User Manual
88 Pages
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About this Manual P/N: 01.54.112593-11 Release Date: June 2010 © Copyright EDAN INSTRUMENTS, INC. 2010. All rights reserved.
Statement This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable. EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages. Materials protected by the copyright law, including but not limited to confidential information such as technical information and patent information are contained in this manual, the user shall not disclose such information to any irrelevant third party. The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use any of the intellectual properties of EDAN. EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety, reliability and performance of the equipment if: Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by EDAN, and The electrical installation of the relevant room complies with national standards, and The instrument is used in accordance with the instructions for use. Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other information to help qualified technician to maintain and repair some parts, which EDAN may define as user serviceable.
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 I
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 Chapter 3 Introduction......................................................................................................................9 3.1 General Information ...............................................................................................................9 3.2 Screen Display .....................................................................................................................10 3.2.1 All Parameters Display..............................................................................................10 3.2.2 Optional Displays......................................................................................................15 3.3 Button Functions ..................................................................................................................17 3.4 Interfaces ..............................................................................................................................19 3.5 Built-in Rechargeable Battery..............................................................................................21 Chapter 4 System Menu ..................................................................................................................23 4.1 Patient Setup.........................................................................................................................23 4.2 Alarm Setup..........................................................................................................................24 4.3 System Setup........................................................................................................................24 4.3.1 General Setup ............................................................................................................25 4.3.2 General Alarm Setup .................................................................................................25 4.3.3 Time & Date Setup....................................................................................................25 4.3.4 Default Configuration ...............................................................................................26 4.4 NIBP Setup...........................................................................................................................27 4.5 SpO2 Setup ...........................................................................................................................27 III
4.6 TEMP Setup .........................................................................................................................28 4.7 Maintenance .........................................................................................................................28 4.8 Data Management ................................................................................................................30 4.9 Standby Mode ......................................................................................................................30 Chapter 5 Alarm...............................................................................................................................32 5.1 Alarm Modes........................................................................................................................32 5.1.1 Alarm Level...............................................................................................................32 5.1.2 Alarm Modes.............................................................................................................32 5.1.3 Alarm Setup...............................................................................................................34 5.2 Alarm Cause .........................................................................................................................34 5.3 Silence ..................................................................................................................................35 5.4 Parameter Alarm...................................................................................................................35 5.5 When an Alarm Occurs ........................................................................................................35 Chapter 6 Trend ...............................................................................................................................36 6.1 Trend List .............................................................................................................................36 6.2 Trend Graph .........................................................................................................................37 Chapter 7 Maintenance and Cleaning............................................................................................39 7.1 System Check.......................................................................................................................39 7.2 General Cleaning..................................................................................................................39 7.3 Sterilization ..........................................................................................................................41 7.4 Disinfection ..........................................................................................................................41 7.5 Replacement of Fuse ............................................................................................................42 7.6 Cleaning Battery and Battery Compartment Cover .............................................................42 Chapter 8 SpO2 Monitoring (Optional) .........................................................................................43 8.1 What is SpO2 Monitoring.....................................................................................................43 8.2 Precautions During SpO2/PR Monitoring ............................................................................44 8.3 Monitoring Procedure ..........................................................................................................45 8.4 Limitations of Measurement ................................................................................................45 8.5 SpO2 Setup Menu.................................................................................................................46 8.5.1 SpO2 Setup ................................................................................................................46 8.5.2 Alarm Setup Menu ....................................................................................................46 8.6 Alarm Description ................................................................................................................47 8.7 Maintenance and Cleaning...................................................................................................49 Chapter 9 NIBP Monitoring (Optional) .........................................................................................50 9.1 Introduction ..........................................................................................................................50
IV
9.2 NIBP Monitoring..................................................................................................................51 9.3 NIBP Setup Menu ................................................................................................................55 9.3.1 NIBP Setup................................................................................................................55 9.3.2 NIBP Alarm Setup.....................................................................................................57 9.4 NIBP Alarm Message and Prompt Message ........................................................................59 9.5 Maintenance and Cleaning...................................................................................................61 Chapter 10 TEMP Monitoring (Optional) .....................................................................................63 10.1 TEMP Monitoring ..............................................................................................................63 10.2 Measuring Procedure .........................................................................................................64 10.3 TEMP Setup Menu.............................................................................................................65 10.3.1 TEMP Setup ............................................................................................................65 10.3.2 TEMP Alarm Setup .................................................................................................65 10.4 TEMP Alarm Message .......................................................................................................66 10.5 Care and Cleaning ..............................................................................................................68 Chapter 11 Accessories and Ordering Information ......................................................................69 Chapter 12 Warranty and Service Policy ......................................................................................72 12.1 Warranty .............................................................................................................................72 12.2 Service Policy.....................................................................................................................72 AppendixⅠSpecification .................................................................................................................73 A1.1 Classification.....................................................................................................................73 A1.2 Specifications ....................................................................................................................73 A1.2.1 Size and Weight......................................................................................................73 A1.2.2 Environment ...........................................................................................................73 A1.2.3 Display ...................................................................................................................74 A1.2.4 Battery ....................................................................................................................75 A1.2.5 Review....................................................................................................................75 A1.2.6 NIBP (Optional) .....................................................................................................75 A1.2.7 SpO2 (Optional)......................................................................................................76 A1.2.8 TEMP (Optional)....................................................................................................77 AppendixⅡ EMC Information - Guidance and Manufacture’s Declaration ...........................78 A2.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS ................................78 A2.2 Electromagnetic Immunity - For all EQUIPMENT and SYSTEMS ................................78 A2.3 Electromagnetic Immunity - For EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING.........................................................................................................80 A2.4 Recommended Separation Distances ................................................................................81 V
M3A Vital Signs Monitor User Manual
Intended Use and Safety
Chapter 1 Intended Use and Safety Guidance 1.1 Intended Use The M3A Vital Signs Monitor (hereinafter called monitor) is intended to be used for non-invasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature). The monitor is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in hospitals, hospital type facilities and intra-hospital moves. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
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℃ and +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 detachable 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 main 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
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 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. 2 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. 3 Only qualified service engineers can install this equipment. And only service engineers authorized by EDAN can open the shell. 4 EXPLOSION HAZARD-Do not use the monitor in a flammable atmosphere where anesthetics or other flammable materials may accumulate. 5 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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Intended Use and Safety
WARNING 6 SHOCK HAZARD- the power receptacle must be a three-wire grounded outlet. A hospital grade outlet is required. Never adapt the three-prong plug of the monitor to fit a two-slot outlet. 7 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g. IEC/EN950 for data processing equipment and IEC/EN60601-1 for medical equipment). 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. 8 Use the battery only in this monitor. Do not connect battery directly to an electric outlet or cigarette lighter charger. 9 Do not unplug the battery when monitoring. 10 Make sure the monitor is used in the appointed range of voltage, the effect of power supply can be ignored. 11 Do not solder the leading wire and the battery terminal directly. 12 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. 13 Always keep the battery away from fire. 14 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. 15 Do not use a battery with serious scar or deformation. 16 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. 17 Please set the alarm according to the individual condition of patient to avoid delaying treatment. Ensure there will be an alarm audio prompt when an alarm occurs. 18 Devices connecting with the monitor should be equipotential. 19 When the monitor and electrosurgical device are used together, the user (physician or nurse) should guarantee the safety of patient. 20 The monitor can provide protective means to prevent the patient from being burned when used with HF SURGICAL EQUIPMENT. -3-
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Intended Use and Safety
WARNING 21 Please disinfect timely to prevent cross infection between patients. 22 This monitor is not a device for treatment purposes. 23 Do not touch the patient, bed or instrument during defibrillation. 24 During monitoring, if the power supply is off and there is no battery for standby, the monitor will be off. After reconnecting the power supply, the user should turn on the monitor for monitoring.
CAUTION 1 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. 2 The monitor is designed for continuous operation and is “ordinary” (i.e. not drip or splash-proof). 3 Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine, dust area, high-temperature and humid environment. 4 Do not immerse transducers in liquid. When using solutions, use sterile wipes to avoid pouring fluids directly on the transducer. 5 Do not sterilize the monitor or any accessories. 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. Batteries are hazardous waste. Do not dispose them together with house-hold garbage. At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries. For more detailed information about recycling of this product or battery, please contact your local Civic Office, or the shop where you purchased the product. 7 Remove a battery whose life cycle has expired from the monitor immediately. 8 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. 9 The disposable accessories can not be reused. 10 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.
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Intended Use and Safety
CAUTION 11 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. 12 Setting alarm limits to extreme values can render the alarm system useless. 13 A potential hazard may exist if different alarm presets are used for the same or similar equipment in any single area.
NOTE: 1 The monitor can only be used on one patient at a time. 2 The function of SpO2 measurement does not require calibration. 3 The equipment can protect against the effects of the discharge of a defibrillator. 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.
1.2.7 Explanation of Symbols on the Monitor 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 CF 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 not suitable for use during defibrillation. CAUTION.
Consult Instructions for Use.
Equipotential grounding system.
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Intended Use and Safety
ON/OFF switch.
It indicates the port has Nurse Call or serial port function.
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.
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M3A Vital Signs Monitor User Manual
Installation of Monitor
Chapter 2 Installation of Monitor NOTE: To ensure that the monitor works properly, please read Chapter 1 Intended Use and Safety Guidance, and follow the steps before using the monitor.
2.1 Opening the Package and Checking 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 the 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 section 1.2 Safety Guidance for details.
NOTE: When the battery is provided, after the monitor is transported or stored, the battery must be recharged. Switching 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 the front panel to power on the monitor, all the seven-segment displays are bright, and LOGO information is 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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M3A Vital Signs Monitor User Manual
Installation of Monitor
NOTE: 1 During POST, make sure all the seven segments are bright, which indicates the seven segments function well. 2 Check all the functions of the monitor and make sure that the monitor is in good condition. 3 If rechargeable batteries are provided, recharge them after using the monitor every time to ensure the electric power is enough. 4 The interval between double presses of the ON/OFF button should be more than 1 second. 5 After continuous 7 days’ (168 hours’) runtime, please restart the monitor to ensure the monitor’s steady performance and long lifespan.
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.
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M3A Vital Signs Monitor User Manual
Introduction
Chapter 3 Introduction 3.1 General Information The monitor integrates the function of parameter measurement modules, display and output to compose a compact, portable device. Its built-in replaceable battery provides convenience for patient movement. 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 M3A Vital Signs Monitor
M3A 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. The monitor provides extensive functions such as visual and audible alarms, storage for data, SpO2/NIBP/TEMP measurements review, nurse call and so on. -9-
M3A 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 has SpO2, NIBP and TEMP functions. As an option, the monitor can be configured to single SpO2, single NIBP, NIBP+SpO2, NIBP+TEMP or NIBP+SpO2+TEMP. The configuration is preset by the manufacturer, and it can not be changed by the user.
3.2.1 All Parameters Display The screen is divided into three areas: 1 Parameter area ① 2 Waveform/ NIBP Multi-Group Review/ Trend list/ Trend Graph ② 3 Information area ③ ④
① ④
② ③
Figure 3-2 Main display - 10 -
M3A Vital Signs Monitor User Manual
Introduction
The NIBP multi-group Review and SpO2 waveform area is displayed as follows:
Figure 3-3 NIBP Multi-group Review
Change the display on the screen to Trend list as follows:
Figure 3-4 Display trend list
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Introduction
Change the display on the screen to Trend graph as follows:
Figure 3-5 Display SpO2 trend graph
The icons on the interface and their meanings are as follows: Battery status indicator Connected to mains power supply Audio system off icon Audio alarm pause icon Parameter alarm off Indicates an error occurs Note Warning Password protection
Patient type: ADU
Patient type: PED
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Introduction
Patient type: NEO
Measuring oral TEMP
Measuring axillary TEMP
Measuring rectal TEMP
ID 23：31：08
Current patient ID Current time
Parameter Area ( ①) Parameter area is on the upper part of main interface, and following 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) TEMP: ⎯ Temperature (Unit: ℃ or ℉). The PR signal from SpO2 measuring takes priority to be displayed. Waveform/Trend List ( ②) It can display SpO2 waveform, NIBP multi-group review, trend list or trend graph. Information Area ( ③ ④) The Information Area is at the right and bottom parts of the screen, displaying operating status of the monitor and condition of the patient. The information area contains the following data: ⎯ Patient type and ID; ⎯ NIBP measuring mode;
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M3A Vital Signs Monitor User Manual
Introduction
⎯ Signs indicating the battery or mains power supply status; ⎯ Current time; ⎯ Signs indicating the sensor or alarm status. Alarm Indicator and Alarm Status － In normal conditions, the alarm indicator does not light. － When an alarm is generated, the alarm indicator lights or flashes. The color of light represents the alarm level. Refer to Chapter 5 Alarm for details. － Refer to relevant content of parameters for Alarm information and prompt. Charging Indicator and Charging Status To indicate the status of charging: when the battery is being charged, the light turns to yellow; after the charge is finished, the light will be off.
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M3A Vital Signs Monitor User Manual
Introduction
3.2.2 Optional Displays SpO2 only measuring mode
Figure 3-6 Display in SpO2 only mode
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M3A Vital Signs Monitor User Manual
Introduction
NIBP only measuring mode In NIBP only measuring mode, the PR from NIBP measurement is also displayed on screen.
Figure 3-7 Display in NIBP only mode
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M3A Vital Signs Monitor User Manual
Introduction
3.3 Button Functions
④ ⑤ ⑥ ⑦ ⑧ ⑨
①
②
③
Figure 3-8 Buttons
All the operations to the monitor can be finished by several buttons. ON/OFF
When the monitor is off, press this button to turn it on. When the monitor is on, press this button and hold for 2s to turn off the monitor; or press this button for less than 1s, the menu for entering Standby Mode is displayed.
NIBP START/STOP
To inflate the cuff and start blood measuring. During the measuring process, press the button to stop measuring. (For the monitor with NIBP function).
ALARM LIMIT
For SpO2 only monitor, the NIBP STASRT/STOP button is changed to ALARM LIMIT button. Press this button to set the alarm limits of the parameters of SpO2.
①
②
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M3A Vital Signs Monitor User Manual
TREND/WAVEFORM ③
Introduction
Press this button to switch among waveform display, trend list and trend graph display. Press this button for less than 2s to stop audio alarm for a period set by the user, then the icon displays, and the indicator beside the button flashes. When repressing it or the pause time is over, the audio alarm can resume to the normal monitoring status, and the indicator is off.
SILENCE ④
Press this button for more than 2s to turn off the audio system, including audio alarm, key volume and pulse tone. The icon displays in Information area. The indicator is on during the alarm silence period. Press the button again can resume the audio system. PATIENT TYPE Press this button for 0.5s to change the patient type which is displayed on the front panel.
⑤
MENU Press to open the Main Menu. Refer to Chapter 4 System Menu for details.
⑥
UP ⑦ OK
Press UP or DOWN to select an item or to increase/ decrease a number. Confirm the selection by pressing OK.
DOWN The icons on the front panel: ⑧ CHARGE Indicator
⑨ POWER Indicator
The LED beside this icon indicates the charging status. When the battery is being recharged, the LED is bright. The LED beside this icon indicates the power condition. When the monitor connects to the mains power supply, the LED is bright. - 18 -
M3A Vital Signs Monitor User Manual
Introduction
3.4 Interfaces For the convenience of operator, interfaces of different functions are in different sites of the monitor. Sensor port on the front panel
①
②
Figure 3-9 Sensor Connectors
Connectors for cables and sensors are as shown in Figure 3-9. 1. SpO2 sensor connector ① 2. NIBP cuff connector ② WARNING Only connect the device to EDAN supplied or recommended accessories.
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M3A Vital Signs Monitor User Manual
Introduction
Rear Panel
① ③
②
Figure 3-10 Rear Panel
Sockets on the rear panel are shown in the above figure: ① Equipotential grounding terminal for connecting to the hospital’s grounding system. ② Power supply socket: 100V–240V ~, 50Hz/60Hz. ③ The port has Nurse Call or serial port function.
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M3A Vital Signs Monitor User Manual
Introduction
Bottom panel There are battery compartment and fuse box on the bottom panel.
Battery compartment cover
Fuse box
Figure 3-11 Bottom panel
3.5 Built-in Rechargeable Battery The monitor is equipped with a built-in rechargeable battery. When switching on AC power supply, the battery will be recharged automatically until full electric energy. There is a sign or
in the bottom right corner of screen.
－ When the monitor is working with AC mains power, and it has no battery or the battery has full electric energy, it displays
;
－ When the monitor is working with AC mains power, and the battery is being recharged, it displays
;
－ When the monitor is working with battery, it displays
.
If the monitor is off, you can see recharging status from the charger indicator. The battery status indicator is light in yellow when being recharged, and off when full. It takes 320 minutes for an empty 4.4 Ah battery to be 90%~100% charged, and 180 minutes for a 2.2 Ah battery. - 21 -
M3A Vital Signs Monitor User Manual
Introduction
Replace Battery In monitoring or communication state, the battery status indicator will flash when the battery is low or empty. When the lifespan of battery is over, foul odor or leakage is detected, please contact the manufacturer or local distributor for replacement of battery. WARNING 1 Do not take off the battery when monitoring. The unexpected power supply off can not impact on the normal monitor working, if it has battery for standby. 2 Stop using the battery if abnormal heat, odor, discoloration, deformation or abnormal condition is detected during use, recharge, or storage. Keep it away from the monitor. 3 Make sure the monitor is used in the appointed range of voltage, so the effect of power supply can be ignored. 4 Before using the rechargeable lithium-ion battery (hereinafter called battery), be sure to read the user manual and safety precautions thoroughly. 5 Do not place battery in the monitor with the (+) and (-) in the wrong way around. 6 Do not connect the positive (+) and negative (-) terminals with metal objects, and do not put the battery together with metal objects, which can result in short circuits. 7 Do not heat or throw battery into fire. 8 Do not use, leave battery close to fire or other places where temperature may be above +60℃. Do not immerse, throw, and wet battery in water/seawater. 9 Do not destroy the battery, do not pierce battery with a sharp object such as a needle; do not hit with a hammer, step on or throw to cause strong shock; do not disassemble or modify the battery. 10 Take out the battery before cleaning or storing the monitor for more than 1 month.
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M3A Vital Signs Monitor User Manual
System Menu
Chapter 4 System Menu The monitor features in flexible configurations. You can configure various aspects of the monitor, including the parameters to be monitored, audio signal volume, and output content. Press the MENU button on the front panel to open Main Menu. You can perform the following operations in this menu.
Figure 4-1 System memu
4.1 Patient Setup Click on Patient Setup in Main Menu to open the following menu.
Figure 4-2 Patient Setup
You can set the following patient information: Patient ID: you can set the patient ID to 1 ~ 200. Patient Type: you can set the patient type to Adult, Pediatry or Neonate. Press the UP/DOWN button on front panel to select the items, then press the OK button to confirm. Select Exit to return to the previous menu. - 23 -
M3A Vital Signs Monitor User Manual
System Menu
4.2 Alarm Setup Select Alarm Setup in Main Menu to open submenu as shown below, in which the user may turn on or off alarm or set the upper alarm limit or lower alarm limit. Set the item to ON, the alarm system is turned on. Pressing the SILENCE button on the front panel can stop the audio alarm or silence the audio system. If you set the item to OFF in this submenu, the monitor will not give an alarm when an alarm is activated.
Figure 4-3 Alarm Setup
WARNING 1 If the user set alarm to OFF, the monitor will not give alarm prompts when an alarm is activated, the user should use this function cautiously. 2 The user should check the alarm limit to ensure it is proper for each patient.
4.3 System Setup There are a few items to be set in this submenu, see as follows:
Figure 4-4 System Setup - 24 -
M3A Vital Signs Monitor User Manual
System Menu
4.3.1 General Setup Select General Setup in System Setup to open submenu as shown below:
Figure 4-5 General Setup
Key Volume: set key volume to level 0 ~ 5. LCD Brightness: set LCD brightness to level 1 ~ 5. Standby Mode: set to ON or OFF. If you set this item to ON, when pressing ON/OFF button for less than 1s, the monitor will enter Standby Mode. Work Mode: set to Spot or Monitor.
4.3.2 General Alarm Setup
Figure 4-6 Alarm Common Setup
Alarm Volume: set alarm volume to level 1 ~ 5. Alarm Mute: set the period of alarm silence to 30s / 60s / 90s / 120s. Exit: press it to return to the previous menu.
4.3.3 Time & Date Setup Select Time & Date Setup in Main Menu to access the submenu as shown below. System time - 25 -
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System Menu
is in format of yy-mm-dd, mm-dd-yy or dd-mm-yy. Users can set the year, month, day, hour, minute and second. Select the item you want to modify and confirm it by pressing Confirm. Select Cancel item to save the setup and return to the previous menu. If you want to exit the menu without saving it, press the MENU button on front panel.
Figure 4-7 Time Setup
4.3.4 Default Configuration NOTE: Select any item in this submenu to cancel the current setup and use the selected default setup.
Figure 4-8 Default Menu
Factory Default Config: select the factory default configuration; User Default Config: select the user-defined default configuration; Restore Selected Config: select this item to restore the selected configuration; Save as User Default Config: save the current setup as the user default configuration; Exit: exit this submenu and return to the previous menu. - 26 -
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System Menu
4.4 NIBP Setup Select NIBP Setup in Main Menu to open the following menu:
Figure 4-9 NIBP Setup
In the submenu, the user may set Interval and Unit, and select NIBP Reset, Continual, Calibration and Leakage Test. Interval: set it as Manual, or 1/2/3/4/5/10/15/30/60/90/120/240/480 min. Unit: set pressure unit to mmHg or KPa. Continual: select it to perform NIBP measurement for consecutive 5 minutes. NIBP Reset: select it to reset the NIBP module. Calibration: select it to perform calibration to NIBP module. Leakage Test: select it to perform leakage test to NIBP module. For details, please refer to Chapter 9 NIBP Monitoring.
4.5 SpO2 Setup Click on SpO2 Setup in Main Menu to open the following menu:
Figure 4-10 SpO2 Setup
Sensitivity: you can set this item to High, Medium or Low. - 27 -
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System Menu
Pulse Volume: Set it to level 0 ~ 5. Pitch Tone: set it to ON or OFF.
4.6 TEMP Setup Click on TEMP Setup in Main Menu to open the following menu:
Figure 4-11 SpO2 Setup
Monitor: when this item is selectable, select it to enter monitor mode. Position: you can set this item to Oral, Auxillary or Recta. TEMP Unit: Set temperature unit to ℃ or ℉.
4.7 Maintenance Select Maintenance in Main Menu to open the following menu. Factory Maintenance is only available for the service engineers of EDAN or representatives authorized by EDAN.
Figure 4-12 Select Maintenance
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System Menu
User Maintenance Input the user password 9 9 8 1 in the Enter Password box and press Confirm:
Figure 4-13 Enter Maintain Password
User Maintenance menu will pop up, in which you can set the following items.
Figure 4-14 User Maintain
Language: set the displaying language. NOTE: The user should restart the monitor after changing the displaying language. Nurse Call: turn on or off the nurse call. When the parameter alarm occurs, the monitor gives a 3s nurse call alarm prompt; if the audio alarm or the audio system is off, the monitor can also give the nurse call alarm in abnormal condition. The relay contact between pin7 and pin8 of RJ45 is normally open. But it is closed when an alarm is audible.
Factory Maintenance Factory maintenance function is only available for the service engineers of EDAN or representative authorized by EDAN.
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System Menu
4.8 Data Management Select Maintenance in Main Menu to open the following menu.
Figure 4-15 Data Management
Start Data Transmission: select this item to start transmitting data from monitor to data management software.
4.9 Standby Mode Entering Standby Mode When the monitor is on, press the ON/OFF button for less than 2 seconds, the dialog box displays as follows:
Figure 4-16 Enter Standby Mode
Select YES to enter the standby mode.
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System Menu
In the following two conditons, the monitor can not enter standby mode. 1. If the monitor is measuring, press the ON/OFF button for less than 2 seconds, the following dialog box displays:
Figure 4-17 Can not enter standby mode for measuring
2. If the battery is low, press the ON/OFF button for less than 2 seconds, the following dialog box displays:
Figure 4-18 Cannot enter standby mode for battery is low
Quitting Standby Mode In Standby Mode, press any button on the front panel to quit standby mode. NOTE: 1 In the following situations, the monitor will return to normal monitoring mode automatically: The monitor receives physiological signal of SpO2, and lasts for 5s; If the monitor is powered by battery, when the battery electric energy is low, it will enter normal monitoring mode, and indicates low battery alarm. 2 In DEMO mode, the monitor can not enter standby mode.
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M3A Vital Signs Monitor User Manual
Alarm
Chapter 5 Alarm This chapter gives general information about the alarm and measures to be taken accordingly. Alarm setup and prompt messages are provided in respective parameter setup sections.
5.1 Alarm Modes 5.1.1 Alarm Level Each alarm, either technical or physiological, has its own level. For an alarm of a higher level, when the alarm is activated, the system will give a prompt in various ways. The alarm’s level can not be changed by the user once defined by the system. Alarms in the monitor are divided into three levels: High, Medium and Low. High-level alarm indicates the patient’s life is in danger or the monitor has serious technical problems. It is a most serious alarm. Medium-level alarm means serious warning. Low-level alarm is a general warning. Alarms are classified into three categories, which are physiological alarm, technical alarm and general alarm. Physiological alarms refer to those alarms triggered by patient’s physiological situation which could be considered dangerous to his or her life. Technical alarm refer to system failure which can make a certain monitoring process technically impossible or make monitoring result unbelievable. Technical alarm is also called System Error Message. General alarm belongs to those situations that can not be categorized into these two cases but still need to pay attention to. The monitor has pre-set the alarm levels for the parameters. Alarm level of the System Error Message (technical alarm) is pre-set in the system. All technical alarms, general alarms and some of the physiological alarms are preset in the system and can not be changed by the user.
5.1.2 Alarm Modes When an alarm occurs, the monitor can raise the user’s attention in at least three ways, which are audio prompt, visual prompt and description. Audio and visual prompts are given by LCD display device, the speaker on the display device and the alarm indicator. Physiological alarm, technical Alarm or description is displayed in information area or beside the parameters at the bottom of the screen. NOTE: The concrete presentation of each alarm prompt is related to the alarm level. Screen display When the measured parameter exceeds its alarm limits and triggers a physiological alarm, the alarm prompt will display on the screen of the monitor. - 32 -
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Alarm
The description will display in Information area, such as “**SYS TOO HIGH” to indicate the low-medium level alarm. Technical alarm will not prompt * signal. Alarm Level
Visual Prompt
High
*** displays in information area of LCD (Physiological alarm only)
Medium
** displays in information area of LCD (Physiological alarm only)
Low
* displays in information area of LCD (Physiological alarm only)
Lamp light The high/medium/low-level alarms are indicated by the system in the following different visual ways: Alarm Level
Visual Prompt
High
Alarm indicator flashes in red with a high frequency.
Medium
Alarm indicator flashes in yellow with a low frequency.
Low
Alarm indicator lights on in cyan.
Alarm sound The high/medium/low-level alarms are indicated by the system in the following different audio ways: Alarm Level
Audio Prompt
High
Mode is “beep-beep-beep------beep-beep, beep-beep-beep------beepbeep”, which is triggered once every 5s.
Medium
Mode is “beep-beep-beep”, which is triggered once every 20s.
Low
Mode is “beep-”, which is triggered once every 25s.
The sound pressure of auditory alarm is in the range of 45dB ~ 85dB. NOTE: 1 The monitor does not have alarm condition delay or alarm signal generation delay. 2 When alarms of different levels occur at the same time, the monitor prompts one of the highest levels. 3 If the monitor is powered off and then turned on, the alarm setup can resume to the setup which is set before the power-off. - 33 -
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Alarm
5.1.3 Alarm Setup Set Alarm Setup in Main Menu to open the submenu as shown below. The user can turn ON or OFF the alarm for each parameter, and set the upper alarm limit and lower alarm limit for each parameter by High or Low.
Figure 5-1 Alarm Setup
Alarm setup of each parameter
In the Alarm Setup menu, set the alarm limit for each parameter: SYS, DIA, MAP, SpO2, PR. For example: Method to set systolic blood pressure alarm limit for SYS alarm: Step 1: Set SYS to ON; Step 2: Set High (higher limit of SYS alarm) and Low (lower limit of SYS alarm). The user can press the UP/DOWN and OK button to set the menu. The method for setting the alarm limits of other parameters is the same as SYS alarm.
5.2 Alarm Cause Alarm occurs when: 1. Physiological alarm is evoked; 2. Alarm for error of the system (technical alarm) is evoked; 3. General alert occurs.
A. Conditions that activate the parameter alarms:
The measurement value exceeds the alarm limit and the alarm is set to ON. Alarms will not be activated if the alarm is set to OFF.
B. Conditions that activate the system alarms (technical alarm):
Upon the system error, the monitor prompts alarm immediately.
C. General alert
In some circumstances, alerts will behave as physiological alarms in normal senses, we do not regard them as real patient health related items. - 34 -
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Alarm
5.3 Silence The user can press SILENCE on front panel to stop audio alarm or turn off the audio system. If an alarm occurs during this period, the monitor can still give alarm. 1. Audio alarm pause icon Press and hold the SILENCE button on front panel for less than 2s, then the audio alarm is stopped for 2 min, and the indicator beside the button flashes. The audio alarm pause icon displays. Pressing SILENCE again can resume the audio alarm. 2. Audio system off icon Press the SILENCE button for more than 2s, the audio system is turned off, including the audio alarm, key volume and pulse tone, at the same time the indicator beside the button is on. Pressing SILENCE again can turn on the audio system.
5.4 Parameter Alarm In Main Menu > Alarm Setup, you can check and set the alarm limit or alarm status. The setup is isolated from each other. displays near the parameter. If the alarms are When a parameter alarm is OFF, an icon turned off individually, they must be turned on individually. For the parameters whose alarm is set to ON, the alarm will be triggered when at least one of them exceeds alarm limits. The following actions take place: 1. 2. 3.
Alarm message displays on the screen as described in alarm mode; The monitor beeps in its corresponding alarm class and volume; Alarm lamp flashes.
5.5 When an Alarm Occurs NOTE: When an alarm occurs, you should always check the patient's condition first. The alarm message appears in Information area of the screen. It is needed to identify the alarm and act appropriately, according to the cause of the alarm. 1.
Check the patient's condition.
2.
Identify the cause of the alarm.
3.
Identify which parameter is alarming or which alarm is happening.
4.
When the cause of the alarm is cleared, check that the alarm is working properly.
You will find the alarm messages for the individual parameters in their appropriate parameter chapters of this manual. - 35 -
M3A Vital Signs Monitor User Manual
Trend
Chapter 6 Trend The monitor provides 100-hour trend data of all parameters (SYS, MAP, DIA, PR, SpO2, TEMP), 2-hour trend graph of NIBP/SpO2/PR/TEMP, storage data of 12, 000 NIBP measurement results and 200 Patient IDs.
6.1 Trend List The NIBP Multi-Group list is displayed as follows:
Figure 6-1 NIBP Multi-Group Review
Press TREND/WAVEFORM button to change the waveform to trend list as follows:
Figure 6-2 Trend list
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Trend
Select one data file and press the OK button, the following menu and deleting process are displayed:
Figure 6-3 Delete data in trend list
When deleting data, the process bar is diaplayed:
Figure 6-4 Deleting process
6.2 Trend Graph Press the TREND/WAVEFORM button to change the displaying list to trend graph of NIBP/SpO2/PR as follows:
Figure 6-5 SpO2 trend graph
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Trend
Figure 6-6 NIBP trend graph
You can set the items below the trend graph. Item: you can set the display parameter to NIBP, SpO2 or PR. Y: it stands for the ordinate which indicates the displayed data range. X: it stands for the abscissa which indicates the displayed time range. After selecting the NIBP, SpO2 or PR, the Y and X can be set as the following table shows: Parameter
Y (data range)
X (time range)
SpO2
0~100, 60~100, 80~100
30 min / 60 min / 120 min
NIBP
10~270, 20~180, 40~160
30 min / 60 min / 120 min
PR
30~300, 40~180, 40~120
30 min / 60 min / 120 min
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M3A Vital Signs Monitor User Manual
Maintenance and Cleaning
Chapter 7 Maintenance and Cleaning 7.1 System Check Before using the monitor, do the following: ■
Check if there is any mechanical damage;
■
Check if all the outer cables, inserted modules and accessories are in good condition;
■
Check all the functions of the monitor to make sure that the monitor is in good condition.
If you find any damage on the monitor, stop using the monitor on patient, and contact the biomedical engineer of the hospital or EDAN immediately. The overall check of the monitor, including the safety check, should be performed only by qualified personnel once every 6 to 12 months, and each time after fixing up. All the checks that need you to open the monitor should be performed by qualified customer service technician. The safety and maintenance check can be conducted by persons from this company. You can obtain the material about the customer service contract from the local company’s office. WARNING 1 If the hospital or agency that is responding to using the monitor does not follow a satisfactory maintenance schedule, the monitor may become invalid, and the human health may be endangered. 2 Replace batteries according to the instruction of our service engineer. 3 The disposable accessories can not be reused.
NOTE: To prolong the life of rechargeable battery, it is recommended to charge it at least once every month, and it must be done after the electric energy runs out.
7.2 General Cleaning WARNING Before cleaning the monitor or the sensor, make sure that the equipment is switched off and disconnected from the power line.
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Maintenance and Cleaning
CAUTION Please pay special attention to the following items: 1 Most cleaning agents must be diluted before use. Follow the manufacturer's directions carefully to avoid damaging the monitor. 2 Do not use the grinding material, such as steel, wool etc. 3 Do not let the cleaning agent enter into the chassis of the system. 4 Do not leave the cleaning agents at any part of the equipment.
The monitor, cables and accessories must be kept dust-free. Regular cleaning of the monitor shell and the screen is strongly recommended. Use only non-caustic detergents such as soap and warm water (+40℃/+104℉ maximum) to clean the monitor shell. Do not use strong solvents such as acetone or trichloroethylene. Take extra care when cleaning the screen of the monitor because it is more sensitive to rough cleaning methods than the housing. Do not permit any liquid to enter the monitor case and avoid pouring it on the monitor while cleaning. Do not allow water or cleaning solutions to enter the measurement connectors. Wipe around, except connector sockets. Recommended cleaning agents are: Tenside (dishwasher detergents)
Edisonite Schnellreiniger, Alconox
Ammonias
Dilution of Ammonia <3%, Window cleaner
Alcohol
Ethanol 70%, Isopropanol 70%, Window cleaner
Sodium Hypochlorite
1% ~ 10%
NOTE: 1 The diluted sodium hypochlorite from 500ppm (1:100 diluted bleaching agent) to 5000ppm (1: 10 bleaching agents) is very effective. The concentration of the diluted sodium hypochlorite depends on how many organisms (blood, mucus) on the surface of the chassis to be cleaned. 2 The monitor and sensor surface can be cleaned with hospital-grade ethanol and dried in air or with crisp and clean cloth. 3 This company has no responsibility for the effectiveness of controlling infectious diseases using these chemical agents. Please contact infectious disease experts in your hospital for details. 4 Please disinfect timely to prevent the cross infection between patients.
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Maintenance and Cleaning
7.3 Sterilization To avoid extended damage to the equipment, sterilization is only recommended when stipulated as necessary in the Hospital Maintenance Schedule. Sterilization facilities should be cleaned first. Recommended sterilization material: Ethylate, and Acetaldehyde. Appropriate sterilization materials for blood pressure cuff are introduced in relative chapters respectively. CAUTION 1 Follow the manufacturer’s instruction to dilute the solution, or adopt the lowest effective concentration. 2 Do not let liquid enter the monitor. 3 No part of this monitor can be subjected to immersion in liquid. 4 Use a moistened cloth to wipe up any agent remaining on the monitor.
7.4 Disinfection To avoid extended damage to the equipment, disinfection is only recommended when stipulated as necessary in the Hospital Maintenance Schedule. Disinfection facilities should be cleaned first. You should use appropriate disinfectant. Recommended types of disinfectants are: ■
Alcohol: Alcohol Ethanol up to 70%, 1- and 2- Propanol up to 70%
■
Aldehyde: Glutaraldehyde up to 3.6% WARNING
Please do not mix disinfecting solutions (such as bleach and ammonia) as hazardous gases may result.
CAUTION 1 Follow the manufacturer’s instruction to dilute the solution, or adopt the lowest effective concentration. 2 Do not let liquid enter the monitor. 3 No part of this monitor can be subjected to immersion in liquid. 4 Use a moistened cloth to wipe up any agent remained on the monitor. 5 Do not use EtO gas or formaldehyde to disinfect the monitor.
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Maintenance and Cleaning
7.5 Replacement of Fuse Unscrew the fuse cap anticlockwise, replace the fuse (protector tube) and screw down the fuse cap clockwise. Fuse size: Ф5×20, Rated value: T 1.6 AL /250 V. NOTE: Switch off the power of the monitor before examining the fuse.
7.6 Cleaning Battery and Battery Compartment Cover Use only non-caustic detergents such as soap and warm water (+40℃/+104℉ maximum) to clean the battery. Do not use strong solvent to clean battery, and do not dip the battery in liquid.
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M3A Vital Signs Monitor User Manual
SpO2 Monitoring
Chapter 8 SpO2 Monitoring (Optional) 8.1 What is SpO2 Monitoring The monitor uses oximetry to measure functional oxygen saturation in the blood. SpO2 Plethysmogram measurement is employed to determine the functional oxygen saturation of hemoglobin in the arterial blood. For example, if 97% hemoglobin molecules in the red blood cells of the arterial blood combine with oxygen, then the blood has an SpO2 oxygen saturation of 97%. The SpO2 numeric on the monitor will read 97%. The SpO2 numeric shows the percentage of hemoglobin molecules which have combined with oxygen molecules to form oxyhemoglobin. The SpO2/PLETH parameter can also provide a pulse rate signal and a plethysmogram wave.
How the SpO2/PLETH Parameter Works ■
Arterial oxygen saturation is measured by a method called pulse oximetry. It is a continuous, non-invasive method based on the different absorption spectra of reduced hemoglobin and oxyhemoglobin. It measures how much light, sent from light sources on one side of the sensor, is transmitted through patient tissue (such as a finger or an ear), to a receiver on the other side.
■
The amount of light transmitted depends on many factors, most of which are constant. However, one of these factors, the blood flow in the arteries, varies with time, because it is pulsating. By measuring the light absorption during a pulsation, it is possible to derive the oxygen saturation of the arterial blood. Detecting the pulsation gives a PLETH waveform and pulse rate signal.
■
The SpO2 value and the PLETH waveform can be displayed on the main interface.
■
The sensor contains LEDs that emit red light at a wavelength of approximately 660 nm and infrared light at a wavelength of approximately 900 nm. The power of the sensor LED is less than 15 mW.
SpO2/Pulse Monitoring WARNING 1 ES (Electrosurgery) equipment wire and SpO2 cable must not be tangled up. 2 Do not put the sensor on extremities with arterial catheter or venous syringe. 3 Pulse oximetry can overestimate the SpO2 value in the presence of Hb-CO, Met-Hb or dye dilution chemicals.
NOTE: 1 Do not perform SpO2 measuring and NIBP measuring on a same arm at one time, because obstruction of blood flow during NIBP measuring may adversely affect the reading of SpO2 value. 2 The monitor should not be used under strong light, or the accuracy may not be satisfied. - 43 -
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SpO2 Monitoring
8.2 Precautions During SpO2/PR Monitoring WARNING 1 Verify sensor cable fault detection before beginning of monitoring phase. Unplug the SpO2 sensor cable from the socket, the screen will display the error message SpO2 SENSOR OFF and the audible alarm is activated. 2 If the SpO2 sensor can not work properly, please reconnect the sensor or change a new one. 3 Do not use the sterile supplied SpO2 sensors if the packaging or the sensor is damaged and return them to the vendor. 4 Prolonged and continuous monitoring may increase the risk of unexpected change of dermal condition such as abnormal sensitivity, rubescence, vesicle, repressive putrescence, and so on. It is especially important to check the sensor placement of neonates and patients of poor perfusion or immature dermogram by light collimation and proper attaching strictly according to changes of the skin. More frequent examinations may be required for different patients. 5 Tissue damage may be caused by incorrect application or prolonged measurement duration using the sensor (more than 4 hours). Inspect the sensor periodically according to sensor user manual. 6 Neonate SpO2 sensor can only be used as required, less than 20min at a time. 7 The sensor complies with the ISO 10993-1 for biocompatibility.
NOTE: 1 Make sure the nail covers the light window; 2 The wire should be on the backside of the hand; 3 Hand should not be too cold when measuring, and the nail polish should be cleaned before measuring, or the data accuracy may be affected. 4 SpO2 waveform is not proportional to the pulse volume. 5 The accuracy of SpO2 has been verified by clinical tests according to ISO9919. The monitor can only be used for SpO2 measurement, not for accuracy assessment of other device. 6 A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter monitor.
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