Bionet BM3 User Manual Download Page 138

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Rev. 3.0

138

BM3 User’s Manual

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Summary of Contents for BM3

Page 1: ...BM3 User s Manual BM3 User s Manual Patient Monitor Rev 3 0 2019 11 22 Warning To ensure proper use of this medical equipment you must read and comply with this user manual ...

Page 2: ...et Co Ltd Before using Bionet devices read all the manual that are provided with your device carefully Patient monitoring equipment regardless of the complexity of the equipment should never be used as a substitute for the patient care attention and critical judgment that only trained health care professionals can provide CAPNOSTAT LoFlo is trademark of Respironics All other brand or product names...

Page 3: ...ution Note 11 Define groups 12 General precaution on environment 13 Electromagnetic Compatibility 14 1 Basic 15 Overview 15 Electric safety precautions 15 Biocompatibility 17 Product Configuration 17 Option Product 18 Basic Unit 19 Device Markings 24 Power 25 How to replace the battery 29 Getting Started 31 2 SETUP 34 Overview 34 ...

Page 4: ...splay Mode 44 4 Admission and Discharge 46 Overview 46 Patient admission 46 Patient discharge 47 Registration of patient ID using barcode 52 5 Alarm 53 Overview 53 Alarm priority 53 Alarm management 55 Alarm settings 56 Alarm event 57 6 TREND 58 Overview 58 Trend setup 58 Graphical trend 61 Tabular trend 62 File export 63 Popup trend 65 ...

Page 5: ...l processing and display 74 Alarm and alarm status 74 Display 75 ECG Settings 75 Trouble shooting 78 8 Arrhythmia Monitoring 80 Overview 80 Arrhythmia templette 80 Arrhythmia Settings 81 9 SpO2 83 Overview 83 Precaution 83 Patient preparation 84 Display 85 Quality of SPO2 Waveform 87 SPO2 Settings 88 Status messages 89 10 RESPIRATION 90 Overview 90 ...

Page 6: ... NIBP 97 Overview 97 Display 99 NIBP Settings 100 Measurement Limitations 103 Status Messages 105 12 EtCO2 106 Overview 106 Precaution 111 Sampling method 112 Display 114 EtCO2 setup 114 Status Message 119 13 Temperature 122 Overview 122 Display 123 Temperature settings 124 14 Printer 125 Overview 125 Printer settings 126 ...

Page 7: ...lfunction 134 NIBP malfunction 135 Abnormality in NIBP measurements 135 EtCO2 malfunction 136 Failure in battery recharge 136 Power failure 137 Data storage failure 137 Periodic noises 138 Print failure 138 16 Clean and Care 139 Overview 139 Monitor and Peripherals 139 17 Technical Specification 143 Overview 143 EMC Compatibility EMC 143 Manufacturer s declaration electromagnetic emission 145 Manu...

Page 8: ...ation electromagnetic immunity 152 System Specification 154 Adult Pediatric ICU Mode 160 Alarm level 160 Neonate ICU Mode 161 Alarm level 161 Parameter Limits 162 Display 163 Abbreviations and Symbols 164 PRODUCT WARRANTY 169 International Sales Service Contact 170 ...

Page 9: ...n this user guide are for illustration purposes only Actual products or screens may vary slightly General Description The BM3 monitor can monitor the following Heart Rate Respiration Rate Non Invasive blood pressure Arrhythmia Temperature SpO2 Pulse Rate Apnea ST segment analysis EtCO2 option FiO2 option This equipment is designed to be used in an environment where a health care professional can d...

Page 10: ...o provide the clinician with meaningful parameter values and to sound an alarm when the established parameter value is exceeded or the function that provides the value is not working properly We assessed the risks associated with the use of these monitors in light of these essential performance features and mitigated the risk of lowering the residual risk to a level that could be used without comp...

Page 11: ...are subject to change without prior notice Warning Warning A warning contains important information regarding possible danger to you or the patient that is present during normal operation of the equipment Caution Caution A caution provides information or instructions that must be followed to ensure proper operation and performance of the equipment Note Note A note presents information that helps y...

Page 12: ...nly be used installed reprocessed maintained and repaired by a defined group User Users use the product for their intended use Service personnel Service personnel are responsible for the maintenance of the product They must be trained in the maintenance of the medical device install reprocess and maintain the product Expert The specialist repairs the product or performs complex maintenance tasks T...

Page 13: ...in the vicinity of Electric heater Avoid placing in an area where there is an excessive humidity rise or ventilation problem Avoid placing in an area where there is an excessive shock or vibration Avoid placing in an area where chemicals are stored or where there is danger of gas leakage Avoid being inserted dust and especially metal material into the equipment Do not disjoint or disassemble the e...

Page 14: ...itoring and life support is used comply to accepted emissions standards CISPR 11 Class A Try to maximize the distance between electro medical devices High power equipment related to electrical simulators electrosurgical instruments and radiators X ray machines as well as evoked potential devices may cause monitor interference Strictly limit exposure and access to portable radio frequency sources e...

Page 15: ...Electric safety precautions Caution Please check the following before using the product 1 Be sure that AC power supply line is appropriate to use AC100 240V 2 Be sure that the power source is the one supplied from Bionet DC18V 2 8A BPM050 Made in BridgePower Co Ltd 3 Be sure that the entire connection cable of the system is properly and firmly fixed 4 Be sure that the equipment is completely groun...

Page 16: ... also produce inaccurate output Note BM3 is classified as follows BM3 classifies as Class II BF CF concerning electric shock It is not proper to operate this Equipment around combustible anesthetic or dissolvent Noise level is A class regarding IEC EN 60601 1 and the subject of Nose is A level concerning IEC EN60601 1 2 Warning Do not touch the patient while using the defibrillator The user may be...

Page 17: ... this operator manual including accessories that come in contact with the patient during the intended use fulfill the biocompatibility requirements of the applicable standards If you have questions about this matter please contact Bionet or its representatives Product Configuration 1 Main body of BM3 Monitor 1 EA 2 3 Lead Patient Cable with extension cable 1EA 3 Disposable electrodes 10 EA 4 NIBP ...

Page 18: ... Lead Patient Cable with extension cable Warning In order to avoid electrical shock do not open the cover Disassembling of the equipment should be done only by the service personnel authorized by Bionet Warning Users must pay attention on connection any auxiliary device via LAN port or nurse calling Always consider about summation of leakage current please check if the auxiliary device is qualifie...

Page 19: ...3 User s Manual Basic Unit Front view 1 Alarm lamp handle 5 Home key 2 Alarm control key 6 Rotary knob key 3 Printer key 7 Power ON OFF Key 4 Blood pressure measurement key 8 Battery status indicator 1 8 2 3 4 5 6 7 ...

Page 20: ... Rev 3 0 20 BM3 User s Manual Right side view 1 ECG connector 2 Blood pressure Hose connector 3 SpO2 connector 4 Temperature connector 5 EtCO2 connector ...

Page 21: ... Rev 3 0 21 BM3 User s Manual Left side view 1 Printer 1 ...

Page 22: ... 0 22 BM3 User s Manual Back side view 1 Potential equivalent 2 NURSE CALL connector 3 USB connector USB 2 0 5Vdc Max 500mA 4 DC input 5 Service port connector 6 Network connector 7 HDMI output 7 6 5 4 3 2 1 ...

Page 23: ...anual Sandisk PNY Transcend Samsung When using a product with high power consumption such as an external hard drive be sure to use the provided adapter for suitable power supply Cannot be used alone as a power supply You should save the data of connected device before connecting the additional device It may not be supported some devices that required high power ...

Page 24: ... Power ON OFF Function WEEE Waste Electrical and Electronic Equipment ECG European Medical Device Directive 93 42 EEC Date of manufacture Consult instructions for use This symbol advises the reader to consult the operating instructions for information needed for the proper use of the device Safety Sign To signify that the instruction manual must be read Reading the instruction manual before starti...

Page 25: ... press of power key makes the machine ready for use Caution This equipment must be connected to a protective earth grounded power supply Using non standard products other than the adapters supplied by us may cause signal distortion or noise Be sure to use a genuine adapter that is supplied by our company and is insulated Battery power DC adapter it uses battery power when power failure and portabl...

Page 26: ...rns off when the battery is depleted The table below describes the function of the battery charging bar graph at the top of the screen Battery charge discharge display Display Charging remain time Description Your battery is fully charging Not applicable Your battery is fully charged Not applicable Your battery is 75 charged Not applicable Your battery is charged at 50 If possible connect it to th...

Page 27: ...fe continues battery life will decrease and frequency of replacement will increase To prevent pre discharge recharge after the battery is discharged Caution The battery charge display is accurate only when the battery is operating normally Battery Charging Time more than 6 hours Continuous Battery Usage Time more than 3 hours for normal operation when fully charged Caution The battery charge displ...

Page 28: ... equipment 5 Presence of battery When the battery is disconnected from the equipment and it malfunctions it shows X as shown below Note Charging is not possible at low power below 16V Cannot be used in vehicles with 24V power supply When replacing the battery be sure to remove the DC adapter and replace it Warning Older or defective batteries will have significantly reduced capacity or operating t...

Page 29: ... monitor This discharge is the result of the Lithium Ion cells and the bias current required for the integrated electronics By the nature of Lithium Ion cells the battery will self discharge The self discharge rate doubles for every 10 C 18 F rise in temperature The capacity loss of the battery degrades significantly at higher temperatures As the battery ages the full charge capacity of the batter...

Page 30: ...red by an AC power source the battery cell temperature increases by 15 C to 20 C 59 F to 68 F above the room s ambient temperature This reduces the life of the battery When the battery is stored inside a monitor that is continuously powered by an AC power source and is not powered by battery on a regular basis the life of the battery may be less than 12 months Bionet recommends that you remove the...

Page 31: ...ghts up the alarm bar lights up the power is turned off the screen lights up the main screen is displayed after running the self test Stopping the monitor Press and hold the power key O for 3 seconds The screen goes off Main screen setup After the monitor is turned on the main screen is displayed 1 Status Message 3 Numeric Window 2 Waveform Window 4 Menu Window 1 2 3 4 ...

Page 32: ...y knob switch allows the user to navigate menus select settings and perform menu functions Rotate the rotary knob to move the menu item To confirm the selection press the rotary knob switch Fixed key The fixed keys on the front panel of the monitor allow you to perform commonly performed functions Fixed key Description Fixed key Description The alarm control key switches between Normal Audio Pause...

Page 33: ...ens a table where you can set the maximum and minimum alarm limits This is an alarm mode key so it enables to change Normal Audio Paused Alarm Paused mode Access the Hospital Emergency menu Displays the setup menu Enable waveform stop function Displays the automatic blood pressure measurement interval setting menu Displays the printer setup menu Displays trend menu Displays the mini Trend window S...

Page 34: ... Rev 3 0 34 BM3 User s Manual 2 SETUP Overview This chapter describes how to configure your monitor and how to upgrade your software Monitor configuration Setup Menu tree Parameter menu tree ...

Page 35: ... performs the desired function or goes one step further down 3 Click Close at the bottom of the submenu list to return to the previous menu or screen Main menu Sub menu A SETUP A 1 PARAMETER SETUP A 2 PARAMETER UNITS A 3 USER SERVICES A 4 SYSTEM INFORMATION A 5 NETWORK INFORMATION A 6 CENTRAL A 7 HL7 A 8 ALARM SETUP A 9 DISPLAY OPTION A 10 HOSPITAL INFORMATION B BIOSIGNAL CALIBRATION B 1 ECG RESP ...

Page 36: ... Kg Lbs A 2 2 Height UNIT Height measurement unit Cm Inch A 2 3 BLOOD PRESSURE UNIT blood pressure measurement unit mmHg kPa A 2 4 ST UNIT ST measurement unit mm mV A 2 5 TEMPERATURE UNIT Temperature measurement unit C F A 2 6 GAS PRESSURE UNIT Gas measurement unit mmHg kPa vol A 2 7 MULTI GAS PRESSURE UNITS Select whether to set the pressure unit for each gas type When OFF unit setting menu by ga...

Page 37: ...n A 4 2 NIBP VERSION Display NIBP Module version A 4 3 LANGUAGE Set language English Korean French Bulgarian Polish German Chinese Portuguese Hungarian Czech Romanian Italian Turkish Spanish Russian Greek Japanese A 5 NETWORK INFORMATION Network information and setup A 5 1 WIRELESS Wireless setup ON OFF A 5 2 DHCP Auto IP allocation setting menu ON OFF A 5 3 DEVICE IP IP setting menu XXX XXX XXX X...

Page 38: ... 15 30min 1 hour 6 hour A 7 5 HL7 NAK NAK Transmission menu setup ON OFF A 7 6 EDIT HL7 LABEL Parameter label edit menu A 8 ALARM SETUP Alarm settings menu A 8 1 ALARM PASSWORD Alarm setup password activation menu ON OFF A 8 2 SETUP PASSWORD Password setup menu A 8 3 ALARM SOUND Alarm sound type selection menu IEC60601 BIONET A 9 DISPLAY OPTION A 9 1 SWEEP SPEED ECG SPO2 RESP 6 25 mm sec 12 5 mm s...

Page 39: ...BP B 2 1 ZERO Calibration NIBP Zero calibration menu Zero calibration menu at atmospheric pressure B 2 2 Gain Calibration NIBP Gain control menu Perform 250mmHg pressure calibration and select menu B 2 3 Pneumatic Pump NIBP Pump control menu ON OFF B 2 4 Pneumatic Valve NIBP valve control menu Close Open C SCREEN Calibration Perform touch screen calibration point input D MAKER SERVICES D 1 MAC ADD...

Page 40: ...ual Parameter color Parameter Basic color Selectable colors Green light blue yellow purple blue sky blue orange gray light green pink white red light yellow ECG ST Green SpO2 Blue RESP Yellow NIBP Purple TEMP Green ETCO2 Yellow ...

Page 41: ...hat can be remotely controlled from a central station Start recording Modify alarm limit Alarm Mute Print the current monitor screen to a network laser printer Using the optional remote keypad Enter edit and view patient data Network connection In a network data can be exchanged over wired or wireless technology All data interfaces e g RS 232 LAN USB interface described in the standard and convent...

Page 42: ...mmended to connect 8 units to the same network Due to the nature of wireless connectivity may not be good depending on the environment Remote View If the monitor is connected to a network you can view other monitors connected to the network on your monitor and make the alarm silent The procedure for displaying the remote view screen is as follows To set the menu display time refer to the setting p...

Page 43: ...ttings B2B VIEW MONITOR LIST sub menu REFRESH Menu to update monitor list connected to network UP Move to upper list DOWN Move to lower list MONITOR LIST List of monitor information connected to the network CONNECT Monitor connection menu for remote connection ...

Page 44: ... Rev 3 0 44 BM3 User s Manual Display Mode Wave and Numeric Mode Numeric Mode ...

Page 45: ...nu for TRACE II in the B2B View window ECG SPO2 RESP ETCO2 A 2 NEXT VITAL Additional parameter selection menu A 3 MORE VITALS WAVE screen and TEXT screen selection menu A 4 NEXT BED Connect to the following connected monitor devices A 5 SETUP ALARM Alarm setting menu of remotely connected monitor Normal Audio Paused Alarm Paused Audio Off Alarm Off A 6 NIBP START STOP NIBP measurement start and st...

Page 46: ...r the Inbound and Outbound monitors are connected to the Central network Patient admission How to admit a patient 1 Press the Patient icon button 2 Click on Admit 3 Click on Patient Information 4 Please select a field The data entry screen appears 5 Click the letter of the word you want to input If you made a mistake click Backspace and try again 6 Click Enter to confirm your entry 7 Click on the ...

Page 47: ...key 2 When you execute the discharging menu on the screen you will be warned that all patient data will be deleted 3 Press the Accept button The discharge procedure is in progress The monitor displays a Discharge message When the patient is successfully discharged a banner with the following message is displayed PATIENT TYPE When you set the animal type type image is displayed on the upper left co...

Page 48: ...st Name First Name setting B 1 4 Last Name Last Name setting B 1 5 Gender Gender setup MALE FEMALE B 1 6 Birthday Birthday setting menu YYYY MM DD B 1 7 Weight Age setting XXX XX Kg B 1 8 Height Weight setting XXX XX Cm B 1 9 Blood Type Default setting A Rh Rh D Rh Null B Rh Rh D Rh Null O Rh Rh D Rh Null AB Rh Rh D Rh Null Unknown C Default Setting Set Patient Info to Default Value D User Drug Ch...

Page 49: ...SIDE INOCOR HEPARIN INSULIN STREPTOKINASE DRUG 1 5 E 1 2 Drug Quantity Set Drug Quantity E 1 3 Solution Volume E 1 4 Dose Quantity Set Dose Quantity E 1 5 Inflation Rate E 1 6 Weight Some drugs may not be supported E 1 7 Dose Step E 2 Titration Table E 2 1 DRUG NAME Set Drug Name E 2 2 DRUG QUANTITY Set Drug Name Refer to drug list bellow E 2 3 SOLUTION VOLUMNE E 2 4 Dose Quantity Refer to drug li...

Page 50: ...TY mg mg min BRETYLIUM LIDOCAINE PROCAINAMIDE Flow rate ml hr Dose mg min SolutionVolume ml 60 Drug QTY mg mcg min EPINEPHRINE LEVOPHED ISOPROTERENOL Flow rate ml hr Dose mcg min SolutionVolume ml 60 Drug QTY mg 1000 Mcg kg min DOPAMINE DOBUTAMINE NITROGLYCERINE NITROPRUSSIDE INOCOR Flow rate ml hr Dose mcg kg min Weight kg SolutionVolume ml 60 Drug QTY mg 1000 units hr HEPARIN INSULIN Flow rate m...

Page 51: ...Proper Range mg hr 0 01 to 500 mg 0 01 to 2000 mg min mg kg hr mg kg min mcg hr mcg min mcg kg hr mcg kg min units hr 10 to 15000 Units 100 to 150000 IU hr 1000 to 1500000 IU 1000 to 1500000 Items Unit Drug QTY unit Volume of Liguid mL 1 to 1000 WEIGHT Kg 0 to 300 Velocity of Flow ml hr 0 1 to 600 ...

Page 52: ... to the USB HOST connector on the left as shown in the figure below After the BEEP sound is generated the barcode icon appears at the bottom of the instrument screen The barcode that you want to input is matched to the index LED generated by the scanner and if you press the input button the corresponding ID is read and sent to the equipment The sender ID is displayed at the top center of the scree...

Page 53: ...ating alarm status External alarm device such as nurse call system Activate alarm recording The monitor generates an alarm when the parameter in the Alarm Limits table is ON It is not a prerequisite that the parameter is displayed on the display or connected in the event of an alarm Alarm priority The alarm type is divided into a patient status alarm and a product status alarm The patient status a...

Page 54: ...e printed out Red color alarm indicator on the screen is blinked Yellow color alarm indicator on the screen is blinked Blue color alarm indicator on the screen is displayed Audible alarm Alarm priority BIONET IEC HIGH Two consecutive square beeps Beep 5 times Short stop time 5 beeps 5 beeps MEDIUM Stop after two short beeps 3 short beeps Short stop time 15second pauses LOW Low sound 30 times per s...

Page 55: ...en After the user switches to another alarm mode or after the timeout period has elapsed if the alarm occurs still visual and audible alarms will be activated again Alarm_Off Stop visual and audible alarms A banner with the message Alarm Off is displayed on the screen The monitor maintains Alarm Off mode until user switch to another alarm mode Audio_Off Stop the audible alarm A banner with the mes...

Page 56: ...rrhythmia Alarm Condition A 3 System Alarm Condition A 4 Alarm Parameter A 5 Nurse Call B Alarm Review MENU Description Available Settings A Alarm Setup menu A 1 Parameter Alarm Limit All parameter alarm level activate Setup menu A 2 Arrhythmia Alarm Condition Arrhythmia alarm level setting menu ASYSTOL VTAC VTAC VFIB A 3 SYSTEM ALARM CONDITION System alarm level setting menu LOW BATTERY A 4 Alarm...

Page 57: ...r Settings menu A 5 1 Nurse call on Alarm NURSE CALL function ON OFF After setting ON check if relay sound is heard in ALARM situation ON OFF A 5 2 Call Type NORMAL CLOSE NORMAL OPEN ACTIVE state change check Normal open Normal close A 5 3 Duration ONE TIME CONTINUE CYCLING One time Continue Cycling A 5 4 Level Message Low Medium High Alarm event ...

Page 58: ...d can also print the screen of trends displayed Triggered alarm events are displayed in red inverted triangles on the Event List and Timeline Trend setup Main menu Sub menu A Trend Setup A 1 Popup Trend B Graphic Trend B 1 Graphic Trend B 2 Tabular Trend C Tabular Trend C 1 Graphic Trend C 2 Tabular Trend D Trend Export E OxyCRG Show Hide ...

Page 59: ...Trend B 1 1 Event List B 1 2 Time Period Saved data can be viewed graphically in sections 30min 60min 90min 2hour 3hour 4hour 6hour 8hour 12hour B 1 3 Display Group B 1 4 Print Set the time and see the stored values at each set time B 2 Tabular Trend B 2 1 Event List B 2 2 Time Period Time period setting 1min 5min 10min 15min 30min 1hour 2hour B 2 3 Display Group B 2 4 Print Graphic trend print ou...

Page 60: ...3 Display Group C 2 4 Print Graphic trend print output D Trend Export menu D 1 Start Time Parameter save start time setting menu hh mm D 2 End Time Parameter Save Last Time Setting Menu hh mm D 3 Export Time Period Time period setting 1min 5min 10min 15min 30min 1hour D 4 Export Order Sequence of parameters Descending Ascending D 5 Export F OxyCRG Show Hide menu When selected the screen shows hear...

Page 61: ...on color and scale Meter labels and numbers are displayed on the left side of the trend channel Vertical lines in each graph This displays the time distribution Trends keeps the most up to date data It is automatically updated on the right side of the graph 1 2 3 4 5 6 7 8 9 10 11 Graphic trend select menu Tabular trend select menu Event list menu Event previous next menu Patient ID Parameter nume...

Page 62: ...mat Up to six are displayed updated every minute The time stamp above each column indicates the interval at which the data in that column was trended The value displayed is the last one acquired during the interval and the most recent data is displayed in the rightmost column 1 2 3 4 5 6 7 8 9 10 11 Graphic trend select menu Tabular trend select menu Event list menu Event previous next menu ...

Page 63: ...arameter select window menu File export The file extract function can transfer trend to a file using USB memory Confirm USB memory connection Press TREND Trend Export button Set a start time end time export time period and export order Press Export button The data is transferred to USB memory A completion message is displayed when the transmission is completed ...

Page 64: ...table power supply Cannot be used alone as a power supply You should save the data of connected device before connecting the additional device It may not be supported some devices that required high power Note Saving Patient Data to a USB Exported patient data on a USB memory drive is not encrypted and therefore raises privacy concerns So only authorized personnel should be allowed to view handle ...

Page 65: ...r indicated by each parameter in the trend setup and is updated with new trend data every 60seconds When selecting pop up trend you can switch to ST analysis window and double zoom mode If there is no parameter set in Trend setup Configure parameters only ST analysis window is displayed To change the popup menu window touch the top and bottom of the popup menu with the touch key or select it with ...

Page 66: ... Rev 3 0 66 BM3 User s Manual Popup ST window Popup enlarge trend window You can change the size of the popup menu by pressing and releasing the center of the popup menu for at least 1second ...

Page 67: ...et upper and lower limit of alarm ECG connector position and measurement cable SpO2 T CO2 ECG Connector Electrode placement 1 If you have a lot of hair shave With alcohol soaked cotton wipe the patient s skin to attach the electrode Avoid wrinkled or uneven skin and wipe off alcohol with a dry cotton towel 2 Unpack the electrode package and remove the electrode 3 Remove the rear mounting surface o...

Page 68: ...ll not be obtained If the contact condition gets worse before expiration date on the packaging replace with a new one To get a stable ECG waveform rub the skin with gel or benzoin tincture ECG Precaution Caution Use caution when using evoked potential equipment as it may interfere with ECG monitoring Do not rely solely on ECG for patients with epileptic tendencies Electrical disturbances of non ca...

Page 69: ...hould be delivered within 60ms of the peak of the R wave The signal at the ECG output on the patient monitors is delayed by a maximum of 30ms If the ECG waveform on the screen is too unstable to synchronize with the patient s heart beat because of the following reason remove the cause of an alarm message or unstable ECG and then use a stable ECG lead for synchronization ECG electrode is detached o...

Page 70: ...th an electrosurgical unit its return plate and the electrodes for monitoring must be firmly attached to the patient If the return plate is not attached correctly it may burn the patient s skin where the electrodes are attached During surgery Use the appropriate orange electrode ECG safety cable or lead cable with an red connector for measuring ECG in the operating room These cables have extra cir...

Page 71: ...sposable electrodes If you are using an electrode with a gel beforehand make sure that the electrode is sufficiently gelled Never use this product if the disposable electrode has expired or the gel is dry Determine the electrode location that will provide the best ECG in the configuration P wave and T wave amplitudes should not exceed 1 3 of the QRS amplitude Choose a flat muscular location to max...

Page 72: ... Rev 3 0 72 BM3 User s Manual ECG lead 5 LEAD electrode placement 3 LEAD electrode placement How to attach neonate electrodes ...

Page 73: ...r is a QRS Complex with a QRS complex amplitude of 0 4 to 5 0 mV 0 2 5 0 mV with a scale setting of 0 5 mV cm or less and an adult with a QRS width of 70 120 ms or a newborn with a QRS ARR Select chapter The heart rate is calculated from 15 to 300 times per minute using the last 10seconds of the R R interval and the two longest intervals and the two shortest intervals at the R R interval The remai...

Page 74: ...lt point no electrical activity 0 mm with a base position on the horizontal axis in hours of 28 ms before QRS complex generation In the ST segment the ST point occurs between the QRS offset J point and the T wave The default position is 80ms after the QRS offset The following figure shows a typical QRS complex The ST analysis features are classified as normal beats in up to 12 selected ECG leads Q...

Page 75: ... maker signal is detected and flashes simultaneously HR Alarm limits Heart rate threshold is display Heart rate Displays the heart rate per minute PVC count number per 1 minute is display ECG Settings Main menu Sub menu ECG A ECG Parameters A 1 Alarm A 2 QRS Volume A 3 Display Option A 4 Arrhythmia A 5 ST PVC A 6 Pace Maker ...

Page 76: ... speed of the ECG displayed on the screen can be set Default setting 25mm s 6 25mm s 12 5mm s 25mm s 50mm s A 3 2 FILTER The filter setting is MONITOR by default ECG FILTER Selects among four frequency bands to filter the signal MONITOR 0 5Hz 40Hz MODERATE 0 5Hz 25Hz MAXIMUM 5Hz 25Hz DIAGONOSIS 0 05Hz 150Hz MONITOR MODERATE MAXIMUM DIAGONOSIS A 3 3 SIZE SENSITIVITY Changes the display amplitude of...

Page 77: ...nel selection ST analysis and ISO R ST R value setting A 5 1 PVC Analysis PVC Diagnostic Results Display Setup Menu ON OFF A 5 2 ST Template Ch ST Diagnostic ECG Channel Setup Menu Menu display according to the currently connected cable Lead I II III aVR aVL aVF V A 5 3 ST Analysis ST Diagnostic ECG Channel Setup Menu A 5 4 ISO R ISO Point Position Setting Menu 120 4ms A 5 5 ST R ST point position...

Page 78: ... for 0 5mV amplitude at normal 1X size at least 0 5mV amplitude is required for QRS detection for borderline signals validate on a graph 4 If amplitudes are low electrodes may need to be repositioned or replaced Problem False ventricular calls Solution Check ECG signal from patient the chest lead may exhibit polarity changes which may occasionally cause an inaccurate call 1 Check adjust lead place...

Page 79: ...l Problem Inaccurate pacemaker detection Solution Use pacemaker processing 1 Select ECG parameter label 2 Display the lead of ECG with the greatest amplitude in the top waveform position 3 Select Pace Maker 4 SELECT PACE MAKER ON ...

Page 80: ...fy the occurrence of an arrhythmia event classify it and then draw clinically useful conclusions based on the frequency and type of the signal The monitor will observe all beats in question if the baseline moves beyond a defined limit The monitor uses QRS processing results for arrhythmia analysis During multiple lead arrhythmia treatment measure the QRS Complex of each lead and compare it to the ...

Page 81: ...ction of Asys VTAC VFIB and VTAC at the selected lead OFF LETHAL A 1 2 Arrhythmia Alarm Condition Alarm setting menu by arrhythmia type Warning Display Heart Beat Equipment Signal Hart Beat equipment signal displays when the PACE mode is the signal appears series form The signal size or form are meaningless clinically Number Of Heart Beat Attention to the patient with heart beat equipment The hear...

Page 82: ...be possible to distinguish the presence or absence of arrhythmias Therefore doctors should analyze the arrhythmia information like other medical information SUSPENDED ANALYSIS Certain conditions can delay the arrhythmia analysis Detection and alarms associated with arrhythmias do not occur when arrhythmia conditions are delayed This message is generated when the arrhythmia analysis is delayed LEAD...

Page 83: ...r pulse rates Patients experiencing shock hypothermia anemia or patients taking medications that reduce arterial blood flow may have incorrect measurements Warning The pulse oximeter cannot be used as an apnea monitor High oxygen levels can make premature babies vulnerable to retrolental fibroplasia When this is the case do not set the maximum alarm limit to 100 such as the effect of turning off t...

Page 84: ... the sensor is properly positioned and that the sensor cover with the opaque body is covered 1 Select the sensor type and size that best suits your patient 2 If the sensor can be reused please wash it before use for each patient 3 Position the sensor correctly and attach it to the patient 4 Connect the sensor to the patient cable 5 Check the application area of the sensor from time to time If the ...

Page 85: ...tion port and it is defibrillator proof The insulated input ensures patient safety and protects the device during defibrillation and electro surgery Display SpO2 pulse rate display SpO2 PI Perfusion Index measurement display SpO2 measurement Cable S pO2 90 100 99 80 PR ...

Page 86: ... Note SpO2 WAVE SIZE is changed automatically Signal and Data Validity It is extremely important to determine that the probe is attached to the patient correctly and the data is verifiable To make this determination three indications from the monitor are of assistance signal strength bar quality of the SPO2 waveform and the stability of the SPO2 values It is critical to observe all three indicatio...

Page 87: ... sample is not too thick Pulse rate is determined from the SPO2 waveform which can be disrupted by a cough or other hemodynamic pressure disturbances Motion at the probe site is indicated by noise spikes in the normal waveform See the figure below It has been noted that letting the patient view the SPO2 waveform enables them to assist in reducing motion artifact SPO2 Waveform with Artifact Stabili...

Page 88: ... regular intervals SPO2 Settings A SPO2 menu MENU Description Available Settings A 1 Alarm SPO2 Alarm setup menu A 1 1 PARAMETER ALARM LIMIT PERCENT PR parameter alarm level activate setup menu A 1 2 TECHNICAL ALARM CONDITION SPO2 PROBEOFF SPO2 CHECKPROBE SPO2 POORSIGNAL SPO2 LOSTPULSE SPO2 ARTIFACT SPO2 PULSE SEARCH A 2 RATE VOLUME Menu in which RATE VOLUME is set up When the ECG volume is set it...

Page 89: ...isplayed but the quality of the signal is questionable Check the patient and the probe ARTIFACT It indicates that something happened to the pulses determine if the artifact to be abnormal and irregular Cleaning Do not autoclave pressure sterilizes or gas sterilizes this oximeter Do not soak or immerse the monitor in any liquid Use the cleaning solution sparingly Excessive solution can flow into th...

Page 90: ...and display the relevant values in the Oxycardiorespirogram RESP precaution Safety and efficacy of respiration measurement methods for apnea detection especially apnea of premature babies and apnea of infants have not yet been established This device does not monitor obstructive apnea Patients in a breathing crisis should be closely monitored Impedance breath monitoring should not be considered th...

Page 91: ... the electrode area is wide To improve the RESP signal use a 5 lead cable set RL as a neutral electrode It is recommended that the electrode be placed in the maximum expansion and contraction range of the lung especially if deep breathing is involved For newborns place the RA and LA electrodes on the mid armpit line with the nipple Place the LL electrodes under the diaphragm and navel Avoid the li...

Page 92: ...M3 User s Manual Respiration connector and measurement cable Respiration connector SpO2 T CO2 ECG Connector Note Respiration Rate measures the cable and connector will be used as the ECG and common Respiration cable ...

Page 93: ...er s Manual Display Breathe indicator indicates the detected breath Breathing number displays the number of respiration per minute Respiration alarm limit indicates respiration limits Apnea limit Setting Apnea limit sign ...

Page 94: ... Wave Display of speed 6 25mm s 12 5mm s 25mm s A 2 2 SIZE A menu to setup Wave Display 2 4 6 8 10 A 2 3 LEAD SELECT This is for changing the reference LEAD for respiration LEAD I LEAD II A 3 APNEA DETECT A menu to setup APNEA alarm display OFF ON OxyCRG monitoring The monitor can display Oxycardiorespirogram OxyCRG or OCRG in neonatal mode OCRG displays updated HR trend SpO2 or trend respiratory ...

Page 95: ...y HR scales Cursor When you select the cursor box a vertical bar is displayed in the trend area of the screen The number on the left of the screen no longer indicates the scale value but the parameter value of the time marked with the cursor is displayed The monitor continuously displays the current value real time on the right side of the screen When the cursor is moved to the right or left with ...

Page 96: ...ser s Manual OxyCRG Setup menu MENU Description Available Settings ECG AUTO SCALE ECG RANGE AUTO SCALE setup ON OFF ECG MANUAL SCALE ECG RANGE MANUAL SCALE setup PARAMETER TYPE RESP ETCO2 parameter setup menu RESP ETCO2 ...

Page 97: ...onic Automated Sphygmomanometers AAMI ANSI SP 10 If the pulse signal is poor due to patient movements improper cuff placement or noise in the signal the cuff deflates and the monitor attempts a second measurement For causes and possible remedies for a poor pulse signal see the alarm message tables The hose connects the cuff to the monitor to determine the contraction expansion and mean blood press...

Page 98: ...t NIBP Cuff Cuff Size 458 143 Arm circumference 35 5 to 46 Cm Option Child Child NIBP Cuff Cuff Size 430 108 Arm circumference 20 5 to 28 5 Cm Option Pediatric Pediatric NIBP Cuff Cuff Size 313 88 Arm circumference 13 8 to 21 5 Cm Option Infant Infant NIBP Cuff Cuff Size 210 60 Arm circumference 9 to 14 8 Cm Option Neonate NIBP Disposable Cuff Neonate 1 3 3 5 6cm Option ...

Page 99: ... 4 6 9 11 7cm Option Note The NIBP should be set in the menu because the measured value differs depending on the patient s age and gender Display Measurement Cuff type Pulse rates Indicates pulse rate Measurement time Indicates the completion time of measuring Measure time Indicates the schedule counter time of measuring Indicates recent measurement data ...

Page 100: ...scription Available Settings A 1 Alarm NIBP Alarm setup menu A 1 1 PARAMETER ALARM LIMIT SYS MEAN DIA Parameter alarm limit level activation setup A 1 2 TECHNICAL ALARM CONDITION NIBP OVER PRESSURE NIBP OVERTIME PRESSURE NIBP INFLATION FAILURE NIBP DEFLATION FAILUER NIBP MEASUREMENT ERROR NIBP PULSE TOO WEAK NIBP AIR LEAK NIBP EXCESSIVE MOTION NIBP SYSTEM FAULT A 2 CUFF SIZE A menu to select cuff ...

Page 101: ... patient s blood pressure value Every Time Whenever blood pressure is measured pressurize to the set pressure value every time Once Every Time A 5 AUTO MEASUREMENT INTERVAL A menu to set Interval time when measures the blood pressure periodically After setting INTERVAL you must press NIBP KEY to start NIBP START periodically 1min 2 3 4 5 10 15 20 30 1hour 2 4 8 B 1 NIBP STAT Patients with severe s...

Page 102: ...ment time is longer than two minutes in Adult Pediatric mode and more than 90seconds in Neonatal mode Extension limits are set for all patient categories to prevent overpressure on the patient The maintenance is performed every 2 years Check the following list devises to operates properly and safety at all times 1 Check for proper cuff size 2 Check for residual air left in the cuff from a previous...

Page 103: ... excessive and continuous patient movement such as shivering or convulsions if a regular arterial pressure pulse is hard to detect With cardiac arrhythmias With rapid blood pressure changes With severe shock or hypothermia that reduces blood flow to the peripheries With obesity where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery On an edematous extremity T...

Page 104: ...ts can be inaccurate if air leaks The air pad should be exactly over the branchial artery Tubing is immediately to the right or left of the branchial artery to prevent kinking when elbow is bent Try to measure infants when they are calm A kicking or crying baby may disturb or jiggle the cuff causing noise within the system and resulting in unstable blood pressure readings If necessary hold the cuf...

Page 105: ...nnected properly INFLATION FAILURE CHECK CUFF When the cuff pressure is excessive OVER PRESSURE When the cuff breaks and cannot exhaust DEFLATION FAILURE When the cuff pressure exceeds the set time OVER TIME CUFF PRESSURE When there is no measurement signal MEASUREMENT ERROR ...

Page 106: ... EtCO2 module can perform mainstream measurements in all monitoring modes and sidestream measurements in the adult and pediatric monitoring modes For sidestream measurements the capnostat fits on the nasal sampling cannula tubing EtCO2 connector position and Accessory Sidestream Respironics EtCO2 connector SpO2 T CO2 EtCO2 Connector CO2 LoFlo sidestream CO2 sensor and connector Sidestream sensor S...

Page 107: ...Nasal CO2 Sampling Cannula Adult 3468PED 00 Nasal CO2 Sampling Cannula Child 3468INF 00 Nasal CO2 Sampling Cannula Neonate 3470ADU 00 Oral Nasal CO2 Sampling Cannula Adult 3470PED 00 Oral Nasal CO2 Sampling Cannula Child 3469ADU 00 Nasal CO2 Sampling Cannula w O2 Delivery Adult 3469PED 00 Nasal CO2 Sampling Cannula w O2 Delivery Child ...

Page 108: ...Nasal CO2 Sampling Cannula w O2 Delivery Adult 3471PED 00 Oral Nasal CO2 Sampling Cannula w O2 Delivery Child Intubation accessories 3473ADU 00 Airway Adapter Kit w Dehumidification Tubing Adult chid ET Tube Size 4 0 mm 3473INF 00 Airway Adapter Kit w Dehumidification Tubing child Neonate ET Tube Size 4 0 mm ...

Page 109: ... Rev 3 0 109 BM3 User s Manual EtCO2 Placements and Accessories Mainstream Respironics EtCO2 connector CAPNOSTAT 5 mainstream CO2 sensor and connector Mainstream Sensor Mainstream Sensor Connector ...

Page 110: ... User s Manual Mainstream EtCO2 Accessories Intubation patient Airway adaptor Model Picture Description 6063 00 Adult Neonate disposable 312 00 Neonate Disposable 7007 00 Adult Neonate Reusable 7053 00 Neonate Reusable ...

Page 111: ...atient conditions and certain environmental conditions If the tube connection is faulty loose or damaged gas may leak and the accuracy of the measurement may be lowered resulting in poor breathing To prevent this connect all component is securely and check the connection according to standard clinical procedures to ensure that there are no leaks Warning Industrial safety Carefully dispose of used ...

Page 112: ...ke sure the arrows on the connector are at the top of the connector and line up the two keys of the connector with the receptacle and insert 3 To remove the connector grasp the body portion of the connector back and remove Note Do not remove by pulling cable Shown below is the CAPNOSTAT 5 CO2 Sensor connection to a Respironics Novametrix CO2 adapter Shown below is the CAPNOSTAT 5 CO2 Sensor with a...

Page 113: ...hown in Figure 1 A click will be heard when the sample cell is properly inserted 2 Inserting the sample cell into the receptacle automatically starts the sampling pump Removal of the sample cell turns the sample pump off 3 To remove the sampling kit sample cell from the sample cell receptacle press down on the locking tab and pull the sample cell from the sample cell receptacle ...

Page 114: ...lue at exhalation Display the carbon dioxide concentration value at inhalation Show respiratory rate per minute EtCO2 setup A EtCO2 menu Menu Description Available settings A 1 Alarm EtCO2 Alarm Setup Menu A 1 1 PARAMETER ALARM LIMIT ETCO2 FICO2 AWRR APNEA parameter alarm level action setup menu A 1 2 TECHNICAL ALARM CONDITION ETCO2 MODULE OFF ETCO2 CHECK ADAPTOR ETCO2 CHECK LINE ETCO2 CHEKC LINE ...

Page 115: ...ure range shown in the waveform When you select a range value the selected pressure range value is displayed below the dotted line above the two dotted lines in the left middle of the WAVE window 40mmHg 5 3 vol 50mmHg 6 6 vol 60mmHg 7 9 vol 80mmHg 10 5 vol 100mmHg 13 2vol 150mmHg 19 7vol A 2 3 FILL Choose whether to fill the waveform inside ON OFF A 2 4 Gas Pressure Unit Choose Gas Pressure Unit m...

Page 116: ...nsor in service the last zero Min display A 4 7 PUMP TOTAL TIME This is the total time the pump has been on LoFlo only Min display A 4 8 PUMP MAX TIME This value indicates the maximum rated lifetime of the sampling pump LoFlo only Min display A 5 MODULE SETUP A 5 1 CURRENT PERIOD This setting is used to set the calculation period of the ETCO2 value The end tidal CO2 value is the highest peak CO2 v...

Page 117: ...until the system has stabilized NORMAL MODE TURNOFF MODE POWER SAVING A 5 4 BARO PRESSURE This setting is used to set current Barometric Pressure 760mmHg A 5 5 GAS TEMPERATURE This setting is used to set temperature of the gas mixture This setting is useful when bench testing using static gasses where the temperature is often room temperature or below 35 0 C A 5 6 O2 COMPENSATION Use this setting ...

Page 118: ... types The Capnostat zero must be performed free of any CO2 1 Set the Host to the zeroing function 2 Connect the CAPNOSTAT 5 CO2 Sensor 3 Place the CAPNOSTAT 5 CO2 Sensor onto a clean and dry CO2 adapter that is exposed to room air and away from all sources of CO2 including the ventilator the patient s breath and your own Start the adapter zero The maximum time for a CAPNOSTAT zero is 40seconds Th...

Page 119: ...not exposed to extreme heat heat lamp etc SENSOR FAULTY Cause One of the following conditions exist Capnostat Source Current Failure EEPROM Checksum Faulty Hardware Error Solution Check that the sensor is properly plugged in Reinsert or reset the sensor if necessary SENSOR WARM UP Cause Sensor under temperature Temperature not stable Source Current unstable Solution This error condition is normal ...

Page 120: ...pnostat or when there is an optical blockage on the windows of the airway adapter May also be caused by failure to perform Capnostat zero to when adapter type is changed Solution To clear clean airway adapter if mucus or moisture is seen If the adapter is clean perform a Capnostat zero message status solution MODULE OFF It occurs when the equipment and module are separated Message output Verify mo...

Page 121: ...re abrupt temperature change takes place 3 When using this in an environment with severely high humidity Caution The measured values may be inaccurate when using this equipment for patients who have very fast or irregular respiration When measuring CO2 from the patient under the anesthesia check it when gas mixture comes in Otherwise the measured result values may be inaccurate When using a anesth...

Page 122: ... function is used to indicate the changes of resistance generated by the changes of temperature in numbers The function involves the process of transferring the changes into electric signals Temperature Connector and Measuring Cable Temperature measuring Cable ...

Page 123: ... Temperature alarm limit display Temperature value display Temperature unit display Note The minimum measuring time required to obtain accurate readings at the specific body site is at least 3minutes If the measurement site is directly exposed to air the temperature may be lower than normal It takes about 20 30minutes to reach temperature equilibrium by attaching this sensor ...

Page 124: ...is sweating or moving heavily fix the pads with surgical tape Temperature settings A Temp menu MENU Description Available Settings A 1 Alarm Temp Alarm Settings menu A 1 1 PARAMETER ALARM LIMIT TEMP1 Parameter Alarm level Action setup menu Settings range from 0 to 50 0 32 F to 122 F A 1 2 TECHNICAL ALARM CONDITION TEMP1 PROBE OFF ...

Page 125: ...are identified by the patient s name ID as well as the date and time of the recording request The monitor can trigger alarm recordings automatically for life threatening alarms and limit violations if the Record function is enabled on the alarm limits table A printer used to print data onto thermal paper Size of the thermal paper roll 58mm wide x 38mm in diameter any thermal paper of same size can...

Page 126: ...A 1 2 Printer Speed Printer speed can select between 25 and 50mm s 25 mm s 50 mm s A 1 3 Waveform1 Channel 1 waveform select menu OFF SPO2 RESP ETCO2 ECG A 1 4 Waveform2 Channel 2 waveform select menu A 1 5 Waveform3 Channel 3 waveform select menu A 1 6 Print From Time This is configuration of printed time in normal printing If the print out is not stopped in manual by PRINTER KEY BM3 print out fo...

Page 127: ...conds when PRINTER key is pressed A 1 7 Time Interval Set the time for printing the printout on normal printout If you do not stop manually after pressing the PRINTER KEY the output will be output only for the following period of time Continue 10sec 20sec 30sec ...

Page 128: ...G Carbon and carbonless forms Non thermal chart papers or any other products containing tributyl phosphate dibutyl phthalate or any other organic solvents Many medical and industrial charts contain these chemicals Document protectors envelopes and sheet separators containing polyvinyl chloride or other vinyl chlorides DO NOT USE mounting forms pressure sensitive tapes or labels containing solvent ...

Page 129: ...nd you consider alternate image storage techniques Paper Change 1 Open the window of the printer 2 3 Press the printer window until it is properly shut Inaccurate shutting may cause failure in printing Insert the paper roll offered with the product into the printing unit Place the roll in a proper way so that the printed paper can roll out upwards ...

Page 130: ...bles transducers sensors and so forth If any show signs of damage do not use Switch the monitor on and make sure the backlight is bright enough Check that screen is at its full brightness If the brightness is not adequate contact your service personnel or your supplier Warning Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper op...

Page 131: ...ometers where not otherwise specified follow local regulations regarding disposal of hospital waste Maintenance Task and Test Schedule All maintenance tasks and performance tests are documented in detail in the service documentation Maintenance and Test Schedule Frequency Monitor Tests Safety checks Selected tests on the basis of IEC 60601 1 At least once every two years or as needed after any rep...

Page 132: ... suspect the measurement values are incorrect Parameter Module Maintenance NBP calibration At least once every two years or as specified by local laws Mainstream and sidestream CO2 calibration check At least once a year or if you suspect the measurement values are incorrect Battery Maintenance Battery See thesection on Maintaining Batteries in chapter 1 ...

Page 133: ...l is dry Electrodes does not stick well to skin The patient s skin is extremely dry Apply ECG gel or water to the area of contact then use the electrode Relpace the electrodes Use CE compatable products Replace lead wires Repair the ECG B D No Yes ...

Page 134: ...les Are disconnected The finger probe is in bad condition No No Replace extension cables Replace the finger probe Repair the ECG B D Yes Yes Temperature malfunction If the temperature cannot be measured check the connection with the equipment The probe is In bad condition No Replace the probe Repair the Temp B D Yes ...

Page 135: ...ctor of cuff No Replace the horse of cuff Repair the NIBP B D Yes Abnormality in NIBP measurements The patient moved While measuring The measurements appear lower No The patient s skin is extremely dry No Make sure the patient stay still during diagnosis Loosen the cuff during diagnosis Tighten the cuff during diagnosis Repair the NIBP B D No Yes Yes Yes ...

Page 136: ...bles Replace the module Repair the adaptor Yes Yes Failure in battery recharge the battery does not fully recharge in 6 hours or more The output voltage of the adapter is 18V The battery voltage is lower than 5V Yes No Replace the adapter the battery will not be changed at the rate lower than 17V Replace the battery Repair the power B D No Yes ...

Page 137: ...r than 18V No No Replace the adapter Replace the adapter Repair the power B D Yes Yes Data storage failure Admit has been selected in the menu The Digital B D Digi Battery has been lower than 3V No No Execute the admit function No data will be stored during battery discharge Replace the battery 3volt Repair the Digi B D Yes Yes ...

Page 138: ...nction abnormally No Turn functions not in use off Mode display set para Replace the printer Repair the accompanying Equipment No Yes Yes Yes Print failure The paper tray cover is properly shut The printing face of paper has been reversed No No Shut the cover tight Reverse the paper face Repair the printer and printer B D Yes Yes ...

Page 139: ... Moisture can damage the monitor and peripherals For example around connectors EtCO2 modules Please read the following instructions carefully before cleaning the basic unit or peripherals The following pages contain precautions for cleaning certain equipment and peripherals Do not spray detergent on the monitor or peripheral devices Wipe it off with a damp cloth Disinfect the surface with gauze wi...

Page 140: ...sories with strong aromatic chlorinated ketone ether or ester solvents Never immerse electrical connectors When cleaning do not apply excessive pressure or bend the cable unnecessarily Excessive pressure can damage the cable Reusable ECG Electrodes Clean the electrode cup regularly with a toothbrush When removing gel like residues use a soft brush with flowing water Wipe the electrode with a soapy...

Page 141: ... alcohol Quickly immerse the cables in a detergent solution Make sure the probe s tip is firmly connected CAUTION Never boil or autoclave the cable Vinyl withstands temperatures up to 100 C but begins to soften at around 90 C Handle gently when hot and wipe away from the tip toward the cable CAUTION Decisions on disinfection should be made by the user organization in accordance with the integrity ...

Page 142: ...tergent Also make sure that no liquid penetrates the instrument or probe Caution Do not dispose of the disposable probe in a potentially hazardous area Always be careful about environmental pollution Caution There is a backup battery inside the system When disposing of the battery dispose of it in an appropriate place for environmental protection Warning When replacing the backup battery check the...

Page 143: ...contained here is useful for users interested in medical equipment The information contained in this section such as separation distance is generally information about the Bionet Patient Monitor detailed above The numbers provided here are not guaranteed but are provided with reasonable assurance of error free operation This information may not apply to other medical and electrical systems and old...

Page 144: ...it is compatible with existing or new wireless systems eg cell phones pager systems cordless phones etc For example a Bluetooth compliant device using the 2 4 GHz frequency band may interfere with the wireless communication of the patient monitor For more information on wireless deployment please contact your Bionet representative Low amplitude signals such as EEG and ECG are particularly sensitiv...

Page 145: ...nt guidance RF emissions CISPR 11 Group 1 The BM3 system 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 CISPR 11 Class A The BM3 system is suitable for use in all establish ments other than domestic and those directly con nected to the public low voltage power supplies b ...

Page 146: ...red with syntheti c material the relative humi dity should be at least 30 Electrical fast Transient burst IEC 61000 4 4 2kV for power supply line s 1kV for input output lin es 2kV for power supply lin es 1kV for input output line s Mains power quality should be that of a typical comme rcial or hospital environmen t Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode ...

Page 147: ...dip in Uт for 0 5cycle 40 Uт 60 dip in Uт for 5 cycle 70 Uт 30 dip in Uт for 25 cycle 5 Uт 95 dip in Uт for 5 s Mains power quality should be that of a typical comme rcial or hospital environmen t If the user of the BM3 system requires continued o peration during power main s interruptions it is recom mended that the BM7 system be powered from an uninterruptible power suppl y or a battery Note Uт ...

Page 148: ...t IEC 60601 Test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 M Hz 3 Vrms 150 kHz to 80 MH z Portable and mobile RF communications equipment should be used no closer to any part of the BM3 system including ca bles than the recommended separation d istance calculated from the equation appli cable to the frequency of the transmitter Reco...

Page 149: ...hs from fixed RF transmitters as deter mined by an electromagnetic site survey a Should be less than the compliance le vel in each frequency range b Interference may occur in the vicinity of equipment marked with the following sy mbol Note 1 Uт is the A C mains voltage prior to application of the test level Note 2 At 80 MHz and 800 MHz the higher frequency range applies Note 3 These guidelines may...

Page 150: ...bile RF Communications Equipment and the BM3 system The BM3 system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the BM3 system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the BM3 system as recommended below according to t...

Page 151: ...c propagation is affected b y absorption and reflection from structures objects and people Immunity and Compliance Level Immunity test IEC 60601 Test Level Actual Immunity Level Compliance Level Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 Vrms 150 kHz to 80 MHz 3 Vrms 150 kHz to 80 MHz Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m 80 MHz to 2 5 GHz 3 V m 80 MHz to 2 5 GHz ...

Page 152: ...rs the shielded location with a minimum RF shielding effectiveness and for each c able that enters the shielded location Radiated RF IEC 61000 4 3 3 V m 80 0 MHz to 2 5 GHz 3 V m 80 0 MHz to 2 5 G Hz Field strengths outside the shielded locati on from fixed RF transmitters as determin ed by an electromagnetic site survey sho uld be less than 3V m a Interference may occur in the vicinity of e quipm...

Page 153: ...relocating th e EUT or using a shielded location with a higher RF shielding effectiveness and filter attenuation Note For Type A Professional ME Equipment intended for use in domestic establishment instructions for use includes a warning This ME equipment is intended for use by professional healthcare personnel only Warning Portable RF communications equipment including peripherals such as antenna...

Page 154: ...onments Temperature Operating 5 40 C 41 104 F Storage 20 60 C 4 140 F Humidity Operating 30 85 Storage 10 95 PACKAGE Operating Attitude Operating 525 795 mmHg 70 106 kPa Storage 375 795 mmHg 50 106 kPa Display TFT LCD Resolution 800 X 600 Display size 8 Measurement Parameter ECG Heart Rate Respiration Rate SpO2 Pulse Rate Systolic BP Diastolic BP Mean BP Temperature EtCO2 FiCO2 Airway Respiration ...

Page 155: ... 0 to 5V pulse Pulse width 100 10 ms LAN digital output for transferring data Nurse call system connection DC output 5VDC 1A Max Battery Rechargeable Li ion battery 1hours for continuous working Thermal Printer option Speed 25 50mm sec Paper width 58mm Data Storage 168hours trends 20cases of 10sec alarm waveform Language English French Spanish Italian Germany Chinese Russian Czech Bulgarian Portug...

Page 156: ...150Hz Monitoring mode 0 5 40 Hz Surgical mode 0 5 25 Hz S T segment detection range 2 0 to 2 0 mV Arrhythmia analysis ASYSTOLE VTACH VFIB BIGEMINY ACCVENT COUPLET IRREGULAR PAUSE PVC RONT TRIGEMINY VBRADY SHORTRUN Pacemaker Detection Mode Indicator on waveform display user selectable Protection Against electrosurgical interference and defibrillation Respiration Performance Method Thoracic impedanc...

Page 157: ...essure 20 to 230 mmHg Neonate Pressure 20 to 120 mmHg Accuracy mean error less than 5 mmHg standard deviation less than 8 mmHg Temperature Performance Measurement range 0 to 50 0 to 122 Accuracy 25 to 50 0 1 0 to 24 0 2 Compatibility YSI Series 400 temperature probes Sidestream CO2 Option Measurement range 0 to 150 mmHg 0 to 19 Accuracy 0 40mmHg 2 mmHg 41 70mmHg 5 of reading 71 100mmHg 8 of readin...

Page 158: ...h per minute C O Option Method Thermodilution Technology Measuring Range C O 0 1 20L min TB 23 45 TI 0 27 Alarm range 23 45 Product Configuration 1 Main body of BM3 Monitor 1 EA 2 3 Lead patient Cable 1EA 3 Disposable electrodes 10 EA 4 NIBP extension horse 1EA 5 Reusable Adult NIBP Cuff 1EA 6 SpO2 extension cable 1EA 7 Reusable Adult SpO2 Probe 1 EA 8 DC Adaptor BPM050S18F02 made in Bridgepower C...

Page 159: ...in TEMPSENS 430 1 EA 2 Sidestream EtCO2 Module Respironics 1 SET 3 Mainstream EtCO2 Module Respironics 1 SET 4 Sidestream EtCO2 airway adapter sampling kit 1 EA 5 Mainstream EtCO2 airway adapter 1 EA 6 Mainstream EtCO2 airway adapter 1 EA 7 5 Lead Patient Cable with extension cable 1 EA ...

Page 160: ...tric ICU Mode Alarm level High Medium Low Message Asystole 0 VTAC VFIB 0 VTAC 0 PVC Count 0 ST 0 HR 0 NIBP S 0 NIBP M 0 NIBP D 0 NIBP PR 0 SpO2 0 SpO2 Rate 0 RR 0 RR Apnea 0 T1 ْ C 0 EtCO2 0 FiCO2 0 AWRR 0 LEAD FAULT 0 CABLE OFF 0 LOW BATTERY 0 ...

Page 161: ... ICU Mode Alarm level High Medium Low Message Asystole 0 VTAC VFIB 0 VTAC 0 PVC Count 0 ST 0 HR 0 NIBP S 0 NIBP M 0 NIBP D 0 NIBP PR 0 SpO2 0 SpO2 Rate 0 RR 0 RR Apnea 0 T1 ْ C 0 EtCO2 0 FiCO2 0 AWRR 0 LEAD FAULT 0 CABLE OFF 0 LOW BATTERY 0 ...

Page 162: ... NIBP D 20 120 30 100 20 60 NIBP PR 50 150 50 160 50 170 SpO2 90 100 90 100 88 100 SpO2 Rate 50 150 50 160 50 170 RR RESP 10 30 10 50 15 100 RR Apnea 0 20 0 20 0 20 T1 C F 34 0 93 2 39 0 102 2 34 0 93 2 39 0 102 2 34 0 93 2 39 0 102 2 ST 0 4 0 4 0 4 0 4 0 4 0 4 PVC Count 0 20 0 20 0 15 AWRR 10 30 10 50 15 100 EtCO2 25 50 25 50 25 50 FiCO2 0 5 0 5 0 5 ...

Page 163: ... Resp Alarm Print Off Off Off NIBP Interval Off Off Off NIBP Cuff Size Adult PEDIATRIC NEONATE RR RESP Lead II II II Alarm Volume 50 50 50 QRS Volume Off Off Off Pulse Volume Off Off Off ECG Lead Fault Message Message Message SpO2 Probe Off Message Message Message Units for Height cm cm cm Units for Weight Kg kg kg Temperature Units ْ C ْ C ْ C NIBP Limit Type Systolic Systolic Systolic ECG Filter...

Page 164: ...ad while reading the manual or using the equipment Abbreviations A A amps AC alternating current ADT adult ARRYTHM arrhythmia ASYS asystole Auto AUTO automatic AUX Auxiliary aVF left foot augmented lead aVL left arm augmented lead aVR right arm augmented lead B BPM beats per minute C C Celsius CAL calibration cm CM centimeter D ...

Page 165: ... DEFIB Defib defibrillator DIA diastolic E ECG electrocardiograph EMC electromagnetic compatibility EMI electromagnetic interference ESU electrosurgical cautery unit F F Fahrenheit G g gram H HR heart rate hour Hz hertz I ICU intensive care unit Inc incorporated ...

Page 166: ...A left arm left atrial LBS pounds LCD liquid crystal display LED light emitting diode LL left leg M M mean minute m meter MIN minminute MM mm millimeters MM S millimeters per second MMHG mmHg millimeters of mercury mV millivolt N NIBP non invasive blood pressure NEO Neo neonatal O ...

Page 167: ...entricular complex Q QRS interval of ventricular depolarization R RA right arm right atrial RESP respiration RL right leg RR respiration rate S S systolic sec second SpO2 arterial oxygen saturation from pulse oximetry SYNC Sync synchronization SYS systolic T Temp TEMP temperature U ...

Page 168: ... s Manual V V precordial lead V volt V Fib VFIB ventricular fibrillation VTAC ventricular tachycardia W X X multiplier when used with a number 2X Symbols and degree s greater than less than minus number percent plus orminus ...

Page 169: ...urchase Date of Purchase Customer section Hospital Name Address Name Phone Sales Agency Manufacturer Thank you for purchasing BM3 The product is manufactured and passed through strict quality control and through inspection Compensation standard concerning repair replacement refund of the product complies with Consumer s Protection Law noticed by Korea Fair Trade Commission ...

Page 170: ...ales service representative Bionet America Inc 2691 Dow Ave Suite B Tustin CA 92780 U S A Toll Free 1 877 924 6638 FAX 1 714 734 1761 e mail support bionetus com Website www bionetus com European sales service representative MGB Endoskopische Geräte GmbH Berlin Schwarzschildstraße 6 D 12489 Berlin Germany Tel 49 0 306392 7000 Fax 49 0 306392 7011 e mail sales mgb berlin de Website www mgb berlin d...

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