Bionet BM1 User Manual Download Page 1

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Rev. 2.2

BM1

User

’

s Manual

Patient Monitor

Rev. 2.2

2021.05.04

BM1 Vital-Sign Monitor

Warning

To ensure proper use of this medical equipment, you must read and comply with this user manual.

Summary of Contents for BM1

Page 1: ...Rev 2 2 1 BM1 User s Manual Patient Monitor Rev 2 2 2021 05 04 BM1 Vital Sign Monitor Warning To ensure proper use of this medical equipment you must read and comply with this user manual ...

Page 2: ... Ltd Before using Bionet devices read all the manuals that are provided with your device carefully Patient monitoring equipment however sophisticated should never be used as a substitute for the human care attention and critical judgement that only trained health care professionals can provide CAPNOSTAT LoFlo is trademark of Respironics All other brand or product names are the property of their re...

Page 3: ...onal Safety 9 Warning Caution Note 10 Define Groups 11 General Precaution on Environment 12 Electromagnetic Compatibility 13 1 Basic 15 Basic Overview 15 Electric Safety Precautions 15 Equipment Connection 17 Biocompatibility 17 Product Configuration 17 Option Product 18 Basic Unit 19 Device Markings 25 Power 26 ...

Page 4: ... Network 43 Network Overview 43 Network Connection 43 IT Network Connection 46 LAN Network 47 VLAN Network 47 When Using an Inappropriate Network 48 4 Patient 49 Patient Overview 49 Continuous Mode 49 Spot Triage Mode 50 Patient Settings 52 5 ALARM 56 ALARM Overview 56 ALARM Priority 56 ALARM Management 58 ALARM Settings 60 ...

Page 5: ...ge Mode 72 8 SpO2 77 SpO2 Overview 77 SpO2 Precautions 77 SpO2 Patient Preparation 78 SpO2 Connector and Measurement Cable 79 SpO2 Display 80 SpO2 Signal and Data Validity 81 SpO2 Settings 83 SpO2 Status Messages 83 9 NIBP 85 NIBP Overview 85 NIBP Precautions 85 NIBP Patient Preparation 87 NIBP Connector and Measurement Cable 89 NIBP Display 91 ...

Page 6: ...ings 103 EtCO2 Status Messages 108 EtCO2 Measurement Failure 109 11 Temperature 110 Temperature Overview 110 Temperature Connector and Measurement Cable 110 Temperature Display 113 How to Take a Temperature 114 Temperature Settings 115 12 Maintenance and Troubleshooting 116 Inspection Equipment 116 Inspection Cables 116 Maintenance Task and Test Schedule 117 Troubleshooting 118 Storage lifetime is...

Page 7: ...ification 127 Technical Specification Overview 127 EMC Compatibility EMC 127 Manufacturer s Declaration Electromagnetic Emission 129 Manufacturer s Declaration Electromagnetic Immunity 129 System Specification 131 Default Alarm Level 134 Parameter Limit 134 Default Display 135 Abbreviations 136 Symbols 139 ...

Page 8: ... are for illustration purposes only Actual products or screens may vary slightly General Description The BM1 monitor can monitor the following Non Invasive blood pressure Temperature SpO2 Pulse Rate Apnea option EtCO2 option FiCO2 option This equipment is designed to be used in an environment where a health care professional can determine when to use the equipment for its intended purpose based on...

Page 9: ...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 compromise as long as the product maintained its regular lifecycle m...

Page 10: ...t 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 you operate...

Page 11: ... 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 expert repairs the product or performs complex maintenance tasks The expert ...

Page 12: ...inity 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 equipment W...

Page 13: ...her products used in areas where patient monitoring 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 ...

Page 14: ...Rev 2 2 14 CAUTION Infectious devices and parts must be sanitized and cleaned before disposal ...

Page 15: ...re 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 Manufacturer BRIDGEPOWER Model JMW128 Rated Voltage DC15V 2 0A 3 Be sure that the entire connection cable of the system is properly and firmly fixed 4 Be sure that the equipment is completely grounded If not there might be the problem occur in th...

Page 16: ...uce inaccurate output NOTE BM1 is classified as follows BM1 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 noise is A level concerning IEC EN60601 1 2 WARNING Do not touch the patient while using the defibrillator The user may be at risk ...

Page 17: ...ed as intended the parts of the product described in 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 BM1 Monitor 1 EA 2 NIBP Extended Hose 1 EA 3 Reusa...

Page 18: ...B 7 Cart and Cradle 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 qualified by IEC 60601 1 or c...

Page 19: ...Rev 2 2 19 Basic Unit Front View Alarm lamp Battery operation indicator AC status indicator ...

Page 20: ...2 2 20 Right Side View Alarm control key Blood pressure measurement key Operation mode home key Power ON OFF Key SpO2 connector Infra Temperature connector Blood pressure cuff hose connector EtCO2 connector ...

Page 21: ...Rev 2 2 21 Left Side View Nurse call connector USB port USB 2 0 5Vdc Max 500mA 2EA HDMI mini Output port Ethernet port Service Port DC adaptor jack ...

Page 22: ...Rev 2 2 22 Back Side View Speaker Hole IV Pole Mount Battery Cover ...

Page 23: ... device before connecting the additional device It may not be supported some devices that required high power NOTE The HDMI output of this device is 800x480 50Hz The screen may not be displayed depending on the monitor specifications so check in advance Barcode Scanners Normally barcode scanners are compatible with all products However because of inconsistencies in barcode scanner manufacturer s i...

Page 24: ...0GHD 1 QR code CAUTION You must read the user manual of the barcode scanner to get complete information about it The initialization codes for various products would be included You must run the initialization after verifying the input type Do not use multi language input with barcode scanner except alphanumeric character ...

Page 25: ...e Connect Port NIBP Connect Port EtCO2 Connect Port Nurse call USB port HDMI mini Output port LAN port Auxiliary Port DC Input Port Alarm Control Key Blood pressure Measurement Key Operation Mode Home Key Power ON OFF DC Input Indicator Battery Operation indicator Address of Manufacturer Safety Sign To signify that the instruction manual must be read Reading the instruction manual before starting ...

Page 26: ... Manufacture BRIDGEPOWER CORP Model name JMW128 Input Power 100V 240V 1 2A Output Power 15V 2 0A DC Power LED is lighted on when the DC Power is plugged into the inlet at the back of the product A 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 ...

Page 27: ...en in a green box with 5 levels 5 25 50 75 100 4 When all batteries are discharged the battery image is displayed in red 5 When the battery is disconnected from the device and the battery is faulty an X appears inside the shape of the battery 6 The monitor automatically turns off when the battery is depleted The table below describes the function of the battery charging bar graph at the top of the...

Page 28: ...rmally NOTE If no AC power is applied the battery charge display will take up to 15 seconds to reflect the actual capacity of the internal battery Battery Information 3BL335 BIO S 10 8V 3250mAh Li ion or 031PpTC3 3ICR19 65 10 8V 2150mAh Li ion Battery charging time More than 6 hours Battery usage time Max 4 hours 3BL335 BIO S NiBP every 15 minutes when using SpO2 NOTE Lithium ion batteries are rec...

Page 29: ...tery after 24 months of use Battery life depends on usage If battery life continues battery life will decrease and frequency of replacement will increase To prevent pre discharge recharge after the battery is discharged WARNING Be careful of the polarity when replacing the battery We strongly recommend that you use the battery supplied by Bionet Using unauthorized batteries may damage the equipmen...

Page 30: ...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 battery will de...

Page 31: ...uces 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 battery and store it near the monitor until it is needed for transport How to Recycle the Battery When the battery no longer holds a charg...

Page 32: ... power light on the monitor lights up the alarm bar lights up the power is turned on the screen lights up the main screen is displayed after running the self test Stopping the Monitor Press and hold the power key for 3 seconds The screen goes off Main Screen Setup After the monitor is turned on the main screen is displayed ...

Page 33: ...password BM1 supports three operation modes Continuous mode It is used for short term patient monitoring Spot mode It is used to collect the patient s vital sign during the round Triage mode It collects patient vital sign information and determines the priority of patient treatment Patient Window The patient information is displayed in the upper corner of the screen There is a save button to save ...

Page 34: ...r You can set the parameters and their associated waveforms so that they are easy to distinguish The character color according to the measurement time of TEMP or NIBP The measured value is displayed in the set color Function Key On the right side of the monitor s front panel the touch screen icon allows you to perform frequently used functions Button Description This is an alarm mode key so it ena...

Page 35: ...s Fixed Key The fixed keys on the front panel of the monitor allow you to perform commonly performed functions Fixed key Description Short press Holds all alarms or cancels the hold at a preset time Long press It enables the current alarm mode one of Alarm off or Audio off modes Start or end non invasive blood pressure NIBP measurements Return to the main screen or switch the operating mode ...

Page 36: ...Rev 2 2 36 2 Setup Setup Overview This chapter describes how to configure your monitor Monitor Configuration Setup Menu tree ...

Page 37: ...k the desired setting to access the submenu that performs the desired function or goes one step further down 3 Click x button at the bottom of the submenu list to return to the previous menu or screen Parameter SpO2 EtCO2 NIBP Temp Alarm Setting EtCO2 Parameters Zeroing Module Reset Alarm Display Option Apnea Detect Module Information Module Setup NIBP Parameters NIBP Stat Vital Sign Review Alarm ...

Page 38: ...ntinuous mode only MENU Description Available settings A SETUP A 1 PARAMETER SETUP A 1 1 MONITORINGS COLORS Parameter selection and color setting used for measurement on the monitor menu SPO2 NIBP TEMP ETCO2 c PARAMETER enable ON OFF PARAMETER COLOR setup A 1 2 UNITS Unit setting menu used for monitor measurement A 1 2 1 WEIGHT Weight unit Kg Lbs A 1 2 2 HEIGHT Height unit Cm Inch A 1 2 3 BLOOD PR...

Page 39: ...MM YYYY A 2 3 SCREEN BRIGHTNESS Set screen brightness 10 100 A 2 4 KEY Sound Set Key activation ON OFF 0 100 A 2 5 BED No c Set bed number 1 300 A 2 6 AUTO SAVE s t Depending on the setting send HL7 or save information A 2 6 1 NIBP TRIGGER s t Auto save when NIBP is measured ON OFF A 2 6 2 TEMP TRIGGER s t Auto save when Temp is measured ON OFF A 2 7 DEMO Set Demo ON OFF A 2 8 SETUP USER PASSWORD ...

Page 40: ...ion and setup A 4 1 WIRELESS Wireless setup ON OFF A 4 2 AP SEARCH A 4 3 SSID Display the connected SSID A 4 4 DHCP Auto IP allocation setting menu ON OFF A 4 5 DEVICE IP IP setting menu XXX XXX XXX XXX A 4 6 SUBNET MASK SUBNET MASK setting menu XXX XXX XXX XXX A 4 7 GATEWAY IP GATEWAY setting menu XXX XXX XXX XXX A 4 8 NETWORK INTERFACE Mac address information A 5 HL7 HL7 Network message settings...

Page 41: ...O2 FICO2 ETCO2 AWRR TEMP 1 A 5 8 2 UNIT LABELS Percent mmHG kPa BPM RPM Cesius Fahrenheit A 5 8 3 ALARM LEVEL LABELS Message Alarm Low Alarm Medium Alarm High Alarm A 5 8 4 PATIENT QUERY Query Name Query Tag User Parameter B BIOSIGNAL CALIBRATION Manufacturer menu not user menu Set calibration menu C SCREEN CALIBRATION Perform touch screen calibration point input D MAKER SERVICES Manufacturer menu...

Page 42: ...rameter Color Parameter Basic color Selectable colors Green Magenta Blue White Scarlet Orange Pink Light Blue Yellow Sky Blue Coral Purple Pale Green Pale Yellow SpO2 Light Blue NIBP Magenta TEMP Green EtCO2 Yellow ...

Page 43: ...ing tasks on a patient monitor that can be remotely controlled from a central station Start recording Modify alarm limit Alarm Mute Print the current monitor screen using a laser printer through network 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 a...

Page 44: ...network example Network configuration change Removing a device from the network Adding new devices to the network Upgrading or updating devices connected to the network WARNING Recommendations for wireless connections BM1 has a change in the number of equipment connections depending on wireless AP Access Point performance When using a general AP it is recommended to connect 8 units to the same net...

Page 45: ... 8821a TP LINK T2UHP 2357 010b MediaTek 7650u TP LINK T2U 148f 761a Ralink 7610u TP LINK T2UH 148f 761a Ralink 7610u TP LINK T2U v2 0e8d 7650 MediaTek 7650u ipTime Model USB VID PID Chipset Other products using 7650u 7610u such as ipTime A1000 148f 7610 0e8d 7610 MediaTek 7650u 7610u ipTime N150UA TP Link TL WN727N v4 148f 7601 Ralink 7601U ipTime N150UA N150U 148f 3070 Realtek 3070 ipTime N150UA ...

Page 46: ...o 5 seconds for the Wifi dongle to connect to the device and be recognized At this time please be careful as USB may not work when detached IT Network Connection No one other than service personnel can connect this device to the network Please consult with the hospital IT staff in advance Please refer to the following document to proceed with the installation Documents attached to this device Netw...

Page 47: ...n In addition it is necessary to establish a network system that detects and defends against denial of service attacks by installing dedicated DDos defense system If the device is used as a layer 2 switch or layer 3 switch the port settings must be configured on the network switch The Bionet equipment must be configured to make network settings compatible with the operating organization s The devi...

Page 48: ...alarm will not be delivered Reactivates with the alarm off or the alarm sound off If you do not have firewall and antivirus software Your data is not protected The device settings are changed The device raises an error alarm or does not generate an alarm Data is sent incomplete to the wrong device or not at all Patient data is blocked falsified or corrupted The time stamp of the data is inaccurate...

Page 49: ...nuous mode you can manage the patient admission and discharge of hospital The admit patient is maintained even when the monitor is turned off and on If the operating mode is switched the admit patient is discharged Admit is also discharged when using demo mode Patient Admission Continuous Mode How to admit a patient 1 Press the Patient window 2 Press the New button 3 Enter the Patient Information ...

Page 50: ...he following message is displayed Spot Triage Mode In the spot and triage modes patient information is not maintained when the monitor is turned off Patient information is entered as unknown id and can be used without registration You can also register by pressing the new button When switching to that mode id is entered as unknown patient When you change the patient all relevant data is deleted fr...

Page 51: ...d Birth Weight are available for neonate mode Day of Life and Corrected GA values are also displayed in read only fields Patient s height and weight related items and changes affect all other monitor menus and displays that use this information Patient data can be stored for up to 5000 people and more than 5 000 patients will be erased from old patients Patient Type Image Type Male Admit Female Ad...

Page 52: ...NG E 2 TITRATION TABLE Menu Description Available Settings A PATIENT WINDOW A 1 PATIENT INFORMATION A 1 PATIENT TYPE Patient Type setting ADULT PEDIATRIC NEONATE A 2 ID Patient ID setting A 3 FIRST NAME First Name setting A 4 LAST NAME Last Name setting A 5 GENDER Gender setup MALE FEMALE A 6 BIRTHDAY Birthday setting menu YYYY MM DD A 7 WEIGHT Weight setting XXX XX Kg A 8 HEIGHT Height setting XX...

Page 53: ...tient Information Using the Barcode Scanner This product can input PATIENT ID in barcode format to the device by using USB barcode scanner Connect the barcode scanner to the USB HOST connecter on the left side from the front of the device as shown below Barcode functionality can be used once after BEEP sound is made and barcode icon is displayed at the screen ...

Page 54: ... popped up with the id entered by Admit Using the HL7 Admit the patient information stored in the server can be loaded by stored in the device If the ID has already been used ID and patient information are stored in the device When ID is entered as scanner patient information is loaded together Patient information loaded in HL7 Admit has higher priority than stored in the device ...

Page 55: ...Rev 2 2 55 ...

Page 56: ...r more of the following devices Hearing sound reflecting alarm severity Change the color in the parameter box of the alarm parameter Alarm messages in the local message area Alarm banner indicating 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 ...

Page 57: ...ch alarm are described as follows The alarm priority is HIGH MEDIUM LOW MESSAGE Alarm priority Alarm sound Alarm status window Number flashes Alarm lamp HIGH 5 MEDIUM 3 LOW 1 MESSAGE No Blinking Product status alarm It is labeled as Technical Alarm in the instrument Alarm priority Alarm sound Alarm status window Number flashes Alarm lamp LOW 1 MESSAGE Blinking red alarm lamp on the front panel ...

Page 58: ...Change Alarm Mode To change alarm mode you can use the Alarm control key on the side of the monitor Alarm mode changes from Normal Audio Paused Alarm Paused Normal Press and hold the alarm control key for 3 seconds to switch from Normal to Audio Off or Alarm Off mode Audio_Paused The alarm is temporarily silenced for 1 minute to hold the audible alarm A banner with the message Audio Paused and a c...

Page 59: ...arms A banner with the message Alarm Off is displayed on the screen All alarms remain stopped until the user switches to another alarm mode Audio_Off Stop an Audible Alarm A banner with the message Audio Off is displayed on the screen The monitor remains silent until the user switches to another alarm mode Alarm Control Various alarm functions such as alarm hold validity and alarm limit indicators...

Page 60: ...tings Main menu Sub menu A ALARM SETUP A 1 PARAMETER ALARM LIMIT A 2 SYSTEM ALARM CONDITION A 3 ALARM PARAMETER A 4 NURSE CALL A 5 SETUP B ALARM REVIEW c MENU Description Available Settings A ALARM SETUP A 1 PARAMETER ALARM LIMIT All parameter alarm level activate Setup menu A 1 1 PARAMETER TYPE SpO2 NIBP TEMP ETCO2 c A 1 2 PARAMETER ALARM LIMIT c ALARM ON OFF LEVEL MESSAGE LOW MEDI UM HIGH UPPER ...

Page 61: ...EC 60601 BIONET A 3 3 ALARM PAUSE TIME Set alarm time in Alarm Paused mode 1 2 3 5 10 15min A 4 NURSE CALL User setting menu A 4 1 SETUP NURSE CALL function ON OFF After setting ON check if relay sound is heard in ALARM situation ON OFF A 4 2 CALL TYPE Set nurse call status in normal situation Normal Open Normal Close A 4 3 DURATION Set the frequency of nurse call occurrence in alarm situation One...

Page 62: ...Rev 2 2 62 Alarm Review ...

Page 63: ... to monitor examination pre and post operative accident and emergency patients Parameters Respiration Rate O2 Saturation Systolic Blood Pressure Pulse Rate Level of conciouness Temperature Urine EWS Variations MEWS Modified Early Warning Score NEWS National Early Warning Score PEWS Pediatric Early Warning Score MEOWS Modified Early Obstetric Warning Score TEWS Triage Early Warning Score ...

Page 64: ... EWS type Score by parameter Total score Save EWS Data Automatic saving by trigger The EWS study is automatically saved as Nibp or Temp is measured By pressing the save button save directly none measurement items EWS window Enter the score Press EWS save button ...

Page 65: ...y EWS window Press the setting icon Enter the user password Press Edit button Select the type you want to change Press Export button EWS Type Delete EWS window Press the setting icon Enter the user password Press Edit button Select the type you want to change Press Delete button Press OK button Up to 10 EWS type files can be saved Edit EWS Type EWS window Press the EWS title button Press Edit butt...

Page 66: ...Rev 2 2 66 Click the numeric window you want to edit Edit total score items Edit numeric items Edit text item ...

Page 67: ...end Trend graph shows saved trend data as individual graph type for each parameter These graphs show that the displayed parameters are active over a significant period of time Shows four channels at a time Confirmation 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 u...

Page 68: ...ove 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 The monitor deletes all trend data when the patient is discharged At the top of the trend screen a summary of the auto saved events alarms is displayed ...

Page 69: ...ect button Tabular trend select button Event list menu Event previous next menu Patient information ID and name Parameter numeric window Period setup menu Parameter window selection menu Event mark Focus bar Export button Display group button Navigator button ...

Page 70: ...ile using USB memory 1 Confirm USB memory connection 2 Press TREND Export button 3 Set a start time end time export time period and export order 4 Press Export button 5 The data is transferred to USB memory A completion message is displayed when the transmission is completed ...

Page 71: ...tion Available settings A TREND SETUP A 1 GRAPHIC TREND A 2 TABULAR TREND A 3 EVENT LIST A 4 PERIOD Graphic Trend Saved data can be viewed graphically in sections Tabular Trend Time period setting Graphic Trend 30min 60min 90min 2hour 3hour 4hour 6hour 8hour 12hour Tabular Trend ...

Page 72: ...saved patient trend is managed Press the save button to save the trend item And the trend item is saved according to the auto save trigger setting The trend item is called spot study How to Save Spot Study Case 1 Using the save button 1 After measurement press Save button in the patient window If there is no patient information add the patient information 2 In Triage mode enter the EWS values and ...

Page 73: ...ayed on the screen 3 Set the search condition by ID name and duration 4 If the ID and name fields are empty they are searched except for those conditions If the ID is empty the search field will search for all IDs 5 Press the search button _ to confirm the spot study of the patient TREND Display SPOT TRIAGE Mode ...

Page 74: ... Study management buttons You can select a study to delete export or transfer using HL7 When HL7 transmission fails the TIME and ID columns are displayed in red EWS SCORE In Triage mode if the study is stored together with EWS in Triage Mode the EWS score will be filled with numbers instead of TIP If the ID or name is omitted as press and hold the omitted ID or name You can check the omitted text ...

Page 75: ...y search A 6 CHECK Change button to multi selectable state At checkable status checked study can be deleted USB export or HL7 data send If you press the check box in the table header you can cancel or check the entire study Change the study to a single selectable state In the single selectable state the stored EWS score can be check A 7 DELETE Delete the checked study A 8 USB EXPORT Export the che...

Page 76: ...ata on a USB memory drive is not encrypted and therefore raises privacy concerns So only authorized personnel should be allowed to view handle store or transmit patient data The file format of the USB memory drive used for the BM1 patient monitoring device is FAT32 ...

Page 77: ...alarm according to the set alarm value SpO2 Precautions SpO2 measurements are particularly sensitive to arterial and arteriolar 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 ...

Page 78: ...nufacturer s recommendations on a per sensor basis If the sensor is not attached correctly the ambient light may interfere with the pulse oximetry making the measurement irregular or causing the value to disappear If you suspect interference from ambient light make sure that the sensor is properly positioned and that the sensor cover with the opaque body is covered Preparation Order 1 Select the s...

Page 79: ...pplication technology and safety information Never use a damaged sensor If the sensor does not turn on after connecting the sensor observe that a message appears on the monitor If the sensor LED does not turn on replace the sensor SpO2 Connector and Measurement Cable SpO2 Connector ...

Page 80: ... insulation port and it is defibrillator proof The insulated input ensures patient safety and protects the device during defibrillation and electro surgery SpO2 Display SpO2 Wave window SpO2 Strength indicator SpO2 PI Perfusion Index display SpO2 Alarm limits display ...

Page 81: ...he 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 indications simultaneously when ascertaining signal and data validity Signal Strength Bar The signal strength bar is displayed within the SpO2 values ...

Page 82: ...and the tissue 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 Stability of SpO2 Val...

Page 83: ... SPO2 displayed on the screen Default 25 mm s 6 25mm s 12 5mm s 25mm s 50mm s A 2 RATE VOLUME OFF or 10 100 setting OFF 0 100 B SpO2 Parameters B 1 ALARM SpO2 Alarm setup menu B 1 1 PARAMETER ALARM LIMIT c PERCENT PR parameter alarm level activate setup menu B 1 2 TECHNICAL ALARM CONDITION SPO2 PROBEOFF SPO2 CHECKPROBE SPO2 POORSIGNAL SPO2 LOSTPULSE SPO2 ARTIFACT SPO2 PULSE SEARCH B 2 SETTING B 2 ...

Page 84: ...and the probe site POOR SIGNAL The SpO2 signal is too low No SpO2 data is displayed This can be due to a low patient pulse patient motion or some other interference Check the patient and the probe LOST SIGNAL SPO2 data continues to be displayed 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 ...

Page 85: ...edies 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 pressure of an adult pediatric or neonatal patient The monitor can start the blood pressure measurement alone with set intervals set rest time or persistence lasting more than 5minutes NIBP Precautions Measurement Limitations The measurement may...

Page 86: ...etween the cuff and the monitor are not kinked or blocked Pay attention to not to block connecting hose when you put cuff on patient Cuff or hose connection for leaks periodically Measurements 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 ...

Page 87: ... of the heart Cuff Selection and Placement The quality of NIBP monitoring depends largely on the quality of the signals received by the monitor For this reason it is important to select the correct cuff size for your patient Cuff sizes are clearly marked on the cuff Measure the circumference of your patient s limb Use only Bionet cuffs with your monitor WARNING Check periodically to see if the cir...

Page 88: ...pressure 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 measurement 3 Make sure cuff is not too tight or too loose 4 Make sure cuff and heart are at same level otherwise hydrostatic pressure will offset the NIBP value 5 mini...

Page 89: ...Rev 2 2 89 NIBP Connector and Measurement Cable NIBP Connector Adult Cuff ...

Page 90: ... Cm Child Child NIBP Cuff Cuff Size 430 108 Cm Arm Size 20 5 to 28 5 Cm Pediatric Pediatric NIBP Cuff Cuff Size 313 88 Cm Arm Size 13 8 to 21 5 Cm Infant Infant NIBP Cuff Cuff Size 210 60 Cm Arm Size 9 to 14 8 Cm Neonate NIBP Disposable Cuff Neonate 1 Size 3 3 5 6Cm NIBP Disposable Cuff Neonate 2 Size 4 2 7 1Cm NIBP Disposable Cuff Neonate 3 Size 5 0 10 5Cm NIBP Disposable Cuff Neonate 4 Size 6 9 ...

Page 91: ...ement time Measurement mode display Interval Time indicates interval time when measures the blood pressure periodically Measurement cuff type Pulse rates Indicates pulse rate Systolic and diastolic Alarm limit Indicates the upper lower alarm limit of blood pressure Systolic blood pressure Diastolic blood pressure Mean blood pressure Unit Start NIBP measurement button ...

Page 92: ... to set the range that is usually used by setting pressure at the beginning because it can give pain to the patient when the equipment is turned on and pressurized to the maximum pressure range at the initial pressurization Default Settings value ADT 170 mmHg PED 140mmHg NEO 120mmHg ADT 120 250 mmHg PED 80 170mmHg NEO 60 140mmHg A 3 Setting Time How to apply pressurization settings Once Applies th...

Page 93: ...dically 1min 2 3 4 5 10 15 20 30 1hour 2 4 8 B 1 NIBP STAT Patients with severe state changes in blood pressure are in continuous mode for 5minutes to check for changes in blood pressure continuously OFF ON C 1 VITAL SIGN REVIEW Record the 40 most recently measured blood pressure values NIBP Status Messages Messages Status OVER PRESSURE When the cuff pressure is excessive OVER TIME CUFF PRESSURE W...

Page 94: ...Rev 2 2 94 PULSE TOO WEAK When the cuff is in the incorrect position AIR LEAK When the cuff is leaking EXCESSIVE MOTION When the patient moves too much SYSTEM FAULT When something goes wrong ...

Page 95: ... measure CO2 anesthetics and or respiratory mechanics cannot be used as apnea monitoring and or recording equipment While these products provide an apnea alarm the alarm condition begins with the elapsed time from when the last breath was detected However there are a number of physiological indications for the clinical diagnosis of real apnea events The CO2 alarm is not activated until the first b...

Page 96: ...ction Dispose of all equipment in accordance with local regulations Optimize reaction time by minimizing dead space and keeping sample collection tubes as short as possible Long sampling tubes can lead to poor accuracy and slow response times for sidestream measurement techniques Do not place the airway adapter between the suction catheter and the endotracheal tube when using the sample collection...

Page 97: ...Rev 2 2 97 EtCO2 Connector And Accessories EtCO2 Connector LoFlo Sidestream CO2 Sensor and Connector Sidestream Sensor Sidestream Sensor Connector ...

Page 98: ...hild 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 3469INF 00 Nasal CO2 Sampling Cannula w O2 Delivery Neonate 3471ADU 00 Oral Nasal CO2 Sampling Cannula w O2 Delivery Adult ...

Page 99: ... 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 100: ...tream Sensor Mainstream Sidestream Sensor Connector Mainstream EtCO2 Accessories Intubation Patient Airway Adaptor Accessories Part Figure Description 6063 00 Adult Neonate disposable 6312 00 Neonate Disposable 7007 00 Adult Neonate Reusable 7053 00 Neonate Reusable ...

Page 101: ...Make 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 Do not remove by pulling cable 4 Shown below is the CAPNOSTAT 5 CO2 Sensor connection to a Respironics Novametrix CO2 adapter 5 Shown below is the CAPNOSTAT 5 CO2 Sensor with ...

Page 102: ...gure 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 103: ...RR alarm upper and lower limit value display Apnea alarm set time in seconds AwRR Respiratory rate per minute EtCO2 Settings A EtCO2 Menu In Wave Window Menu Description Available settings A EtCO2 A 1 SWEEP SPEED EtCO2 Waveform sweep speed setup 6 25mm s 12 5mm s 25mm s A 2 SCALE Display waveform scale setup The selectable value is the maximum pressure range shown in the waveform 40mmHg 5 3vol 50m...

Page 104: ...ameter alarm level action setup menu B 1 1 1 ETCO2 ETCO2 Alarm Level Upper Lower On Off Message Low Medium High 0 100 mmHg B 1 1 2 ETCO2 FICO2 Alarm Level Upper Lower On Off Message Low Medium High 0 20 mmHg B 1 1 3 ETCO2 AWRR Alarm Level Upper Lower On Off Message Low Medium High 0 150 RPM B 1 1 4 ETCO2 APNEA Alarm Level Upper On Off Message Low Medium High 10 60 s B 1 2 TECHNICAL ALARM CONDITION...

Page 105: ... menu ON OFF B 4 MODULE INFORMATION B 4 1 SENSOR PN The sensor part number PNXXXXXX B 4 2 OEM ID The id is a 7bit identifier which is set at the factory to a unique value for each OEM 0X01 B 4 3 SENSOR SN The serial number of the module B 4 4 H W VERSION The hardware version number of the module B 4 5 TOTAL USAGE TIME Total use time of the module B 4 6 LAST ZERO TIME This is the total time that ha...

Page 106: ... the heaters so the Capnostat is able to run immediately after exiting the sleep mode Mode 2 will require the Capnostat to go through its warm up sequence when exiting this mode and a delay will be introduced until the system has stabilized NORMAL MODE TURNOFF MODE POWER SAVING B 5 4 BARO PRESSURE This setting is used to set current Barometric Pressure 400 850mmHg Default 760mmHg B 5 5 GAS TEMPERA...

Page 107: ...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 The typical t...

Page 108: ...should clear when the warm up is complete CHECK SAMPLING LINE This error occurs whenever the pneumatic pressure is outside the expected range Check that the sampling line is not occluded or kinked Replace the sample line ZERO REQUIRED Zero Required Zero Error To clear check airway adapter and clean if necessary If this does not correct the error perform an adapter zero If you must adapter zero mor...

Page 109: ... measured values may be inaccurate Read the measured values carefully 1 When using this in an environment of using Nitrous Oxide gas of high concentration 2 When using this in an environment where 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 fa...

Page 110: ...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 Measurement Cable Temperature Connector ...

Page 111: ...using the FS 300 but use it in body temperature mode Body Temperature Wide temperature Able to perform measurement only when the FS 300 is in Body Mode The measurement of temperature using this product does not represent a Doctors medical examination Consult with your medical professional if any abnormality is found ...

Page 112: ...ore the thermometer in a cool dry place This product is NOT waterproof Direct contact with water or other liquids should be avoided Do not leave the thermometer with infants or children at any time The protective glass over the lens is fragile handle with care Do not touch the glass of the infrared lens with bare fingers Do not modify or repair the thermometer ASTM laboratory accuracy requirements...

Page 113: ...ature between right and left forehead could be different When measuring the temperature of a liquid milk water place the probe as close as possible to the liquid but ensure that it is not immersed into the liquid as this may damage your thermometer Check your product regularly for damage Temperature Display Display data measurement time Temperature alarm limit display Temperature measurement value...

Page 114: ...of measurement from forehead to temple Therefore we recommend to measure the temperature at more than 2 points on the forehead Use the highest temperature rating as the most accurate reading NOTE If sweating on the forehead is present we recommend changing the measurement point to behind the earlobe ...

Page 115: ...d rays the body temperature can be measured This product is a contactless type thermometer and does not make direct contact with forehead The temperature measurement can be taken 2 to 3cm away from the body or object This will decrease discomfort or possible infections caused by touch Temperature Settings MENU Description Available Settings A TEMP A 1 ALARM Temp Alarm Settings menu A 1 1 PARAMETER...

Page 116: ...s cables 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 Inspection Cables Examine all system cables the power plug for damage Make sure that the prongs of the plug do not move in the...

Page 117: ...or Tests Safety checks Selected tests on the basis of IEC 60601 1 At least once every two years or as needed after any repairs where the power supply is removed or replaced or if the monitor has been dropped Monitor Maintenance Replace backlight integrated displays only 35 000 40 000 hours about four years of continuous usage or as needed Parameter Module Tests Performance assurance for all measur...

Page 118: ...ion Replace the adapter Is the output voltage of the adapter lower than 15V Replace the adapter Contact the place of purchase or customer service Is the output voltage of the adapter lower than 15V Replace the adapter If the charging Voltage is lower than 14V charging is not possible Is the battery voltage lower than 10V Replace the Battery Contact the place of purchase or customer service ...

Page 119: ... normally connected YES NO Is the extension cable connected poorly Replace the extension cables Is the SpO2 probe in poor condition Replace the finger probe Contact the place of purchase or customer service Are leaks from the hose connector of cuff Replace the hose of cuff Contact the place of purchase or customer service ...

Page 120: ...nt moved While measuring Make sure the patient stay still during diagnosis The measurements appear higher Loosen the cuff during diagnosis The measurements appear lower Contact the place of purchase or customer service Loosen the cuff during diagnosis Loosen the cuff during diagnosis ...

Page 121: ...Rev 2 2 121 EtCO2 Malfunction YES NO YES NO Temperature Malfunction The extension cables Are disconnected Replace extension cables The module is in bad condition Replace the module Repair the adaptor ...

Page 122: ...e immediately disconnect the device from the network and contact the hospital staff or manufacturer Storage lifetime issues When storage is nearing the end of its life the following warning message appears when booting the device admiting a patient continuous mode or saving measurements spot triage mode If the warning message appears contact the customer center or the purchasing agent to check the...

Page 123: ...ics see the information provided by the detergent manufacturer Monitor and Peripherals 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 o...

Page 124: ...fe of cables and lead wires is reduced Dry thoroughly with a lint free cloth CAUTION Do not use disinfectants that contain phenol as they can spot plastics Do not autoclave or clean accessories 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 damag...

Page 125: ...the exterior of the equipment at least once a month using a soft cloth moistened with lukewarm water or alcohol Do not use lockers thinners ethylene or oxidizers that could damage the equipment Make sure that the cables and accessories are free from dust and dirt then wipe them with a soft cloth moistened with 40 C water Please wipe it with clinical alcohol at least once a week Do not immerse the ...

Page 126: ...tion WARNING When replacing the backup battery check the battery electrode Installation and Storage of Equipment If you suspect the installation or disposition of the external ground wire operate the equipment by means of the internal power supply If the unit is not used for a certain period of time remove the backup battery if safety hazards do not occur ...

Page 127: ... 2 for medical electrical equipment issued by the International Electro technical Commission and is available from a variety of sources Although primarily aimed at equipment manufacturers most of the information 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 M...

Page 128: ... wireless network This is also true if the equipment complies with the CISPR emission requirements When using patient monitoring equipment to communicate over a wireless network be sure to check that 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...

Page 129: ...r domestic purposes Harmonics emission IEC 61000 3 2 A Voltage fluctuation IEC 61000 3 3 Complies Manufacturer s Declaration Electromagnetic Immunity Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the BM1 system The BM1 system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the BM1 syst...

Page 130: ...idelines may not apply in all situations Electromagnetic 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 3Vrms 150kHz to 80MHz 3Vrms 150kHz to 80MHz 3Vrms 150kHz to 80MHz Radiated RF IEC 61000 4 3 3V m 80MHz to 2 5GHz 3V m 80MHz...

Page 131: ...rity levels Visual alarm lamp handle SpO2 pulse pitch tone Battery status External power LED Interfaces DC input connector 15VDC 2 0A LAN digital output for transferring data Nurse call system connection 0 3A 125VAC 1A 24VDC USB Barcode Scanner USB data storage Battery Rechargeable Li ion battery Max 4hours Data Storage 168hours trends 5000 cases of patient data Language English French Spanish Ita...

Page 132: ...asurement range Adult Pressure 20 to 260 mmHg Pediatric Pressure 20 to 230 mmHg Neonate Pressure 20 to 120 mmHg Accuracy mean error less than 5 mmHg standard deviation less than 8 mmHg Meets accuracy requirements of ANSI AAMI SP10 1992 and 2002 Temperature Performance Measurement range 34 to 42 5 93 2 to 108 5 Accuracy 36 to 39 0 2 Other 0 3 Sidestream CO2 Option Measurement range 0 to 150 mmHg 0 ...

Page 133: ...Respiration accuracy 1breath per minute Mainstream 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 reading 101 150mmHg 10 of reading Respiration rate 0 to 150 breath per minute Respiration accuracy 1breath per minute ...

Page 134: ...rameter Limit Adult Pediatric Neonate NIBP S 80 200 60 160 40 100 NIBP M 40 140 40 120 30 70 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 TEMP 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 AWRR 10 30 10 50 15 100 EtCO2 25 50 25 50 25 50 FiCO2 0 5 0 5 0 5 Apnea 0 20 0 20 0 15 ...

Page 135: ...Rev 2 2 135 Default Display Item Value NIBP Interval Off Alarm Volume 50 Pulse Volume Off SpO2 Probe Off Message Units for Height cm Units for Weight Kg Temperature Units NIBP Limit Type Systolic ...

Page 136: ...thmia 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 D diastolic DC direct current DEFIB Defib defibrillator DIA diastolic E ECG electrocardiograph EMC electromagnetic compatibility EMI electromagnetic interference ESU electrosurgical cautery ...

Page 137: ... K kg KG kilogram kPa kilopascal L L liter left LA 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 persecond MMHG mmHg millimeters of mercury mV millivolt N NIBP non invasive blood pressure ...

Page 138: ...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 temperature V V precordial lead V volt V Fib VFIB ventricular fibrillation VTAC ventricular tachycardia X X multiplier when used with a number 2X ...

Page 139: ...Rev 2 2 139 Symbols and degree s greater than less than minus number percent plus or minus ...

Page 140: ... Customer section Hospital Name Address Name Phone Sales Agency Manufacturer This product is a medical device Thank you for purchasing BM1 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 BIONET CO LTD ...

Page 141: ...oll Free 1 877 924 6638 FAX 1 714 734 1761 e mail support bionetus com Website www bionetus com European sales service representative Bionet Europe GmbH 2Li Bessemerstr 51 D 12103 Berlin Germany Tel 49 30 240 374 52 e mail bionetEU ebionet com Website www ebionet com Authorized European representative CMC Medical Devices Drugs S L C Horacio Lengo Nº 18 CP 29006 Málaga Spain Tel 34 951 214 054 Fax ...

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