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manual monitor constantes vitales edan m3a

1. Exit Default Configuration Wi Factory Default Config User Default Config Save as User Default Config Figure 4 10 Default Configuration 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 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 Factory Maintenance gt gt Demo About Exit Figure 4 11 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 A BS Al Ep EH Confirm Cancel Figure 4 12 Enter the Password User Maintenance menu will pop up in which you can set the following items User Maintenance Language English v NOTE Restart to change language Nurse Call fon A MIBP Setup SpOz Setup Alarm Setup Net Setup Exit Figure 4 13 User Maintenance B Language Set the displaying language NOTE The user should restart the monitor after changing the displaying language B Nurse Call Turn on or off the nurse call When the parameter alarm occurs the monito
2. Message Cause Alarm Level What to do M i ti h MEASURE a D be iud It ii Lo Measure again or use other TIMEOUT jo M w measuring methods 90s neonatal Measure again if failure INIT m persists stop using measuring Th tial t PRESSURE hi Pa VEE B d Low function of NIBP module and u i TOO HIGH E notify biomedical engineer or manufacturer s service staff dA RE The measured pressure RANGE PA s 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 Automatic measuring During automatic measuring mode Continual measuring During 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 65 M3A Vital Signs Monitor User Manual NIBP Monitoring Optional 10 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
3. 42 M3A Vital Signs Monitor User Manual Recording Chapter 7 Recording 7 1 Recorder A thermal dot matrix recorder is used for the monitor It supports the printout of real time data trend graph and trend table 7 1 1 Performance of the Recorder Waveform record is printed at the rate of 25 mm s 48mm wide printout papaer A real time waveform onscreen can be printed out 7 1 2 Operations Requirement for the Recording Paper Use only specified thermal paper The use of any other paper can result in malfunction of the recorder poor recorder performance or damage to the thermal printhead Proper Operation When the recorder is working the recording paper goes out steadily Do not pull the paper outward with force otherwise the recorder may be damaged Do not operate the recorder without recording paper in the compartment Paper Out When the alarm prompt OUT OF PAPER is displayed onscreen the recorder can not start Please load recording paper properly Replacing Paper Supply Hold the upper arc part of the recorder door and pull it outwards to open the door 2 Insert a new roll of paper into the compartment with the printable surface of the paper facing upwards 3 Make sure that the paper is properly loaded with the edge of paper paralleling with the edge of the recorder door 4 Ensure that a minimum of 2 cm of paper extends beyond the edge of the recorder door 5 Close the recorder door NOTE
4. NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM 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 Vital Signs 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 r
5. Guidance and Manufacture s Declaration 91 A2 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS sess 91 A2 2 Electromagnetic Immunity For all EQUIPMENT and SYSTEMS ss 9 A2 3 Electromagnetic Immunity For EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING itin A2 4 Recommended Separation Distances VI M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance Chapter 1 Intended Use and Safety Guidance 1 1 Intended Use The M3A Vital Signs Monitor hereinafter called monitor is intended to be used for non invasive continuous monitoring of SpO oxygen saturation of arterial 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 moun
6. Hl LCD Brightness Standby Mode ov A Work Mode Spot E Exit Figure 4 7 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 Please refer to 4 10 Standby Mode for more information B Work Mode set to Spot or Monitor 4 8 2 General Alarm Setup General Alarm Setup Alarm volume S Exit Figure 4 8 General Alarm Setup B Alarm Volume set alarm volume to level 1 5 4 8 3 Time amp Date Setup Select Time amp Date Setup in Main Menu to access the submenu as shown below System time 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 zd M3A Vital Signs Monitor User Manual System Menu Time amp Date Setup Date Format Penner v Year 2009 E Hour 18 Month o9 Minute o3 Day o3 zl Second 13 Confirm Cancel Figure 4 9 Time Setup 4 8 4 Default Configuration NOTE Select any item in this submenu to cancel the current setup and use the selected default setup 4 9 Maintenance
7. ADU PED Ear 42 0 407 6 F 35 5 C 95 9 F 01 C Physiological alarms Message Cause Alarm Level TEMP HIGH Measuring value of TEMP is above upper alarm limit Medium TEMP LOW Measuring value of TEMP is below lower alarm limit Medium Technical alarms Message Cause Alarm Level What to do The TEMP value is Check the integrity of the TEMP EXCEED probe cover make sure it is th f M LIMIT Beyond ie tense ou clean and take a new 34 C 42 2 C measurement ET M3A Vital Signs Monitor User Manual TEMP Monitoring Optional The infrared ear thermometer will also give error messages on its screen For details about the error messages refer to the accompanying operating instructions of the thermometer NOTE If the infrared ear thermometer frequently signals ERR alarms the insulated board inside the thermometer housing is malfunctioning or the ambient temperature changes the monitor will delete the measurement values onscreen to avoid misoperation 11 2 5 Replacing the Battery The device is supplied with one lithium cell CR2032x1 To replacing the battery follow the procedure 1 Open the battery cover by inserting a pointed object into the battery cover pin hole meanwhile use thumb to push battery cover out EN Wy 2 Hold the thermometer and flip the battery out with a small screwdriver 3 Insert the new battery under t
8. Trend Graph 3 Information area 3 4 ll M3A Vital Signs Monitor User Manual Introduction Figure 3 2 Main display The NIBP multi group Review and SpO waveform area is displayed as follows sre Loa ap PR me 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 T 23 31 08 Figure 3 3 NIBP Multi group Review Change the display on the screen to Trend list as follows 12 M3A Vital Signs Monitor User Manual Introduction ee NIBP ILLEGAL RESET ame mk HEE e0 136 90 110 E 10 05 18 02 50 110 a8 100 10 01 15 02 30 ag s 10 01 15 02 00 94 60 10 01 15 01 30 90 40 60 10 01 15 01 00 ag 10 01 15 00 30 70 98 97 ES Tr 23 31 09 Figure 3 4 Display trend list Change the display on the screen to Trend graph as follows ID 1 120min 80min 40min Omin Item Eo 4 Y 80 100 a x 120min 4 Searching Pulse j 23 31 22 Figure 3 5 Display SpO trend graph The icons on the interface and their meanings are as follows Battery status indicator Connected to mains power supply Audio system off E E DD i Audio alarm pause Parameter alarm off X EET M3A Vital Signs Monitor User Manual Indicates an error occurs Note Warning Password protection Patient type ADU adult Patient type PED pediatric Patient type
9. 1 Be careful not to insert paper with force and avoid touching the printhead 2 Do not leave the recorder door open unless when replacing paper or removing fault Removing Paper Jam If the recorder works improperly or produces unusual sound open the recorder door and check whether there is a paper jam If yes remove it following the procedure below 43 M3A Vital Signs Monitor User Manual Recording 1 Cut the paper from the feeding edge 2 Open the recorder door 3 Reload the paper and close the recorder door 7 2 Outputing the Monitoring Data By selecting the items on Main Menu gt Recorder Figure 7 1 you can output the real time data trend graph and trend table Record Trend Graph Record Trend Table Exit Figure 7 1 B Record Realtime Data Select this item and the recorder will output the real time data including measurements and SpO waveforms B Record Trend Graph Select this item and the recorder will output the trend graph B Record Trend Table Select this item and the recorder will output the trend table Press the buttom UP or DOWN on the front panel to select an item among the above mentioned items from the menu and press co on the front panel to confirm it Subsequently the recorder will start outputting the monitoring data Meanwhile the selected item will be changed into Stop Record as shown below Stop Record Figure 7 2 You can stop the current recording proce
10. 10 cm 19 cm 8cm Pediatric 18 cm 26 cm 10 6 cm Adult 25 cm 35 cm 14 cm 1 5mor3m Large Adult 33 cm 47 cm 17 cm Thigh 46 cm 66 cm 2 cm f 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 cem 13 1 cm 5 1 em 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 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 If the cuff is placed higher than the heart level add 0 75 mmHg 0 10 kPa for each inch of difference If it is placed lower than the heart level deduct 0 75 mmHg 0 10 kPa for each inch of difference Press the NIBP START STOP on the front panel to start a measurement You can also stop this measurement by pressing this button 58 M3A Vital Signs Monitor User Manual NIBP Monitoring Optional 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 measu
11. 4 lt a osasesarucacscccovetarcivossaaushedtesarnodseeriuuetauchooaasuaeuatesiuensiensdtasat 1 1 2 4 Equipotential CTDUDU BBC ose ed san IRA S PIRA Exo centacobadevacaganceatsundssaseaanstntoandseaiansndsina 2 12 5 Condensation tts cp elses Eer Mea eR RON CUM Rd ru LO ML nOD QI 2 1 2 6 Safety PLCC AMOS es caatvss evasios sasavnseed arniarna pae brat r TEENE Peta OEO Ea EEEE EEEN EA 2 1 2 7 Explanation of Symbols on the Monitor eerie eene eerte enn nnt tnn onnoennse 5 Chapter 2 Installation of MOnMOF sesscssissessssssesssccesssescesssescssesensseossssesssssoessssosesassoscssossssoeesssosssssnossans 8 2 1 Opening the Package and CDeekimb usan pense oao bees rna eben sab sutdseeebusa iatri dante bc en aa oos eirese 8 2 2 Connecting th Power AIG sc cx sasnadseansgcadeaganntdusaeyacceutenadsancspusecansnadetnanancheasadsusaniaideacepetnaes 8 2 3 Powering oa the Monitor ausssio ccssuneiangiadudadaussunndesidatediasnasuagsedane douninducisss S E E 8 2 4 Connecting Sensor to PALIBBE scene ibm s n dme pit o eda 9 Murillo m 10 ERE IC Bins ino m 10 3 2 Sereen Display rinnen e a a a R 11 32 NINE AR aE E Ea 11 322 CMON Display Srecna o LO Lo 5 IT 16 2 2 Button Puno TOS sos pup ee iR ui eui bed Dip Sii dn DUE reer etree 18 CR terfa CES MP D TCR ede 20 3 5 B iltain Rechargeable Baby aee aae bdo o pi vip Adaptec sad a dba indes dud oa dp UG RC Vp US
12. 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 IEC60601 2 49 EN 12470 4 EN 12470 5 A1 2 Specifications A1 2 1 Size and Weight Size 200 8 mm L x241 mm H x189 mm D Weight 2 4 kg without battery A1 2 2 Environment The monitor may not meet the performance specifications given here if stored or used outside the specified temperature and humidity ranges 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 With TEMP 10 C 40 C 85 M3A Vital Signs Monitor User Manual Specifications Transport and Storage 20 C 55 C With TH module 20 C 50 C Humidity Working 25 80 non condensing Transport and Storage 25 93 non 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 m
13. NEO neonatal Measuring oral TEMP Measuring axillary TEMP For device with the T2 TEMP module only e A F f 2 w 1 1 if Measuring rectal TEMP For device with Measuring ear the Intrared Ear TEMP Temperature module only ID Current patient ID 23 31 08 Current time Parameter Area D Introduction Parameter area is on the upper part of main interface and following parameters are displayed SpO SpO Unit 96 PR Pulse Rate Unit BPM 14 M3A Vital Signs Monitor User Manual Introduction 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 SpO waveform NIBP multi group review trend list or trend graph Information Area 3 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 Signs indicating the battery or mains power supply status Current time Signs indicating the sensor or alarm status Alarm Indicator and Alarm Status n normal conditions the alarm indicator does not light When an alarm is generated the alarm indicator lights or fla
14. Setup Menu High 160 High 90 High 110 High 100 High 120 High Alarm Setup 39 0 alll Exit Low Low Low Low Low Low TEMP Monitoring Optional 90 30 60 90 30 36 0 olla B 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 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 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 4107 6 F 35 5 C 95 9 F 01 C PED Oral Axillary Rectal 42 C 107 6F 35 5 C 95 9 T 40 1 C 11 1 4 Alarm Message Tables below describe the possible physiological alarms and technical alarms occurring during TEMP measurement Physiological alarms Message Cause Alarm Level TEMP TOO HIGH Measuring value of TEMP is above upper alarm limit Medium TEMP TOO LOW Measuring value of TEMP is below lower alarm limit Medium NUM M3A Vital Signs Monitor User Manual Technical alarms TEMP Monitoring Optional Message Cause Alarm Level What to do Stop using measuring function TEMP COMM TEMP module failure or Hich of TEMP modu
15. and Low High level alarm indicates the patient s life is in danger or the monitor has serious technical problems It is a most serious alarm Medium level alarm means serious warning Low level alarm is a general warning Alarms are classified into three categories which are physiological alarm technical alarm and general alarm Physiological alarms refer to those alarms triggered by patient s physiological situation which could be considered dangerous to his or her life Technical alarm refer to system failure which can make a certain monitoring process technically impossible or make monitoring result unbelievable Technical alarm is also called System Error Message General alarm belongs to those situations that can not be categorized into these two cases but still need to pay attention to The monitor has pre set the alarm levels for the parameters Alarm level of the System Error Message technical alarm is pre set in the system All technical alarms general alarms and some of the physiological alarms are preset in the system and can not be changed by the user 5 1 2 Alarm Modes When an alarm occurs the monitor can raise the user s attention in at least three ways which are audio prompt visual prompt and description Audio and visual prompts are given by LCD display device the speaker on the display device and the alarm indicator Physiological alarm technical Alarm or description is displayed in information area or beside the
16. button is changed to ALARM LIMIT button Press this button to set the alarm limits of the parameters of SpO2 18 M3A Vital Signs Monitor User Manual Introduction TREND WAVEFORM a Press this button to switch among waveform display trend list and trend graph display DN E Z O E Press this button for less than 2s to silence the audible alarm for a period the icon DX displays in the information area and the indicator beside the button flashes When pressing it again or the pause time is over the audible alarm will resume to the normal monitoring status and the indicator is off You can set the duration for silencing the audible alarm to 1 min 2 min or 3 min For more information please refer to 4 9 Maintenance Press and hold this button for more than 2s to turn off the audio system including audio alarm key volume and pulse tone The icon displays in the information area and the indicator is on during the alarm silence period until the button is pressed again PATIENT TYPE G 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 3006 DOWN Press UP or DOWN to select an item or to increase decrease a number Confirm the selection by pressing OK The icons on the front panel CHARGE Indicator The LED besi
17. 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 Tc Ss 0rel IZIS Linav 5 V8 NOLIV T3NI XLVI AAND MOT aaLyuervo Jo emouemneg Figure 10 4 Replace Rubber Bag in Cuff 66 M3A Vital Signs Monitor User Manual NIBP Monitoring Optional 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
18. device to sale by or on the Rx only os order of a physician M3A Vital Signs Monitor User Manual Installation of Monitor Chapter 2 Installation of Monitor NOTE To ensure that the monitor works properly please read Chapter 1 Intended Use and Safety Guidance and follow the steps before using the monitor 2 1 Opening the Package and Checking Visually examine the package prior to unpacking If any signs of mishandling or damage are detected contact the carrier to claim for damage Open the package and take out the monitor and accessories carefully Keep the package for possible future transportation or storage Check the components according to the packing list B Check for any mechanical damage B 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 B Make sure the AC power supply complies with the following specification 100V 240V 50Hz 60Hz B 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 B 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
19. observe the following precautions during the operation of the instrument WARNING 1 If liquid is inadvertently splashed on the equipment or its accessories it may enter the conduit or inside the monitor At this moment contact local Customer Service Center 2 The monitor is intended to be used by qualified physicians or personnel professionally trained And they should be familiar with the contents of this user manual before operation 3 Only qualified service engineers can install this equipment And only service engineers authorized by EDAN can open the shell 4 EXPLOSION HAZARD Do not use the monitor in a flammable atmosphere where anesthetics or other flammable materials may accumulate 5 Do not attempt to connect or disconnect a power cord with wet hands Make certain that your hands are clean and dry before touching a power cord M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance 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 EN60950 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 c
20. 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 SpO Pulse Monitoring WARNING 1 ES Electrosurgery equipment wire and SpO 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 SpO 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 49 M3A Vital Signs Monitor User Manual SpO Monitoring Optional 9 2 Precautions During SpO PR Monitoring WARNING 1 Verify sensor cable fault detection before beginning of monitoring phase Unplug the SpO sensor cable from the socket the screen will display the error
21. 2 000 groups measuring data A1 2 7 NIBP Optional Method Oscillometric 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 Measuring type Systolic Pressure Diastolic Pressure Mean Pressure 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 300 mmHg Pressure resolution 1 mmHg Maximum mean error t5 mmHg Maximum standard deviation 8 mmHg Maximum measuring time of single ADU PED 120s measurement NEO 90s Typical measuring period 30s 45s depend on HR motion disturbance Overpressure protection Dual overpressure protection 88 M3A Vital Signs Monitor User Manual Specifications ADU 297 3 mmHg PED 240 3 mmHg NEO 147 3 mmHg PR Measuring range 40 bpm 240bpm Accuracy The maximum of 3bpm or 3 5 A1 2 8 SpO Optional Measuring Range 0 100 Alarm Range 0 100 Resolution 1 Accuracy ADU amp PED 2 70 100 SpO2 Undefined 0 69 SpO NEO 3 70 100
22. 2 lt etzscscansossndansdsaenacnnatcadadagssauassnsadaasdanenansondeanesauceys 75 T21 TOME TOM 5 ooi eA RUE Pris E a pu ADEL Grid 75 112 2 Meas ri s Proc d te sieren i ee E NEEE E EEEE 76 IE E TEMPE SEUD PIPER OP 78 14 2 4 S Tacna MOSS DO sadip taxlospin Dope dv ien fata setivetu Dr cer Dp MU Dade cus Ta 78 IE Bess R pl cing the Battery PORE 79 I1 2 5 Maintenance and C IC WB ee ade a eR PIS ae tDxscu c bnu taa dui e PR MEOnEU Iq tini us PE PNE UE 80 Chapter 12 Accessories and Ordering Information 4 eese eee eerte eee e eene een netten ae tnnu 81 Chapter 13 Warranty and Servite gd ie Qi dT e vip hoa eri EH S rib FO EMI escossa ssri oe esssS 84 RA CDL UT Tc 84 13 2 Contact Information asso ober uan Decani ona alana per EFL iE 84 Appendix I Specifications siscessscdssieaascssessccasonsssconsdarssvensseetansbacaunsbeadausisbea CERE UAR AR FEN EFE MM sedsss isesi 85 FEN Sue nr ELE 85 AT Speer ga DOR c eisde onsec scire e e dedi inge eua ND Dus uL E DIETS dM IVa Dun TUR E E 85 ATL T Size and Weight stas tap ea db ape E nay o pRaN Mb apa TE P ped DR ME MAE 85 BAD ad ENVTONNE Ns ae do area 85 PUA DISplay M M 86 AL2 4 EAU UE Fe P 87 21 2 5 REDOPBUC niin nsn bens sesaaoacasyan icone shai n MN Um aoa 87 r8 2 Nul T ER 88 A27 TUNIS ESL TE PR NR E TOSS 88 PAD ELE Optional RR RH 89 A29 TEMP Optional S scs aee tect ied os pne ev unas UL ue Pus ute E RA EE 90 Appendix II EMC Information
23. 7 NIBP Alarm Off re 23 31 09 Figure 6 2 Trend List 40 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 Trend List JS Clear Current ID Clear All ID NO Figure 6 3 Delete Data in Trend List When deleting data the process bar is diaplayed E wo 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 120min 80min 40min Omin Item BA v 20 100 a x 120min 4 Searching Pulse T 23 31 22 Figure 6 5 SpO Trend Graph A M3A Vital Signs Monitor User Manual Trend 3 0min 20min 10min Omin Item NIBP aT v 40 160 4 x EL Searching Pulse Tr 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 selecting the NIBP SpO or PR the Y and X can be set as the following table shows Parameter Y data range X time range SpO 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
24. Avda Constituci n 124 n GPS y Google Maps Calle Sierra Filabres 1 f a F ISQU de 28946 Fuenlabrada Madrid User Tfno 91 632 77 40 EDANUSA M3A Vital Signs Monitor Version 1 3 C About this Manual P N 01 54 112593 13 Release Date April 2012 Copyright EDAN INSTRUMENTS INC 2010 2012 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 itse
25. CE 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 38 M3A Vital Signs Monitor User Manual Alarm 5 4 Parameter Alarm WARNING 1 Prior to monitoring make sure that the alarm limit settings are appropriate for your patient 2 Setting alarm limits to extreme values may cause the alarm system to become ineffective 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 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 Check the patient s condition 2 Identify the cause of the alarm 3 Identify which parameter is alarming
26. DAN SHS pediatric Silicone Soft tip SpO2 Sensor DB9 Only compatible with EDAN SpO2 module and EDAN SpO2 Extension cable 1m Neonatal 1 Disposable Blood Pressure Cuff 3 6cm Only compatible with Connecting Tube for Neonatal Cuff 12 01 110515 02 01 210121 01 57 471157 82 M3A Vital Signs Monitor User Manual Accessories and Ordering Information Neonatal 2 Disposable Blood Pressure Cuff 4 8cm Only compatible with 1 57 4711 01 57 471158 Connecting Tube for Neonatal Cuff Neonatal 3 Disposable Blood Pressure Cuff 6 11cm Only compatible with 1 57 4711 01 57 471159 Connecting Tube for Neonatal Cuff Neonatal 4 Disposable Blood Pressure Cuff 7 13cm Only compatible with 1 57 4711 01 57 471160 Connecting Tube for Neonatal Cuff Neonatal 5 Disposable Blood Pressure Cuff 8 15cm Only compatible with 1 57 471161 Dese Connecting Tube for Neonatal Cuff Connecting Tube for Neonatal Cuff Only compatible with Neonatal Disposable Cuff TEMP 02 04 110140 Oral Auxiliary Probe 02 04 110139 Rectal Probe 01 13 36014 Power supply cable 220V EUR Standard 83 01 57 471021 M3A Vital Signs Monitor User Manual Warranty and Service Chapter 13 Warranty and Service 13 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 is void in cases of
27. E 22 Chapter 4 System Menu P RH 24 Z IE uin sede T IM RE NT M 24 A2 NIBP SGU ETT 24 A SPOS SEUD enr a gunn E E r GE EPA MM qq 25 4 A TEMP SetUP esse ion adiu E a E EEEE A EE E Ed 25 A SAAS EUD eeo e E E E O n CS nS 25 4 6 Data Management uso sssr dia ua a M er E E 25 4T ROCOLL ET oeira aea mau RUDI e a e i a E a a i iasa 26 A S SYSTEM SE Deea sac e E E ates awa E E E OE 26 45 1 General Setup p bete n r utum Se EE N ESER 26 4 8 2 General Alarmi Set D ERR aa EE E TEER 27 Z5 IO X Date SetuP reene E EA EE EE EE 27 4 8 4 Default Configuratio sses ii E rrr ub ite ausim rU PUE 28 zb Man c M DH 28 4 MP SUA Md INNEN E OD ARa S 33 Chapter S Alar M 35 SM Pal TN Modes spiser m m 35 MA Vea Level ATTE 35 SA2 Alarmi ionic iessen HERE 35 BMG Alarm Seprene en r E E EAEE EE E EEE EET 37 SP I IRE TUER RET m 38 uS DUE NT Hc E 38 5 4 Parameter Pal Eo UTEM 39 5 5 When an Alarm OCCUTS MR RE 39 2 0 Testing AlafMS e R E EE Ru E IUE 39 Chapt r 6 Trend e 40 D MANAG pact cave mE cn spp ann RERUM yates e DA PRIME EM tva MdU tM Duc NUT IM RE 40 6 2 Trend CIEGDIBS ouest adiu ED E a 41 Chapter 7 Recording yissecnssecnicicsmsicensnpaunsiionsheaiecinmNaE 43 AMICO RR vm 43 7 1 Patformance of the Record t ssrseisinicnsnieene iinan a dte PME 43 y X Operations esar e Sm 43 7 2 Outputing the Monitoring Data sass xia lt air
28. EMP ON v High 39 0 E Low 36 0 Exit sla 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 6 Data Management Select Maintenance in Main Menu to open the following menu Trend Data Used 100 Start Data Transmission Exit Figure 4 4 Data Management ELT M3A Vital Signs Monitor User Manual System Menu B Start Data Transmission select this item to start transmitting data from monitor to data management software 4 7 Recorder Select Recorder in Main Menu to open the following menu Record Trend Graph Record Trend Table Exit Figure 4 5 Recorder B Record Realtime Data Select it to output the real time data from the monitor B Record Trend Graph Select it to output the trend graph B Record Trend Table Select it to output the trend table Please refer to Chapter 7 Recording for more information 4 8 System Setup There are a few items to be set in this submenu see as follows General Alarm Setup Time amp Date Setup Default Configuration Exit Figure 4 6 System Setup 4 8 1 General Setup Select General Setup in System Setup to open submenu as shown below 26 M3A Vital Signs Monitor User Manual System Menu Key Volume
29. If the battery is low press the ON OFF button for less than 2 seconds the following dialog box displays Cannot enter standby mode due to BATTERY LOW alarm oK Figure 4 22 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 SpOz 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 34 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 WARNING A potential hazard can exist if different alarm presets are used for the same or similar equipment in any single area e g an intensive care unit or cardiac operating room 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
30. NT and SYSTEMS that are not LIFE SUPPORTING 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 Immunity IEC EN 60601 test Compliance 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 recommended separation distance calculated from the equation applicable to Radiated RF 3 V m oy SOMA RO CO Ne the frequency of the transmitter 61000 4 3 Recommended separation distance del p L 3 5 d JP 80 MHz to 800 MHz LL l P 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 a 93 M3A Vital Signs Monitor User Manual EMC Information NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies
31. 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 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 10 1 Applying Cuff 57 M3A Vital Signs Monitor User Manual 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 5096 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 Size o The lifespan of cuff is 480mmHg 20000 times 300mmHg 50000 times NIBP Monitoring Optional Patient Type Limb perimeter Cuff width Hose Infant
32. Protection class 1 instruments are already included in the protective grounding protective earth system of the room by way of grounding contacts in the power plug For internal examinations on the heart or the brain the Monitor must have a separate connection to the equipotential grounding system One end of the equipotential grounding cable potential equalization conductor is connected to the equipotential grounding terminal on the rear panel of the instrument and the other end to one point of the equipotential grounding system The equipotential grounding system assumes the safety function of the protective grounding conductor if ever there is a break in the protective grounding system Examinations in or on the heart or brain should only be carried out in medically used rooms incorporating an equipotential grounding system Check each time before use that the instrument is in perfect working order The cable connecting the patient to the instrument must be free of electrolyte WARNING If the protective grounding protective earth system is doubtful the monitor must be supplied by internal power only 1 2 5 Condensation Make sure that during operation the instrument is free of condensation Condensation can form when equipment is moved from one building to another thus being exposed to moisture and differences in temperature 1 2 6 Safety Precautions WARNING and CAUTION messages must be observed To avoid the possibility of injury
33. 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 37 M3A Vital Signs Monitor User Manual 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 B A Conditions that activate the parameter alarms The measurement value exceeds the alarm limit and the alarm is set to ON Alarms will not be activated 1f the alarm is set to OFF B B Conditions that activate the system alarms technical alarm Upon the system error the monitor prompts alarm immediately B 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 5 3 Silence The user can press SILENCE on front panel to stop audio alarm or turn off the audio system If an alarm occurs during this period the monitor can still give alarm 1 Audio alarm pause icon LX 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 SILEN
34. SpO Undefined 0 69 SpO gt Pulse Rate Measuring Range 25 bpm 300 bpm Alarm Range 30 bpm 300 bpm Resolution 1 bpm Accuracy 2 bpm Data update period ls Wave length Red light 660 3 nm Infrared light 905 5 nm Emitted light energy Less than 15 mW 89 M3A Vital Signs Monitor User Manual A1 2 9 TEMP Optional T2 Module Specifications Measuring range 25 C 45 C Working temperature 10 C 40 C Sensor type Oral axillary rectal Alarm range 35 5 C 42 C Resolution 0 1 C Accuracy 0 1 C 25 C 45 C Response time lt 60s Update time ls 2s TH Module Measuring range 34 C 42 2 C Working temperature 10 C 40 C Alarm range 35 5 C 42 C Resolution 0 1 C Accuracy 0 2 C 35 5 C 42 C 0 3 C out of the limits Response time ls 90 M3A Vital Signs Monitor User Manual Appendix II 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 emis
35. a damage caused by mishandling 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 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 13 2 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 84 M3A Vital Signs Monitor User Manual Specifications Appendix I Specifications A1 1 Classification Anti electroshock type Class I equipment and internally powered equipment EMC type Group I Class A Anti electroshock degree SpO NIBP BF Defibrillation type TEMP CF type T2 module BF type TH module 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
36. arm Setup High 160 ul on B Low High oo RE Low High 10 HJ Low SpOz ou v High 1 00 E Low High i20 RE Low ou v High 39 0 EY Low 36 0 Exit alla Figure 10 3 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 61 M3A Vital Signs Monitor User Manual NIBP Monitoring Optional 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 If the measured value is higher than High or lower than Low the monitor will give an alarm The adjusting range of NIBP alarm limits is 0 mmHg 300 mmHg Default NIBP alarm limits 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 23 70 The adjusting range of NIBP alarm limits Adult Mode SYS 40 mmHg 270 mmHg DIA 10 mmHg 215 mmHg MAP 20 mmHg 235 mmHg Pediatric Mode SYS 40 mmHg 200 mmHg DIA 10 mmHg 150 mmHg MAP 20 mmHg 165 mmHg Neonatal Mode SYS 40 mmHg 135 mmHg DIA 10 mmHg 100 mmHg MAP 20 mmHg 110 mmHg When the monitor is configured to NIBP only measuring mode the adjusting alarm limits of PR are displaye
37. ast 5 min To stop continuous measuring During continuous measuring press the NIBP START STOP on the front panel at any time to stop continuous measurement 59 M3A Vital Signs Monitor User Manual NIBP Monitoring Optional 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 Initial Inflation Pressure Patient Type ADU PED NEO Inflation Value 160mmHg 140mmHg 100mmHg 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 increases 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 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 I
38. battery must be recharged Switching on AC power supply can recharge the battery no matter if the monitor is powered on 2 3 Powering on the Monitor Press the ON OFF button on the front panel to power on the monitor all the seven segment displays are bright and LOGO information is displayed on the screen WARNING Do not use it on any patient if any sign of damage is detected or the monitor displays some error messages Contact biomedical engineer in the hospital or Customer Service Center immediately 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 integ
39. be submerged into liquids For more details about using the infrared ear thermometer refer to the accompanying operating instructions of the thermometer The monitor outfitted with the TH module must not be used together with other electrosurgery equipment for example ESU 11 2 2 Measuring Procedure I Align the center of the probe to the center of the probe cover Make sure to place the adhensive side of probe cover upward 2 Insert the probe into the probe cover on the probe cover loader until the probe cover clicks in place NOTE If the probe cover did not install well the icon D will flash on the LCD of the thermometer and you cannot take the ear temperature with four beep sounds heard and without reading on the LCD when measuring 3 Press ON MEM button of the thermometer The icon 3 will display on the LCD of the thermometer and you will hear two beep sounds Gently pull the ear back to straighten the ear cannal and snugly fit the probe into the ear canal aiming towards the membrane of the eardrum to obtain an accurate reading 776 M3A Vital Signs Monitor User Manual TEMP Monitoring Optional NOTE For children over two year old and adults pull the ear straight up and back as shown below Press the Scan button for one second until you hear a long beep sound which signals the end of the measurement and rusults will be shown on the display of the monitor Before starting another measu
40. burst IEC supply lines supply lines that of a typical commercial or 61000 4 4 With TH module With TH module hospital environment 1 kV for power 1 kV for power supply lines supply lines Surge IEC 1 kV differential 1 kV differential Mains power quality should be 61000 4 5 mode mode 2 kV that of a typical commercial or 2 kV common mode common mode hospital 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 79594 dip in UT 79594 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 10 UT 30 dip in 70 UT 30 dip poet i a UT for 25 cycles in UT for 25 s cycles lt 5 UT 95 dip in UT for 5 sec lt 5 UT 95 dip in UT for 5 sec NOTE UT is the a c mains voltage prior to application of the test level 92 M3A Vital Signs Monitor User Manual EMC Information A2 3 Electromagnetic Immunity For EQUIPME
41. ca csectspastdeeccta de ats ease haciseseety e deuten tnr due eaters Sd Mat MANU ptE Up UN PUR 53 9 7 M intenanc and Cleanin S creser E E Ne qp E NE 55 Chapter 10 NIBP Monitoring Optional sssesssesssesssocssoossosssssesssecssosesoossooesssesssesssocssoossosssssssssee 56 TOL Inir oduchon seee E E E EEE 56 10 2 NIBP MOMtOrINg sensies e E R epu mH r A E ER AU 57 IV 10 3 NIBP Setup Memu Pawnee eer anne en rect bap EMUR Euer RU uS Cu NEE in aS IRR URS ED 61 10 3 NIBP sario ETT E 61 10 32 NIBP Alarm S GU ste aelin care Od dale Uo puede add b va Desa ERE Qus dude Gu toma Sue a buc Bie rus SU S 61 10 4 NIBP Alarm Message and Prompt Message ccssccssccsssceeceeeseeceseceeeeeeseeeseeeseeeeneeeaeees 63 10 5 Mainte ance and Cleanings tt riv ba qi Rb ER cO PURI REDE batum nne LIRE UI EDU 66 Chapter 11 TEMP Monitoring Optlonal scess skesnboti va Fea Yvo ki qe Y a EES E QV EVE EIER EYE CUWER OEV cR EE Ca E 68 11 1 TEMP Monitoring with T2 Modulen Pte ntt Re RR SEE Po kn Pap eax pda Minden eva SER bd eO 68 TIT Tie UGTA qose p UE RR EUEXbE UR Ipei o bc bus eiit br P Me drei ee Minor RM US 68 11 2 WCAG PEOGOUUPE erisin ri ibvva Dena Sema o dud len todo Rage esu rade pn au UNUS 69 I1 3 TEMP S tup Ment aient iekase rero era e ora tut inl de d v Raga ETA IE EERTE 70 11 14 ATE IG 5h caressa acy ea case caesar OUR Lacuna cut mM Maratona EUN Lu aaa 71 PM Mss Care and EB SCIUNT UL 73 11 2 TEMP Monitoring with TH Module 5
42. cal STOP communication failure E engineer or manufacturer s service staff SpO Change the sensor If the problem SENSOR The sensor or connector persists please notify biomedical High 3 ERR has shortcut engineer or manufacturer s service staff C The parts of module have Please notify biomedical engineer MODULE P dad High baden PD MERE error or manufacturer s service staff ERR Reconnect the sensor well or SpO LOW The measured signals change the measuring site of body coming from pulse are too Low If the problem persists please PERFUSION weak notify biomedical engineer or manufacturer s service staff SpO SpO sensor may be High Low Make sure that the monitor and the SENSOR disconnected from the Configured patient are in correct connection OFF patient or the monitor bytheuser with the cables SpO NO SpO sensor was not Make sure the monitor and sensor SENSOR connected well or the Low is well connected reconnect the connection is loose sensor SpO NOISY There is interference with Check the condition of patient SIGNAL SpO measurement and avoid patient movement Medium signals and the waveform make sure the cable is well is abnormal connected 54 M3A Vital Signs Monitor User Manual SpO Monitoring Optional Prompt message Message Cause Searching pulse SpO sensor may be disconnected from the patient or the monitor SpO2 ALARM OFF The alarm o
43. ctor Batter Cover Pin Hole ON MEM Button owe Battery Cover WARNING 1 Keep the probe covers away from children 2 Donotresue the disposable probe covers 3 Only use the disposable probe covers supplied or recommended by EDAN Use of other manufacturer s probe covers reuse of disposable probe covers or absence of probe covers may produce temperature measurement errors and or inaccuraies 4 The intrared ear thermometer is not intended for neonatal patients CAUTION 1 Keep the probe window clean dry and undamaged at times to ensure accuate measurements To protect the probe window always keep the thermometer in the storage cover while transporting or when not in use 2 Proper installation of the probe cover ensures accurate measurements 3 Do not autoclave 4 The thermometer is not waterproof Do not immerse or drip fluids on it Should this occur dry the thermometer with warm air Check for proper operation and accuracy a5 M3A Vital Signs Monitor User Manual TEMP Monitoring Optional co 10 CAUTION Holding the thermometer too long may cause a higher ambient temperature reading of the probe which could make the body temperature measurements lower than usual Check whether the thermometer is damaged once it drops If you cannot make sure of it send the complete device to your local dealer for recalibration Keep the unit dry and away from any liquids and direct sunlight The probe should not
44. d in the ALARM SETUP menu 62 M3A Vital Signs Monitor User Manual NIBP Monitoring Optional 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 10 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 Message Cause Alarm Level NIBP SY i lue i SYS TOO HIGH SYS measuring value is above Medium upper alarm limit NIBP SY i lue i l SYS TOO LOW SYS measuring value is below Medium lower alarm limit DIA TOO HIGH NIBP DIA measuring value is above M dia upper alarm limit DIA TOO LOW NIBP DIA measuring value is below Meakin lower alarm limit MAP TOO HIGH NIBP MAP measuring value is above Wedin upper alarm limit P MAP i lue i l MAP TOO LOW NIB measuring value is below Medium lower alarm limit 63 M3A Vital Signs Monitor User Manual Technical alarms display in the area below the NIBP value NIBP Monitoring Optional Message Cause Alarm Level What to do Stop using measuring function NIBP COMM NIBP module failure or of NIBP module notify PAM High i STOP co
45. de this icon indicates the charging status When the battery is being recharged the LED is bright 19 M3A Vital Signs Monitor User Manual Introduction The LED beside this icon indicates the power condition When the monitor connects to the mains power supply the POWER Indicator LED is bright 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 jh _ Figure 3 9 Sensor Connectors Connectors for cables and sensors are as shown in Figure 3 9 1 SpO sensor connector CD 2 NIBP cuff connector 2 WARNING Only connect the device to EDAN supplied or recommended accessories 20 M3A Vital Signs Monitor User Manual Introduction Rear Panel TUTTI TUTTI Figure 3 10 Rear Panel Sockets on the rear panel are shown in the above figure D Equipotential grounding terminal for connecting to the hospital s grounding system Q Power supply socket 100V 240V 50Hz 60Hz The port can be used as the Nurse Call connector and serial port or as the interface to the Ethernet 25d M3A Vital Signs Monitor User Manual Introduction Bottom panel There are battery compartment and fuse box on the bottom panel g 3c sg 22 23 g2 st EL F z Battery FM 972 compartment 28 99 cover 8 g3 2 82 S ERI lt aS i Fu
46. easuring 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 Yellow Red 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 Relay 86 M3A Vital Signs Monitor User Manual Specifications Electronic 1A lt 125V lt 110V DC Isolated voltage 1500V line to ground Action Normal open 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 8 5 hours 4 4 Ah 17 hours At 25 C continuous SpO measuring automatic NIBP measuring per 15min Rechargeable period 2 2 Ah 180 min 4 4 Ah 360 min A1 2 5 Recorder Record width 48 mm Paper speed 25 mm s Recording types Current displayed parameter list recording Current displayed alarm list recording Real time 8s waveform recording Recording of all the parameter of current patient ID BF M3A Vital Signs Monitor User Manual A1 2 6 Review Specifications Trend List Review 100 hours 30 seconds Resolution Measurement Review 1
47. ecommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum 159 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz output power of transmitter W d E d EI d i o V 1 E 0 01 0 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 94
48. f SpO is turned off 9 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 deteriorated 5 The disposable accessories can not be reused For cleaning M 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 M 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 55 M3A Vital Signs Monitor User Manual NIBP Monitoring Optional Chapter 10 NIBP Monitoring Optional 10 1 Introduction This monitor uses the oscillometric method for measuring NIBP It can be used for adult pediatric and neonatal patients Oscillometric devices measure the amplitude of pressure chan
49. f protection against shock and is suitable for use during defibrillation M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance This symbol indicates that the instrument is IEC EN60601 1 Type BF equipment The unit displaying this symbol contains an F Type isolated floating patient applied part providing a high degree of protection against shock It is not suitable for use during defibrillation This symbol indicates that the instrument is IEC EN60601 1 Type CF equipment The unit displaying this symbol contains an F Type isolated floating patient applied part providing a high degree of protection against shock and is not suitable for use during defibrillation CAUTION Consult Instructions for Use Equipotentiality ON OFF switch It indicates the port has Nurse Call or serial port function Serial number 2035 hr SO gt The symbol indicates that the device complies with the C European Council Directive 93 42 EEC concerning medical devices REP Authorized representative in the European community padl Date of manufacture t Manufacturer M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance P N Part Number os 9 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 Federal law U S restricts this
50. g electromagnetic interference such as radio transmitters mobile telephones etc 3 The monitor is designed for continuous operation and is ordinary i e not drip or splash proof 4 Keep the environment clean Avoid vibration Keep it far from corrosive medicine dust area high temperature and humid environment 5 Do not immerse transducers in liquid When using solutions use sterile wipes to avoid pouring fluids directly on the transducer Do not sterilize the monitor recorder 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 your local Civic Office or the shop where you purchased the product 8 Remove a battery whose life cycle has expired from the monitor immediately M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance CAUTION 9 Before use the equipment patient cable and sensor should be checked Replacement should be taken if there is any evident defectiveness or aging symptom which may impair the safety or performance 10 The disposab
51. ges in the occluding cuff as the cuff deflates from above systolic pressure The amplitude suddenly increases as the pulse breaks through the occlusion in the artery As the cuff pressure decreases further the pulsations increase in amplitude reach a maximum which approximates to the mean pressure and then diminish In adult and pediatric mode the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers ANSI AAMI SP10 1992 in relation to mean error and standard deviation when compared to auscultatory measurements in a representative patient population For the auscultatory reference the fifth Korotkoff sound was used to determine the diastolic pressure In neonatal mode the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers ANSI AAMI SP10 1992 in relation to mean error and standard deviation when compared to intra arterial measurements in a representative patient population 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 co
52. h is triggered once every 25s The sound pressure of auditory alarm is in the range of 45dB 85dB 36 M3A Vital Signs Monitor User Manual Alarm WARNING Do not rely exclusively on the audible alarm system for patient monitoring Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment NOTE 1 The monitor does not have alarm condition delay or alarm signal generation delay 2 When alarms of different levels occur at the same time the monitor prompts one of the highest levels 3 If the monitor is powered off and then turned on the alarm setup can resume to the setup which is set before the power off 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 sys SN High 160 Low 90 DIA High 90 Low 50 MAP High 110 E Low so SpOz ou v High fico ES Low 90 PR High 120 Low 50 TEMP ON High 39 0 Low 36 0 Exit sila Figure 5 1 Alarm Setup B 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
53. he metal hook on the left side and press the right side of the battery down until the it clicks in place V WARNING 1 Keep the battery away from children 2 Ensure the positive side is up and the negative side down 79 M3A Vital Signs Monitor User Manual TEMP Monitoring Optional 11 2 6 Maintenance and Cleaning Calibration Mode To switch to calibration mode follow the steps below a Press the ON MEM button to turn the thermometer on The display of the thermometer shows symbols and functions b Keep pressing the ON MEM button for five seconds and you will see the OFF symbol on the display Do not release the button until you see a dot onscreen c The thermometer is now in the Calibration Mode and the display is flashing and showing the CAL symbol NOTE It is suggested that a re test is performed for the device on accuracy after three years Please send the complete device to the dealers or nearest service address However if this device is used according to the operation instructions periodic re calibration is not required Cleaning The probe is the most delicate part of the thermometer Use it with care when cleaning the lens to avoid damage If the device is accidentally used without a probe cover clean the probe as follows 1 After the measurement use the cotton swab moistened with alcohol 70 concentration to clean the lens on the inside of the probe 2 Allow the probe to full
54. 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 67 M3A Vital Signs Monitor User Manual TEMP Monitoring Optional Chapter 11 TEMP Monitoring Optional 11 1 TEMP Monitoring with T2 Module 11 1 1 Introduction M3A with the T2 module takes a temperature in either Predict or Monitor Mode 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 temperature 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 Toensure optimal accuracy always co
55. ion The use of any other probe cover may produce temperature measurement errors or result in inaccurate readings 9 TEMP measurement isn t suitable for use during defibrillation 11 1 2 Measuring Procedure 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 patient s tongue on either side of the mouth to reach the rear sublingual pocket Have the patient close his lips around the sensor Sublingual Pocket f Figure 11 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
56. l 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 30 300 Default PR alarm limits Max Upper Limit Min Lower Limit Step ADU 120 50 1 PED 160 75 1 NEO 200 100 1 9 6 Alarm Description Tables below describe the possible physiological alarms technical alarms occurring during SpO gt measurement When there is no SpO2 or PR input it prompts weak signal Physiological alarm Message Cause Alarm Level SpO2 TOO HIGH SpO gt measuring value is above upper alarm limit Medium SpO TOO LOW SpO 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 53 M3A Vital Signs Monitor User Manual SpO Monitoring Optional Message Cause Alarm Level Sphygmic signal from the measured position is too SpO NO PULSE weak the monitor does not detect any sphygmic High signal Technical alarms Message Cause Alarm Level What to do Stop using measuring function of SpO COMM SpO module failure or Hich SpO module notify biomedi
57. le notify STOP communication failure amp 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 module again AMBIENT Tuc Sensor temperaturne is PN TEMP HIGH higher than 40 C L bracket measure again after the OW AMBIENT The Sensor temperature is iin M M IBS TEMP LOW lowerthan 10 C p TEMP Offline NTC resistance Put the sensor into the sensor SENSORERR gt RO bracket take it out and measure Short NTC resistance HET H in prom pomat n 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 sensor into the sensor HEATER ERR bracket take it 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 it descends Medium sure that the cable is properly to the value lower than connected Predict value lt 3 M3A Vital Signs Monitor User Manual TEMP Monitoring Optional Message Cause Alarm Level What to do Put the sensor into the se
58. le accessories can not be reused 11 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 12 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 13 Setting alarm limits to extreme values can render the alarm system useless 14 A potential hazard may exist if different alarm presets are used for the same or similar equipment in any single area NOTE 1 Position the device in a location where the operator can easily see the screen and access the operating controls 2 The monitor can only be used on one patient at a time 3 The equipment is calibrated to display functional oxygen saturation 4 This equipment is not intended for family usage 5 If the device is discolored or damaged then discontinue use of the device 6 The pictures and interfaces in this manual are for reference only 7 Regular preventive maintenance should be carried out every two years You are responsible for any requirements specific to your country 1 2 7 Explanation of Symbols on the Monitor This symbol indicates that the instrument is IEC EN60601 1 Type BF equipment The unit displaying this symbol contains an F Type isolated floating patient applied part providing a high degree o
59. lf responsible for any effect on safety reliability and performance of the equipment if Assembly operations extensions re adjustments modifications or repairs are carried out by persons authorized by EDAN and The electrical installation of the relevant room complies with national standards and The instrument is used in accordance with the instructions for use Upon request EDAN may provide with compensation necessary circuit diagrams and other information to help qualified technician to maintain and repair some parts which EDAN may define as user serviceable Terms Used in this Manual This guide is designed to give key concepts on safety precautions WARNING A WARNING label advises against certain actions or situations that could result in personal 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 Gitano c oiscscsesssasvesssscvsseonsavcessvsnensetnacsoreesstensessiananeseanavenssaie 1 BIB Intended U SCs cT 1 1 2 Safety Ci NC SUPERI DR ER 1 12 3 TET TOMI ANC eanna aee E etet dina US p Md d eto NIRE M EN 1 1 22 Power Source Boquiremeilgascieo ec voqerr vene eb Nord rn Qe Eee erences T a ES 1 1 2 3 Grounding de IVIOPIMOE
60. m is OFF the monitor will not automatically output the alarm information 32 M3A Vital Signs Monitor User Manual System Menu B Net Setup Access Net Setup and you can see the menu below Bed No Server IP poH fis a ERI 119 E Server Port sto o Exit Figure 4 19 Net Setup Bed No Set the bedside monitor number to a value from 1 64 Server IP The default server IP is 202 114 4 119 It can be changed by the user according to the IP of PC installed with MFM CMS of EDAN Server Port Set the server port B Exit Exit the menu Factory Maintenance Factory maintenance function is only available for the service engineers of EDAN or representative authorized by EDAN Version Select Main Menu gt Maintenance gt About to check the version of the modules 4 10 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 YES Figure 4 20 Enter Standby Mode Select YES to enter the standby mode 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 33 M3A Vital Signs Monitor User Manual System Menu Cannot enter standby mode while measurement going ENTIENE Figure 4 21 2
61. 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 SpO 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 SpO 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 waveform is not proportional to the pulse volume 5 The accuracy of SpO has been verified by clinical tests according to I5809919 The m
62. mmunication failure biomedical engineer or manufacturer s service staff NIBP ILLEGAL The hardware pressure is 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 Cuff i l LOOSE CUFF z is no P rop ad Low Properly wrap the cuff wrapped or no cuff exists Cuff hose or connector is AIR LEAK damaged Low Check and replace the leaking parts if required notify AIR Th aieway of NIBP has biomedical engineer or PREESURE failure Low manufacturer s service staff ERR l NIBP SIGNAL Cuff is too loose or patient Lo Use other method to measure TOO WEAK pulse is too weak T blood pressure NIBP NOISE Because GE arm motion Make sure that the patient signal noise is too large or Low under monitoring is SIGNAL pulse rate is not regular motionless Measure again if failure OVER Pressure has exceeded the persists stop using measuring specified upper safety Low function of NIBP module and PRESSURE ae l l limit notify biomedical engineer or manufacturer s service staff MRE PIONS Excessive motion L Stop the patient fi i SATURATED ve motion OW op the patient from moving CUFF TYPE Cuff type does not comply L ERR with the Patient type OW Select appropriate cuff type 64 M3A Vital Signs Monitor User Manual NIBP Monitoring Optional
63. n addition the measurement time will be prolonged 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 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 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 Heart Rate Extremes Measurements can not be made at a heart rate of less than 40 bpm and greater than 240 bpm 60 M3A Vital Signs Monitor User Manual NIBP Monitoring Optional 10 3 NIBP Setup Menu 10 3 1 NIBP Setup In Main Menu open the NIBP Setup menu shown as below Interval Manual v Unit Continual Exit Figure 10 2 NIBP SETUP B Interval Set it to Manual or 1 2 3 4 5 10 15 30 60 90 120 240 480 min B Unit Set the pressure unit to mmHg or KPa The setting unit will display on the main interface B Continual select it to do NIBP measuring continuously within 5min 10 3 2 NIBP Alarm Setup Enter Main Menu Al
64. nfirm 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 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 Donottake an axillary temperature through patient s clothing Direct probe cover to skin contact is required 68 M3A Vital Signs Monitor User Manual TEMP Monitoring Optional WARNING 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 contaminat
65. nsor bracket take it out and measure in If the probl ist TEMP TEMP module self check cai e prob em persists f High stop using measuring function a dl ee of TEMP module notify biomedical engineer or Manufacturer s service staff Prompt Message Cause What to do Ready to TEMP The monitor prompts it after taking Put the sensor to the measuring predict the sensor out of the bracket and position and start measuring warm up is over TEMP Predict After the Predict measuring is over Enter monitoring state after the complete the data and message display on the Predict state After monitoring for interface 10 min it returns to waiting state 11 1 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 2 The probe must not be sterilized in steam 3 Only detergents containing no alcohol can be used for disinfection 4 All the sensors should be used with a protective rubber cover 5 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
66. onitor can only be used for SpOz measurement not for accuracy assessment of other device 6 A functional tester cannot be used to assess SpO accuracy 50 M3A Vital Signs Monitor User Manual SpO Monitoring Optional 9 3 Monitoring Procedure SpO plethysmogram measurement Connect the SpO sensor and extension cable to the SpO sensor port of monitor Switch on the monitor Enter Patient Setup menu to set Patient Type as required Attach the sensor to the appropriate site of the patient finger FE cw d de s The measured SpO is displayed on screen Figure 9 1 Mounting of the Sensor 9 4 Limitations of Measurement In operation the accuracy of oximetry readings can be affected by 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 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 pressure cuff arterial catheter or intravascular line Significant concentration of dysfunctional hemoglobin such as carboxyhemog lobin and methemoglobin Low SpO gt Circular pe
67. onnects additional equipment to the signal input connector or signal output connector configures a medical system and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC EN60601 1 1 If in doubt consult our technical service department or your local distributor 8 Use the battery only in this monitor Do not connect battery directly to an electric outlet or cigarette lighter charger 9 Do not unplug the battery when monitoring 10 Make sure the monitor is used in the appointed range of voltage the effect of power supply can be ignored 11 Do not solder the leading wire and the battery terminal directly 12 If liquid leaking from the battery gets into your eyes onto your skin or clothes do not rub your eyes Wash them well with clean water and go to see a doctor immediately 13 Always keep the battery away from fire 14 Stop using the battery if abnormal heat odor discoloration deformation or abnormal condition is detected during use charge or storage Keep it away from the monitor 15 Do not use a battery with serious scar or deformation 16 Only patient cable and other accessories supplied by EDAN can be used Or else the performance and electric shock protection can not be guaranteed and the patient may be injured 17 Please set the alarm according to the individual condition of patient to avoid delaying treatment Ensure there will be an alarm audio prom
68. or 3 Make sure the monitor is used in the appointed range of voltage so the effect of power supply can be ignored 4 Before using the rechargeable lithium ion battery hereinafter called battery be sure to read the user manual and safety precautions thoroughly 5 Do not place battery in the monitor with the and in the wrong way around 6 Do not connect the positive and negative terminals with metal objects and do not put the battery together with metal objects which can result in short circuits 7 Do not heat or throw battery into fire 8 Do not use leave battery close to fire or other places where temperature may be above 60 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 23 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 Data Management NIBP Setup Recorder SpOz Setup System Setup g
69. or which alarm is happening 4 When the cause ofthe 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 5 6 Testing Alarms When you switch the monitor on a selftest is started You must check that the alarm indicator lights and that you hear a single tone This indicates that the visible and audible alarm indicators are functioning correctly For further testing of individual measurement alarms perform the measurement on yourself or use a simulator Adjust alarm limits and check that appropriate alarm behavior is observed 39 M3A Vital Signs Monitor User Manual Trend Chapter 6 Trend The monitor provides 100 hour trend data of all parameters SYS MAP DIA PR SpO TEMP 2 hour trend graph of NIBP SpO2 PR TEMP storage data of 12 000 NIBP measurement results and 200 Patient IDs 6 1 Trend List The NIBP Multi Group list is displayed as follows 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 ra 23 31 08 Figure 6 1 NIBP Multi Group Review Press TREND WAVEFORM button to change the waveform to trend list as follows He aL NIBP ILLEGAL RESET 10 05 18 03 20 136 90 110 96 10 05 18 03 2 PE 10 05 18 02 100 10 01 15 02 melsa E 10 01 15 02 94 60 10 01 15 01 40 60 10 01 15 01 99 10 01 15 00 70 98 9
70. ories 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 8 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 45 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 avoid pouring it on the monitor while cleaning Do not allow water or cleaning solutions to enter the measurement connectors Wipe around except connecto
71. otherwise the monitor enter monitor mode immediately after the predict measuring The 69 M3A Vital Signs Monitor User Manual TEMP Monitoring Optional 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 11 1 3 TEMP Setup Menu 11 1 3 1 TEMP Setup Click on the TEMP Setup in the Main Menu to display the following figure Position TEMP Unit E x Exit Figure11 2 TEMP Setup Monitor when this item is selectable 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 B TEMP Unit Set temperature unit to C or F 11 1 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 EST M3A Vital Signs Monitor User Manual sys SI DIA MAP spoz ow v PR Temp fon v Figure 11 3 Alarm
72. parameters at the bottom of the screen 235 M3A Vital Signs Monitor User Manual Alarm NOTE The concrete presentation of each alarm prompt is related to the alarm level Screen display When the measured parameter exceeds its alarm limits and triggers a physiological alarm the alarm prompt will display on the screen of the monitor 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 iei Mode is beep beep beep beep beep beep beep beep beep beep which is triggered once every 5s Medium Mode is beep beep beep which is triggered once every 20s Low Mode is beep whic
73. pt 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 Guidance WARNING 21 The simultaneous use of cardiac pacemaker and other patient connected equipment may cause safety hazard 22 Please disinfect timely to prevent cross infection between patients 23 This monitor is not a device for treatment purposes 24 Only NIBP and SpO applied parts of the monitor are defibrillation proof When a defibrillator is applied keep other accessories away from the patient Otherwise it may result in damaging the monitor or harming the patient 25 Do not touch the patient bed or instrument during defibrillation 26 During monitoring if the power supply is off and there is no battery for standby the monitor will be off and only the patient information and alarm settings can be saved After reconnecting the power supply the user should turn on the monitor for monitoring CAUTION 1 Federal law U S restricts this device to sale by or on the order of a physician 2 Electromagnetic Interference Ensure the environment in which the monitor is installed is not subject to any sources of stron
74. r 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 B NIBP Setup Access NIBP Setup and you can see the menu as follows NIBP Memory STI NIBP Reset Calibration Leak Test Exit Figure 4 14 NIBP Setup 29 M3A Vital Signs Monitor User Manual System Menu NIBP Memory You can set this item to ON or OFF If the item is ON the monitor will automatically memorize the initial measurements of the patient when measuring his or her blood pressure Then the monitor will inflate the cuff according to the previous memorized measurements This function accelerates the measuring of the patient s blood pressure 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 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 calibra
75. r sockets Recommended cleaning agents are Tenside dishwasher detergents Edisonite Schnellreiniger Alconox Ammonias Dilution of Ammonia 396 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 46 M3A Vital Signs Monitor User Manual Maintenance and Cleaning 8 3 Sterilization To avoid extended damage to the equipment sterilization is only recommended when stipulated as necessary in the Hospital Maintenance Schedule Sterilization facilities should be cleaned first Recommended sterilization material Ethylate and Acetaldehyde Appropriate sterilization materials for blood pressure cuff are introduced in relative chapters respectively CAUTION 1 Follow the manufacturer s instruction
76. rates the function of parameter measurement modules display and output to compose a compact portable device Its built in replaceable battery provides convenience for patient movement The monitor is a user friendly device with operations conducted by a few buttons on the front panel Refer to section 3 3 Button Functions for more details M3A with the TH TEMP module Figure 3 1 M3A Vital Signs Monitor 10 M3A Vital Signs Monitor User Manual Introduction M3A Vital Signs Monitor can monitor SpO Oxygen saturation of arterial blood SpO Pulse Rate PR SpO 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 3 2 Screen Display The monitor is equipped with LCD The patient parameters waveforms alarm messages patient ID time monitor status and other information can be reflected from the screen If the monitor has SpO2 NIBP and TEMP functions As an option the monitor can be configured to single SpO single NIBP NIBP SpO2 NIBP TEMP or NIBP SpO 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
77. rement wait until all icons stop flashing and two beep sounds are heard WARNING Replace the probe cover after each use to ensure an accurate reading and avoid cross contamination NOTE 1 The thermometer will automatically shut down after one minute pending to extend battery life 2 The device must stay in stable ambient room temperature for 30 minutes before operation 3 Before the measurement please stay in a stable environmrnt for five minutes and avoid exercise or bath for 30 minutes 4 Itis recommended that you measure the same ear for three times If the three measurements are different select the highiest temperature 5 Remember to compare the measurement result to the regular temperature of the patient 6 There is no gender and age limitation for using infrared ear thermometer 7 The data saved in the thermometer is the last measurement data before the thermometer is powered off 8 Clinical repeatability 0 12 C 1 5 years old 0 10 C 55 years old sys M3A Vital Signs Monitor User Manual TEMP Monitoring Optional 11 2 3 TEMP Setup Menu Click on the TEMP Setup in the Main Menu to display the following figure TEMP Unit ec x Exit Figure11 2 TEMP Setup B TEMP Unit Set temperature unit to C or F For information about alarm setup refer to section 3 2 TEMP Alarm Setup 11 2 4 Alarm Message The alarm limits are as follows Patient Type Measure ALM HI ALM LO Step position
78. rements 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 To start a manual measuring B 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 B 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 To start a manual measuring during the automatic mode Press the NIBP START STOP on the front panel 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 To start a continuous measuring Access the NIBP Setup menu and pick the Continual item to start a continuous measurement The continuous measurement will l
79. 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 73 M3A Vital Signs Monitor User Manual TEMP Monitoring Optional 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 It 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 Em M3A Vital Signs Monitor User Manual TEMP Monitoring Optional 11 2 TEMP Monitoring with TH Module 11 2 1 Introduction M3A with the TH module Intrared Ear Temperature Module takes a temperature in the ear Diagram of the Intrared Ear Thermometer Probe Cover Probe Cover Scan Button Ejector ia N 7 Key ew Probe Cover Dete
80. rfusion is not good for test part The dissipation power is less than 50 uW when the sensor temperature is higher than 41 C you should shorten the measuring time 5 M3A Vital Signs Monitor User Manual 9 5 SpO Setup Menu 9 5 1 SpO Setup Click on SpO Setup in Main Menu to open the following menu Pulse volume 2 SpO Monitoring Optional Pitch Tone On x PI OFF Exit Figure 9 2 SpO Setup Pulse Volume Set it to level 0 5 Pitch Tone set it to ON or OFF PI If it is set to ON the perfusion index will be presented on the main interface If it is set to OFF the perfusion index is unavailable onscreen 9 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 Ls 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 SYS DIA High 160 zl Low High 90 3J Low on Ez MAP High 110 z Low SpOz ON 7 High 100 zl Low ON soll 90 50 60 90 PR High 120 zl Low 5 TEMP High 39 0 3J Low 136 0 Exit Figure 9 3 Alarm setup s7 M3A Vital Signs Monitor User Manual SpO Monitoring Optiona
81. rrect 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 continuous measuring automatic measuring and calibration can not be operated on neonatal or pediatric patients 3 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 56 M3A Vital Signs Monitor User Manual NIBP Monitoring Optional 4 It is suggested that the user should not start NIBP measuring when the low battery displays or the monitor may be turned off automatically 10 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
82. scaasaotaaiedaasdigcedacsnulns lt nbsanscacosecadaandscenanboateatebaansanaomitneds 44 Chapter 8 Maintenance and Cleaning siccisisessssssescssocsssessssssescssossesssesessosssssoensssocsessnessseessssoessseeses 45 BS us EB CETT TTE 45 8 2 General IeanWg cesse aem Nue rid ae bans E T de nee RN DA SR IN uU R E NES QU AERE oada OTENE ANM PLU Ede DS 45 S Ster A BOI aio losoaioisumad E bua aca E A 47 S A NTS AS LIT sd oq erii att ede Dota peu ist RT Nd Rue Cd rap DE DUE 47 8 5 Replacement OTF SG race sas irere iaeei des tan Kt evan RRE RERA TEATAR AR ER E EEE RERE EEEIEE 48 8 6 Cleaning Battery and Battery Compartment Cover sisicssss cosscasescsiessscageesdeeasszascacugiatadaoraarians 48 Chapter 9 SpO Monitoring Optional sssssssssissssssrsssssssssssssssssosssssisssorss sssssssdsssocssssssssasossessss sssess 49 9 1 Whatis SpOz MOTO eissir donetur rren sorteo rd aan ees rar oiire sisacdtorctasehosssenactvosiaauabodesaeedoss 49 9 2 Precautions During SDOPR Monitoring sssssssesessssesseserssressesstssresseesrestessteseesresresseeseese 50 9 3 Monitoring ProCeOUEB essc potat etas r DAE rd EAE a E EES ee a AE 51 9 4 Limitati ns oFVIGASUEGEIEDL aos ipuceh ordei pecore nteeva lanas diat bertus sued even sa Peas pna eater bnt pe eo UN EES 51 D SPO Setup MENU sanoen EA O T 52 DD IS SEUD en e E E meee S 52 9 5 2 Alarm Sep MENU actison snp ports ta tues atred Eetapesa aate eE ar r EEE EEE na po ES EEr NE vu opns paio cR 52 9 6 Alarm Descriptio s
83. se 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 Ea or in the bottom right corner of screen When the monitor is working with AC mains power and it has no battery or the battery has full electric energy it displays ECs When the monitor is working with AC mains power and the battery is being recharged it displays b m When the monitor is working with battery it displays E If the monitor is off you can see recharging status from the charger indicator The battery status indicator is light in yellow when being recharged and off when full 22 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 nottake 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 monit
84. shes 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 15 M3A Vital Signs Monitor User Manual Introduction 3 2 2 Optional Displays SpO only measuring mode EDAN 77 ze oe SpO 45 dx e o Figure 3 6 Display in SpO only mode 16 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 EDAN a Figure 3 7 Display in NIBP only mode 17 M3A Vital Signs Monitor User Manual Introduction 3 3 Button Functions EDAN 7773 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 D 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 NB STARIS TA To inflate the cuff and start blood measuring During the measuring process press the button to stop measuring For the monitor with NIBP function 4 ALARM LIMIT For SpO only monitor the NIBP STASRT STOP
85. sions 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 equipment 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 Elect ti Immunity test TEC 60601 test level Compliance level romagnene environment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood discharge ESD 8 KV air ES kV ait concrete or ceramic tile If IEC 61000 4 2 i floor are covered with With TH module With TH module synthetic material the relative 2 kV contact 2 kV contact humidity should be at least 4kV air 4kV air 3096 9l EMC Information M3A Vital Signs Monitor User Manual Electrical fast 2kV for power 2 kV for power Mains power quality should be transient
86. ss by select Stop Record on the menu NOTE Do not use the recording function when a low battery alarm occurs or automatic shutdown of the monitor may result A4 M3A Vital Signs Monitor User Manual Maintenance and Cleaning Chapter 8 Maintenance and Cleaning 8 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 24 months and each time after fixing up All the checks that need you to open the monitor should be performed by qualified customer service technician The safety and maintenance check can be conducted by persons from this company You can obtain the material about the customer service contract from the local company s office WARNING 1 If the hospital or agency that is responding to using the monitor does not follow a satisfactory maintenance schedule the monitor may become invalid and the human health may be endangered 2 Replace batteries according to the instruction of our service engineer 3 The disposable access
87. t gt TEMP Setup Maintenance gt gt Alarm Setup Exit 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 x Exit Figure 4 2 Patient Setup You can set the following patient information B Patient ID you can set the patient ID to 1 200 B Patient Type you can set the patient type to Adult Pediatry or Neonate Press the UP DOWN button on front panel to select the items then press the OK button to confirm Select Exit to return to the previous menu 4 2 NIBP Setup Please refer to 70 3 1 NIBP Setup for more information 24 M3A Vital Signs Monitor User Manual System Menu 4 3 SpO Setup Please refer to 9 5 7 SpO Setup for more information 4 4 TEMP Setup Please refer to 7 1 3 1 or 11 2 3 TEMP Setup for more information 4 5 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 ss EN High 160 EH Low so DIA High 90 E Low so MAP High 110 E Low so SpOz ou v High 1 00 EH Low 90 PR High 120 E Low so T
88. ted 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 Requirements 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 mains system If it is not evident from the instrument specifications whether a particular instrument combination is hazardous or not for example due to summation of leakage currents the user should consult the manufacturers concerned or an expert in the field to ensure that the necessary safety of all instruments concerned will not be impaired by the proposed combination M3A Vital Signs Monitor User Manual Intended Use and Safety Guidance 1 2 4 Equipotential Grounding
89. the pulse oximeter responds to the changes in the patient s oxygen saturation level Contrarily the lower the sensitivity is the slower the pulse oximeter responds to the changes in the patient s oxygen saturation level but the measurement accuracy will be improved When a critical patient is monitored selecting high sensitivity will help to understand the patient s state Sensor Off You can configure the alarm level for SpO Sensor Off to Low or High B Alarm Setup Access Alarm Setup and you can see the menu below Alarm Mute Alarm Silence o o Alarm Record ov A Exit Figure 4 18 Alarm Setup for monitor with recorder Alarm Mute Set the duration of silencing the audible alarm to 1 min 2 min or 3 min Alarm Silence You can set this item to ON or OFF If the item is ON you can turn off the audio system by pressing the SILENCE button on the front panel for more than 2s In this case all sounds including the alarm sound key sound and sphygmic sound coming from the monitor will be mute If the item is OFF the function mentioned above is unavailable Alarm Record only available for the monitor outfitted with a recorder By configuring Alarm Record the function of automatically outputting the alarm information in case of any physiological alarm can be enabled or disabled If the item is ON the monitor will automatically print out the alarm information once any physiological alarm is triggered If the ite
90. tion 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 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 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 4 15 NIBP Calibration 30 M3A Vital Signs Monitor User Manual System Menu Leak 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 Proced
91. 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 8 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 7096 1 and 2 Propanol up to 7096 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 adc M3A Vital Signs Monitor User Manual Maintenance and Cleaning 8 5 Replacement of Fuse Unscrew the fuse cap anticlockwise replace the fuse protector tube and screw down the fuse cap clockwise Fuse size 05x20 Rated value T 1 6 AL 250 V NOTE Switch off the power of the monitor before examining the fuse 8 6 Cleaning Ba
92. ttery 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 48 M3A Vital Signs Monitor User Manual SpO Monitoring Optional Chapter 9 SpO Monitoring Optional 9 1 What is SpO2 Monitoring The monitor uses oximetry to measure functional oxygen saturation in the blood SpO 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 SpOz numeric on the monitor will read 97 The SpOz numeric shows the percentage of hemoglobin molecules which have combined with oxygen molecules to form oxyhemoglobin The SpO 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 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
93. ure 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 the 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 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 4 16 Diagram of NIBP Air Leakage Test B SpO Setup Access SpO Setup and you can see the menu below 31 M3A Vital Signs Monitor User Manual System Menu SpOz Setup Sensitivity DERBI T Sensor Off Low Exit Figure 4 17 SpO Setup Sensitivity The SpO reading is the average of data collected within a specific time You can set Sensitivity to Low Medium or High via the menu The higher the sensitivity is the quicker
94. y dry for at least one minute 80 M3A Vital Signs Monitor User Manual Accessories and Ordering Information Chapter 12 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 02 01 210119 E adult reusable SpO sensor Only compatible with EDAN SpO 01 57 040205 12 Adult NIBP cuff 25cm 35cm CM1303 Grounding line Optional Standard configuration including EDAN SpO 02 01 210119 EDAN SHI Adult Reusable SpO2 Sensor Lemo Only compatible with in EDAN SpO2 module 2 5 m 12 01 109079 EDAN SHI Adult Reusable SpO2 Sensor DB9 Only compatible with m EDAN SpO2 module and EDAN SpO2 Extension cable 1m 01 13 210001 11 EDAN SpO2 Extension cable Only compatible with Disposable SpO2 D Sensor EDAN SpO2 Sensors and EDAN SpO2 module 2m 01 13 210001 EDAN SpO extension cable DB9 to LEMO TPU 2M EDAN SH3 neonatal SpO sensor Only compatible with EDAN SpO 12 01 110492 module and extension cable 81 M3A Vital Signs Monitor User Manual Accessories and Ordering Information EDAN SH4 adult silicone soft tip SpO sensor Only compatible with EDAN SpO module and extension cable 02 01 110531 EDAN SH4 adult silicone soft tip SpO sensor Immersion disinfection E

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