Fazzini FM5000C User Manual Download Page 132

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II-7

FM5000C - FM5000PLUS
Maternal/Fetal Monitor

User Manual

(8) Respiration

Name

Specification

Method

Thoracic impedance method

Measurement

range

and

accuracy

Range

Adult

～

120 rpm

Pediatric/neonate

～

150 rpm

Accuracy

7rpm

～

150rpm: ±1rpm or 1%, whichever is the larger;

0rpm

～

6rpm

：

Not specified

Alarm range and

accuracy

Adult

7rpm

～

120rpm

Pediatric/ neonate

7rpm

～

150rpm

Accuracy

±1bpm

Apnea alarm time

10s, 15s, 20s, 25s, 30s, 35s, 40s,error:

5s.

(9) NIBP

Name

Specification

Measuring method

Oscillation method

Measurement

range and accuracy

Adult

Systolic pressure

40mmHg

～

270mmHg(5.3kPa

～

36.0kPa)

Mean arterial pressure

20mmHg

～

235mmHg(2.7kPa

～

31.3kPa)

Diastolic pressure

10mmHg

～

215mmHg(1.3kPa

～

28.7kPa)

Pediatric

Systolic pressure

40mmHg

～

200mmHg(5.3kPa

～

26.7kPa)

Mean arterial pressure

20mmHg

～

165mmHg(2.7kPa

～

22.0kPa)

Diastolic pressure

10mmHg

～

150mmHg(1.3kPa

～

20.0kPa)

Neonate

Systolic pressure

40mmHg

～

135mmHg(5.3kPa

～

18.0kPa)

Mean arterial pressure

20mmHg

～

110mmHg(2.7kPa

～

14.7kPa)

Diastolic pressure

10mmHg

～

100mmHg(1.3kPa

～

13.3kPa)

Accuracy

The maximum mean deviation is

5mmHg(

0.667kPa) and the

maximum standard deviation is 8mmHg(

1.067kPa).

Overpressure

protection

Adult

300mmHg

Pediatric

240mmHg

Neonate

150mmHg

Error

±3mmHg

Static

pressure

measurement

range

0mmHg~300mmHg,

Accuracy

±3mmHg

Alarm range and

accuracy

Adult

Systolic pressure:

40mmHg

～

270mmHg(5.3kPa

～

36.0kPa)

Mean arterial pressure:

20mmHg

～

235mmHg(2.7kPa

～

31.3kPa)

Diastolic pressure

10mmHg

～

215mmHg(1.3kPa

～

28.7kPa)

Pediatric

Systolic pressure:

40mmHg

～

200mmHg(5.3kPa

～

26.7kPa)

Summary of Contents for FM5000C

Page 1: ...ANTE Leggere attentamente le istruzioni prima dell utilizzo WARNING Read the instructions carefully before using the device IMPORTANT Lisez attentivement la notice avant l emploi IMPORTANTE Lea atentamente las instrucciones antes de utilizar el aparato IMPORTANTE Ler atentamente as instruções antes de utilizar o aparelho ...

Page 2: ...ury to the patient and the operator Note Important points to be noted Intended Use This product is intended to be used in surgeries ICU wards CCU wards and other places requiring monitoring for patients It can display in real time the fetal heart rate FHR TOCO fetal movement mark maternal heart rate ECG non invasive blood pressure NIBP SpO2 pulse rate RESP and TEMP etc Working Environment 1 Workin...

Page 3: ...afety 4 1 4 1 Safety Instruction 4 1 4 2 Enviroment Requirements 4 1 4 3 Grounding protection 4 1 4 4 Equipotential Grounding 4 2 4 5 Condensation 4 2 Chapter 5 Basic Operations 5 1 5 1 Using the Main Menu 5 1 5 2 General Settings 5 1 5 2 1 Setting the System time 5 1 5 2 2 Changing System Language 5 2 5 2 3 Adjusting Alarm Volume 5 2 5 2 4 AdjustingHeartbeat Volume 5 2 5 2 5 AdjustingFHR Volume 5...

Page 4: ... 2 8 3 1 Visual Alarm 8 2 8 3 2 Audio Alarm 8 2 8 3 3 Alarm Message 8 3 8 3 4 Alarm Parameter Flashing 8 3 8 4 Adjusting the Alarm Volume 8 3 8 4 1 Adjusting the MinimumAlarm Volume 8 3 8 4 2 Adusting the Alarm Volume 8 3 8 4 3 Setting the Reminder Tone 8 4 8 5 Alarm Settings 8 4 8 5 1 Setting the Alarm Level 8 4 8 5 2 Setting the Alarm Limit 8 5 8 5 3 Alarm Recording 8 6 8 5 4 Setting the Alarm D...

Page 5: ...nance Check 13 1 13 2 Maintenance Schedule 13 1 13 3 ECG calibration 13 2 13 4 NIBP Air Leakage Test 13 2 13 5 NIBP Calibration 13 3 13 6 Touch Screen Calibration 13 4 Chapter 14 Fetus Monitoring 14 1 14 1 Difference betweenAntepartum and Intrapartum Monitor 14 1 14 1 1 Antepartum Monitoring Principles 14 1 14 1 2 Terms about Monitor 14 1 14 2 FHR Monitoring 14 2 14 2 1 Connect the FHR Transducer ...

Page 6: ...he Calculation Channel 15 9 15 6 6 Setting the Notch 15 10 15 7 ST Segment Analysis 15 10 15 7 1 About ST Segment Analysis 15 10 15 7 2 Impact on ST segment 15 10 15 7 3 Enabling ST Segment Analysis 15 11 15 7 4 Adjusting the ST Segment Analysis Point 15 11 15 8 Arrhythmia Analysis 15 12 15 8 1 EnablingArrhythmia Analysis 15 13 15 8 2 Arrhythmia Alarm Settings 15 13 15 8 3 Arrhythmia Relearning 15...

Page 7: ...8 3 Safety Information 18 2 18 4 NIBP Measurement 18 2 18 4 1 Measurement Steps 18 2 18 4 2 Operation Prompt 18 4 18 4 3 Measurement Limitations 18 5 18 5 NIBP Settings 18 6 18 5 1 Setting the Measure Mode 18 6 18 5 2 Setting the Interval Time 18 6 18 5 3 Setting the Pressure Unit 18 6 18 5 4 Setting the Pre inflation Value 18 6 18 6 NIBP Reset 18 7 Chapter 19 TEMP Monitoring 19 1 19 1 Overview 19...

Page 8: ...his instrument and its accessories can work normally and safely prior to use The alarm volume and alarm limits shall be set for different patients When a patient is monitored the audible alarm system cannot be merely depended on If the alarm volume is set too low or is completely turned off the alarm will not be heard and the patient will be endangered The most reliable patient monitoring method s...

Page 9: ...s for example Mobile phone X ray or MRI equipment near this monitor must meet corresponding EMC requirements because they will transmit high strength electromagnetic radiation Conductive parts of electrodes and associated connectors for applied parts including the neutral electrode should not contact any other conductive parts including earth This is not a treatment device Do not posit the equipme...

Page 10: ...tion Refer to instruction manual booklet Defibrillation proof type BF applied part Defibrillation proof type CF applied part Battery indicator Dateof manufacture On Off key Serial number AC power indicator Equipotential Freeze key Network Alarm reset key NIBP start key Print key TOCO zero key Europeancommunity representative The monitor is Protectedfrom vertically falling water drops Manufacturer ...

Page 11: ...1 4 FM5000C FM5000PLUS Maternal Fetal Monitor User Manual ctr r r t This side up Maximum stacking layer c J L l Fragile L Keep dry ...

Page 12: ...All operations on the monitor can be performed by keys and touch screen The monitor can be configured with the maximum configuration including fetus parameter and maternal vital signs monitoring functions 2 1 Intended Use The monitor is applicable to monitoring FHR FM and TOCO as well as pregnant woman s and patient s ECG PR NIBP SpO2 TEMP and RESP in clinic units 2 2 Components The monitor is com...

Page 13: ...tor On when the monitor is connected with AC power supply Off when the monitor is disconnected with AC power supply Battery indicator On when the battery is being charged Off when no battery is installed or no AC power supply is connected Flash when the monitor operates on battery power Freeze key Press to freeze or unfreeze the waveforms on the screen Alarm reset key Press to reset the alarm syst...

Page 14: ... 2 4 4 RearView Network connector USB connector AC power supply scoket Handle Equipotential terminal Figure2 4Rear view Warning The network connector is designed for Our company central monitoring system only Only the analog or digital equipments complying with the specified IEC standards like IEC 60950 for data processing equipments IEC 60601 1 for medical equipments etc are allowed ...

Page 15: ...y question please contact the supplier If more than one external equipment are connected to the monitor at one time through the patient cable socket network connector or other signal interfaces the total leakage current should not exceed the allowance 2 4 5 Bottom View Handle Fetal Heart Speaker Paper tray Battery compartment Nameplate Alarm Speaker Figure 2 2 Bottom View 2 5 On screen Display The...

Page 16: ...ETWORK SET menu 2 Patient information area If no patient is admitted the promt message No Patient Admitted will be displayed here If a patient has been admitted the patient name bed number etc will be displayed here circularly Click here to directly access PATIENT INFO menu 3 Technical alarm message area Display technical alarm message and status message When there are multiple messages they will ...

Page 17: ...ime Display the system time Click here to directly access DATETIME SETUP menu 8 Waveform area Display the measurement waveforms with the waveform name at the left top corner Click the waveform area and the corresponding setup menu will be displayed 9 Parameter area Display the measured value and the set alarm limit of each measurement parameter The color of a certain parameter is the same as that ...

Page 18: ...FHR transducer and consumable materials provided or designated by Our company Please connect Our company equipment to the monitor only If you connect any other electrical equipment or device to the monitor there could be safety problems caused by superimposed leakage current Plug the power cord to the dedicated hospital socket Please charge the battery after the transport or storage of the monitor...

Page 19: ...in one minute after turning off Warning If any damage to the monitor or an error message is found do not use this monitor for patient monitoring Please contact the biomedical engineer of your hospital or maintenance engineer of Our company 3 4 Connect the Sensors Connect the required sensor to the monitor and the monitoring part of patient For the correct connection methods and related requests pl...

Page 20: ...uld be at least 2 inches or 5 centimeters away from around the cabinet for good ventilation The monitoring system should be in the ambient temperature 5 40 runing to satisfise the requirements An ambient environment out of this range may impair the instruments accuracy and cause damages to its components and circuits 4 3 Grounding protection To protect the patients and operator the enclosure of th...

Page 21: ...th protective grounding systems A check of the instruments should be conducted to guarantee the instruments are in good repair before each examination The cables connecting with patients and instruments should be guaranteed not having been subjected to electrolytic pollution Warning Battery power should be used to power the monitor against unstable protective grounding system 4 5 Condensation The ...

Page 22: ...er failure or power interruption unless you restore the factory default settings manually In case of power interruption the mointor will save all the settings and saved patient data when restarting the monitor the monitor will restore to the settings before power interruption 5 2 General Settings 5 2 1 Setting the System time There are two methods of setting the system time 1 Click the system time...

Page 23: ... are two methods of adjusting the FHR volume 1 Access MAIN MENU SELECTION FHR VOL 2 Or click FHR volume icon 3 Select the FHR volume in the pop up list box 4 Available volume levels are 0 to 6 0 means off and 6 is the maximum volume When the FHR volume is 0 the FHR volume icon turns to indicating the FHR volume is 0 5 2 6 Adjusting Key Volume 1 Access MAIN MENU SELECTION KEY VOL 2 Select the key v...

Page 24: ...NU and click INFO to view the software version information 5 5 Demo Function To enable Demo function 1 Access MAIN MENU 2 Click DEMO and enter the password Warning Demo waveform is a kind of simulation of waveforms which is made by the manufacturer only to demonstrate the machine performanceand help users to conduct training In actual clinical use the demo function should be disabled because the m...

Page 25: ...ing system The server IP and IP address of the monitor must be in the same network segment How to recognize whether the network has been connected successfully Icon indicates the network between this monitor and central monitoring system has not been connected successfully Icon indicates the network between this monitor and central monitoring system has been connected successfully Attention The ne...

Page 26: ...5 5 FM5000C FM5000PLUS Maternal Fetal Monitor User Manual 3 All displayed waveforms are frozen without being refreshed or scrolling But the measured parameter values are refreshed normally ...

Page 27: ...waveform can be reviewed on this monitor 1 Under frozen waveform status click PRE PAGE or NEXT PAGE to view the frozen waveforms on previous page or next page respectively 2 Click FIRST PAGE or LAST PAGE to view the frozen waveforms on the first page or on the last page respectively 3 Click BACK or press the key to unfreeze the displayed waveforms How to record the frozen waveforms Please refer to...

Page 28: ...ase previous patient s hist data ADMIT will be displayed Select Yes to admit the patient and the ADMIT item turns to DISCHARGE select No the patient will not be admitted Warning When change the patient type or admit a new patient the monitor will restore to the alarm settings of that patient type set previously Therefore the users should check whether the alarm settings are suitable for the patien...

Page 29: ...art to save the patient case Any patient case which has been saved for more than 10 seconds will be stored after pressing the Stop Save on screen key 4 All the saved patient cases can be viewed in the Case list window How to save patient case automatically 1 Access MAIN MENU Case List 2 Click Case save and set it to ON If Case save is set to OFF no patient cases will be saved 3 Click Least time an...

Page 30: ...py appear in the case list window the monitor has recognized the USB flash disk or please reconnect the USB flash disk 5 To export patient cases select USB Copy and a dialogue box will appear and then select Copy to USB to export all patient cases to USB flash disk oryou can also select a certain patient and then select Copy to USB and this patient case will be exported to the USB flash disk 6 To ...

Page 31: ...oxyCRG screen and big font screen User can get different screen messages from different screens 7 1 1 Fetal Monitoring Screen You can see the FHR value FHR trace TOCO value TOCO waveform manual auto FM mark and auto FM waveform on the fetal monitoring screen To open the fetal monitoring screen a Click SCREENS on screen key b Or access MAIN MENU and select SCREENS c Select FETAL SCREEN to open the ...

Page 32: ...NS on screen key e Or access MAIN MENU and select SCREENS f Select MOTHER FETUS CARE FACE to open the mother fetus monitoring screen as shown below Figure7 2 Mother fetus monitoring screen 7 1 3 Mother Monitoring Screen The mother monitoring screen can only display mother parameter value and waveform Up to 4 channels of waveform can be displayed with a separate parameter area To open the mother mo...

Page 33: ...red values for parameters The list occupieshalfof the entire waveform area On the list screen you can review the recently measured data which is stored 10groups per page To open the list screen d Click SCREENS on screen key e Or access MAIN MENU and select SCREENS f Select LIST FACE to open the mother monitoring screen as shown below Figure7 4 List screen ...

Page 34: ...ency chart with the scale on the leftand the time below as shown in the figure below Figure 7 5 HR dynamic short tendency The position of the dynamic short tendency chart of each parameter is not fixed You can change the position of the tendency chart as needed Take the SpO2 dynamic short tendency for example with the steps as follows Select the SPO2 dynamic short tendency and select HR in the pop...

Page 35: ...ncy and RR tendency or compressed respiratory wave and occupies one half of the entire waveform area To open the OXYCRGscreen a Click SCREENS on screen key b Or access MAIN MENU and select SCREENS c Select OXYCRGSCREEN to open the oxyCRG screen as shown below Figure7 7 OxyCRGscreen Select the length of time for OXYCRGchart Select the oxyCRG chart and one menu OXYCRG will be displayed Select TIME a...

Page 36: ...ct SCREENS c Select BIG FONT to open the big font screen as shown below Figure 7 8 Big font screen 7 2 Swipe the Screen The monitor allows you to swipe the screen up and down or left and right to switch the screens 1 Swipe Up and Down Byswiping the screen from up to down the waveform area and parameter area will expand and hide the screen keys so that the doctor can observe the measured data more ...

Page 37: ...m for example FHR1 waveform and the menu FHR SETUP will be displayed Select FHR1 DISP COLOR and choose the display color for FHR1 waveform from GREEN CYAN RED YELLOW WHITE BLUE and PURPLE 2 Select mother monitoring waveform for example ECG waveform and the menu ECG WAVE will be displayed Select WAVE COLOR and choose the display color for ECG waveform from GREEN CYAN RED YELLOW WHITE BLUE and PURPL...

Page 38: ...area 8 2 Alarm Level The monitor can give an alarm in three levels high medium and low based on the severity Physiological alarm Technical alarm High level The patient is in a critical condition endangering the patient s life emergent attention required Indicate a severe device malfunction or an improper operation which could make it possible that the monitor cannot detect critical patient status ...

Page 39: ...llow Low level alarm the right alarm lamp turns cyan without flashing When physiological alarm and technical alarm are triggered simultaneously the flashing frequency and color of alarm lamp are based on alarm level priority But when only physiological alarm and technical alarm of the same level are triggered the flashing frequency and color of alarm indicator are that of physiological alarm 8 3 2...

Page 40: ...larm Medium level alarm Low level alarm 8 3 4 Alarm Parameter Flashing When a parameter is alarming the parameter will flash once every second The upper alarm limit or lower alarm limit will also flash in the same frequency indicating the parameter has violated the upper limit or lower limit repectively 8 4 Adjusting the Alarm Volume 8 4 1 Adjusting the Minimum Alarm Volume The minimum alarm volum...

Page 41: ...ure levels which are less than ambient levels can impede operator recognition of alarm conditions 8 4 3 Setting the Reminder Tone When alarms are switched off the monitor will give periodic reminder signal Ting Ting Ting How to set reminder tone 1 Access MAIN MENU select MAINTAIN and enter the password 2 Select ALARM SETUP 3 Select REMINDER TONE toadjust the reminder volume from 0 to 6 0 means off...

Page 42: ...ct FHR1 parameter area and the FHR1 SETUP menu will be displayed 2 Select FHR1 ALARM SETUP and enter FHR1 alarm limit setup menu as shown below Here we can set the alarm limits of high level alarm medium level alarm and low level alarm together Hi Level means high level alarm When the measured value is higher than the upper limit of high level alarm or lower than the lower limit of high level alar...

Page 43: ...or HR alarm to an appropriate value Do not set it to be 20bpm higher than the patient s HR Attention The monitor will always save the alarm settings in case of power interruption and the alarm settings are restored automatically after power interruption 8 5 3 Alarm Recording The monitor can record alarms automatically when the alarms are triggered if the parameter alarm function and alarm recordin...

Page 44: ...aused status 1 Stop all the indications of physiological alarms and no new physiological alarm will be triggered 2 The remaining pause time ALM PAUSE xxS will appear at the physiological alarm message area 3 ALM PAUSE on screen key flashes in red 4 For technical alarm the audio and visual alarm indicationwill be paused but alarm message still appears in technical alarm message area If new technica...

Page 45: ...MENU select MAINTAIN and enter the password 2 Select ALARM SETUP 3 Select ALM and toggle between ON and OFF Moreover the operator can be authorized to switch off all parameter alarms following the steps below 1 Access MAIN MENU select MAINTAIN and enter the password 2 Select ALARM SETUP 3 Select ALM OFF Authorize 4 Select ON and the operator can access MAIN MENU MONITOR SETUP ALARM SETUP ALARM OFF...

Page 46: ...8 9 FM5000C FM5000PLUS Maternal Fetal Monitor User Manual How to cancel all alarms off status 1 Access MAIN MENU MONITOR SETUP ALARM SETUP ...

Page 47: ...IN MENU select MAINTAIN and enter the password 2 Select ALARM SETUP 3 Select LATCH ALARM and toggle between ON and OFF 8 9 Alarm Reset By pressing the ALARM RESET screen key the following operations can be conducted 1 Clear the latching alarm signals for which no associated alarm condition currently exists 2 Cease the audio alarm signals of all physiological alarms and technical alarms 3 Clear the...

Page 48: ...en modified the monitor will always save the modified alarm settings When changing the patient type the monitor will restore to the alarm settings of that patient type set previously Therefore the users should check whether the alarm settings are suitable for the patient to be monitored prior to monitoring 2 The user can press the parameter area of a certain parameter to enter the setup menu and t...

Page 49: ... no battery installed or damaged battery Attention Please remove the battery if it will be not be used for a long time and store it properly If a battery is installed in the moitor the battery must be recharged after each use to ensure enough battery power Warning The battery liquid is harmful In case the liquid contacts your skin or eye wash it immediately with clean water or seek medical advise ...

Page 50: ...changing or installing the battery 1 Turn off the monitor and disconnect the power cord and other connection lines 2 Place the monitor with the back up 3 Unscrew the battery cover 4 Take out the used battery and put the new one into the battery holder making sure the positive and negative poles match what is indicated on its shell 5 Replace the battery and screw it on and turn the monitor upright ...

Page 51: ...suspend all monitoring and measuring procedures d When charging the battery at least six hours of charging should be ensured until it is fully charged e Disconnect the AC power supply power on the monitor with the battery until it is fully discharged and the monitor shuts off automatically Record the start and stop time f The duration of battery discharge will reflect the battery performance g Onc...

Page 52: ...ery second or every 5 seconds and the trend graph in the latest 120 hours can be displayed with the resolution of one data every minute or every 5 or 10 minutes How to enter trend graph review window 1 Click INFO RECA on screen key 2 Select TREND GRAPH to enter the trend graph review window as shown below Figure 10 1 Trend graph review window The vertical and horizontal axis respectively represent...

Page 53: ...nge the scale of the vertical axisand the scale of the trend curve will change accordingly 5 Obtain trend data at a certain moment Click CURSOR and then press or to move cursorand the selected moment will change when the cursor moves The measured parameter values at the selected moment will be displayed below the trend graph 10 2 Trend Table Review The trend table data in the latest 150 hours can ...

Page 54: ...nd data respectively 10 3 NIBPMeasurement Review This monitor can display the latest 2000 groups of NIBP measurement data in the NIBP measurement review window How to enter NIBP measurement review window 1 Click INFO RECA on screen key 2 Select NIBP RECALL to enter the NIBP measurement review window as shown below Figure 10 3 NIBP measurement review window Data is displayed in the sequence of time...

Page 55: ...following operations can be performed in the alarm event review window 1 Set the starttime Click START TIME and set the start time in the pop up menu All the physiological alarm events occurredafter the start time will be displayed in this windowin chronological order 2 Select the alarm event Click RECALL EVE and select the alarm event in the pop up list box Available options include ALL andsperat...

Page 56: ...r ones will be overwritten The alarm log is not maintained when the alarm system is powered down and the time of powering down is not captured in the alarm log neither All the physiological alarm events will be cleard after the alarm system has experienced a total loss of power for a finite duration 10 5 Waveform Review The monitor can save 120 minute parameter waveform for review in the waveform ...

Page 57: ... 6 Waveform review menu 3 Set the RECALL DATE RECALL TIME END DATE and END TIME respectively 4 Select WAVE RECALL and enter the waveform review window as shown below Figure10 7 Waveform review window 5 Press or to observe earlier or later paramter waveform respectively ...

Page 58: ...ingpaper into the paper tray with the grid side facing up and the black labelat the left 3 Pull the recording paper slowly out of the recorder tray and then adjust the position of the recording paper 4 Push the paper tray in until it is locked Note Please do not pull the recordingpaper when it is out from the recorder at a constant speed or the recorder could be damaged Do not use the recorder wit...

Page 59: ...nel or click the PRINT on screen key and enter the Patient Info Fischer Grade window 2 Confirm the patient information and score results and click Confirm The monitor starts to print the fetal waveoform according to the speed set in REAL SPEED and the time set in REAL TIME 3 To stop printing during printing process just press the print key on the front panel or click the PRINT on screen key If REP...

Page 60: ...tient case 1 Access Case List window 2 Select a certain patient case and enter Patient Review window 3 Click Load and enter the patient case review window 4 Press the print key on the front panel or click the PRINT on screen key and enter the Patient Info Fischer Grade window 5 Confirm the patient information and score results and click Confirm The monitor will start to print the fetal waveform fr...

Page 61: ...elect the print speed for real time fetal waveform printing Available print speed includes 1 CM MIN 2 CM MIN and 3 CM MIN Click REAL TIME and select the print time for real time fetal waveform printing Available print time includes 1 MIN 3 MIN 5 MIN 10 MIN 15 MIN 20 MIN 30 MIN 45 MIN 60 MIN 90 MIN 120 MIN and Infinite Click FREEZE TIME and select the print time for frozen fetal waveform printing a...

Page 62: ...6 6 Accelerate times 20mins None 1 4 4 Decelerate times 20mins 2 1 2 None FM bpm None 1 4 4 Advanced Fischer score criterion is as follows Items 0 point 1 point 2 point Results Score FHR baseline bpm 100 180 100 109 161 180 110 160 Variation range bpm 0 4 5 9 30 10 30 Variation frequency cpm 0 1 2 6 6 Accelerate times 20mins None 1 4 4 Decelerate times 20mins Decelerate later or severe variation S...

Page 63: ...ults output by doctors are only selectable software functions of the monitor which can only be reference to doctors clinical diagnosis Doctors should make diagnosis based on the actual waveforms and then sign to confirm Doctors are responsible for the conclusion ofthe output reports ...

Page 64: ...he lowest possible concentration Do not allow liquid to enter the enclosure Do not pour liquid onto any part of the equipment or accessories Do not immerse any part of the equipment into liquid Do not use abrasive materials bleaching powder or erosive cleaners such as acetone or acetone based cleaners 12 2 Cleaning and Disinfection of the Monitor and Accessories To avoid cross infection please cle...

Page 65: ...n peroxide Isopropyl alcohol 70 Glutaraldehyde solution 2 Sodium hypochlorite SpO2 sensor Isopropyl alcohol 70 Glutaraldehyde solution 2 Sodium hypochlorite TOCO transducer Alcohol free soap Sodium hypochlorite with chlorine bleaching powder and 3 water Hydrogen peroxide Isopropyl alcohol 70 Glutaraldehyde solution 2 Sodium hypochlorite FHR transducer Alcohol free soap Sodium hypochlorite with chl...

Page 66: ...tact the customer service immediately 12 2 1 Cleaning and Disinfection of the Cuff Take out the rubber bag before cleaning the cuff The cuff can be hand washed or machine washed in warm water or with mild detergent Hand wash can extend the service life of the cuff Air dries the cuff after cleaning The cuff may be disinfected with a cloth moistened with 70 ethanol or 70 isopropanol Prolonged use of...

Page 67: ...12 4 FM5000C FM5000PLUS Maternal Fetal Monitor User Manual 12 2 2 Cleaning the Belt The belt should be cleaned with soapy water with warmth lower than 60 C ...

Page 68: ...ge on the monitor stop using the monitor on patient and contact the biomedical engineer of the hospital or our customer service immediately All the safety and maintenance checks that need to dismantle the monitor should be performed by a qualified customer service technician Non professional operation can cause the monitor damage or cause a security risk and human health may be endangered The circ...

Page 69: ...oved by Our company at least once a year or when you doubt the measured value Specific steps are as follows 1 Press ECG parameter area in the pop up ECG SETUP menu press ECG CAL Then the screen displays square wave signal and displays prompt message ECG CALIBRATING 2 Compare the amplitude of the square wave with the wave scale The difference should be within 5 After calibrating press STOP CAL 13 4...

Page 70: ...errorless 8 If the error message still appears please contact the manufacturer for repair Warning This air leakage test different from those described in the standard EN 1060 1 is for users to simply test air leakage in NIBP inflation If the system displays an error message Pump Leaking at the end of testing please contact the Our company maintenance engineers 13 5 NIBP Calibration Calibration of ...

Page 71: ...13 4 FM5000C FM5000PLUS Maternal Fetal Monitor User Manual to NIBP jack on the module Set the monitor to calibration mode and then inflate the metal ...

Page 72: ...ent Monitoring NIBP Gas pipe Standard pressure meter Round pump Metal vessel 13 6 Touch Screen Calibration Touch screen calibration should be conducted at least once a year or when the touch screen is insensitive or after changing the touch screen Calibration methods are as follows 1 Enter MAIN MENU 2 Press MAINTENANCE and enter the password 3 Press SCREEN ADJUST 4 Press the five symbols one by on...

Page 73: ...les Below is the ultrasound Doppler FHR monitoring principles The Doppler FHR monitoring is supported by the Doppler Effect The ultrasound wave will be reflected when meeting any obstacle in the propagation process If the obstacle is still the reflection frequency will be identical with the transmitting frequency If the obstacle moves the reflection frequency will change become higher or lower whe...

Page 74: ...ronger penetrability and a higher or lower resolution for tissue structure Therefore the transmitting frequency of the ultrasound transducer used for superficial vascular disease diagnosis can reach 810MHz According to national safety standards the transmitting power of the ultrasound transducer should not exceed 10MW cm2 affected adversely otherwise the fetus tissue could be 14 2 FHR Monitoring 1...

Page 75: ...14 3 FM5000C FM5000PLUS Maternal Fetal Monitor User Manual Figure14 2 FHR Transducer ...

Page 76: ...l to detect whether the same heart rate is being monitored by more than one transducer How to activate the cross channel verification feature 1 Select FHR waveform in the pop up FHR SETUP menu select CROSS DUR and adjust the duration for cross channel verification Available duration includes OFF 30 S 60 S 90 S and 120 S OFF means the monitor will not give alarms even though the monitored heart rat...

Page 77: ...n the recording paper has an offset but the FHR2 value on the screen remains unchanged Subtract 20 from the recorded trace for FHR2 to obtain the true FHR2 For example if the recorded FHR2 trace is 180bpm the true FHR2 is 160bpm Disable Trace Separation Select FHR waveform in the pop up FHR SETUP menu select FHR OFFSET and select 0bpm The FHR2 trace recorded on the recording paper is thinner with ...

Page 78: ...and FHR2 When there is only one FHR transducer connected the FHR sound channel will be locked as FHR1 and when there are two FHR transducers connected the users can select the FHR sound channel as needs How to set the FHR sound channel 1 Select FHR1 parameter area select Sound channel and select FHR1 or FHR2 2 Select FHR2 parameter area select Sound channel and select FHR1 or FHR2 14 3 TOCO Monito...

Page 79: ... one of the following three methods Enter TOCO SETUP menu and select TOCO BASE Or click the TOCO BASE on screen key Or press the TOCO zero key on the front panel 3 When the TOCO transducer is placed on the pregnant woman please observe the TOCO value on the screen 14 3 1 Setting the TOCO Zero Value If you set TOCO Base to 0 the minimum TOCO value will be 0 after zeroing This operation will also ze...

Page 80: ... Counting FM automatically means the monitor will auto count the FM according to the FM threshold value set in FM Limen and clinical situations Please place the FM marker at the place where is no interference and impact The FM mark displayed on the screen is with the same color as that of the AFM Auto Fetal Movement waveform To change the AFM color select TOCO waveform area enter the TOCO SETUP me...

Page 81: ...uations and also the pregnant woman can hold the FM marker and count the FM manually when she feels the fetal movement MANUAL means the pregnant woman holds the FM marker and counts the FM manually when she feels the fetal movement OFF means the FM will not be counted How to set the FM counting mode 1 Select FHR waveform area in the pop up FHR SETUP menu select Fetal Move and select the FM countin...

Page 82: ...Slow press to decrease the vibration speed Cable to connect the monitor Vibration part Battery the fetus awakening acoustic stimulator is powered by two AA batteries Attention The fetus awakening acoustic stimulator cannotcontact with the pregnant women s skin directly When using the acoustic stimulator its vibration part should be coated with one layer of disposable medicalgauzeand stuck firmly w...

Page 83: ...14 10 FM5000C FM5000PLUS Maternal Fetal Monitor User Manual patient to avoid cross infection ...

Page 84: ...he screen or click TIMER on screen key and the TIMER menu will be displayed 2 Select TIME END PROMPT and toggle between ON and OFF ON means the monitor will give a high level technical alarm when the timed monitoring ends 3 Select TIMING CARE and select the duration for timed monitoring from 10 minutes to 120 minutes 4 Select STARUP TIMER and the timed monitoring starts The STARTUP TIMER turns to ...

Page 85: ...rately assess the physiological status of the patient To get accurate measured value the ECG lead wired should be placed correctly This monitor is applicable to 3 lead 5 lead and 12 lead ECG monitoring Different waveformscan be displayed according to different lead wires 15 2 ECG Display 2 3 4 6 1 7 5 Figure 15 1 ECG display 1 ECG lead name 2 Waveform gain 3 Filter mode 4 1 mV scale 5 The alarm li...

Page 86: ...trodes and associated connectors for applied parts including the neutral electrode should not contact any other conductive parts including earth and make sure that all the electrodes are placed on the patient to prevent them from contacting the conductive parts or earth Inspect the electrode application site for skin irritation daily If there is sign of allergy replace the electrodes or change the...

Page 87: ...ectrodes on the patient If the electrodes used do not have conductive gel apply the conductive gel before placement g Connect the electrode lead and the patient cable h Check that the monitor power is on 15 4 2 Placement of ECG Electrodes 15 4 2 1 Identifiers and Color Code of Electrodes The table below shows the lead names in the European and American standards The leads are represented by RA LA ...

Page 88: ... near the right shoulder Black yellow left arm electrodes placed under the clavicle near the left shoulder Red green left leg electrodes placed in the left lower abdomen Figure15 2 Positions of 3 lead ECG electrodes 15 4 2 3 Placement of 5 lead ECG Electrodes The position of electrode of 5 lead ECG cable is divided into American standard and European standard White red right arm electrodes placed ...

Page 89: ...V2 and V4 V4 in the fifth intercostal space of the left mid clavicular line V5 at the left anterior axillary line with horizontal position the same as the V4 V6 at the left median axillary line with horizontal position the same as the V4 V3R V6R in the right chest wall with its position corresponding to the left position VE at the eminence of xiphoid V7 in the fifth intercostal space of left poste...

Page 90: ...green left leg electrodes placed in the left lower abdomen Figure 15 5Position of electrodes of 12 leadECG cable The chest electrode placement sites are generally six taking spatiuminterosseum of costal bone as the locating basis V1 V6 V1 C1 in the fourth intercostal space on the right edge of the sternum V2 C2 in the fourth intercostal space on the left edge of the sternum V3 C3 at the midpoint o...

Page 91: ...sition of ECG lead depends on the type of surgery For example for the thoracotomy electrode can be put on the chest or the back In the operating room because of usingelectrosurgical knife equipment sometimes artifact may affect ECG waveform in order to cut the artifact you can put the electrode on left and right shoulder near the abdomen of left or right side and the breast lead can be put on the ...

Page 92: ...tored include I II III aVR aVL aVF and V1 When using 12 lead ECG lead wire the leadscan be monitored include I II III aVR aVL aVF V1 and V2 and V3 V4 V5and V6 When using the 3 lead ECG lead wire only one channel ECG waveform can be displayed on the screen while when using the 5 lead or 12 lead ECG lead wire only one ECG waveform can be displayed on the fetal mathor monitoring screen and big font s...

Page 93: ...ncy response range of this mode is 0 05Hz 40Hz The good scalability of low frequency ensures undistorted interpretation of patient s ST segment and can effectively filter high frequency interference signals over 40Hzincluding power frequency interference In this mode the user can more accurately acquire the measured ST segment value by adjusting the position of the ST segment analysis points a Cli...

Page 94: ...ent The monitor can display the information in ST numerical form It can continuously monitor all available leads For ST segment analysis the ECG waveform is not required to be displayed on the monitor For ST analysis it usually uses a special filter which ensures diagnostic quality If you use the diagnostic filter mode to monitoring ECG the ST segment of the ECG wave will be slightly different fro...

Page 95: ...15 11 FM5000C FM5000PLUS Maternal Fetal Monitor User Manual Patients have left bundle branch block When these things happen you should consider to turning off ST monitoring ...

Page 96: ...nts as shown below R Wave P Q BP ISO T S ST Measuring Point DIF ST Value 78 ms Initial Value 109 ms 109 ms Figure 15 8 ST analysis point Attention If the patient s heart rate or ECG waveform changes obviously you need to adjust the location of ISO and ST point The abnormal QRS complex are not considered when the ST analysis is made Method to adjust the ISO and ST point a Select ECG parameter area ...

Page 97: ...15 13 FM5000C FM5000PLUS Maternal Fetal Monitor User Manual baseline ...

Page 98: ...to decide position of each point Warning Please ensure that the location of the ST measurement points suitable for the patients 15 8 Arrhythmia Analysis Arrhythmia analysis is used for the clinical monitoring of patients ECG to detect changes in heart rate and ventricular premature beat to save the arrhythmic events and to generate alarm information Arrhythmia analysis can be used to monitor pacem...

Page 99: ...NALYSIS menu b Select ARR ALARM c Select ARR TYPE select ALL or separate arrhythmia ASYSTOLE VFIB VTAC R ON T VT 2 COUPLET PVC BIGEMINY TRIGEMINY TACHY BRADY PNC PNP MISSED BEATS ARRHYTHMIA d Others Upper and lower limit of alarm Name Maximum Minimum One time adjustment PVCs 31 1 1 15 8 3 Arrhythmia Relearning During ECG monitoring when great changes of patient s ECG template takes place the users...

Page 100: ...onitor User Manual Figure 15 8 Arrhythmia review c Adjust the END TIME d Click an alarmevent like BIGEMINY to enter the review window as shown below and view the parameter values and waveform related to such alarm Figure 15 9 Arrhythmia review ...

Page 101: ...orm on the screen 16 2 RESP Display RESP waveform RESP measured value Figure 16 1 RESP display 16 3 Placing Electrodes for RESP Measurement Alarm limit RESP measurement applies the same electrodes and placement methods as that of ECG monitoring For example if the 5 lead ECG cable is applied the placement method is shown on the figure below for the placement methods of the ECG cable of other lead t...

Page 102: ...16 1 FM5000C FM5000PLUS Maternal Fetal Monitor User Manual Figure 16 2 Positions of electrodes of 5 lead ECG cable ...

Page 103: ...ry line and the left lateral thorax where the patient has the maximum breathing movement to make sure that the breathing waveform is distinct See the following figure Abdominal respiration For some patients the chest movement is limited so they primarily conduct a abdominal respiration And right now you shall remove the electrode which was placed on the left leg to the left abdomen where there is ...

Page 104: ... apnea alarm OFF means the apnea alarm function is disabled 16 4 3 Setting the RESP Lead RESP lead is where the current respiratory waveform comes from There are RA LA I and RA LL II to choose a Select RESP parameter area and he RESP SETUP menu will be displayed b Select RESP LEAD and select RA LA I or RA LL II 16 4 4 Setting the RESP Filter Enhancing filter is to enhance filtering the interferenc...

Page 105: ...ds on many factors most of them are constant However one of the factors is that blood flow in the arteries changes with time since it is pulsatile It is possible to obtain arterial blood oxygen saturation by measuring the amount of light absorbed during the pulse And surveying pulse itself can supply a PLETH waveform and pulse rate signal The main screen can display SpO2 value and PLETH waveform W...

Page 106: ...display alarm message SpO2 NO SENSOR on the screen If the sensor or its packaging has signs of damage do not use it and return to the factory Continuous and prolonged monitoring may increase the risk of undesirable changes in skin characteristics such as irratation reddenning blistering or even pressure necrosis etc especially for the neonates or patients with perfusion disorders and varying or im...

Page 107: ...4 Steps of Monitoring Warning Select the appropriate placement according to the instrument and its supporting probe which is fundamentally vital to neonates 1 Turn on the monitor 2 Insert the connector of the sensor cable into the SpO2socket 3 Attach the sensor to the appropriate position on the patient Placement of finger adult pediatric SpO2 sensor Figure17 2Placement of finger adult pediatric S...

Page 108: ...en stop monitoring because of the failure of searching pulse In this case you should re position these two Excessive movement of measured sites may affect the accuracy of the measurement therefore you should calm the patient or replace sites in order to reduce the impact of excessive movement Warning The maximum measuring time of SpO2 sensor on a single measuring site is 2 hours In a long and cont...

Page 109: ...b and methemoglobin MetHb etc Extremely low degree of blood oxygen saturation The measured area has poor circulation Syndromes such as shock a Extreme low degree of blood oxygen saturation anemia or low temperature etc and application of vasoconstrictor drugs can reduce blood flow to the level of not being able to be measured Measurement also depends on both the oxyhemoglobin and reduced hemoglobi...

Page 110: ...0 90 78 x 2 24 Total SatSeconds 54 Figure17 6 Example figure SatSeconds Example After about 4 9 seconds the instrument will report SatSeconds alarm because 54 is beyond the intelligent alarm range 50 SatSeconds Within a few seconds saturation will fluctuate a bit and not be stable Generally the patient s SpO2 value may fluctuate between the upper and lower limits of the alarm and may re enter to n...

Page 111: ...Select AVG TIME s 3 Select 2 4 4 6 8 10 12 14 or 16 NOTE This feature is only available onMasimo SpO2 17 6 5 Setting the Quick SpO2 Quick SpO2 enables rapid response to and display of fast changes in SpO2 by giving priority to the most recent data When the AVG TIME s is set to 2 4 or 4 6 the FAST SAT turns to ON automatically and the users can perform the rapid SpO2 measurement When AVG TIME s is ...

Page 112: ... non motion accuracy verification by compared to the laboratory joint photoelectric oximeterand monitor in the human blood research where healthy adult volunteers SpO2 value are at 70 to 100 under the inducible hypoxic condition This difference equals to one standard deviation which contains 68 of the sample Masimo SpO2 has passed the motion accuracy verification in the human blood research where ...

Page 113: ...6 430 525 6 360 114 6 263 222 6 236 872 6 229 856 6 206 830 6 157 830 6 067 462 6 011 986 6 002 952 5 919 134 5 823 950 5 769 785 5 758 644 5 685 299 5 632 272 5 490 505 5 482 036 international patents or a item or a number of patents referred to in the www masimo com patents Including functions from products of Satshare and the U S Patent 6 770 028 Other patents are under application Other Inform...

Page 114: ...re at the maximum scope is the mean blood pressure The systolic pressure and diastolic pressure can be calculated after measuring the mean blood pressure Generally speaking auscultatorymethod measures the systolic pressure and diastolic pressure to calculate the mean blood pressure Oscillation method measures mean arterial pressure to calculate systolic pressure and diastolic pressure When perfomi...

Page 115: ... Do not place the cuff on any limb whereintravascular access or therapy or an arterio venous A V shunt is present as thiscould cause temporary interference to blood flow and result in injury to the patient Do not place the cuff on the arm on the side of a mastectomy Pressurization of the cuff can temporarily cause loss offunction of simultaneously used monitoring equipment on the same limb NIBP me...

Page 116: ... reading If you have a problem about the size of the cuff use a larger cuff in order to reduce errors Adult pediatric neonateresuable cuff Patient type Limb Circumference Cuff width Gastube length Neonate 6 11cm 5cm 2 m Infant 10 19 cm 8 cm Pediatric 18 26 cm 10 6 cm Adult 1 25 35 cm 14 cm Adult2 33 47 cm 17 cm Leg 46 66 cm 21 cm Neonate disposable cuff Size Limb Circumference Cuff width Gastube l...

Page 117: ...surement for the hypertension patient the patient position should be as follows a Comfortably seated b Legs uncrossed c Feet flat on the floor d Back and arm supported e Middle of the cuff at the level of the right atrium of the heart 18 4 2 Operation Prompt 1 Start an auto measurement Enter the menu NIBP SETUP and select INTERVAL to select the time interval for auto measurement and then press the...

Page 118: ...on difficult measurement values will become unreliable and load time will increase Users should be aware that the following conditions will interfere with the measurement method so that pressure is not reliable or load time increases In this case the patient s condition will make measurement impossible 1 Patient Mobility If patient is moving shaking or in spasms measurement will be unreliable or e...

Page 119: ...18 6 FM5000C FM5000PLUS Maternal Fetal Monitor User Manual Blood pressure measurement cannot be performed when heart rate is lower than 40bpm beats per minute or higher than 240bpm beats per minute ...

Page 120: ... be displayed b Select INTERVAL c Select MANUAL to conduct a manual measurement d Select 1MIN 2MIN 3MIN 4MIN 5MIN 10MIN 15MIN 30MIN 60MIN 90MIN 120MIN 180MIN 240MIN or 480MIN for auto measurement 18 5 3 Setting the Pressure Unit a Select NIBP parameter area and the NIBP SETUP menuwill be displayed b Select UNIT c Select mmHg or kPa 18 5 4 Setting the Pre inflation Value a Select NIBP parameter are...

Page 121: ...ect NIBP parameter area and select RESET Reset can restare the inflation value of the blood pressure pump to the initial setting If the blood pressure pump is working abnormally it can be checked by means of reset and will recover from any anomaly caused by an accidental reason ...

Page 122: ...ll trigger a technical alarm and display alarm message T1 SENSOR OFF on the screen Be careful in handling the TEMP probe and cable when not in use the probe and cable should be pulled into the loose ring If the wire is pulled too tight it will lead to mechanical damage Calibrate the temperature measuring instrument at least once every two years or according to the required time in the hospital dir...

Page 123: ...n connect the cable to the TEMP socket on the monitor For reusable temperature probe it can be directly connected to the TEMP socket 2 Securely attach the temperature probe onto the patient s body 3 Turnon the monitor 19 5 Setting the TEMP Unit a Select TEMP parameter area and the TEMP SETUP menu will be displayed b Select TEMP UNIT c Select Celsius degree or Fahrenheit degree according to your ha...

Page 124: ... CM FSM FM Marker Waterproof 040 000226 00 HX 1 Wake Probe 040 000867 FS TC1 Adult Electrode 040 000868 Adult Electrode 040 000320 00 98ME01AC473 ECG Cable 040 000321 00 98ME01AC474 ECG Cable 040 000322 00 98ME01AC475 ECG Cable 040 000368 00 98ME01EC477 ECG Cable 040 000369 00 98ME01EC478 ECG Cable 040 000370 00 98ME01EC479 ECG Cable 040 000479 00 98ME01AC458 ECG Cable 040 000480 00 98ME01AC457 EC...

Page 125: ...26 Cable extender NIBP Cuff 040 000591 00 U1880S NIBP Cuff 040 000592 00 U1880S NIBP Cuff 040 000593 00 U1881S NIBP Cuff 040 000594 00 U1882S NIBP Cuff 040 000595 00 U1883S NIBP Cuff 040 000596 00 U1884S NIBP Cuff 040 000597 00 U1885S NIBP Cuff 040 000598 00 U1869S NIBP Cuff 040 000599 00 U1889S NIBP Cuff Temp Probe 040 000246 00 TAS03 04 Surface Probe 040 000387 00 TPS03 03 Surface Probe 040 0003...

Page 126: ...0 2010 EN ISO 80601 2 55 2011 Ingress protection IPX1 Safety level if there is any mixture of flammable anesthetic gas and air or oxygen nitrous oxide not applicable The monitor is not allowed to be used if there is any mixture of flammable anesthetic gas and air or mixture of flammable anesthetic gas and oxygen or nitrous oxide Work mode Continuous running equipment 2 Monitor Specifications 1 Dim...

Page 127: ...solution of 1 minute 5 minutes and 10 minutes Trend chart and trend table 120hours Alarm events 300parameter alarm events and related parameter waveform Measured NIBP data 2 000 groups Waveform history Up to 120 minutes subject to the type and quantity of the saved waveform Frozen waveform 240s mother waveform 60h fetus waveform 6 Fetus Monitoring Item Specification Work mode Pulse wave Ultrasound...

Page 128: ... Monitor and surgical mode the 50 60Hz notch function is auto activated Diagnostic mode the 50 60Hz notch function can be select to activate or deactivate mannually Power frequency interference rejection capability 20dB Noise level 25μVP P CMRR 105dB Overload protection Load 1V power frequency differentialmode AC voltage for 10s without damage p v Respiration lead off sensing and active noise supp...

Page 129: ...annel crosstalk 5 Time reference selection and accuracy Time reference selection Permanent display 25mm s Non permanent display 12 5mm s 25mm s 50mm s Accuracy 10 Output display Channel width 30mm Aspect ratio 0 4s mV Input signal reproduction accuracy Total system error 20 or 100µV whichever is larger Frequency response Sinusoidal input 0 67 40Hz attenuation 3dB Response to 20ms width triangular ...

Page 130: ...Fetal Monitor User Manual Baseline control and stability Reset time 3s Drift rate in 10s 10µV s Baseline drift in 1h 500µV Baseline drift under working temperature 50µV Pulse inhibition of Amplitude 2mV 700mV width 0 1ms 2 0ms method A ...

Page 131: ...is computed like this If the last 3 continousRR intervals are greater than 1200ms the last 4 RR intervals are averaged to compute the HR Otherwise the last 12 RR intervals with the longest interval and shortest interval excluded are averaged to compute the HR Heart ratemeter accuracy and response to irregular rhythm Meet the requirementsofIEC 60601 2 27 Clause 201 12 1 101 17 b 4 the HR is display...

Page 132: ...re 10mmHg 215mmHg 1 3kPa 28 7kPa Pediatric Systolic pressure 40mmHg 200mmHg 5 3kPa 26 7kPa Mean arterial pressure 20mmHg 165mmHg 2 7kPa 22 0kPa Diastolic pressure 10mmHg 150mmHg 1 3kPa 20 0kPa Neonate Systolic pressure 40mmHg 135mmHg 5 3kPa 18 0kPa Mean arterial pressure 20mmHg 110mmHg 2 7kPa 14 7kPa Diastolic pressure 10mmHg 100mmHg 1 3kPa 13 3kPa Accuracy The maximum mean deviation is 5mmHg 0 66...

Page 133: ...tinuous 5min 10 SpO2 Item Specification Display resolution 1 Measurement range and accuracy a Analog SpO2 module Measurement range 0 100 Accuracy 2 measured without motion in adult pediatric mode or 3 measured without motion in neonate mode within the measurement range of 70 100 b MasimoSpO2 module Measurement range 1 100 Accuracy 2 measured without motion in adult pediatric mode 3 measured with m...

Page 134: ...Maternal Fetal Monitor User Manual Alarm range and accuracy Alarm range 0 100 Accuracy 1 Data update period 2 seconds Data and other signal processing time 8 seconds Low perfusion Conditions Pulse amplitude 0 2 SpO2 Accuracy 3 ...

Page 135: ... without motion c Nellcor SpO2 module Measurement range 25bpm 250bpm Resolution 1bpm Accuracy 3bpm within the measurement range of 20bpm 250bpm Not specified within the measurement range of 251bom 300bpm Alarm range and accuracy Alarm range 20 bpm 300 bpm Accuracy 1bpm 12 Body Temperature Item Specification Measurement range 0 50 Accuracy 0 2 sensor included Alarm range 0 50 0 32 122 Alarm resolut...

Page 136: ...High Medium HR TOO LOW Medium High Medium ST1 TOO HIGH Medium High Medium ST1 TOO LOW Medium High Medium ST2 TOO HIGH Medium High Medium ST2 TOO LOW Medium High Medium PVC TOO HIGH Medium High Medium PVC TOO LOW Medium High Medium SPO2 TOO HIGH Medium High Medium High Medium SPO2 TOO LOW Medium PR TOO HIGH Medium High Medium PR TOO LOW Medium High Medium NS TOO HIGH Medium High Medium NS TOO LOW M...

Page 137: ...m BIGEMINY Medium High Medium TRIGEMINY Medium High Medium Supraventricular tachycardia Medium High Medium TACHY Medium High Medium BRADY Medium High Medium MISSED BEATS Medium High Medium ARRHYTHMIA Medium High Medium PNC Medium High Medium PNP Medium High Medium 2 Technical alarm message There is only one alarm level for a certain alarm condition and the user cannot change it Alarm Message Defau...

Page 138: ...larm limit for a certain parameter has been accidentally changed Please contact the serviceman PVCS ALM LMT ERR High ST ALM LMT ERR High RR ALM LMT ERR High SPO2 ALM LMT ERR High NS ALM LMT ERR High NM ALM LMT ERR High ND ALM LMT ERR High PR ALM LMT ERR High TEMP1 ALM LMT ERR High ECG NOISE High There is too much interference signal in ECG signal Check if there is any possible source of signal noi...

Page 139: ...se contact the serviceman UNKNOWN SENSOR Low The SpO2 sensor has damaged or the SpO2 sensor not specified is being used Replace the SpO2 sensor DEFECTIVE SENSOR Low Masimo SpO2 sensor is open circuit INTERFERENCE Low There is interference signal when measuring SpO2 Check if there is any possible source of signal noise around the SpO2 sensor and check the patient for great motion MUCH LIGHT Low The...

Page 140: ...III 5 FM5000C FM5000PLUS Maternal Fetal Monitor User Manual NIBP INIT ERR High process contact the serviceman SPO2 COMM STOP High The module failed to ...

Page 141: ...tery level of TOCO wireless transducer is too low Change the battery of TOCO wireless transducer ADJT ULTRAS POSITION High FHR is the same as maternal heart rate Please adjust the position of FHR transducer RECORDER PAPER LACK High No record paper loaded Load record paper Paper Tray Not Closed High The paper tray has not closed well Close the paper tray well MONITOR STOP High Timed monitoring stop...

Page 142: ...III 7 FM5000C FM5000PLUS Maternal Fetal Monitor User Manual MEASURE FAIL CUFF TYPE ERR Wrong type of NIBP cuff is being used ...

Page 143: ...ting External printing External printer is being used to print MANUAL MEASURE Manual NIBP measurement is being performed PNEUM TESTING Pneumatic test is being performed RESETTING Manual reset is being performed CONT MEASURING Continual NIBP measurement is being performed PLEASE START Please press NIBP start key to start NIBP measurement AUTO MEASURING Auto NIBP measurement is being performed ...

Page 144: ... delay time 10 seconds Language English Time end prompt On Timedmonitoring 20 minutes Grade On Print report On Paper type 30 240 Printer select Internal printer Score select FHR1 Grade criterion Advanced FISCHER Real time print speed 3cm minute Real time print time 20 minutes Review print time 20 minutes Print ECG waveform On ECG print speed 25 ECG print time 8 seconds 2 FHR1 Default Settings Item...

Page 145: ...TOCO Default Settings Items Factory adult pediatric neonate default settings Remarks Display color Purple FM threshold 50 TOCO zero 10 AFM color Yellow 5 NIBP Default Settings Items Factory default settings Remarks Adult Pediatric Neonate Unit mmHg Display color White Measure mode Adult Pediatric Neonate Interval Manual Initial inflation 160 120 100 6 ECG Default Settings Items Factory adult pedia...

Page 146: ...l indication On Only available on Masimo SpO2 module Pulse tone On Sat second Off Average time 8S Sensitivity Normal Intelligent alarm 10 Only available on NELLCOR SpO2 module Sweep 25 0mm Wave type Line 9 TEMP Default Settings Items Factory adult pediatric neonate default settings Remarks Display color White Unit 10 Default Alarm Settings Items Factory default settings FHR1 FHR2 Alarm recording O...

Page 147: ...itch On Alarm level Medium Alarm recording On PVCS alarm settings Upper limit 10 Lower limit 0 RESP Alarm recording On Alarm level Low Alarm switch On Apnea alarm 10s Alarm limit Upper limit 28 28 100 Lower limit 10 10 30 TEMP Alarm recording On Alarm level Medium Alarm switch On Alarm limit Upper limit 39 0 Lower limit 36 0 NIBP Alarm recording On Alarm switch On Alarm limit SYS Upper limit 170 1...

Page 148: ...IV 2 FM5000C FM5000PLUS Maternal Fetal Monitor User Manual PR alarm limit Lower limit 45 70 110 ...

Page 149: ...ronment specified below The customer or the user of the monitor should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The monitor uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CIS...

Page 150: ...0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s Mains power quality should be that of a typical commercial or hospital environment If the user of the monitor requires continued operation during power mains interruptions Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fieldsshould be at levels characteri...

Page 151: ...no closer to any part of the monitor includingcables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P d 1 2 P 80MHz to 800MHz d 2 3 P 800MHz to 2 5GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended s...

Page 152: ...y range 150kHz to 80MHz field strengths should be less than 3V m Recommended separation distances between portable and mobile RF communications equipment and the monitor The monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the monitor can help prevent electromagnetic interference by maintaining a minimum dist...

Page 153: ...onitor is connected with AC power supply Off when the monitor is disconnected with AC power supply Battery indicator On when the battery is being charged Off when no battery is installed or no AC power supply is connected Flash when the monitor operates on battery power Freeze key Press to freeze or unfreeze the waveforms on the screen Alarm reset key Press to reset the alarm system NIBP start key...

Page 154: ...Sensor sockets Product Introduction Display screen Recorder Net connector USB connector Power connector Handle Equipotential connector Right View Left View Rear View ...

Page 155: ...Product Introduction Rear View Handle Paper tray Battery compartment Alarm Speaker Fetal Heart Speaker Nameplate ...

Page 156: ...sage area Click here to directly access ALARM RECALL window 5 Timed monitoring information area Click here to directly access TIMER menu 6 Icons area Printer icon FHR volume icon Alarm volume icon Battery icon 7 System time 8 Waveform area 9 Parameter area 10 On screen keys The monitor is equipped with a 12 1 inch TFT touch screen All operations on the monitor can be performed by keys and touch sc...

Page 157: ...t the alarm volume in the pop up list box from X to 6 Adjusting Heartbeat Volume 1 Access MAIN MENU Option Setup Beat Vol Select the heartbeat volume in the pop up list box Adjusting FHR Volume 1 Access MAIN MENU Option Setup FHR Vol 2 Or click FHR volume icon Select the FHR volume in the pop up list box Adjusting Key Volume 1 Access Main Menu Option Setup Key Vol 2 Select the key volume in the po...

Page 158: ...e patient information and discharge the patient How to save user default settings 1 Access Main Menu select Maintain and enter the password 2 Select Save Current As User Config to save current settings How to use factory adult pediatric neonate default settings 1 Access Main Menu Monitor Setup Restore Default Configuration 2 Select Adopt Factory Default Adu Config Adopt Factory Default Ped Config ...

Page 159: ... figure above 2 Put the recording paper into the paper tray with the grid side facing up and the black label at the left 3 Pull the recording paper slowly out of the recorder tray and then adjust the position of the recording paper 4 Push the paper tray in until it is locked Loading Recording Paper ...

Page 160: ...t is set to ON the monitor will output the score report immediately and then stop printing if Report is set to OFF the monitor will stop printing immediately Stored Patient Case Printing Stored patient case printing means the printing triggered by pressing the print key on the front panel or clicking the Print on screen key after loading the patient case and enter patient case review interface How...

Page 161: ...onitor will start to print the frozen fetal waveform from the very left waveform on current screen according to the time length set in Freeze Time 3 If the Report is set to ON the score report will be printed after frozen fetal waveform How to select score 1 Enter Main Menu Monitor Setup Print Setup 2 Or click print icon on icon area 3 Click Score Select to show the scores on the case report 4 Cli...

Page 162: ... the monitor will be auto powered by the battery without operation interruption and the battery work indicator will be lit up 30s after the power failure To understand the battery icon indicating the battery is fully charged indicating moderate battery power indicating low battery power indicating critically low battery power please charge the battery immediately indicating no battery installed or...

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