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Manual - Cardiac Direct

1. INTERVAL Set it to MANUAL or 1 2 3 4 5 10 15 30 60 90 120 240 480 min STAT Once this itme is selected the menu will automatically exit from the screen and the monitor will perform continuous measurement immediately 9 3 2 NIBP Unit Setup If you want to change the NIBP unit please select SYSTEM MENU gt MAINTAIN gt ENTER MAINTAIN PASSWORD gt USER MAINTAIN and you will see the item PRES UNIT on the menu as follows ae M3 Vital Signs Monitor User Manual NIBP Monitoring Optional NIBP SETUP Figure 9 3 System Setup PRES UNIT You may set the pressure unit to mmHg or KPa The selected unit will present itself on the main interface 9 3 3 NIBP Alarm Setup Enter SYSTEM MENU gt ALARM SETUP 68 M3 Vital Signs Monitor User Manual NIBP Monitoring Optional ALARM SETUP Figure 9 4 Alarm Setup Set the SYS DIA MAP alarm to turn on or off the alarm Pick ON to enable prompt message during the NIBP alarm pick OFF to disable the alarm function and there will be a besides each parameter Set the ALM HI for the higher alarm limit and set ALM LO for the lower alarm limit Set the ALM HI for the higher alarm limit and set ALM LO for the lower alarm limit If the measured value is higher then ALM HI or lower than ALM LO the monitor will give an alarm WARNING In order to avoid endangering the patient s life the user should use this function cautiously The adjusting range of NIBP alarm limits is
2. Technical alarm will not prompt signal Alarm Level Visual Prompt High l AY displays in Parameter area 2 displays beside the parameter Physiological alarm only Medium 1 rN displays in Parameter area 2 displays beside the parameter Physiological alarm only 1 rN displays in Parameter area 2 displays beside the parameter Physiological alarm only Low Lamp light The high medium low level alarms are indicated by the system in following different visual ways Alarm Sound The high medium low level alarms are indicated by the system in following different audio ways Alarm Level Audio Prompt Mode is beep beep beep beep beep High 6 Hen me which is triggered once every 5 s Medium Mode is beep beep beep which is triggered once every 20 s Mode is beep which is triggered once every 25 s 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 45 M3 Vital Signs Monitor User Manual Alarm 5 1 3 Alarm Setup Select the ALARM SETUP in the SYSTEM MENU to open the submenu as shown below ALARM SETUP Figure 5 1 Alarm Setup Alarm setup of each parameter You can turn ON or OFF the alarm for ea
3. User Manual M3 Vital Signs Monitor Release 1 4 with Software Revision 1 3 C Go About this Manual P N 01 54 109395 14 Release Date November 2010 Copyright EDAN INSTRUMENTS INC 2008 2010 All rights reserved Statement This manual will help you understand the operation and maintenance of the product better It 1s reminded that the product shall be used strictly complying with this manual User s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS INC hereinafter called EDAN can not be held liable EDAN owns the copyrights of this manual Without prior written consent of EDAN any materials contained in this manual shall not be photocopied reproduced or translated into other languages Materials protected by the copyright law including but not limited to confidential information such as technical information and patent information are contained in this manual the user shall not disclose such information to any irrelevant third party The user shall understand that nothing in this manual grants him expressly or implicitly any right or license to use any of the intellectual properties of EDAN EDAN holds the rights to modify update and ultimately explain this manual Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety reliability and performance of the equipment 1f Assembly operations
4. 0 mmHg 300 mmHg Default NIBP alarm limits E ADU mmHg PED mmHg NEO mmHg Lower Upper Lower Upper Lower Upper Limit Limit Limit Limit Limit Limit o ho w o o w MAP The adjusting range of NIBP alarm limits 69 M3 Vital Signs Monitor User Manual NIBP Monitoring Optional 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 PR is displayed in the ALARM SETUP menu Default PR alarm limit Max Upper Limit BPM Min Lower Limit BPM Step BPM The range of PR alarm limit a Max Upper Limit BPM Min Lower Limit BPM Step BPM Pee e o o 9 4 NIBP Alarm Message and Prompt Message Tables below describe the possible physiological alarms technical alarms and prompt messages occurring during NIBP measurement Physiological alarms NIBP SYS measuring value is above aad Medium upper alarm limit NS TOO HIGH NIBP SYS measuring value is below lower alarm limit NS TOO LOW Medium _70 M3 Vital Signs Monitor User Manual ND Too prgy NIBP DIA measuring value is upper alarm limit NIBP DIA measuring value is ND TOO LOW prs lower alarm limit NM Too HIGN NIBP MAP measuring value is upper alarm
5. 3 V m recommended separation distance 80 MHz to 2 5 GHz calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 33 Ne V 1 d 32 Ve 80 MHz to 800 MHz 1 d ENP 800 MHz to 2 5 GHz 1 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 2 93 M3 Vital Signs Monitor User Manual EMC Information NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation 1s 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 app
6. Significant concentration of dysfunctional hemoglobin such as carboxyhemog lobin and methemoglobin Low SpO2 Circular perfusion is not good for test part It is recommended to use SpO gt sensors described in Chapter 10 Accessories and Ordering Information The dissipation power is less than 50 uW when the sensor temperature is higher than 41 C you should shorten the measuring time 8 5 Alarm Setup Menu Enter SYSTEM MENU gt ALARM SETUP and you will see the menu below 57 M3 Vital Signs Monitor User Manual SpO gt 2 Monitoring Optional Figure 8 2 Alarm setup In the menu the alarm for SpO2 or PR can be turned on or off and the alarm limits can be adjusted Select ON to enable alarm during SpO2 monitoring select OFF to disable the alarm function and will be displayed on the screen beside the corresponding parameter Set ALM HI for the higher alarm limit and set ALM LO for the lower alarm limit If the measured value is higher then ALM HI or lower than ALM LO the monitor will give an alarm WARNING In order to avoid endangering the patient s life the user should use this function cautiously Default SpO alarm limits m Max Upper Limit Min Lower Limit JSE M3 Vital Signs Monitor User Manual SpO2 Monitoring Optional Default PR alarm limits i Max Upper Limit Min Lower Limit PED 160 NEO 200 SpO PR alarm range ce 8 6 Alarm Description Tables below describe the possible p
7. 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 Select the correct sensor according to the measuring position and patient type Apply the sensor to the patient You are advised to use a protective rubber cover on sensor Ensure the alarm settings on or off higher alarm or lower alarm limit are appropriate for the patient and the type of temperature measurement Select the correct measuring position in menu Switch on the monitor 0 9094 It takes 2 min 3 min for the body temperature to stabilize WARNING To ensure optimal accuracy always confirm that the correct mode and alarm limit are selected Changing the measure position may lead to the change of alarm limit 2 Verify probe cables fault detection before the beginning of monitoring phase Unplug the temperature probe cable from the socket and then the screen will display the error message TEMP SENSOR OFF and the audible alarm is activated 3 Take the TEMP probe and cable carefully When they are not in use you should coil up the probe and cable into a loose circle If the wire inside the cable is tensely pulled it may cause mechanical damage to the probe and the cable 4 The calibration of the temperature module is necessary every two years or as frequently
8. UT for 5 sec EMC Information Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the EUS TUltrasound Scanner requires continued operation during power mains interruptions it is recommended that the EUS T Ultrasound Scanner be powered from an uninterruptible power supply or a battery NOTE UT is the a c mains voltage prior to application of the test level _92 M3 Vital Signs Monitor User Manual EMC Information A2 3 Electromagnetic Immunity For EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and manufacturer s declaration electromagnetic Immunity The M3 is intended for use in the electromagnetic environment specified below The customer or the user of M3 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 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 Radiated RF Scanner including cables than the IEC EN 61000 4 3
9. Velcro fastening Allow the cuff to dry thoroughly after washing then reinsert the rubber bag SS 0r8l AZIS NAY OVd NOILLWIANI XALV1 JejomNouemNeg aaLv alTvo d4NO AOTA i P et Pal F 7 i Figure 9 5 Replace Rubber Bag in Cuff To replace the rubber bag in the cuff first place the bag on top of the cuff so that the rubber tubes line up with the large opening on the long side of the cuff Now roll the bag lengthwise and insert it into the opening on the long side of the cuff Hold the tubes and the cuff and shake the complete cuff until the bag is in position Thread the rubber tubes from inside the cuff and out through the small hole under the internal flap Disposable Blood Pressure Cuffs Disposable cuffs are intended for one patient use only Do not use the same cuff on any other patient Do not sterilize or use autoclave on disposable cuffs Disposable cuffs can be cleaned using soap solution to prevent infection NOTE For protecting environment the disposable blood pressure cuffs must be recycled or disposed of properly ee M3 Vital Signs Monitor User Manual TEMP Monitoring Optional Chapter 10 TEMP Monitoring Optional 10 1 TEMP Monitoring The TEMP measuring has Predict and Monitor modes In the Predict mode the monitor measures oral axillary rectal TEMP in a short time calculates and gets the measuring results In Monitor mode it can monitor patient for 10 min
10. discomfort of patient 6 It is suggested that the user should not start NIBP measuring when the low battery displays or the monitor may be turned off automatically 9 2 NIBP Monitoring J WARNING Before starting a measurement verify that you have selected a setting appropriate for your patient adult pediatric or neonate 62 M3 Vital Signs Monitor User Manual NIBP Monitoring Optional WARNING 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 1 Plug in the air hose and switch on the system 2 Apply the blood pressure cuff to the patient s arm or leg following the instructions below Ensure that the cuff is completely deflated 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 9 1 Applying Cuff NOTE The width of the cuff should be either 40 of the limb circumference 50 for neonates or 2 3 of the upper arm length The inflatable part of the cuff should be long enough to encircle 50 80 of the limb The wrong size of cuf
11. instrument to the power line ground protective earth when plugged into an appropriate 3 wire receptacle If a 3 wire receptacle 1s not available consult the hospital electrician Connect the grounding wire to the equipotential grounding terminal on the main system If it is not evident from the instrument specifications whether a particular instrument combination 1s 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 M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance 1 2 4 Equipotential Grounding Protection class instruments are already included in the protective grounding protective earth system of the room by way of grounding contacts in the power plug For internal examinations on the heart or the brain the Monitor must have a separate connection to the equipotential grounding system One end of the equipotential grounding cable potential equalization conductor is connected to the equipotential grounding terminal on the rear panel of the instrument and the other end to one point of the 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
12. 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 lf the protective grounding protective earth system is doubtful the monitor must be supplied by internal power only 1 2 5 Condensation Make sure that during operation the instrument is free of condensation Condensation can form when equipment is moved from one building to another thus being exposed to moisture and differences in temperature 1 2 6 Safety Precautions WARNING and CAUTION messages must be observed To avoid the possibility of injury observe the following precautions during the operation of the instrument WARNING 1 If liquid is inadvertently splashed on the equipment or its accessories it may enter the conduit or inside the monitor At this moment contact local Customer Service Center 2 The monitor is intended to be used by qualified physicians or personnel professionally trained And they should be familiar with the contents of this user manual before operation 3 Only qualified service engineers can install this equipment And only service engineers authorized by EDAN can open the shell 4 EXPLOSION HAZARD Do not use the monitor in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur 5 SHOCK HAZARD
13. 49 6l General Inironmanon on ReCOLUA Oi N a 49 OZ RECOrder Opera GON aaa N a a a E O 49 Chapter 7 Maintenance Cleaning sssssecessscccccccccccoococoocceccssscceccesecsocsocososoccseccecccseccessosossesssssseecse 51 Teed YS UCT NG Cs st is otter aoa esata a a ee asad caren danas A a a 51 Tees SG MCT AN CLC AMIN OS toy tices tet laces E E ih Tae tat ad tthe eee tied es one ias teres 51 Kao UTM ALO DN a 4S ergot cn eN Mot E N AEE EENE OTE AEO 52 FDIS UNE CC O igra E E TAA A OT 53 Tod IK COIACCING MU of FUs narina anaa a aa a T 53 7 6 Cleaning Battery and Battery Compartment Cover 0 ccccccccccssssssseseeeseeeeeeeeeeeeeeeeeeeeeaaaaas 54 Chapter 8 SpO Monitoring Optional sssssssssssscscccccccccccccsssssssssssssssssccsccsccccccscsssssessssssess 55 Sail What 1S SOs Monitorni cisonioarir o nn EA E EEA E OE 55 8 2 Precautions During SpO2 Pulse Monitoring cccccccceecccccceeeeeceeeeeeaaaeseesesseeeeeeeeeeeeeees 56 S9 MIONILOMM OS PROCCOMIG nzoto naa e EAE TE EEE EAS 56 SA Limitations Or Measure me ileer E E E EER 57 Ae N NVE M a A E EO E ET 57 SOAT DESCI DO sieran Er Set e E A E EEEE EE 59 Sd IV PALI Le ANG and C Canne oien EE EAEE T 60 Chapter 9 NIBP Monitoring Optional ssssssssscececcccsssscceccccsssssccecoccsssssccccosossssssececssssssseceeosssssos 62 SL MNT OCMC Oense E E AAE TR 62 92 NIBPMONNONN S issiria TEE T E E ig as 62 9 3 NIBP Setup Menu snotra eens E ET A cans eesua aches 67 9 ENI
14. CUFF TYPE Cuff type does not comply lect iate cuff t ERR with the patient type Select appropriate cuff type NIBP TIME Measuring time has exceeded Measure again or use other OUT 120s adult or 90s neonatal measuring method Prompt message display in the prompt area below NIBP value Manual measuring During manual measuring mode Auto measuring During automatic measuring mode Measurement over Measurement over No alarm Reset failed NIBP module reset failed 9 5 Maintenance and Cleaning WARNING Do not squeeze the rubber tube on the cuff Do not allow liquid to enter the connector socket at the front of the monitor Do not wipe the inner part of the connector socket when cleaning the monitor When the reusable cuff is not connected with the monitor or being cleaned always place the cover on the rubber tube to avoid liquid permeation A U N gt Reusable Blood Pressure Cuff The cuff can be sterilized by means of conventional autoclaving gas or radiation sterilization in 290 lt M3 Vital Signs Monitor User Manual NIBP Monitoring Optional 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
15. Neonate OxiClig I 2 5 70 100 SpO gt D YS Infant to Adult DS 100A OXI AIN 3070 100 SpO2 OXI P I D YS including D YSE ear clip D YS including 3 5 70 100 SpO2 D YSPD spotclip When the sensor is used on neonates as recommended the specified accuracy range increases by 1 compared with that used on adults 3bpm 20bpm 250bpm A1 2 9 TEMP Optional 0 1 90 M3 Vital Signs Monitor User Manual EMC Information Appendixll EMC Information Guidance and Manufacture s Declaration A2 1 Electromagnetic Emissions For all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic emission The M3 is intended for use in the electromagnetic environment specified below The customer or the user of the M3 should assure that it is used in such and environment Emission test Compliance Electromagnetic environment guidance The M3 uses RF energy only for its internal function Therefore its RF emissions are very low and are not RF emissions Group CISPR 11 likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The M3 is suitable for use in all establishments other Class A than domestic and those directly connected to the public low voltage power supply network that supplies building used for domestic purposes Harmonic emissions IEC EN 61000 3 2 Voltage fluctuations flicke
16. Signs Monitor User Manual Accessories and Ordering Information NELLCOR SPO Nellcor Reusable Adult SpO2 Sensor DS 100A OxiMax Weak Perfusion 11 15 30043 Resistance 11 15 40096 Nellcor Reusable Adult Neonate SpO 2 Sensor OXI A N OxiMax Nellcor SpO Extension cable Compatible with Nellcor OXI Max SpO gt module and Nellcor sensor Disposable and NIBP Tube 01 57 040205 Adult Cuff 25 35cm CM1303 11 57 40029 Adult Cuff 25 35cm CM1203 TEMP OTHERS 01 57 78035 Printing paper 12 01 109480 Trolley IRR 11 13 30131 11 M3 Vital Signs Monitor User Manual Accessories and Ordering Information 11 13 36015 Power cable USA standard 01 21 064115 Rechargeable Lithium Ion Battery H Y LB 1049 14 8V 4 4 Ah 11 13 114214 Grounded cable 84 M3 Vital Signs Monitor User Manual Warranty and Service Chapter 12 Warranty and Service 12 1 Warranty EDAN warrants that EDAN s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period The warranty is void in cases of 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 defect
17. 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 CALIBRATE 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 a va M3 Vital Signs Monitor User Manual System Menu Wlomtor Reference manometer Metal vessel Figure 4 25 NIBP Calibration LEAK TEST This item is used for an air leakage test Select this item to start the air leakage test Then the item will change into STOP LEAK TEST Select it again and the system will stop the air leakage test WARNING This pneumatic test other than being specified in the IEC EN1060 1 standard is to be used by the user to simply determine whether there are air leaks in the NIBP airway If at the end of the test the system gives the prompt that the NIBP airway has air leaks please contact the manufacturer for repair Procedure of the Air Leakage Test 1 Connect t
18. give alarm and display icon in TEMP parameter area 4 If measured value is lower than ALM LO the monitor will give alarm and display icon X During the measuring the following icon is always displayed in TEMP parameter area 78 2 M3 Vital Signs Monitor User Manual TEMP Monitoring Optional The range for ALM HI and ALM LO is as follows Oral Axillary Rectal 102 2 F 439 C 96 8 F 436 C Oral Axillary Rectal 102 2 F 439 C 96 8 F 436 C 10 4 TEMP Alarm Message Tables below describe the possible physiological alarms and technical alarms occurring during TEMP measurement Physiological alarms TEMP TOO HIGH Measuring value of TEMP is above upper alarm limit TEMP TOO LOW Measuring value of TEMP is below lower alarm limit Technical alarms TEMP module Stop using measuring function Temp COMM failure or l of TEMP module notify STOP communication biomedical engineer or failure Manufacturer s service staff The TEMP value is Put the sensor into the sensor beyond the range of bracket take it out and 25 C 457 measure again No TEMP TEMP sensor is not Connect the sensor and the SENSOR connected to the monitor well and measure TEMP module again Ambient temp too The Sensor high temperature is higher Put the sensor into the sensor than 40 C bracket measure again after the ambient temperature Ambient temp too The Sensor l reaches normal value low
19. limit AP lue i NM TOO LOW NIBP M measunne value is lower alarm limit Technical alarms display in the area below the NIBP value NIBP Monitoring Optional Medium NIBP COMM NIBP module failure or ERR communication failure LOOSE CUFF Cuff is no properly wrapped eau or no cuff exists ATR LEAK Cuff hose or connector is eas damaged WEAK Cuff is too loose or patient haw SIGNAL pulse is too weak ai EXCESSIVE Alter by arm motion signa noise is too large or pulse Low MOTION rate is not regular OVER Pressure has exceeded the baw PRESSURE specified upper safety limit SIGNAL Excessive motion Low SATURATED at Stop using measuring function of NIBP module notify biomedical engineer or Manufacturer s service staff Properly wrap the cuff Check and replace the leaking parts if required notify biomedical engineer or manufacturer s service staff Use other method to measure blood pressure Make sure that the patient under monitoring IS motionless Measure again if failure persists stop using measuring function of NIBP module and notify biomedical engineer or manufacturer s service staff Stop the patient from moving M3 Vital Signs Monitor User Manual NIBP Monitoring Optional Check and replace the PNEUMATIC During pneumatic test leak leaking parts if required LEAK is detected notify biomedical engineer or manufacturer s service staff
20. list or an alarm list is displayed onscreen the following menu will pop up DELETE DATA Figure 4 15 Delete Data DELETE ID Entirely delete the trend and alarm data of the current monitored patient DELETE ALL DATA Entirely delete the trend and alarm data of all the monitored patients Select YES to make the operation effective select NO to cancel the operation 4 6 Version Select VERSION in SYSTEM MENU to check the version of the monitor and the module details zI s M3 Vital Signs Monitor User Manual System Menu VERS ON Figure 4 16 Version 4 7 Time Setup Select TIME SETUP in SYSTEM MENU to access the submenu of TIME SETUP as shown below System time is in format of Y M D M D Y or D M Y Users can set the year month day hour minute and second Pick the item you want to modify and confirm it by pressing OK Select EXIT item to save the setup and return to the previous menu If you want to exit the menu without saving it press the MENU on front panel TIME SETUP CONF RM Figure 4 17 Time Setup 4 8 NIBP Setup Select NIBP SETUP in SYSTEM MENU to enter the following menu 230 2 M3 Vital Signs Monitor User Manual System Menu NIBP SETUP Figure 4 18 NIBP Setup INTERVAL Set it to MANUAL or 1 2 3 4 5 10 15 30 60 90 120 240 480 min STAT Select it to start the continual NIBP measuring For details please refer to Chapter 9 NIBP Monitoring 4 9 TEMP Setup Click on TEMP SETU
21. 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 In 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 66 M3 Vital Signs Monitor User Manual NIBP Monitoring Optional 9 3 NIBP Setup Menu 9 3 1 NIBP Setup Select SYSTEM MENU gt NIBP SETUP and you will see the menu below NIBP SETUP Figure 9 2 NIBP SETUP
22. method It is applicable for adult pediatric and neonatal usage The NIBP measurement can measure the diastolic systolic and mean blood pressure The measuring mode can be set to the following modes lt MANUAL mode one measurement is conducted for each time lt Automatic measuring interval is 1 2 3 4 5 10 15 30 60 90 120 240 480 min lt CONTINUAL mode the system executes NIBP measurement continuously within 5 min WARNING lt is forbidden to perform NIBP measurements on patient with sickle cell disease or under any condition where the skin is damaged or expected to be damaged 2 For a thrombasthenia patient it is important to determine whether measurement of the blood pressure shall be done automatically The determination should be based on the clinical evaluation 3 Ensure that the correct setting is selected when performing measurements on children It may be dangerous for the children to use an over pressure level NOTE 1 The equipment is suitable for use in the presence of electrosurgery 2 The equipment can protect against the effects of the discharge of a defibrillator 3 The continuous measuring automatic measuring and calibration can not be operated on neonate or pediatric patient 4 Please use the proper type of cuff as recommended in this manual or the wrong type may lead to injury on patient especially when measuring neonate 5 Continuous use of the automatic measuring mode for short interval may lead to the
23. temperature is lower than 10 C 79 M3 Vital Signs Monitor User Manual Probe data error Probe heater error Probe temp too high Temp SENSOR OFF Prompt Offline resistance gt R 0 C Short NTC resistance lt R 100 C Single failure The original temperature of sensor gt 33 C amp lt 40 C After the sensor temperature reaches Predict value t descends to the value lower than Predict value TEMP Monitoring Optional Put the sensor into the sensor bracket take it out and measure again If the problem persists stop using measuring function of TEMP module notify biomedical engineer or Manufacturer s service staff Put the sensor into the sensor bracket take it out and measure again If the problem persists stop using measuring function of TEMP module notify biomedical engineer or Manufacturer s service staff Put the sensor into the sensor bracket measure again after the sensor temperature reaches normal value Reconnect the sensor and make sure that the cable is properly connected Warm up over Measure over Measure time out The monitor prompts it after taking the sensor out of the bracket and warm up is Over After the Predict measuring is over the data and message display on the interface No measuring result after the module entering Predict state for 30s 80 Put the sensor to the measuring position and start measuring Enter monito
24. the monitor please contact the service personnel authorized by EDAN 11 Setting alarm limits to extreme values can render the alarm system useless 12 A potential hazard can exist if different alarm presets are used for the same or similar equipment in any single area NOTE 1 The monitor can only be used on one patient at a time 2 The function of SoO2 measurement does not require calibration 3 The equipment can protect against the effects of the discharge of a defibrillator 4 This equipment is not intended for family usage 5 Ifthe device is discolored or damaged then discontinue use of the device 6 The pictures and interfaces in this manual are for reference only M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance 1 2 7 Explanation of Symbols on the Monitor This symbol indicates that the equipment is IEC EN60601 1 Type CF equipment The unit displaying this symbol contains an F Type isolated floating patient applied part providing a high degree of protection against shock It is not suitable for use during defibrillation This symbol indicates that the instrument is IEC EN60601 1 Type BF equipment The unit displaying this symbol contains an F Type isolated floating patient applied part providing a high degree of protection against shock and is suitable for use during defibrillation Consult Instructions for Use Equipotential grounding system Stand by It designates that the switch or switch positi
25. 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 circuit 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 2992 M3 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 MENU on the front panel to open SYSTEM MENU You can perform the following operations in this menu SYSTEM MENU PATIENT SEM ACAI TIME SETUP OYOTEM SETUP NIBP SETUP SELECTION TEMP SETUP VERSION ALARM SETUP DATA STORE EXIT Figure 4 1 System memu 4 1 Patient Setup Click on PATIENT SETUP in SYSTEM MENU to open the following menu PATIENT SETUP EXIT Figure 4 2 Patient Setup You can set the follow
26. BE Se UDan a eines a a a a a a Dita ladies 67 O92 NIBP Unit S e UDe a E A d eles a tua ad alate seca Ln 67 Deo NEB Alan SCUIp siiectis carts deal a tienes E E saves dull ah aa taetes 68 9 4 NIBP Alarm Message and Prompt Messaer esatia eaea aie pedi hain aeons 70 OD Maintenance and C leat E aia teeta E TE cara My Aaa enccnytelodastaas 72 Chapter 10 TEMP Monitoring Optional csssssssssccccsssssssssssccccccccccsssssscccssssscsssscsscscooses 74 1O TEME IMO OTN nnp sata hak We coe E E inertial haste coe MN cartele Cease 74 102 Measuring Procegure serren n a E E ee a 75 10 gt TEME SSP MNU eee mre ri Pt oe EET O 76 lOt TEMP SED erea a A anaes iacceeaeteaoecn bacccane EATE 76 10 2 TEMP UMCS EUD ees en eee ee en eee 76 105333 TEMPAT S e UPa n O aces oat arcana eens 71 104 TEMPA MESSA OS neer T acl Ride a tsa Ramet laa tt delat 79 10 Carcand CICaniho aan e E ER CeO En aN Ce SP eee 8l Chapter 11 Accessories and Ordering Information sseseeeccoossssceeeocccssssceecoccossssccecesossssssceeososssoe 82 Chapter 12 Warranty and SOF VICE ssssiccacesccessienseuiaeestceves seoeeczesbedenceadeeeiaceedcekacebeasstpeondceaeeceeeseveancshaee 85 IEW an anes hoe e a a a E TO 85 122 Contact nonni ENO 25th tar Suet e ata Ae ac toa ket catak tasaa guia E giactstidetosecieneed 85 Appendix Specifications ssassn esee A eE E ENA EEN 86 VAN el LSID ore 1 0 0 Reece nee a a a a See ev ne ee ee 86 PAN 2S PCCM ALON S pen Iealaetatea ia i
27. CU Te ee ne ec rr le aaa ages ate aga ae apenas lat gd paleo ct raat Sta dea iia 26 ey Se Lt A Aa ete assesses eaves N veeur a ase ees oe tinea en eee oe eens 31 BOON CHAO Miata E ns isa A A E E cot A EA E A anes ce eee a ee 31 bs Vee NAO gs LUN 8 PEE EAEE A saad ease ad E ce ease A E A A ansaid eee 32 aero NU Db J cau as 01 emt a E E T E T T ee eo Pe E 32 kL TEMP SG UNO a Sie iach cn hd a E ae Sova deh aes dda aden atesaeewaas 33 BE MOSM arin SUE aia E a E Saaasebeianled eases cieaabe 33 NA IN Mea MR CAA tes Ria eb task cesarean es tin E E descend escent gases Gsacaa and T 34 bs MS ANA a WOM TIN hot tect ne eetat tees at Aee aan ieee sateen staid took Gases T ssa aga saeco aes 40 MI Bs De NC CP Mod aciczhanh acai bedicsue a A E AEE EL EE TREAT 43 Chapter S Alaria A aa T aT EEE 44 SLALI VOC Sre a E E E leah tat stall aaah 44 De cM Al m Leye atest et ee tec cea ace ae ia E a Phiad a iat ac aia ett a 44 SLZA IN OES casein ss orcad yrs ahead aces Yuna dandy anceps ahead aanenr OS 44 Dee Fait yc FU asaars tact otrnsla E cw oe ae cant eee 46 De E E sesh aen tate tea eae ae eee E A 47 Do gre lho fol A E nara Ea ec Pin Ome eee ORR rr ns One ena er ere ee eee me ge 47 DA ATAU LC Al AUN gecesi cted toate saceattaia E E aos adune and oeaectan anaes 47 JANN Mic tical AlI CVC CUES chet isnot aoa teeta ad set aac angsty teat Mad te cat ieed elas Mic aami ane cates desu adaneciatiels 48 Chapter o Trend ang Recording s ssisse csecsen isenta A
28. G 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 NOTE To prolong the life of rechargeable battery it is recommended to charge it at least once every month and it must be done after the electric energy runs out 7 2 General Cleaning WARNING Before cleaning the monitor or the sensor make sure that the equipment is switched off and disconnected from the power line 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 _5 M3 Vital Signs Monitor User Manual Maintenance Cleaning CAUTION 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 sensitiv
29. In the spot check mode audio and visual prompts for all medium and low technical alarms will be disabled medium and low technical alarms will only be indicated by turns in the information area In the monitoring mode audio and visual prompts for all alarms will be effective and alarms will be indicated by turns in the information area 3 In the spot check mode medium and low technical alarms cannot disable the settings of silencing the alarm Only when a new physiological alarm or a high technical alarm occurs can the monitor automatically exit the alarm silenced status In the monitoring mode if a new alarm of any type occurs the monitor will automatically exit the alarm silenced status 4 Inthe spot check mode no trend graph will be shown WAVE FORM Set displayed waveforms to UNFILLEDor FILLED FACE SELECT Set NIBP or SpO as the main displayed parameter onscreen FACE SELECT is only available for the monitor with the configured modules NIBP SpOz EXIT Return to the previous menu 25 M3 Vital Signs Monitor User Manual System Menu 4 4 Selection For the monitor outfitted with SpO2 NIBP and TEMP modules you may select SELECTION in SYSTEM MENU to access this submenu in which six selections are available NIBP TREND TAB SpO TREND TAB TEMP TREND TAB ALARM LIST TREND GRAPH and PARAMETER TAB Only one item can be selected to display information on the lower part of the interface SELECT ON NIBP TREND TAB
30. 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 P N 01 54 109395 14 EDAN www edan com cn EC REPRESENTATIVE Shanghai International Trading Corp GmbH Hamburg Eiffestrasse 80 D 20537 Hamburg Germany TEL 49 40 2513175 FAX 49 40 255726 E mail antonjin yahoo com cn EDAN INSTRUMENTS INC 3 F B Nanshan Medical Equipment Park Nanhai Rd 1019 Shekou Nanshan Shenzhen 518067 PR CHINA Email info edan com cn TEL 86 755 2689 8326 FAX 86 755 2689 8330
31. P in SYSTEM MENU to open the following menu TEMP SETUP EXIT Figure 4 19 TEMP Setup MEASURE MODE Set this item to PREDICT or MONITOR MEASURE POS Set this item to ORAL AXILLARY or RECTA The axillary sensor can be used for measuring oral axillary temperature while the rectal sensor for measuring rectal temperature 4 10 Alarm Setup Select ALARM SETUP in SYSTEM MENU to open ALARM SETUP submenu as shown below in which the user may turn on or off alarm or set the upper alarm limit or lower alarm limit If ALM is ON by pressing the SILENCE button on the front panel you can silence the audible alarm or turn off the audio system If the ALM is OFF in this submenu the monitor will not give 283 2 M3 Vital Signs Monitor User Manual System Menu an alarm when alarm condition is active By configuring ALM REC you may also enable the automatic outputting of the alarm information in case of any physiological alarm For more information please refer to 5 1 3 Alarm Setup ALARM SETUP Figure 4 20 Alarm Setup WARNING lf the user set ALM to OFF the monitor will not give alarm prompt when alarm condition is active thus the user should use this function cautiously 4 11 Maintain Select MAINTAIN item in SYSTEM MENU to open ENTER MAINTAIN PASSWORD dialog box in which you can enter password and then customize maintenance settings Factory maintenance function is only available for the service engineers of EDAN
32. TREND GRAPH op02 TREND TAB TEMP TREND TAB ALARM LISI EXIT Figure 4 5 Selection NIBP TREND TAB to display NIBP trend table Figure 4 6 NIBP Trend Table _ 26 M3 Vital Signs Monitor User Manual System Menu SpO TREND TAB to display SpO gt trend table Figure 4 7 SpO Trend Table TEMP TREND TAB to display TEMP trend table Figure 4 8 SpO Trend Table sI M3 Vital Signs Monitor User Manual System Menu ALARM LIST to display alarm list Figure 4 9 Alarm List TREND GRAPH to display the trend graph TREND GRAPH EXIT Figure 4 10 Trend Graph _ 28 M3 Vital Signs Monitor User Manual System Menu PARAMETER TAB to display SpO and NIBP parameters in the area 36 8 112 30 0 111 36 3 113 36 8 118 Figure 4 11 Parameter Table You can shift the data list to waveform display by pressing the TREND WAVEFORM button on front panel The waveform displays as shown in the following figure 29 M3 Vital Signs Monitor User Manual System Menu op 2 4 Figure 4 12 Waveform Display For Single display mode the Selection menus are different see the following menu SELECT ON sp0z TREND TAB ALARM LIST TREND GRAPH EXIT Figure 4 13 Selection for SpO2 _ 30 M3 Vital Signs Monitor User Manual System Menu SELECTION NIBP TREND TAB Figure 4 14 Selection for NIBP 4 5 Deleting Data If you press the button when a trend
33. also stop this measurement by this button WARNING Prolonged non invasive blood pressure measurements in automatic mode may be associated with purpuric ischemic and neuropathy in the limb wearing the cuff When monitoring a patient examine the extremities of the limb frequently for normal color warmth and sensitivity If any abnormality is observed stop the blood pressure measurements 64 M3 Vital Signs Monitor User Manual NIBP Monitoring Optional 1 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 2 To start a manual measuring mM Access NIBP SETUP menu and pick the INTERVAL item Select the MANUAL selection Then press the NIBP START STOP on the front panel to start a manual measurement E During the idle period of auto measuring process press the NIBP START STOP on the front panel at any time to start a manual measurement Then press the NIBP START STOP on the front panel to stop manual measurement and the system continues executes automatic measuring program according to selected time interval 3 To start a manual measuring during the automatic mode Press the NIBP START STOP on the front panel 4 To stop a manual measuring Repress the NIBP START STOP on the front panel again WARNING Prolonged non inva
34. an be selected Click on DEFAULT to return to the default configuration COLOR SELECT CONF RM Figure 4 27 Color Select ALARM SETUP ALARM NUTE Set the duration of silencing the audible alarm to 60s 120s or 180s ALARM SILENCE You can set this item to ON or OFF If the item 1s 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 EXIT Exit the menu Factory Maintain Factory maintenance function is only available for the service engineers of EDAN or 39 M3 Vital Signs Monitor User Manual System Menu representative authorized by EDAN 4 12 Data Storing The monitor can support the USB storage for the Data Store function Enter the menu by SYSTEM MENU gt DATA STORE to set the data storing function You can set the storing interval browse data search data and delete all the data or single item data DATA STORE 15 BROWSE Figure 4 28 Data Store ON OFF set the Data Store function to ON or OFF WARNING 1 If you want to stop the data storing function you should set this item to OFF before unplugging the USB disk 2 Do not unplug the USB storage when storing data If the data damaged by unplugging the USB storage during data storing can not be deleted on the m
35. arek fete tattle eat can are fl eaettch are deo a acy ca alee asad Gauci 86 AN2 FSZ and Woeii Seen ee ne ee eee a ne ee eee 86 Pad 2 2B Ay UOT CIAL ea n cee es aarti E wnat veda ventana cout eaau nats 86 ROAA HIS 0 kc gare eno eee ot ee Meee Cee nee AE mee ne 87 AE NENE Ley rte es weet tn R ts Rescate reat Reshma vatican A A aati A 87 MIC OM Cl os Peet ta red ett ca eee ee 88 PND GTR VC Wy carena the ioe eat saree hast Sea ctic che tha herearie kN GS atin keane 88 ALZ 7 INSP CO PINOM Als teetsicstscosatictaisenctaieatase beatles taeasesshectataalactato sees teaeeasnotdetavene cao 88 ALZ S OPO Opona scrsccsasicees syste banc ose Neate nee aac eee eae SE aes 89 Al 2 OCT TIMP ODHODA rinin a a a a 89 Appendix EMC Information Guidance and Manufacture s Declaration ssssessoeees 91 A2 1 Electromagnetic Emissions For all EQUIPMENT and SYSTEMS eee 9 A2 2 Electromagnetic Immunity For all EQUIPMENT and SYSTEMS ee eeeeeeeees 9 A2 3 Electromagnetic Immunity For EQUIPMENT and SYSTEMS that are not LIFE SUFPORTEING anrea a T ee ee 93 A24 Recommended Separation Distans saroiaren n E eine ENNE 94 M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance Chapter 1 Intended Use and Safety Guidance 1 1 Intended Use The Vital Signs Monitor hereinafter called monitor is intended to be used for non invasive continuous monitoring of SpO2 oxygen saturation of the blood NIBP non invasive blood p
36. arm is set to OFF B Conditions that activate the system alarms technical alarm Upon the system error the monitor prompts alarm immediately C General alert In some circumstances alerts will behave as physiological alarms in normal senses we do not regard them as real patient health related items 5 3 Silence The user can press SILENCE button on the front panel to silence the audible alarm or turn off the audio system If an alarm occurs during this period the monitor can still give alarm 1 Alarm silenced icon Press the SILENCE button on the front panel for less than 2s and the audible alarm is mute The alarm silenced icon displays Pressing SILENCE again can resume the audible alarm 2 Audio system off icon Press the SILENCE button for more than 2s the audio system is turned off including the audible alarm key volume and pulse tone Pressing SULENCE again can turn on the audio system 5 4 Parameter Alarm The setup for parameter alarms is in the menus In the SYSTEM 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 limit The following actions take place 1 Alarm message disp
37. 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 activity has ended 6 Do not take an axillary temperature through patient s clothing Direct probe cover to skin contact is required 7 Biting the sensor tip while taking a temperature may result in damage to the sensor 8 Use disposable TEMP sensor covers recommended by EDAN to limit patient cross contamination The use of any other probe cover may produce temperature measurement errors or result in inaccurate readings ook FA lt M3 Vital Signs Monitor User Manual TEMP Monitoring Optional 10 2 Measuring Procedure 1 Ensure the sensor are well installed The icon indicating measuring position flashes in TEMP parameter area on the main interface If necessary change the MEASURE MODE and MEASURE POS measure position in menu 2 Take out the sensor from the sensor bracket After warm up it beeps and displays WARM UP OVER 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 thum
38. asing NOTE Be careful when inserting paper Avoid damaging the thermo sensitive print head Unless when inserting paper or shooting troubles do not leave the recorder catch open Removing Paper Jam When the recorder functions or sounds improperly you should open the recorder casing to check for a paper jam Removing the paper jam in the following way Cut the record paper from the feeding edge Open the recorder casing Re insert the paper 50 M3 Vital Signs Monitor User Manual Maintenance Cleaning Chapter 7 Maintenance Cleaning 7 1 System Check Before using the monitor do the following Check if there is any mechanical damage Check if all the outer cables inserted modules and accessories are in good condition Check all the functions of the monitor to make sure that the monitor is in good condition If you find any damage on the monitor stop using the monitor on patient and contact the biomedical engineer of the hospital or EDAN immediately The overall check of the monitor including the safety check should be performed only by qualified personnel once every 6 to 12 months and each time after fixing up All the checks that need you to open the monitor should be performed by qualified customer service technician The safety and maintenance check can be conducted by persons from this company You can obtain the material about the customer service contract from the local company s office WARNIN
39. b 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 Figure 10 1 Measuring position in mouth For measuring oral TEMP do not take an axillary temperature through patient s clothing 5 The monitor enters PREDICT measuring mode displays in the TEMP parameter area After Predict measuring is over the measuring result displays and MEASURE OVER appears on the interface 6 If the predict measuring is successfully finished the monitor enters MONITOR mode after 30s otherwise the monitor enter MONITOR mode immediately after the predict measuring The monitoring state lasts for 10 min then the monitor enters waiting state displays in the TEMP parameter area on interface Put the sensor back into the sensor bracket 7 If necessary repeat the measurement according to the procedure above NOTE 1 After one measurement the user should put the sensor back to the sensor bracket and then take it out for starting a new measurement Se M3 Vital Signs Monitor User Manual TEMP Monitoring Optional 2 The monitors state can change from the PREDICT mode into the MONITOR mode but it can not change from the MONITOR mode into the PREDICT mode 10 3 TEMP Setup Menu 10 3 1 TEMP Setup Click on the TEMP SETUP
40. ch parameter and set the upper and lower alarm limit for each parameter by ALM HI or ALM LO In the ALARM SETUP menu set the alarm limit for each parameter SYS DIA MAP SpQ PR For example Method to set systolic blood pressure alarm limit for SYS alarm Step 1 Set the SYS alarm to ON Step 2 Select the ALM HI higher alarm limit of SYS ALM LO lower alarm limit of SYS The user can press UP DOWN and OK to set the menu The method for setting the alarm limits of other parameters is the same as SYS alarm ALM REC and ALM REC TIME By configuring ALM REC 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 happens If the item is OFF the monitor will not automatically output the alarm information Additionally if ALM REC is ON you can also adjust the recording time of the alarm waveform to be outputted by setting ALM REC TIME Available options are 8s 16s and 32s _ 46 M3 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 A Conditions that activate the parameter alarms The measurement value exceeds the alarm limit and the alarm is set to ON Alarms will not be activated if the al
41. configure the alarm level for SpO2 SENSOR OFF to HIGH or LOW SENSITIVITY The SpO reading is the average of data collected within a specific time You can set Sensitivity to HIGH MED or LOW via the menu The higher the sensitivity is the quicker 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 NIBP SETUP Access NIBP SETUP and you can see the menu as follows 6 2 M3 Vital Signs Monitor User Manual System Menu NIBP SETUP CALIBRATE ON Figure 4 24 NIBP Setup 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 CALIBRATE Calibrate the cuff pressure reading with a calibrated reference manometer Select CALIBRATE to start the calibration and the item will change into STOP CAL which if is selected the system will stop calibration WARNING The calibration of the NIBP measurement is necessary
42. cted to mains power supply E oe Network connection indicator Network connection off 7 Medium Low alarm 7 High alarm icon Audio system off Alarm silenced Parameter alarm off Patient type ADU Patient type NEO NIBP manual mode NIBP interval mode Q NIBP continual mode 9 n Measuring oral TEMP in ADU mode Patient type PED 4 11 M3 Vital Signs Monitor User Manual Information Measuring axillary TEMP in ADU mode Measuring rectal TEMP in ADU mode Measuring oral TEMP in PED mode Measuring axillary TEMP in PED mode Measuring rectal TEMP in PED mode Current patient ID Parameter Area Parameter area is on the right of Waveform area and parameters are displayed SpO2 SpO gt Unit PR Pulse Rate Unit BPM NIBP SYS DIA MAP Unit mmHg or kPa Pulse Rate Pulse Rate Unit BPM TEMP Temperature Unit C or F The PR signal from SpOz measuring takes priority to be displayed Waveform Trend List Alarm List Area It can display SpOz waveform Trend tab or Alarm list You can select it in the SELECTION of SYSTEM MENU Information Area The information areas are to display operating status of the monitor and condition of the patient including the following data Patient type and ID NIBP measuring mode Signs indicating the net connection status Signs indicating the battery or mains power supply status Cur
43. cuff connector 8 Right side of the monitor If the monitor has TEMP function there will be TEMP module and sensor on the right side 19 M3 Vital Signs Monitor User Manual Information TEMP sensor TEMP sensor bracket Figure 3 12 Right Panel WARNING Only connect the device to EDAN supplied or recommended accessories Rear Panel Figure 3 13 Rear Panel of M3 20 M3 Vital Signs Monitor User Manual Information Sockets on the rear panel are shown in the above figure Equipotential grounding terminal for connection with the hospital s grounding system Power supply socket 100V 240V 50Hz 60Hz USB connecting port for USB storage Network Interface Standard RJ45 Socket for connecting to MFM CMS of EDAN Bottom panel There are battery compartment and fuse box on the bottom panel gt Battery compartment cover e6es0 s 10 FUSE T1 6AL250VP Ss 3 Fuse box s emje ewep As yeq piore OL o o g 0 ho a a E oo OY 5 0 D 2 p D a gt 0O 5 5 ao o p F9 lt Burddiys 104 q Asoyeg eAowe gt Figure 3 14 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 rt or 24 in the bottom right corner of screen When the monitor is work
44. e sensor is attached to the patient s inger or another appropriate position If no pulse information is displayed after 30s passes check whether the sensor the finger If necessary attach the sensor to another position which provide better signal is connected with patient s might Stop using measuring function of SpO2 module notify biomedical engineer or manufacturer s service staff Reconnect the sensor or choose another measured position If the problem remains please notify biomedical engineer or manufacturer s service staff Reconnect the sensor with the monitor Make sure the monitor is well connected with the cable 4 Do not use any sensor or cable that may be damaged or deteriorated 60 M3 Vital Signs Monitor User Manual SpOs2 Monitoring Optional For cleaning 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 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 abl s M3 Vital Signs Monitor User Manual NIBP Monitoring Optional Chapter 9 NIBP Monitoring Optional 9 1 Introduction The Non invasive Blood Pressure NIBP module measures the blood pressure using the oscillometric
45. e 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 solution to enter the measurement connectors Wipe around except connector sockets Recommended cleaning agents are Tenside dishwasher detergents Edisonite Schnellreiniger Alconox Ammonias Dilution of Ammonia lt 3 Window cleaner Alcohol Ethanol 70 Isopropanol 70 Window cleaner Sodium Hypochlorite 1 10 NOTE 1 The diluted sodium hypochlorite from 500ppm 1 100 diluted bleaching agent to 5000ppm 1 10 bleaching agents is very effective The concentration of the diluted sodium hypochlorite depends on how many organisms blood mucus on the surface of the chassis to be cleaned 2 The monitor and sensor surface can be cleaned with hospital grade ethanol and dried in air or with crisp and clean cloth 3 This company has no responsibility for the effectiveness of controlling infectious disease using these chemical agents Please contact infectious disease experts in your hospital for details 7 3 Sterilization To avoid extended damage to the equipment sterilization 1s 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 re
46. eceives 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 Sleep mode Ae M3 Vital Signs Monitor User Manual Alarm Chapter 5 Alarm This chapter gives general information about the alarm and measures to be taken accordingly Alarm setup and prompt messages are provided in respective parameter setup sections 5 1 Alarm Modes 5 1 1 Alarm Level Each alarm either technical or physiological has its own level For alarm of higher level when the alarm condition is active the system will give a prompt in various ways Alarms in the monitor are divided into three levels high medium and low High level alarm indicates the patient s life 1s in danger or the monitor has serious problem in technical respect It is the 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 certain monitoring process technically impossible or make monitoring result unbelievable Technical alarm is also called System Error M
47. ectly 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 Always keep the battery away from fire 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 Do not use a battery with serious scar or deformation 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 The user should check the monitor and accessories before use Please set the alarm according to the individual status of patient to avoid delaying treatment Ensure there will be alarm audio prompt when alarming Devices connecting with monitor should be equipotential When the monitor and electrosurgical device are used together the user physician or nurse should guarantee the safety of patient During monitoring if the power supply is off and there is no battery for standby the monitor will be off After reconnecting the power supply the user should turn on the monitor for monitoring Please disinfect timely to prevent cross infection between patients This monitor is not a device for treatment purposes Do not touch the patient bed or instrument during defibrillation M3 Vital Signs Monitor User Manual Intended Use and Safety G
48. essage General alarm belongs to those situations that can not be categorized into these two cases but still need to pay attention 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 The alarm levels for technical alarms general alarms and some physiological alarms are pre set by the system and cannot be changed by the user in most of the cases But you can alter the alarm level for SpO2 SENSOR OFF For more information please refer to SpO2 SETUP in 4 11 Maintain 5 1 2 Alarm Modes When 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 prompt is given by LCD display device the speaker on the display device and the alarm indicator Physiological alarm Technical Alarm or description is displayed in information area or beside the parameters at the bottom of the screen NOTE The concrete presentation of each alarm prompt is related to the alarm level Screen Display When the measured parameter exceeds its alarm limits and triggers a physiological alarm the monitor will give alarm prompt on the screen indicating the occurrence of alarm The description will display in Information area such as NS TOO HIGH and rN _44 M3 Vital Signs Monitor User Manual Alarm displays beside the parameter to indicate the low medium level alarm
49. 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 Guidance cccccccsssssssssssccccccccssssssccscccccscccsssscssccccssssssess 1 Wid MICO MOCO UTi a secant nee aie ayia avacseocaan E aes enemas l EZ SAY da Ea E E xan tinea T A es aoa ete atau l Ti Zee TV ronen ern Aa e Garg E E eee ataeGes l 1 2 2 POWEr Source Reguirenie MiS anien e an EA E E l t2 Croundine De MON OL seere r N E E l TZ sas GUA POLE Mel alla OUIN 1 eee E E ones 2 WD S4C ONCE Ws aO eins soutien na A AA 2 WD o Saey TEC AUT ONS sna S 2 1 2 7 Explanation
50. f can cause erroneous readings If the cuff size is in question then use a larger cuff Size of reusable cuff for neonate pediatric adult Patient Type Limb perimeter Cuff width Hose Child 18cem 26cm _ 63 M3 Vital Signs Monitor User Manual NIBP Monitoring Optional Large Adult 33 cm 47 cm Thigh 46 cm 66 cm Size of disposable cuff for neonate children adult 1 5m or 3 m The lifespan of cuff is 480mmHg 20000 times 300mmHg 50000 times 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 3 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 Ifthe 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 4 Check whether the patient mode is appropriately selected Access PATIENT SETUP menu from SYSTEM MENU and pick PAT TYPE item and select the required patient type 5 Select a measurement mode in the NIBP SETUP menu Pick the INTERVAL item for MANUAL or set the interval for auto measurement or select the CONTINUAL mode 6 Press the NIBP START STOP on the front panel to start a measurement You can
51. he 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 LEAK TEST by pressing UP DOWN It indicates Leak testing in the information area 5 The system will automatically inflate the pneumatic system to about 180mmHg 6 After 20 seconds 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 situation 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 Bee og M3 Vital Signs Monitor User Manual System Menu Figure 4 26 Diagram of NIBP Air Leakage Test 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 COLOR SELECT Set the color of displayed waveforms 16 kinds of colors c
52. hysiological alarms technical alarms occurring during SpO gt measurement When there is no SpO gt or PR input it prompts weak signal Physiological alarm SpO2 TOO HIGH SpO measuring value is above upper alarm limit Medium SpO2 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 Sphygmic signal from the measured position is too NO PULSE weak the monitor does not detect any sphygmic High signal _ 59 M3 Vital Signs Monitor User Manual Technical alarms SpO Monitoring Optional Al Message Cause a What to do Level SpO SENSOR OFF SEARCH PULSE SpO COMM STOP SpO2 PERFUSION LOW NO SpO SENSOR The SpOz sensor may be disconnected from the patient SpO2 disconnected from sensor may be the patient or the monitor SpO2 module failure or communication failure The measured signals coming from pulse are too weak The SpO2 sensor is disconnected from the monitor or the sensor is not connected well to the device 8 Maintenance and Cleaning ee High Low Configured by the user 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 Do not immerse the sensor into any liquid Make sure th
53. in the SYSTEM MENU to display the following figure TEMP SETUP EXIT Figure10 2 TEMP Setup MEASURE MODE Set the measuring mode to PREDICT or MONITOR MEASURE POS Set the measuring position to ORAL AXILLARY or RECTA The axillary sensor can be used for measuring oral axillary temperature while the rectal sensor for measuring rectal temperature 10 3 2 TEMP Unit Setup If you want to change the TEMP unit please select SYSTEM MENU gt MAINTAIN gt ENTER MAINTAIN PASSWORD gt USER MAINTAIN and you will see the item TEMP UNIT on the menu as follows 965 M3 Vital Signs Monitor User Manual TEMP Monitoring Optional Figure10 3 System Setup TEMP UNIT You may set the TEMP unit to C or F The selected unit will present itself on the main interface 10 3 3 TEMP Alarm Setup Click on ALARM SETUP in the SYSTEM MENU and set the alarm higher limit or lower limit in the following figure sT M3 Vital Signs Monitor User Manual TEMP Monitoring Optional ALARM SETUP Figure 10 4 Alarm Setup Menu ALM pick ON to enable prompt message during the TEMP alarm pick 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 ALM HI for the higher alarm limit and set ALM LO for the lower alarm limit In PREDICT mode if measured value is higher than ALM HI the monitor will
54. ing patient information PAT ID Patient ID 1 1000 e M3 Vital Signs Monitor User Manual System Menu PAT TYPE Patient type ADU PED or NEO Press the UP DOWN button on the front panel to select the items then press the OK button to confirm Pick EXIT to return to the previous menu 4 2 Default Setup NOTE Select any item in this submenu to cancel the current setup and use the selected default setup DEFAULT L SAVE CURRENT AS USER CONTIG CONF IRM Figure 4 3 Default Menu FAC DEF CONFIG factory default configuration USER DEF CONFIG user defined default configuration SAVE CURRENT AS USER CONFIG Save the current setup as the user default configuration CONFIRM Confirm your choice exit this submenu and return to the previous menu 4 3 System Setup In this submenu SYSTEM SETUP has a few items to set see the following menu 24 M3 Vital Signs Monitor User Manual System Menu SYSTEM SETUP MED MONI UNFILLED EXIT Figure 4 4 System Setup ALARM VOL Set alarm volume to HIGH MED or LOW STANDBY Set it to ON or OFF to enable or disable the Sleep Mode function Refer to 4 12 Sleep Mode KEY VOL Set key volume to HIGH MED LOW or OFF SPHY VOL Set sphygmic volume to HIGH MED LOW or OFF WORK MODE Set work mode to MONI monitoring mode or SPOT spot check mode NOTE 1 The work mode will be indicated in the information area 2
55. ing with AC mains power and it has no battery or the battery has full electric energy it displays rch When the monitor is working with AC mains power and the battery is being recharged it displays FA When the monitor is working with battery it displays FFA Pis M3 Vital Signs Monitor User Manual Information If the monitor is off you can see recharging status from the charger indicator Battery status light is yellow when recharging off when full For recharging the battery is 90 to 100 charged after 300min of recharging Replace Battery During monitoring state or communication state when the battery is low or empty the battery state indicator will display and flash When the lifespan of battery is over or foul odor and leakage has been detected please contact the manufacturer or local distributor for replacement of battery WARNING 1 Do not take off the battery when monitoring The unexpected power supply off can not impact the monitor normal working if it has battery for standby 2 Stop using the battery if abnormal heat odor discoloration deformation or abnormal condition is detected during use recharge or storage Keep it away from the monitor 3 Make sure the monitor is used in the appointed range of voltage the effect of power supply can be not noticeable 4 Before using the rechargeable lithium ion battery hereinafter called battery be sure to read the user manual and safety precautions
56. ions for monitor 3 2 Screen Display The monitor is equipped with LCD The patient parameters waveforms alarm messages patient ID time monitor status and other information can be reflected from the screen If the monitor is outfitted with the modules SpO2 NIBP and TEMP the three parameters SpO NIBP and TEMP are onscreen in the general display mode If the monitor is configured to the double parameter measuring function as NIBP SpO or NIBP TEMP double parameters will be displayed onscreen Also the monitor can be configured to single parameter mode with SpOz measuring only or NIBP measuring only In SpO2 only or NIBP only measuring mode the single parameter of SpO2 or NIBP is displayed The configuration is preset by the manufacturer it can not be changed by the user 3 2 1 General Display Mode The screen is divided into three areas 1 Parameter area Q 2 Waveform Trend list Alarm list area 3 Information area 8 Figure 3 2 Main display with waveform _Q M3 Vital Signs Monitor User Manual Information The Waveform area can display parameter trend list or alarm list It displays as follows Figure 3 3 Main display with alarm list The display on the screen can be changed to a trend graph as follows TREND GRAPH Figure 3 4 Display trend graph 10 M3 Vital Signs Monitor User Manual Information The icons on the interface and their meanings are as follows Battery status indicator Conne
57. ive 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 1s being repaired 12 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 85 M3 Vital Signs Monitor User Manual Specifications Appendix Specifications A1 1 Classification Anti electroshock type Class equipment and internal powered equipment Anti electroshock degree SpO2 NIBP BF Defibrillation type TEMP CF type 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 IEC 60601 1 1988 A1 A2 ISO 9919 EN 12470 4 EN 60601 1 1990 A1 A2 IEC EN 60601 2 30 IEC EN 60601 1 2 2001 A1 ANSI AAMI SP 10 A1 2 Specifications A1 2 1 Size and Weight A1 2 2 Environment S cca mtiy 25 80 no coagulate 25 93 no coagulate a Power supply Voltage 10O0V 240V 86 M3 Vital Signs Monitor User Manual Specifications FUSE T 1 6AL A1 2 3 Display Device 5 7 inches LCD Monochrome LCD
58. lative chapters respectively WARNING Please disinfect timely to prevent the cross infection between patients _52 M3 Vital Signs Monitor User Manual Maintenance Cleaning CAUTION 1 Follow the manufacturer s instruction to dilute the solution or adopt the lowest effective concentration Do not let liquid enter the monitor No part of this monitor can be subjected to immersion in liquid Do not pour liquid onto the monitor during sterilization Use a moistened cloth to wipe up any agent remained on the monitor O A W DN 7 4 Disinfection To avoid extended damage to the equipment disinfection 1s only recommended when stipulated as necessary in the Hospital Maintenance Schedule Disinfection facilities should be cleaned first 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 for SpO2 sensor blood pressure cuff or TEMP sensor Recommended types of disinfectants are Alcohol Alcohol Ethanol up to 70 1 and 2 Propanol up to 70 Aldehyde Glutaraldehyde up to 3 6 WARNING Please do not mix disinfecting solutions such as bleach and ammonia as hazardous gases may result CAUTION 1 Follow the manufacturer s instruction to dilute the solution or adopt the lowest effective concentration Do not let liquid enter the monitor No part of this monitor can be subjected to immersion in liquid Do not pour liq
59. lays on the screen as described in alarm mode 2 The monitor beeps in its corresponding alarm class and volume 3 Alarm lamp flashes AT M3 Vital Signs Monitor User Manual Alarm 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 l 2 3 4 Check the patient s condition Identify the cause of the alarm Identify which parameter is alarming or which alarm is happening When cause of alarm has been over check that the alarm is working properly You will find the alarm messages for the individual parameter in their appropriate parameter chapters of this manual _ Ag M3 Vital Signs Monitor User Manual Trend and Recording Chapter 6 Trend and Recording The monitor provides 72 hour trend data of all parameters SYS MAP DIA PR SpO2 storage of 30 000 NIBP measurement results 5 hour SpO2 waveform and 800 alarm events In SELECTION submenu the user can set the displayed contents to waveform trend table or alarm list which can be printed out via RECORD 6 1 General Information on Recording A thermal dot matrices recorder with printout paper of 48mm wide is used for the monitor Performance of the Recorder Trend list is printed out at the rate of 25 mm s English printout Set the displayed con
60. licable 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 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 M3 Fetal amp maternal Monitor The M3 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the M3 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the M3 as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz output power of transmitter W Hz 3 5 JP J 23 Ne Ae ENP 1 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
61. n the monitoring mode this hot key is configured as the RECORD record button by default Press it and you can print out the SHORTCUT KEY currently displayed waveforms trend graph trend lists or FOR CHANGING alarm lists Pressing it while recording can stop recording PATIENT TYPE In the spot check mode this hot key is configured as the shortcut key for changing the patient type You can rapidly alter the patient type by pressing this button Press to open the SYSTEM MENU Refer to Chapter 4 System Menu for details Select the items in menu or decrease or increase the items Confirm the selection by pressing OK The LED besides this icon indicates the charging status When the battery is being recharged the LED is bright 18 M3 Vital Signs Monitor User Manual Information The LED besides this icon indicates the power status When the monitor connects to the mains power supply the lt POWER Indicator LED is bright 3 4 Interfaces For the convenience of operator interfaces of different functions are in different sites of the monitor There is a USB port on rear panel for Data storing function Left side of the monitor At the left side of the monitor is the recorder s paper inlet cover nntg MAP me of wv Wi Figure 3 11 Left Panel Sensor port on the front panel Connectors for cables and sensors are as shown in Figure 3 8 1 SpO s sensor connector Q 2 NIBP
62. nitor is equipped with a recorder open the recorder door to check if paper is properly installed in the slot If no paper is present refer to Chapter 6 Trend and Recording for details M3 Vital Signs Monitor User Manual Information Chapter 3 Introduction 3 1 General Information The monitor integrates the function of parameter measurement modules display recording and output to compose a compact portable device Its built in replaceable battery provides convenience for patient movement On the LCD display screen SpO2 waveform and all the monitoring parameters can be displayed clearly The monitor is a user friendly device with operations conducted by a few buttons on the front panel Refer to section 3 3 Button Functions for more details PR BPM A 99 60 28118318 DIA 76 NIBP 119 MAP 88 NIBP el 8 18 se SYS z 114 NIBP SP02 Figure 3 1 M3 Vital Signs Monitor M3 Vital Signs Monitor can monitor SpO2 Arterial Oxygen Saturation SpO2 Pulse Rate PR SpO PLETH Plethysmogram NIBP Systolic Pressure SYS Diastolic Pressure DIA Mean Pressure MAP Pulse Rate PR TEMP Temperature TEMP M3 Vital Signs Monitor User Manual Information The monitor provides extensive functions such as visual and audible alarms recording and storage for trend data SpO2 NIBP TEMP measurements review net connection nurse call alarm events and so on Recording and mobile storage are optional funct
63. nnect the power line to the jack special for hospital usage Connect to the ground line if necessary Refer to section1 2 Safety Guidance for details NOTE When the battery configuration is provided after the monitor is transported or stored the battery must be recharged Switch on AC power supply can recharge the battery no matter if the monitor is powered on 2 3 Powering on the Monitor Press the ON OFF button on front panel to power on the monitor LOGO information will be displayed on the screen WARNING Do not use it on any patient if any sign of damage is detected or the monitor displays some error messages Contact biomedical engineer in the hospital or Customer Service Center immediately M3 Vital Signs Monitor User Manual Installation of Monitor NOTE 1 Check all the functions of the monitor and make sure that the monitor is in good condition 2 If rechargeable batteries are provided recharge them after using the monitor every time to ensure the electric power is enough 3 The interval between double presses of ON OFF button should be more than 1 second 4 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 2 5 Checking the Recorder If your mo
64. of Symbols on the Monitor ccccccccccccccccceceseeeeessseseeeeeeeceeeeeeeeeeeaaaaas 5 Chapter 2 installation of MOnitor siciscccsehedes Biaiecsesietcoe seiadavecteeites Biase vaneietiesusicsaveviseedes cebeeaesversicacesecs 6 2 Openine the Package and Checking 5 55 10 siiederasvedolebodveanlabiwstinieialsvataviadwhedeeaniebiorahewebeenieds 6 Z2 Connectie NE POWEL GCaD e ariera N E ASA 6 2 SP OWT INOPO0 UNC IN IOM LOK zere E E 6 ZAC ONNECUNS SENSOP lO Pa CN ek picacecadabsiabnyeddhensiedodete bwasnsdbagedaunsread bea viwboduie teneandbaned eaten T Zoe MeCKIn a The RECOLIE aaa E EE E O 7 Chapter 3 PIU OCG Honn essei a E E ages incsantens 8 Jl Genera TA LOMMATIOM ese O EO 8 32 DCCC MIS play eaea O bab exedamsasawesiat aus RO 9 Za MGCMELAl Display Mod Coesersen dV enedviecdtigcatuow R tedadonsieneees 9 32 2 Doubice Parane LOL Mod arat A N seats E E 13 5 2 5 oee Parameter VOC ee ne a e EEE A aE e EEES 15 3 ButOm F UNCHONS seareiro ror e O E vounstan ewsecenaaeteed 17 o OLEE O S E SEET E EE EE T AO T EEE E E E E A ee 19 JS Dult ReECharsea Die Baiter mesicni EA EE a ARE 21 CHapter 4 System Menu sss ccusavucasustuasies sivedeiuasascecusanaandsancuaces sagusdiuaiatessteacucnasaaunaces degussinaiesdectdauessieseues 23 AM PALI ent Se UU riba es etc dard lensia E sana errant den gna EO 23 AyD NDT AUIS CU ae ese ates gs eevee cnt aieseint eo awand ameea ne nreaee ty aeeser eo wasa ue 24 Ay DY SUCIN SC UU actions E E E E O 24 AR TS
65. on which one part of the monitor has been switched on while the monitor is at the status of stand by The symbol indicates that the device complies with the European Council Directive 93 42 EEC concerning medical devices Authorized representative in the European community Date of manufacture Part Number M3 Vital Signs Monitor User Manual Installation of Monitor Chapter 2 Installation of Monitor NOTE To ensure that the monitor works properly please read Chapter Intended Use and Safety Guidance and follow the steps before using the monitor 2 1 Opening the Package and Checking Visually examine the package prior to unpacking If any signs of mishandling or damage are detected contact the carrier to claim for damage Open the package and take out the monitor and accessories carefully Keep the package for possible future transportation or storage Check the components according to the packing list Check for any mechanical damage Check all the cables modules and accessories If there is any problem contact the manufacturer or local representative immediately 2 2 Connecting the Power Cable Connection procedure of the AC power line Make sure the AC power supply complies with following specification 100V 240V 50Hz 60Hz Apply the power line provided with the monitor Plug the power line to input interface of the monitor Connect the other end of the power line to a grounded power output NOTE Co
66. on Functions Figure 3 10 Buttons All the operations to the monitor can be finished by several buttons ON OFF When the monitor is off press this button to switch on the monitor When the monitor is on press this button and 9 hold for 2s to switch off the monitor press this button for less than 1s the monitor will enter the sleep mode Press this button for less than 2s to silence the audible alarm then the icon x appears and a message SILENCE SILENCE XXX S shows in the information area Repress it or wait until the pause time is over and the Sac ey audible alarm resumes to the normal monitoring status You can set the duration for silencing the audible alarm to 60s 120s or 180s For more information please refer to 4 11 Maintain Press this button for more than 2s to turn off the audio a ae M3 Vital Signs Monitor User Manual Information system including audible alarm key volume and pulse tone Then the icon displays in the information area Pressing the button again can resume the audio system To inflate the cuff and start blood measuring During the measuring process press the button to stop measuring For the monitor with NIBP function For SpO only monitor the NIBP STASRT STOP button is changed to ALARM LIMIT button Press this button to set the alarm limit of the parameters of SpOd Press this button to switch between waveform display trend graph and trend list display HOT KEY I
67. onitor the user can delete them on the PC NOTE lf you set the item to ON after restarting the monitor this item will resume OFF automatically INTERVAL set the storing interval by this item it can be set to 1S 5S 10S 30S IMIN or 5MIN MANAGEMENT select BROWSE to browse data stored before _ AQ M3 Vital Signs Monitor User Manual System Menu DATA BROWSER QOL 20081009 16244550 QL 2001009 Lbs 46302 OO 2 20081009 Lb 44 10 DELETE ALL UF DOMN SEARCH RETURN Figure 4 29 Data Browser DELETE ALL select this item to delete all the data stored before The following dialog box displays DELETE ALL RECORDS Figure 4 30 Data Browser Select YES to delete all the data UP DOWN select this item then turn the page by pressing UP or DOWN to browse data SEARCH search data by patient ID date and time The following box displays SEARCH PATIENT ID lol G 0 DATE egg 10 4 CONF IRM Figure 4 31 Search sils M3 Vital Signs Monitor User Manual System Menu RETURN select this item to return to the previous menu Select the single item data in DATA BROWSER menu press OK to display the following menu DELETE TREND TAELE TREND GRAFH ALARM LIST RETURN Figure 4 32 Menu The user can select to browse TREND TABLE or ALARM LIST of NIBP or select to browse the TREND TABLE TREND GRAPH or ALARM LIST of SpO2 For example select TREND TABLE
68. or representative authorized by EDAN _ 34 M3 Vital Signs Monitor User Manual System Menu ENTER MAINTAIN PASSWORD CONFIRM CONF RM CONFIRM Figure 4 21 Enter Maintain Password User Maintain Input the user password 9 9 8 1 in the USER KEY box and press OK USER MAINTAIN menu will pop up in which you can set following items USER MAINTAIN Figure 4 22 User Maintain BED No Set the bedside number to a value from 1 to 64 LANGUAGE Set the displayed language NOTE You should restart the monitor after changing the displayed language to make the operation effective NURSE CALL Turn on or off the nurse call When the parameter alarm occurs the monitor gives 3s nurse call alarm prompt if the audible alarm or the audio system is off the monitor can _35 M3 Vital Signs Monitor User Manual System Menu 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 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 server port PRES UNIT Set the pressure unit to mmHg or kPa TEMP UNIT Set the temperature unit to C or F HOT KEY Set the hot key to PATIENT or PRINT SpO2 SETUP Access SpO2 SETUP and you can see the menu below Sp02 SETUP Figure 4 23 SpOs Setup SpO ALARM LEV You can
69. pped 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 8 M3 Vital Signs Monitor User Manual Accessories and Ordering Information Chapter 11 Accessories and Ordering Information WARNING The specification of accessories recommended is listed below Using other accessories may damage the monitor The following accessories are recommended when using this monitor Standard accessories Adult Cuff 25 35em CM1203 11 13 36015 Power cable USA standard Optional accessories EDAN SPO 12 01 109069 EDAN SH1 Adult Reusable SpO2 Sensor Lemo EDAN SH4 Adult Silicone Soft tip SpO2 Sensor DB9 Immersion Disinfection 12 01 110521 EDAN SH5 pediatric Silicone Soft tip SpO2 Sensor DB9 01 57 040196 Adult disposable SpO sensor 01 57 040197 Pediatric e SpO sensor 01 57 040198 57 040198 Infant Infant Disposable SpO gt sensor SpO gt sensor 01 57 040199 Neonatal Disposable SpO gt sensor 02 01 110531 82 M3 Vital
70. pulse rate signal and a plethysmogram wave How the SpO PLETH Parameter Works Arterial oxygen saturation is measured by a method called pulse oximetry It is a continuous non invasive method based on the different absorption spectra of reduced hemoglobin and oxyhemoglobin It measures how much light sent from light sources on one side of the sensor is transmitted through patient tissue such as a finger or an ear to a receiver on the other side The amount of light transmitted depends on many factors most of which are constant However one of these factors the blood flow in the arteries varies with time because it 1s pulsating By measuring the light absorption during a pulsation it is possible to derive the oxygen saturation of the arterial blood Detecting the pulsation gives a PLETH waveform and pulse rate signal The SpO value and the PLETH waveform can be displayed on the main interface The sensor contains LEDs that emit red light at a wavelength of approximately 660 nm and infrared light at a wavelength of approximately 900 nm The power of the sensor LED 1s less than 15 mW WARNING Pulse oximetry can overestimate the SpOs value in the presence of Hb CO Met Hb or dye dilution chemicals SpO Pulse Monitoring WARNING 1 ES Electrosurgery equipment wire and SpOz2 cable must not be tangled up 2 Do not put the sensor on extremities with arterial catheter or venous syringe NOTE Do not perform SpO2 measu
71. r 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 8 3 Monitoring Procedure SpO plethysmogram measurement l Switch on the monitor 2 Attach the sensor to the appropriate site of the patient finger 3 Plug the connector of the sensor extension cable into the SpO2 socket on the SpO2 module _ 56 M3 Vital Signs Monitor User Manual SpO Monitoring Optional Figure 8 1 Mounting of the Sensor 8 4 Limitations of Measurement In operation the accuracy of oximetry readings can be affected by 0 00000 o F 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
72. r emissions Complies IEC EN 61000 3 3 A2 2 Electromagnetic Immunity For all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity The M3 is intended for use in the electromagnetic environment specified below The customer or the user of M3 should assure that it is used in such an environment IEC EN 60601 test Compliance Electromagnetic environment Immunity test level level guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood discharge ESD Hekar RIVA concrete or ceramic tile If floor IEC EN 61000 4 2 are covered with synthetic material the relative humidity should be at least 30 _9 M3 Vital Signs Monitor User Manual Electrical fast transient burst IEC EN 61000 4 4 Surge IEC EN 61000 4 5 Power frequency 50 60Hz magnetic field IEC EN 61000 4 8 Voltage dips short interruptions and voltage variations on power supply input lines IEC EN61000 4 11 2 kV for power 2 kV for supply lines kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT 95 dip in UT for 5 sec power supply lines differential mode 2 kV common mode kV lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in
73. rent time Signs indicating the sensor off or alarm off 2s M3 Vital Signs Monitor User Manual Information Alarm Indicator and Alarm Status In normal condition the alarm indicator does not light When an alarm is generated the alarm indicator lights or flashes The color of light represents the alarm level Refer to Chapter 5 Alarm for details Refer to relevant content of parameters for Alarm information and prompt Charging Indicator and Charging Status To indicate the status of charging when the battery is being charged the light turns to yellow after the charge is finished the light will be off 3 2 2 Double Parameter Mode NIBP SpO Interface EA ofA Figure 3 5 NIBP as the Main Parameter alse M3 Vital Signs Monitor User Manual Information SYS IN mmHg 1 1 3 DIA Figure 3 6 SpO 2 as the Main Parameter NIBP TEMP Interface ADU mmHg Figure 3 7 NIBP TEMP Interface 14 M3 Vital Signs Monitor User Manual Information 3 2 3 Single Parameter Mode SpO only measuring mode 99 60 OOA 16319208 Figure 3 8 Display in SpOs only mode _15 M3 Vital Signs Monitor User Manual Information NIBP only measuring mode In NIBP only measuring mode the PR from NIBP measurement is also displayed on screen CUFF PRCBPR 60 OO OA 16 17 07 Figure 3 9 Display in NIBP only mode 16 M3 Vital Signs Monitor User Manual Information 3 3 Butt
74. resolution 320x240 Multicolor LCD resolution 640x480 rs ooo o ee rs se sti in a inti is gn ale sue lt 1A lt 125V lt 110V DC A1 2 4 Battery Working period At 25 C continuous SpO measuring automatic NIBP measuring automatic recording per 10min Rechargeable period lt 300 min 7 M3 Vital Signs Monitor User Manual Specifications A1 2 5 Recorder Recording types Current displayed parameter list recording aaa Current displayed alarm list recording Recording of all the parameter of current patient ID A1 2 6 Review Trend list recall 72 hours 1 min Resolution NIBP measurement recall 30 000 NIBP measurement data Alarm list recall 800 groups A1 2 7 NIBP Optional Meswingange Se ee eS ee eS ee M3 Vital Signs Monitor User Manual Specifications Maximum measuring time of single ADU PED 120s measurement NEO 90s 30s 45s typical depend on HR motion disturbance mo Measuring range 40 bpm 240bpm The maximum of 43bpm or 3 5 A1 2 8 SpO Optional Resolution 1 Accuracy a ADU amp PED 2 70 100 SpO2 Undefined 0 69 SpO2 3 70 100 SpO gt Undefined 0 69 SpO2 89 M3 Vital Signs Monitor User Manual Specifications Measuring Range 1 100 Alarm Range 1 100 MAX A MAX AL MAX N MAX P MAX I 2 70 100 SpOz MAX FAST OxiCliq A OxiCliq P OxiCliqg N Adult Accuracy OxiCliq N
75. ressure and TEMP temperature The monitor is intended to be used only under regular supervision of clinical personnel It 1s applicable to adult pediatric and neonatal usage in hospitals hospital type facilities and intra hospital moves The monitor 1s equipped with alarms that indicate system faults such as loose or defective electrodes physiologic parameters that have exceeded the limits set by the operator or both 1 2 Safety Guidance 1 2 1 Environment Follow the instructions below to ensure completely safe electrical installation The environment where the monitor will be used should be reasonably free from vibration dust corrosive or explosive gases extremes of temperature humidity and so on For a cabinet mounted installation allow sufficient room at the front for operation and sufficient room at the rear for servicing with the cabinet access door open The monitor operates within specifications at ambient temperatures between 5 C 40C 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 Scm 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 1s equipped with a detachable 3 wire cable which grounds the
76. ring 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 gt z value _55 M3 Vital Signs Monitor User Manual SpOs2 Monitoring Optional 8 2 Precautions During SpO2 Pulse Monitoring WARNING Verify sensor cable fault detection before beginning of monitoring phase Unplug the SpOs sensor cable from the socket the screen will display the error message SpOQo SENSOR OFF and the audible alarm is activated 2 Ifthe SpOs sensor can not work properly please reconnect the sensor or change a new one 3 Do not use the sterile supplied SpO2 sensors if the packaging or the sensor is damaged and return them to the vendor 4 Prolonged and continuous monitoring may increase the risk of unexpected change of dermal condition such as abnormal sensitivity rubescence vesicle repressive putrescence and so on It is especially important to check the sensor placement of neonate and patient 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 SpOs sensor can only be used when it requires to less than 20min at a time 7 Thesenso
77. ring state after the Predict state After monitoring for 10 min it returns to waiting state After monitoring for 10 min it returns to waiting state M3 Vital Signs Monitor User Manual TEMP Monitoring Optional 10 5 Care and Cleaning WARNING Before cleaning the monitor or the probe make sure that the equipment is switched off and disconnected from the power line Reusable TEMP Probes l 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 remove any remaining solution The probe can only be reused after being dried thoroughly 2 Do not disinfect the probe by means of boiled water 3 The product has not been disinfected at the factory 4 Any residue should be removed from the probe before being disinfected and sterilized and avoid contacting corrosive solvent Dipping the cable into alcohol or alkalescent solvent for a long time may reduce the flexibility of the scarfskin of the cable Also the connector should not be di
78. sive blood pressure 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 5 To start a continuous measuring Access the NIBP SETUP menu and pick the CONTINUAL item to start a continuous measurement The continuous measurement will last 5 min 6 To stop continuous measuring During continuous measuring press the NIBP START STOP on the front panel at any time to stop continuous measurement WARNING If liquid is inadvertently splashed on the equipment or its accessories or 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 65 M3 Vital Signs Monitor User Manual NIBP Monitoring Optional 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
79. tent via SYSTEM MENU gt SELECTION trend table or alarm list Then print it via RECORD Press the RECORD to print out the currently displayed content Press the UP DOWN button to page up or down the screen then press RECORD to print it out The real time waveform of 8s can be printed out NOTE 1 You can press the RECORD on the control panel to stop the current recording process 2 It is suggested that the user should not use the recorder when the low battery displays or the monitor may be turned off automatically 6 2 Recorder Operations Record Paper Requirement Only standard thermosensitive record paper can be used otherwise the recorder may not function the recording quality may be poor and the thermosensitive printhead may be damaged Proper Operation When the recorder is working the record paper goes out steadily Do not pull the paper outward with force otherwise the recorder may be damaged Do not operate the recorder without record paper Paper Out When RECORDER OUT OF PAPER alarm is displayed the recorder can not start Please insert record paper properly _ AQ M3 Vital Signs Monitor User Manual Trend and Recording Inserting Paper Pull outwards the upper arc part of the recorder casing to release the casing Insert a new roll of paper into the paper cassette printing side facing upwards Ensure proper position and tidy margin Pull about 2cm of the paper out then close the recorder c
80. the power receptacle must be a three wire grounded outlet A hospital grade outlet is required Never adapt the three prong plug from the monitor to fit a two slot outlet M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance 11 12 13 14 15 16 17 18 19 20 21 22 23 24 WARNING 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 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC EN standards e g IEC EN950 for data processing equipment and IEC EN60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the system standard IEC EN60601 1 1 Everybody who connects additional equipment to the signal input connector or signal output connector configures a medical system and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC EN60601 1 1 If in doubt consult our technical service department or your local distributor Use the battery only in this monitor Do not connect battery directly to an electric outlet or cigarette lighter charger Do not unplug the battery when monitoring Make sure the monitor is used in the appointed range of voltage the effect of power Supply can be ignored Do not solder the leading wire and the battery terminal dir
81. to display the following screen TREND TABLE 09116 46 09 16 45 Od I 16s44 09 16 43 0911642 0911641 0911640 09 16 39 09 16 38 lO 16237 09 116736 09 116735 RESOLUTION MIN UP DOWN Figure 4 33 Trend Table The user can select DELETE to delete the single item data or select the RETURN to return to the previous menu NOTE 1 The Trend graph of NIBP can not be reviewed in the USB storage while the Trend graph of SpOz2 can be reviewed in the USB storage _42 M3 Vital Signs Monitor User Manual System Menu 2 he data which is being stored can not be browsed in real time Before searching data you should turn off the Data Store function at first 4 13 Sleep Mode Entering the Sleep Mode Select SYSTEM MENU gt SYSTEM SETUP gt STANDBY and configure the item to ON Then you will see the following dialoge box after pressing the switch for less than 1s ENTER SLEEP MODE Figure 4 34 Enter Sleep Mode Select YES to enter the Sleep mode NOTE When the SYSTEM SETUP gt STANDBY is OFF or the monitor is in DEMO mode or there is any inputting signal pressing the ON OFF button can not make the monitor enter the sleep mode Quitting the Sleep Mode In the sleep mode if a new signal occurs or you press any button on the front panel the monitor will enter the working mode NOTE 1 If the following situation occurs monitor will return to normal monitoring mode automatically The monitor r
82. uid onto the monitor during sterilization Use a moistened cloth to wipe up any agent remained on the monitor Do not use EtO gas or formaldehyde to disinfect the monitor Oo oF W DMN 7 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 T1 6AL 250V NOTE Switch off the power of the monitor before examining the fuse _ 53 M3 Vital Signs Monitor User Manual Maintenance Cleaning 7 6 Cleaning Battery and Battery Compartment Cover Use only non caustic detergents such as soap and warm water 40 C 104 F maximum to clean the battery Do not use strong solvent to clean battery and do not dip the battery 1n liquid _ 54 M3 Vital Signs Monitor User Manual SpO Monitoring Optional Chapter 8 SpO Monitoring Optional 8 1 What is SpO2 Monitoring The monitor uses oximetry to measure functional oxygen saturation in the blood SpO gt 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 gt oxygen saturation of 97 The SpO2 numeric on the monitor will read 97 The SpO2 numeric shows the percentage of hemoglobin molecules which have combined with oxygen molecules to form oxyhemoglobin The SpO PLETH parameter can also provide a
83. uidance CAUTION Electromagnetic Interference Ensure the environment in which the monitor is installed is not subject to any sources of strong electromagnetic interference such as radio transmitters mobile telephones etc 2 he monitor is designed for continuous operation and is ordinary i e not drip or splash proof 3 Keep the environment clean Avoid vibration Keep it far from corrosive medicine dust area high temperature and humid environment 4 Do not immerse transducers in liquid When using solutions use sterile wipes to avoid pouring fluids directly on the transducer 5 Do not sterilize the monitor recorder or any accessories 6 The device and accessories are to be disposed of according to local regulations after their useful lives Alternatively they can be returned to the dealer or the manufacturer for recycling or proper disposal 7 Remove a battery whose life cycle has expired from the monitor immediately 8 Avoid liquid splash and excessive temperature The temperature must be kept between 5 C and 40 C while working And it should be kept between 20 C and 55 C during transportation and storage 9 Before use the equipment patient cable and sensor should be checked Replacement should be taken if there is any evident defectiveness or aging symptom which may impair the safety or performance 10 Ifthe monitor gets damp put it in dry circumstance to dry it until it can work normally lf liquid pours on

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