Philips IntelliVue MX User manual

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Service Guide

IntelliVue Patient Monitor

MX400/MX450/MX500/MX550

Release K.2x.xx

Patient Monitoring

1Table of Contents

1 Introduction 5

Who Should Use This Guide 5 How to Use This Guide 5 Abbreviations 5 Responsibility of the Manufacturer 6 Passwords 6 Safety Information 7

2 Theory of Operation 11

Integrated Monitor Theory of Operation 11

3 Testing and Maintenance 31

Introduction 31 Terminology and Definitions 31 Recommended Frequency 32 When to Perform Tests 33 Testing Sequence 36 Visual Inspection 36 Safety Tests 37 System Test 52 Preventive Maintenance Procedures 63 Performance Assurance Tests 63 Reporting of Test Results 90 Other Regular Tests 93 Touchscreen Calibration 93 Disabling/Enabling Touch Operation 94 Printer Test Report 94 Battery Handling, Maintenance and Good Practices 95 After Installation, Testing or Repair 102

4 Troubleshooting 103

Introduction 103 How To Use This Section 103 Who Should Perform Repairs 103 Replacement Level Supported 103 Software Revision Check 104 Software Compatibility Matrix 104 Obtaining Replacement Parts 104 Troubleshooting Guide 104

5 Repair and Disassembly 139

Tools Required 139 Monitor Disassembly 139 Plug-in Modules 182 Multi-Measurement Module (MMS) Disassembly 186 MMS Extensions - Exchanging the Top Cover, MSL Flex Cable and the Dual Link Bar 203

6 Parts 217

MX400/450/500/550 Parts 218 Remote Control Parts 225 Multi-Measurement Module (MMS) Parts 225 MMS Extension Parts (M3012A, M3014A, M3015A/B) 233 IntelliVue X2 Part Numbers 235 Plug-in Modules Part Numbers 235 Smart Battery Charger Part Numbers 241 External Display Part Numbers 241 Test and Service Tools 242

7 Installation Instructions 245

Electromagnetic Emissions 245 Installation Checklist 246 Unpacking the Equipment 246 Initial Inspection 247 Installing the MX400/450/500/550 Monitor 247 Connecting the Monitor to AC Mains 259

8 Site Preparation 289

Introduction 289 Monitor MX400/450/500/550 Site Requirements 292 Electrical and Safety Requirements (Customer or Philips) 293 Remote Device Site Requirements 293 RS232/MIB/LAN Interface 300 Nurse Call Paging Cable 301 ECG Out Interface 302

9 Gas Analyzers 303

10 Specifications 305

Essential Performance Characteristics 305 MDD Classification 308 Safety and Regulatory Information 308

11 IntelliVue MX400-550 Product Structure 309

1Introduction

This Service Guide contains technical details for the IntelliVue MX400/450/500/550 Patient Monitor, the measurement modules, the Multi-Measurement Module (MMS), the IntelliVue X2, and the Measurement Server Extensions.

This guide provides a technical foundation to support installation, effective troubleshooting and repair. It is not a comprehensive, in-depth explanation of the product architecture or technical implementation. It offers enough information on the functions and operations of the monitoring systems so that engineers who install or repair them are better able to understand how they work.

It covers the physiological measurements that the products provide, the Measurement Server that acquires those measurements, and the monitoring system that displays them.

Who Should Use This Guide

This guide is for biomedical engineers or technicians responsible for installing, troubleshooting, repairing, and maintaining Philips’ patient monitoring systems.

How to Use This Guide

Navigate through the table of contents at the left of the screen to select the desired topic. Links to other relevant sections are also provided within the individual topics. You can also scroll through the topics using the page up and page down keys.

Abbreviations

Abbreviations used throughout this guide are:

Name Abbreviation

IntelliVue MX400/450/500/550 Patient Monitor the monitor

Multi-Measurement Module MMS

Measurement Link MSL

Medical Information Bus MIB

IntelliVue G1/G5 Gas Analyzers G1/G5, the gas analyzer

1Introduction

Responsibility of the Manufacturer

Philips only considers itself responsible for any effects on safety, EMC, reliability and performance of the equipment if:

• assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by Philips, and

• the electrical installation of the relevant room complies with national standards, and

• the instrument is used in accordance with the instructions for use.

To ensure safety and EMC, use only those Philips parts and accessories specified for use with the monitor. If non-Philips parts are used, Philips is not liable for any damage that these parts may cause to the equipment.

This document contains proprietary information which is protected by copyright. All Rights Reserved. Reproduction, adaptation, or translation without prior written permission is prohibited, except as allowed under the copyright laws.

Philips Medizin Systeme Böblingen GmbH

Hewlett-Packard Str. 2

71034 Böblingen, Germany

The information contained in this document is subject to change without notice.

Philips makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties or merchantability and fitness for a particular purpose.

Philips shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material.

Passwords

In order to access different modes within the monitor a password may be required. The passwords are listed below.

CAUTION

Your hospital/organization is responsible that the passwords listed below are revealed to authorized personnel only.

Monitoring Mode: No password required

Configuration Mode: 71034

Demo Mode: 14432

Service Mode: 1345

Consult the configuration guide before making any changes to the monitor configuration.

Safety Information

Warnings and Cautions

In this guide:

•A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient.

•A caution alerts you where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury.

Electrical Hazards and Interference

WARNING

Grounding: To avoid the risk of electric shock, the monitor must be grounded during operation. If a three-wire receptacle is not available, consult the hospital electrician. Never use a three-wire to twowire adapter.

Electrical shock hazard: Do not open the monitor or measurement device. Contact with exposed electrical components may cause electrical shock. Refer servicing to qualified service personnel.

1 Introduction

Leakage currents: If multiple instruments are connected to a patient, the sum of the leakage currents may exceed the limits given in IEC/EN 60601-1, IEC 60601-1-1, UL 60601-1. Consult your service personnel.

Radio frequency interference: The monitor generates, uses and radiates radio-frequency energy, and if it is not installed and used in accordance with its accompanying documentation, may cause interference to radio communications.

Use Environment

WARNING

Explosion Hazard: Do not use in the presence of flammable anesthetics or gases, such as a flammable anesthetic mixture with air, oxygen or nitrous oxide. Use of the devices in such an environment may present an explosion hazard.

Positioning Equipment: The monitor should not be used next to or stacked with other equipment. If you must stack the monitor, check that normal operation is possible in the necessary configuration before you start monitoring patients.

Environmental Specifications: The performance specifications for the monitors, measurements and accessories apply only for use within the temperature, humidity and altitude ranges specified in .

Liquid Ingress: If you spill liquid on the equipment, battery, or accessories, or they are accidentally immersed in liquid, contact your service personnel or Philips service engineer. Do not operate the equipment before it has been tested and approved for further use.

1Introduction

Alarms

Prohibited Environments: The monitors are not intended for use in an MRI environment or in an oxygen-enriched environment (for example, hyperbaric chambers).

WARNING

• Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.

• Be aware that the monitors in your care area may each have different alarm settings, to suit different patients. Always check that the alarm settings are appropriate for your patient before you start monitoring.

Accessories

WARNING

Philips' approval: Use only Philips-approved accessories. Using other accessories may compromise device functionality and system performance and cause a potential hazard.

Reuse: Never reuse disposable transducers, sensors, accessories and so forth that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance and cause a potential hazard.

Electromagnetic compatibility: Using accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the monitoring equipment.

Damage: Do not use a damaged sensor or one with exposed electrical contacts.

Cables and tubing: Always position cables and tubing carefully to avoid entanglement or potential

strangulation.

MR Imaging: During MR imaging, remove all transducers, sensors and cables from the patient. Induced currents could cause burns.

Maintenance, Repair and Care

WARNING

Maintenance and Repair:

• Do not maintain or repair the device in patient vicinity.

• Failure on the part of the responsible individual hospital or institution using this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.

• Performance verification: do not place the system into operation after repair or maintenance has been performed, until all performance tests and safety tests listed in Testing and Maintenance of this service manual have been performed. Failure to perform all tests could result in erroneous parameter readings, or patient/operator injury.

Care and Disinfection:

• To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the monitor appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts.

• For disposal of parts and accessories such as thermometers, where not otherwise specified, follow local regulations regarding disposal of hospital waste.

1 Introduction

1Introduction

2Theory of Operation

Integrated Monitor Theory of Operation

The IntelliVue MX400/450/500/550 Patient Monitor:

• displays real-time data

• controls the attached multi-measurement modules

• alarms in the case of patient or equipment problems

• offers limited data storage and retrieval (trending)

• interfaces to the Philips Clinical Network and other equipment

A monitor with just a single integrated measurement module can be connected to additional building blocks to form a monitoring system with a large number of measurements and additional interface capabilities and multiple slave displays. These elements cooperate as one single integrated real-time measurement system.

2 Theory of Operation

System Boundaries

The following diagram discusses specific boundaries within the overall system with respect to their openness and real-time requirements:

System Boundaries

Measurement connections

Built-in measurement block

Philips Clinical Network (wired LAN)

connects multiple patient monitors, information centers, application servers; closed system, only Philips qualified products (tested and with regulatory approval) are connected, Philips is responsible for guaranteed real-time functionality and performance

Philips Clinical Network (wireless)

like Philips Clinical Network (wired) LAN, however due to current wireless technologies available it has reduced bandwidth, longer latencies, reduced functionality

Hospital LAN, Internet

Standard Network, not under Philips control, no guaranteed service, no real-time requirements

Hardware Building Blocks

The following hardware building blocks make up the monitoring system:

IntelliVue MX400/450/500/550

The IntelliVue MX400/450/500/550 Monitor:

• integrates the display and processing unit into a single package

• uses a 9" TFT WVGA Color display (MX400)

• uses a 12" TFT WXGA Color display (MX450/500)

• uses a 15" TFT WXGA Color Display (MX550)

• uses the touch screen as primary input device; a remote control and computer devices such as mice, trackball, and keyboard can be added optionally.

• has an optional built-in recorder (MX400/450 only)

• has an integrated 3-slot rack (MX500/550 only)

NOTE

The 802.11 Bedside Adapter (WLAN) and IIT are mutually exclusive.

2 Theory of Operation

MX400 Hardware Building Blocks

2 Theory of Operation

MX450 Hardware Building Blocks

2 Theory of Operation

MX500/MX550 Hardware Building Blocks

Compatible Devices

M3001A Multi-Measurement Module (MMS)

M3002A IntelliVue X2

2 Theory of Operation

M3012A MMS Extension

M3014A MMS Extension

2 Theory of Operation

M3015A/B MMS Extension

865244 Remote Control

Power Supply

2 Theory of Operation

Main Board

I/O Boards

The AC/DC converter transforms the AC power coming from the plug into 15V/ 70W DC source and isolates the monitoring system from the AC power mains. The 15V is distributed via power bus either directly or over additional converters to all components of the system:

The battery charger is supplied with 15V and switches between AC/DC supply and battery depending on whether AC power cord is plugged or unplugged.

The 48V DC power needed for the MSL is created by an isolating DC/DC converter.

The LED backlight converter located on the panel adapter board is supplied with 9V - 12.6V / 15V.

The isolated interfaces are supplied with 2.5V AC. The main board is supplied with 5V, 3.3V, 1.5V,

1.4V and 1.2V.

Additionally, for some infrastructural functions 3.6V is provided to the main board.

The main board contains the CPU which includes the graphic processing unit and USB controller. The main memory, a system FPGA, a system controller including watchdogs and various power supplies are located on this board. Additionally, this board contains the MSL interface, the recorder interface, the ECG Out hardware and various other interfaces.

System information is stored in serial EEPROMs to support the automatic configuration of the operating system at boot time.

A dual MIB/RS232 board, a Flexible Nurse Call Relay board or an IntelliBridge board can be added optionally.

2 Theory of Operation

Data Flow

The following diagram shows how data is passed through the monitoring system. The individual stages of data flow are explained below.

Data Flow

Data Acquisition

Monitoring data (for example patient measurement data in the form of waves, numerics and alerts) is acquired from a variety of sources:

• Measurement Servers The Measurement Servers connected to the internal LAN convert patient signals to digital data

and apply measurement algorithms to analyze the signals.

• External measurement devices Data can be also acquired from devices connected to interface boards of the monitor. Software

modules dedicated to such specific devices convert the data received from an external device to the format used internally. This applies to parameter modules and the Anesthetic Gas Module.

• Server systems on the Philips Clinical Network To enable networked applications such as the other bed overview, data can be acquired from server

systems attached to the Philips Clinical Network, for example a Philips Information Center

Data Provider System Service

All data that is acquired from measurement servers or external measurement devices is temporarily stored by a dedicated data provider system service. All monitor applications use this central service to access the data in a consistent and synchronized way rather than talking to the interfaces directly.

This service makes the applications independent of the actual type of data acquisition device.

The amount of data stored in the data provider system service varies for the different data types. For example several seconds of wave forms and the full set of current numerical values are temorarily stored in RAM.

Persistent Data Storage System Service

Some applications require storage of data over longer periods of time. They can use the persistent data storage system service. Dependent on the application requirements, this service can store data either in battery backed-up (buffered) memory or in flash memory. The buffered memory will lose its contents if the monitor is without power (not connected to mains) for an extended period of time. The flash memory does not lose its contents.

The trend application for example stores vital signs data in a combination of flash memory and buffered memory, while the system configuration information (profiles) is kept purely in flash memory.

Display and User Interface Service

Applications can use high level commands to display monitoring data or status and command windows on the internal LCD panel. These commands are interpreted by the display manager application. This application controls the dedicated video hardware.

User input is acquired from a variety of input devices, for example the touchscreen or other standard input devices (keyboard, mouse). The system software makes sure that the user input is directed to the application which has the operating focus.

2 Theory of Operation

Data Output

The monitoring system is very flexible and customizable regarding its data output devices. Built-in devices (for example LAN, video) provide the basic output capabilities.

These capabilities can be enhanced by adding additional I/O boards, as required in the specific enduser setup. The additional I/O boards typically provide data to externally attached devices, for example to RS232 based data collection devices.

The monitor can identify I/O boards by means of a serial EEPROM device that stores type and version information. The operating system detects the I/O boards and automatically connects them with the associated (interface driver) application. For some multi-purpose boards it is necessary to configure the board for a particular purpose first (for example the MIB/RS232 board can support external touch display , data import, data export).

Monitor Applications

The monitor applications provide additional system functionality over the basic measurement and monitoring capabilities. This includes for example trending, report generating, event storage or derived measurements.

In general, the monitor applications use the data provider system service to access the measurement data. Application interfaces to the other system services allow the application to visualize data, to store data over extended periods of time or to output data to other devices.

Internal LAN (Measurement Link)

The monitor and multi-measurement modules communicate using an IEEE802.3/ Ethernet LAN in the Measurement Link (MSL). This network is used to distribute data between the components, for example:

• Digitized patient signals including wave data, numerical data and status information (typically from the measurement server to a display unit)

2 Theory of Operation

• Control data representing user interactions (typically from the display unit to a measurement server)

• Shared data structures, for example representing patient demographical data and global configuration items

The internal LAN allows plug and play configuration of the monitoring system. The system automatically detects plugging or unplugging of measurement servers and configures the system accordingly.

The components on the internal LAN are time-synchronized to keep signal data consistent in the system. Dedicated hardware support for synchronization eliminates any latency of the network driver software.

The integrated LAN provides deterministic bandwidth allocation/reservation mechanisms so that the real-time characteristic of signal data and control data exchange is guaranteed. This applies to the data flow from the measurement server to the monitor (for example measurement signal data) and the data flow from the monitor to a measurement server (for example to feed data to a recorder module).

Philips Clinical Network

The monitoring system may be connected to the Philips Clinical Network, for example to provide central monitoring capabilities or other network services. This connection may be through a normal wired connection or through a wireless connection.

The monitor supports the connection of an internal wireless adapter (#J35). Switching between wired and wireless networks is automatically triggered by the plugging or unplugging of the network cable.

The Philips Clinical Network protocols function very similarly to the protocols used on the internal LAN.

After configuration, the monitoring system sends the digitized patient signals including wave data, numerical data and status information onto the network. Control data representing user interactions can be exchanged between the monitoring system and a central station bi-directionally.

Additional protocols are supported for networked applications, for example for the other bed overview function, which allows viewing of monitoring data from other patients on the network.

For plug and play operation, the monitoring system uses the standard BootP protocol to automatically acquire a network address.

Ambient Light Sensor

The monitor adjusts its display brightness depending on the ambient light level. Therefore an Ambient Light Sensor is integrated in the front bezel of the display.

Although there is an automatic brightness adjustment, it is still possible for the user to change the brightness. As shown in the figure above, the user can select between different brightness level curves.

If a constant brightness is desired, it is possible to deactivate the automatic brightness control via the Config mode of the monitor. Without automatic brightness control, the user can select between different constant brightness levels as shown below.

Microstream CO2

CO2 sample rate: 20 samples/second

2 Theory of Operation

Calculation of end tidial CO2 (etCO2)

The M3015A/B MMS Extensions use Microstream® non–dispersive infrared (NDIR) spectroscopy to continuously measure the amount of CO2 during every breath, the amount of CO2 present at the end of exhalation (etCO2), the amount of CO2 present during inhalation (imCO2), and the respiratory rate. The displayed etCO2 is the maximum etCO2 over the previous peak-picking interval as defined by the Max Hold setting (configuration mode). It can be set to no peak picking (off), 10 seconds and 20 seconds.

Test method for respiration rate range

A breath simulator system combined with CO2 and N2 gases was used to simulate respiration rates covering the specified range. The resulting end tidal CO2 values were compared to the expected value. Differences between actual and expected end tidal CO2 values were within the limits of the specified accuracy for the respective respiration rate, i.e. there was no effect of the respiration rate on the end tidal CO2 values beyond those limits.

How does the Support Tool Work with the Monitor

The Support Tool Mark2 is a Windows application typically installed on the laptop of a customer engineer or a biomedical engineer working in the customer’s own service department.

The purpose of the Support Tool Mark2 is to upgrade, configure and diagnose all monitoring components (modules, measurement servers, and monitors) in the system over the network.

The tool allows access to internal service information and to serial numbers. It can be remotecontrolled, for example via a dial-up connection from a response center, provided the proper infrastructure is in place.

For details see the Instructions for Use for the Support Tool Mark2.

2 Theory of Operation

Monitor Software Block Diagram

Block Diagram Legend

Functional Block Description

Services

Operating System The Operating System (OS) provides a layer of isolation between

the specific hardware implementation and the application software. The OS performs system checks and allocates resources to ensure safe operation when the system is first started. This includes internal self-tests on several hardware modules and configuration checks for validity of configuration with the operating software. During normal operation, the OS continues to run checks on system integrity. If error conditions are detected the OS will halt monitoring operations and inform the operator about the error condition.

2 Theory of Operation

Functional Block Description

System Services The System Services provide generic common system services.

In particular: They use a real-time clock component to track time. They synchronize to network time sources and verify the accuracy of the system time information. They are also responsible for managing persistent user configuration data for all Measurement Servers and IntelliVue Patient Monitoring System software modules. User configuration data is stored in a non-volatile read/write storage device

Applications

Reports The Reports Service retrieves current and stored physiological

data and status data to format reports for printing paper documentation. The following reports are supported:

• Vital Signs Report

• Graphical Trend Report

• Event Review Report

• Event Episode Report

• ECG Report (12 Lead/Multi-Lead)

• Cardiac Output Report

• Calculations Report (Hemodynamic/Oxygenation/ Ventilation)

• Calculations Review Report

•Wedge Report

•Test Report

• Other reports (e.g. Loops, Review Applications, Drug report)

The Reports service generates report data which can be printed on a local or a central printer.

Record The Record Service retrieves current and stored physiological data

and status data to format a continuous strip recording. A recording can be triggered manually by the operator or automatically by an alarm condition. The Record Service can also send data to a recorder.

2 Theory of Operation

Functional Block Description

Alarm The Alarm Service contains logic that prioritizes alarm conditions

Trend The Trend service stores the sample values of physiological data

OxyCRG The OxyCRG (Oxygen CardioRespiroGram) service derives a

ADT The ADT (Admit/Discharge/Transmit) service maintains the

Events The Events Application captures physiological data from episodes

that are generated either by the Measurement Servers or by IntelliVue Patient Monitoring System software modules. Visual alarm signals (messages) are displayed at the top of the IntelliVue Patient Monitoring System display and alarm sounds are generated by a loudspeaker. Alarm conditions may be generated when a physiological parameter exceeds preselected alarm limits or when a physiological parameter or any other software module reports an inoperative status (technical alarm, for example, the ECG leads may have fallen off the patient). The Alarm service manages the alarm inactivation states, for example suspension of alarms, silencing of alarms, and alarm reminder. Alarm signals may also be configured as latching (alarm signals are issued until they are acknowledged by the operator, even when the alarm condition is no longer true). The Alarm service controls the visual alarm signals (alarm lamps).

and status data with a resolution of 12 seconds, 1 minute or 5 minutes for a period of up to 48 hours. The data is kept in battery buffered read/write storage and flash memory devices to be preserved across power failures. The stored data is protected via consistency checks and checksums. When a new patient is admitted, the trend database erases all data of the previous patient.

high-resolution trend graph from the Beat-to-Beat Heart Rate, SpO2 or tcpO2, and Respiration physiological data. The OxyCRG is specialized for neonatal applications, allowing the operator to identify sudden drops in Heart Rate (Bradycardia) and SpO2 or tcpO2 (Desaturations), and supporting the operator in visualizing Apnea situations.

patient demographics information. The operator may admit a new patient, discharge the old patient and enter or modify the patient demographics. The ADT service also supports the transport of a patient (trend database) with the M3001A Multi-Measurement Module. The ADT service controls the deletion of old patient data, the upload of trend data from the M3001A and the switching back of all settings to user defaults. It also synchronizes patient information with a central station on the network.

for later review and documentation purposes. Events can be triggered automatically by an alarm condition, by user-defined conditions or manually by the operator.

2 Theory of Operation

Functional Block Description

Protocol Watch ProtocolWatch allows the execution of pre-defined clinical

protocols in the IntelliVue patient monitor by combining events such as automatically triggered events, time and manually triggered events with textbook knowledge thus aiding the operator to follow clinical guidelines. ProtocolWatch notifies the operator when certain combinations of clinical conditions occur and it documents the developments and clinician actions in a log which can be reviewed on the monitor and documented on a printer.

Calc Param The Calc Param (Calculated Parameters) service accesses current,

stored and manually entered physiological data as input to calculation formulas. With these formulas, derived hemodynamic, oxygenation and ventilation variables are computed. The calculation results, including the input parameters, are stored for later review using the Trend service.

Heart Mgr. The Heart Manager Application allows the selection of the

alarming source to be either heart rate (from ECG) or the system pulse rate. The system pulse rate can be chosen from any of the possible pulse rate sources (e.g., SpO2 and invasive pres-sures). The module implements automatic fall-backs when selected signal sources are not available.

Drug Calc The Drug Calc application aids in calculating drug dosages for

patients.

EGM EGM (extensible Gas Module) interface aneasthesia gas

measurement devices. The EGM Module interfaces the M1013A or M1019A Gas Analyzer devices. The EGM Module retrieves the measurement data and controls the external device. It provides numerical data, wave form data and alarm data for the gas parameters measured by the attached analyzers.

PV Loops The PV Loops application compares graphic representations of

airway waves to help detect changes in the patient airway condition.

Interface Managers

MDSE The MDSE (Medical Data Service Element) Interface Manager is

responsible for the exchange of real-time data between the IntelliVue Patient Monitoring System display unit and the Measurement Servers as well as between the IntelliVue Patient Monitoring System display unit and other devices attached to the network. MDSE establishes and maintains a data communication link between the devices. It provides configuration information about the remote device to applications in the local device and it allows the exchange of measurement data and status information between the devices.

2 Theory of Operation

Functional Block Description

Printer The Printer Interface Manager provides a high level interface to a

Display & Operator Interface The Display and Operator Interface Manager performs the

printer. It provides means to:

• establish a connection to the printer

• transfer data to the printer

• get status of the printer

• close connection to the printer

The Printer Interface Manager also supervises the connection to the printer and whether the printer accepts data (for example paper out). The Printer Interface Manager notifies the operator in such cases.

following tasks:

• Screen presentation of real-time and stored physiological measurement data, alarm condition data and status information received from the MDSE interface manager, the Alarm service or other IntelliVue Patient Monitoring System modules

• Screen presentation of operating controls (control windows)

• Processing of operating control commands received from HIF Control interface. The module verifies and interprets the received commands and forwards them to other software modules of the IntelliVue Patient Monitoring System display unit or Measurement Servers

• Sound generation (issues audible alarm signals and generates audible information signals, for example QRS and SpO2 tones, operator audible feedback)

LabData/Manual Data The Laboratory Data/ Manual Data Entry Interface Manager

allows acquisition of laboratory data (e.g. acquired by the central station from a laboratory information system). It also allows to manually enter measurement data to make additional, manually acquired measurements available to internal applications and to the system.

Wireless Measurement Manager (WMM)

The WMM Interface Manager provides connectivity to the SRR interface. It establishes communication between SRR enabled devices and the ASW module that manages the data provided by the device

Interfaces

LAN The LAN interface implements the physical layer of IEEE 802.3,

electrical isolation, and ESD protection. Electronically separated interfaces are used for communication to the Measurement Servers and to the network.

WLAN The WLAN Interface is a network interface that provides access

to an IEEE 802.11 wireless Local Area Network. The configuration of this interface is done by an OS Service.

2 Theory of Operation

Functional Block Description

Display Controller The display controller is integrated into the CPU. The video RAM

is shared with the main memory. The display controller processes the high level display commands (character and graphic generation, wave drawing) and translates them into pixels, which are written into the video RAM, where the display controller generates the video synchronization signals and the pixel stream for the internal and external display.

HIF Control The HIF (Human Interface Control) interface scans the Human

Interface devices for operator controls (Touch Screen, and USB devices), formats the collected data and sends it to the display and Operating Interface.

ECG-Out The ECG Out interface receives the ECG waveform directly from

the ECG/Resp Arrhythmia ST-Segment physiological algorithm via an RS-422 serial interface and converts the digital ECG signal to an analog ECG signal.

Sync Out (ECG) A pulse signal is provided on the Sync Out connector to allow

synchronization with other medical devices.

RS-232 The RS-232 component represents a generic serial communication

interface to connect external devices as shown in the diagram, also providing power in MP5, MX400/450/500/550.

RS-422 The serial link RS-422 interface communicates the ECG signal to

the ECG Output of the IntelliVue Patient Monitoring System display unit. The interface is a serial, differential, full-duplex link. The interface is ESD protected.

Nurse Call The Nurse Call has a modular jack 6P6C connector. The

connector has an open and close contact on alarm.

MIB The MIB interface allows full-duplex, short-haul asynchronous

binary communication between the monitor and an arbitrary (medical/non-medical) device using an eight-pin RJ45 modular connector. Switching between MIB and RS232 protocol is possible.

IIT Interface The IIT Interface allows operation of the monitors with IntelliVue

Instrument Telemetry

SRR The SRR interface allows operation of the monitor with an

IntelliVue Remote Control.

USB Interface The USB interface allows connection of USB devices (Mouse,

Keyboard, Barcode Scanner, Printer) to the monitor.

Remote Control The remote control allows remote operation of the monitor via a

USB cable or SRR connection.

2 Theory of Operation

3Testing and Maintenance

Introduction

This chapter provides a checklist of the testing and maintenance procedures to ensure the performance and safety of the monitor, the Multi-Measurement Module (MMS), the MMS Extensions and the parameter modules.

These tests must be performed only by qualified personnel certified by the responsible organization. Qualifications required are: training on the subject, knowledge, experience and acquaintance with the relevant technologies, standards and local regulations. The personnel assessing safety must be able to recognize possible consequences and risks arising from non-conforming equipment.

All recurring safety and performance assurance tests must be performed under equal environmental conditions to be comparable.

Preventive Maintenance refers specifically to the series of tests required to make sure the measurement results are accurate. The accuracy and performance procedures are designed to be completed as specified in the following sections or when readings are in question.

For detailed instructions on the maintenance and cleaning of the monitor and its accessories, see Care and Cleaning, Using Batteries and Maintenance and Troubleshooting in the monitor's Instructions for Use.

Terminology and Definitions

The following terms and definitions are used throughout this chapter and taken from the international standards IEC 60601-1, IEC 60601-1-1 and IEC 62353.

• Medical System: a medical electrical system is a combination of at least one medical electrical device and other electrical equipment, interconnected by functional connection or use of a multiple portable socket-outlet.

• Patient Environment: any area in which intentional or unintentional contact can occur between the patient and parts of the medical system or between the patient and other persons who have had contact with parts of the medical system. The patient environment is defined anywhere within

1.5m (5 feet) of the perimeter of the patient's bed and 2.5m (8.2 feet) from the floor.

• Separation Device/Transformer: a component or arrangement of components with input parts and output parts that, for safety reasons, prevent a transfer of unwanted voltage or current between parts of a medical system.

• Multiple Portable Socket-Outlet: a combination of two or more socket-outlets intended to be connected to or integrated with flexible cables or cords, which can easily be moved from one place to another while connected to the power mains.

3 Testing and Maintenance

• Functional Connection: an electrical connection for transfer of signals and/or power.

• Tests: Safety or Performance Assurance test procedures which may consist of several steps.

Recommended Frequency

Perform the procedures as indicated in the suggested testing timetable. These timetable recommendations do not supersede local requirements.

Table 1 Suggested Testing Timetable

Tests Frequency

Preventive Maintenance*

Other Regular Tests

Performance Assurance Tests

NBP Performance Once every two years, or more often

if specified by local laws.

Microstream CO2 Calibration Once a year or after 4000 hours of

continuous use and following any instrument repairs or the replacement of any instrument parts.

Visual Inspection Before each use.

Power On Test

ECG/Resp Performance Once every two years, or if you

ECG Out Performance

SpO2 Performance

NBP Performance

Invasive Pressure Performance

Temperature Accuracy

M3014A Capnography Extension Performance Tests

Microstream CO2 Performance Test

Spirometry Accuracy Test

C.O. Performance

NMT Performance

IntelliBridge Performance Test

Nurse Call Relay Performance

MSL Assurance Test

Power Loss Alarm Buzzer Performance Test

Recorder M1116C Performance Test

Mounting Integrity Test

suspect the measurement is incorrect, except Mainstream CO

Check, Sidestream CO Check and Flow Check - required

once a year.

Accuracy

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Tests Frequency

Safety Tests Visual

Electric al

NOTE

The EEG parameter does not require performance testing. See “EEG, SvO2 (SO2) and tcGas Performance Tests” on page 84 for details.

Visual Inspection After each service event

Protective Earth Once every two years and after

Equipment Leakage Current

Applied Part Leakage Current

System Test Once every two years

When to Perform Tests

This table tells you when to perform specific tests.The corresponding test procedures are described in the following sections All tests listed below must be performed on the monitor itself and any

attached MMS/X2 and parameter modules.

Table 2 When to perform tests

Service Event

(When performing...

repairs where the power supply has been removed or replaced or the monitor has been damaged by impact.

Tests Required

...Complete these tests)

Installation

Installation of a monitor in combination with a

medical or non-medical device connected to the same multiple socket outlet.

Installation of a monitor with no display connected to the video output

Installation of a monitor with a medical display specified by Philips

Installation of a monitor with an off-the-shelf display (non-compliant with IEC 60601-1)

Installation of a monitor with IntelliVue G1/ G5, connected to separate mains sockets.

Installation of a monitor with an IntelliBridge connection to another medical device (compliant with IEC 60601-1), connected to separate mains sockets.

Installation of a monitor with recorder module M1116C

Installation of a monitor with IT equipment e.g. printer, PC connected via a functional connection USB.

Perform Visual Inspection, Power On and System Tests

Perform Visual Inspection and Power On Test

Perform Visual Inspection, Power On and System Test (per each affected video port)

Perform Visual Inspection and Power On Tests

Perform Visual Inspection, Power On and Recorder Performance Test

Perform Visual Inspection, Power On and System Tests

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Service Event

(When performing...

Installation of monitor with IntelliVue 802.11

Bedside Adapter

Tests Required

...Complete these tests)

Perform Visual Inspection, Power On and IntelliVue 802.11 Bedside Adapter Communication Test

Installation of a monitor with IntelliVue Instrument Telemetry

Installation of monitor with Short Range Radio (SRR)

Perform Visual Inspection, Power On and IIT Communication Test

Perform Visual Inspection, Power On and SRR Communication Test.

Installation of networked monitor (LAN) Perform Visual Inspection and Power On Test

Preventive Maintenance

Preventive Maintenance* Perform preventive maintenance tests and

procedures:

NBP calibration

Microstream CO

calibration

Other Regular Tests and Tasks

Visual Inspection Perform Visual Inspection

Power On Test Perform Power On test

Repairs

Repairs where the monitor, parameter modules,

MMS or X2 have been damaged by impact, liquid

Perform Visual Inspection, Power On, all Safety Tests and Full Performance Assurance Tests

ingression, fire, short circuit or electrical surge.

Repairs where the power supply, the mains socket or an interface board of the monitor is

Perform Visual Inspection, Power On, all Safety

Tests and Basic Performance Assurance Test removed or replaced or the protective earth ground connection is disrupted.

Repairs of IntelliVue 802.11 Bedside Adapter Perform Visual Inspection, Power On and

IntelliVue 802.11 Bedside Adapter

Communication Test

Repairs of IntelliVue Instrument Telemetry (IIT) Module

Perform Visual Inspection, Power On and IIT

Communication Test

Repairs of Short Range Radio (SRR) Interface Perform Visual Inspection, Power On and SRR

Communication Test

Repairs of the parameter modules, MMS or X2 (all service events where the parameter modules MMS or X2 have been opened)

Perform Visual Inspection, Power On, all Safety

Tests and Basic Performance Assurance Test.

If a certain parameter seems suspicious, perform

Full Performance Assurance Test for this

parameter.

Repairs where the NBP pump of the MMS or X2 has been replaced

Perform Visual Inspection, Power On, all Safety

Tests, Basic Performance Assurance Test and NBP

Performance Test and Calibration

Repairs where the parameter module, MMS or X2 has been replaced.

Perform Visual Inspection, Power On and Basic

Performance Assurance

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Service Event

(When performing...

Repairs where the recorder module M1116C has

been replaced or repaired.

Tests Required

...Complete these tests)

Perform Visual Inspection, Power On and

Recorder Performance Test

Repairs of the IntelliVue G1/G5 Perform Basic Performance Assurance Test. For

further testing requirements, see IntelliVue G1/

G5 Service Guide

Repairs where the printer connected to the monitor via connector board has been replaced.

All other IntelliVue Monitoring System repairs (except when power supply is removed)

Perform Visual Inspection, Power On, System

Test and Printer Test.

Perform Visual Inspection, Power On Test and

Basic Performance Assurance Test

Performance Assurance

Basic Performance Assurance Perform basic performance assurance tests for the

respective monitoring system component.

Full Performance Assurance Perform all accuracy and performance test

procedures listed in the following sections. If a

particular measurement is in question, perform the

measurement performance test only.

Upgrades

Software Upgrades Perform Visual Inspection, Power On Test and

Basic Performance Assurance Test unless

otherwise specified in the Upgrade Installation

Notes shipped with the upgrade.

Hardware Upgrades Perform Visual Inspection, Power On Test and

Basic Performance Assurance Test unless

otherwise specified in the Upgrade Installation

Notes shipped with the upgrade.

Hardware Upgrades where IntelliVue 802.11 Bedside Adapter is installed

Perform Visual Inspection, Power On Test, Basic

Performance Assurance Test and IntelliVue 802.11

Bedside Adapter Communication Test

Hardware Upgrades where IntelliVue Instrument Telemetry (IIT) is installed

Perform Visual Inspection, Power On Test, Basic

Performance Assurance Test and IIT

Communication Test

Hardware Upgrades where Short Range Radio (SRR) is installed

Perform Visual Inspection, Power On Test, Basic

Performance Assurance Test and SRR

Communication Test

Installation of Interfaces or Hardware Upgrades where the power supply of the monitor or

Perform Visual Inspection, Power On Test, Basic

Performance Tests and all Safety Tests interface boards of the monitor need to be removed.

Combining or Exchanging System Components (non-medical equipment

Perform the System Test for the respective system

components connected to an IntelliVue monitor or medical system equipment operated on a multiple socket outlet)

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NOTE

It is the responsibility of the facility operator or their designee to obtain reference values for recurring safety and system tests. These reference values are the results of the first test cycles after an installation. You may also purchase this service from Philips.

Testing Sequence

Summary of the recommended sequence of testing:

NOTE

If any single test fails, testing must be discontinued immediately and the device under test must be repaired or labeled as defective.

Visual Inspection

Before Each Use

Check all exterior housings for cracks and damage. Check the condition of all external cables, especially for splits or cracks and signs of twisting. If serious damage is evident, the cable should be replaced immediately. Check that all mountings are correctly installed and secure. Refer to the instructions that accompany the relevant mounting solution.

After Each Service, Maintenance or Repair Event

Check:

• the integrity of mechanical parts, internally and externally.

• any damage or contamination, internally and externally

• that no loose parts or foreign bodies remain in the device after servicing or repair.

• the integrity of all relevant accessories.

Power On Test

1 Connect the monitoring system to mains and switch it on. This includes connected displays, MMS,

MMS Extensions, X2, and parameter modules, gas analyzers and IntelliBridge devices.

2 Make sure that all steps listed in the table Initial Instrument Boot Phase in the Troubleshooting section

are completed successfully and that an ECG wave appears on the screen.

The expected test result is pass: the monitor boots up and displays an ECG wave. The wave might be a flat line if no simulator is attached.

Safety Tests

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Safety tests are comprised of the following tests performed on the monitoring system:

• protective earth resistance

• equipment leakage current

• applied part leakage current

• system test (if applicable)

Safety test requirements are set according to international standards, their national deviations and specific local requirements. The safety tests detailed in this Service Guide are derived from international standards but may not be sufficient to meet local requirements. We recommend that you file the results of safety tests. This may help to identify a problem early particularly if the test results deteriorate over a period of time.

Each individual piece of equipment which has its own connection to mains or which can be connected or disconnected from mains without the use of a tool must be tested individually. The monitoring system as a whole must be tested according to the procedure described in “System Test” on page 52.

Accessories which can affect the safety of the equipment under test or the results of the safety test must be included in the tests and documented.

Warnings, Cautions, and Safety Precautions

• These tests are well established procedures of detecting abnormalities that, if undetected, could result in danger to either the patient or the operator.

• Disconnect the device under test from the patient before performing safety tests.

• Disconnect the device under test from mains before performing safety tests. If this is not possible, ensure that the performance of these tests does not result in danger to the safety analyzer operator, patients or other individuals.

• Test equipment (for example, a Safety Analyzer) is required to perform the safety tests. Please refer to Annex C of IEC/EN 62353 for exact requirements for the measurement equipment and for measurement circuits for protective earth resistance and leakage currents. Refer to the

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documentation that accompanies the test equipment. Only certified technicians should perform safety testing.

• The consistent use of a Safety Analyzer as a routine step in closing a repair or upgrade is emphasized as a mandatory step to maintain user and patient safety. You can also use the Safety Analyzer as a troubleshooting tool to detect abnormalities of line voltage and grounding plus total current loads.

• During safety testing, mains voltage and electrical currents are applied to the device under test. Ensure that there are no open electrical conductive parts during the performance of these tests. Avoid that users, patients or other individuals come into contact with touch voltage.

• For Europe and Asia/Pacific, the monitor complies with: IEC 60601-1:1988 + A1:1991 + A2:1995(Ed.2); EN60601-1:1990 + A1:1993 + A2:1995(Ed.2); IEC 60601-1-1:2001; EN 60601-1-1:2001; IEC 60601-1-2:2001+A1:2004; EN 60601-12:2001+A1:2006. For USA, the monitor complies with: UL60601-1:2003 For Canada, CAN/CSA C22.2#601.1-M90+S1+A2

• Local regulations supersede the testing requirements listed in this chapter.

• If a non-medical electrical device is connected to a medical electrical device, the resulting medical electrical system must comply IEC 60601-1-1:2000/ EN 60601-1-1:2001 or IEC 60601-1:2005/ EN 60601-1:2006+A1:2012 (Ed.3) Section 16 "ME Systems"

• Perform safety tests as described on the following pages.

Safety Test Procedures

Use the test procedures outlined here only for verifying and recording the initial values prior to or at installation, safe installation or service of the product, and for periodic recurrent testing. The setups used for these tests and the acceptable ranges of values are derived from local and international standards but may not be equivalent. These tests are not a substitute for local safety testing where it is required for an installation or a service event. If using an approved safety tester, perform the tests in accordance with the information provided by the manufacturer of the tester and in accordance with your local regulations, for example IEC/EN 60601-1, UL60601-1 (US), IEC/EN 62353, and IEC/EN 60601-1-1. The safety tester should print results as detailed in this chapter, together with other data.

Please refer to Annex C of IEC/EN 62353 for requirements for the measurement equipment and for measurement circuits for protective earth resistance and leakage currents.

The following symbols are used in the diagrams illustrating the safety tests:

Supply mains Protective earth

L, N Supply mains terminals PE Protective earth terminal

Mains part Applied part

F-type applied part Measuring device

Resistance measuring device Connection to accessible

......... Optional connection

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conductive parts

CAUTION

After each service, maintenance or repair event:

Ensure all fuses accessible from the outside comply with the manufacturer’s specification.

Check:

• the integrity of mechanical parts, internally and externally.

• any damage or contamination, internally and externally.

• that no loose parts or foreign bodies remain in the device after servicing or repair.

• the integrity of all relevant accessories.

Hints for Correct Performance of Safety Tests

• Perform a visual inspection on all detachable power cords used with the monitoring system and include these in all safety test procedures.

• Connection lines such as data lines or functional earth conductors may appear to act like protective earth connections. These may lead to incorrect measurements and need to be considered during testing. If necessary, unplug these connections.

• During measurements, the device under test shall be isolated from earth (e.g. test on an insulated work bench), except the protective earth conductor in the power supply cord.

• Position all cables and cords in such a manner that they do not influence the safety tests.

• Measurement of insulation resistance is not required.

• When testing a medical electrical system, where possible, test it such that potential ground voltage variations are present as they may be during actual use.

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Guideline for Performance of Safety Tests

This section introduces the general principle of performing recurrent safety tests. Product specific test descriptions are described in the following sections.

Connect the detachable power cord of the device under test to the safety analyzer's test mains port. Connect the enclosure test lead of the safety analyzer to the enclosure of the device under test, e.g. to the equipotential connector or unearthed conductive accessible parts where applicable during Equipment Leakage Current Tests and Applied Part Leakage Current Tests. For testing the applied part leakage current, connect all applied parts to the safety analyzer using the appropriate patient lead or adapter cable. For the ECG parameter all ten ECG-leads need to be connected to the safety analyzer. If necessary, use an adapter cable to connect all ten ECG-leads. If necessary, repeat the safety test procedure until all available applied parts have been tested. Refer to the documentation that accompanies the safety analyzer for further details on how to set up and perform the test.

Protective Earth Resistance Test - Setup Example

NOTE

The test lead needs to go to parts that require protective earthing. This may be a single connection or several tested after each other

Equipment Leakage Current Test - Setup Example

NOTE

The test lead needs to go to the grounded enclosure parts, the ungrounded enclosure parts and all of the applied parts connected together.

Applied Part Current Test - Setup Example

NOTE

The above graphics resemble the Metron QA-90 setup and are protected by copyright. Copyright owned by Fluke (Metron).

Safety Test Adapter Cable - Schematics

The following graphics provide schematics of safety test (patient lead) adapter cables which can be used for electrical safety testing. These schematics can also be used as a guideline for making your own safety test adapter cables. Alternatively, other methods to make safety test adapter cables can be used, e.g. using a modified accessory cable.

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NOTE

You may not need all of the cables displayed below for electrical safety testing of your respective monitor.

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ECG

SpO2 (MP2/X2, MP5, M3001A & M1020B #A01, #A02, #A03, #A04)

Invasive Pressure

Invasive Pressure (M1006B #C01)

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Temperature

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CO2 (MP5, M3014A)

Cardiac Output

NMT

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IntelliBridge

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EEG

ScVO2 (M1011A)

TcG10

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Electrical Safety Testing

S(1): Protective Earth Resistance Test

Test to perform:

Measuring circuit for the measurement of Protective Earth Resistance in medical electrical equipment that is disconnected from the supply mains.

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This measures the impedance of the Protective Earth (PE) terminal to all exposed metal parts of the Device under Test (DUT), which are for safety reasons connected to the Protective Earth (PE).

You can find metal parts of the device at the equipotential connector.

Measurements shall be performed using a measuring device capable to deliver a current of at least 200 mA into 500 mOhms with maximum open circuit voltage of 24V

This safety test is based on IEC/EN 62353.

Report the highest value (X1).

Test Expected test results

Protective Earth Resistance Test (with

X1 <= 300mOhms

mains cable)

NOTE

• If the protective earth resistance test fails, testing must be discontinued immediately and the device under test must be repaired or labeled as defective.

• All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.

• Flex the power cord during the protective earth resistance test to evaluate its integrity. If it does not pass the test, exchange the power cord. Then repeat the test. If it still does not pass, follow the instructions in the first bullet point of this note above.

S(2): Equipment Leakage Current Test - Normal Condition

Test to perform:

Measuring circuit for the measurement of Equipment Leakage Current - Direct method according to IEC/EN 62353.

This test measures leakage current of accessible conductive and non-conductive metal parts of the monitor and the functional earth leakage current. It tests normal and reversed polarity. Perform the test with S1 closed (Normal Condition).

There are no parts of the equipment that are not protectively earthed. Disconnect any data cables and any connections that may provide an extraneous earth path. Test the device under test (DUT) on an insulated surface. Do not touch the DUT during testing.

This safety test is based on IEC/EN 62353.

Report the highest value (X1).

Test Expected test results

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Equipment Leakage Current Test

X1 <= 100μA

(Normal Condition - with mains cable)

NOTE

All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.

In case of an IT-power system, this safety test measurement requires a special measuring circuit, for example with its own integrated TN-system or use of an external isolation transformer attached to the safety test device.

S(3): Equipment Leakage Current Test - Single Fault Condition

Test to perform:

Measuring circuit for the measurement of Equipment Leakage Current - Direct method according to IEC/EN 62353.

This safety test is based on IEC/EN 62353.

Report the highest value (X2).

Test Expected test results

Equipment Leakage Current Test (Single

X2 <= 300μA

Fault Condition - with mains cable)

NOTE

All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.

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S(4): Applied Part Leakage Current - Mains on Applied Part

NOTE

During measurement of the Applied Part Leakage Current it is possible that the measured current can exceed the allowed limit (per IEC/EN 60601-1 or IEC/EN 62353).

This can occur when the safety tester is connected to the invasive blood pressure and temperature connectors at the same time during the applied leakage current measurement.

The connectors for the invasive blood pressure and temperature are independently functioning connectors.

Although there are individual connectors on the front end, internally those parameters use the same electrical insulation interface and are hardwired to each other. This results in an electrical short of those connectors during measurement if a test current is applied simultaneously. Therefore this should be avoided.

Due to the combined insulation interface, it is sufficient to connect to only one parameter interface (that is, Invasive Blood Pressure or Temperature) of the invasive blood pressure/temperature measurement block. This avoids a short and the potential of exceeding the limit for the current.

Test to perform:

Measuring circuit for the measurement of Applied Part Leakage Current - Direct method according to IEC/EN 62353.

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This test measures applied part leakage current from applied part to earth caused by external main voltage on the applied part. Each polarity combination possible shall be tested. This test is applicable to each Applied Part tested and results recorded in turn with all other Applied Parts left floating. Applied Parts with multiple connections (e.g. ECG) are tested with the connections short-circuited.

There are no parts of the equipment that are not protectively earthed.

This safety test is based on IEC/EN 62353.

For measurement limits and test voltage, refer to Safety (4) test, Test and Inspection Matrix.

Report the highest value. (X1).

Test Expected test results

Applied Part Leakage Current Test (Single Fault Condition - mains on applied part)

NOTE

All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.

X1 <= 50μA (CF)

Reference: Allowable Values for IEC 60601-1:1998 and UL 60601-1 Measurements

Protective Earth resistance (between the PROTECTIVE EARTH TERMINAL and any ACCESSIBLE METAL PART which is PROTECTIVELY EARTHED, w/o power cord): 100mOhms

Protective Earth resistance of power cord: 100mOhms

Enclosure leakage current (IEC 60601-1 and UL60601-1): 100 μA (N.C.)

Enclosure leakage current:(IEC 60601-1): 500 μA (S.F.C)

Enclosure leakage current (UL 60601-1): 300 μA (S.F.C)

Patient leakage current: (IEC 60601-1 and UL60601-1): 100 μA (N.C.) for BF

Patient leakage current: (IEC 60601-1 and UL60601-1): 500 μA (S.F.C.) for BF

Patient leakage current: (IEC 60601-1 and UL60601-1): 10 μA (N.C.) for CF

Patient leakage current: (IEC 60601-1 and UL60601-1): 50 μA (S.F.C.) for CF

All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated

Insulation Resistance

It is not recommended to perform measurements of the insulation resistance. Refer to IEC 62353 for details about methods of the insulation resistance measurement.

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System Test

After mounting and setting up a system, perform system safety tests according to IEC/EN 60601-1-1.

What is a Medical Electrical System?

A medical electrical system is a combination of at least one medical electrical piece of equipment and other electrical equipment, interconnected by functional connection or use of a multiple portable socket-outlet.

• Devices forming a medical electrical system must comply either with IEC/EN 60601-1-1 or IEC/ EN 60601-1+A1 Ed.3 clause 16.

• Any electrical device such as IT equipment that is connected to the medical electrical equipment must comply either with IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16 and be tested accordingly.

• Non-medical electrical equipment may require connection through a separating device (e.g. an isolation transformer).

General Requirements for a System

After installation or subsequent modification, a system must comply with the requirements of the system standard IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16. Compliance is checked by inspection, testing or analysis, as specified in the IEC/EN 60601-1-1 or in this book.

Medical electrical equipment must comply with the requirements of the general standard IEC/EN 60601-1, its relevant particular standards and specific national deviations. Non-medical electrical equipment shall comply with IEC safety standards that are relevant to that equipment.

Relevant standards for some non-medical electrical equipment may have limits for equipment leakage currents higher than required by the standard IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16. These higher limits are acceptable only outside the patient environment. It is essential to reduce equipment leakage currents to values specified in IEC/EN 60601-1 when non-medical electrical equipment is to be used within the patient environment.

System Example

This illustration shows a system where both the medical electrical equipment and the non-medical electrical equipment are situated at the patient’s bedside.

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WARNING

• Do not use additional AC mains extension cords or multiple portable socket-outlets. If a multiple portable socket-outlet is used, the resulting system must be compliant with IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16. Do not place multiple socket-outlets on the floor. Do not exceed the maximum permitted load for multiple socket-outlets used with the system. Do not plug additional multiple socket outlets or extension cords into multiple socket outlets or extension cords used within the medical electrical system.

• Do not connect any devices that are not supported as part of a system.

• Do not use a device in the patient vicinity if it does not comply with IEC/EN 60601-1 or IEC 60601-1 edition 3 clause 16. The whole installation, including devices outside of the patient vicinity, must comply with IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16. Any nonmedical device placed and operated in the patient’s vicinity must be powered via a separating transformer (compliant with IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16) that ensures mechanical fixing of the power cords and covering of any unused power outlets.

System Installation Requirements

• Ensure that the medical electrical system is installed in a way that the user achieves optimal use.

• Make sure the user is informed about the required cleaning, adjustment, sterilization and disinfection procedures listed in the Instructions for Use.

• The medical electrical system must be installed in such a way that the user is able to carry out the necessary cleaning, adjustment, sterilization and disinfection procedures listed in the Instructions for Use.

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• Ensure that the medical electrical system is installed in a way that an interruption and restoration of power to any part of the medical electrical system does not result in a safety hazard.

• We recommend using fixed mains socket outlets to power the medical system or parts thereof. Avoid using multiple portable socket-outlets.

• Any multiple portable socket outlets used must be compliant with IEC 60884-1 and IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16.

• Ensure that any part of the system connected to multiple portable socket-outlets is only removable with a tool, i.e. the multiple portable socket-outlet provides a locking mechanism to prevent power cords from being plugged or unplugged unintentionally. Otherwise, the multiple portable socketoutlet must be connected to a separation device. Multiple Socket Outlets used within the medical electrical system must only be used for powering medical electrical equipment which is part of the system.

• Ensure that any functional connections between parts of the medical electrical system are isolated by a separation device according to IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16 to limit increased equipment leakage currents caused by current flow through the signal connections where necessary (e.g. leakage current coming from non-medical electrical equipment into medical electrical equipment or building ground voltage differences providing leakage current through grounded data cables). This only works if the equipment leakage current of the respective medical electrical system parts is not exceeded under normal conditions. This isolation is especially important where the non-medical electrical equipment leakage currents can pass to the medical electrical equipment in the system or building ground voltage differences can pass to the medical electrical equipment via ground in a data cable connection in the system

• Avoid increase of equipment leakage currents when non-medical electrical equipment within the medical electrical system is used. This only applies when if the equipment leakage current of the respective medical electrical system parts is not exceeded under normal conditions. Use of an additional protective earth connection, separation device or additional non-conductive enclosures are options that can prevent a problem.

• Within the patient environment it is important to limit electrical potential differences between different parts of a system. If necessary, use potential equalization equipment (equipotential cable) or additional protective earth connections.

• Medical electrical equipment used in medical rooms must be connected to potential equalization equipment (equipotential cable) to avoid electrical potential differences. Check your local requirements for details.

Required Protective Measures at System Installation

For any IT equipment (IEC60950-1) operated in the patient environment ensure that the equipment leakage current does not exceed the limits described in IEC 60601-1. Use a separation device to ensure compliance. After installation of IT equipment in the patient environment, an equipment leakage current test is required.

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Case 1: Medical Device Combined with Medical Device

If you combine a medical device with another medical device (incl. Philips specified displays) to form a medical electrical system according to IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16, no additional protective measures are required. The medical electrical devices may be located in or outside the patient vicinity in a medically used room. This is valid as long as the medical devices are connected to separate mains outlets. No system test is required.

NOTE

The pictures below and in the following chapters show the MX800 monitor as an example. All cases apply to the MX400/450/500/550/600/700 monitors as well.

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If the combined medical devices are connected to the same multiple portable socket outlet an enclosure leakage current test of the entire device combination on the multiple portable socket outlet is required to ensure that the resulting protective earth leakage current and equipment leakage current does not exceed the limits of IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16. Avoid using multiple portable socket outlets. The medical electrical devices may be located in or outside the patient vicinity in a medically used room. If the limits are exceeded, additional protective measures are required, e.g. a separation device or the connection of each device to separate mains.

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Case 2: Medical Device Combined with a Non-Medical Device

If you combine a medical device with a non-medical device to form a medical electrical system according to IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16, additional protective measures are required, e.g. usage of a separation device. The medical electrical devices or the IT equipment may be located in or outside the patient vicinity in a medically used room. After system installation incl. protective measures, a system test is required to ensure that the resulting equipment leakage current and applied part leakage current does not exceed the limits of IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16.

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For any IT equipment (IEC60950-1) operated in patient vicinity ensure that the equipment leakage current does not exceed the limits described in IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16. Use a separation device to ensure compliance. After installation of IT equipment in patient vicinity, an equipment leakage current test is required.

If the combined devices forming the medical electrical system are connected to the same multiple portable socket outlet, ensure that the resulting protective earth leakage current and equipment leakage current do not exceed the limits of IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16. The medical electrical devices or IT equipment may be located in or outside the patient vicinity in a medically used room. Avoid using multiple portable socket outlets. If the limits of IEC/EN 60601-1-1

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or IEC/EN 60601-1+A1 Ed.3 clause 16 are exceeded, additional protective measures are required, e.g. a separation device or the connection of each device to separate mains.

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Case 3: Medical Device Combined with a Medical or Non-Medical Device with one Device in a Non-Medically-Used Room

If you combine a medical device with a medical or non-medical device to form a medical electrical system according to IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16 using a common protective earth connection and one of the devices is located in a non-medically used room, additional protective measures are required, e.g. usage of a separation device or additional protective earth connection. The medical electrical devices or IT equipment may be located in or outside the patient vicinity. After system installation incl. protective measures, a system test is required to ensure that the resulting equipment leakage current does not exceed the limits of IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16.

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If you combine a medical device with a medical or non-medical device to form a medical electrical system according to IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16 using two separate protective earth connections and one of the devices is located in a non-medically used room creating a potential voltage difference, additional protective measures are required, e.g. usage of a separation device or additional protective earth connection. The medical electrical devices or IT equipment may be located in or outside the patient vicinity. After system installation incl. protective measures, a system test is required to ensure that the resulting equipment leakage current does not exceed the limits of IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16.

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System Test Procedure

If the medical electrical device has already been tested as a standalone device e.g. during factory safety testing, an equipment leakage current test must only be performed once the device is connected to another electrical device/system. If the medical electrical system has not been tested as a standalone device, the device has to be tested as a standalone device (without connection to the system) and as part of the system (with connection to the system).

Connect the detachable power cord of the device under test to the safety analyzer's test mains port. Connect the enclosure test lead of the safety analyzer to the enclosure of the device under test as described in the "Equipment Leakage Test" section . Refer to the documentation that accompanies the safety analyzer for further details on how to set up the test.

Test Expected test results

Equipment Leakage Current Test (Normal Condition)

Equipment Leakage Current Test (Single Fault Condition)

After the testing of the device as a standalone device and as part of the system, check that the resulting values (without connection and with connection to the system) do not differ by more than +/- 10% from each other.

If the devices in the medical electrical system are connected to a multiple portable socket outlet the resulting protective earth leakage current needs to be determined. All system components must be connected to the multiple portable socket outlet and be switched on during this measurement.

Sys1 <= 100μA

Sys2 <= 300μA

Test Expected test results

Protective Earth Leakage Current of Multiple Socket Outlets

Sys3 <= 300μA

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Refer to the documentation that accompanies the safety analyzer for further details on how to set up the test.

Preventive Maintenance Procedures

Noninvasive Blood Pressure Measurement Calibration

Carry out the noninvasive blood pressure measurement performance tests at least every two years , or as specified by local laws (whichever comes first).

Microstream CO2 Calibration

Carry out the Microstream CO2 calibration once a year or after 4000 hours of continuous use and following any instrument repairs or the replacement of any instrument parts.

Performance Assurance Tests

Some of the following test procedures must be performed in service mode. To enter service mode

Operating Modes in the main menu. Then select Service Mode and enter the password.

select

If required, open the screen menu in the monitor info line at the top of the screen and select access the service screen. This is required particularly for Anesthetic Gas Module testing procedures.

Basic Performance Assurance Test

This section describes the basic performance test procedure. Please refer to the section for detailed information on when which test procedure is required.

Procedure:

Power on the monitoring system and go into demo mode. Check that each connected parameter (module, MMS, Gas Analyzer, IntelliBridge connected device) displays values.

Full Performance Assurance Test

The following sections describe the full performance testing procedures i.e. detailed testing of each parameter with a patient simulator or specified tools. Please refer to the section for information on when which testing procedure is required.

ECG/Resp Performance Test

This test checks the performance of the ECG and respiration measurements.

Tools required: Patient simulator.

ECG Performance

1 Connect the patient simulator to the ECG/Resp connector on the MMS/IntelliVue X2.

Service to

2 Configure the patient simulator as follows:

– ECG sinus rhythm. – HR = 100 bpm or 120 bpm (depending on your patient simulator).

3 Check the displayed ECG wave and HR value against the simulator configuration.

4 The value should be 100bpm or 120 bpm+/- 2 bpm.

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Respiration Performance

1 Change the Patient Simulator configuration to:

– Base impedance line 1500 Ohm. – Delta impedance 0.5 Ohm. – Respiration rate 40 rpm or 45 rpm.

2 The value should be 40 rpm +/- 2 rpm or 45 rpm +/- 2 rpm.

Test Expected test results

ECG Performance Test 100 bpm +/- 2 bpm or

Respiration Performance Test 40 rpm +/- 2 rpm or

ECG Out Performance Test

This test checks the performance of ECG synchronization between the monitor and a defibrillator. It only needs to be performed when this feature is in use as a protocol at the customer site.

Tools required:

• Defibrillator with ECG Input.

120 bpm +/- 2 bpm

45 rpm +/- 2 rpm

• Patient simulator.

1 Connect the patient simulator to the ECG connector of the MMS and the defibrillator to the ECG

Output on the monitor with the ECG Sync cable.

2 Set the patient simulator to the following configuration:

– HR = 100 bpm or 120 bpm (depending on your patient simulator). – ECG sinus rhythm.

3 Switch the defibrillator to simulation mode.

4 Check that the ECG signal is displayed.

Test Expected test results

ECG Out Performance Test ECG signal is displayed (pass/fail)

SpO2 Performance Test

This test checks the performance of the SpO2 measurement.

Procedure for Philips FAST SpO

Tools required: none

1 Connect an adult SpO

2 Measure the SpO

3 The value should be between 95% and 100%.

value on your finger (this assumes that you are healthy).

Technology:

transducer to the SpO2 connector.

Test Expected test results

SpO

Performance Test 95% and 100%

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Procedure for Nellcor OxiMax SpO2 Technology:

Nellcor recommends that the functionality of this parameter be verified using the SRC-MAX.

A possible performance assurance check requiring no tools would be:

1 Connect an adult SpO

2 Measure the SpO

3 The value should be between 95% and 100%.

Test Expected test results

SpO2 Performance Test 95% and 100%

Procedure for Masimo SET SpO

The end user may verify SpO designed to work with Masimo Pulse Oximeter technology. Optical simulators are recommended as

they use the patient cable and sensor as part of the test setup. Additionally, a test that includes placing the sensor on a healthy subject and confirming the device reads a normal saturation and pulse rate and displays a clean pleth waveform (while the subject is still) may further increase the confidence that the device is functioning properly.

Measurement Validation

NOTE

A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor. However, it can be used to demonstrate that a particular pulse oximeter monitor reproduces a calibration curve that has been independently demonstrated to fulfill a particular accuracy specification.

transducer to the SpO2 connector.

value on your finger (this assumes that you are healthy).

Technology:

performance via commercially available SpO2 simulators specifically

Philips FAST SpO

The SpO

accuracy has been validated in human studies against arterial blood sample reference

Technology

measured with a CO-oximeter. In a controlled desaturation study, healthy adult volunteers with saturation levels between 70% and 100% SaO

were studied. The population characteristics for those

studies were:

• about 50% female and 50% male subjects

• age range: 19 to 39

• skin tone: from light to dark brown

Pulse rate accuracy has been validated with an electronic pulse simulator.

Nellcor OxiMax Technology

Accuracy specifications are based on controlled hypoxia studies with healthy non-smoking adult volunteers over the specified saturation SpO2 range(s). Pulse oximeter SpO2 readings were compared to SaO2 values of drawn blood samples measured by hemoximetry. All accuracies are expressed as ± "X" digits. Pulse oximeter equipment measurements are statistically distributed; about two-thirds of pulse oximeter measurements can be expected to fall in this accuracy (ARMS) range. Because scatter and bias of pulse oximeter SpO2 and blood SaO2 comparisons commonly increase as the saturation decreases, and accuracy specifications are calculated from data spanning the stated range, different accuracy values may result when describing partially overlapping ranges.

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Subjects used to validate SpO2 measurement accuracies were healthy and recruited from the local population. Comprised of both men and women, subjects spanned a range of skin pigmentations and ranged in age from 18-50 years old.

Oxygen saturation accuracy can be affected by certain environmental, equipment, and patient physiologic conditions (as discussed in the Instructions for Use for the monitor) that influence readings of SpO2, SaO2, or both. Accordingly, observations of clinical accuracy may not achieve the same levels as those obtained under controlled laboratory conditions.

Pulse rate accuracy has been validated with an electronic pulse simulator.

Masimo SET SpO2 Technology

The SpO2 accuracy (except for LNOP Blue sensors) has been validated in human studies against arterial blood sample reference measured with a CO-oximeter. In a controlled desaturation study, healthy adult volunteers with saturation levels between 70% and 100% SpO2 were studied.

The population characteristics for those studies were:

• healthy female subjects: 22 to 39 years of age; light to dark skin pigmentation

• healthy male subjects: 19 to 37 years of age; light to dark skin pigmentation

The LNOP Blue SpO2 accuracy has been validated in human blood studies on neonatal, infant and pediatric patients with congenital cyanotic cardiac lesions in the range of 60%-100% SpO2 against a laboratory CO-oximeter.

The population characteristics for those studies were:

• female patients: 5 days to 20 months of age; light and dark skin pigmentation

• male patients: 1 day to 13 months of age; light and dark skin pigmentation

Pulse rate accuracy has been validated with an electronic pulse simulator or ECG as reference.

For further information please refer to the Instructions for Use of the Device and Accessories.

NBP PerformanceTest

This section describes NBP test procedures.The monitor must be in service mode and the screen “Service A” must be selected to perform these tests. The NBP Performance Test consists of:

• NBP Accuracy Test

• NBP Leakage Test

•NBP Linearity Test

•Valve Test

NBP Accuracy Test and Calibration

This test checks the performance of the non-invasive blood pressure measurement. Connect the equipment as shown:

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Tools required:

• Reference manometer (includes hand pump and valve), accuracy +/-0.8mmHg.

• Expansion chamber (volume 250 ml +/- 10%)

• Appropriate tubing.

In service mode, the systolic and diastolic readings indicate the noise of NBP channels 1 and 2 respectively. When static pressure is applied, the reading in NBP channel 1 should be below 50. The value in parentheses indicates the actual pressure applied to the system.

1 Connect the manometer and the pump with tubing to the NBP connector on the MMS and to the

expansion chamber.

2 In service mode, select the Setup NBP menu.

3 Select Close Valves: On

4 Raise the pressure to 280 mmHg with the manometer pump.

5 Wait 10 seconds for the measurement to stabilize.

6 Compare the manometer values with the displayed values.

7 Document the value displayed by the monitor (x1).

8 If the difference between the manometer and displayed values is greater than 3 mmHg or if the

NBP pump assembly has been exchanged, calibrate the MMS. If not, proceed to the leakage test.

9 To calibrate the MMS, select Close Valves off then Calibrate NBP and wait for the instrument to

pump up the expansion chamber.Wait a few seconds after pumping stops until highlighted and then move the cursor to the value shown on the manometer. If one of the following prompt messages appears during this step, check whether there is leakage in the setup:

– NBP unable to calibrate–cannot adjust pressure – NBP unable to calibrate–unstable signal

10 Press Confirm.

If the INOP NBP Equipment Malfunction message occurs in monitoring mode, go back to service mode and repeat the calibration procedure.

NBP Leakage Test

The NBP leakage test checks the integrity of the system and of the valve. It is required once every two years and when you repair the MMS or X2 or replace parts.

EnterPrVal is

1 If you have calibrated, repeat steps 2 to 6 from the accuracy test procedure so that you have 280

mmHg pressure on the expansion chamber.

2 Watch the pressure value for 60 seconds.

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Calculate and document the leakage test value (x2). x2 = P1 - P2 where P1 is the pressure at the beginning of the leakage test and P2 is the pressure displayed after 60 seconds. The leakage test value should be less than 6 mmHg.

NOTE

The leakage test value of 6 mmHg applies for an expansion chamber of 250ml. When using a different size of expansion chamber, the expected test result needs to be adapted accordingly. E.g for an expansion chamber of 500ml, the leakage test value should be less than 3 mmHg. All other NBP performance tests are independent of the expansion chamber size.

NBP Linearity Test

1 Reduce the manometer pressure to 150 mmHg.

2 Wait 10 seconds for the measurement to stabilize.

3 After these 10 seconds, compare the manometer value with the displayed value.

4 Document the value displayed by the monitor (x3)

5 If the difference is greater than 3 mmHg, calibrate the MMS or X2 (see steps 9 to 10 in the

accuracy test procedure).

Valve Test

1 Raise the pressure again to 280 mmHg.

2 Select Close valves: Off.

3 Wait five seconds and then document the value displayed. The value should be less than 10 mmHg.

4 Document the value displayed by the monitor (x4).

Test Expected test results

Accuracy test x1 = 280 ± 3mmHg

Difference ≤ 3mmHg

Leakage test x2 = leakage test value

x2 < 6 mmHg (with 250ml expansion chamber)

Linearity test x3 = 150 ± 3mmHg

Difference ≤ 3mmHg

Valve Test x4 = value < 10 mmHg

Invasive Pressure Performance Test

This test checks the performance of the invasive pressure measurement.

Tools required: Patient simulator.

1 Connect the patient simulator to the pressure connector.

2 Set the patient simulator to 0 pressure.

3 Make a zero calibration.

Configure the patient simulator as P(static) = 200 mmHg.

5 Wait for the display.

6 The value should be 200 mmHg ± 5 mmHg. If the value is outside these tolerances, calibrate the

Invasive Pressure measurement. If the measurement was calibrated with a dedicated reusable catheter, check the calibration together with this catheter.

Test Expected test results

Invasive Pressure Performance Test 200 mmHg ± 5 mmHg

Temperature Performance Test

This test checks the performance of the temperature measurement.

Tools required: Patient simulator (with 0.1°C or 0.2°F tolerance).

1 Connect the patient simulator to the temperature connector.

2 Configure the patient simulator to 40°C or 100°F.

3 The value should be 40°C ± 0.2°C or 100°F ± 0.4°F.

Test Expected test results

Temperature Performance Test 40°C ± 0.2°C or 100°F ± 0.4°F

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M3014A Capnography Extension Performance Tests

The procedures below describe the mainstream and sidestream CO2 performance tests for the M3014A Capnography Extension.

Mainstream CO2 Accuracy Check

Tools Required:

• three airway adapters

• Verification Gas M2506A

• Gas cylinder regulator M2505A

You also need a local barometric pressure rating received from a reliable local source (airport, regional weather station or hospital weather station) which is located at the same altitude as the hospital.

Procedure:

1 Attach the M2501A CO

Make sure that the sensor is disconnected from the patient circuit.

2 Switch on the patient monitor.

3 Enter the monitor’s Service Mode.

4 Using the sensor status provided in the M2501A Serial protocol, wait for the M2501A sensor to

warm up to its operating temperature.

sensor to the patient monitor. Attach an airway adapter to the sensor.

5 The default setting for gas temperature is 22°C. If the gas temperature is significantly above or

below this value, correct the gas temperature setting.

6 Zero the sensor on the airway adapter being used in this test. Ensure Zero Gas is set to Room Air

7 Attach a regulated flowing gas mixture of 5% CO2, balance N2 to the airway adapter.

8 Set the gas correction to off.

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Allow a few seconds for the gas mixture to stabilize and observe the CO2 value. The expected value is 5% of the ambient pressure ±2mmHg

NOTE

Make sure that you follow the above steps correctly. If the sensor fails this check it must be exchanged. The sensor cannot be calibrated.

Example for an expected test result:

The expected test result for an altitude of 0 m (sea level) at approximately 760 mmHg ambient pressure is:

Test Expected test results (x1) Acceptance Range

Mainstream CO2 Accuracy Test

NOTE

The expected test results will differ depending on the conditions (i.e. altitude or ambient pressure).

Sidestream CO2 Accuracy Check

Tools Required:

• Cal gas flow regulator M2267A

• Cal tube 13907A

• Verification Gas M2506A

• Straight Sample Line M2776A

Procedure:

1 Attach the M2741A CO2 sensor to the patient monitor. Attach the sample line and the cal tube to

the sensor. Make sure that the sensor is disconnected from the patient circuit.

2 Switch on the patient monitor.

3 Enter the monitor’s Service Mode.

5% of 760 mmHg pressure ±2mmHg 36 mmHg - 40 mmHg

4 Using the sensor status provided in the M2741A Serial protocol, wait for the M2741A sensor to

warm up to its operating temperature.

5 Zero the sensor. Ensure Zero Gas is set to Room Air

6 Attach a regulated flowing gas mixture of 5% CO2, balance N2 to the cal tube.

7 Set the gas correction to off.

8 Allow a few seconds for the gas mixture to stabilize and observe the CO2 value. The expected

value is 5% of the ambient pressure ±2mmHg

NOTE

Make sure that you follow the above steps correctly. If the sensor fails this check it must be exchanged. The sensor cannot be calibrated

Example for an expected test result:

The expected test result for an altitude of 0 m (sea level) at approximately 760 mmHg ambient pressure is:

Test Expected test results (x2) Acceptance Range

Sidestream CO2 Accuracy Test 5% of 760 mmHg pressure ±2mmHg 36 mmHg - 40 mmHg

NOTE

The expected test results will differ depending on the conditions (i.e. altitude or ambient pressure).

Sidestream CO2 Flow Check

Check the flow rate in the Sidestream CO2 extension as follows:

1 Connect the flowmeter to the sample line

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2 Check on the flowmeter the flow that the Sidestream CO

ml/min ± 10 ml/min. If the value is not within tolerance check your setup again and perform another flow check. If it fails again, the sensor must be replaced. The sensor cannot be calibrated.

Example for an expected test result:

The expected test result for an altitude of 0 m (sea level) at approximately 760 mmHg ambient pressure is:

Test Expected test results (x3) Acceptance Range

Sidestream CO2 Flow Check 50 ml/min ±10 ml/min 40 ml/min - 60 ml/min

NOTE

The expected test results will differ depending on the conditions (i.e. altitude or ambient pressure).

Microstream CO2 Performance Test

Allow five seconds between individual service procedures to ensure stable equipment conditions. When certain monitor procedures are running, service procedures are not possible and trying to start them will result in a message completes the current operation, then restart the service procedure.

This test checks the performance of the Microstream CO2 measurement. The Microstream CO2 measurement can either be integrated into the IntelliVue MP5 monitor or, for other IntelliVue monitors, into the M3015A/B MMS Extensions. The Microstream CO2 performance test is required once per year or after 4000 hours of continuous use and when the instrument is repaired or when parts are replaced.

Service Operation Failed in the monitor’s status line. Wait until the monitor

extension pump draws. It should be 50

This test uses calibration equipment that you can order (see the Parts section for the part number). The procedure is summarized in the following steps. Refer to the documentation accompanying the equipment for detailed instructions.

Tools Required:

• Standard tools, such as screwdriver, tweezers

• Electronic flowmeter, M1026-60144 or Mass Flowmeter 453564178121

• Digital Barometer ±2mbar or better

• Gas calibration equipment:

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• Cal 1 gas 15210-64010 (5% CO2)

• Cal 2 gas 15210-64020 (10% CO

)

• Cal gas flow regulator M2267A

• Cal tube 13907A

• Calibration Line M3015-47301

• Leakage Test Kit M1013-64002 (451261014851) (only required for leakage test without M102660144 Flowmeter)

• Flexible Connecting Tube

The CO2 calibration for the Microstream extension consists of the following steps:

• Leakage check, either with M1026-60144 Flowmeter or with 453564178121 Mass Flowmeter*

• Barometric pressure check and calibration, if required.*

• Flow check and calibration, if required

•Noise check

• CO2 Cal check and calibration, if required

•CO2 Cal verification

Perform all checks in the same session.

* Not applicable for all HW Revisions. See individual test sections for details.

NOTE

The M3015A/B HW Rev C is indicated as HW Rev. Q.xx.xx in the IntelliVue Revision Screen.

Leakage Check with M1026-60144 Flowmeter (only for M3015A with HW Rev. A and B and Firmware Revision < P.01.32)

The leakage check consists of checking the tubing between:

• the pump outlet and the mCO

• the pump inlet and calibration line inlet.

Check the user’s guide of the flowmeter for details on how to make a correct flow reading.

Part 1

1 Go into service mode and select Setup CO2 menu.

2 Connect a calibration line to the Microstream CO

3 Check the ambient pressure and the cell pressure shown in the monitor’s status line. The cell

pressure should be approximately 20 mmHg lower than ambient pressure. (This test is only to check that the pump starts and is running, which is also indicated by the noise generated by the running pump.)

4 Connect the flowmeter outlet to the calibration line inlet using a flexible connecting tube.

5 Block the mCO

outlet using your fingertip and observe the flowmeter display. The value on the

flowmeter (x1) should decrease to between 0 and 4 ml/min, accompanied by an audible increase in pump noise. If the value is within the tolerance limits, continue with part 2 of the leakage check.

outlet and

input to start the pump running.

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If the value is outside the tolerance limits, there is a leakage between the pump outlet and the

outlet.

mCO

7 Open the MMS Extension or MP5 and check the tubing connections at the pump outlet and the

extension gas outlet. If the connections are good, then there is a leakage in the tubing and you must exchange the MMS Extension or the mCO

Assembly of the MP5 respectively.

Part 2

1 Disconnect the flowmeter from the Part 1 setup and connect the flowmeter inlet to the M3015A

gas outlet or the MP5 mCO

2 Leave the calibration line connected to the M3015A inlet or the MP5 mCO

3 Block the inlet of the calibration line using your fingertip and observe the flowmeter display. The

gas outlet.

inlet..

value on the flowmeter (x2) should decrease to between 0 and 4 ml/min, accompanied by an audible increase in pump noise. The cell pressure shown in the status line on the display should decrease to between 300 and 500 mmHg. Do not block the inlet for longer than 25 seconds as this will lead to an “Occlusion” INOP. If the value is within the tolerance limits, there are no leakages and the leakage check is completed; proceed to the pump check.

4 If the value is not within the tolerance limits, there is a leakage between the calibration line inlet

and the pump inlet.

5 Check the calibration line connections and open the M3015A or MP5 to check the tubing

connections at the pump inlet and the M3015A or MP5 mCO

gas inlet. If the connections are

good, try replacing the calibration line and repeating the leakage check. If the situation remains, there is a leakage in the tubing and the M3015A or the mCO

assembly of the MP5 must be

exchanged.

Test Expected test results

Leakage Check Parts 1 and 2 x1 = value of part 1 leakage check on flowmeter

(x1< 4.0 ml/min)

x2 = value of part 2 leakage check on flowmeter (x2< 4.0 ml/min)

Leakage Check for M3015B and M3015A with HW Rev C or M3015A with HW Rev. A/B without M1026-60144 Flowmeter

Preparation of Leakage Test Kit:

Remove two Luer connectors from the Leakage Test Kit, as shown in the following picture.

NOTE

These Luer connectors are not required for the actual Leakage Check. However, you should keep them, as they are required for other tests (e.g. for the kit leak test as documented later in this section).

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Test Setup:

1 Connect the Calibration Line (M3015-47301) to the inlet of the M8105A/M3015A/B (the

M8105A/M3015A/B must be switched off, either by disconnecting from the host monitor or by switching off the monitor).

2 Connect the leakage test tubing to the outlet of the M8105A/M3015A/B, to the digital barometer,

to the calibration line, and the (empty) syringe as shown below. Make sure all connections have a tight fit!

Test Procedure:

1 Open the 3-way stopcock for all three limbs.

2 Switch on the digital barometer (the digital barometer should now display the actual ambient

pressure).

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Now slowly draw at the syringe, as if filling the syringe, until the pressure (as displayed on the digital barometer) drops to approximately 350 mbar below ambient pressure.Then close the line to the syringe at the 3-way stopcock to syringe (circled in picture below).

4 Let the reading on the digital barometer stabilize for a moment and then perform the leakage

check: for 30 seconds the change of the pressure reading should be less than 20 mbar.

5 If the leakage test is NOT passed, check all connections once more and repeat the test.

Test Expected test results

Leakage Check Reading on the digital barometer

change is less than 20 mbar for 30 seconds (pass/fail)

NOTE

To ensure the integrity of the Leakage Test Kit (M1013-64002, 451261014851) the following Kit Leak Test Procedure must be performed:

a. Form a loop with the leakage test kit as shown in the picture below.

b. Connect the syringe to the 3-way stopcock and the digital barometer to the open tubing.

c. Draw at the syringe until the digital barometer shows approximately 350 mbar below ambient

pressure.

d. Close the 3-way stopcock to the syringe and wait 5 - 10 seconds. In this time, the overall

pressure should stabilize.

e. After 1 minute, check the pressure. The pressure should not increase more than 8 mbar in 1

minute for the test to pass.

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f. If this test fails, exchange the leakage test kit.

Barometric Pressure Check and Calibration

NOTE

The M3015A with HW Rev C and the M3015B do not require calibration of the barometric pressure. Therefore you will not be able to activate a barometric pressure calibration. If you are using a HW Rev C M3015A or M3015B, perform the barometric pressure check as described below, making sure that only a sample line is connected to the MMS Extension. If the pressure check fails, the M3015A/B needs to be exchanged.

Check the barometric pressure value in the M3015A/B MMS Extension or the MP5 as follows:

1 Go into service mode and select Setup CO

2 Connect a calibration line to the Microstream CO

menu.

input. This activates the pump in the M3015A/

B MMS Extension or the MP5.

3 The status line at the bottom of the screen displays “CO

pressure reading (ambient/cell) xxx/

yyy” where xxx is the ambient pressure and yyy is the measured cell pressure. Check whether the ambient pressure value (x3) matches (within the acceptable tolerance of ±12mm Hg) the reference value you have received. If so, proceed to the leakage check.

If the value is not correct, calibrate as follows.

a. Select

then select Barom.Press to activate a table of values.

b. Select the value in the table which matches the reference value received from a reliable local source

(airport, regional weather station or hospital weather station). (The values are displayed with a resolution of 2 mmHg up to 500 mmHg and a resolution of 1 mmHg from 500 mmHg to 825 mmHg.) Note: the selected value must be within ±10% of the current measured ambient pressure, otherwise an error message will occur at restarting the monitor.

c. Confirm the barometric pressure setting.

d. Check that the ambient pressure displayed in the status line at the bottom of the screen is the same

as the value which you selected from the list in step b.

Test Expected test results

Barometric Pressure Check x3 = difference between the reference

pressure and the measured ambient pressure displayed on the monitor

Flow Rate Check and Calibration

Check the flow rate in the M3015A/B MMS Extension or the MP5 as follows:

1 Connect the calibration line to the mCO

2 Check on the flowmeter the flow that the M3015A/B MMS Extension or MP5 mCO2 pump

draws (x5). It should be 50 +15/-7.5 ml/min. If the value is within tolerance, proceed to the CO Gas calibration check. If the value is not within tolerance, calibrate as follows.

a. Adjust the flow in the instrument by selecting

possible to 50 ml per minute as indicated on the flowmeter gauge.

(x3<12 mmHg)

inlet and the flowmeter outlet to the calibration line.

Increase Flow or Decrease Flow until it is as close as

Noise Check

3 Testing and Maintenance

b. When you are satisfied that the flow is set as close as possible to 50 ml per minute, select Store Flow

and confirm the setting. If you do not store the adjusted flow within 60 seconds of the adjustment, the old flow setting is restored.

c. If you cannot adjust the flow to within tolerance, replace the pump . If you still cannot make the

flow adjustment, this indicates a fault in the measurement extension, which must be replaced. Note that the pump can only be replaced on M3015A with the old hardware Rev. A (i.e. Serial No.

DE020xxxxx)

Test Expected test results

Flow Rate Check Flow rate is 50 +15/-7.5 ml/min

1 With the monitor in service mode, select Setup CO

2 Connect the calibration line, the cal tube, the flow regulator and the 5% calibration gas to the

inlet.

mCO

menu.

3 Open the valve to apply the 5% calibration gas and wait until the value is stable.

4 Check the noise index (x6) displayed next to the CO

of noise on the CO

wave). If the value exceeds 3 mmHg, replace the measurement extension.

Test Expected test results

Noise Check x6 = noise index displayed on monitor

CO2 Cal Check and Calibration

After switching the measurement extension on, wait at least 20 minutes before checking the calibration. Check the calibration of the CO

value on the display (this indicates the level

(x6<3.0)

gas measurement as follows:

3 Testing and Maintenance

Connect the calibration line, the cal tube, the flow regulator and the 5% calibration gas to the

inlet.

mCO

2 Calculate the expected measurement value in mmHg as follows:

0.05 x (ambient pressure) = value mmHg for example 0.05 x 736 = 36.8 mmHg (with an ambient pressure of 736 mmHg)

3 Open the valve on the flow regulator to allow 5% CO

gas to flow into the extension. Allow the

value to stabilize.

4 Check that the value on the instrument (measurement value on the main screen, x7) matches the

calculated mmHg value ± 2.6 mmHg. If the value is outside the tolerance, calibrate as described in step 8a to 8e below.

5 Disconnect the 5% calibration gas and connect the 10% calibration gas.

6 Calculate the expected measurement value and tolerance in mmHg as follows:

0.1 x (ambient pressure) = value mmHg ±0.07 x (value mmHg) = tolerance

for example 0.1 x 737 mmHg = 73.7 mmHg (with an ambient pressure of 737 mmHg) ±0.07 x 73.7 mmHg = ±5.16 mmHg tolerance

7 Open the valve on the flow regulator to allow 10% CO

gas to flow into the extension. Allow the

value to stabilize.

8 Check that the value on the instrument (x8) matches the calculated mmHg value within the

calculated tolerance. If so, the measurement extension is correctly calibrated. If the value is outside the tolerance, calibrate as follows.

a. Keep the same setup and connect the 5% calibration gas.

b. Select

Cal. CO

c. Select the value for the calibration gas. (The default value is 5.0%.)

d. Open the valve on the calibration gas to allow CO2 gas to flow into the extension. Allow the value

to stabilize before the start of the calibration. Leave the valve open until the instrument gives a prompt that gas can be removed.

e. The extension calibrates and prompts when calibration is successful.

Test Expected test results

CO2 Cal Check x7 = calculated mmHg value ±2.6 mmHg

Calibration Verification

1 Keep the same setup as described in “CO2 Cal Check and Calibration” on page 77.

2 Reopen the 5% gas valve and allow the value to stabilize.

3 Check that the value displayed on the monitor is correct within the tolerance (see step above).

4 Disconnect the 5% calibration gas and connect the 10% calibration gas.

5 Open the valve on the flow regulator to allow 10% CO2 gas to flow into the extension. Allow the

value to stabilize.

6 Check that the value displayed on the monitor is correct within the tolerance (see step above).

If one or both values are not within tolerances, you must exchange the M3015A/B MMS Extension or the MP5 mCO

Assembly.

3 Testing and Maintenance

x8 = calculated mmHg value within calculated tolerance

Test Expected Test Results

Leakage Check parts 1 and 2*

x1 = value of part 1 leakage check on flowmeter (x1< 4.0 ml/min)

x2 = value of part 2 leakage check on flowmeter (x2< 4.0 ml/min)

Leakage Check without Flowmeter

Barometric Pressure Check

reading on the digital barometer change is less than 20 mbar for 30 seconds

x3 = difference between the reference pressure and the measured ambient pressure displayed on the monitor

(x3<12 mmHg)

Flow Check x4 = difference between measured value and 50.0 ml/min

(x4 = 50+15/-7.5 ml/min)

Noise Check x5 = noise index displayed on monitor (x5<3.0)

Gas Calibration

Check

x6 = difference between measured CO2 value and calculated value, based on 5% CO

cal. gas. (x6 < 2.6

mmHg)

CO2 Cal Verification x7 = difference between measured CO2 value and

calculated value, based on 10% CO

cal. gas.

(x7 < ± {0.07 x value calculated})

* M3015A HW Rev. B and FW Revision < P.01.32 only

3 Testing and Maintenance

Spirometry Performance Tests

These tests verify the performance accuracy of the M1014A Spirometry module.

Equipment Required

• Leak test kit (Part number: M1014-64100)

• calibrated barometer

• M2785A Pediatric/Adult Flow Sensor

• 500ml calibration syringe, Hans Rudolph model 5550 or equivalent

Flow Test

1 Connect the M1014A Spirometry Module to the host monitor and go into service mode.

2 Connect the flow sensor to the module.

3 Connect the 500ml calibration syringe to the flow sensor. Make sure the syringe is set to the

“empty” position.

4 Press the Setup key on the module and select Show all Values in the Setup Spirometry menu.

5 Pump the calibration syringe back and forth with a steady motion at a rate of 20 cycles and verify

that the readings for TVexp and TVin are 500 ± 25 ml.

If the readings are not within the specified range, try another flow sensor. Ensure that the syringe is calibrated correctly and that the procedure is performed exactly as described above. If the test fails again, replace the module.

Leakage Test

1 Connect the M1014A Spirometry Module to the host monitor and go into service mode.

2 Connect the leak test adapter to the module.

3 Press the Setup key on the module and then select Show all Values in the Setup Spirometry menu.

4 Press the Purge key on the module and start a purge cycle. At the end of the purge cycle, the values

5 Verify that the pressure difference between Ppeak and Paw remains less than 10 cmH2O after 30

If the readings are not within the specified range or if an INOP (e.g. SPIRO PURGE FAILED) is issued, check the leak test adapter for any leaks. Disconnect the adapter from the module and start the test procedure from the beginning. If the test fails again, replace the module.

Test Expected test results

Flow Test TVexp and TVin are 500 ± 25 ml

for Paw and Ppeak should both be above 100 cmH2O.

seconds.

Test Expected test results

Leakage Test Paw and Ppeak >100 cmH2O

Barometer Check

1 Connect the M1014A Spirometry Module to the host monitor and go into service mode.

2 Attach any airway adapter to the module.

Press the Setup key on the module and then select Show all Values in the Setup Spirometry menu.

4 Check that the barometric reading (PB) is within ± 5 mmHg of a reference barometer.

5 If the readings are not within the specified range, check the accuracy of the barometric pressure

reference again. If the test fails again, replace the module.

Test Expected test results

Barometer Check PB is within ± 5 mmHg of a reference

barometer

NOTE

The built-in barometer cannot be recalibrated.

Cardiac Output (C.O.) Performance Test

These tests check the performance of the cardiac output measurement.

1 Connect the patient simulator to the C.O. module using the patient cable.

2 Configure the patient simulator as follows:

Injection temperature: 2 °C Computation Const: 0.542 (Edward's Catheter) Flow: 5 l/min

3 Testing and Maintenance

3 Check displayed value against the simulator configuration.

4 Expected test result: C.O. = 5 +/– 1 l/min.

Test Expected test results

Cardiac Output Performance Test C.O. = 5 +/– 1 l/min

Service Tool Procedure, Version 1

This procedure applies for Service Tool M1012-61601 in combination with C.O. modules without option C10 and M3012A MMS extensions with option C05.

1 In monitoring mode, connect the C.O. interface cable to the module.

2 Connect one side of the service tool to the injectate receptacle of C.O. interface cable and the

other side to catheter cable receptacle.

3 Enter the C.O. Procedure window and check the results. The expected test result is:

Tblood = 37.0

C +/- 0.1oC

Test Expected test results

Cardiac Output Service Tool Procedure Version 1

Service Tool Procedure, Version 2

This procedure applies only for Service Tool M1012-61601 in combination with C.O. modules with option C10 and for the M3012A MMS Extension with option C10.

Tblood = 37.0

C +/- 0.1oC

1 In monitoring mode, connect the C.O. interface cable to the module.

3 Testing and Maintenance

Connect one side of the service tool to the injectate receptacle of the C.O. interface cable and the other side to the catheter cable receptacle.

3 Enter C.O. Procedure window and check results for:

– Method of measurement – Arterial Catheter constant – Tblood The expected results are: – Transpulmonary – 341

– Tblood = 37.0

4 Make sure the main alarms are switched on.

5 Disconnect the Catheter cable receptacle from the service tool

6 Enter the Setup C.O Window and change the method of measurement to “Right Heart”

7 Enter the C.O. Procedure window and check the Tinj value. The expected result is:

Tinj = 0.0

Test Expected test results

C +/- 0.1oC

Cardiac Output Service Tool Procedure Version 2

NMT Performance Test

NMT Stimulation Output Test

1 Short circuit the stimulation cables by connecting the two cable clamps to each other as shown

below.

Tinj = 0.0oC +/- 0.1oC

2 In service mode, select the Setup NMT menu.

3 Select Start Test.

4 Select Confirm.

Test Expected test results

NMT Stimulation Output Test

NMT Stimulation Output Test passed is

displayed on the monitor.

NMT Transducer Test

1 Go into Service Mode. In Service Mode the NMT Bar Graph only contains three bars instead of

four.

2 Place the NMT Transducer on a flat surface with the flat side facing downwards. Two of the three

bars in the NMT bar graph should be at the same level and the third one should be higher than the other two.

3 Testing and Maintenance

3 Turn the NMT Transducer 180° and place it on a flat surface with the flat side facing upwards.

The bar that was higher than the other two before should now be lower than the other two by approximately the same amount.

Test Expected test results

NMT Transducer Test First two bars in the NMT bar graph

are at the same level, third bar is higher when the flat side of the transducer is facing downwards and lower by the same amount when the transducer is facing upwards.

3 Testing and Maintenance

IntelliBridge Performance Test

This test checks the performance of the IntelliBridge EC10 & EC5 modules.

Tools required: none / external device (i.e. ventilator) and the required IntelliBridge EC5 Module

1 Plug the IntelliBridge EC10 module into the Philips patient monitor or run the test with the built-

in EC10 I/O board.

2 Connect the Service PC to the IntelliBridge EC10 module or I/O board and make sure the correct

drivers for the external devices are installed. (See the chapter for details).

3 Depending on your external device, connect the appropriate EC5 ID module (indicated on the

EC5 label) to the external device.

4 Connect the EC5 to the EC10 module or I/O board using the supplied cable.

5 Switch the external device on. The connection status LED will flash green until it has correctly

identified the external device and started communication. Check that the connection status LED then lights green continuously indicating that communication has been established. Information from the external device should now be available on the Philips patient monitor.

6 Select Main Setup -> Measurements -> <External Device Name> to enter the setup menu for the

connected device.

7 Select Setup Waves or Setup Numerics and make any required changes.

8 Close the setup menu.

9 Select the wave segment on the screen, in which you want the waves to be displayed. In the pop-up

menu, select Change Wave, and then select WAVE.

10 We recommend that you confirm with the user that waves and numerics required from the

external device are being accurately received. If the external device has a demo mode, use this.

Test Expected test results

IntelliBridge Performance Test Numerics are visible on screen (pass/

fail)

Recorder Performance Test - M1116C

This test checks the performance of the recorder module M1116C.

1 Load paper into the recorder (for paper loading instructions, refer to your monitor's Instructions

for Use).

2 Start a recording, e.g. an Alarm Limits Recording.

3 If no print-out appears, the paper may be loaded backwards or the wrong paper may be inserted.

4 Try reloading the paper. Make sure you are using the correct paper.

Test Expected test results

Recorder Performance Test Recording is printed correctly

EEG, SvO2 (SO2) and tcGas Performance Tests

The EEG and SVO2 (SO2) parameters do not require performance tests because the modules perform internal self-tests regularly. These tests suffice for performance testing of these three parameters.

Since the tcGas Module is calibrated regularly it also does not require a separate performance test.

Nurse Call Relay Performance Test

The nurse call relay performance test can be performed at the Modular Jack 6P6C connector.

This test checks the operation of the Nurse Call Relay. The Nurse Call Relay test is recommended for customer sites where the nurse call is in use. The Nurse Call relay functions as follows:

• Standard Operation—connector contact 1-2 open; 1-5 closed.

• Alarm Condition—connector contact 1-2 closed; 1-5 open.

Tools required: Ohmmeter.

1 Plug a 6P6C Modular Plug into the Nurse Call Relay connector.

2 Connect the ohmmeter.

3 When no alarm occurs, connector contacts 1-2 are open and connector contacts 1-5 are closed.

When an alarm occurs, connector contacts 1-2 are closed and connector contacts 1-5 are open.

3 Testing and Maintenance

4 The expected test result is: Alarm condition - Connector contacts 1-2 are closed and connector

contacts 1-5 are open.

Test Expected test results

Nurse Call Relay Performance Test Alarm Condition—

Connector contacts 1-2 are closed and Connector contacts 1-5 are open

Multi-Port Nurse Call Connector Test (Flexible Nurse Call)

This test checks the operation of the Flexible Nurse Call Relay. The Nurse Call Relay test is recommended for customer sites where the nurse call is in use. The following diagram and table show the pins and relay identifiers of the connector:

3 Testing and Maintenance

Pin Cable Color

Relay

Coding

1black R2-closure

2brown R2-middle

3red R2-opener

4orange R3-closure

5 yellow R3-middle

6 green R3-opener

7blue n/a

8purple n/a

9gray n/a

10 white n/a

11 pink R1-closure

12 light green R1-middle

13 black/white R1-opener

14 brown/white n/a

15 red/white n/a

16 orange/white n/a

17 blue/white R_failure_closure

18 purple/white R_failure_middle

19 green/white R_failure_opener

20 red/black n/a

The Nurse Call relay functions as follows:

• During standard operation R1,R2,R3_opener are closed; R1,R2,R3_closure are open.

• During alarm condition—R1,R2,R3_opener are open; R1,R2,R3_closure are closed.

Tools required: Ohmmeter.

1 Plug an M8087-61001 cable into the Nurse Call Relay connector.

2 Connect the ohmmeter and measure the pins as indicated in the diagram and table.

3 The relay contacts should behave as described above. The behavior may vary depending on

configuration choices. See the Configuration Guide for details on Alarm Relay settings.

4 The expected test results depend on the relay contact used. Please check that the correct relay

activity is initiated during alarm condition.

Test Expected test results

Multi-Port Nurse Call Connector Test Correct relay activity is initiated during

alarm condition (pass/fail)

MSL Assurance Test

Visually inspect all MSL connector sockets (cable/monitor/MMS).

1 Make sure that the pins of the connectors are not jolted.

2 Make sure that no pin is bent inwards or outwards.

3 Exchange connectors that show any evidence of damage or breakage

3 Testing and Maintenance

Examples of damaged connectors

Test Expected test results

MSL Assurance Test Pins of connector not jolted/bent

(pass/fail)

Power Loss Alarm Buzzer Performance Test

1 Switch on the monitor.

2 Disconnect the monitor from AC power.

3 The Power Loss Alarm Buzzer should beep for about one minute.

4 To switch off the alarm sound, either press the power button or connect the monitor to AC power

Test Expected test results

Power Loss Alarm Buzzer Performance

Beep for one minute

Test

IntelliVue 802.11 Bedside Adapter Communication Test

1 Make sure the LAN cable is disconnected from the rear of the monitor, then switch on the

monitor.

2 Go into Service Mode and select Main Setup -> Network -> Setup WLAN. In the Setup WLAN menu:

–set

–set – set the

Mode to either 802.11Ah, 802.11G, 802.11Bg (not recommended), Auto (not

recommended) or

None (this setting disables the wireless LAN functionality permanently), to

match your wireless infrastructure installation.

SSID to match your installation.

Country code to “1000”. Setting the country code to this value will automatically adjust

the regulatory domain to match the configuration of the infrastructure. Do not set the country code to values other than “1000” unless otherwise instructed.

3 Testing and Maintenance

– set the Security Mode to match your installation. – Enter the required keys/passwords.

3 Select Main Setup -> Network -> WLAN Diagnostic to access the WLAN Diagnostic window.

4 Proper installation of the IntelliVue 802.11 Bedside Adapter is assured by connecting to an access

point over the wireless link. Place the monitor with the IntelliVue 802.11 Bedside Adapter installed in close proximity to the access point (e.g. if the access point is mounted on the ceiling, place the monitor directly below). Wait until the (for Rel. C.0 monitors) or Connected (for Rel D.0 or higher). Take the monitor approximately 5 m away from the access point. There should be no walls or other obstacles between the monitor and the access point. The following should apply:

– Observe the

RSSI value will fluctuate but should stay above 30 in a 5 m distance from the access point used.

The wireless link should be active, i.e. the monitors) or Connected (for Rel D.0 or higher), and the other fields should contain values. If the

RSSI value is significantly lower, check the distance to the access point and the antenna

orientation at the monitor. The antenna orientation should be vertical, but the physical placement of the monitor or other equipment within its vicinity as well as walls or other obstacles may influence the antenna orientation required to receive the best RSSI value.

5 If this test fails, retry in a different physical area with a different access point and/or check the

credential settings in the monitor.

Conn.Status field in the service window shows Authenticatd

RSSI (Received Signal Strength Indicator) value for at least 5 - 10 seconds. The

Conn.Status field should be Authenticatd (for Rel. C.0

Test Expected test results

IntelliVue 802.11 Bedside Adapter Performance Test

IIT Communication Test

1 Make sure the LAN cable is disconnected from the rear of the monitor, then switch on the

monitor.

2 Go into Service mode and, select Main Setup -> Network -> Setup IIT. In the Setup IIT menu, set

RF Access Code in each profile to match your installation.

the

3 Go into Service Mode. Select Main Setup -> Network -> IIT Diagnostic to access the Instrument

Telemetry Diagnostic window.

4 Proper installation of the IIT module is assured by connecting to an access point over the wireless

link. Place the monitor with the IIT module installed in close proximity to the access point (e.g. if the access point is mounted on the ceiling, place the monitor directly below). Wait until the

Conn.Status field in the Instrument Telemetry Service window shows Active. Take the monitor

approximately 5 m away from the access point. There should be no walls or other obstacles between the monitor and the access point. The following should apply:

– Observe the

RSSI value should be around -50 ±10 in a 5 m distance from the access point used and the IIT

link should be active, i.e. the contain values. If the and the antenna orientation at both the monitor and the access point (both should be vertical).

– Remove the antenna. The

the connection could be unreliable. The Seeking. If the difference between the significantly lower, check the antenna and the antenna connector for damage and verify that the cable fom the IIT adapter to the antenna connector plate is connected properly.

RSSI (Received Signal Strength Indicator) value for at least 5 - 10 seconds. The

RSSI value above 30

Conn.Status field should be Active and the other fields should

RSSI value is significantly lower, check the distance to the access point

RSSI value should be around -90 ±10. The IIT link may be active but

Conn. Status field may toggle between Inactive and

RSSI values measured with and without antenna is

If this test fails, retry in a different physical area with a different access point. Error Conditions: –The field MAC IIT should show a value unequal to 0000 0000 0000. If it does not, there is a

communication problem between the monitor and the IIT adapter.

– With an incorrect RF Access Code or an incorrect or defective antenna installation, the fields

IP Address,Server IP, Subnet Mask, and RSSI in the Instrument Telemetry Service window will

stay blank. The field

6 Perform the Access Point Controller (APC) test blocks as described in the Philips IntelliVue

Wireless Network Installation and Configuration Guide.

Test Expected test results

IIT Communication Test IIT Communication without

Conn. Status will slowly toggle between Inactive and Seeking.

interference

Short Range Radio (SRR) Performance Test

1 Make sure that the short range radio interface is configured as follows: SRR On and appropriate

channel selected.

2 Assign a wireless remote control to the monitor as described in .

3 Check that you can operate the monitor with the remote control.

3 Testing and Maintenance

Test Expected test results

SRR Performance Test Wireless Remote Control functions

Mounting Integrity Test

Perform the Mounting Integrity Test

– whenever you have removed and reassembled a quick mount – if one or both of the quick mount screws are loose – if there is a clearance between the quick mount and the monitor bottom housing – if the monitor mounting is unstable

Remove the monitor from the mount and disassemble the quick mount. Ensure that the threading of the MX400/450/500/550 is not damaged or separated from the chassis.

If the quick mount is damaged, exchange the quick mount.

Ensure that all quick mount screws are tight (1.3 Nm). Test the quick mount by pressing the quick release button. If it comes back out gradually and regularly, the quick mount is inserted correctly. If it gets stuck, the quick mount is not centered and must be reinserted correctly.

If you notice any damage to the threading of the MX400/450/500/550 chassis, send the MX400/450/ 500/550 in for bench repair.

correctly. Monitor can be operated with Remote Control

Test Expected test results

Mounting Integrity Test All quick mount screws are tight. No

damage to quick mount. No damage to threading of MX400/450/500/550. Quick release button comes back out gradually and regularly.

3 Testing and Maintenance

Reporting of Test Results

Philips recommends all test results are documented in accordance with local laws. Authorized Philips personnel report the test result back to Philips. While hospital personnel (biomedical engineers or technicians) do not need to report results to Philips, Philips recommends that they record and store the test results in accordance with local laws.

The following table lists what to record after completing the tests in this chapter. Record the results in the empty column in the Test and Inspection Matrix.

The following is a guide as to what your documentation should include:

• Identification of the testing body (for example, which company or department carried out the tests).

• Name of the person(s) who performed the tests and the concluding evaluation.

• Identification of the device(s) and accessories being tested (serial number, etc.).

• The actual tests (incl. visual inspections, performance tests, safety and system tests) and measurements required

• Date of testing and of the concluding evaluation.

• A record of the actual values of the test results, and whether these values passed or failed the tests.

• Date and confirmation of the person who performed the tests and evaluation.

The device under test should be marked according to the test result: passed or failed.

Carrying Out and Reporting Tests

Test Report

3 Testing and Maintenance

Testing Organization:

Name of testing person:

Date:

Responsible Organization:

Device Under Test: ID-Number

Product Number: Serial No.:

Accessories:

Measurement Equipment (Manufacturer, Type, Serial No., Calibration Date):

Safety Test Method used

Functional Test (parameters tested):

Mains voltage and frequency used during safety testing:

(Check one of the following three options) Test before putting into service (reference value) Recurrent Test Test after Repair

Test and Inspection Matrix

Test Test or Inspection

to be Performed

Expected Test Results Record the Results (mandatory for

Philips Personnel only)

What to record Actual Results

Visual Inspection

Power On Power on the unit.

Noninvasive Blood Pressure Performance Tests

Temperature Performance Test

Perform Visual Inspection

Does the self-test complete successfully

Perform the Accuracy Test

Performance Leakage Test

Performance Linearity Test

Performance Valve Test

Perform the Temperature Performance Test

Pass or Fail V:P or V:F

If Yes, Power On test is passed PO:P or PO:F

X1 = value displayed by monitor

Difference <= 3mmHg

X2 = leakage test value

X2 < 6 mmHg

X3 = value displayed by monitor

Difference <= 3mmHg

X4 = value < 10 mmHg PN:P/X4 or

X1= 40°C ± 0.2°C or 100°F ±

0.4°F

PN:P/X1 or

PN:F/X1

PN:P/X2 or

PN:F/X2

PN:P/X3 or

PN:F/X3

PN:F/X4

PT: P/X1 or

PT: F/X1

3 Testing and Maintenance

Test Test or Inspection

to be Performed

Expected Test Results Record the Results (mandatory for

Philips Personnel only)

What to record Actual Results

All other performance tests

Perform the remaining parameter

See expected results in test procedures

P: P or

P: F

performance tests, if applicable

Safety (1) Perform Safety Test

(1): Protective Earth Resistance

Safety (2) Perform Safety Test

(2): Equipment Leakage Current -

With mains cable: Maximum impedance (X1): <=300 mOhms

With mains cable: Maximum leakage current (X1):<= 100 μA

S(1):P/X1 or

S(1):F/X1

S(2): P/X1 or

S(2): F/X1

Normal Condition.

Safety (3) Perform Safety Test

(3): Equipment Leakage Current -

With mains cable: Maximum leakage current (X2):<= 300 μA

S(3): P/X2 or

S(3): F/X2

Single Fault Condition (Open Earth)

Safety (4) Perform Safety Test

(4): Applied Part Leakage Current -

Maximum leakage current (X1): <=50 μA (CF)

S(4): P/X1 or

S(4): F/X1

Single Fault Condition, mains on applied part.

System (Sys 1-2)

Perform the system test according to subclause 19.201 of IEC/EN 60601-1-1 or IEC/EN 606011+A1 Ed.3 clause

Equipment Leakage Current:

Sys1 <= 100 μA (Normal Condition)

Sys2 <= 300μA (Single Fault Condition

Sys: PSys1/PSys2

Sys: FSys1/Fsys2

16, if applicable, after forming a system

System (Sys 3)

Perform the system test according to subclause 19.201 of IEC/EN 60601-1-1 or IEC/EN 606011+A1 Ed.3 clause 16, if applicable,

Protective Earth Leakage Current if medical electrical system components are connected to the same Multiple Portable Socket Outlet:

Sys3 <= 300 μA

Sys: PSys3

Sys: FSys3

after forming a system

Key: P = Pass, F = Fail, X or Sys = test value to be recorded, * = Record the worst-case results and the associated switch positions (e.g. normal/reverse polarity)

NOTE

All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.

Evaluation

Safety and Functional Test passed

Repair required at a later date, safety and functional test passed

Device must be taken out of operation until repair and passed tests

Device failed and must be taken out of operation.

Notes:

Next Recurrent Test:

Name:____________________________________________________

Date/Signature:_____________________________________________

3 Testing and Maintenance

Yes No

Evaluation of Test Results

The evaluation of the test results must be performed by appropriately trained personnel with sufficient product, safety testing and application knowledge.

If any test results are between 90% and 100% of the respective expected result, the previously measured reference values must be taken into consideration for the assessment of the electrical safety of the device under test. If no reference values are available, you should consider shorter intervals between upcoming recurrent tests.

NOTE

If any single test fails, testing must be discontinued immediately and the device under test must be repaired or labeled as defective. Be sure to inform the user about the test failure in writing.

Other Regular Tests

The care and cleaning requirements that apply to the monitor and its accessories are described in the Instructions for Use. This section `details periodic maintenance procedures recommended for the monitor and its accessories.

Touchscreen Calibration

To access the touchscreen calibration screen:

1 Enter service mode

2 Select Main Setup

3 Select Hardware

3 Testing and Maintenance

Select Touch Calibration

Touchscreen Calibration Screen

Make sure you complete the calibration procedure without powering off the monitor mid-way. If the monitor is powered off after the first point is touched, the touch panel will be deactivated until the touch calibration is performed again.

If the touchscreen is accidentally mis-calibrated by selecting the wrong spot, you must use another input device to re-enter calibration mode. If you have the Support Tool, you can initiate a touch calibration from there.

Please refer to the documentation shipped with your selected display for further details on touchscreen calibration procedures.

NOTE

If a touchscreen calibration is started on a multiple display system, the calibration is started for all displays at the same time.

Disabling/Enabling Touch Operation

To temporarily disable touchscreen operation of the monitor, press and hold the Main Screen key. A padlock symbol will appear on the key. Press and hold the touchscreen operation.

Main Screen key again to re-enable

Printer Test Report

To verify your printer configuration you may want to print a test report.

To print a test report select

Your test report should look like this:

Main Setup -> Reports -> Setup Printers -> Print Test Rep.

3 Testing and Maintenance

Battery Handling, Maintenance and Good Practices

This section provides some information on how to handle and maintain the battery in order to get the best usage from it. Additionally, some good working practices are also given regarding the correct disposal of the batteries.

Battery Care

Battery care begins when you receive a new battery and continues throughout the life of the battery. The table below lists battery care activities and when they should be performed.

Activity When to Perform

Perform a visual inspection Before inserting a battery into the

Charge the battery Upon receipt, after use, or if a low

Condition the battery When the "battery requires

Store the battery in a state of charge in the range of 40% to 50%

monitor

battery state is indicated. To optimize performance, a fully (or almost fully) discharged battery should be charged as soon as possible.

maintenance" symbol appears

When not in use for an extended period of time

Refer to your monitor's Instructions for Use for details on how to perform battery care activities, including charging and conditioning. We recommend using the Philips Smart Battery Conditioner LG 1480 (865432)

3 Testing and Maintenance

Handling Precautions

Lithium ion batteries store a large amount of energy in a small package.Use caution when handling the batteries; misuse or abuse could cause bodily injury and/or property damage.

• Do not short circuit - take care that the terminals do not contact metal or other conductive materials during transport and storage

• Do not crush, drop or puncture - mechanical abuse can lead to internal damage and internal short circuits which may not be visible externally

• Do not apply reverse polarity

• Do not expose batteries to liquids

• Do not incinerate batteries or expose them to temperatures above 60°C (140°F)

• Do not attempt to disassemble a battery.

If a battery has been dropped or banged against a hard surface, whether damage is visible externally or not:

• discontinue use

• dispose of the battery in accordance with the disposal instructions

If a battery shows damage or signs of leakage, replace it immediately. Do not use a faulty battery in the monitor.

Storage

When storing batteries, make sure that the battery terminals do not come into contact with metallic objects, or other conductive materials.

If batteries are stored for an extended period of time, they should be stored in a cool place, ideally at 15°C (60°F), with a state of charge of 20% to 40%. Storing batteries in a cool place slows the aging process.

The batteries should not be stored at a temperature outside the range of -20°C (-4°F) to 60°C (140°F).

Do not store batteries in direct sunlight.

Stored batteries should be partially charged to 20% to 40% of their capacity every 6 months. They should be charged to full capacity prior to use.

NOTE

Storing batteries at temperatures above 38°C (100°F) for extended periods of time could significantly reduce the batteries’ life expectancy.

Battery Lifetime Management

The lifetime of a Lithium Ion battery depends on the frequency and duration of use. When properly cared for, the useful life is approximately 3 years or 500 charge-discharge cycles, whichever comes first. In addition, experience indicates that the incidence of failure may increase with battery service life due to the accumulated stresses of daily use. We therefore strongly recommend that lithium ion batteries be replaced after 3 years or 500 charge-discharge cycles.

The age of a lithium ion battery begins at the date of manufacture. To see the date of manufacture and the number of charge-discharge cycles, select the battery symbol on the patient monitor screen.

The date of manufacture and the number of charge-discharge cycles are listed with other battery data on the screen.

WARNING

The risk of battery failure increases with age, when a battery remains in use longer than 3 years or 500 charge-discharge cycles. Such failures can result in overheating that in rare cases can cause the battery to ignite or explode.

Disposal

Batteries should be disposed of in an environmentally-responsible manner. Consult the hospital administrator or your local Philips representative for local arrangements.

Discharge the batteries and insulate the terminals with tape before disposal. Dispose of used batteries promptly and in accordance with local recycling regulations.

About the Battery

The rechargeable Lithium-Ion batteries used in the monitor are regarded as Smart batteries because they have built-in circuitry. (This circuitry communicates battery status information to the monitor.)

Actual current/voltage: depends on smart battery request and monitor configuration. The approximate charging time is 3 hours with the monitor switched off and up to 5 hours during monitor operation, depending on the monitor configuration.

3 Testing and Maintenance

NOTE

Batteries will discharge within about 20 days if they are stored inside the monitor without AC power connection.

Checking the Battery Status

When the Monitor is connected to the AC power supply, the battery charges automatically. The battery can be charged remotely from the Monitor by using the battery charger. Use only the 865432 Smart battery conditioner.

Battery status (level of charge) is indicated in several ways:

• LED on the front panel of the Monitor.

• Battery gauge.

• Display of battery time below gauge.

• Battery status window.

• INOP messages.

The AC Power LED is only on when the power cord is connected and AC power is available to the Monitor. In this case, the battery can be either charging or fully charged.

The battery LED can be green, yellow, or red depending on the following conditions:

Battery LED Colors If the monitor is connected to

AC power, this means

If the monitor is running on battery power, this means

Green

battery full (≥90%)

3 Testing and Maintenance

Battery LED Colors If the monitor is connected to

AC power, this means

Yellow

Red, flashing

Red, flashes intermittently

Red, flashing when on/ standby switch is pressed

1 indicated by malfunction symbol and INOP 2 for further details see Troubleshooting section

battery charging (battery power < 90%)

battery or charger malfunction1,2 battery or charger malfunction1,2

Battery Status on the Main Screen

Battery status information can be configured to display permanently on all Screens. It shows the status of the battery and the battery power and battery time remaining. The battery time is only displayed when the monitor is not running on AC power. Note that the battery status information may take a few minutes after the monitor is switched on to stabilize and show correct values.

If the monitor is running on battery power, this means

≤ 10 minutes power remaining

not enough battery power left to power monitor

Battery power gauge:

This shows the remaining battery power. It is divided into sections, each representing 20% of the total power. If three and a half sections are shaded, as in this example, this indicates that 70% battery power remains. If no battery is detected, the battery gauge is greyed out.

Battery malfunction symbols:

If a problem is detected with the battery, these symbols are displayed. They may be accompanied by an INOP message or by a battery status message in the monitor information line (if battery window is open) providing more details.

Battery Status Symbols

Battery requires maintenance

Battery is empty

Battery not charging as the temperature is above or below the specified range

Charging stopped to protect the battery

Battery Malfunction Symbols

Incompatible Battery

3 Testing and Maintenance

Battery Malfunction

Battery temperature too high

Battery has no power left

Explanations of Battery Status and Malfunction Symbols:

Battery requires maintenance: The battery requires conditioning. Refer to “Conditioning Batteries” for details.

Battery is empty: The capacity of the battery is ≤10 min. Recharge the battery as soon as possible.

Temperature outside specified range: The charging of the battery is stopped if the temperature is below 15°C

or above 50°C in order to protect the battery. Charging is resumed as soon as the temperature is within this range.

Incompatible Battery: The inserted battery is checked for certain battery internal parameters. If these are not correct, the incompatible battery symbol is displayed. Please use only M4605A batteries with the MX400/450/500/550 monitor. Note that the incompatible battery symbol may also appear if there is a communication problem between the battery and the Standard System Interface board.

Battery Malfunction:Communication between the battery and the Standard System Interface board could not be established or battery internal data indicates malfunction. Please see the “Troubleshooting” section for remedies.

Battery Temperature too high: This symbol is displayed if the battery temperature goes above 65°C. In addition the INOP message CHECK BATT TEMP is displayed. If the battery temperature increases further above 70°C the batteries will switch off for safety reasons. Allow the battery to cool down to avoid the monitor switching off.

Battery has no power left: If the monitor is not running on AC power: battery will switch off power delivery at any moment - in this case recharge the battery immediately - or, if the monitor is running on AC power, the battery is in deep discharge and requires pre-charging to restore communication. To avoid this condition charge batteries to 50% for storage. Note that the battery malfunction INOP will eventually be issued if the pre-charging does not restore battery communication within about 4 minutes.

3 Testing and Maintenance

Battery Status Window

♦ To access the Battery Status window and its associated pop-up keys, select the battery status

information on the Screen, or select

State of Charge tells you the state of charge of the battery.

Time To Empty tells you approximately how long you can continue to use the monitor with this battery.

Note that this time fluctuates depending on the system load (how many measurements and recordings you carry out), the age of the battery, and the remaining capacity of the battery. The time indication appears after AC has been unplugged for about 10 seconds (after finishing calculation of the Time to Empty)

Main Setup -> Battery.

Time To Full is shown in place of Time To Empty if the monitor is connected to AC power, and tells you

how much time is left until the battery is charged to 90%. Please allow indication to stabilize for 3 to 5 minutes after beginning the charging cycle. If the battery is charged over 90% displayed until they are charged to 100%. Then

Documenting Battery Status

To print all battery information in the Battery Status window,

1 Select the battery status information on the Screen or select Main Setup -> Battery to open the

Battery Status window

2 Select the Record Status pop-up key to print the information on a recorder

Select the

Print Status pop-up key to print the information on a connected printer.

Conditioning a Battery

What is Battery Conditioning?

Battery conditioning recalibrates the battery to ensure that it has accurate information on the actual battery capacity.

Why is Battery Conditioning Necessary?

The capacity of a battery decreases gradually over the lifetime of a battery. Each time a battery is charged its capacity decreases slightly. Therefore, the operating time of a monitor running on batteries also decreases with each charge cycle.

Battery Full (>90%) is

Batt Fully Charged is displayed.

100

Philips IntelliVue MX User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1Introduction

Who Should Use This Guide

How to Use This Guide

Abbreviations

Responsibility of the Manufacturer

Passwords

Safety Information

Warnings and Cautions

Electrical Hazards and Interference

Use Environment

Alarms

Accessories

Maintenance, Repair and Care

2Theory of Operation

Integrated Monitor Theory of Operation

System Boundaries

Hardware Building Blocks

IntelliVue MX400/450/500/550

Compatible Devices

Power Supply

Main Board

I/O Boards

Data Flow

Data Acquisition

Data Provider System Service

Persistent Data Storage System Service

Display and User Interface Service

Data Output

Monitor Applications

Internal LAN (Measurement Link)

Philips Clinical Network

Ambient Light Sensor

Microstream CO2

How does the Support Tool Work with the Monitor

Monitor Software Block Diagram

Block Diagram Legend

3Testing and Maintenance

Introduction

Terminology and Definitions

Recommended Frequency

When to Perform Tests

Testing Sequence

Visual Inspection

Before Each Use

After Each Service, Maintenance or Repair Event

Power On Test

Safety Tests

Warnings, Cautions, and Safety Precautions

Safety Test Procedures

Hints for Correct Performance of Safety Tests

Guideline for Performance of Safety Tests

Safety Test Adapter Cable - Schematics

SpO2 (MP2/X2, MP5, M3001A & M1020B #A01, #A02, #A03, #A04)

Invasive Pressure

Invasive Pressure (M1006B #C01)

Temperature

CO2 (MP5, M3014A)

Cardiac Output

IntelliBridge

ScVO2 (M1011A)

TcG10

Electrical Safety Testing

S(1): Protective Earth Resistance Test

S(2): Equipment Leakage Current Test - Normal Condition

S(3): Equipment Leakage Current Test - Single Fault Condition

S(4): Applied Part Leakage Current - Mains on Applied Part

Reference: Allowable Values for IEC 60601-1:1998 and UL 60601-1 Measurements

Insulation Resistance

System Test

What is a Medical Electrical System?

General Requirements for a System

System Example

System Installation Requirements

Required Protective Measures at System Installation

Case 1: Medical Device Combined with Medical Device

Case 2: Medical Device Combined with a Non-Medical Device