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M3A Operators manual

1. Message Cause Alarm Level SYS TOO HIGH NIBP SYS measuring value is above Medium upper alarm limit SYS TOO LOW NIBP SYS measuring value is below Medium lower alarm limit IBP DIA i lue i DIATOO HIGH N oa a Ae JRO Ve Medium upper alarm limit DIA TOO LOW NIBP DIA measuring value is below Medium lower alarm limit MAP TOO HIGH NIBP MAP measuring value is above Medium upper alarm limit MAP TOO LOW NIBP MAP measuring value is below Medium lower alarm limit Technical alarms display in the area below the NIBP value Message Cause Alarm Level What to do Stop using measuring function NIBP COMM NIBP module failure or Hich of NIBP module notify STOP communication failure E biomedical engineer or manufacturers service staff NIBP ILLEGAL The hardware pressure 1s High Measure again if failure RESET too high persists stop using measuring function of NIBP module and NIBP The NIBP module has notify biomedical engineer or MODULE ERR failure High manufacturer s service staff ff i l LOOSE CUFF cu ee rop ee Low Properly wrap the cuff wrapped or no cuff exists 59 M3A Vital Signs Monitor User Manual NIBP Monitoring Cuff hose or connector is eee damaged Low Check and replace the leaking parts if required notify AIR e biomedical engineer or The airway of NIBP has PREESURE k Low manufacturer s service staff failure ERR NIBP SIGNAL Cuff is too loose o
2. eE Tn A A sh F Hi ee En wt T EAS ji a A a 1 la j Ard APT A x J l En i i Fa Y IN a J A 7 y pa O A A A f A K Figure 9 6 Replace Rubber Bag in Cuff To replace the rubber bag in the cuff first place the bag on top of the cuff so that the rubber tubes line up with the large opening on the long side of the cuff Now roll the bag lengthwise and insert it into the opening on the long side of the cuff Hold the tubes and the cuff and shake the complete cuff until the bag is in position Thread the rubber tubes from inside the cuff and out through the small hole under the internal flap Disposable Blood Pressure Cuffs Disposable cuffs are intended for one patient use only Do not use the same cuff on any other patient Do not sterilize or use autoclave on disposable cuffs Disposable cuffs can be cleaned using soap solution to prevent infection NOTE For protecting environment the disposable blood pressure cuffs must be recycled or disposed of properly 62 M3 Vital Signs Monitor User Manual TEMP Monitoring Chapter 10 TEMP Monitoring Optional 10 1 TEMP Monitoring The TEMP measuring has Predict and Monitor modes In the Predict mode the monitor measures oral axillary rectal TEMP in a short time calculates and gets the measuring results In Monitor mode it can monitor patient for 10 min The Oral Axillary sensor and Rectal sensor are of standard configuration The monitor can only measure tempera
3. M3A Vital Signs Monitor User Manual Accessories and Ordering Information 01 57 040142 Infant blood pressure cuff SURGI CUF 5105 12 cm 18cm Quick TEMP 02 01 110131 TEMP oral axillary sensor 02 01 110130 TEMP recta sensor 11 57 110159 TEMP disposable sensor cover 25 pcs Others 01 57 78035 Recording paper 12 01 109480 Trolley 02 01 109481 Wall mount bracket 02 01 109592 Pole clamp 1 piece 02 01 109636 Pole clamp 4 pieces 01 13 36014 Power supply cable 220V EUR Standard 11 13 36015 Power supply cable USA Standard 01 21 064115 Rechargeable lithium ion battery HYLB 1049 14 8V 4 4 Ah optional 11 13 114214 Grounding line le M3A Vital Signs Monitor User Manual Warranty and Service Policy Chapter 12 Warranty and Service Policy 12 1 Warranty EDAN warrants that EDAN s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period The warranty period begins on the date the products are shipped to distributors The warranty is void in cases of a damage caused by handling during shipping b subsequent damage caused by improper use or maintenance c damage caused by alteration or repair by anyone not authorized by EDAN d damage caused by accidents e replacement or removal of serial number label and manufacture label If a product covered by this warranty is determined to be defective because
4. 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 E Check for any mechanical damage E 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 NH Make sure the AC power supply complies with the following specification 100V 240V 50Hz 60Hz E 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 E Connect to the ground line if necessary Refer to section 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
5. 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 i
6. 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 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 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 B
7. sas M3A Vital Signs Monitor User Manual Specification Humidity Working 25 80 no condensing Transport and Storage 25 93 no condensing Altitude Working 860hPa 1060hPa Transport and Storage 700hPa 1060hPa Power Supply Voltage 100V 240V Frequency 50Hz 60Hz Input power 70VA Battery 14 8 V 4 4 Ah 14 8 V 2 2 Ah A1 2 3 Display Multicolor LCD Resolution 320x240 adjustable brightness 1 PLETH waveform Seven segment display Display NIBP SpO gt measuring values and unit Patient type Pulse amplitude display Messages 1 power supply indicator LED Green 1 power on indicator LED Green 1 alarm indicator LED Cyan Y ellow Red 1 alarm silence indicator LED Yellow 1 charge indicator LED Yellow 1 NIBP working status indicator LED Backlight 3 indicating modes correspond to alarm mode NURSE CALL Drive mode Electronic Relay lt 1A lt 125V lt 110V DC Isolated voltage Action 1500V line to ground Normal open 74 Specification M3A Vital Signs Monitor User Manual A1 2 4 Battery Quantity 1 Type Li battery Power off delay 5 min 15 min After the low battery alarm Voltage 14 8 VDC Capacitance 2 2 Ah 4 4 Ah optional Working period 2 2 Ah 10 hours 4 4 Ah 21 hours At 25 C continuous SpO measuring automat
8. Figure 3 3 NIBP Multi group Review Change the display on the screen to Trend list as follows 1D 1 NIBP ILLEGAL RESET ilis ime __L Svs Dia map lepo PR Ma 10 05 18 03 20 136 90 110 98 10 05 18 02 50 08 100 10 01 15 02 30 99 a6 10 01 15 02 00 94 60 10 01 15 01 30 40 60 10 01 15 01 00 TEET 10 01 15 00 30 70 98 97 X NIBP Alarm Off re 23 31 09 Figure 3 4 Display trend list 11 M3A Vital Signs Monitor User Manual Introduction Change the display on the screen to Trend graph as follows 120min 80min 40min Item BA v 80 100 4 x 120min 4 Searching Pulse Tr 23 31 22 Figure 3 5 Display SpOz 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 xpa e r 7 Audio alarm pause icon r gt Parameter alarm off x e Indicates an error occurs 3 Note Warning Password protection Patient type ADU Patient type PED m BD S 12 M3A Vital Signs Monitor User Manual Introduction W Patient type NEO 9 Measuring oral TEMP 9 Measuring axillary TEMP 2 Measuring rectal TEMP ID Current patient ID 23 31 08 Current time Parameter Area 1 Parameter area is on the upper part of main interface and following parameter
9. 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 E B Conditions that activate the system alarms technical alarm Upon the system error the monitor prompts alarm immediately E 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 M3A Vital Signs Monitor User Manual 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 Kee 1 Audio alarm pause icon Pa 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 gt Alarm Setup you can check and set the alarm limit or alarm status The setup is isolated from each other When a parameter alarm is OFF an icon displays near the parameter If the alarms are turned off individually
10. User Manual Y EDAN M3A Vital Signs Monitor Release 1 1 with Software Revision 1 1 C Er About this Manual P N 01 54 112593 11 Release Date June 2010 O 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 extensio
11. 1 SpO2 sensor connector 2 NIBP cuff connector WARNING Only connect the device to EDAN supplied or recommended accessories 19 M3A Vital Signs Monitor User Manual Introduction Rear Panel Figure 3 10 Rear Panel Sockets on the rear panel are shown in the above figure Equipotential grounding terminal for connecting to the hospital s grounding system Power supply socket 100V 240V 50Hz 60Hz The port has Nurse Call or serial port function 20 M3A Vital Signs Monitor User Manual Introduction Bottom panel There are battery compartment and fuse box on the bottom panel Battery compartment cover ebeJo s Jo Buidd ys eJojeq 1eyeq anoulas s emje oBewep Jeyeq piore oL S O 29 2 lt 3 so E Q 065 0 go 28 Se as of go FS E lt 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 mu 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 ECs When the monitor is working with AC mains power and the battery is being recharged it displays ma When the monitor is working with battery it displays mu If the monitor is off you can
12. 12 0 12 0 23 0 1 0 37 0 37 0 73 1 1 2 1 2 2 3 10 3 7 3 7 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 81 P N 01 54 112593 11 EDAN www edan com cn EC REPRESENTATIVE Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 D 20537 Hamburg Germany TEL 49 40 2513175 FAX 49 40 255726 E mail antonjin yahoo com cn EDAN INSTRUMENTS INC 3 F B Nanshan Medical Equipment Park Nanhai Rd 1019 Shekou Nanshan Shenzhen 518067 PR CHINA Email info edan com cn TEL 86 755 2689 8326 FAX 86 755 2689 8330
13. Figure 8 3 Alarm setup 46 M3A Vital Signs Monitor User Manual SpO Monitoring WARNING In order to avoid endangering the patient s life the user should use this function cautiously The range of SpO alarm limit is 0 100 Default SpO alarm limits Max Upper Limit Min Lower Limit Step ADU 100 90 1 PED 100 90 1 NEO 95 90 1 The range of PR alarm limit is 0 300 Default PR alarm limits Max Upper Limit Min Lower Limit Step ADU 120 50 1 PED 160 75 1 NEO 200 100 1 8 6 Alarm Description Tables below describe the possible physiological alarms technical alarms occurring during SpO measurement When there is no SpO or PR input it prompts weak signal Physiological alarm Message Cause Alarm Level SpO2 TOO HIGH SpO measuring value is above upper alarm limit Medium SpO TOO LOW SpO gt measuring value is below lower alarm limit Medium PR TOO HIGH PR measuring value is above upper alarm limit Medium PR TOO LOW PR measuring value is below lower alarm limit Medium 2 AF M3A Vital Signs Monitor User Manual SpO Monitoring Technical alarms Message Cause Alarm Level What to do Stop using measuring function of SpO2 COMM SpO module failure or Hish SpO2 module notify biomedical STOP communication failure j engineer or manufacturer s service staff SpO2 Change the sensor I
14. OFF button for less than 2 seconds the following dialog box displays Cannot enter standby mode due to BATTERY LOW alarm OK 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 SpO 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 31 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
15. SpO only measuring mode EDAN reed 2D Oo Figure 3 6 Display in SpO2 only mode 15 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 v meen 590 1 a de Oo Figure 3 7 Display in NIBP only mode 16 M3A Vital Signs Monitor User Manual Introduction 3 3 Button Functions EDAN r77 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 O 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 y ALARM LIMIT For SpO 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 SpO 17 M3A Vital Signs Monitor User Manual Introduction TREND WAVEFORM O 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 oa Ho period set by the user then the
16. TEMP High 39 0 EJ Low 36 0 Exit d Figure 9 5 Alarm Setup ssi M3A Vital Signs Monitor User Manual The adjusting range of NIBP alarm limits is 0 mmHg 300 mmHg Default NIBP alarm limits NIBP Monitoring ADU mmHg PED mmHg NEO mmHg Lower Upper Lower Upper Lower Upper Limit Limit Limit Limit Limit Limit SYS 90 160 70 120 40 90 DIA 50 90 40 70 20 60 MAP 60 110 50 90 25 70 The adjusting range of NIBP alarm limits Adult Mode SYS DIA MAP Pediatric Mode SYS DIA MAP Neonatal Mode SYS DIA MAP 40 mmHg 270 mmHg 10 mmHg 215 mmHg 20 mmHg 235 mmHg 40 mmHg 200 mmHg 10 mmHg 150 mmHg 20 mmHg 165 mmHg 40 mmHg 135 mmHg 10 mmHg 100 mmHg 20 mmHg 110 mmHg When the monitor is configured to NIBP only measuring mode the adjusting alarm limits of PR are displayed in the ALARM SETUP menu Default PR alarm limit Max Upper Limit BPM Min Lower Limit BPM Step BPM ADU 120 50 1 PED 160 75 1 NEO 200 100 1 The range of PR alarm limit Max Upper Limit BPM Min Lower Limit BPM Step BPM PR 300 0 1 58 M3A Vital Signs Monitor User Manual NIBP Monitoring 9 4 NIBP Alarm Message and Prompt Message Tables below describe the possible physiological alarms technical alarms and prompt messages occurring during NIBP measurement Physiological alarms
17. 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 SpO 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 C and 40 C 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 Require
18. fault detection before beginning of monitoring phase Unplug the SpO sensor cable from the socket the screen will display the error message SpO2 SENSOR OFF and the audible alarm is activated 2 If the SpO sensor can not work properly please reconnect the sensor or change a new one 3 Do not use the sterile supplied SpOz 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 SpOz 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 SpO
19. icon EMBA displays and the indicator beside the button flashes When repressing it SILENCE or the pause time is over the audio alarm can resume to the a normal monitoring status and the indicator is off A 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 MENU Press to open the Main Menu Refer to Chapter 4 System Menu for details a UP D Press UP or DOWN to select an item or to increase OK decrease a number Confirm the selection by pressing OK Y DOWN he icons on the front panel The LED beside this icon indicates the charging status CHARGE Indicator When the battery is being recharged the LED is bright The LED beside this icon indicates the power condition O When the monitor connects to the mains power supply the POWER Indicator 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 EDAN 7 Ill i Figure 3 9 Sensor Connectors Connectors for cables and sensors are as shown in Figure 3 9
20. 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 39 M3A Vital Signs Monitor User Manual 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 C 104 F 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 a
21. 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 9 monitor will be off After reconnecting the power supply the user should turn on the monitor for monitoring CAUTION 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 The monitor is designed for continuous operation and is ordinary i e not drip or splash proof Keep the environment clean Avoid vibration Keep it far from corrosive medicine dust area high temperature and humid environment Do not immerse transducers in liquid When using solutions use sterile wipes to avoid pouring fluids directly on the transducer Do not sterilize the monitor or any accessories 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
22. 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
23. 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 Alarm message displays on the screen as described in alarm mode 2 The monitor beeps in its corresponding alarm class and volume 3 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 SpOy 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 2009 04 08 23 31 45 2009 10 05 10 03 44 2009 04 08 23 31 45 2009 10 05 10 03 44 Searching Pulse 23 31 08 Figure 6 1 NIBP Multi Group Revi
24. to confirm Select Exit to return to the previous menu 293 4 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 Alarm Setup sys ED High 160 E Low foo E DIA High oo E Low so E MAP High 110 E Low feo E SpOz on 5 High 100 E Low so E PR High 120 E Low so E Temp fon 3 High 39 0 E Low 36 0 E Exit 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 System Setup General Alarm Setup Time amp Date Setup Default Configuration Exit 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 Key Volume LED Brightness 3 E Standby Mode ON Work Mode
25. 074 11 57 40097 11 57 40098 01 57 040139 11 57 040215 01 57 040140 01 57 040141 Accessories and Ordering Information EDAN SH4 adult silicone soft tip SpOz sensor Immersion disinfection EDAN SH5 child silicone soft tip SpO sensor Adult disposable SpO sensor SESIOO1B Pediatry disposable SpO gt sensor SESJOO1B Infant disposable SpO sensor SELK001B Neonate disposable SpO sensor SELLOO1B NIBP cuff extension tube 3m TPU NIBP cuff extension tube 3m TPU Optional Neonate disposable blood pressure cuff extension tube 3m Adult blood pressure cuff 33cm 47cm CM1304 with sensor 190 Adult blood pressure cuff 25 cm 35cm CM1303 Pediatry blood pressure cuff 18 cm 26cm CM1302 with sensor 190 Infant blood pressure cuff 10 cm 19cm CM1301 with sensor 190 Infant blood pressure cuff 10 cm 19cm CM1201 with sensor 190 Pediatry blood pressure cuff 18 cm 26cm CM1202 with sensor 190 Adult blood pressure cuff 25 cm 35cm CM1203 with sensor 190 Larger adult blood pressure cuff 33 cm 47cm CM1204 with sensor 190 Neonate disposable blood pressure cuff 5102 6 cm 9 cm Neonate disposable blood pressure cuff 5104 9 cm 14cm Infant blood pressure cuff SURGI CUF 5101 3 cm 6cm Infant blood pressure cuff SURGI CUF 5102 6cm 9 5cm Infant blood pressure cuff SURGI CUF 5103 8 cm 12cm Infant blood pressure cuff SURGI CUF 5104 9 cm 14cm 70
26. 10 SpO2 Setup E Sensitivity you can set this item to High Medium or Low Me M3A Vital Signs Monitor User Manual System Menu E Pulse Volume Set it to level 0 5 E Pitch Tone set it to ON or OFF 4 6 TEMP Setup Click on TEMP Setup in Main Menu to open the following menu TEMP Setup Position CE TEMP Linit E Exit Figure 4 11 SpO2 Setup E Monitor when this item is selectable select it to enter monitor mode Position you can set this item to Oral Auxillary or Recta E TEMP Unit Set temperature unit to or F 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 Maintenance Factory Maintenance gt gt Gema About Exit Figure 4 12 Select Maintenance 28 M3A Vital Signs Monitor User Manual System Menu User Maintenance Input the user password 9 9 8 1 in the Enter Password box and press Confirm Enter Password Confirm Cancel Figure 4 13 Enter Maintain Password User Maintenance menu will pop up in which you can set the following items User Maintenance Language English Ba NOTE Restart to change language Nurse Call On Exit Figure 4 14 User Maintain E Language set the displaying language NOTE The user should restart the monitor after changing the displaying language E Nurse Call turn o
27. Installation of Monitor ii 7 2 1 Opening the Package and AECI a A e A a ao wore 7 2 2 SOME CNN Uds 7 23 Powering on the Monitor A ah edna Roem ican a aes OR A 7 2 4 Connecting Sensor to Patti 8 Chapt r 3 Introductio a A sosede vovit osvobo soseri 9 DA General OOO trios 9 A y iiini n a T Walt IEA E E Ral A R O T 10 3 2 LAI Par meters DIS E e NE e e h meen sans 10 3 2 2 Optional DISPARA 15 3 3 Button FOCOS it AA tdi 17 A e a a a oldie 19 3 5 Built in Rechargeable Battery ii AEREA Ria 21 Chapter 4 System Me AAA peses snost osot ness ro oseo ei osos estao eseist Seiso 23 O e E 23 AZAT Sep A A A GONG 24 A i a a ER E ne NE A av ee ee 24 431 General Set precre sire de 25 43 2 General Alarm A O 25 4 3 3 Time amp Date A a i apnea cas E EE AE winced AEA E E aa 25 e A a E ves ax OR A tae eae Mae 26 AA NIBP SEaren a a e do 2T AS SPO AU A A a AG E AA Aes A a AAA 27 40 TEMP SUP it A A A nia 28 AN 55 ot aah ace anes cian Anaahat a ais eee aah Co 28 4 8 Data IN ATV GAS TINS IN ocena aS Na a Sn a tee Sa ae 30 AcO Standby Mod o da 30 Chapter AMA ewes Rare iones 32 S A M OA 32 Solel Alar ins 32 3 1 2 Alarm Modes iia ii es 32 A A dd add 34 5 2 Alarm A O O A a i eias 34 O 35 5 4 Parameter Alione e E a E tea tance ai E ees REO Ree Oe 35 5 5 When an Alarm OU A a aa ii ai 35 Chapter 6 Trend O dada 36 G Tend S a a a a a a A BOP a aS 36 6 2 Trend OTAN ES 37 Chapter 7 Maintenance and Cleaning seeesccesccessocessccssoceso
28. Spot Exit 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 E Work Mode set to Spot or Monitor 4 3 2 General Alarm Setup eneral Alarm Setup Alarm Volume Alarm Mute 90s Exit Figure 4 6 Alarm Common Setup E Alarm Volume set alarm volume to level 1 5 E Alarm Mute set the period of alarm silence to 30s 60s 90s 120s E Exit press it to return to the previous menu 4 3 3 Time amp Date Setup Select Time amp Date Setup in Main Menu to access the submenu as shown below System time e M3A Vital Signs Monitor User Manual 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 Time amp Date Setup Date Format emma Year 2009 Hour 18 Month 09 Minute 03 Day 03 Second 13 Confirm Cancel 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 Default Configuration MM F
29. able select it to enter monitor mode Position you can set this item to Oral Auxillary or Recta The axillary sensor can be used for measuring oral axillary temperature while the rectal sensor for measuring rectal temperature E TEMP Unit Set temperature unit to or F 10 3 2 TEMP Alarm Setup Click on ALARM SETUP in the SYSTEM MENU and set the alarm higher limit or lower limit in the following figure Alarm Setup sys ED High 160 El Low oo DIA High 90 E Low so MAP High 110 E Low feo SpOz on 5 High fico E Low 90 PR High 120 E Low 50 Temp on y High 39 0 EH Low 36 0 Exit slollooll Figure 10 3 Alarm Setup Menu E TEMP set it to ON to enable prompt message during the TEMP alarm while set to OFF to disable the alarm function and display the symbol besides TEMP numeric 65 M3 Vital Signs Monitor User Manual WARNING TEMP Monitoring In order to avoid endangering the patient s life the user should use this function cautiously Set High for the higher alarm limit and set Low for the lower alarm limit The range for higher alarm limit and lower alarm limit is as follows Patient Type Measure position High Low Step ADU Oral Axillary Rectal 42 C 107 6 F 35 5 C 95 9 F 0 1 C PED Oral Axillary Rectal 42 C 107 6F 35 5 C 95 9 F 0 1 C 10 4 TEMP Alarm Message Tables below describe the possible physiological alarms and tec
30. accurate oral temperature readings Ingesting hot or cold liquids eating food chewing gum or mints brushing teeth smoking or performing strenuous activity may affect temperature readings for up to 20min after ending activity 6 Do not take an axillary temperature through patient s clothing Direct probe cover to skin contact is required 7 Biting the sensor tip while taking a temperature may result in damage to the sensor 8 Use disposable TEMP sensor covers recommended by EDAN to limit patient cross contamination The use of any other probe cover may produce temperature measurement errors or result in inaccurate readings 63 M3 Vital Signs Monitor User Manual TEMP Monitoring 10 2 Measuring Procedure 1 Ensure the sensor are well installed There are icons indicating TEMP measuring position on the main interface If changing measuring position or measuring mode is necessary enter menu for setting 2 Take out the sensor from the sensor bracket After warm up it beeps and displays prompt for starting TEMP measuring in information area 3 Load a sensor cover by inserting the sensor into a sensor cover and press the sensor handle firmly The sensor handle will move slightly to engage the sensor cover 4 Holding the sensor handle with your thumb and two fingers insert it to the measuring position For measuring oral TEMP place the sensor tip under the patients tongue on either side of the mouth to reach the rear sublingual po
31. actory Default Config User Default Config Save as User Default Contig Exit 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 M3A Vital Signs Monitor User Manual System Menu 4 4 NIBP Setup Select NIBP Setup in Main Menu to open the following menu NIBP Setup Interval Pemma v Unit mmHo Continual NIBP Reset Calibration Leakage Test Exit 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 1t to perform leakage test to NIBP module For details please refer to Chapter 9 NIBP Monitoring 4 5 SpO Setup Click on SpO Setup in Main Menu to open the following menu 5pOz Setup Sensitivity medium B Pulse Volume 2 Pitch Tone on y Exit Figure 4
32. al NIBP Monitoring NOTE The width of the cuff should be either 40 of the limb circumference 50 for neonates or 2 3 of the upper arm length The inflatable part of the cuff should be long enough to encircle 50 80 of the limb The wrong size of cuff can cause erroneous readings If the cuff size is in question then use a larger cuff Size of reusable cuff for neonatal pediatric adult patients Patient Type Limb perimeter Cuff width Hose Infant 10 cm 19 cm 8 cm Pediatric 18 cm 26 cm 10 6 cm Adult 25 cm 35 cm 14 cm 15mor3m Large Adult 33 cm 47 cm 17 cm Thigh 46 cm 66 cm 21 cm Size of disposable cuff for neonatal pediatric adult patients Size No Limb perimeter Cuff width Hose 1 3 1 cm 5 7 cm 2 5 cm 2 4 3 cm 8 0 cm 3 2 cm 1 5mor3m 3 5 8 cm 10 9 cm 4 3 cm 4 7 1 cm 13 1 cm 5 1 cm The lifespan of cuff is 480mmHg 20000 times 300mmHg 50000 times m Make sure that the cuff edge falls within the range of mark lt gt If it does not use a larger or smaller cuff that fits better 5 Connect the cuff to the air hose The limb chosen for taking the measurement should be placed at the same level as the patient s heart If this is not possible you should apply the following corrections to the measured values m If the cuff is placed higher than the heart level add 0 75 mmHg 0 10 kPa for each inch of difference m If it is placed lower tha
33. amp custom charges for product Contact information If you have any question about maintenance technical specifications or malfunctions of devices contact your local distributor Alternatively you can send an email to EDAN service department at support edan com cn 72 M3A Vital Signs Monitor User Manual Appendix Specification A1 1 Classification Specification Anti electroshock type Class equipment and internally powered equipment EMC type Group I Class A Anti electroshock degree SpO2 NIBP Type BF defibrillation proof TEMP Type CF Ingress Protection IPX1 No protection against ingress of water if configured with TEMP module Working system Continuous running equipment no more than 7 days Compliant with Safety Standards A1 2 Specifications A1 2 1 Size and Weight IEC 60601 1 1988 A1 A2 EN 60601 1 1990 A1 A2 IEC EN 60601 1 2 2001 A1 IEC 60601 1 8 ISO 9919 EN 1060 1 EN 1060 3 EN 1060 4 ANSI AAMI SP10 IEC EN 60601 2 30 1EC60601 2 49 Size 200 8 mm L x241 mm H x189 mm D Weight 2 4 kg without battery A1 2 2 Environment NOTE When the monitor and related products have differing environmental specifications the effective range for the combined products is that range which is common to the specifications for all products Temperature Working 5 C 40 C Transport and Storage 20 C 55 C
34. and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the EUS TUltrasound Scanner is used exceeds the applicable RF compliance level above the EUS T Ultrasound Scanner should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the EUS TUltrasound Scanner gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m A2 4 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the M3A Fetal amp maternal Monitor The M3A is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the M3A can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the M3A as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz output power of transmitter W ye 3 5 JP 7 3 5 JP da T JP Y E E 0 01 0
35. ce 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 a T 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 BH Consult Instructions for Use Equipotential grounding system M3A Vital Signs Monitor User Manual Intended Use and Safety OY o ON OFF switch gt It indicates the port has Nurse Call or serial port function Ss N Serial number The symbol indicates that the device complies with the C En European Council Directive 93 42 EEC concerning medical devices REP Authorized representative in the European community padl Date of manufacture sal Manufacturer P N Part Number amp 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 M3A Vital Signs Monitor User Manual Installation of Monitor Chapter 2 Installation of Monitor
36. cesocsesocsssesssocesocesoosesocessecssecesocsseoseoo 39 AS A A A AN 39 O A en e a E aang an anes atten cap astana eae eae uaa 39 is A Sedat eva qulteneads daa aaa aa ai aaa deka AGO 41 de e o o eee 41 ES Replacement a at 42 7 6 Cleaning Battery and Battery Compartment Covet coooconcccnococonoconcnonnncnnnononocono cono nconncconccnnnos 42 Chapter 8 SpO2 Monitoring Optional ocmoooommss 43 8 1 What is SpO2 MONO a Td Na Saute Ne 43 8 2 Precautions During SpOy PR Monitoring oooocooccooccnonnconncconoconn nono nooo nccnocnnn cono ncon nono nncnnncnnncnns 44 S 5 Monitoring Procedure A A A AA A as Cg Ro tae ke 45 SA Limitations of Me o o 45 o A AA O A A EE E O ESAR e aA 46 SIMPOSIO iii 46 8 5 2 Alarm E MI as 46 NAAA a Ais ee e na tcc dea Aaa Aan Sac de 47 8 7 Maintenance and Cleamin gs ssicccy lt ittcaed Sabsdtiastacontsanincic btveaeiocad ease edeanioda tvaeintauiaeas 49 Chapter 9 NIBP Monitoring Optional cscsossecosscsocsssesoessssorsesoassercesssenessseverovssasounesessneesssooessnese 50 a a RTR 50 IV 9 2 NIBP Monitoring aa Ao ae Ries 51 IND BS SEU Mi a do e O 55 ON Soa a Ne a at ae Sa ea eat i al 55 032 NIBP AS denia 57 9 4 NIBP Alarm Message and Prompt Message ooooocooccncoccnoccnonocoonoconononnncon cono noconn nono cconcccn nacion 59 9 5 Maintenance and Cleaning ad 61 Chapter 10 TEMP Monitoring Optional oooooooccooooccoonoccooonccnnncccnnnccconoccnnnoccnnncccnonoccnonoccncnoccnnno 63 10 TEMP Monito
37. cket Have the patient close his lips around the sensor Sublingual Pocket _ Pez ua we gd t Figure 10 1 Measuring position in mouth For measuring oral TEMP do not take an axillary temperature through patient s clothing 5 The monitor enters Predict measuring mode displays in the TEMP parameter area After Predict measuring is over the measuring result displays and MEASURE OVER appears on the interface 6 If the predict measuring is successfully finished the monitor enters monitor mode after 30s otherwise the monitor enter monitor mode immediately after the predict measuring The monitoring state lasts for 10 min then the monitor enters waiting state displays in the TEMP parameter area on interface Put the sensor back into the sensor bracket 7 If necessary repeat the measurement according to the procedure above NOTE 1 After one measurement the user should put the sensor back to the sensor bracket and then take it out for starting a new measurement 2 The monitor s state can change from the PREDICT mode into the MONITOR mode but it can not change from the MONITOR mode into the PREDICT mode 64 M3 Vital Signs Monitor User Manual TEMP Monitoring 10 3 TEMP Setup Menu 10 3 1 TEMP Setup Click on the TEMP Setup in the Main Menu to display the following figure TEMP Setup Position TEMP Unit fec y Exit Figure10 2 TEMP Setup Monitor when this item is select
38. continual measuring mode Measurement over Measurement over Calibrating During calibrating Calibration over Calibration over Leakage testing During leakage test Leakage test over Leakage test over NIBP Resetting NIBP module is resetting NIBP Alarm Off The alarm of NIBP is turned off 9 5 Maintenance and Cleaning WARNING 1 Do not squeeze the rubber tube on the cuff 2 Do not allow liquid to enter the connector socket at the front of the monitor 3 Do not wipe the inner part of the connector socket when cleaning the monitor 4 When the reusable cuff is not connected with the monitor or being cleaned always place the cover on the rubber tube to avoid liquid permeation Reusable Blood Pressure Cuff The cuff can be sterilized by means of conventional autoclaving gas or radiation sterilization in hot air ovens or disinfected by immersion in decontamination solutions but remember to remove the rubber bag if you use this method The cuff should not be dry cleaned The cuff can also be machine washed or hand washed the latter method may prolong the service life of the cuff Before washing remove the latex rubber bag and for machine washing close the Velcro fastening Allow the cuff to dry thoroughly after washing then reinsert the rubber bag 61 M3A Vital Signs Monitor User Manual NIBP Monitoring Ss Orel 3ZIS Lindv Ova NOLLWISNI X3 1V1 34N9 AOT aalvuarvo A 19 9MOUBUINeg
39. e cuff arterial catheter or intravascular line e Significant concentration of dysfunctional hemoglobin such as carboxyhemog lobin and methemoglobin Low SpO Circular perfusion is not good for test part e The dissipation power is less than 50 uW when the sensor temperature is higher than 41 C you should shorten the measuring time 45 M3A Vital Signs Monitor User Manual SpO Monitoring 8 5 SpO2 Setup Menu 8 5 1 SpO Setup Click on SpO Setup in Main Menu to open the following menu SpOz Setup Sensitivity medium BA Pulse Volume 2 Pitch Tone Jon a Exit Figure 8 2 SpO Setup E Sensitivity you can set this item to High Medium or Low E Pulse Volume Set it to level 0 5 E Pitch Tone set it to ON or OFF 8 5 2 Alarm Setup Menu Enter Main Menu gt Alarm Setup In the menu the alarm for SpO or PR can be turned on or off and the alarm limits can be adjusted Select ON to enable alarm during SpO2 monitoring select OFF to disable the alarm function and will be displayed Set High for the higher alarm limit and set Low for the lower alarm limit If the measured value is higher than the higher alarm limit or lower than the lower alarm limit the monitor will give an alarm Alarm Setup sys E High 160 E Low fso E DIA High 90 Ej Low so E MAP High 110 E Low feo E SpOz on 7 High 100 E Low so E PR High jizo E Low so E Temp om 3 High 39 0 E Low 36 0 amp Exit
40. e system will automatically open the deflating valve which marks the completion of a pneumatic measurement 7 If no prompt appears on the bottom of the NIBP parameter area it indicates that the 56 M3A Vital Signs Monitor User Manual NIBP Monitoring airway is in good status and no air leaks exist However if the prompt PNEUMATIC LEAK appears in the place it indicates that the airway may have air leaks In this case the user should check for loose connection After confirming secure connections the user should re perform the pneumatic test If the failure prompt still appears please contact the manufacturer for repair Figure 9 4 Diagram of NIBP Air Leakage Test 9 3 2 NIBP Alarm Setup Enter Main Menu gt Alarm Setup Set the SYS DIA MAP to turn on or off the alarm Click ON to enable prompt message during the NIBP alarm pick OFF to disable the alarm function and there will be a icon displayed WARNING In order to avoid endangering the patient s life the user should use this function cautiously Set High for the higher alarm limit and set Low for the lower alarm limit Set High for the higher alarm limit and set Low for the lower alarm limit If the measured value is higher than High or lower than Low the monitor will give an alarm Alarm Setup SYS High 160 Low EN DIA High 90 Low MAP High 110 5 Low SpOz on y High 100 Low ON soll 90 30 60 90 0 PR High 120 E Low 5
41. eases The user should be aware that the following conditions could interfere with the measurement making the measurement unreliable or longer to derive In some cases the patient s condition will make a measurement impossible O Patient Movement Measurements will be unreliable or may not be possible if the patient is moving shivering or having convulsions These motions may interfere with the detection of the arterial pressure pulses In addition the measurement time will be prolonged O Cardiac Arrhythmia s Measurements will be unreliable and may not be possible if the patient s cardiac arrhythmia has caused an irregular heartbeat The measuring time thus will be prolonged O Heart lung Machine Measurements will not be possible if the patient is connected to a heart lung machine Pressure Changes Measurements will be unreliable and may not be possible if the patient s blood pressure is changing rapidly over the period of time during which the arterial pressure pulses are being analyzed to obtain the measurement O Severe Shock If the patient is in severe shock or hypothermia measurements will be unreliable since reduced blood flow to the peripheries will cause reduced pulsation of the arteries O Heart Rate Extremes Measurements can not be made at a heart rate of less than 40 bpm and greater than 240 bpm 54 M3A Vital Signs Monitor User Manual NIBP Monitoring 9 3 NIBP Setup Menu 9 3 1 NIBP Setup In Main Menu ope
42. eteriorated 5 The disposable accessories can not be reused For cleaning E Use a cotton ball or a soft mull moistened with hospital grade ethanol to wipe the surface of the sensor and then dry it with a cloth This cleaning method can also be applied to the luminotron and receiving unit E The cable can be cleaned with 3 hydrogen dioxide 70 isopropanol or other active reagents However connector of the sensor shall not be subjected to such solution For disinfecting Use a cotton ball or a soft mull moistened with disinfectant to wipe the surface of the sensor and then dry it with a cloth You should use appropriate disinfectant Recommended types of disinfectants are m Alcohol Alcohol Ethanol up to 70 1 and 2 Propanol up to 70 m Aldehyde Glutaraldehyde up to 3 6 49 M3A Vital Signs Monitor User Manual NIBP Monitoring Chapter 9 NIBP Monitoring Optional 9 1 Introduction m The Non invasive Blood Pressure NIBP module measures the blood pressure using the oscillometric method m It is applicable for adult pediatric and neonatal usage m The measured parameters of NIBP Systolic Pressure SYS Diastolic Pressure DIA Mean Pressure MAP it displays the cuff pressure Pulse Rate PR m The NIBP measurement can measure the diastolic systolic and mean blood pressure The measuring mode can be set to the following modes lt gt Manual mode one measurement is conducted each time lt gt Automat
43. ew Press TREND WAVEFORM button to change the waveform to trend list as follows 1D 1 NIBP ILLEGAL RESET PX aids time Tv oia map pos er e 10 05 18 03 20 136 90 110 nas ESC IS O CIC 10 05 18 02 50 98 100 10 01 15 02 30 99 10 01 15 02 00 94 60 10 01 15 01 30 40 60 10 01 15 01 00 99 10 01 15 00 30 70 98 97 x NIBP Alarm Off ra 23 31 09 Figure 6 2 Trend list 36 M3A Vital Signs Monitor User Manual Trend Select one data file and press the OK button the following menu and deleting process are displayed Clear Current ID Clear All ID 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 SpO PR as follows ID 1 W 98s 120min 80min 40min Item BA v s0 100 4 x 120min 4 Searching Pulse T 23 31 22 Figure 6 5 SpO trend graph 237 M3A Vital Signs Monitor User Manual Trend IDI 20min 10min Item NIBP 4 v 40 160 4 x EA Searching Pulse T 23 31 06 Figure 6 6 NIBP trend graph You can set the items below the trend graph Item you can set the display parameter to NIBP SpO 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 se
44. f the problem SENSOR The sensor or connector persists please notify biomedical High E ERR has shortcut engineer or manufacturer s service staff EPO The parts of module have Please notify biomedical engineer MODULE p u v High ease notify biomedical enginee error or manufacturer s service staff ERR Reconnect the sensor well or The measured signals change the measuring site of body SpO LOW coming from pulse are too Low If the problem persists please PERFUSION y weak notify biomedical engineer or manufacturer s service staff SpO SpO sensor may be Make sure that the monitor and the SENSOR disconnected from the Low patient are in correct connection OFF patient or the monitor with the cables SpO NO SpO2 sensor was not Make sure the monitor and sensor SENSOR connected well or the Low is well connected reconnect the connection is loose sensor Prompt message Message Cause Searching pulse SpO sensor may be disconnected from the patient or the monitor SpO ALARM OFF The alarm of SpO is turned off 48 M3A Vital Signs Monitor User Manual SpO Monitoring 8 7 Maintenance and Cleaning WARNING 1 Before cleaning the monitor or the sensor make sure that the equipment is switched off and disconnected from the power line 2 Do not subject the sensor to autoclaving 3 Do not immerse the sensor into any liquid 4 Do not use any sensor or cable that may be damaged or d
45. hnical alarms occurring during TEMP measurement Physiological alarms Message Cause Alarm Level TEMP TOO HIGH Measuring value of TEMP is above upper alarm limit Med TEMP TOO LOW Measuring value of TEMP is below lower alarm limit Med Technical alarms Message Cause Alarm Level What to do Stop using measuring function TEMP COMM TEMP module failure or Hich of TEMP module notify STOP communication failure A biomedical engineer or Manufacturer s service staff TEMP The TEMP value is Put the sensor into the sensor EXCCED beyond the range of 25 C Medium bracket take it out and measure LIMIT 45 C again TEMP NO TEMP sensor is not Connect the sensor and the connected to the TEMP Low monitor well and measure SENSOR i module again 66 M3 Vital Signs Monitor User Manual TEMP Monitoring AMBIENT The Sensor temperature is Put the sensor into the sensor TEMP HIGH higher than 40 C L bracket measure again after the ow AMBIENT The Sensor temperature is i ae scape TEMP LOW lower than 10 C TEEN es TEMP Offline NTC resistance Put the sensor into the sensor SENSOR ERR gt RO bracket take it out and measure Short NTC eane again lr the problem persists A Medium stop using measuring function lt R 100 C l of TEMP module notify biomedical engineer or Manufacturer s service staff TEMP Single failure Put the senso
46. ic NIBP measuring per 15min Rechargeable period 2 2 Ah 180 min 4 4 Ah 320 min A1 2 5 Review Trend List Review 100 hours 30 seconds Resolution Measurement Review 12 000 groups measuring data A1 2 6 NIBP Optional Oscillometric Method Measuring Type Systolic Pressure Diastolic Pressure Mean Pressure PR Mode Manual Auto Continuous Measuring Interval in AUTO Mode 1 2 3 4 5 10 15 30 60 90 120 240 480 min Continuous 5 min interval is 5s Typical Measuring Period 30s 45s depend on HR motion disturbance Calibration Every 30 s In standby mode 75 Specification M3A Vital Signs Monitor User Manual Measuring Range ADU Mode SYS 40 mmHg 270 mmHg DIA 10 mmHg 215 mmHg MAP 20 mmHg 235 mmHg PED Mode SYS 40 mmHg 200 mmHg DIA 10 mmHg 150 mmHg MAP 20 mmHg 165 mmHg NEO Mode SYS 40 mmHg 135 mmHg DIA 10 mmHg 100 mmHg MAP 20 mmHg 110 mmHg Alarm type SYS DIA MAP Cuff Pressure Measuring Range 0 mmHg 290 mmHg Pressure Resolution 1 mmHg Maximum mean error 5 mmHg Maximum Standard deviation 8 mmHg Overpressure protection Dual overpressure protection ADU 29743 mmHg PED 240 3 mmHg NEO 145 3 mmHg PR Measuring Range 40 bpm 240 bpm Resolution 1 bpm Accuracy The maximum of 3 bpm or 3 5 A1 2 7 SpO Optiona
47. ic measuring interval is 1 2 3 4 5 10 15 30 60 90 120 240 480 min lt gt Continual mode the system executes NIBP measurement for consecutive 5 minutes WARNING 1 It is forbidden to perform NIBP measurements on the patient with sickle cell disease or under any condition where the skin is damaged or expected to be damaged 2 For a thrombasthenia patient it is important to determine whether measurement of the blood pressure shall be done automatically The determination should be based on the Clinical evaluation 3 Ensure that the correct setting is selected when performing measurements on children It may be dangerous for children to be subjected to overpressure 4 Continuous use of the automatic measuring mode for short interval may lead to the discomfort of patient If the deflated period is less than 30s releases cuff pressure to below 15mmHg adult patients or below 5mmHg neonatal patients NOTE 1 The equipment is suitable for use in the presence of electrosurgery 2 The equipment can protect against the effects of the discharge of a defibrillator 3 The continuous measuring automatic measuring and calibration can not be operated on neonatal or pediatric patients 4 Please use the proper type of cuff as recommended in this manual or the wrong type may lead to injury on the patient especially when measuring neonatal patients 5 It is suggested that the user should not start NIBP measuring when the low battery displays o
48. igns Monitor User Manual Accessories and Ordering Information Chapter 11 Accessories and Ordering Information WARNING The specification of accessories recommended is listed below Using other accessories may damage the monitor The following accessories are recommended when using this monitor Standard configuration including Part Number Accessories 12 01 109069 EDAN SHI adult reusable SpO gt sensor Only compatible with EDAN SpO module 11 57 40029 Adult NIBP cuff 25cm 35cm CM1203 with sensor 190 01 57 471005 NIBP cuff extension tube 3m TPU Optional Standard configuration including 12 01 109069 a adult reusable SpO sensor Only compatible with EDAN SpO2 12 01 109079 EDAN SH1 adult reusable SpO finger sensor DB9 1m 01 13 110513 EDAN SpO gt extension cable 01 13 210001 EDAN SpO gt extension cable DB9 to LEMO TPU 2M EDAN SH3 neonatal SpO2 sensor Only compatible with EDAN SpO 12 01 110492 module and extension cable EDAN SH4 adult silicone soft tip SpO2 sensor Only compatible with EDAN 12 01 110515 l SpO2 module and extension cable 69 wo gt lt S e Q 5 D je gt e E D 2 D 5 fa v 02 01 110531 12 01 110521 01 57 040196 01 57 040197 01 57 040198 01 57 040199 NIBP 01 57 471005 01 59 036118 01 57 471021 01 57 040210 01 57 040205 01 57 040211 01 57 040212 01 57 40020 01 57 40018 01 57 40029 01 57 40
49. ion 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 M3A Vital Signs Monitor User Manual 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 Alarm Setup sys E High 160 El Low oo DIA High 90 E Low 50 MAP High 110 E Low 60 SpOz on 5 High jico E Low 90 PR High 120 E Low 50 Temp ON y High 39 0 E Low 36 0 Exit soll Figure 5 1 Alarm Setup E Alarm setup of each parameter In the Alarm Setup menu set the alarm limit for each parameter SYS DIA MAP SpO 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 E A Conditions that activate the parameter alarms
50. l Measuring Range 0 100 Alarm Range 0 100 76 Specification M3A Vital Signs Monitor User Manual Resolution 1 Accuracy ADU amp PED 2 digits 70 100 SpOz Undefined 0 70 SpO NEO 3 digits 70 100 SpO Undefined 0 70 SpO Pulse Rate 30 bpm 300 bpm Measuring and Alarm Range Resolution 1 bpm Accuracy 3 bpm Data update period 2s A1 2 8 TEMP Optional Measuring Range 25 C 45 C Sensor Type Oral Axillary sensor Rectal sensor Alarm Range 25 C 45 C Resolution 0 1 C Accuracy 0 1 C 25 C 45 C Response time lt 60s Update time ls 2s E M3A Vital Signs Monitor User Manual Appendix I EMC EMC Information Information Guidance and Manufacture s Declaration A2 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic emission The M3A is intended for use in the electromagnetic environment specified below the customer or the user of the M3A should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions Group 1 The M3A uses RF energy only for its internal function CISPR 11 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipme
51. lecting the NIBP SpO 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 38 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 m Check if there is any mechanical damage m Check if all the outer cables inserted modules and accessories are in good condition m 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
52. manometer with an error less than 0 8 mmHg and a ball pump by means of a T piece connector and hoses to the pneumatic system Select Calibration in menu Inflate the pneumatic system to 0 mmHg 50 mmHg and 200 mmHg by ball pump separately The difference between the indicated pressure of the reference manometer and the indicated pressure of the monitor will not exceed 3 mmHg Otherwise please contact our customer service Monitor Reference manometer Metal vessel Figure 9 3 NIBP Calibration E Leakage Test This item is used for air leakage test Press this item to start the air leakage test Then the item will change into Stop Leakage Test If it is picked again the system will stop air leakage test WARNING This leakage test other than being specified in the IEC EN1060 1 standard is to be used by the user to simply determine whether there are air leaks in the NIBP airway If at the end of the test the system gives the prompt that the NIBP airway has air leaks please contact the manufacturer for repair Procedure of the Air Leakage Test 1 Connect the cuff securely with the socket for NIBP air hole 2 Wrap the cuff around the cylinder of an appropriate size 3 Access the NIBP Setup menu 4 Select the Leakage Test item by pressing the UP DOWN button It displays indicates Leakage Test on the bottom of the parameter area 5 The system will automatically inflate the pneumatic system to about 180mmHg 6 After 20s or so th
53. ment 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 M3A Vital Signs Monitor User Manual 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 su
54. ments Refer to Appendix 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 M3A Vital Signs Monitor User Manual Intended Use and Safety 1 2 4 Equipotential Grounding Protection class 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 e
55. mpliance Electromagnetic environment test level level guidance Conducted 3 Vrms 3Vrms Portable and mobile RF communications RF IEC EN 150 kHz to 80 MHz equipment should be used no closer to 61000 4 6 any part of the EUS T Ultrasound Scanner including cables than the Radiated RF 3 V m 3 V m recommended separation distance calculated from the equation applicable to IEC EN 80 MHz to 2 5 GHz 61000 4 3 the frequency of the transmitter Recommended separation distance E ENS LY pales JP 80 MHz to 800 MHz E 1 JP 800 MHz to 2 5 GHz 1 d Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol W M3A Vital Signs Monitor User Manual EMC Information NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM
56. n 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 29 M3A Vital Signs Monitor User Manual System Menu 4 8 Data Management Select Maintenance in Main Menu to open the following menu Figure 4 15 Data Management E 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 Sure to enter stanby mode Press any key to return MES Figure 4 16 Enter Standby Mode Select YES to enter the standby mode 30 M3A Vital Signs Monitor User Manual 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 Cannot enter standby mode while measurement going a Figure 4 17 Can not enter standby mode for measuring 2 If the battery is low press the ON
57. n the NIBP Setup menu shown as below NIBP Setup Interval elie v Unit mmHo Continual NIBP Reset Calibration Leakage Test Exit Figure 9 2 NIBP SETUP E Interval set it to Manual or 1 2 3 4 5 10 15 30 60 90 120 240 480 min E Unit set the pressure unit to mmHg or KPa The setting unit will display on the main interface E NIBP Reset select it to reset the NIBP module Restore measurement status Pick this item to restore initial settings of the pressure pump When the pressure pump does not work properly and the system fails to give message for the problem pick this item to activate self test procedure thus restore the system from abnormal performance E Continual select it to do NIBP measuring continuously within 5min E Calibration Calibrate the cuff pressure reading with a calibrated reference manometer Pick the Calibration item to start the calibration and the item will change into STOP CAL which if picked the system will stop calibration WARNING The calibration of the NIBP measurement is necessary every two years or as frequently as dictated by your Hospital Procedures Policy The performance should be checked according to the following details 55 M3A Vital Signs Monitor User Manual NIBP Monitoring Procedure of the Pressure Transducer Calibration Replace the cuff of the monitor with a rigid metal vessel with a capacity of 500 25 ml Connect a calibrated reference
58. n the heart level deduct 0 75 mmHg 0 10 kPa for each inch of difference 6 Press the NIBP START STOP on the front panel to start a measurement You can also stop this measurement by pressing this button SIS M3A Vital Signs Monitor User Manual NIBP Monitoring WARNING Prolonged NIBP measurements in automatic mode may be associated with purpuric ischemic and neuropathy in the limb wearing the cuff When monitoring a patient examine the extremities of the limb frequently for normal color warmth and sensitivity If any abnormality is observed stop the blood pressure measurements e To stop auto measuring During auto measuring press the NIBP START STOP on the front panel at any time to stop auto measurement WARNING If you repeatedly use AUTO measuring in a short term it may lead to inaccurate readings or endanger patient s life O To start a manual measuring E Access NIBP Setup menu and pick the Interval item Select the Manual selection Then press the NIBP START STOP on the front panel to start a manual measurement E During the idle period of auto measuring process press the NIBP START STOP on the front panel at any time to start a manual measurement Then press the NIBP START STOP on the front panel to stop manual measurement and the system continues to execute automatic measuring program according to selected time interval e To start a manual measuring during the automatic mode Press the NIBP START STOP on the f
59. 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 C 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 22 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 Main Menu Patient Setup Alarm Setup NIBP Setup Data Management SpOz Setup System Setup gt gt TEMP Setup Maintenance gt gt Figure 4 1 System memu 4 1 Patient Setup Click on Patient Setup in Main Menu to open the following menu Patient ID 1 Patient Type adult Exit Figure 4 2 Patient Setup You can set the following patient information E Patient ID you can set the patient ID to 1 200 E 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
60. ns 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 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 II Table of Contents Chapter 1 Intended Use and Safety Guidance ccscccsssscssssccssssccssssccssssccssssscsssssssessssscssssecees 1 LLO Us A AA a At eves eke aa aed 1 LD Steyl 1 A O a e a a Re fe 1 1 22 Power S tires Requirements ais ios iio a 1 1 2 3 Grounding the Monitor o das 1 1 2 4 Equipotential OU O A A A A aa 2 1 2 5 CO A aa a a a a a aa Bava 2 1 2 6 Safety Precauti ns nsien es ae hk ds a ee 2 1 2 7 Explanation of Symbols on the MOMitor ssesessseeseesessseessesessssessessrsseessessessresseeseese 5 Chapter 2
61. nt RF emissions Class A CISPR 11 Harmonic emissions Class A The M3A is suitable for use in all establishments other IEC 61000 3 2 than domestic and those directly connected to the public low voltage power supply network that supplies building Voltage Complies used for domestic purposes fluctuations flicker emissions IEC61000 3 3 A2 2 Electromagnetic Immunity For all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity The M3A is intended for use in the electromagnetic environment specified below The customer or the user of M3A should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact Floors should be wood 8 KV air concrete or ceramic tile If floor are covered with synthetic material the relative humidity should be at least 30 78 EMC Information M3A Vital Signs Monitor User Manual Electrical fast 2 kV for power 2KV for power Mains power quality should be transient burst IEC supply lines supply lines that of a typical commercial or 61000 4 4 hospital environment Surge IEC 1 kV line to line 1 kV line to line Mains power quality should be 61000 4 5 2 kV line to ground 2 kV line to that of a typical commercial or ground ho
62. of defective materials components or workmanship and the warranty claim is made within the warranty period EDAN will at its discretion repair or replace the defective part s free of charge EDAN will not provide a substitute product for use when the defective product is being repaired 12 2 Service Policy All repairs on products must be performed or approved by EDAN Unauthorized repairs will void the warranty In addition whether or not covered under warranty any product repair shall be exclusively be performed by EDAN certified service personnel If the product fails to function properly or if you need assistance service or spare parts contact EDAN s service center A representative will assist you troubleshooting the problem and will make every effort to solve it over the phone or Email avoiding potential unnecessary returns In case a return can not be avoided the representative will record all necessary information and will provide a Return Material Authorization RMA form that includes the appropriate return address and instructions An RMA form must be obtained prior to any return Freight policy Under warranty the service claimer is responsible for freight amp insurance charges when a return is shipped to EDAN for service including custom charges EDAN is responsible for freight insurance amp custom charges from EDAN to service claimer Out of warranty the service claimer is responsible for any freight insurance
63. patient tissue such as a finger or an ear to a receiver on the other side m 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 m The SpO value and the PLETH waveform can be displayed on the main interface m 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 SpOy Pulse Monitoring WARNING 1 ES Electrosurgery equipment wire and SpOz2 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 SpO value in the presence of Hb CO Met Hb or dye dilution chemicals NOTE 1 Do not perform SpO2z 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 SpO value 2 The monitor should not be used under strong light or the accuracy may not be satisfied 43 M3A Vital Signs Monitor User Manual SpO Monitoring 8 2 Precautions During SpO2 PR Monitoring WARNING 1 Verify sensor cable
64. quipotential 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 equip
65. r into the sensor HEATER ERR bracket take 1t out and measure again If the problem persists Medium stop using measuring function of TEMP module notify biomedical engineer or Manufacturer s service staff TEMP After the sensor SENSOR OFF temperature reaches Reconnect the sensor and make Predict value 1t descends Medium sure that the cable is properly to the value lower than connected Predict value Put the sensor into the sensor bracket take it out and measure again If the problem persists TAR TENE gE sem beck High stop using measuring function MEE ES prats of TEMP module notify biomedical engineer or Manufacturer s service staff Prompt Message Cause What to do Ready to TEMP predict TEMP Predict complete warm up is over interface The monitor prompts it after taking the sensor out of the bracket and After the Predict measuring is over the data and message display on the Put the sensor to the measuring position and start measuring Enter monitoring state after the Predict state After monitoring for 10 min it returns to waiting state 10 5 Care and Cleaning WARNING Before cleaning the monitor or the probe make sure that the equipment is switched off and disconnected from the power line Reusable TEMP Probes 1 The TEMP probe should not be heated above 100 C 212 F It should only be briefly exposed to temperatures between 80 C 100 C 176 F 212 F The p
66. r patient Low Use other method to measure TOO WEAK pulse is too weak blood pressure EXCESSIVE Because of arm motion Make sure that the patient signal noise is too large or Low under monitoring 1S MOTION pulse rate is not regular motionless Measure again if failure Pressure has exceeded the persists stop using measuring OVER specified upper safety Low function of NIBP module and PRESSURE ae l limit notify biomedical engineer or manufacturer s service staff Dee ey E i tion L Stop the patient from movin SATURATED xcessive motion ow op the patie ving CUFF TYPE Cuff type does not comply l L lect te cuff t ERR with the patient type D e e ao i ti h MEASURE oe 120 ee It 5 Lo Measure again or use other TIMEOUT SA j DUS sil measuring methods 90s neonatal Measure again 1f failure INIT as persists stop using measuring t PRESSURE ay pa sa Low function of NIBP module and TOO HIGH Oe rae notify biomedical engineer or manufacturer s service staff eee URE The measured pressure RANGE isih Ee pressu Low Measure by other method EXCEED exceeds the Prompt message Message Cause Press NIBP START You can start NIBP measuring of continual mode Manual measuring During manual measuring mode 60 M3A Vital Signs Monitor User Manual NIBP Monitoring Automatic measuring During automatic measuring mode Continual measuring During
67. r the monitor may be turned off automatically 50 M3A Vital Signs Monitor User Manual NIBP Monitoring 9 2 NIBP Monitoring WARNING 1 Before starting a measurement verify that you have selected a setting appropriate for your patient adult pediatric or neonatal 2 Do not apply the cuff to a limb that has an intravenous infusion or catheter in place This could cause tissue damage around the catheter when infusion is slowed or blocked during cuff inflation 3 Make sure that the air conduit connecting the blood pressure cuff and the monitor is neither blocked nor tangled Measuring procedure 1 Plug in the sensor and switch on the system 2 Check whether the patient type is appropriately selected Enter Main Menu gt Patient Setup menu and set Patient Type to required one 3 Enter the NIBP Setup menu set the Unit of NIBP and select a measurement mode Select the Interval item for Manual or set the interval for auto measurement or select the Continual 4 Apply the blood pressure cuff to the patient s arm or leg following the instructions below m Ensure that the cuff is completely deflated m Apply the appropriate size cuff to the patient and make sure that the symbol O is over the appropriate artery Ensure that the cuff is not wrapped too tightly around the limb Excessive tightness may cause discoloration and eventual ischemia of the extremity Figure 9 1 Applying Cuff 51 M3A Vital Signs Monitor User Manu
68. re 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 M3A Vital Signs Monitor User Manual Intended Use and Safety WARNING 21 Please disinfect timely to prevent cross infection between patients 22 This monitor
69. ring A A A aad ad 63 10 2 Measuring Prod dd aaaieiast 64 10 3 TENE SUPE dt A vd 65 10 3 A TEMP S CUD salir 65 10 3 2 TEMP A OS O o eS 65 10 4 TEMP A latin Message nt toe aes ian 66 10 5 Care and Cleaning naninita Gebers sctesute ceajae RE AEE E E 68 Chapter 11 Accessories and Ordering Information o mooomm 69 Chapter 12 Warranty and Service Policy siassisssseossssssossessocssnessnasseesssceosecnssosenvscontensosesoasotesenssonse 72 124 Warranty A A A IA Pee area T2 PR EO A A TEE Les AN TANE AE EEA 72 Appendix Specification ssip ssecesascsansedsssnasossoasienssenniunsscanserts tuna encdbuasescasnidessabonsenddseaasstsoisensessvaeise 73 PUD MATS O sass ue oti gia ce cee cA ck ag a oa ei a ane 73 AV Specifications ta aa 73 ALS O ha anh 73 A ace AE A e aes aaa Oa 73 AT 3 Display A tesa gers eine Ae ke aes a A ea ao 74 AZAR 75 A A T T EEE a ee ak are 75 A1 2 6 NIBP Optional sti iaa dieta 75 ADIOS AE A al 76 A TEMPLO a A ias 77 Appendix IJ EMC Information Guidance and Manufacture s Declaration ssescseeee 78 A2 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS sassone 78 A2 2 Electromagnetic Immunity For all EQUIPMENT and SYSTEMS eee eeeereeeeeeees 78 A2 3 Electromagnetic Immunity For EQUIPMENT and SYSTEMS that are not LIFE SUPPORTIN Ga 80 A2 4 Recommended Separation Distances ii dis 81 M3A Vital Signs Monitor User Manual Intended Use and Safety Chapter 1 Intended
70. robe must not be sterilized in steam Only detergents containing no alcohol can be used for disinfection All the sensors should be used with a protective rubber cover nA A q N To clean the probe hold the tip with one hand and rub the probe down from the connector with the other hand using a moist lint free cloth NOTE 1 Wash the probe with clean water after disinfecting and sterilizing to remove any remaining solution The probe can only be reused after being dried thoroughly 2 Do not disinfect the probe by means of boiled water 3 The product has not been disinfected at the factory 4 Any residue should be removed from the probe before being disinfected and sterilized and avoid contacting corrosive solvent Dipping the cable into alcohol or alkalescent solvent for a long time may reduce the flexibility of the scarfskin of the cable Also the connector should not be dipped 5 After monitoring disinfect the probe according to the instruction described in the user manual 6 Cavity temperature probe is suggested to be used only inside the recta lt is recommended to use the disposable cannula to prevent cross infection 7 For protecting the environment the disposable TEMP probe cover must be recycled or disposed of properly 8 Do not force the cavity temperature probe against resistance when inserted into human body Also it is not recommended to use it in bleeding part or cankerous part of human body 68 M3A Vital S
71. ront panel e To stop a manual measuring Repress the NIBP START STOP on the front panel again WARNING Prolonged NIBP measurements in Auto mode may be associated with purport ischemia and neuropathy in the limb wearing the cuff When monitoring a patient examine the extremities of the limb frequently for normal color warmth and sensitivity If any abnormality is observed stop the blood pressure measurements O To start a continuous measuring Access the NIBP Setup menu and pick the Continual item to start a continuous measurement The continuous measurement will last 5 min e To stop continuous measuring During continuous measuring press the NIBP START STOP on the front panel at any time to stop continuous measurement 53 M3A Vital Signs Monitor User Manual NIBP Monitoring WARNING If liquid is inadvertently splashed on the equipment or its accessories or it may enter the conduit or inside the monitor contact local Customer Service Center NOTE If you are in doubt about the accuracy of any reading s check the patient s vital signs by an alternative method before checking the functioning of the monitor Measurement Limitations For different patient conditions the oscillometric measurement has certain limitations The measurement is in search of regular arterial pressure pulse In those circumstances when the patient s condition makes it difficult to detect the measurement becomes unreliable and measuring time incr
72. s are displayed SpO SpO Unit PR Pulse Rate Unit BPM NIBP SYS DIA MAP Unit mmHg or kPa Pulse Rate Pulse Rate Unit BPM TEMP Temperature Unit C or F The PR signal from SpO measuring takes priority to be displayed Waveform Trend List It can display SpO2 waveform NIBP multi group review trend list or trend graph Information Area O 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 13 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 14 M3A Vital Signs Monitor User Manual Introduction 3 2 2 Optional Displays
73. se cap clockwise Fuse size 5x20 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 C 104 F maximum to clean the battery Do not use strong solvent to clean battery and do not dip the battery in liquid 42 M3A Vital Signs Monitor User Manual SpO Monitoring Chapter 8 SpO 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 SpO oxygen saturation of 97 The SpO numeric on the monitor will read 97 The SpO numeric shows the percentage of hemoglobin molecules which have combined with oxygen molecules to form oxyhemoglobin The SpOy PLETH parameter can also provide a pulse rate signal and a plethysmogram wave How the SpO PLETH Parameter Works m 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
74. spital environment Power frequency 3A m 3A m Power frequency magnetic 50 60Hz fields should be at levels magnetic field characteristic of a typical IEC61000 4 8 location in a typical commercial or hospital environment Voltage dips short lt 5 UT lt 5 UT Mains power quality should be interruptions and gt 95 dip in UT gt 95 dip in UT that of a typical commercial or voltage variations on power supply for 0 5 cycle for 0 5 cycle hospital environment If the user of the M3A requires input lines IEC continued operation during 61000 4 11 40 UT 60 dip in 40 UT 60 dip power mains interruptions it is UT for 5 cycles in UT for 5 cycles recommended that the M3A be powered from an 70 UT 30 dip in 70 UT 30 dip uninterruptible power supply UT for 25 cycles in UT for 25 CEER cycles lt 5 UT gt 95 dip in UT for 5 sec lt 5 UT 295 dip in UT for 5 sec NOTE UT is the a c mains voltage prior to application of the test level 79 EMC Information M3A Vital Signs Monitor User Manual A2 3 Electromagnetic SYSTEMS that are not LIFE SUPPORTING Immunity For EQUIPMENT and Guidance and manufacturer s declaration electromagnetic immunity The M3A is intended for use in the electromagnetic environment specified below The customer or the user of M3A should assure that it is used in such an environment 80 Immunity IEC EN 60601 test Co
75. te 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 m Alcohol Alcohol Ethanol up to 70 1 and 2 Propanol up to 70 m 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 41 M3A Vital Signs Monitor User Manual Maintenance and Cleaning 7 5 Replacement of Fuse Unscrew the fuse cap anticlockwise replace the fuse protector tube and screw down the fu
76. ts alarm limits and triggers a physiological alarm the alarm prompt will display on the screen of the monitor 32 M3A Vital Signs Monitor User Manual 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 Mode is beep beep beep beep beep beep beep beep beep High e ee ad E beep 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 condit
77. ture of adult and pediatric patients If the user measure temperature of neonate patient the monitor will not display data Making a TEMP Measurement e Select the correct sensor according to the measuring position and patient type e Apply the sensor to the patient You are advised to use a protective rubber cover on sensor e Switch on the monitor and ensure the alarm settings on or off higher alarm or lower alarm limit are appropriate for the patient and the type of temperature measurement e Select the correct measuring position in menu WARNING 1 To ensure optimal accuracy always confirm that the correct mode and alarm limit are selected Changing the measure position may lead to the change of alarm limit 2 Verify probe cables fault detection before the beginning of monitoring phase Unplug the temperature probe cable from the socket and then the screen will display the error message TEMP SENSOR OFF and the audible alarm is activated 3 Take the TEMP probe and cable carefully When they are not in use you should coil up the probe and cable into a loose circle If the wire inside the cable is tensely pulled it may cause mechanical damage to the probe and the cable 4 The calibration of the temperature module is necessary every two years or as frequently as dictated by your Hospital Procedures Policy When you need to calibrate the temperature measurement please contact the manufacturer 5 Patient actions may interfere with
78. utton Functions for more details Figure 3 1 M3A Vital Signs Monitor M3A Vital Signs Monitor can monitor SpO Arterial Oxygen Saturation SpO 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 SpO NIBP and TEMP functions As an option the monitor can be configured to single SpO 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 2 Waveform NIBP Multi Group Review Trend list Trend Graph 3 Information area 8 PZ 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 2009 04 08 23 31 45 2009 10 05 10 03 44 2009 04 08 23 31 45 2009 10 05 10 03 44 Searching Pulse Tr 23 31 08
79. void 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 lt 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 40 M3A Vital Signs Monitor User Manual 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 Appropria
80. waveform is not proportional to the pulse volume 5 The accuracy of SpOz has been verified by clinical tests according to 1509919 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 44 M3A Vital Signs Monitor User Manual SpO Monitoring 8 3 Monitoring Procedure SpO plethysmogram measurement 1 Connect the SpO sensor and extension cable to the SpO sensor port of monitor Switch on the monitor 2 3 Enter Patient Setup menu to set Patient Type as required 4 Attach the sensor to the appropriate site of the patient finger 5 The measured SpO gt is displayed on screen Figure 8 1 Mounting of the Sensor 8 4 Limitations of Measurement In operation the accuracy of oximetry readings can be affected by e High frequency electrical noise including noise created by the host system or noise from external sources such as electrosurgical apparatus which is admitted by the host system e Do not use monitor and oximetry sensors during magnetic resonance imaging MRI scanning Induced current could potentially cause burns Intravenous dye Excessive patient movement Outside ray radiation Improper sensor application Sensor temperature maintain between 28 C and 42 C for best operation Placement of the sensor on an extremity that has a blood pressur
81. your local Civic Office or the shop where you purchased the product Remove a battery whose life cycle has expired from the monitor immediately 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 The disposable accessories can not be reused 10 Avoid liquid splash and excessive temperature The temperature must be kept between 5 C and 40 C while working And it should be kept between 20 C and 55 C during transportation and storage M3A Vital Signs Monitor User Manual 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 SoOz2 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 referen

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