Cardiocap 5 Technical Reference Manual June 2004

NOTICE Intended use The Datex-Ohmeda Cardiocap/5 and accessories are indicated for indoor monitoring of hemodynamic (ECG, impedance respiration, NIBP, temperature, SpO2, and invasive pressure), respiratory (CO2, O2, N2O, respiration 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.

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. IEC 60529 (degree of protection against harmful ingress of water): IPX1 EU Medical Device Directive: IIb

Responsibility of the manufacturer Datex-Ohmeda Division, Instrumentarium Corp. 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 Datex-Ohmeda. • 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. Datex-Ohmeda assumes no responsibility for the use or reliability of its software on equipment that is not furnished by Datex-Ohmeda.

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 O2, and Patient Spirometry) are the property of Instrumentarium Corp. or its subsidiaries. Nellcor® is a registered trademark of Mallinckrodt Inc. All other product and company names are the property of their respective owners. © 2004 General Electric Company. All rights reserved.

Cardiocap/5 Technical Reference Manual Part I – General Service Guide Overview

1

Monitor Structure Safety Precautions Product Specifications

Installation and Functional Check

2

Installation Interfacing Functional Check Functional Check Form

Planned Maintenance

3

Planned Maintenance Instructions Planned Maintenance Form

Troubleshooting

4

Messages Troubleshooting Charts

Part II – Product Service Guide Frames and Software

5

Hemodynamic Frame (F-MX) Hemodynamic with Airway Gases Frame (F-MXG) Anesthesia and Critical Care Software

Measurement Parameters

6

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

7

Repair and Replacement Checks, Adjustments, and Calibration

Service Menus

8

Spare Parts

9

Contents

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

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 Power connection ... 1-8 External connection ... 1-8 Electrical shock hazard... 1-8 Fuse replacement ... 1-8 Explosion hazard... 1-8 Patient safety... 1-8 Temperature probes... 1-9 Service and cleaning... 1-9 1.5.2 Cautions ... 1-9 General ... 1-9 Installation ... 1-9 Before use ... 1-9 Airway gas measurement ... 1-9 Autoclaving, sterilizing, and cleaning ... 1-9

Cardiocap/5 Technical Reference Manual

Service ...1-10 Batteries ...1-10 Special components and modifications...1-10 Storage and transport...1-10 Disposal ...1-10

1.6 Specifications...1-11 1.6.1 F-MX and F-MXG frames ...1-11 Power supply...1-11 Environmental conditions ...1-11 Mechanics ...1-11 LCD display...1-11 Battery...1-11 1.6.2 NIBP...1-11 1.6.3 Temperature ...1-11 1.6.4 ECG...1-12 1.6.5 Impedance respiration ...1-12 1.6.6 Pulse oximetry, standard ...1-12

1.7 Specifications for options ...1-13 1.7.1 Pulse oximetry, Datex-Ohmeda enhanced (N-XOSAT) ...1-13 1.7.2 Pulse oximetry, Nellcor compatible (N-XNSAT) ...1-13 1.7.3 Invasive blood pressure (N-XP)...1-14 1.7.4 Airway gases (N-XC, N-XCO, and N-XCAiO)...1-14 General...1-14 Respiration rate (RR) ...1-14 Carbon Dioxide (CO2), Oxygen (O2), and Nitrous Oxide (N2O) ...1-15 Anesthetic agents (AA)...1-15 Agent identification ...1-15 MAC ...1-15 Normal conditions...1-16 Conditions exceeding normal ...1-16 1.7.5 Patient Spirometry (N-XV) ...1-17 Conditions exceeding normal ...1-18 1.7.6 NeuroMuscular Transmission (N-XNMT)...1-18 NMT stimulation modes ...1-18 Stimulator...1-18 Regional block mode...1-18 1.7.7 Recorder (N-XREC) ...1-18

Table of Figures Figure 1-1. Cardiocap/5 monitor structure...1-3

Overview

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.

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.

Related documentation For information about using the monitor, refer to the following: Cardiocap/5 User’s Guide, Anesthesia Cardiocap/5 User’s Guide, Critical Care Cardiocap/5 User’s Reference Manual, Anesthesia Cardiocap/5 User’s Reference Manual, Critical Care 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 Datex-Ohmeda 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.

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 N-XREC

Two invasive pressure channels and second temperature (T2) Recorder

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

Nellcor® compatible pulse oximetry (SpO2) Datex-Ohmeda enhanced pulse oximetry (SpO2)

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 N-XCO N-XCAiO

Carbon Dioxide (CO2) CO2, N2O, and Patient Oxygen (O2) CO2, anesthetic agents, agent identification, N2O, and O2

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

Two invasive pressure channels and second temperature (T2) Patient Spirometry (N-XCO or N-XCAiO option required) Recorder

The F-MXG can also be configured with one of the following options: N-XNSAT N-XOSAT N-XNMT

Nellcor® compatible pulse oximetry (SpO2) Datex-Ohmeda enhanced pulse oximetry (SpO2) NeuroMuscular Transmission (NMT) for relaxation measurement (N-XCAiO option required)

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: N-XNET N-XDNET

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Network Data card and Network

Overview

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.

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 can not 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 SpO2 interface board. 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.

•

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 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.

•

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.

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Overview

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.

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 (SpO2), temperature (T) and invasive pressure (P) measurement.

•

When displayed beside the O2 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. Pb

This battery contains lead and can be recycled. Pb

Dangerous voltage. Gas outlet (in airway gas models only). Ethernet connectors. Equipotentiality. Monitor can be connected to potential equalization conductor. Alternating current. Fuse.

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Overview

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. The monitor is connected to the Datex-Ohmeda 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.

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. Connect the monitor to a three-wire, grounded, hospital-grade receptacle. Do not remove the grounding prong from the power plug. Use an intact power cord. Replace the cord if it is cracked, frayed, broken, or damaged. Do not apply tension to the power cord. The cord may break. Do not use extension cords or adapters.

External connection Connect the monitor only to other monitors or external devices specified by Datex-Ohmeda.

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 the fuse with a fuse of the same type and with the same rating.

Explosion hazard Do not use the monitor in the presence of flammable anesthetics.

Patient safety Do not test or perform maintenance on the monitor while it is being used on a patient. Use only cables and accessories approved by Datex-Ohmeda. Do not modify them. 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. 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

1-8

Overview

sensor or cable repaired by others. A damaged sensor or a sensor soaked in liquid may cause burns during electrosurgery. 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 the impedance respiration measurement off on the monitor.

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

Service and cleaning 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. Turn off the power and unplug the power cord before cleaning or service. Make sure the monitor is completely dry before reconnecting it to the mains outlet.

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.

General US Federal law restricts this device to sale by or on the order of a licensed medical practitioner. Do not apply presurized air to any outlet or tubing connected to the monitor. Pressure may destroy sensitive elements. Use only cables and accessories approved by Datex-Ohmeda. Other cables and accessories may damage the system or interfere with measurement. Vibrations during transport may disturb SpO2, ECG, impedance respiration, and NIBP measurements.

Installation Leave space behind the monitor to allow proper ventilation.

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, sterilizing, and cleaning Do not steam autoclave or gas sterilize the monitor. 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. Clean the fan dust filter on the rear panel once a month or whenever necessary.

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Cardiocap/5 Technical Reference Manual

Service 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.

Batteries There is a lithium battery on the CPU board. Discard broken 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. Datex-Ohmeda assumes no responsibility for damage if replacement components not approved by Datex-Ohmeda 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 and pressure range: Temperature Ambient pressure Relative humidity

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

Disposal Dispose of the device and its parts according to local environmental and waste disposal regulations.

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Overview

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)

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: adult 25 to 260 mmHg child 25 to 195 mmHg infant 15 to 145 mmHg Pulse rate range accepted: 30 to 250 bpm Typical measuring time: adults 23 seconds, infants 20 seconds

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

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Cardiocap/5 Technical Reference Manual

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

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 (% SpO2 ±1 SD): 80 to 100% ± 2 digits; 50 to 80% ± 3 digits; Below 50% unspecified NOTE: SpO2 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 SpO2 accuracy data. Pulse rate Measurement range: 30 to 250 bpm Measurement accuracy: ± 5% or ± 5 bpm Default alarm limits SpO2: high Off, low 90% Pulse rate: high 160, low 40 NOTE: Limits are adjustable. Sensor emitter wavelength ranges Red LED: 660 nm Infrared LED: 900 nm

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Overview

1.7 Specifications for options 1.7.1 Pulse oximetry, Datex-Ohmeda enhanced (N-XOSAT) Display update time: 5 seconds Averaging time: 12 seconds Plethysmographic waveform scaling: automatic SpO2 Calibration range: 70 to 100% Calibrated against functional saturation Measurement range: 1 to 100% Measurement accuracy (% SpO2 ±1 SD): 70 to 100% ± 2 digits 70 to 100% ± 3 digits during conditions of clinical patient motion Below 70% unspecified NOTE: SpO2 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 SpO2: high Off, low 90% 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

1.7.2 Pulse oximetry, Nellcor compatible (N-XNSAT) Display update time: 5 seconds Averaging time: 5 to 7 seconds Plethysmographic waveform scaling: automatic SpO2 Calibrated against functional saturation Measurement range: 1 to 100% Measurement accuracy (% SpO2 ±1 SD): 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: SpO2 measurement accuracy is based on testing healthy adult volunteers in induced hypoxia studies.

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Cardiocap/5 Technical Reference Manual

Pulse rate Measurement range: 30 to 250 bpm Measurement accuracy: ± 3 digits Default alarm limits SpO2: 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

1.7.3 Invasive blood pressure (N-XP) Measurement range: –40 to 320 mmHg 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

1.7.4 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 m, normal conditions) Sampling delay: 2.5 seconds typical with a 3 m sampling line Total system response time: 2.9 seconds typical with a 3 m sampling line, including sampling delay and rise time Display update rate: breath-by-breath Automatic compensation for pressure, CO2-N2O and CO2-O2 collision broadening effect Warm-up time: 2 minutes for operation with CO2, 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

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Overview

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

Carbon Dioxide (CO2)

Oxygen (O2)

Nitrous Oxide (N2O)

Range

0 to 15 vol%, (0 to 15 kPa) (0 to 113 mmHg)

0 to 100%

0 to 100%

Rise time

< 400 ms typical

< 400 ms typical

< 450 ms typical

Accuracy (typical value)

≤ 0.3 vol%

≤ 2 vol%

≤ 3 vol%

Gas cross effects

< 0.2 vol% (O2, N2O, and anesthetic agents)

< 1 vol% (anesthetic agents); < 2 vol% (N2O)

< 2 vol% (anesthetic agents)

NOTE: • If CO2 concentration is below 0.1%, 0.0% is displayed. •

O2 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

0 to 6%

0 to 8%

0 to 20%

Rise time

< 400 ms typical ≤ 0.2 vol%

0 to 5% ≤ 0.2 vol% 5 to 10% ≤ 0.5 vol% 10 to 20% ≤ 1.0 vol%

Accuracy (typical value)

≤ 0.2 vol%

Gas cross effects

< 0.15 vol% N2O

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.

MAC Range: 0 to 9.9 MAC Equation:

MAC(AA) =

%(ETAA) %ETN2O + x(AA) 100

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

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