M3 Vital Sign Monitor User Manual Ver 1.7 April 2013

Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure.

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Table of Contents Chapter 1 Intended Use and Safety Guidance ...1 1.1 Intended Use...1 1.2 Safety Guidance ...1 1.2.1 Environment...1 1.2.2 Power Source Requirements ...1 1.2.3 Grounding the Monitor ...1 1.2.4 Equipotential Grounding...2 1.2.5 Condensation...2 1.2.6 Safety Precautions...2 1.2.7 Explanation of Symbols on the Monitor ...5 Chapter 2 Installation of Monitor ...7 2.1 Opening the Package and Checking...7 2.2 Connecting the Power Cable...7 2.3 Powering on the Monitor ...7 2.4 Connecting Sensor to Patient ...8 2.5 Checking the Recorder...8 Chapter 3 Introduction...9 3.1 General Information ...9 3.2 Screen Display ...10 3.2.1 General Display Mode ...10 3.2.2 Double-Parameter Mode ...15 3.2.3 Single Parameter Mode ...17 3.3 Button Functions ...19 3.4 Interfaces ...21 3.5 Built-in Rechargeable Battery...25 3.5.1 Battery Safety Information...25 3.5.2 Battery Status on the Main Screen ...25 3.5.3 Checking Battery Performance ...26 3.5.4 Replacing the Battery...26 III

3.5.5 Recycling the Battery...26 3.5.6 Maintaining the Battery...26 Chapter 4 System Menu ...27 4.1 Patient Setup...27 4.2 Default Setup...28 4.3 System Setup...28 4.4 Selection...29 4.5 Deleting Data ...34 4.6 Version...34 4.7 Time Setup ...34 4.8 NIBP Setup...35 4.9 TEMP Setup ...35 4.10 Alarm Setup...35 4.11 Maintain ...35 4.12 Data Storing ...41 4.13 Sleep Mode...42 Chapter 5 Alarm...44 5.1 Alarm Modes...44 5.1.1 Alarm Level...44 5.1.2 Alarm Modes...44 5.1.3 Alarm Setup...46 5.2 Alarm Cause ...47 5.3 Silence ...47 5.4 Parameter Alarm...48 5.5 When an Alarm Occurs ...48 5.6 Testing Alarms...49 Chapter 6 Trend and Recording ...50 6.1 General Information on Recording ...50 6.2 Recorder Operations...50 Chapter 7 Maintenance/ Cleaning...52

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7.1 System Check...52 7.2 General Cleaning...52 7.3 Disinfection ...53 7.4 Replacement of Fuse ...53 Chapter 8 SpO2 Monitoring (Optional) ...54 8.1 What is SpO2 Monitoring...54 8.2 Precautions during SpO2/Pulse Monitoring ...55 8.3 Monitoring Procedure ...55 8.4 Limitations of Measurement ...56 8.5 Alarm...56 8.5.1 Adjutable Range of Alarm Limits ...56 8.5.2 Alarm Information and Prompts...57 8.6 Maintenance and Cleaning...58 Chapter 9 NIBP Monitoring (Optional) ...59 9.1 Overview ...59 9.2 NIBP Safety Information ...59 9.3 NIBP Monitoring...60 9.4 NIBP Setup...63 9.5 Alarm...64 9.5.1 Adjutable Range of Alarm Limits ...64 9.5.2 Alarm Information and Prompts...65 9.6 Maintenance and Cleaning...67 Chapter 10 TEMP Monitoring (Optional) ...68 10.1 TEMP Monitoring with T2 Module ...68 10.1.1 Introduction ...68 10.1.2 Measuring Procedure ...69 10.1.3 TEMP Setup for T2 Module...70 10.1.4 Alarm...70 10.1.5 Care and Cleaning ...72 10.2 TEMP Monitoring with TH Module ...73

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10.2.1 Introduction ...73 10.2.2 Measuring Procedure ...74 10.2.3 Alarm...75 10.2.4 Replacing the Battery...76 10.2.5 Maintenance ...77 10.3 TEMP Monitoring with F3000 Module ...78 10.3.1 General Information ...78 10.3.2 Safety Information ...78 10.3.3 Probe Covers -Applying & Removing ...79 10.3.4 Changing Isolation Chambers and Probes ...79 10.3.5 Measuring Mode ...80 10.3.6 Measuring Procedure ...81 10.3.7 TEMP Setup for F3000 Module...83 10.3.8 Alarm...83 Chapter 11 Other Functions...87 11.1 Nurse Call...87 11.2 Wireless Network* ...87 Chapter 12 Accessories and Ordering Information ...88 Chapter 13 Warranty and Service...91 13.1 Warranty ...91 13.2 Contact Information ...91 AppendixⅠSpecifications ...92 A1.1 Classification...92 A1.2 Specifications ...92 A1.2.1 Size and Weight...92 A1.2.2 Environment ...92 A1.2.3 Display ...93 A1.2.4 Battery ...94 A1.2.5 Recorder ...94 A1.2.6 Data Storage ...94

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A1.2.7 NIBP (Optional) ...95 A1.2.8 SpO2 (Optional)...96 A1.2.9 TEMP (Optional)...97 A1.2.10 Wirless Network...99 AppendixⅡ EMC Information - Guidance and Manufacture’s Declaration ...100 A2.1 Electromagnetic Emissions - For all EQUIPMENT and SYSTEMS ...100 A2.2 Electromagnetic Immunity - For all EQUIPMENT and SYSTEMS ...101 A2.3 Electromagnetic Immunity - For EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING...103 A2.4 Recommended Separation Distances ...104

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M3 Vital Signs Monitor User Manual

Intended Use and Safety Guidance

Chapter 1 Intended Use and Safety Guidance 1.1 Intended Use The monitor is intended to be used by qualified physicians or personnel professionally trained and it is for monitoring adults, pediatrics and neonates in hospital environments. This monitor is used to monitor vital signals for patients and is suitable for use in hospital environments including out-patient department, wards and NICU. Monitored paramenters include: NIBP, SpO2, pulse rate, Quick TEMP/Infrared TEMP.

1.2 Safety Guidance 1.2.1 Environment Follow the instructions below to ensure completely safe electrical installation. The environment where the monitor will be used should be reasonably free from vibration, dust, corrosive or explosive gases, extremes of temperature, humidity, and so on. For a cabinet mounted installation, allow sufficient room at the front for operation and sufficient room at the rear for servicing with the cabinet access door open. The monitor operates within specifications at ambient temperatures between +5℃~+40℃. Ambient temperatures that exceed these limits could affect the accuracy of the instrument and cause damage to the modules and circuits. Allow at least 2 inches (5cm) clearance around the instrument for proper air circulation.

1.2.2 Power Source Requirements Refer to AppendixⅠ.

1.2.3 Grounding the Monitor To protect the patient and hospital personnel, the cabinet of the monitor must be grounded. Accordingly, the monitor is equipped with a 3-wire cable which grounds the instrument to the power line ground (protective earth) when plugged into an appropriate 3-wire receptacle. If a 3-wire receptacle is not available, consult the hospital electrician. Connect the grounding wire to the equipotential grounding terminal on the mains system. If it is not evident from the instrument specifications whether a particular instrument combination is hazardous or not, for example due to summation of leakage currents, the user should consult the manufacturers concerned or an expert in the field, to ensure that the necessary safety of all instruments concerned will not be impaired by the proposed combination.

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Intended Use and Safety Guidance

1.2.4 Equipotential Grounding Protection class 1 instruments are already included in the protective grounding (protective earth) system of the room by way of grounding contacts in the power plug. For internal examinations on the heart or the brain, the Monitor must have a separate connection to the equipotential grounding system. One end of the equipotential grounding cable (potential equalization conductor) is connected to the equipotential grounding terminal on the rear panel of the instrument and the other end to one point of the equipotential grounding system. The equipotential grounding system assumes the safety function of the protective grounding conductor if ever there is a break in the protective grounding system. Examinations in or on the heart (or brain) should only be carried out in medically used rooms incorporating an equipotential grounding system. Check each time before use that the instrument is in perfect working order. The cable connecting the patient to the instrument must be free of electrolyte. WARNING If the protective grounding (protective earth) system is doubtful, the monitor must be supplied by internal power only.

1.2.5 Condensation Make sure that during operation, the instrument is free of condensation. Condensation can form when equipment is moved from one building to another, thus being exposed to moisture and differences in temperature.

1.2.6 Safety Precautions WARNING and CAUTION messages must be observed. To avoid the possibility of injury, observe the following precautions during the operation of the instrument. WARNING 1 2

3 4 5

If liquid is inadvertently splashed on the equipment or its accessories, it may enter the conduit or inside the monitor. At this moment, contact local Customer Service Center. The monitor is intended to be used by qualified physicians or personnel professionally trained. And they should be familiar with the contents of this user manual before operation. Only qualified service engineers can install this equipment. And only service engineers authorized by EDAN can open the shell. EXPLOSION HAZARD-Do not use the monitor in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur. SHOCK HAZARD- the power receptacle must be a three-wire grounded outlet. A hospital grade outlet is required. Never adapt the three-prong plug from the monitor to fit a two-slot outlet.

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M3 Vital Signs Monitor User Manual

Intended Use and Safety Guidance

WARNING 6

Do not attempt to connect or disconnect a power cord with wet hands. Make certain that your hands are clean and dry before touching a power cord.

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Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards. Furthermore all configurations shall comply with the valid version of the system standard IEC/EN60601-1-1. Everybody who connects additional equipment to the signal input connector or signal output connector configures a medical system, and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC/EN60601-1-1. If in doubt, consult our technical service department or your local distributor.

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The simultaneous use of cardiac pacemaker and other patient-connected equipment may cause safety hazard. Use the battery only in this monitor. Do not connect battery directly to an electric outlet or cigarette lighter charger.

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10 Do not unplug the battery when monitoring. 11 Make sure the monitor is used in the appointed range of voltage so that the effect of power supply can be ignored. 12 Do not solder the leading wire and the battery terminal directly. 13 If liquid leaking from the battery gets into your eyes, onto your skin or clothes, do not rub your eyes. Wash them well with clean water and go to see a doctor immediately. 14 Always keep the battery away from fire. 15 Stop using the battery if abnormal heat, odor, discoloration, deformation or abnormal condition is detected during use, charge, or storage. Keep it away from the monitor. 16 Do not use a battery with serious scar or deformation. 17 Only patient cable and other accessories supplied by EDAN can be used. Or else, the performance and electric shock protection can not be guaranteed, and the patient may be injured. 18 The user should check the monitor and accessories before use. 19 Please set the alarm according to the individual status of patient to avoid delaying treatment. Ensure there will be alarm audio prompt when alarming. 20 Devices connecting with monitor should be equipotential. 21 The monitor is equipped with a wireless AP via network interface to receive RF electromagnetic energy. Therefore, any other equipment complies with CISPR radiation requirements may also interfere with the wireless communication and make it interrupted. 22 Wireless LAN equipment contains an intentional RF radiator that has the potential of interfering with other medical equipment, including patient implanted devices.

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Intended Use and Safety Guidance

WARNING 23 When the monitor and electrosurgical device are used together, the user (physician or nurse) should guarantee the safety of patient. 24 Please disinfect timely to prevent cross infection between patients. 25 This monitor is not a device for treatment purposes. 26 Only NIBP and SpO2 applied parts of the monitor are defibrillation-proof. When a defibrillator is applied, keep other accessories away from the patient. Otherwise, it may result in damaging the monitor or harming the patient. 27 Do not touch the patient, bed or instrument during defibrillation. 28 During monitoring, if the power supply is off and there is no battery for standby, the monitor will be off, and only the patient information and alarm settings can be saved. After reconnecting the power supply, the user should turn on the monitor for monitoring.

CAUTION 1 2

Federal law (U.S.) restricts this device to sale by or on the order of a physician. Electromagnetic Interference – Ensure the environment in which the monitor is installed is not subject to any sources of strong electromagnetic interference, such as radio transmitters, mobile telephones, etc. 3 The monitor is designed for continuous operation and is “ordinary” (i.e. not drip or splash-proof). 4 Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine, dust area, high-temperature and humid environment. 5 Do not immerse transducers in liquid. When using solutions, use sterile wipes to avoid pouring fluids directly on the transducer. 6 The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. 7 Remove a battery whose life cycle has expired from the monitor immediately. 8 Avoid liquid splash and excessive temperature. The temperature must be kept between +5℃ and +40℃ while working. And it should be kept between -20℃ and +55℃ during transportation and storage. 9 Before use, the equipment, patient cable and sensor should be checked. Replacement should be taken if there is any evident defectiveness or aging symptom which may impair the safety or performance. 10 If the monitor gets damp, put it in dry circumstance to dry it until it can work normally. If liquid pours on the monitor, please contact the service personnel authorized by EDAN.

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Intended Use and Safety Guidance

CAUTION 11 Setting alarm limits to extreme values can render the alarm system useless. 12 A potential hazard can exist if different alarm presets are used for the same or similar equipment in any single area.

NOTE: 1 Position the device in a location where the operator can easily see the screen and access the operating controls. 2

The monitor can only be used on one patient at a time.

3

The equipment is calibrated to display functional oxygen saturation.

4

This equipment is not intended for family usage.

5

If the device is discolored or damaged, then discontinue use of the device.

6

The pictures and interfaces in this manual are for reference only.

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Regular preventive maintenance should be carried out every two years. You are responsible for any requirements specific to your country.

1.2.7 Explanation of Symbols on the Monitor This symbol indicates that the equipment is IEC/EN60601-1 Type CF equipment. The unit displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock. It is not suitable for use during defibrillation. This symbol indicates that the instrument is IEC/EN60601-1 Type BF equipment. The unit displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock, and is suitable for use during defibrillation This symbol indicates that the instrument is IEC/EN60601-1 Type BF equipment. The unit displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock. It is not suitable for use during defibrillation. Caution

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M3 Vital Signs Monitor User Manual

Intended Use and Safety Guidance

Consult Instructions for Use

Equipotentiality Stand-by. It designates that the switch or switch position which one part of the monitor has been switched on, while the monitor is at the status of stand-by.

Serial number

The symbol indicates that the device complies with the European Council Directive 93/42/EEC concerning medical devices. Authorized representative in the European community

Date of manufacture Manufacturer

P/N

Part Number Recycle The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life.

Rx only

Federal (US) law restricts this device to sale by or on the order of a physician.

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M3 Vital Signs Monitor User Manual

Installation of Monitor

Chapter 2 Installation of Monitor NOTE: To ensure that the monitor works properly, please read Chapter1 Intended Use and Safety Guidance, and follow the steps before using the monitor.

2.1 Opening the Package and Checking Visually examine the package prior to unpacking. If any signs of mishandling or damage are detected, contact the carrier to claim for damage. Open the package and take out the monitor and accessories carefully. Keep the package for possible future transportation or storage. Check the components according to the packing list. ‹ Check for any mechanical damage. ‹ Check all the cables, modules and accessories. If there is any problem, contact the manufacturer or local representative immediately.

2.2 Connecting the Power Cable Connection procedure of the AC power line: ‹ Make sure the AC power supply complies with following specification: 100V–240V ~, 50Hz/60Hz. ‹ Apply the power line provided with the monitor. Plug the power line to input interface of the monitor. Connect the other end of the power line to a grounded power output. NOTE: Connect the power line to the jack special for hospital usage. ‹ Connect to the ground line if necessary. Refer to section1.2 Safety Guidance for details. NOTE: When the battery configuration is provided, after the monitor is transported or stored, the battery must be recharged. Switch on AC power supply can recharge the battery no matter if the monitor is powered on.

2.3 Powering on the Monitor Press the ON/OFF button on front panel to power on the monitor, LOGO information will be displayed on the screen. WARNING Do not use it on any patient if any sign of damage is detected, or the monitor displays some error messages. Contact biomedical engineer in the hospital or Customer Service Center immediately.

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Installation of Monitor

NOTE: 1 Check all the functions of the monitor and make sure that the monitor is in good condition. 2 If rechargeable batteries are provided, recharge them after using the monitor every time to ensure the electric power is enough. 3 The interval between double presses of ON/OFF button should be more than 1 second.

2.4 Connecting Sensor to Patient Connect all the necessary patient sensors between the monitor and the patient. NOTE: For information on correct connection, refer to related chapters.

2.5 Checking the Recorder If your monitor is equipped with a recorder, open the recorder door to check if paper is properly installed in the slot. If no paper is present, refer to Chapter 6 Trend and Recording for details.

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M3 Vital Signs Monitor User Manual

Introduction

Chapter 3 Introduction 3.1 General Information The monitor integrates the function of parameter measurement modules, display, recording and output to compose a compact, portable device. Its built-in replaceable battery provides convenience for patient movement. On the LCD display screen, SpO2 waveform and all the monitoring parameters can be displayed clearly. The monitor is a user-friendly device with operations conducted by a few buttons on the front panel. Refer to section 3.3 Button Functions for more details.

Figure 3-1 M3 Vital Signs Monitor

M3 Vital Signs Monitor can monitor: SpO2: Arterial Oxygen Saturation (SpO2); Pulse Rate (PR); SpO2 PLETH (Plethysmogram); NIBP:

Systolic Pressure (SYS); Diastolic Pressure (DIA); Mean Pressure (MAP); Pulse Rate (PR).

TEMP: Temperature (TEMP) -9-

M3 Vital Signs Monitor User Manual

Introduction

3.2 Screen Display The monitor is equipped with LCD. The patient parameters, waveforms, alarm messages, patient ID, time, monitor status and other information can be reflected from the screen. If the monitor is outfitted with the modules SpO2, NIBP and TEMP, the three parameters SpO2, NIBP and TEMP are onscreen in the general display mode. If the monitor is configured to the double-parameter measuring function as NIBP+SpO2 or NIBP+TEMP, double parameters will be displayed onscreen. Also, the monitor can be configured to single parameter mode with SpO2 measuring only or NIBP measuring only. In SpO2 only or NIBP only measuring mode, the single parameter of SpO2 or NIBP is displayed. The configuration is preset by the manufacturer; it can not be changed by the user.

3.2.1 General Display Mode The screen is divided into three areas: 1 Parameter area ① 2 Waveform/Trend list/Alarm list area ② 3 Information area ③ ④ ④

①

②

③ Figure 3-2 Main display with waveform

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M3 Vital Signs Monitor User Manual

Introduction

The Waveform area can display parameter trend list or alarm list. It displays as follows:

②

Figure 3-3 Main display with alarm list

The display on the screen can be changed to a trend graph as follows:

Figure 3-4 Display trend graph - 11 -

M3 Vital Signs Monitor User Manual

Introduction

The icons on the interface and their meanings are as follows: Battery status indicator Connected to mains power supply Network connection indicator Network connection off Medium/Low alarm High alarm icon Audio system off Alarm silenced Parameter alarm off

Patient type: ADU

Patient type: PED Patient type: NEO NIBP manual mode NIBP interval mode NIBP continual mode Heart beat

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M3 Vital Signs Monitor User Manual

Introduction

Measuring oral TEMP in ADU mode

Measuring axillary TEMP in ADU mode

Measuring rectal TEMP in ADU mode Measuring oral TEMP in PED mode Measuring axillary TEMP in PED mode

For device with the T2 or F3000 TEMP module only.

Measuring rectal TEMP in PED mode Measuring TEMP Measuring value of TEMP is above the upper alarm limit. (Only for Predictive Mode) Measuring value of TEMP is below the lower alarm limit. (Only for Predictive Mode) For device with the Infrared Ear Temperature module only.

Measuring ear TEMP

ID 09：00：43

Current patient ID Current time

Parameter Area ( ①) Parameter area is on the right of Waveform area, and parameters are displayed: SpO2: ⎯ SpO2 (Unit: %) ⎯ PR (Pulse Rate, Unit: BPM). NIBP: ⎯ SYS, DIA, MAP (Unit: mmHg or kPa) ⎯ Pulse Rate (Pulse Rate, Unit: BPM) - 13 -