Special components and modifications ......................................................1-11

Storage and transport................................................................................1-11

1.5.3 ESD precautionary procedures...................................................................1-11

ESD precautionary procedure training.........................................................1-12

1.5.4 Disposal...................................................................................................1-12

1.5.5 Points to note ...........................................................................................1-12

1.6 Specifications.................................................................... 1-12

1.6.1 F-MX and F-MXG frames ............................................................................1-12

Power supply ............................................................................................1-12

Environmental conditions...........................................................................1-12

Mechanics................................................................................................1-13

LCD display...............................................................................................1-13

Battery .....................................................................................................1-13

1.6.2 NIBP ........................................................................................................1-13

1.6.3 Temperature.............................................................................................1-13

1.6.4 ECG .........................................................................................................1-13

1.6.5 Impedance respiration ..............................................................................1-14

1.6.6 Pulse oximetry, standard............................................................................1-14

1.7 Specifications for options ................................................... 1-14

1.7.1 Classifications .......................................................................................... 1-14

According to IEC 60601-1 .........................................................................1-14

Classification according to EU Medical Device Directive ...............................1-15

1.7.2 Pulse oximetry, Datex-Ohmeda enhanced (N-XOSAT) ...................................1-15

1.7.3 Pulse oximetry, Nellcor compatible (N-XNSAT) ............................................. 1-16

1.7.4 Invasive blood pressure (N-XP)...................................................................1-16

1.7.5 Airway gases (N-XC, N-XCO, and N-XCAiO)...................................................1-16

General ....................................................................................................1-16

Respiration rate (RR)..................................................................................1-17

Carbon Dioxide (CO2), Oxygen (O2), and Nitrous Oxide (N2O) .........................1-17

Anesthetic agents (AA)............................................................................... 1-17

Agent identification ...................................................................................1-17

MAC.........................................................................................................1-18

Normal conditions.....................................................................................1-18

Conditions exceeding normal .....................................................................1-18

1.7.6 Patient Spirometry (N-XV) ..........................................................................1-19

Conditions exceeding normal .....................................................................1-20

1.7.7 NeuroMuscular Transmission (N-XNMT).......................................................1-20

NMT stimulation modes .............................................................................1-20

Stimulator.................................................................................................1-21

Regional block mode.................................................................................1-21

1.7.8 Recorder (N-XREC) ....................................................................................1-21

Table of Figures

Figure 1-1. Cardiocap/5 monitor structure........................................................................ 1-3

Contents

1. OVERVIEW

1.1 About this manual

The Technical Reference Manual is for use by service personnel who are qualified to perform service and maintenance procedures on the Datex-Ohmeda Cardiocap/5. The information in this manual is believed to be accurate and reliable, however, the manufacturer assumes no responsibility for its use.

The manual is organized as follows:

• Part I (chapter 1 – chapter 4) provides a general overview of the Cardiocap/5, including the

information needed to install, checkout, and maintain the monitor. Part I also includes information for troubleshooting problems that may occur while using the monitor or that you may encounter while perfoming procedures in this manual, such as the Functional Check, for example.

• Part II (chapter 5 – chapter 9) contains detailed functional descriptions of the Cardiocap/5

hardware and software, including measurement principles and components for each measurement parameter. Procedures for replacing parts and making adjustments are also included. Part II also contains illustrations and detailed descriptions of all service screens used during checkout, maintenance, and other service-related activities. A list of parts with illustrations is located at the end of Part II.

Overview

Read the entire manual and make sure you understand the procedures described before installing, repairing, or adjusting the monitor. To avoid risks concerning safety or health, strictly observe all safety precautions.

This manual relates to the monitor versions 6051-0000-164..00 and ..01.

Related documentation

For information about using the monitor, refer to the following:

Cardiocap/5 for Anesthesia User’s Guide Cardiocap/5 for Critical Care User’s Guide Cardiocap/5 for Anesthesia User’s Reference Manual Cardiocap/5 for Critical Care User’s Reference Manual

For PCA drawings, circuit diagrams, and component lists, order the PCA Drawings Service Kit. See the Spare Parts chapter.

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Cardiocap/5 Technical Reference Manual

1.2 Cardiocap/5 models and features

The Cardiocap™/5 is a configured monitor that is intended for indoor monitoring of the hemodynamic, respiratory, relaxation, and ventilatory status of the patient. Two models of the monitor are available: hemodynamic (F-MX) and hemodynamic with airway gas measurement (F-MXG). Both models can be equipped with built-in options.

• All measurement parameter options (and the Recorder option, N-XREC) are factory-configured

and cannot be added after purchase.

• Data collection and management options (N-XNET and N-XDNET) can be added later, if the CPU

board supports Network functionality.

1.2.1 Options for hemodynamic model (F-MX)

The F-MX measures NIBP, ECG (3-lead and 5-lead), pulse oximetry (SpO2), temperature (T1), and impedance respiration. The F-MX can be configured with the following built-in options:

N-XP Two invasive pressure channels and second temperature (T2)

N-XREC Recorder

The F-MX model can also be configured with one of the following built-in options:

N-XNSAT Nellcor® compatible pulse oximetry (SpO

N-XOSAT Datex-Ohmeda enhanced pulse oximetry (SpO

)

1.2.2 Options for hemodynamic model with airway gas measurement (F-MXG)

The F-MXG measures NIBP, ECG (3-lead and 5-lead), pulse oximetry (SpO2), temperature (T1), impedance respiration, and airway gases. Gas measurement depends on which airway gas option is installed (N-XC, N-XCO, or N-XCAiO):

N-XC Carbon Dioxide (CO

N-XCO CO

N-XCAiO CO

, N2O, and Patient Oxygen (O2)

, anesthetic agents, agent identification, N2O, and O2

The F-MXG can also be equipped with each of these built-in options:

N-XP Two invasive pressure channels and second temperature (T2)

N-XV Patient Spirometry (N-XCO or N-XCAiO option required)

N-XREC Recorder

The F-MXG can also be configured with one of the following options:

N-XNSAT Nellcor® compatible pulse oximetry (SpO

N-XOSAT Datex-Ohmeda enhanced pulse oximetry (SpO

N-XNMT NeuroMuscular Transmission (NMT) for relaxation measurement (N-XCAiO option required)

)

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1.2.3 Data collection and management options (for F-MX and F-MXG)

For both models, these options can be factory-built or added later as upgrades, if the CPU board supports Network functionality:

N-XNET Network

N-XDNET Data card and Network

1.3 Monitor structure

The Cardiocap/5 can be equipped with several factory-configured options. The block diagram and descriptions that follow represent the maximum functionality of the monitor with all options installed.

Overview

Figure 1-1. Cardiocap/5 monitor structure

The main software and measurement technologies are based on AS/3 hardware and software. Some parameter-measuring unit boards are interchangeable with AS/3 module boards, however, the units cannot be replaced with the corresponding modules as the hardware of the assemblies is different.

1.3.1 Measurement parameter units

The maximum Cardiocap/5 parameter measurement configuration consists of the NESTPR, PVX, and CAiO units plus ONE of the following units: NMT or NSAT or OSAT.

The NESTPR, CAiO, and NMT units are connected to the CPU through the Mother board and communicate with the CPU over a standard AS/3 module bus. The NSAT or OSAT pulse oximetry unit is also connected to the CPU through the Mother board and communicates with the CPU over a standard AS/3 module bus, which is located on the SpO

Each parameter measurement board contains a CPU that processes measurement data for the parameter(s) associated with that board before sending the data to the main CPU.

NESTPR unit

The NESTPR unit contains three boards for measuring hemodynamic parameters:

• The ECG board measures ECG (3-lead and 5-lead) and impedance respiration.

• The STP board measures oxygen saturation, temperature, and invasive blood pressure.

interface board.

• The NIBP board measures noninvasive blood pressure.

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Cardiocap/5 Technical Reference Manual

PVX unit for Patient Spirometry (N-XV option)

The PVX unit connects to the CAiO unit and measures the patient’s airway flow and pressure (Patient Spirometry).

CAiO unit (N-XC, N-XCO, and N-XCAiO options)

The CAiO unit measures airway gases. It is capable of measuring CO2, N2O, O2, anesthetic agents (AA) and also identifying the present anesthetic agent.

Datex-Ohmeda enhanced pulse oximetry (N-XOSAT option)

The OSAT unit measures oxygen saturation and pulse rate using Datex-Ohmeda enhanced pulse oximetry technology.

Nellcor® compatible pulse oximetry (N-XNSAT option)

The NSAT unit measures oxygen saturation and pulse rate using signal processing electronics and software that are based on Nellcor stand-alone oximeters.

NeuroMuscular Transmission (N-XNMT option)

The NMT unit measures the relaxation status (TOF, DBS, and ST) of patients. When used with a regional block cable, the unit acts as a nerve locator.

1.3.2 Communication

The CPU communicates with the hemodynamic parameters measuring unit (NESTPR) and airway gas measuring unit (CAiO) over a standard AS/3 module bus. It is based on the widely used industry standard RS485, which uses a differential serial method to transfer data and is quite robust.

RS485 serial communication supports multidrop or party line connections. This means all units connected to the module bus use the same two physical wires for communication purposes. The module bus uses a 500 kbps data transfer rate.

Communication with the I/O board and the DC/DC board takes place over an internal synchronous serial bus. The same bus also controls display brightness and audio signals by means of D/A converters located on the CPU board.

Communication with the Net takes place over a separate synchronous serial channel. Communication with the Net is possible, if the CPU board is equipped with an Ethernet controller.

Communication with the Recorder takes place over an asynchronous serial channel.

1.3.3 CPU board

The control functions of the monitor are centralized on the CPU board. The CPU:

• Controls the power on/off sequencing.

• Controls the brightness of the LCD screen by means of the Backlight board.

• Controls the Inverter board that provides the high voltage for the display backlights.

1-4

• Reads input from the keyboard and ComWheel.

• Controls the serial channels and I/O functions of the monitor.

Two PCMCIA-compatible data card slots on the board are for loading software and transferring data.

Distributed processing

The parameter and airway measuring units contain their own microprocessor systems for performing low level functions, such as waveform filtering and pneumatics control. At the same time, the main CPU performs higher level tasks (trending and alarm control, for example).

1.3.4 Display

The main CPU directly controls the monitor display, a 10.4 inch color LCD. Supply voltages for the display are connected via the CPU board and the Backlight board. The Inverter board provides high voltage for the display backlights. The CPU controls the display brightness by adjusting the backlight voltage.

1.3.5 I/O board

The I/O board contains D/A converters for analog outputs and the audio output amplifier. It also contains connectors for the network identification plug, serial I/O, analog output, and external keyboard.

Analog outputs are created by transferring digital data from the CPU to the D/A converters on the I/O board through the internal synchronous serial bus. The network identification plug is connected to the CPU over a separate synchronous serial channel.

Overview

1.3.6 DC/DC board

The DC/DC board converts 15 VDC coming from the AC/DC unit to different supply voltages for the monitor. All outputs are short-circuit and over-voltage protected. The CPU controls the output voltages. If the mains voltage drops, the 12 VDC back-up battery automatically supplies power to the monitor. The battery will run the monitor for at least 15 minutes. The battery is always charged when mains voltage is connected. The temperature sensor that measures the monitor’s internal temperature is located on the board. The DC/DC board communicates with the CPU over the internal synchronous serial bus.

1.3.7 AC/DC unit

The AC/DC unit converts the mains voltage to 15 VDC that is fed to the DC/DC board. The input voltage range of the unit is 100 to 240 VAC. The DC/DC board shuts down the AC/DC unit when there is over voltage detected on the 15 VDC output. The shutdown mode is reset by detaching the mains power cord for 30 seconds.

1.3.8 Recorder (N-XREC option)

The Recorder prints trend data and record parameter waveforms. It connects to the CPU through an asynchronous serial channel. Recorder supply voltages connect through a Recorder board that is permanently attached to the recorder mounting box. The board contains a voltage filter and a delay circuit for 12 V.

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Cardiocap/5 Technical Reference Manual

1.4 Symbol definitions

Symbols on equipment

Attention! Read accompanying instructions, including all warnings and cautions, before using this device.

This symbol has the following meanings when it appears on the screen:

• On the front panel indicates that protection against cardiac defibrillator discharge is

due in part to the accessories for pulse oximetry (SpO invasive pressure (P) measurement.

), temperature (T) and

• When displayed beside the O

value, indicates that the FiO2 low-alarm limit is set

below 21%.

• When displayed next to the HR value, indicates that there is a risk that the monitor

counts pacemaker spikes (pacer is set ON R) or the monitor counts T-waves (a wide QRS is selected).

Type BF applied part (IEC 60601-1). Defibrillator-proof protection against electric shock.

Type CF applied part (IEC 60601-1). Defibrillator-proof protection against electric shock.

Main Menu. Located beside the ComWheel to indicate you can open the Main Menu by pressing the ComWheel when no other menu is displayed.

Power On/Standby.

This battery contains lead. Separate from other waste for disposal according to local regulations.

This battery contains lead and can be recycled.

1-6

Dangerous voltage.

Gas outlet (in airway gas models only).

Ethernet connectors.

Equipotentiality. Monitor can be connected to potential equalization conductor.

Alternating current.

Fuse.

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.

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

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.

Symbols on screens

When displayed on the upper left corner of the screen, indicates alarms are silenced. When in the menu or digit fields, indicates that the alarm source has been turned off.

Sub menu. Selecting an alternative with this symbol in a menu opens a new menu.

Overview

The monitor is connected to the Monitor Network.

Data card (green) and/or Menu card (white) is inserted.

Indicates the beats detected.

Respiration rate is measured using impedance respiration measurement.

Back-up battery operation and remaining capacity.

Back-up battery charging.

Symbols on transport packaging

The contents of the package are fragile and have to be handled with care.

Indicates the correct upright position of the transport package.

The package must be kept in a dry environment.

The package should be kept within the indicated temperature limitations.

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Cardiocap/5 Technical Reference Manual

1.5 Safety precautions

1.5.1 Warnings

Refer to the User’s Reference Manual for additional warnings to be observed while monitoring a patient.

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

Installation

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 “1.5.3 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.

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, have it checked by authorized service personnel prior to clinical use.

To avoid explosion hazard, do not use the monitor in presence of flammable anesthetics. The monitor measures only non-flammable anesthetics.

Do not touch the patient, table, instruments, modules or the monitor during defibrillation.

Power connection

Before connecting the power cord to the mains outlet, check that the local voltage and frequency rating corresponds with the rating stated on the device plate on the rear panel of the monitor.

Use only hospital-grade grounded power outlets and power cord. Do not remove the grounding pin from the power plug.

Use only an intact power cord. Replace the cord if it is cracked, frayed, broken, or otherwise damaged.

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 the requirements of the local authorities. Do not connect any external devices to the system other than those specified.

1-8

To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

External connection

Do not connect any external devices to the monitor other than those specified.

Overview

Electrical shock hazard

When you connect equipment to the Cardiocap/5 input and output connectors, you are configuring a medical system and are responsible for ensuring that the system complies with IEC/EN 60601-1-1 and with local requirements.

Do not touch any exposed wire or conductive surface while covers are off and the monitor is energized. The voltages present can cause injury or death.

Always perform an electrical safety check and leakage current test of the monitor after service.

Fuse replacement

Replace a fuse only with one of the same type and rating.

Explosion hazard

To avoid explosion hazard do not use the monitor in the presence of flammable anesthetics.

Patient safety

Do not perform any testing or maintenance on the monitor while it is being used on a patient.

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

The monitor must not be used without manufacturer approved mounting attached.

Operation of the monitor outside the specified values may cause inaccurate results.

To prevent erroneous readings, do not use physically damaged sensors or sensor cables. Discard a damaged sensor or sensor cable immediately. Never repair a damaged sensor or cable; never use a sensor or cable repaired by others. A damaged sensor or a sensor soaked in liquid may cause burns during electrosurgery.

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. In this case, set the pacemaker rate responsive mode off or turn the monitor impedance respiration measurement off.

Temperature probes

To prevent injury, use Datex-Ohmeda temperature probes only.

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.

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Cardiocap/5 Technical Reference Manual

Always perform an electrical safety check and a leakage current test on the monitor after service.

Handle the water trap and its contents as you would any body fluid. Infectous hazard may be present.

Accessories

Use only accessories, mounts and defibrillator-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, transducers and accessories may cause a safety hazard, damage the equipment or 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 (SpO measurement.

Single-use accessories are not designed to be reused. Reuse may cause a risk of contamination and/or affect the measurement accuracy.

1.5.2 Cautions

Refer to the User’s Reference Manual for additional cautions to be observed while monitoring a patient.

A CAUTION indicates a condition that may lead to equipment damage or malfunction.

), temperature (T) and invasive pressure (P)

General

US Federal law restricts this device to sale by or on the order of a licensed medical practitioner.

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

Turn off the power before making any rear panel connections.

Use only cables and accessories approved by GE Healthcare. Other cables and accessories may damage the system or interfere with measurement.

Vibrations during transport may disturb SpO

, ECG, impedance respiration, and NIBP measurements.

Installation

Leave space for air circulation to prevent the monitor from overheating.

Before use

Allow two minutes for warm-up and note any error messages or deviations from normal operation.

Airway gas measurement

Strong scavenging suction may change the operating pressure of the monitor and cause inaccurate readings or internal damage.

Autoclaving and sterilizing

Do not steam autoclave or gas sterilize the monitor.

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Cleaning and service

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

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

Overview

Do not apply pressurized air to any outlet or tubing connected to the monitor.

Clean the fan dust filter on the rear panel once a month or whenever necessary.

Electrostatic discharge through the PC boards may damage the components. Before handling printed circuit boards, wear a static control wrist strap. Handle all boards by their nonconductive edges and use antistatic containers when transporting them.

Do not break or bypass the patient isolation barrier when testing PC boards.

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.

Batteries

• A lithium battery on the CPU Board. Dispose of the faulty IC containing the battery

according to local regulations.

The battery package of the power supply unit in this device contains lead, which is hazardous to the environment. Dispose of the battery according to local regulations.

To replace the batteries safely, please refer to the instructions in this manual.

• Do not short-circuit the battery terminals. Short-circuiting the battery may produce a very high

current, which damages the battery and may cause injury to personnel.

• Do not dispose of the battery into open flame, nor put the battery near fire, as it may explode.

• Do not disassemble the battery. It contains electrolyte, which may damage clothing or cause

injury to skin or eyes. If exposed to electrolyte, wash the injured area with plenty of water and contact a doctor.

See Symbols on equipment earlier in this chapter.

Special components and modifications

Special components used in this monitor are vital to assure reliability and safety. GE Healthcare assumes no responsibility for damage if replacement components not approved by GE Healthcare are used.

The manufacturer accepts no responsibility for modifications made to the monitor outside the factory.

Storage and transport

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

Temperature -10 to +50 °C (14 to 122°F) Ambient pressure 660 to 1060 hPa (500 to 800 mmHg) 660 to 1060 mbar Relative humidity 0 to 85 % non-condensing

1.5.3 ESD precautionary procedures

• To avoid electrostatic charges building up, it is recommended to store, maintain and use the

equipment at a relative humidity of 30% or greater. Floors should be covered by ESD dissipative carpets or similar. Non-synthetic clothing should be used when working with the component.

• To prevent applying a possible electrostatic discharge to the ESD sensitive parts of the

equipment, one should touch the metallic frame of the component or a large metal object

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located close to the equipment. When working with the equipment and specifically when the ESD sensitive parts of the equipment may be touched, a grounded wrist strap intended for use with ESD sensitive equipment should be worn. Refer to the documentation provided with the wrist straps for details of proper use.

ESD precautionary procedure training

• It is recommended that all potential users receive an explanation of the ESD warning symbol

and training in ESD precautionary procedures.

• The minimum contents of an ESD precautionary procedure training should include an

introduction to the physics of electrostatic charge, the voltage levels that can occur in normal practice and the damage that can be done to electronic components if they are touched by an operator who is electrostatically charged. Further, an explanation should be given of methods to prevent build-up of electrostatic charge and how and why to discharge one’s body to earth or to the frame of the equipment or bond oneself by means of a wrist strap to the equipment or the earth prior to making a connection.

1.5.4 Disposal

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

1.5.5 Points to note

Medical electrical equipment needs special precautions regarding electromagnetic compatibility and needs to be installed and put into service by qualified personnel according to the electromagnetic compatibility information provided in Chapter 2.

Portable and mobile RF communications equipment can affect the medical electrical equipment.

Service and reparations are allowed for authorized service personnel only.

1.6 Specifications

All product specifications are subject to change without prior notice.

1.6.1 F-MX and F-MXG frames

Power supply

Rated voltages and frequencies: 100 to 240 VAC 60/50 Hz Allowed voltage fluctuations: ± 10% Maximum power consumption: 80 VA Fuses (2): T2AH/250V

Environmental conditions

Operating temperature: +10 to +40 °C (50 to 104 °F) Storage and transport temp: –10 to +50 °C (14 to 122 °F) Relative humidity: 10 to 85 % noncondensing, in airway 0 to 100 % condensing Atmospheric pressure: 660 to 1060 hPa (500 to 800 mmHg)

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Mechanics

Dimension: 330 mm × 220 mm × 300 mm (width × depth × height) Weight: <11.2 kg / <24.8 lbs (F-MXG with all options); <10.2 kg / <22.6 lbs (F-MX with all options)

LCD display

Display size: 10.4 inch Display type: Active matrix color LCD display

Resolution: 640 × 480

Battery

Type: 12V 2.6AH, lead acid Back-up battery time: at least 15 minutes when fully charged Charging time: 5 hours (typical) The green battery charge status LED is On when the battery is fully charged, on the holding voltage. The

LED flashes when the battery is being charged.

1.6.2 NIBP

Measurement range:

Pulse rate range accepted: 30 to 250 bpm Typical measuring time: adults 23 seconds, infants 20 seconds

Overview

adult 25 to 260 mmHg (3.3 to 34.7 kPa) child 25 to 195 mmHg (3.3 to 26.0 kPa) infant 15 to 145 mmHg (2.0 to 19.3 kPa)

1.6.3 Temperature

Measurement range: 10 to 45°C (50 to 113°F) Measurement accuracy: 25 to 45.0 °C ± 0.1 °C (77 to 113 °F ± 0.2 °F)

10 to 24.9 °C ± 0.2 °C (50 to 76.8 °F ± 0.4 °F)

Probe type: Compatible with Datex-Ohmeda temperature probes only

1.6.4 ECG

Waveform display (with 50 Hz power supply frequency):

Monitoring filter: 0.5 to 30 Hz ST filter: 0.05 to 30Hz Diagnostic filter: 0.05 to 100 Hz

Waveform display (with 60 Hz power supply frequency):

Monitoring filter: 0.5 to 40 H ST filter: 0.05 to 40 Hz Diagnostic filter: 0.05 to 100 Hz

Heart rate

Measurement range: 30 to 250 bpm Measurement accuracy: ± 5% or ± 5 Pacemaker pulse detection level: 2 to 500 mV Pacemaker pulse duration: 0.5 to 2 ms

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1.6.5 Impedance respiration

Respiration range: 4 to 120 respirations/minute Accuracy: ± 5% or ± 5 bpm

1.6.6 Pulse oximetry, standard

Display update time: 5 seconds Averaging time: adjustable Plethysmographic waveform scaling: adjustable

SpO2

Calibration range: 50 to 100% Calibrated against functional saturation Measurement range: 40 to 100% Measurement accuracy (% SpO

80 to 100% ± 2 digits; 50 to 80% ± 3 digits; Below 50% unspecified

NOTE: SpO

measurement accuracy is based on deep hypoxia studies using Datex-Ohmeda FingerSat

sensors on volunteered subjects. Arterial blood samples were analyzed by a Radiometer OSM CO-oximeter. Refer to the sensor instructions for specific SpO

±1 SD):

accuracy data.

Pulse rate

Measurement range: 30 to 250 bpm Measurement accuracy: ± 5% or ± 5 bpm

Default alarm limits

: high Off, low 90%

SpO

Pulse rate: high 160, low 40 NOTE: Limits are adjustable.

Sensor emitter wavelength ranges

Red LED: 660 nm Infrared LED: 900 nm

1.7 Specifications for options

1.7.1 Classifications

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 by a symbol beside each patient connector.

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• 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, only 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 ANAESTHETIC MIXTURE with

air or with oxygen or nitrous oxide.

• CONTINUOUS OPERATION according to the mode of operation.

• 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 radio-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.

Classification according to EU Medical Device Directive

• The monitor is classified as IIb.

1.7.2 Pulse oximetry, Datex-Ohmeda enhanced (N-XOSAT)

Display update time: 5 seconds Averaging time: 12 seconds Plethysmographic waveform scaling: automatic

Overview

SpO

Calibration range: 70 to 100% Calibrated against functional saturation Measurement range: 1 to 100% Measurement accuracy (% SpO

±1 SD):

70 to 100% ± 2 digits 70 to 100% ± 3 digits during conditions of clinical patient motion Below 70% unspecified

NOTE: SpO

measurement accuracy is statistically derived and correlated to simultaneous arterial

blood gases measured on a Radiometer OSM3 CO-oximeter. Refer to the sensor instructions for specific accuracy data.

Pulse rate

Measurement range: 30 to 250 bpm Measurement accuracy: ± 2% or ± 2 bpm (whichever is greater)

Default alarm limits

: high Off, low 90%

SpO

Pulse rate: high 160, low 40 NOTE: Limits are adjustable.

Sensor emitter wavelength ranges

Red LED: 650 to 665 nm Infrared LED: 930 to 950 nm Average power: ≤ 1 mW

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1.7.3 Pulse oximetry, Nellcor compatible (N-XNSAT)

Display update time: 5 seconds Averaging time: 5 to 7 seconds Plethysmographic waveform scaling: automatic

SpO

Calibrated against functional saturation Measurement range: 1 to 100% Measurement accuracy (% SpO

70 to 100% (± 2 digits to ± 3.5 digits, depending on the sensor) Below 70% unspecified

See the User's Reference Manual (Pulse Oximetry chapter) for a list of approved sensors and accuracy details.

NOTE: SpO

Pulse rate

Measurement range: 30 to 250 bpm Measurement accuracy: ± 3 digits

measurement accuracy is based on testing healthy adult volunteers in induced hypoxia

studies.

±1 SD):

Default alarm limits

SpO

: high Off, low 90%

Pulse rate: high 160, low 40 NOTE: Limits are adjustable.

Sensor emitter wavelength ranges

Red LED: 660 nm Infrared LED: 920 nm

1.7.4 Invasive blood pressure (N-XP)

Measurement range: –40 to 320 mmHg (-5.3 to 42.7 kPa) Measurement accuracy: ± 5% or ± 2 mmHg Transducer sensitivity: 5 µV/V/mmHg, 5 Vdc, max 20 mA

Pulse rate

Measurement range: 30 to 250 bpm Accuracy: ± 5% or ± 5 bpm

1.7.5 Airway gases (N-XC, N-XCO, and N-XCAiO)

Accuracy specifications apply in normal conditions.

General

Airway humidity: 0 to 100%, condensing Sampling rate: 200 ± 20 ml/min. (sampling line 2, 3 and 6 m, normal conditions)

Sampling delay: 2.5 seconds typical with a 3 m sampling line

3.4 seconds typical with a 6 m sampling line

Total system response time: 2.9 seconds typical with a 3 m sampling line, including sampling delay

and rise time

4.4 seconds typical with a 6 m sampling line Value update rate: breath-by-breath

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Overview

Automatic compensation for pressure, CO2-N2O and CO2-O2 collision broadening effect Warm-up time:

2 minutes for operation with CO

, O2, and N2O

5 minutes for operation of anesthetic agents 30 minutes for full specifications

Autozeroing interval:

immediately after “Calibrating gas sensor” message and 2, 5, 10, 15, 30, 45, 60 minutes after start-up, then every 60 minutes

Respiration rate (RR)

Measurement range: 4 to 60 breaths/minute Detection criteria: 1 % variation in CO2

Carbon Dioxide (CO2), Oxygen (O2), and Nitrous Oxide (N2O)

Measurement Carbon Dioxide (CO2) Oxygen (O2) Nitrous Oxide (N2O)

Range

Rise time

Accuracy (typical value)

Gas cross effects

0 to 15 vol%, (0 to 15 kPa)

(0 to 113 mmHg)

< 400 ms typical < 400 ms typical < 400 ms typical

± (0.2 vol% + 2 % of reading) ± (1 vol% + 2 % of

< 0.2 vol%

, N2O, and anesthetic agents)

0 to 100% 0 to 100%

± (2 vol% + 2% of reading)

reading)

< 1 vol% (anesthetic

agents);

< 2 vol% (N2O)

(0%< N2O<85%)

± (2 vol% + 8% of reading)

(85%< N2O<100%)

(anesthetic agents)

< 2 vol%

NOTE:

• If CO

• O

concentration is below 0.1%, 0.0% is displayed.

Fi-Et difference: resolution 0.1 vol%

Anesthetic agents (AA)

Resolution is two digits when the AA concentration is below 1.0 vol%. If AA concentration is below 0.1 vol%, 0.0% is displayed.

Measurement Halothane, Isoflurane, Enflurane Sevoflurane Desflurane

Range

Rise time

Accuracy (typical value)

Gas cross effects

< 600 ms (<1 000 ms for Hal)

typically with a 3 m sampling line

< 650 ms (<1 050 ms for Hal)

typically with a 6 m sampling line

± (0.15 vol% + 5 % of reading) ± (0.15 vol% + 5 % of

0 to 6% 0 to 8% 0 to 20%

< 600 ms typically with

a 3 m sampling line

< 650 ms typically with

a 6 m sampling line

reading)

< 0.15 vol% N2O < 0.15 vol% N2O < 0.15 vol% N2O

< 600 ms typically with

a 3 m sampling line

< 650 ms typically with

a 6 m sampling line

± (0.15 vol% + 5 % of

reading)

Agent identification

Identification threshold: 0.15 vol% typically Identification time: < 20 seconds (for pure agents)

Mixture identification threshold for 2nd agent: 0.2 vol% +10% of total conc.

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MAC

Range: 0 to 9.9 MAC Equation:

MAC( AA) =

%(ETAA)

x(AA)

ETN O

100

where x(AA): Hal = 0.75%, Enf = 1.7%, Iso = 1.15%, Sev = 2.05%, Des = 6.0%.

Normal conditions

After 30-minute warm-up period:

Ambient temperature: 18 to 28 °C, within ± 5 °C of calibration Ambient pressure: 500 to 800 mmHg, ± 50 mmHg of calibration Ambient humidity: 20 to 80% RH, ± 20% RH of calibration

Non-disturbing gases:

Ethanol C Acetone (< 0.3%) Methane CH

Nitrogen N Carbon monoxide CO

Nitric oxide NO (< 200 ppm) Water vapor

Maximum effect on readings:

< 0.2 vol%

O2, N2O < 2 vol% Anesthetic agents < 0.15 vol%

Effect of helium: decreases CO decreases O Effect of Xenon: decreases CO Effect of anesthetic agents to monitors without anesthetic measurement: decreases CO

OH (< 0.3%)

2H5

(< 0. 3%)

readings < 0.6 vol% typically

readings < 3 vol% typically

readings < 0.4 vol% typically

readings < 0.5 vol% typically

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Conditions exceeding normal

Accuracy specifications under conditions n o p q:

n Ambient temperature: 10 to 40 °C, within ± 5 °C of calibration

Ambient pressure: 500 to 800 mmHg, ± 50 mmHg of calibration Ambient humidity: 10 to 98% RH, ± 20% RH of calibration (non-condensing)

Respiration rate: 35 to 60 breaths per minute

o During warm-up, 2 to 10 minutes (anesthetic agents 5-10 minutes) under normal conditions p During warm-up, 10 to 30 minutes under normal conditions

O > 85%

q N

Overview

Parameter

CO2

N2O

Agents (Des, Enf, Hal, Iso, Sev)

Parameter

CO2

N2O

Agents (Des, Enf, Hal, Iso, Sev)

Parameter

CO2

Accuracy under Condition

± (0.3 vol% + 4% of reading); at 5 vol% error ± 0.5 vol%

± (2 vol% + 2% of reading)

± (3 vol% + 3% of reading

± (0.2 vol% + 10% of reading)

Accuracy under Condition

± (0.4 vol% + 7% of reading); at 5 vol% error ± 0.75 vol%

± (3 vol% + 3% of reading)

± (3 vol% + 5% of reading)

± (0.3 vol% + 10% of reading)

Accuracy under Condition

± (0.3 vol% + 4% of reading); at 5 vol% error ± 0.5 vol%

± (2 vol% + 2% of reading)

N2O

Agents (Des, Enf, Hal, Iso, Sev)

Parameter

N2O

1.7.6 Patient Spirometry (N-XV)

Accuracy specifications apply in normal conditions.

After 10-minute warm-up period

Ambient temperature: 10 to 40 °C Ambient pressure: 500 to 800 mmHg

Ambient humidity: 10 to 98% RH Airway humidity: 10 to 100% RH Respiration rate: 4 to 35 breaths/minute (adult); 4 to 50 breaths/minute (pediatric) I:E ratio: 1:4.5 to 2:1 Intubation tube: 5.5 to 10 mm (adult); 3 to 6 mm (pediatric)

± (3 vol% + 3% of reading

± (0.2 vol% + 10% of reading)

Accuracy under Condition

± (2 vol% + 8% of reading)

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Detection through D-lite™ or Pedi-lite™ flow sensor and gas sampler:

Measurement D-lite flow sensor (adult) Pedi-lite flow sensor (pediatric)

Tidal volume

Measurement range Resolution Accuracy (typical value)

Minute volume

Measurement range Resolution Accuracy (typical value)

Airway pressure (Paw)

Measurement range Resolution Accuracy (typical value)

Airway flow

Measurement range (for both directions)

Compliance

Measurement range Resolution

Airway resistance (Raw)

Measurement range Resolution

150 to 2000 ml 1 ml ± 6% or 30 ml (whichever is larger)

2 to 20 l/minute

0.1 l/minute ± 6%

–20 to +100 cmH

0.5 cmH

± 1 cmH2O

1.5 to 100 l/minute

4 to 100 ml/cmH

1 ml/cmH2O

O/ l/s

O/l/second

0 to 40 cm H 1 cmH

15 to 300 ml 1 ml ± 6% or 4 ml (whichever is larger)

0.5 to 5 l/minute

0.1 l/minute ± 6%

–20 to +100 cmH

0.5 cmH

not applicable

0.25 to 25 l/minute

1 to 100 ml/cmH

0.1 ml/cmH2O

0 to 40 cm H 1 cmH

O/ l/s

O/l/second

Sensor specifications

Dead space Resistance at 30 l/minute Resistance at 10 l/minute

9.5 ml

0.5 cmH

not applicable

Conditions exceeding normal

Accuracy specifications during warm-up (first 2 to 10 minutes after power is turned on):

Airway pressure (P

) accuracy: ± 2 cmH2O

Tidal volume accuracy: ± 10% or 100 ml (adult); ± 10% or 10 ml (pediatric)

1.7.7 NeuroMuscular Transmission (N-XNMT)

NMT stimulation modes

Stimulation modes

Train of four (TOF) Double burst, 3.3 (DBS) Single twitch (ST) 50 Hz tetanic + post tetanic count (PTC)

Measurement intervals (TOF and DBS): manual; 10 seconds, 12 seconds, 15 seconds, 20 seconds,

1 minute, 5 minutes, 15 minutes

Measurement intervals (ST): manual; 1 second, 10 seconds, 20 seconds

2.5 ml not applicable

1.0 cmH

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Stimulator

Stimulus pulse: Square wave, constant current Pulse width: 100, 200 or 300 µs Stimulus current range (supramax and manual): 10 to 70 mA with 5 mA steps

Stimulus current accuracy: 10% or ±3 mA (whichever is greater) Maximum load: 3 kΩ Maximum voltage: 300 V

Regional block mode

Stimulation modes: Single twitch Intervals: 1 second, 2 seconds, 3 seconds Stimulus pulse: Square wave, constant current Pulse width: 40 µs Stimulus current range: 0 to 5.0 mA with 0.1 mA steps Stimulus current accuracy: 20% or 0.3 mA (whichever is greater)

1.7.8 Recorder (N-XREC)

Principle: thermal array Print resolution

Vertical: 8 dots/mm (200 dots/inch)

Horizontal: 32 dots/mm (800 dots/inch) at speed of 25 mm/second and slower Paper width: 50 mm, printing width 48 mm Traces: selectable; 1, 2, or 3 traces Print speed: 1, 6.25, 12.5, 25 mm/second

Overview

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