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D - 2

BeneVision TM80 Telemetry Monitor Operator’s Manual

D.2

Symbols

D.3

Abbreviations

second

volt

volt ampere

ohm

μA

microampere

μm

micron

μV

microvolt

watt

minus

percent

per; divide; or

power

plus

equal to

less than

greater than

≤

less than or equal to

≥

greater than or equal to

plus or minus

multiply

AAMI

Association for Advancement of Medical Instrumentation

alternating current

AHA

American Heart Association

ANSI

American National Standard Institute

ARR

arrhythmia

ART

arterial

Summary of Contents for TM80

Page 1: ...BeneVision TM80 Telemetry Monitor Operator s Manual...

Page 2: ......

Page 3: ...zhen Mindray Bio Medical Electronics Co Ltd All rights reserved Release time October 2020 Revision 6 0 WARNING Federal Law USA restricts this device to sale by or on the order of a physician or other...

Page 4: ...her trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them They are the property of their respective owners This posting serves as no...

Page 5: ...ics Co Ltd Address Mindray Building Keji 12th Road South High tech Industrial park Nanshan Shenzhen 518057 P R China Website www mindray com E mail Address service mindray com Tel 86 755 81888998 Fax...

Page 6: ...anual is an integral part of the product It should always be kept close to the equipment so that it can be obtained conveniently when needed Intended Audience This manual is geared for clinical profes...

Page 7: ...alling the Batteries 3 5 3 4 1 Installing the Lithium ion Rechargeable Battery Pack 3 5 3 4 2 Installing the AA Batteries 3 6 3 5 Powering On the Unit 3 7 3 6 Understanding Touch Gestures 3 8 3 7 Basi...

Page 8: ...5 3 3 Changing the Paced Status 5 2 5 3 4 Changing the Department Name Room Number and Bed Number 5 3 5 4 Entering the Standby Mode 5 3 5 5 Exiting the Standby Mode 5 4 5 6 Discharging the Patient 5...

Page 9: ...h Filter 7 14 7 5 Configuring the HR Alarm Source 7 15 7 6 Understanding the ECG Display 7 15 7 6 1 HR Digital Area 7 15 7 6 2 About the HR Digital Area 7 16 7 6 3 ECG Waveform Area 7 16 7 6 4 About t...

Page 10: ...al 9 1 9 1 Introduction 9 1 9 2 Measurement Limitations 9 1 9 3 Safety 9 3 9 4 Connecting the SpO2 Module 9 4 9 5 Changing the SpO2 Settings 9 6 9 5 1 Configuring the SpO2 Setup 9 6 9 5 2 Configuring...

Page 11: ...Example Events Review Page 11 5 11 3 3 Example Event Details Page 11 6 12 Configuring the Telemetry Monitor 12 1 12 1 Introduction 12 1 12 2 Entering the Maintenance menu 12 1 12 3 Configuring the Gen...

Page 12: ...3 6 1 Adjusting ST Measurement Points 13 7 13 6 2 Entering the ST Graphic Window 13 7 13 6 3 Entering the ST View 13 8 13 7 Arrhythmia Monitoring 13 9 13 7 1 Configuring the PVC Related Alarm Threshol...

Page 13: ...6 16 5 Cleaning and Disinfecting Other Parts 16 6 16 6 Sterilization 16 7 16 7 Impact of Improper Cleaning or Disinfection 16 7 17 Maintenance 17 1 17 1 Introduction 17 1 17 2 Safety 17 1 17 3 Regula...

Page 14: ...l Specifications A 3 A 5 Hardware Specifications A 3 A 5 1 TM80 A 3 A 5 2 A 4 A 5 3 Central Charger A 4 A 6 Data Storage A 4 A 7 Wireless Specification A 5 A 7 1 Mindray Patient Area Network MPAN Spec...

Page 15: ...be used for a single patient at a time The telemetry monitor must be operated by medical personnel in hospitals For continued safe use of the telemetry monitor the instructions given in this manual m...

Page 16: ...ll servicing and future upgrades must be carried out by trained and authorized personnel Do not rely exclusively on the audible alarm system for patient monitoring Adjustment of alarm volume to a low...

Page 17: ...al waste control regulations and keep it out of children s reach After the configurations such as the patient category paced status are changed at the telemetry monitor the medical personnel should ch...

Page 18: ...At the end of its service life the telemetry monitor and its accessories must be disposed of in compliance with the guidelines regulating the disposal of such products to prevent bringing potential n...

Page 19: ...ic resonance imaging MRI Protection against fluid ingress Non ionizing radiation General warning sign Refer to instruction manual booklet Standby Humidity limitation Atmospheric pressure limitation Te...

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Page 21: ...lthcare facilities under the direct supervision of a licensed healthcare practitioner WARNING Only skilled trained clinical professionals should operate the equipment The equipment is not designed for...

Page 22: ...the CMS operator s manual AP The AP is the access point used to bridge the telemetry monitor to the wired network For details on the AP refer to the user manual of the AP TM80 The TM80 is the telemet...

Page 23: ...sp SpO2 and NIBP parameter numerics and ECG SpO2 and Resp waveforms Battery options of three AA batteries or one lithium ion battery pack are available Display supports parameter auto sizing 2 5 TM80...

Page 24: ...a nurse call request to the CMS The alarm light indicator will illuminate cyan and a Nurse Call Initiated message will display in the message area if the display is on 3 Main Menu key Pressing this k...

Page 25: ...ailable for authorized service personnel 11 Battery compartment Contains the lithium ion battery pack or AA battery frame 2 7 TM80 Touch Screen Display WARNING Do not operate the touch screen with wet...

Page 26: ...patient ID of the telemetry monitor are dimmed grey when it is connected to the CMS please check the version of the CMS and make sure it is 04 04 00 or above 2 Alarm symbol indicates the status of th...

Page 27: ...access point and the signal coverage is very weak Wireless offline would occur indicates that the telemetry monitor is not connected to the wireless access point 5 Battery symbol This symbol indicates...

Page 28: ...ft button tap to switch the case of the letter This switch is active for one character entry 2 7 2 2 Numeric Keyboard 1 Numeric buttons tap to input the desired numbers 2 Punctuation buttons tap to in...

Page 29: ...BeneVision TM80 Telemetry Monitor Operator s Manual 2 9...

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Page 31: ...quipment The system configuration must meet the requirements of the IEC 60601 1 medical electrical systems standard Any personnel who connect devices to the equipment s signal input output port is res...

Page 32: ...any mechanical damage Contact Mindray in case of any problem WARNING The telemetry monitor may be subject to microbacteria contamination during storage transport or use Prior to use please verify tha...

Page 33: ...transmits data through a wireless connection External radio frequency interference may result in occasionally data dropout Contact Mindray for any questions regarding the electromagnetic environment 3...

Page 34: ...llowing performance may be affected by a weak connection ECG signal quality Water resistance Do not use the ECG leadwire to move or lift the telemetry monitor This may cause the device to fall which m...

Page 35: ...erse Never use brute force to install the lithium ion battery pack or AA battery tray Otherwise the waterproof ring surrounding the battery frame edge may be broken to affect the waterproof performanc...

Page 36: ...ing the AA Batteries To install the AA batteries 1 Make sure the battery compartment is empty 2 Insert three 1 5V alkaline AA batteries according to the diagram in the bottom of the battery tray as sh...

Page 37: ...est during startup The alarm light flashes red yellow and cyan in turn and then off This indicates that the alarm system functions correctly When the telemetry monitor installed with the rechargeable...

Page 38: ...Before using the telemetry monitor understand the supported touch screen gestures 3 7 Basic Operations This section describes the basic operations for the telemetry monitor WARNING Patients should be...

Page 39: ...Swipe your finger up or down on the screen 3 7 3 Switching the Screen Display Orientation To switch the screen display orientation follow this procedure 1 Swipe your finger down from the top of the m...

Page 40: ...s changed to II lead waveform Alarm Pause Tap the button to pause the alarm system Refer to 6 6 Pausing Alarms for details Print Tap the button to notify the CMS to start real time print The Print Ini...

Page 41: ...isplay off or let the display automatically turn off based on the configured timeout Press the key to manually turn the display off If the touch screen is not touched for the configured Display Auto O...

Page 42: ...play is on 3 7 8 Unlocking the Screen in Locked Mode If you set the screen lock you need to input the correct passcode to unlock the screen after the display turns off 1 If the screen is off press the...

Page 43: ...Disposable pouches specified in this manual can be used for the telemetry monitor For details about the pouch refer to 18 4 Miscellaneous For how to use the pouch for BP10 refer to BP10 Operator s Man...

Page 44: ...th ties around the patient s shoulder and under the arm as shown in the following figure WARNING While using a pouch with the telemetry monitor on the patient consider the patient s condition Be caref...

Page 45: ...elemetry monitor and BP10 simultaneously follow steps in 3 8 1 Securing the Pouch for the Telemetry Monitor to secure the pouch for the telemetry monitor on the left or right side of the patient s bod...

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Page 47: ...lt Orientation Two buttons display Portrait and Landscape 2 Tap a button to set the default orientation The selected orientation displays to the right of Default Orientation 3 Restart the telemetry mo...

Page 48: ...ne half of the width of the screen Therefore a row with a digital tile in it shall be split into two half tiles 4 A digital area shall not be the only parameter in a row unless an odd number of digi t...

Page 49: ...ain menu tap Audio Volume 2 In the Sounds Touch Screen Click or Systole Beep section drag the slider to the left or right to decrease or increase the volume 3 Tap the icon to exit the Audio Volume men...

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Page 51: ...ent category paced status department name room number and bed number 5 3 1 Changing Last Name First Name and Patient ID To change the last name first name and patient ID follow this procedure 1 In the...

Page 52: ...t specified at the telemetry monitor the symbol displays in the waveform area of the Central Monitoring System s screen WARNING For paced patients you must set Paced to Yes If it is incorrectly set to...

Page 53: ...menu you can change a department name room number and bed number in the Patient Info menu For information about settings in the Maintenance menu refer to 12 3 1 Configuring Device Location To change d...

Page 54: ...lemetry monitor can admit next new patient by applying the user configuration If the telemetry monitor does not save the user configuration it will apply the factory configuration for the new patient...

Page 55: ...adds a record of the patient s history data 5 6 2 Restarting the Telemetry Monitor To restart the telemetry monitor follow this procedure 1 If the telemetry monitor is powered off press the key to tur...

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Page 57: ...riate for your patient before starting monitoring Always make sure that necessary alarm limits are active and set according to the patient s clinical condition Setting alarm limits to extreme values m...

Page 58: ...fied into the following severity levels High priority alarms indicates a life threatening situation or a severe device malfunction High priority alarms require an immediate response Medium priority al...

Page 59: ...ingle beep None Alarm message White text inside a red box Black text inside a yellow box Black text inside a cyan box White text Alarm messages are displayed in the prompt message area at the top of t...

Page 60: ...displayed 6 3 4 Alarm Status Symbols Apart from the alarm indicators as described in 6 3 3 Alarm Indicators The telemetry monitor uses the following symbols to indicate the alarm status indicates that...

Page 61: ...the Audio Volume 6 5 2 Initiating Auto Alarm Limits The telemetry monitor provides the auto alarm limits function to automatically adjust alarm limits according to the patient s vital signs used When...

Page 62: ...n alarms are paused the following indicators are given No physiological alarm will be presented within the alarm pause time Module Parameter Low Limit High Limit Auto Limit Range Adult Pediatric Adult...

Page 63: ...ision Central Monitoring System Operator s Manual 6 7 Resetting Alarms You can acknowledge the on going alarms by resetting alarms After being reset the alarm system can respond to a subsequent alarm...

Page 64: ...when the alarm system is reset refer to 15 3 Technical Alarm Messages at the Telemetry Monitor NOTE If an operator disconnects an SpO2 sensor or a module purposefully resetting alarms can turn off ala...

Page 65: ...BeneVision TM80 Telemetry Monitor Operator s Manual 6 9 5 Make sure the alarm condition is corrected For more information refer to 15 Troubleshooting...

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Page 67: ...on Use manufacturer specified electrodes and lead wires Make sure the conductive parts of electrodes and associated connectors for applied parts including the neutral electrode do not contact any othe...

Page 68: ...lectrical activity and inaccurate readings may arise from incorrect skin preparation The following procedure is recommended for secure electrode application 1 Shave the chest hair from the electrode s...

Page 69: ...ay need to be adjusted until the optimum ECG tracing is obtained To position the electrodes follow this procedure 1 Peel the backing off of the electrode Visually inspect the contact gel medium for mo...

Page 70: ...ng the ECG Lead Labeling 7 3 3 1 Lead Naming Standards This manual presents lead placement according to the guidelines of the American Heart Association AHA and the International Electro Technical Com...

Page 71: ...significant R wave 7 3 4 1 Standard 3 Leadwire Electrode Placement A 3 wire lead set can monitor one of three ECG vectors I II or III The recommended 3 wire lead placement is as follows 7 3 4 2 Stand...

Page 72: ...of Vb and Cb is V2 and C2 respectively The positions of Va Ca and Vb Cb can also be placed at a proper position according to the clinician s needs AHA IEC Electrode Placement RA white R red At the pa...

Page 73: ...frame Va brown Ca white The Va Ca electrode is placed in any one of the positions from V1 C1 V6 C6 positions By default Va Ca electrode is placed at V1 C1 and the Vb Cb electrode is placed at V2 C2 V1...

Page 74: ...ment For Pacemaker Patients The recommended lead placement for monitoring a pacemaker patient is as follows RA R LA L LL F Pacemaker 3 wire lead placement for a pacemaker patient AHA IEC 5 wire Lead P...

Page 75: ...ight subclavian area relocate the Right Arm electrode closer in towards the center of the chest 7 3 5 Checking the Lead Placement With the Lead Placement function you can check the lead status informa...

Page 76: ...g circle indicates the disconnected lead The color of the flashing circle is based on the alarm priority 7 3 6 Checking the Paced Status To check the paced status follow this procedure 1 On the main s...

Page 77: ...ging at the electrode and ECG artifact 7 4 Changing ECG Settings You can change the ECG settings from the ECG menu 7 4 1 Entering the ECG Menu Enter the ECG menu in either of the following ways On the...

Page 78: ...e main screen Drag the switch to right or left to enable or disable the Smart Lead function 6 Lead the leadwire types is set to 6 lead If the leadwire type is set to 6 lead there will be two options V...

Page 79: ...V 40 mm mV Auto This configuration will be applied for all ECG waveform sizes Speed Selects the waveform sweep speed 6 25 mm s 12 5 mm s 25 mm s The factory default settings are in bold Options Descri...

Page 80: ...er filters out AC line noise from the ECG waveform Refer to 12 3 Configuring the General Menu for details Options Description Settings HR PR Configures whether to trigger a HR PR high or low alarm On...

Page 81: ...ECG measurements as the alarm source whenever a valid heart rate is available If the heart rate becomes unavailable for example the ECG module becomes disconnected the telemetry monitor will automati...

Page 82: ...a displays heart rate in the unit of bpm with a resolution of 1 bpm If the HR measurement is invalid displays in place of the HR value The HR value displays 0 when the HR value is less than 15 bpm 7 6...

Page 83: ...sensitivity and specificity are less than 100 sometimes there may be some false arrhythmias detected and also some true arrhythmia events may not be detected This is especially true when the signal is...

Page 84: ...reme tachycardia limit Extreme Brady The heart rate is less than the extreme bradycardia limit R on T R on T PVC is detected Run PVCs More than two consecutive PVCs but lower than the V Brady PVCs lim...

Page 85: ...ious RR interval and The next RR interval is lower than 1 5 x average RR interval and HR lower than 100 and the current RR interval is greater than 1 75 x average RR interval or HR is greater than or...

Page 86: ...alarms On Off Asystole Delay 3 seconds to 10 seconds The default is 5 sec Alarm priority High V Fib V Tach On Off Alarm priority High V Tach On Off V Tach PVCs 3 beats to 99 beats the default is 6 be...

Page 87: ...ric Alarm priority High Extreme Brady On Off Extreme Brady 15 bpm to 119 bpm the default is 35 for adult and 50 for pediatric Alarm priority High R on T On Off Alarm priority Prompt Low Med High Run P...

Page 88: ...120 bpm the default Brady threshold is consistent with the HR alarm low limit Alarm priority Med High Pacer Not Capture On Off Alarm priority Prompt Low Med High Pacer Not Pacing On Off Alarm priorit...

Page 89: ...If any of the lethal arrhythmia alarms is switched off the ECG waveform area at the telemetry monitor displays the Lethal Arrhys Off message The ECG waveform area on the screen of the CMS displays Asy...

Page 90: ...he Arrhythmia Alarm Timeout Period The arrhythmia algorithm can disable alarm light and alarm tone for designated period of time when certain arrhythmia alarms are detected You can set the arrhythmia...

Page 91: ...hythmia alarm chain refer to 7 7 4 1 Arrhythmia Alarm Chains 7 7 4 3 Arrhythmia Alarm Refractory Period For the following eight alarms in medium priority chain there is a 30 second refractory period T...

Page 92: ...main screen tap the HR digital area or ECG waveform area to enter the ECG menu 2 In the Parameter Setup section tap ST 3 Switch on ST Analysis Reliable ST monitoring can hardly be ensured if You are...

Page 93: ...ST numerics a positive value indicates ST segment elevation and a negative value indicates ST segment depression 7 8 4 Configuring ST Alarm Settings To configure ST alarm settings follow this procedur...

Page 94: ...patients Options Description Settings ST I ST II ST III ST aVR ST aVF ST V ST Va ST Vb These options are displayed when ST Alarm Mode is set to Absolute The lead label behind ST is consistent with the...

Page 95: ...d no visible flutter activity and without a predominant U wave or P wave Some conditions such as left or right bundle branch block or hypertrophy can lead to a widened QRS complex If a long QTc is obs...

Page 96: ...ment unit 5 QTc alarm off symbol 6 QTc value the difference between the current and baseline QTc values 7 QT value 7 9 4 Configuring QT QTc Alarm Settings To configure QT QTc alarm settings 1 Tap the...

Page 97: ...ECG Relearning Auto arrhythmia relearning is initiated in the following situation The ECG lead type or lead label is changed ECG leads are off and are not reconnected within 60 seconds The patient s...

Page 98: ...in screen tap the ST digital area to enter the ST menu 2 Tap Relearn CAUTION Initiate ECG relearning only during periods of predominantly normal rhythm and when the ECG signal is relatively noise free...

Page 99: ...ectly in manual detection mode it may not be possible for the telemetry monitor to detect apnea If you set the detection level too low the telemetry monitor is more likely to detect cardiac activity a...

Page 100: ...rub the skin until it is raw or bleeding NOTE Proper skin preparation is necessary for good signal quality at the electrode site as the skin is a poor conductor of electricity 8 3 2 Positioning the El...

Page 101: ...electrode application site to ensure skin quality If the skin quality changes replace the electrodes or change the application site NOTE Store the electrodes at room temperature Open the electrode pac...

Page 102: ...8 4 5 Configuring Resp Alarm Settings To configure Resp alarm settings follow this procedure 1 In the Alarms section of the Resp menu tap Resp Alarm Setup 2 Select the options described in the followi...

Page 103: ...ault alarm low limit is 8 The alarm high limit should be at least 2 rpm greater than the alarm low limit Alarm Priority Low Med High No Chest Movement The telemetry monitor will trigger the No Chest M...

Page 104: ...area displays the respiration rate in the unit of RPM with a resolution of 1 RPM If the Resp measurement is invalid displays in place of the RR value 8 5 3 Resp Waveform Area 1 Resp lead label 2 Resp...

Page 105: ...out the SpO2 parameter setup at the Central Monitoring System refer to 13 Monitoring with the Telemetry Monitor at the CMS NOTE A functional tester or SpO2 simulator cannot be used to assess the accur...

Page 106: ...or hypercapnic conditions Birthmark s tattoos skin discolorations moisture on skin deformed or abnormal fingers etc Interfering substances Intravascular dyes such as indocyanine green methylene blue...

Page 107: ...ry two to three hours and move to another location if the skin deteriorates More frequent examinations may be required for different patients Change the application site or replace the sensor and or p...

Page 108: ...may be found in the sensor s directions for use DFU To protect from electric shock always remove the sensor and completely disconnect the pulse oximeter before bathing the patient The pulse oximeter i...

Page 109: ...BeneVision TM80 Telemetry Monitor Operator s Manual 9 5 Connecting the Masimo SpO2 module SpO2 module SpO2 sensor SpO2 sensor connector...

Page 110: ...can change the SpO2 settings from the SpO2 menu 9 5 1 Configuring the SpO2 Setup Enter the SpO2 menu in either of the following ways On the main screen tap the SpO2 digital area or SpO2 waveform area...

Page 111: ...n signal quality and patient motion High This mode should be used for the sickest patients where obtaining a reading is most difficult High Sensitivity is designed to interpret and display data for ev...

Page 112: ...lity to subtle desaturations while also being long enough to minimize major changes in SpO2 due to quick transitory desaturations Although averaging times greater than 10 seconds are more likely to re...

Page 113: ...he SpO2 and SpO2 Desat alarm properties You can also set whether to measure SpO2 and NIBP simultaneously 1 In the Alarms section of the SpO2 menu select the options described in the follow ing table O...

Page 114: ...alarm limits and alarm priority For SpO2 Alarm switch On Off Alarm limit range 0 to 100 The default alarm upper limit is 100 The default alarm low limit is 90 Alarm Priority Med High For Desat Alarm...

Page 115: ...sor is connected to the patient WARNING When equipped with Masimo SpO2 module use only Masimo SpO2 sensors specified in this manual Use of other SpO2 sensors may cause improper oximeter performance Wh...

Page 116: ...s 9 7 Understanding the SpO2 Display 9 7 1 SpO2 Digital Area The SpO2 digital area displays 1 Parameter name 2 SpO2 value 3 Perfusion indicator 4 Perfusion index PI label 5 Perfusion index value 6 SpO...

Page 117: ...I resolution as 0 01 when the PI value is smaller than 10 Displays Masimo PI resolution as 0 1 when the PI value is greater than or equal to 10 If the SpO2 measurement or PR is invalid displays in pla...

Page 118: ...plied License Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables which would alone or in combination with this d...

Page 119: ...For the functionalities and operations of the BP10 refer to BP10 NIBP Module Operator s Manual 10 2 Pairing a Telemetry Monitor with a BP10 10 2 1 Pairing Procedures Before pairing the telemetry moni...

Page 120: ...e differences see 10 3 3 System Responses after Successful Unpairing 10 2 2 System Responses after Successful Pairing Once a telemetry monitor is paired successfully with a BP10 the following system r...

Page 121: ...automatically and the data history related to this patient will be cleared Patient Category can be changed at the telemetry monitor only A patient cannot be discharged from the BP10 and NIBP related s...

Page 122: ...ful Unpairing Once a telemetry monitor is unpaired successfully with a BP10 the following system responses occur The status of the BP10 connected previously will be changed to Disconnect under Devices...

Page 123: ...essure 4 Diastolic pressure 5 Diastolic pressure low limit 6 Diastolic pressure high limit 7 Mean pressure displayed after measurement is completed or cuff pressure dis played during measurement 8 Mea...

Page 124: ...ce or ABPM mode at the BP10 Tap NIBP STAT to start the series measurement in continuous mode at the BP10 10 5 3 Configuring NIBP Settings To configure NIBP settings follow this procedure 1 In the Setu...

Page 125: ...mmHg to 280 mmHg the default is 160 For pediatric 80 mmHg to 210 mmHg the default is 140 Color Configures the color of NIBP numeric data 16 colors The default color is white The factory default settin...

Page 126: ...it 5 Default value 50 For pediatric Range 11 to high limit 5 Default 40 Alarm priority Med High MAP Configures whether to trigger the NIBP mean pressure alarm On Off Alarm high limit For adult Range l...

Page 127: ...t 5 Default value 75 For pediatric Range 25 to SYS low limit 5 Default 60 Alarm priority High DIA Extreme Configures whether to trigger the extreme NIBP diastolic pressure alarm On Off Alarm high limi...

Page 128: ...gh limit should beat least 5mmHg greater than its alarm low limit MAP Extreme Configures whether to trigger the extreme NIBP mean pressure alarm On Off Alarm high limit For adult Range MAP high limit...

Page 129: ...llowing ways Option 1 1 Press the key to enter the main menu 2 Tap Review 3 Tap Tabular Trends Option 2 Tap the Tabular Trends button in the upper right corner of the events review page For how to ent...

Page 130: ...s button goes to the events review page 4 Event type indicator different color blocks indicate different types of events Red high priority alarm event Yellow medium priority alarm event Cyan low prior...

Page 131: ...ap the button on the tabular trends review page the tabular trends data search page is displayed The following figure is for reference only 1 Timeline indicates the entire time length indicates the ti...

Page 132: ...ent the SpO2 No Sensor technical alarm event physiological alarm events manual events and operational events NOTE A total loss of power has no impact on the events stored Alarms are saved as events an...

Page 133: ...top The following figure is for reference only 1 The position of current page in the total pages of events for example 39 56 indicates that there is a total of 56 pages of events and currently display...

Page 134: ...all the measurement numerics at the event trigger time The following figure is for reference only The event trigger time is marked in a colored block along the timeline at the top of the event details...

Page 135: ...BeneVision TM80 Telemetry Monitor Operator s Manual 11 7 If you wish to return to the event list tap the icon...

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Page 137: ...2 Select the options described in the following table Options Description Settings Display Auto Off Configures the time for display auto off 1 min 2 min 5 min 15 min 30 min Off Language Configures the...

Page 138: ...xed you cannot modify Department in the Patient Info menu Department is the one entered in the Department field of the Device Location menu Unfixed you can modify Department in the Patient Info menu 7...

Page 139: ...tone pattern ISO Mode 1 Mode 2 Minimum Alarm Volume Allows an authorized user to configure the minimum alarm volume The minimum alarm volume defines the minimum value you can set for the alarm volume...

Page 140: ...the audible alarm system for monitoring Adjustment of alarm volume to a low level may result in a hazard to the patient Reminder Interval Allows an authorized user to configure the intervals between...

Page 141: ...ck Keys Menu 12 5 1 Changing the Quick Keys 1 In the Maintenance menu tap Quick Keys The Quick Keys configuration menu displays 2 From the quick keys area at the bottom of the screen tap a quick key y...

Page 142: ...u you can configure the network and connect the telemetry monitor to the BeneVision Central Monitoring System via the wireless network To configure the Network menu 1 In the Maintenance menu tap Netwo...

Page 143: ...is capable of connecting up to 128 telemetry monitors via the wireless network 12 6 1 Configuring IP Settings The telemetry monitor provides two ways to get IP address Dynamic Host Configuration Prot...

Page 144: ...mber before the first decimal point 0 to 255 for the number after the first decimal point Factory default 255 255 255 0 IP Gateway Select to input the IP gateway address Range 1 to 255 for the number...

Page 145: ...nitor to the CMS in multicast or unicast mode 12 6 3 1Connecting the CMS in Multicast Mode 1 In the Network menu tap Connect CMS 2 Tap Connection Mode 3 Select Multicast 4 Configure the desired option...

Page 146: ...ress Range 1 to 255 for the number before the first decimal point 0 to 255 for the number after the first decimal point Factory default 225 0 0 8 Port It is a public port to communicate with the Centr...

Page 147: ...ed tap AN Channels 5 Select the desired channels NOTE BGN Channels and AN Channels default to be blank Channels need to be selected to improve roaming performance 12 6 6 EAP Certificate Management for...

Page 148: ...cable and connect the USB male connector of the upgrade cable to the USB power adapter as shown below 5 Power on the TM80 6 Press the key to enter the main menu tap Maintenance enter the required pass...

Page 149: ...metry monitor B in this example found is listed in the Export Device Settings menu 3 Select the desired external device telemetry monitor B in this example by tapping the check box 4 Tap Export to sta...

Page 150: ...etry monitor A tap the icon at telemetry monitor B to exit the Import Device Settings To retry the import from the telemetry monitor A tap the external devices where the Failure message is displayed a...

Page 151: ...Maintenance menu tap Screen Lock 2 Tap Screen Lock Passcode 3 Input the current password 4 Input and verify the new password 12 8 4 Changing the Screen Lock Mode Follow this procedure to change the sc...

Page 152: ...1 In the Maintenance menu tap Auto Enter Monitor Mode 2 Choose the desired option No Central Monitoring When disconnected from the CMS the telemetry monitor switches from telemetry mode to monitor mod...

Page 153: ...connect a telemetry monitor hereinafter called the telemetry with the N series monitor hereinafter called the monitor to measure the ECG Resp SpO2 and NIBP of ambulatory adult and pediatric patients...

Page 154: ...nd the monitor enters standby Monitor the monitor is used to continue monitoring the patient Patient is discharged from the telemetry and the telemetry enters standby Cancel do not unpair the telemetr...

Page 155: ...y monitor under the following circumstances The telemetry monitor is connected to the CMS for the first time User configurations are saved at the telemetry monitor The telemetry monitor is connected t...

Page 156: ...ss setting is correct Changing the network settings may result in network disconnection Contact your service personnel if you have any problems on setting the IP address Disconnecting from the network...

Page 157: ...etup menu select the Telemetry tab input the password select OK 3 Select Analysis Leads 4 Set Analysis Leads On you can select analysis leads Off ECG1 and ECG2 are used as analysis leads When Analysis...

Page 158: ...er to BeneVision Central Monitoring System Operator s Manual 13 5 2 QT View In the QT View menu you can view a snapshot of the real time wave and to verify that the QT algorithm detects correct Q and...

Page 159: ...nfigure the QT view follow this procedure 1 Enter QT View 2 Select the buttons described in the following table as desired Buttons Description Settings Left or right arrow Select the desired lead to d...

Page 160: ...ween the end of the P wave and the onset of the QRS complex The ISO point provides the baseline for this measurement The ST point is a fixed distance from the J point at the end of the QRS complex The...

Page 161: ...ificantly Exceptional QRS complexes are not considered for ST segment analysis WARNING Always make sure that the ST measurement points are appropriate for your patient To adjust ST measurement points...

Page 162: ...an yellow or red if an alarm occurs indicates ST 13 6 3 Entering the ST View The ST View shows a complete QRS segment for each ST lead The color of current ST segments and ST values is consistent with...

Page 163: ...S select the ECG digital area or waveform area to enter the ECG menu 2 Select the Arrhythmia tab 3 Select the More Threshold section 4 Set the desired items using the right or left arrow The following...

Page 164: ...o configure arrhythmia shield time follow this procedure 1 Select the system menu area in the upper left corner of the CMS screen 2 Select System Setup to access the System Setup menu 3 Select the Tel...

Page 165: ...emetry monitor and displayed on the main screen of this telemetry monitor 4 If you wish to confirm the notification tap Confirm at the telemetry monitor 13 10Triggering an Alarm Reminding Patients Loc...

Page 166: ...ly start ECG Relearn Modify patient demographics Discharge patient and enter standby To set the permission follow this procedure 1 Select the system menu area in the upper left corner of the CMS scree...

Page 167: ...her AA batteries can give unacceptable performance Do not mix batteries of different charge voltage levels Do not mix batteries of different chemistries Only use specified rechargeable lithium ion bat...

Page 168: ...of it properly Do not incinerate batteries or expose them to temperatures above 60 C 140 F The rechargeable lithium ion batteries should be charged in the specified central charger CAUTION Remove the...

Page 169: ...cause a battery to overheat during using High temperature can cause burns to the patient or user If the device becomes too hot to the touch remove it from the patient and place aside until it cools Th...

Page 170: ...ains extension cords Use an IEC 60601 1 approved isolation separation transformer otherwise it may result in leakage current Insure that the sum of the individual ground leakage currents does not exce...

Page 171: ...ce in clean place to avoid the dust or liquid entering the battery compartment Storing batteries at high temperatures for an extended period of time will significantly shorten their life expectancy Do...

Page 172: ...e reduced battery life is unacceptable for your device Mindray recommends the battery be replaced 14 9 Disposing of the Batteries 14 9 1 Disposing of the Rechargeable Lithium ion Battery Discard the l...

Page 173: ...Discharge the battery and insulate the terminals with tape before disposal Properly dispose of the batteries according to local regulations 14 9 2 Disposing of the AA Batteries The batteries may be s...

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Page 175: ...ntact with the skin 2 Check that the ECG leadwires are connected securely 3 Check that the patient does not contact any ungrounded electric equipment ECG signal saturated The telemetry monitor detecte...

Page 176: ...the telemetry monitor Contact your service personnel Items like SSID WMTS band are not configured properly for the wireless access point The telemetry monitor has a fault The telemetry monitor has bee...

Page 177: ...e blocked by the patient s body Put the telemetry monitor and BP10 closer The telemetry monitor and BP10 are prone to offline in certain area As there are many wireless devices in this area communicat...

Page 178: ...Extreme Tachy Extreme Brady R on T Med Run PVCs Low Couplet Prompt Multiform PVC Med PVC Prompt Bigeminy Med Trigeminy Tachy Brady Missed Beats Prompt Nonsus V Tach Med Vent Rhythm Pause Low Irr Rhyth...

Page 179: ...it Check the patient s condition and check if the patient category and alarm limit settings are correct ST Dual Alarm Violation Med The ST value of two or more ST leads has risen above the high alarm...

Page 180: ...alarm limit Check the patient s condition and make sure that the patient category and alarm limit settings are correct RR Low No Chest Movement High The respiration signal was so weak that the monito...

Page 181: ...not perform pulse analysis Check the patient s condition SpO2 sensor and measurement site NIBP NIBP S High Med The NIBP systolic pressure has risen above the high alarm limit or fallen below the low a...

Page 182: ...cated by the alarm light C The technical alarms are cleared there will be no alarm indications NIBP NIBP S Extremely High High The NIBP systolic pressure has risen above the extreme alarm high limit o...

Page 183: ...e has become disconnected from the adapter cable Check the connections of the electrodes and leadwires ECG XX Lead Off Low B ECG Module Error High A An error occurred to the ECG module There is a prob...

Page 184: ...ng is manually or automatically triggered Cannot perform ST analysis Prompt A Cannot Analyze QT Prompt A Check Leads Prompt ECG original sampling exceeds signal saturation threshold Resp Electrode Poo...

Page 185: ...much light on the SpO2 sensor Move the sensor to a place with lower level of ambient light or cover the sensor to minimize the ambient light SpO2 No Pulse Low A SpO2 sensor failed to obtain pulse sig...

Page 186: ...gnal noise and check the patient for excessive motion SpO2 Low Perfusion Prompt The SpO2 sensor is not properly placed or the patient s perfusion index is too low 1 Check the sensor and sensor positio...

Page 187: ...Maintenan ce Required Med A The lithium ion battery is aging MPAN Disconnec ted Med C The MAPN is disconnected Enable the MPAN switch NIBPClock Needs To Be Set Low C The button cell does not have suf...

Page 188: ...is loose Check the patient s condition and change the cuff application site If the error persists replace the cuff NIBP Overrange Low C The measured NIBP value is not within the specified range Contac...

Page 189: ...ff NIBP Cuff and Patient Mismatch Low C The cuff type applied mismatches the patient category 1 Check the patient s category 2 Replace the cuff Intervals Not Set Low C The interval in Sequence mode is...

Page 190: ...most depleted Battery Maintenan ce Required Med A The lithium ion battery is aging Battery Error Med A The lithium ion battery communication error occurred Battery Type Error Med A The battery contact...

Page 191: ...rt the telemetry monitor If the problem persists contact your service personnel Real Time Clock Error High A An error occurred while initializing the real time clock Restoring Last Defaults Failed Low...

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Page 193: ...lectrical shock Do not touch the patient and any part of nonmedical equipment at the same time Some examples of non medical equipment are laser printers and nonmedical computers The responsible hospit...

Page 194: ...oxide 3 Isopropanol Isopropanol 70 1 Propanol 1 Propanol 50 Metrex CaviCide1TM Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride 0 28 Isopropanol 17 2 Virex II 256 Didecyl dimethyl ammoni...

Page 195: ...AF3 Germicidal Disposable Wipe n Alkyl dimethyl ethylbenzyl ammonium chlorides 0 14 n Alkyl dimethyl benzyl ammonium chlorides 0 14 PDI Sani Cloth Bleach Germicidal Disposable Wipe Sodium Hypochlorit...

Page 196: ...ent consult your hospital s regulations for cleaning the equipment Before cleaning the equipment make the following preparation Install the battery pack or battery tray and firmly close to seal the ba...

Page 197: ...on battery pack AA battery tray and AA batteries in any fluids As the battery compartment is not water proof do not contact the battery contacts when cleaning the equipment Do not hook the battery con...

Page 198: ...pO2 connector and SpO2 cable as shown below Clean or disinfect other parts only when needed or as required in your hospital s servicing schedule To clean and disinfect other parts follow this procedur...

Page 199: ...ries or supplies unless otherwise indicated in the instructions for use delivered with the products accessories or supplies 16 7 Impact of Improper Cleaning or Disinfection Using cleaning agents or di...

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Page 201: ...ual hospital employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards The safety checks or maintenance involvi...

Page 202: ...repaired or upgraded a thorough inspection should be performed by qualified service personnel to ensure the reliability Follow these guidelines when inspecting the devices Make sure that the environme...

Page 203: ...s or replacement of relevant component ECG verification Performance test 1 If the user suspects that the measure ment is incorrect 2 Following any repairs or replacement of relevant module 3 Once ever...

Page 204: ...te ECG 17 7 NIBP Accuracy Test The NIBP accuracy test is required at least once a year or when you doubt the measured NIBP result Contact your service personnel to perform NIBP accuracy test 17 8 NIBP...

Page 205: ...BeneVision TM80 Telemetry Monitor Operator s Manual 17 5 17 12Viewing System Information To view the system information of the telemetry monitor such as battery tap System Info from the main menu...

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Page 207: ...ies may cause damage to the monitor or not meet the claimed specifications Single use accessories are not designed to be reused Reuse may cause a risk of contamination and affect the measurement accur...

Page 208: ...00 3 Lead New Telemetry AHA Pinch 36 115 032954 00 3 Lead New Telemetry Disp AHA Snap 24 20 box Disposable PN Description Applicable property Applicable patient 009 004782 00 5 Lead New Telemetry AHA...

Page 209: ...atric PN Description Applicable property Applicable patient 040 003381 00 RD to LNCS adapter cable Masimo Reusable PN Description Applicable property Applicable patient 0600 00 0121 LNCS Adtx Adult Si...

Page 210: ...10 05161 Reusable SpO2 sensor finger clip Reusable Adult 9000 10 07308 Reusable Pediatric Infant SpO2 sensor with wraps Ped Infant Reusable Pediatric 0010 10 12476 Nellcor reusable D YS SpO2 sensor wi...

Page 211: ...ock TM80 energized from an internal electrical power source Central Charger Class I Degree of protection against electrical shock for the TM80 Type CF defibrillation proof for ECG and SpO2 Mode of ope...

Page 212: ...orage conditions Battery type AA batteries three Rechargeable lithium ion battery one Capacity for lithium ion battery 3500 mAh Charge time for lithium ion battery At the room temperature 5 hours to 9...

Page 213: ...The charger automatically stops charging when the lithium ion battery charge is full Size Weight TM80 126 mm 64 mm 23mm 140 g 30g without batteries SpO2 module ECG leadwires or accessories 230g 30g wi...

Page 214: ...equal to or greater than 1 minute Up to 200 events Up to two hour full disclosure waveforms of ECG I II III and V Va leads Speaker 1 Sound Pressure Range 45 dBA to 85 dBA Keys Nurse call 1 Power On O...

Page 215: ...ency 2402 MHz to 2480 MHz Channel spacing 2 MHz Wireless baud rate 1 Mbps Output power 2 5 mW Data Security Private protocol Data integrity Code error rate 1 Data latency Total delay of data transmiss...

Page 216: ...vices intercoms and cordless phones Communication interruption message When the bluetooth communication is interrupted the TM80 displays a prompt message Protocol IEEE 802 11 a b g n ac Modulation mod...

Page 217: ...over is automatically implemented when TM80 moves from the coverage area of AP1 to the coverage area of AP2 no network interruption alarm event will occur System capacity Number of the TM80s supported...

Page 218: ...ion recovers automatically Wireless networking stability The ratio of the communication data lost on center station from TM80 is less than 0 1 in 24 hours under the following circumstances When 16 TM8...

Page 219: ...0 25 5 mm mV 0 5 10 mm mV 1 20 mm mV 2 40 mm mV 4 Accuracy 5 Input signal range 8 mV peak to peak value Calibration signal 1 mV peak to peak value Accuracy 5 Differential input impedance 5 M Bandwidth...

Page 220: ...y 1 bpm or 1 whichever is greater Sensitivity 160 V accuracy range 0 16 mV to 0 21 mV HR averaging method In compliance with the requirements in Clause 201 7 9 2 9 101 b 3 of IEC60601 2 27 the followi...

Page 221: ...bpm Time to alarm for tachycardia Meets the requirements of IEC60601 2 27 Clause 201 7 9 2 9 101 b 6 Waveform B1h range 11 s B1 range 11 s B1d range 11 s B2h range 11 s B2 range 11 s B2d range 11 s ST...

Page 222: ...QT HR measurement range Adult 15 bpm to 150 bpm Pediatric 15 bpm to 180 bpm Resp Technique Trans thoracic impedance Lead Lead II Respiration excitation waveform 300 A RMS 32kHz 10 Baseline impedance r...

Page 223: ...against a laboratory CO Oximeter SpO2 accuracy was determined on 16 neonatal NICU patients ranging in age from 7 135 days old and weighing between 0 5 4 25 kg Seventy nine 79 data samples were collec...

Page 224: ...dy LNCS Adtx LNCS Pdtx RD SET Adt RD SET PDT LNCS DCI LNCS DCIP RD SET DCI Adult Pediatric Accuracy 3 0 bpm measured without motion 5 0 bpm measured with motion PI Measurement range 0 02 to 20 Least r...

Page 225: ...cy for Nellcor Sensors vs Co Oximeters Arms SpO2 Measurement range 0 to 100 Resolution 1 Accuracy 70 100 2 ABS 60 80 3 ABS 0 59 Not specified Data update rate 2s PR Measurement range 20 bpm to 300 pm...

Page 226: ...ion TM80 Telemetry Monitor Operator s Manual Modified Bland Altman for SpO2 DS 100A Sensor SpO2 SaO2 vs SaO2 Modified Bland Altman for SpO2 D YS OXI P I Sensors SpO2 SaO2 vs SaO2 D YS OXI P I 2 41 1 3...

Page 227: ...ed no closer than 20 cm to any part of the this device including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result The non ME EQUIPMENT e g I...

Page 228: ...ct the service personnel If the system is operated within the electromagnetic environment listed in Table Guidance and declaration electromagnetic immunity the system will provide the following essen...

Page 229: ...ith no false alarm Detect for connection The connection status shall be detected normally Wireless The system shall be able to detect network connection data transmission and caution for disconnection...

Page 230: ...wer quality should be that of a typical commercial or hospital environment If the user of our product requires continued operation during power mains interruptions it is recommended that our product b...

Page 231: ...s as determined by an electromagnetic site surveyb should be less than the compliance level in each frequency rangec Interference may occur in the vicinity of equipment marked with the following symbo...

Page 232: ...ency ranges 150 kHz to 80 MHz field strengths should be less than 3V m Recommended Separation Distances between Portable and Mobile RF Communications Equipment and This Equipment The equipment is inte...

Page 233: ...centered on If the installation distance is not enough obtain the written concurrence of the Director of the affected radio astronomy station before the equipment can be installed or oper ated RF par...

Page 234: ...rence The radio device used in this product is in compliance with the essential requirements and other relevant provisions of Directive 2014 53 EU Radio Equipment and Telecommunications Terminal Equip...

Page 235: ...minute C centigrade cc cubic centimeter cm centimeter dB decibel DS dyne second F fahrenheit g gram hr hour hPa hundred pascal Hz hertz in inch k kilo kg kilogram kPa kilopascal l litre lb pound m met...

Page 236: ...rovolt W watt minus percent per divide or power plus equal to less than greater than less than or equal to greater than or equal to plus or minus multiply copyright AAMI Association for Advancement of...

Page 237: ...lectrosurgical ESU electrosurgical unit HR heart rate HT height IEC International Electrotechnical Commission ISO International organization for standardization MRI magnetic resonance imaging LA L lef...

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