Page 1 BeneVision TM80 Telemetry Monitor Operator’s Manual...
Page 4 Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray intends to maintain the contents of this manual as confidential information.
Page 5 Manufacturer’s Responsibility Contents of this manual are subject to changes without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.
Page 6 Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.
Page 7 Company Contact Manufacturer: Shenzhen Mindray Bio-Medical Electronics 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: +86 755 26582680 EC-Representative: Shanghai International Holding Corp. GmbH (Europe) Address: Eiffestraβe 80, 20537 Hamburg, Germany Tel:...
Page 8 Preface Manual Purpose This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety.
Page 9: Table Of Contents
3.5 Using the Pouch ............................3 - 7 3.5.1 Securing the Pouch for TM80 ....................3 - 8 3.5.2 Securing Pouches for TM80 and BP10 ................. 3 - 9 4 Basic Operations ........................4 - 1 4.1 Overview ................................ 4 - 1 4.1.1 Display Screen ..........................
Page 10 6.5 Exiting the Standby Mode ........................6 - 4 6.6 Discharging the Patient ..........................6 - 4 6.6.1 Selecting the Discharge Patient Menu ................6 - 4 6.6.2 Restarting the TM80 ........................6 - 5 7 Alarms ............................7 - 1 7.1 Introduction ..............................7 - 1 7.2 Alarm Safety Information ........................
Page 11 7.5.1 Changing Alarm Properties ..................... 7 - 5 7.5.2 Changing the Alarm Volume ....................7 - 5 7.5.3 Initiating Auto Alarm Limits ....................7 - 5 7.5.4 Restoring Default Alarm Settings ..................7 - 6 7.6 Pausing Alarms ............................7 - 6 7.7 Resetting Alarms ............................
Page 12 8.8.2 Enabling ST Monitoring ......................8 - 25 8.8.3 Displaying ST Numerics ......................8 - 26 8.8.4 Configuring ST Alarm Settings .....................8 - 26 8.9 QT/QTc Interval Monitoring ........................8 - 28 8.9.1 QT/QTc Monitoring Limitations ...................8 - 28 8.9.2 Enabling QT/QTc Monitoring ....................8 - 29 8.9.3 Displaying QT/QTc Numerics and Segments ..............8 - 29 8.9.4 Configuring QT/QTc Alarm Settings ..................8 - 29 8.10 Relearning ..............................8 - 30...
Page 13 11.3.2 Unpairing via the BP10 ......................11 - 4 11.3.3 System Responses after Successful Unpairing .............11 - 4 11.4 Screen Display after Pairing a TM80 with a BP10 ...............11 - 4 11.5 Interactions after Pairing a TM80 with a BP10 ................11 - 5 11.5.1 Overview of Interactions ......................11 - 5...
Page 14 13.12.1 Confirm the Pairing of the Telemetry and the Monitor ........13 - 16 13.12.2 Unpair the Telemetry with the Monitor ..............13 - 16 14 Monitoring with the TM80 at the CMS ................14 - 1 14.1 Introduction .............................14 - 1 14.2 Network Safety Information .......................14 - 2...
Page 15 15.9.2 Disposing of the AA Batteries ....................15 - 6 Troubleshooting ......................16 - 1 16.1 General Problems ...........................16 - 1 16.2 Physiological Alarm Messages at the TM80 .................16 - 3 16.3 Technical Alarm Messages at the TM80 ..................16 - 7 Care and Cleaning ......................17 - 1 17.1 Introduction .............................17 - 1...
Page 16 19.1.1 ECG Electrodes .........................19 - 1 19.1.2 ECG Leadsets ..........................19 - 2 19.2 SpO2 Accessories ...........................19 - 3 19.2.1 Mindray SpO2 Sensor ......................19 - 3 19.2.2 Masimo SpO2 Module and Sensor ...................19 - 4 19.3 NIBP Accessories .............................19 - 4 19.4 Miscellaneous ............................19 - 4 A Product Specifications ......................
Page 17 C.6 Mains on Applied Part Leakage ......................C - 3 C.7 Patient Auxiliary Current .........................C - 3 D Electronic Interface ........................D - 1 E Symbols and Abbreviations .....................E - 1 E.1 Units ................................E - 1 E.2 Symbols ................................E - 2 E.3 Abbreviations ...............................
Page 19: Safety
The TM80 Telemetry Monitor must be operated by medical personnel in hospitals or medical institutions. • For continued safe use of the TM80 Telemetry Monitor, the instructions given in this manual must be followed. But instructions in this manual in no way supersede established medical procedures.
Page 20 The equipment will not function properly due to the strong magnetic and radio frequency fields generated by the MR scanner. • The TM80 Telemetry Monitor is intended to be used for a single patient at a time. • The TM80 Telemetry Monitor should not be used for primary monitoring in applications where momentary loss of the ECG is unacceptable at the Central Monitoring System.
Page 21: Cautions
• As the TM80 Telemetry Monitor transmits data wirelessly, there might be a risk of data loss. The TM80 Telemetry Monitor should not be used for primary monitoring in applications where momentary loss of the ECG is unacceptable at the Central Station.
Page 22: Notes
• If you wish to pair a TM80 Telemetry Monitor with a BeneVision N series patient monitor, contact your service personnel. For details about pairing and unpairing procedures, refer to BeneVision N Series Patient Monitor Operator's Manual.
Page 23: Equipment Symbols
• Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when needed. Equipment Symbols Symbol Description Symbol Description Power On/Off key Main menu key Nurse call key DEFIBRILLATION-PROOF TYPE CF APPLIED PART Standby Serial number Date of manufacture Manufacturer...
Page 24 Nurse call Black White Mandatory Blue White White action Warning Yellow Black Black NOTE • Some symbols may not appear on your equipment. 1 - 6...
Page 25: General Product Description
2.1.3 Intended Medical Conditions It must be operated by trained medical personnel in hospitals or medical institutions. 2.1.4 Intended Users The TM80 Telemetry Monitor must be operated by medical personnel in hospitals or medi- cal institutions. 2.1.5 Intended Patient Population The TM80 Telemetry Monitor is intended for use on ambulatory adult and pediatric patients.
Page 26: Applied Parts
The AP is used to bridge the telemetry monitor to the wired network. ■ TM80 The TM80 is used to monitor the patient's ECG, SpO2, NIBP, and Resp physiological data. ■ NIBP module NIBP module is used to measure, display, review, store the NIBP parameter for ambulating adult and pediatric patients, and transfer the information to other devices in this system.
Page 27: Key Features
Audio response for TM80 that is out of range or lost. ■ Communicates with the Central Station via WLAN. ■ Displays the battery gauge on the TM80 and at the Central Monitoring System (hereinafter called CMS) ■ Provides disposable and reusable pouches with clear front that closes securely...
Page 28: Components
Operator’s Manual and BeneVision Central Charger Opeartor’s Manual respectively. Physical View Display Activation (Power On/Off ) button ■ When the TM80 is powered off, pressing this button will turn it on. ■ When the TM80 is powered on: ◆ If the screen display is on, pressing this button will turn it off.
Page 29: Screen Display Status
TM80 and at the CMS, if networked connected. ■ If the TM80 is not connected to the CMS, the “No Central Monitoring” message will display in the prompt message area of the TM80. When the display of the TM80 is off: ■...
Page 30 The temperature of the display rises when the TM80’s display is on and the TM80 is connected to the CMS. If the display contacts the patient’s skin for a long time, skin burns may occur. Do not let the display directly touch the patient’s skin when the display is on.
Page 31: Getting Started
The TM80 shall be installed by Mindray authorized personnel. • The software copyright of the TM80 is solely owned by Mindray. No organization or individual shall resort to altering, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission.
Page 32: Unpacking And Checking
The operating environment of the TM80 should be reasonably free from noises, vibration, dust, corrosive, flammable and explosive substances. When the TM80 is moved from one place to another, condensation may occur as a result of temperature or humidity difference. In this case, never start the system before the condensation disappears.
Page 33: Preparation
Contact Mindray for any questions regarding the electromagnetic environment in the field where the TM80 is to be installed. Preparation 3.3.1 Connecting the ECG Leadwire To connect the ECG leadwire, follow this procedure: Align the ECG leadwire plug with the ECG connector as indicated by the arrow in the following figure.
Page 34: Installing The Batteries
◆ECG signal quality ◆Water resistance • Do not use the ECG leadwire to move or lift the TM80. This may cause the TM80 to fall, thus damaging the equipment or injure the patient. NOTE •...
Page 35 To install the rechargeable lithium-ion battery, follow this procedure: Lift up on both bottom sides of the battery compatment door to open the compart- ment. Remove the AA battery tray if present. Align the raised tab in the upper part of the lithium-ion battery with the cutout in the base of the battery compartment, as indicated by the enlarged figure below.
Page 36 NOTE • All batteries should be inserted in correct direction which matches the positive polarity mark + in the battery tray. Insert the AA battery tray. Align the raised tab in the upper part of the battery tray with the cutout in the base of the battery compartment, as indicated by the enlarged part in the following fig- ure.
Page 37: Powering On The Tm80
If the TM80 is turned on for the first time, the equipment will request you to configure first time startup. Please make your desired configurations as prompted. ■ If the TM80 is turned on next time, the equipment will prompt whether it is a new patient. Select [Yes] or [No] as desired. WARNING •...
Page 38: Securing The Pouch For Tm80
CAUTION • If a patient needs to take a shower, check the TM80 as described in Regular Check on Page 18-2 before showering, use the specified disposable pouch only, and secure the pouch on the patient as described in this section.
Page 39: Securing Pouches For Tm80 And Bp10
When a patient wears the pouches for the TM80 and BP10 simultaneously, follow steps in 3.5.1 Securing the Pouch for TM80 to secure the pouch for the TM80 on the patient’s waist and follow steps in BP10 NIBP Module Operator’s Manual to secure the pouch for the BP10 on the patient’s waist or arm.
Page 40 Wearing the disposable pouches Wearing the reusable pouches Wearing pouches with BP10 on the arm 3 - 10...
Page 41: Basic Operations
Basic Operations Overview This chapter gives you an overview of basic operations related to the TM80. The fundamental way of operating the telemetry monitor is through the touch screen.Almost all elements on the touch screen are interactive.Display elements include measurement numerics, information prompts, waveforms, quick keys, menus, and so on.
Page 42 : indicates that the alarm system is reset. MPAN indicator ◆ indicates that the TM80 is not paired with the BP10 or one TM80 is not connected to another TM80 for configuration transfer. ◆ indicates that the TM80 is paired with the BP10 successfully or configu ration transfer of the TM80 is in progress.
Page 43: On-Screen Keyboard
You may also tap this area to display the setup menu for the corresponding parameter/waveform. 4.1.2 On-Screen Keyboard The TM80 uses an on-screen keyboard to enter alphanumeric information, such as the device name and passwords. 4.1.2.1 Alphabetic Keyboard Alphabetic buttons: tap to input the desired alphabetic text.
Page 44: Understanding The Touch Screen Gestures
Space button: tap to input a space. Alphabetic switch button: tap to switch to the alphabetic keyboard. More punctuation buttons: tap to display the punctuation keyboard. Understanding the Touch Screen Gestures Before using the TM80, understand the supported touch screen gestures: Gesture Action Description Briefly touch the surface with your fingertip to select a target.
Page 45: Understanding The Screen Display Orientation
: exits the current menu and returns to the previous menu or the main screen. 4.3.2 Understanding the Screen Display Orientation The TM80 supports both the portrait and landscape display orientations. 4 - 5...
Page 46: Browsing The Screen Display
• The methods given in this section only change the screen display orientation temporarily. Once the TM80 is restarted, the default display orientation will apply. To set the default screen display orientation, refer to Configuring the Default Display Orientation on Page 5-1.
Page 47: Displaying The Quick Keys Area
Telemetry Mode close attention to the patient's status on the patient’s side. In this case, tap [Monitor Mode]. Then, the TM80's display is always on and alarms are issued locally. If the patient returns to the department area, tap [Telemetry Mode].
Page 48: Turning The Display On
General Menu on Page 13-1. NOTE • While the display is off, the TM80 enters the power saving mode, and does not provide audio or visual alarms. • If the telemetry monitor is not connected to the CMS or lethal arrhythmia alarm occurs, the telemetry monitor’s display is automatically turned on and it will...
Page 49 WARNING • Do not rely exclusively on the nurse call function. The medical personnel should also pay close attention to the patient’s condition. For details about how to trigger a nurse call, refer to Physical View on Page 2-4. 4 - 9...
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Page 51: User Configurations
For details about the display orientation, refer to Understanding the Screen Display Orientation on Page 4-5. NOTE • The TM80 must be restarted for the default display orientation selected to be effective. • Once the default display orientation takes effective, you can switch the display orientation by following steps in Switching the Screen Display Orientation on Page 4-6.
Page 52: Understanding Portrait Orientation Display Rules
5.2.3 Understanding Portrait Orientation Display Rules In portrait orientation, both digital and waveform areas take up the entire width of the screen. Therefore, these parameters will be displayed in the exact order set in the [Display Setup] menu. 5.2.4 Configuring the Portrait Display To configure the portrait display, follow this procedure: In the [Portrait] section of the [Display Setup] menu, tap [Rows].
Page 53: Configuring The Landscape Display
History ECG II ECG V Pleth Resp ECG1 ECGIII ECG aVR ECG aVL ECG aVF The landscape layout displays as follows: Resp NIBP HISTORY ECG II ECG V Pleth Resp ECG I ECG III ECG aVR ECG aVL ECG aVF Bold is displaying on screen;...
Page 54: Configuring The Display Brightness
It indicates that the alarm sound is turned off. • When your TM80 is connected to the CMS and [Sounds] is turned off, [Sounds] automatically changes to [2] if the CMS is disconnected. 5 - 4...
Page 55: Patient Management
Introduction The chapter describes how to admit a patient, change patient information, enter and exit the Standby mode, and discharge the patient at the TM80. Admitting a Patient After discharging the current patient, you can admit a new patient by pressing .
Page 56: Changing The Paced Status
If the paced status setting is not correct, tap [Paced] and select the correct option. ◆ When [Paced] is set to [Yes] at the TM80, if pace pulses are detected, the symbol displays in the waveform area of the Central Monitoring System’s screen, and the pace pulse marks will display on the ECG waveform both at the TM80 and Central Station.
Page 57: Changing The Department Name, Room Number, And Bed Number
NOTE • After a TM80 is connected to the Central Station, when it enters or exits Standby mode, the Central Station is also notified to enter or exit Standby mode. Refer to BeneVision Central Monitoring System Operator’s Manual for details.
Page 58: Exiting The Standby Mode
Discharging the patient will stop monitoring at the TM80 and CMS. After discharging the patient, the patient’s configuration is cleared at the TM80. The TM80 can admit next new patient by applying the user configuration. If the TM80 does not save the user configuration, it will apply the factory configuration for the new patient.
Page 59: Restarting The Tm80
→tap [Discharge Patient]. Press In the [Discharge Patient] confirmation menu, tap [Yes]. ◆ The patient is discharged from both the TM80 and the CMS. ◆ The patient’s configuration is cleared and the default departmental settings are restored.
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Page 61: Alarms
• When the alarm sound is switched off, the TM80 gives no alarm tones even if a new alarm occurs. Be careful when considering to switch off the alarm sound. When the alarms are off, observe the patient frequently.
Page 62: Understanding The Alarms
Low priority alarms require you to be aware of this condition. ■ Messages: provides additional information on the patient or the equipment. 7.3.3 Alarm Indicators When an alarm occurs, the TM80 indicates it through visual or audible alarm indications. For more information, see the following table. Medium High Priority...
Page 63 NOTE • When multiple alarms of different priority levels occur simultaneously, the TM80 selects the highest priority alarm to light the alarm lamp and issue the alarm tone, 7 - 3...
Page 64: Alarm Status Symbols
: indicates that the alarm system is reset. Viewing Alarms If the TM80 has more than one alarm, you can view all the active alarms in the [Alarm List]. To view alarms, follow this procedure: Tap the prompt message area on the main screen. The [Alarm List] dialog is displayed.
Page 65: Changing Alarm Settings
In the [Priority] section, set the desired alarm priority. NOTE • Any changes to the alarm properties on the TM80 will change alarms on the CMS and vice versa if configured. 7.5.2 Changing the Alarm Volume For information on changing the alarm volume, see Configuring the Audio Volume on Page 5-4.
Page 66: Restoring Default Alarm Settings
In the dialog that pops up, tap [OK]. Then the TM80 will automatically calculate alarm limits based on the latest measured values. Before applying these automatically created alarm limits, confirm if they are appropriate for your patient from the Limits menu. If not, you can adjust them manually.
Page 67: Resetting Alarms
When the TM80 is connected to the CMS and the function of remotely pausing alarms is enabled at the CMS, alarms can be paused either at the TM80 or at the CMS. For information on pausing alarms at the CMS, refer to BeneVision Central Monitoring System Operator’s Manual.
Page 68: Resetting Physiological Alarms
Latching Alarms When physiological alarms are latched, the time when the alarm is last triggered is displayed behind the alarm message. Resetting or pausing alarms via the TM80 or the CMS clears latched alarms. NOTE •...
Page 69: Actions When An Alarm Occurs
For more information, refer to Troubleshooting on Page 16-1. 7.10 Operator’s Position The TM80 is designed that the operator can identify the alarm condition and priority from a distance of four meters, and can identify specific alarm details from a distance of one meter.
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Page 71: Monitoring Ecg, Arrhythmia, St And Qt
Operations such as configuring the QRS threshold, adjusting the ST point/ISO point/J point, configuring the ST template/QT template are performed at the CMS. For details about these operations, refer to Monitoring with the TM80 at the CMS on Page 14-1. ECG Safety Information WARNING •...
Page 72: Preparation For Monitoring Ecg
NOTE • After defibrillation, the waveform recovers within 10 seconds applied in accordance with the manufacturer’s instructions for use. Preparation for Monitoring ECG 8.3.1 Preparing the Patient’s Skin Proper skin preparation is essential in obtaining an accurate ECG reading. Electrode sites should be clean and dry and should provide a smooth flat surface.
Page 73: Configuring The Ecg Lead Labeling
electrodes. ECG electrodes may need to be repositioned and the ECG lead viewed may need to be adjusted until the optimum ECG tracing is obtained. To position the electrodes, follow this procedure: Peel the backing off of the electrode. Visually inspect the contact gel medium for moistness.
Page 74: Placing The Electrodes
P wave or the T wave. If the R wave is not significantly larger than other lower voltage waves on the ECG tracing, the TM80 may have some difficulty in identifying the appropriate waves. For some patients, you need to adjust electrode placement and/or the viewed ECG lead to obtain a significant R wave.
Page 75 8.3.4.1 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: RA (R) LA (L) LL (F) Electrode Placement RA (white) R (red) At the patient's 2nd ICS midclavicular line to the right of the sternum.
Page 76 8.3.4.2 Standard 5-Leadwire Electrode Placement A 5-wire lead set can monitor seven ECG vectors (I, II, III, aVR, aVL, aVF, and V) simultaneously. The recommended 5-wire lead placement is as follows: RA (R) LA (L) V(C) LL (F) RL (N) Electrode Placement RA (white) R (red)
Page 77 (C6) positions shown in the chest electrode diagram below. The default position of Va and Ca is V1 and C1 respectively. The default position 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.
Page 78: Checking The Lead Placement
Electrode Placement V1 (brown) C1 (white) On the fourth intercostal space at the right border of sternal. V2 (brown) C2 (white) On the fourth intercostal space at the left border of sternal. V3 (brown) C3 (white) Midway between V2 and V4. V4 (brown) C4 (white) On the fifth intercostal space...
Page 79: Checking The Paced Status
8.3.5.2 Understanding the Lead Placement Instructions The [Lead Placement] window indicates the lead status. Information bar Lead on indicator Lead off indicator Example lead placement window When any of the leads are off, the indications are as follows: ■ The lead off message displays on the information bar. The background color of the information bar corresponds to the alarm priority.
Page 80: Maintaining Quality Ecg Signal
8.3.7 Maintaining Quality ECG Signal Regardless of patient age, electrodes should be replaced at least every 24 hours to maintain quality signals during long-term monitoring. Over the course of 24 hours, the electrode gel will start to dry out and the adhesive will age.
Page 81: Ecg Leadwire Types
Options Description Settings* Filter Selects the ECG filter. Monitor, ST ■ Monitor Used under normal measurement conditions. ■ Used when ST monitoring is applied. Color Selects the color of ECG numeric data 16 colors and waveform. The default color is green. The factory default settings are in bold.
Page 82: Configuring The Pacer
Options Description Settings* All Lead Size Selects the waveform size for all the 1.25 mm/mV, 2.5 mm/mV, 5 leads. mm/mV, 10 mm/mV, 20 mm/ mV, 40 mm/mV, Auto To set the waveform size for a specific lead, select that lead from the [Waveform Size] field.
Page 83: Configuring The Ecg Waveform Size
NOTE • When [Paced] is set to [Yes], the [Markers] option can be available. 8.4.6 Configuring the ECG Waveform Size The [Waveform Size] field of the [ECG] menu lists all available leads. You can select the desired ECG lead to set the waveform size. For details about the waveform size setting, refer to Configuring ECG Waveforms on Page 8-11.
Page 84: Configuring The Notch Filter
In most cases, the HR and PR numerics are identical. In order to avoid simultaneous alarms on HR and PR, the TM80 uses either HR or PR as its active alarm source. To change the alarm source, follow this procedure: In the [Parameter Setup] section of the [ECG] menu, tap [HR].
Page 85: About The Hr Digital Area
NOTE • Both the HR value displayed on the TM80’s main screen and that at the Central Station can meet relevant standards and are reliable. HR trended, alarm checking, and arrhythmia are based on the HR calculated at the Central Station.
Page 86: Arrhythmia Monitoring
Arrhythmia Monitoring Arrhythmia monitoring is intended for adult and pediatric patients. 8.7.1 Arrhythmia Safety Information WARNING • Heart rate reading may be affected by cardiac arrhythmias. Do not rely entirely on heart rate alarms when monitoring patients with arrhythmia. Always keep these patients under close surveillance.
Page 87: Arrhythmia Events
8.7.2 Arrhythmia Events This section lists all arrhythmia events and their criteria. 8.7.2.1 Lethal Arrhythmia Events Arrhythmia message Description Asystole No QRS complex detected within the set time interval in the absence of ventricular fibrillation or chaotic signal. V-Fib/V-Tach A fibrillatory wave for 6 consecutive seconds. A dominant rhythm of adjacent PVCs and the ventricular rate is greater than the V-Tach rate limit.
Page 88: Changing Arrhythmia Alarm Settings
Pacer Not Capture No QRS complex detected for 300 ms following a pace pulse (for paced patients only). Pacer Not Pacing No pace pulse detected for 1.75 x average R-to-R intervals following a QRS complex (for paced patients only). Missed Beats At least 3 consecutive Ns, and The current RR interval is greater than 1.5 x previous RR interval, The next RR interval is lower than 1.5 x average RR interval, and...
Page 89 ◆ [All On]：switches on all arrhythmia alarms. ◆ [All Off ]：switches off all arrhythmia alarms. This button becomes inactive when [Lethal Arrhy Alarms Off ] is disabled in the System Setup menu of the CMS. ◆ [Lethals Only]: switches on all the lethal arrhythmia alarms only. Other types of arrhythmia alarms are off.
Page 90 Options Description Settings* Vent Brady Configures On, Off arrhythmia alarms. V-Brady PVCs:3 beats to 99 beats; the default is [5 beats]. V-Brady Rate: 15 bpm to 60 bpm; the default is [40 bpm]. Alarm priority: High Extreme Tachy On, Off Extreme Tachy: 61 bpm to 300 bpm;...
Page 91 Options Description Settings* Bigeminy Configures On, Off arrhythmia alarms. Alarm priority: Prompt, Low, Med, High Trigeminy On, Off Alarm priority: Prompt, Low, Med, High Tachy On, Off 60 bpm to 299 bpm; the default Tachy threshold is consistent with the HR alarm high limit.
Page 92 NOTE • The priority of lethal arrhythmia alarms is always high. • When the TM80 is connected to the CMS, any changes made either at the TM80 or the CMS will be communicated to the other side. • symbol is When lethal arrhythmia alarms are set to Disable at the CMS, the displayed on the lethal arrhythmia alarms at the TM80.
Page 93: Arrhythmia Alarms Timeout
8.7.4 Arrhythmia Alarms Timeout The monitor generally issures an alarm once an arrhythmia condition is detected. However, in some conditions, alarm light and alarm tone are disabled although the arrhythmia condition is detected. 8.7.4.1 Arrhythmia Alarm Chains If multiple alarms overlap, announcing all of the detected alarm conditions would be confusing, and a more serious condition might be overlooked.
Page 94 NOTE • For the following alarms, alarm light and alarm tone cannot be disabled: HR high, HR low, Tachycardia, Bradycardia, Afib End, Irr. Rhythm End. • The timeout period is only applicable to the alarms in the medium priority chains and atrial fibrillation chain. For the alarms in the high priority chain, alarm tone and alarm light are presented as soon as the alarm condition is detected.
Page 95: Understanding The Arrhythmia Display
ST segment analysis is intended for adult and pediatric patients. When the TM80 is connected to the CMS, you can adjust ST points, enter the ST graphic window and the ST view at the CMS. For more information, refer to ST Monitoring on Page 14-6.
Page 96: Displaying St Numerics
■ The patient is implanted with a ventricular pacemaker. ■ The patient has left bundle branch block. ■ Arrhythmias such as atrial fibrillation or flutter occur, which may cause irregular baseline. ■ All ECG leads are noisy. 8.8.3 Displaying ST Numerics When [ST Analysis] is switched on, ST digital area is displayed on the screen.
Page 97 In the [Setup] section, tap [ST Alarm Mode] and then select the desired mode: ◆ Absolute]: you can separately set the alarm properties for each ST alarm. After selecting this option, the [ ] option is displayed Auto Limits where you can initiate auto adjustment of alarm limits. ◆...
Page 98: Qt/Qtc Interval Monitoring
QT/QTc interval monitoring is intended for adult and pediatric patients. When the TM80 is connected to the CMS, you can set the QTc formula and enter the QT view at the CMS. For more information, refer to QT Monitoring on Page 14-3.
Page 99: Enabling Qt/Qtc Monitoring
8.9.2 Enabling QT/QTc Monitoring The QT monitoring function is disabled by default. Before you start QT monitoring, enable the QT function. To do so, follow this procedure: On the main screen, tap the HR digital area or ECG waveform area to enter the [ECG] menu.
Page 100: Relearning
8.10 Relearning Changes in ECG beat morphology could result in incorrect arrhythmia alarms and/or inaccurate heart rate. ECG relearning allows the TM80 to learn the new dominant beat morphology and thus reduce false arrhythmia alarms and inaccurate HR values. Once learning is complete, the dominant QRS complex is stored as a reference template.
Page 101: Automatically Initiating An Ecg Relearning
8.10.1 Automatically Initiating an 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 paced status is changed. ■...
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Page 103: Monitoring Respiration (Resp) (Optional)
Monitoring Respiration (Resp) (Optional) Introduction Impedance respiration is measured across the thorax. When the patient is breathing or ventilated, the volume of air changes in the lungs, resulting in impedance changes between the electrodes. Respiration rate (RR) is calculated from these impedance changes, and a respiration waveform appears on the screen.
Page 104: Changing Resp Settings
For more information, see.8.3.4.1 Standard 3-Leadwire Electrode Placement. RA (R) LL (F) Lead II CAUTION • To reduce cardiovascular artifact, apply the respiration electrodes so that the liver area and the ventricles of the heart are not in the line between the respiratory electrodes.
Page 105: Enabling/Disabling The Resp Functionality
In the [Setup] section of the [Resp] menu, select the options described in the follow- ing table. Options Description Settings* NCM Alarm Delay The TM80 will trigger the “No Chest 10s, 15s, 20s, 25s, 30s, 35s, 40s Movement” alarm if the patient has stopped breathing for longer than the set apnea time. Color...
Page 106: Configuring Resp Alarm Settings
In the [Waveform] section of the[Resp] menu, select the options described in the fol- lowing table. Options Description Settings* Gain Selects the waveform size. x0.25, x 0.5, x 1, x2, x3, x4, x5 Speed Selects the waveform sweep speed. 3mm/s, 6.25 mm/s, 12.5 mm/s, 25 mm/s The factory default settings are in bold.
Page 107: Understanding The Resp Display
When the TM80 is connected to the Central Monitoring System, switching on or off this option at the Central Monitoring System also switches it on or off at the TM80, and vice versa. After tapping this option, you can configure the alarm priority.
Page 108: Resp Waveform Area
9.5.3 Resp Waveform Area Resp lead label Resp waveform Resp waveform gain 9.5.4 About the Resp Waveform Area ■ The Resp waveform, lead label, and waveform gain display in the configured Resp color. ■ The Resp waveform area scrolls the waveform at the configured sweep speed. 9 - 6...
Page 109: Monitoring Pulse Oxygen Saturation (Spo2) (Optional)
SpO and pulse rate. The TM80 can be configured with Mindray SpO2 module or Masimo SpO2 module. NOTE • The TM80 is calibrated to display functional oxygen saturation.
Page 110 • Change the application site or replace the sensor and/or patient cable when a persistent SpO2 Low Signal Quality message is displayed on the equipment. These messages may indicate that patient monitoring time is exhausted on the patient cable or sensor. •...
Page 111: Measurement Limitations
10.3 Measurement Limitations The following factors may influence the accuracy of SpO measurement: Patient physiological characteristics: ■ ◆ Cardiac arrest ◆ Hypotension ◆ Darkly pigmented skin ◆ Shock ◆ Severe vasoconstriction ◆ Hypothermia ◆ Severe anemia ◆ Ventricular septal defects (VSDs) ◆...
Page 112 SpO connector in the TM80. To disconnect the SpO module from the TM80, pinch the left and right sides near the helix parts circled in red (as shown below) on the SpO module cable and pull the SpO module out horizontally.
Page 113 Small red circle module sensor connector sensor Masimo SpO module 10.5 Changing SpO Settings You can change SpO settings from the [SpO ] menu. 10.5.1 Entering the SpO Menu Enter the [SpO ] menu in either of the following ways: ■...
Page 114 Options Description Settings* Display PI Configures whether or not to show the On, Off perfusion index (PI) value in the digital area. The perfusion index allows clinicians to assess the pulse strength at the monitoring site for optimal sensor placement. PI indicates the percentage of pulsatile signal to non pulsatile signal.
Page 115 Options Description Settings* Sensitivity Selects the sensitivity mode depending upon High, Normal, and APOD 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 even the weakest of signals.
Page 116 Options Description Settings* Averaging The user-selectable averaging feature allows 2-4 sec, 4-6 sec, 8 sec, 10 the clinician to select the desired level of sec, 12 sec, 14 sec, 16 sec visibility to subtle variations in the measured value. Depending on the patient acuity and area of care, shorter averaging times are sometimes preferred (sleep testing) over longer averaging times (telemetry) and vice-...
Page 117 10.5.3 Configuring the SpO Waveform To configure the SpO waveform, follow this procedure: In the [Waveform] section of the [SpO ] menu, select the options described in the following table. Options Description Settings* Speed Selects the SpO pleth waveform speed. 6.25 mm/s, 12.5 mm/s, 25 mm/s Display SIQ...
Page 118: Performing Spo2 Measurement
Options Description Settings* Alarm Setup Configures whether to switch on SpO For SpO Desat alarms. [SpO ] and [Desat] Alarm switch: On, Off default to be switched on. After tapping [SpO ] or [Desat] you can Alarm limit range: configure alarm limits and alarm priority. 1% to 100%;...
Page 119: Applying The Sensor
Apply the sensor to the patient. Connect the sensor to the SpO module and the SpO module to the TM80. The SpO measurement displays when the TM80 detects that a sensor is connected to the patient. WARNING • When equipped with Mindray SpO...
Page 120: Understanding The Spo2 Display
10.7 Understanding the SpO Display 10.7.1 SpO Digital Area Mindray SpO digital area (for portrait display) Masimo SpO digital area (for portrait display) Parameter name value Perfusion indicator Perfusion index (PI) label Perfusion index value: gives the numerical value for the pulsatile portion of the mea- sured signal caused by arterial pulsation.
Page 121: About The Spo2 Digital Area
Alarm high limit and low limit.When SpO alarm is switched off, the alarm off symbol instead of alarm limits is displayed. 10.7.2 About the SpO Digital Area ■ The SpO digital area displays in units of % with a resolution of 1%. ■...
Page 122: Masimo Information
■ If using Masimo SpO2, the Signal Quality Index (SIQ) will display below the waveform if enabled. 10.8 Masimo Information Masimo Patents This posting serves as notice under 35 U.S.C.§287(a) for Masimo patents: http:// www.masimo.com/patents.htm. No Implied 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 device, fall within the scope of one or more of the patents relating to this device.
Page 123: Monitoring Noninvasive Blood Pressure (Nibp) (Optional)
When the TM80 is paired with the BP10, measured NIBP data and NIBP-related technical alarms will be transferred from the BP10 to the TM80. You can view NIBP data and NIBP- related technical alarms and physiological alarms on the TM80’s screen.
Page 124: System Responses After Successful Pairing
Tap [Start] to start NIBP measurement. Verify that the NIBP measurement results dis- played at the BP10 are consistent with that displayed on the main screen of the TM80 and are the data for the same patient. WARNING • Before pairing a BP10 with a new TM80, unpair it with the current TM80 first.
Page 125: Unpairing The Tm80 With The Bp10
You can unpair the TM80 with the BP10 either via the TM80 or via the BP10. 11.3.1 Unpairing via the TM80 You can choose either of the two methods to unpair the TM80 with the BP10 via the TM80. Option 1: Press to enter the main menu of the TM80.
Page 126: Unpairing Via The Bp10
• Before moving a TM80 or BP10 to another area, unpair them first. • Before admitting a new patient at a BP10, you need to unpair it with a TM80 first. • When the “MPAN Disconnected” message is displayed, medical staff should pay close attention to the patient’s status.
Page 127: Interactions After Pairing A Tm80 With A Bp10
NIBP measurement history area: displays NIBP measurement history information. 11.5 Interactions after Pairing a TM80 with a BP10 11.5.1 Overview of Interactions Once a TM80 is paired successfully with a BP10, the interactions proceed as shown below. Action At the TM80...
Page 128: Operating The Bp10 Via The Tm80
Set venipuncture Set the cuff pressure for venipuncture 11.5.2 Operating the BP10 via the TM80 When the TM80 is paired successfully with the BP10, you can enter the [NIBP] menu in either of the following ways: ■ On the main screen, tap the NIBP digital area.
Page 129: Configuring Nibp Alarm Settings
Options Description Settings* Initial Pressure Configures the initial cuff pressure. For adult: 80 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 16 colors data.
Page 130 Options Description Settings* Configures whether to trigger On, Off the NIBP diastolic pressure Alarm high limit: alarm. • For adult: Range: (low limit + 5) to 249 Default value: 90 • For pediatric: Range: (low limit + 5) to 199 Default: 70 Alarm low limit: •...
Page 131 Options Description Settings* Configures whether to trigger On, Off Extreme the extreme NIBP systolic Alarm high limit: pressure alarm. • For adult: Range: (SYS high limit + 5) to 290 Default value: 175 • For pediatric: Range: (SYS high limit +5) to 240 Default: 130 Alarm low limit: •...
Page 132 Options Description Settings* Configures whether to trigger On, Off Extreme the extreme NIBP mean Alarm high limit: pressure alarm. • For adult: Range: (MAP high limit + 5) to 260 Default value: 125 • For pediatric: Range: (MAP high limit + 5) to 215 Default: 100 Alarm low limit: •...
Page 133: Review
Review 12.1 Introduction You can review patients’ history data on the tabular trends review page and the events review page. 12.2 Tabular Trends Review Page The tabular trends review page displays trend data in a tabular form. 12.2.1 Entering the Tabular Trends Review Page Enter the tabular trends review page in either of the following ways.
Page 134 Current system date and trend data time. The interval of the trend data time is dependent on the option selected for [Interval]. Digital area: displays numeric values at the cursor indicated time. The background color of numeric values indicates the alarm priority. ◆...
Page 135: Example Tabular Trends Data Search Page
Next event button: tapping this button locates the next event. Previous event button: tapping this button locates the previous event. Interval setup button: tapping this button opens the [Interval] menu. For more information regarding this menu, refer to Changing the Resolution of Trend Data on Page 12-4.
Page 136: Changing The Resolution Of Trend Data
Earlier events will be overwritten by later ones if the capacity is reached. • When the TM80 is connected to the CMS, if events of the TM80 are deleted from the CMS, they will not be deleted from the TM80 and vice versa.
Page 137: Example Events Review Page
• Alarms are saved as events and will be maintained if the equipment is powered down. The time of equipment power down is not recorded as an event and cannot be reviewed. • Earlier events will be overwritten by later ones if the storage capacity is reached.
Page 138: Example Event Details Page
12.3.3 Example Event Details Page After selecting the desired event overview area, you can view the event details. ■ For manual events, you can view all the monitored waveforms 16 seconds before and after the event trigger time and all the measurement numerics at the event trigger time.
Page 139: Configuring The Tm80
Configuring the TM80 13.1 Introduction The [Maintenance] menu provides access to the system settings such as location, device name, alarm settings, quick keys, screen lock, and passcode updates. Entering this menu requires a passcode. 13.2 Entering the Maintenance Menu To enter the [Maintenance] menu, follow this procedure: Press to enter the main menu.
Page 140: Configuring Device Location
NOTE • Mindray recommends the same SpO tone mode be used for the TM80 within a monitoring area. 13.3.1 Configuring Device Location You can change and set whether to allow modifying a department name, device location room number, and bed number in the [Patient Info] menu.
Page 141: Configuring The Alarms Menu
◆ [Fixed]: 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. Tap [Bed No./Room No.]. Select the desired option.
Page 142 NOTE • When [Minimum Alarm Volume] is set to [Off] and [Sounds] is set to 0, alarm sound is turned off, the TM80 will not enunciate alarms when they occur. Be careful when turning off the alarm sound. • Do not exclusively rely on audible alarms for patient monitoring. Adjusting alarm volume to a low level or turning off alarm sound may result in patient hazards.Keep patients under close surveillance.
Page 143: Quick Keys Menu
13.5 Quick Keys Menu 13.5.1 Changing the Quick Keys To change quick keys, follow this procedure: In the [Maintenance] menu, tap [Quick Keys]. The [Quick Keys] configuration menu displays. From the quick keys area at the bottom of the screen, tap a quick key you want to configure.
Page 144: Deleting A Quick Key
13.6 Configuring the Network Menu The wireless module used in the TM80 is in compliance with IEEE 802.11 a/b/g/n/ac. In the [Network] menu, you can configure the network and connect the TM80 to the BeneVision Central Monitoring System via the wireless network.
Page 145: Configuring Ip Settings
The CMS is capable of connecting up to 16 Telemetry Monitors via the wireless network. 13.6.1 Configuring IP Settings The TM80 provides two ways to get IP address: Dynamic Host Configuration Protocol (DHCP) and Static IP address. To configure IP settings, follow this procedure: In the [Network] menu, tap [IP Address Setup].
Page 146: Configuring Wlan Settings
• We recommend that the WPA2-PSK or WPA2 CCKM security mode be used when the TM80 is in use. It provides a strong method of security when used with rotating strong passwords. Besides, it can provide optimal mobility and connectivity performance.
Page 147: Configuring Cms Connection
13.6.3 Configuring CMS Connection You can connect the TM80 to the CMS in multicast or unicast mode. 13.6.3.1Connecting the CMS in Multicast Mode To connect the CMS in multicast mode, follow this procedure: In the [Network] menu, tap [Connect CMS].
Page 148: Selecting A Cms
Tap [Confirm] to apply the settings and exit the [Connect CMS] menu. 13.6.4 Selecting a CMS When you connect the TM80 to the CMS in unicast mode, you can select a CMS by one of the following ways: Select [Select CMS] from the [Connect CMS] menu. For details, refer to ■...
Page 149: Eap Certificate Management
13.6.6 EAP Certificate Management Certificates can be imported into the TM80 or deleted from the TM80. 13.6.6.1Importing Certificates Up to 10 certificates can be imported from a USB drive. Only authorized personnel can import certificates. 13.6.6.2Deleting Certificates To delete a certificate, follow this procedure: →...
Page 150: Transferring A Configuration
“Complete” message will be displayed on the TM80 A’s screen. ■ If the import fails, the “Import attempt failed. ” message will be displayed on the TM80 B’s screen. The “Failure” message will be displayed in the prompt message list of TM80 A’s screen.
Page 151: Screen Lock Menu
TM80 enters corresponding screen lock mode when its display is turned off. 13.8.1 Understanding the Screen Lock Mode The Locked and View Only modes assist in preventing unauthorized use of the TM80. Each mode allows you to access certain features of the device after entering a passcode. When the correct passcode is entered, all features are available.
Page 152: Changing The Screen Lock Mode
Use the on-screen keyboard to input the device name. Tap [Accept] to save the setting and exit the [Device Name] menu. NOTE • Every TM80 should have a different device name. 13.11 Auto Enter Monitor Mode Auto Enter Monitor Mode 13.11.1Understanding Auto Enter Monitor Mode allows the telemetry monitor to switch from telemetry mode to monitor mode when No Central Monitoring or Lethal Arrhy.
Page 153 To configure Auto Enter Monitor Mode, follow this procedure: In the Maintenance menu, tap Auto Enter Monitor Mode. Choose the desired option: ◆ No Central Monitoring: When disconnected from the CMS, the telemetry monitor switches from telemetry mode to monitor mode and displays no central monitoring alarm.
Page 154: Using With A Patient Monitor
13.12 Using with a Patient Monitor You can connect a telemetry monitor (hereinafter called the telemetry) with the N series monitor (hereinafter called the monitor) to measure the ECG, Resp, SpO , and NIBP of ambulatory adult and pediatric patients. The process of connecting the telemetry and the monitor is called "pairing”.
Page 155: Monitoring With The Tm80 At The Cms
The department is modified at the TM80 and corresponding department configurations are available at the CMS. The configurations will be saved as user configurations at the TM80. They will be automatically loaded when a patient category is changed or a patient is discharged at the TM80.
Page 156: Network Safety Information
• It is not recommended to assign a TM80 to a department in the [Configuration] tab of the CMS. 14.2 Network Safety Information CAUTION • Wireless network designing, deploying, debugging, and maintenance should be executed by Mindray service personnel or authorized technicians.
Page 157: Qt Monitoring
• If QRS amplitude is low, the TM80 might not be able to calculate heart rate and false asystole may occur. 14.4 QT Monitoring A normal ECG waveform (as shown in the following figure) typically includes a sharp and well defined QRS complexes with consistent spacing between R waves, and an ECG baseline that is free of noise and artifact.
Page 158 Select the [QT] tab. Select [QT View] at the bottom of the [QT] menu. The [QT View] menu displays, as shown in the following figure: ■ The current waveform and parameter values display in green. ■ The template waveform and parameter values display in white. ■...
Page 159: St Monitoring
Buttons Description Settings* Left or right arrow Select the desired lead to display on the II, I, III, aVR, aVL, aVF, V [QT View menu screen by selecting the Note: the leads here serve as an left or right arrow. example only.
Page 160: Adjusting St Measurement Points
ST deviation is the vertical distance between the isoelectric (ISO) point level and signal level at ST point. The ISO point is located between the end of the P-wave and the onset of the QRS complex. The ISO point provides the baseline for ST deviation measurement. The ST point is a fixed distance from the J point at the end of the QRS complex.
Page 161: Entering The St Graphic Window
Select the [ST] tab. Select the [Adjust] section. Set [ST Point]. Enable or disable [Auto Adjust]. This option defines the method of adjusting the ISO point and J point. ◆ Enabled: It is enabled by default. In this case, positions of ISO point and J point are automatically adjusted accordingly.
Page 162: Entering The St View
14.5.3 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 the color of ECG waveforms, normally green. The color of baseline ST segments and ST values is white. To enter the ST View, follow this procedure: On the ViewBed screen of the CMS, select the ECG digital area or waveform area to enter the [ECG] menu.
Page 163 To configure the threshold of PVC-related alarm threshold, follow this procedure: On the ViewBed screen of the CMS, select the ECG digital area or waveform area to enter the [ECG] menu. Select the [Arrhythmia] tab. Select the [More Threshold] section. Set the desired items using the right or left arrow.
Page 164: Configuring The Arrhythmia Shield Time
14.8 Sending a Notification to the TM80 You can send a notification to the TM80 to remind a patient to perform certain activity such as taking medicine. To send a notification, follow this procedure:...
Page 165: Triggering An Alarm Reminding Patients' Location
Enter a notification into the pop-up window. Select [Send]. This message will be sent to the corresponding TM80 and displayed on the main screen of this TM80. If you wish to confirm the notification, tap [Confirm] at the TM80. 14.9 Triggering an Alarm Reminding Patients' Location You can enable the functionality of triggering an alarm when patients enter or move out of the restricted area at the CMS.
Page 166 Select the system menu area in the upper left corner of the CMS screen. Select System Setup to access the System Setup menu. Select the Telemetry tab→ Authorization Setup. Select the desired option: ◆ No Password: the setting is allowed and not password protected on the telemetry monitor.
Page 167: Battery
Battery 15.1 Introduction The TM80 can be powered by a lithium-ion rechargeable battery or AA batteries. This chapter provides instructions on how to use, maintain, and dispose of the batteries. For how to use, maintain, and dispose of the batteries used for BP10, refer to BP10 NIBP Module Operator’s Manual.
Page 168: Installing The Battery
In case of battery leakage, use caution to remove the batteries and clean the battery compartment. Install fresh AA batteries and check if the TM80 can power on properly. If the TM80 fails to power on, contact your service personnel.
Page 169: Checking The Battery Charge Status
Avoid scraping the metal contact in the battery compartment while removing the lithium-ion battery or AA battery tray. Otherwise, the broken contact will affect the power supply performance. • Remove the battery before transporting the TM80 if the TM80 is not in use or is being stored. NOTE •...
Page 170: Charging The Rechargeable Lithium-Ion Battery
Remove the lithium-ion battery or AA battery tray from the TM80. 15.6 Charging the Rechargeable Lithium-ion Battery WARNING • Only use the specified central charger to charge to the lithium-ion batteries designated by Mindray. • Only use the approved power cord with the grounded mains plug to solidly link the central charger to a grounded AC mains socket.
Page 171: Storing Aa Batteries
20°C (-4°F). 15.7.2 Storing AA Batteries If you need to store AA batteries after removing them from the TM80 man unit, keep the batteries together as a set for later re-use so that all batteries will have the same level of remaining power.
Page 172: Disposing Of The Batteries
The life expectancy of a lithium-ion battery is dependent on the duration and frequency of use. With good maintenance, the useful life is approximately 500 complete charge- discharge cycles. Empirically, the possibility of battery failure may increase due to accumulated stresses of daily use. Therefore, it is strongly suggested to replace the lithium- ion battery after two years or 500 complete charge-discharge cycles.
Page 173: Troubleshooting
The following table lists the problems that are likely to occur. If the problem persists after corrective actions have been taken, contact your service personnel. For methods to troubleshoot the central charger, refer to BeneVision Central Charger Operator’s Manual. For methods to troubleshoot the BP10, refer to BP10 NIBP Module Operator’s Manual.
Page 174 Wireless interference The TM80 cannot Configuration error Verify that [MPAN ] at the TM80 is set to [Connect to BP10] and the MPAN key on the establish connection BP10 is pressed. with the BP10. The TM80 and BP10 When the TM80 and BP10 are Put the TM80 and BP10 closer.
Page 175: Physiological Alarm Messages At The Tm80
Some TM80 or BP10 Device malfunction is prone to offline. 16.2 Physiological Alarm Messages at the TM80 The following table lists the major physiological alarm messages displayed in the prompt message area of the TM80. Default Alarm...
Page 176 Default Alarm Measurement Alarm Possible cause Solution message priority Asystole High The patient is in Check the patient’s arrhythmia. condition and the ECG V-Fib/V-Tach connections. V-Tach Vent Brady Extreme Tachy Extreme Brady R on T Med* Run PVCs Low* Couplet Prompt* Multiform PVC Med*...
Page 177 Default Alarm Measurement Alarm Possible cause Solution message priority Irr Rhythm End Prompt Irregular rhythm no Check the patient’s longer detected for the condition and the ECG irregular rhythm end connections. delay time. A-Fib End Prompt Atrial fibrillation no longer detected for the Afib end delay time.
Page 178 Default Alarm Measurement Alarm Possible cause Solution message priority Resp RR High Med* RR value has risen Check the patient’s above the high alarm condition and make RR Low limit or fallen below the sure that the patient low alarm limit. category and alarm limit settings are correct.
Page 179: Technical Alarm Messages At The Tm80
The asterisk (*) means the alarm priority is configurable. XX is the ECG lead name 16.3 Technical Alarm Messages at the TM80 The following table lists the major technical alarm messages displayed in the prompt message area of the TM80.
Page 180 ECG XX** Low* Lead Off High An error occurred to Restart the TM80. If Module the ECG module. the problem Error persists, contact your service There is a problem personnel. with the...
Page 181 Default Alarm Alarm Measurement Alarm Possible cause Solution message Indication priority Prompt ECG learning is Learning manually or automatically triggered. Cannot Prompt perform analysis Cannot Prompt Analyze Check Prompt ECG original Leads sampling exceeds signal saturation threshold. Resp Electrod Prompt The electrode has Check the electrode e Poor...
Page 182 Reconnect the SpO Unplugg connector is module to the disconnected from TM80. the TM80. Prompt is searching for Search pulse. Pulse Prompt The SpO sensor is 1. Check the sensor not properly placed and sensor position.
Page 183 Restart the BP10. occurred to the Module NIBP module. Error ■ There is a problem with communication between the TM80 and BP10. ■ NIBP Cuff The NIBP cuff is Check the not properly patient's con- Loose connected. dition and ver- ify patient ■...
Page 184 Default Alarm Alarm Measurement Alarm Possible cause Solution message Indication priority NIBP Cuff The NIBP airway may Check the airway Overpres be occluded. and measure again. sure NIBP NIBP Cuff The NIBP airway may Verify that the cuff is properly leak air.
Page 185 Battery The battery contacts Type are in bad contact. Error System Device High An error occurred Restart the TM80. If Error while performing the the problem self-test of the main persists, contact board. your service personnel. An error occurred...
Page 186 Measurement Alarm Possible cause Solution message Indication priority System Loading An error occurred Restart the TM80. If Defaults while loading the the problem Failed default persists, contact configuration. your service personnel. The asterisk (*) means the alarm priority is configurable.
Page 187: Care And Cleaning
Care and Cleaning 17.1 Introduction In this chapter we describe how to clean and disinfect the TM80 and its accessories. 17.2 Care and Cleaning Safety Information WARNING • Use only cleaners, disinfectants, and methods specifed in this chapter. Using unapproved substances or methods may damage the equipment and void the warranty.
Page 188: Cleaning And Disinfecting The Tm80
Check the equipment after cleaning and disinfecting. If there is any sign of damage, remove it from use. 17.3 Cleaning and Disinfecting the TM80 17.3.1 Approved Cleaning Agents and Disinfectants The following table lists approved cleaning agents and disinfectants for the TM80: Product Name Product Type Manufacturer Alpet®...
Page 189 Product Name Product Type Manufacturer PDI Sani-Cloth® HB Wipes PDI Inc. Germicidal Disposable Wipe PDI Sani-Cloth® Plus Wipes PDI Inc. Germicidal Disposable Cloth PDI Super Sani-Cloth® Wipes PDI Inc. Germicidal Disposable Wipe VIRAGUARD® Wipes VERIDIEN corporation Hospital Surface Disinfectant Towelettle Virex®...
Page 190 Product Name Product Type Manufacturer Surfa 'safe Liquid, spray ANIOS LABORATORIES Wip' Anios premium Wipes ANIOS LABORATORIES Aniosurf ND premium, Liquid ANIOS LABORATORIES 0.25% Mikrobac® Wipes BODE Chemie GmbH Tissues Cleanisept® Wipes Dr. Schumacher GmbH Wipes mikrozid® PAA Wipes Schülke & Mayr GmbH Wipes mikrozid®...
Page 191: Cleaning The Tm80
Clean your equipment on a regular basis. Before cleaning the equipment, consult your hospital’s regulations for cleaning the equipment. Before cleaning your TM80, do as follows: ■ Install the battery pack or battery tray and firmly close to seal the battery compartment.
Page 192: Disinfecting The Tm80
Keep the battery compartment free away from any foreign objects. 17.3.3 Disinfecting the TM80 Disinfect the TM80 as required in your hospital’s servicing schedule using the disinfectants listed in Approved Cleaning Agents and Disinfectants on Page 17-2 only. Cleaning before disinfection is recommended.
Page 193: Sterilization
To disinfect the SpO module, follow this procedure: Clean the SpO module per Disinfecting the TM80 on Page 17-6. Wipe the SpO module using a cotton or soft cloth soaked in one of the recommended disinfectants. Use caution to avoid the SpO module plug.
Page 194 This page intentionally left blank. 17 - 8...
Page 195: Maintenance
18.1 Introduction The chapter outlines the routine maintenance guidelines for the TM80. The TM80 is designed for stable operation over long periods of time and under normal circumstances should not require technical maintenance beyond that described in this chapter. However, calibration and safety checks are recommended at least once a year or more often as required by local statutory or hospital administration practice.
Page 196: Regular Check
18.3 Regular Check Perform a visual inspection before the TM80 is first used every day. Verify that the equipment meets the following requirements: ■ The housing and display screen are free from cracks or other damages. ■ All keys funtion properly.
Page 197: Power-On Test
18.4.2 ECG Verification When the TM80 is in use, the ECG signal may be inaccurate due to hardware or software problems. As a result, the ECG wave amplitude becomes greater or smaller. To verify the ECG waveform amplitude, follow this procedure: Press to enter the main menu.
Page 198: Nibp Accuracy Test
Rechargeable Lithium-ion Battery on Page 15-5. 18.5 Viewing System Information You can view the system information of TM80, such as battery, network, MPAN, and system statistics in the [System Info] menu. Enter the [System Info] menu in either of the following ways: ■...
Page 199: Accessories
The accessories listed in this chapter comply with the requirements of IEC 60601-1-2 when in use with the TM80. The accessory material that contacts the patients has undertaken the bio-compatibility test and is verified to be in compliance with ISO 10993-1. For details about the accessories, refer to the instructions for use provided with the accessory.
Page 200: Ecg Leadsets
19.1.2 ECG Leadsets 3-Lead Applicable Applicable Description property patient 009-004765-00 3-Lead, New Telemetry, AHA, Snap, 24" Reusable Adult, Pediatric 009-004766-00 3-Lead, New Telemetry, AHA, Snap, 36" 009-004771-00 3-Lead, New Telemetry, AHA, Pinch, 24" 009-004772-00 3-Lead, New Telemetry, AHA, Pinch, 36" 009-004768-00 3-Lead, New Telemetry, IEC, Snap, 24"...
Page 201: Mindray Spo2 Sensor
6-Lead Applicable Applicable Description property patient 009-004794-00 6-Lead, New Telemetry, AHA, Snap, 24" Reusable Adult, Pediatric 009-004795-00 6-Lead, New Telemetry, AHA, Snap, 36" 009-004798-00 6-Lead, New Telemetry, AHA, Pinch, 24" 009-004799-00 6-Lead, New Telemetry, AHA, Pinch, 36" 009-004796-00 6-Lead, New Telemetry, IEC, Snap, 24" 009-004797-00 6-Lead, New Telemetry, IEC, Snap, 36"...
Page 202: Nibp Accessories
19.2.2 Masimo SpO Module and Sensor Applicable Applicable Description property patient 125-000058-00 Masimo SpO2 module (SET uSpO2) Reusable Adult, Pediatric 0600-00-0121 LNCS Adtx-Adult Single Patient Adhesive Sen- Disposable Adult sors, >30 kg (20/box) 0600-00-0122 LNCS Pdtx-Pediatric Single Patient Adhesive Pediatric Sensors,10-50 kg (20/box) 0600-00-0126 LNCS DCI Adult Reusable Finger Sensor, >30 kg...
Page 203: A Product Specifications
Product Specifications This chapter provides specifications of the TM80 only. For specifications of the BP10 and the central charger, refer to BP10 NIBP Module Operator’s Manual (P/N 046-008269-00) and BeneVision Central Charger Operator’s Manual (P/N 046-007483-00) respectively. Classifications The TM80 Telemetry Monitor is classified, according to IEC60601-1: Energized from an internal electrical power source.
Page 204: Power Supply Specifications
The battery life listed below may be shortened by the following factors: ■ Wireless signal interference ■ Aging battery ■ Frequent operation of turning on/off the TM80 display ■ Wireless network coverage which does not meet the technical specifications in Wi-Fi Specifications on Page A-4. AA batteries (three) Battery type Rechargeable lithium-ion battery (one) ≥...
Page 205: Physical Specifications
Lithium-ion battery (P/N 022-000196-00) 5-lead ≥14 hours Continuous runtime when the display is on 5-lead ≥12 hours ECG+Min dray SpO Note: Prerequisites for this continuous working state: The operating temperature is at 25 °C±5°C, the display is on, and no visual or audible alarm indicators are available by default.
Page 206: Data Storage
Supports capacitive touch screen Functionality 1 (three colors: red, yellow, and cyan) Alarm lamp Audio Indicator Speaker Buttons Nurse call Power On/Off Main menu External Connectors ECG connector connector Data Storage The telemetry monitor stores data as below: ■ Most recent 48 hours of tabular trends for all parameters at the trend interval equal to or greater than 1 minute.
Page 207: Implemented Functions
TM80 Telemetry Monitor. The TM80 Telemetry Monitor can work with APs which support POE, if the RSSI from APs is higher than -65 dbm. One example of the APs is AIR-AP2802I-H-K9 which work with the AC: AIR-CT2504-15- K9.
Page 208 When the network is reconnected, wireless connection recovers automatically. 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 TM80 Telemetry Monitors are connected to...
Page 209: Mpan Specifications
A.8.2 Implemented Functions This function is provided to transfer configuration information between TM80 Telemetry Monitors and to perform communication between a TM80 Telemetry Monitor and a BP10. BP10 transmits NIBP parameters, status, and prompt messages to the TM80 Telemetry Monitor. The TM80 Telemetry Monitor transmits control information and settings information to the BP10.
Page 210: Measurement Specifications
The MPAN function of the TM80 Telemetry Monitor is normal, when the distance between the following interfering devices and the TM80 Telemetry Monitor or BP10 Resistance to wireless are as follows: interference ■ > 1 m for microwave ovens. ■...
Page 211 Monitor mode: > 105 dB Common mode rejection ratio ST mode: > 105 dB (with Notch off) 50/60 Hz, rejection capacity ≥ 20 dB Notch filter ± 500 mV Electrode offset potential tolerance ≤ 30 μV (p-v RTI) Noise < 5 s (after defibrillation) Baseline recovery time Input electrode: <...
Page 212 12 RR intervals and then averaging them. The HR value displayed on the TM80’s screen is updated every second. When the test is performed based on Clause 201.7.9.2.9.101...
Page 213: Resp
0.01 mV Resolution -0.8 mV to +0.8 mV: ± 0.02 mV or ± 10%, whichever is greater Accuracy Beyond this range: Not specified Arrhythmia Analysis Asystole, V-Fib/V-Tach, V-Tach, Vent Brady, Extreme Tachy, Extreme Brady, PVCs/min, Pauses/min, R on T, Run PVCs, Arrhythmia analysis Couplet, Multiform PVC, PVC, Bigeminy, Trigeminy, Tachy, classifications...
Page 214 0.2 Hz to 2.5 Hz (-3 dB) Bandwidth 3mm/s, 6.25 mm/s, 12.5 mm/s, 25 mm/s Sweep speed Respiration Rate Adult: 0 rpm to 120 rpm Measurement range Pediatric: 0 rpm to 150 rpm 1 rpm Resolution 7 rpm to 150 rpm: ±2 rpm or ±2%, whichever is greater Accuracy 0 rpm to 6 rpm: Not specified 10s, 15s, 20s, 25s, 30s, 35s, 40s...
Page 215 A.9.3.1 Mindray SpO Module Meet the standard of ISO 80601-2-61 Standard *Measurement accuracy verification: The SpO accuracy has been verified in human experiments by comparing with arterial blood sample reference measured with a CO- oximeter. Pulse oximeter measurements are statistically distributed and about two-thirds of the measurements are expected to come within the specified accuracy range compared to CO-oximeter measurements.
Page 216: Spo2
A.9.3.2 Masimo SpO Module 1% to 100% Measurement range Resolution 70-100%: ±2.0% (measured without motion) Accuracy* 70-100%: ±3.0% (measured with motion) 1-69%: Not specified Pulse amplitude: > 0.02% Low Perfusion Conditions Light penetration: > 5% Accuracy: ±2% ≤2s Data update rate *SpO accuracy was determined by testing on healthy adult volunteers in the range of 60% to 100% SpO...
Page 217 0.02% to 20% Measurement range 0.01, use three valid digits Least resolution Response Time ■ ≤ 25 s (PR 75 bpm, average time 8 s, no disturbance, SpO value rises from 50% to 100%) ■ ≤ 20 s (SpO value 98%, average time 8 s, no disturbance, PR value rises from 60 bpm to 150 bpm) A.9.3.3 Fitting Curve for Masimo SpO Sensors...
Page 218: Operating System
LNCS DCI/LNCS DCIP A.10 Operating System ■ The operating system running on the TM80 is Linux3.2.0. ■ The GUI system is QT5.2.1. ■ The software features for this system are implemented using the C++ programming language and assembly language and the executable output target is intended to run on a TI AM3358 CPU with 32MB NOR FLASH and 256MB LPDDR RAM.
Page 219: B Emc And Radio Regulatory Compliance
EMC and Radio Regulatory Compliance The system complies with the EMC standard IEC60601-1-2:2020. WARNING • Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this device could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in improper operation.
Page 220 Voltage Complies fluctuations and flicker IEC 61000-3-3 Note: The TM80 Telemetry Monitor and BP10 (subpart) are classified by is their using environment or intended function. NOTE • The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below.
Page 221 If the system is operated within the electromagnetic environment listed in Table Guidance and declaration - electromagnetic immunity, the system will provide the following essential performance: ■ Operating mode No cessation or interruption of any intended operation. ■ Accuracy The change of the parameter’s numerical value shall not exceed the specified accuracy. ■...
Page 222 Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that of a transient/burst supply lines supply lines typical commercial or hospital environment. IEC 61000-4-4 ±1 kV for input/ ±1 kV for input/ output lines output lines (length greater (length greater...
Page 223   150kHz to 80 MHz   Radiated RF EM 10V/m 10V/m (Only   fields TM80 and BP10) 80 MHz to 2.7 GHz   80 MHz to 800 MHz IEC61000-4-3     Radiated RF EM...
Page 224 Recommended Separation Distances between Portable and Mobile RF, Communications Equipment and This Equipment The equipment is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communication equipment.
Page 225: Radio Regulatory Compliance
Proximity magnetic 8 A/m 8 A/m fields 30 kHz 30 kHz IEC 61000-4-39 65 A/m 65 A/m 134,2 kHz 134,2 kHz Pulse modulation Pulse modulation 2,1 kHz 2,1 kHz 7,5 A/m 7,5 A/m 13,56 MHz 13,56 MHz Pulse modulation Pulse modulation 50 kHz 50 kHz Radio Regulatory Compliance...
Page 226: Radiofrequency Radiation Exposure Information
This device complies with part 15 of the FCC Rules and with RSS-210 of Industry Canada. Operation is subject to the condition that this device does not cause harmful interference. This device must accept any interference received, including interference that may cause undesired operation.
Page 227: C Electrical Safety Inspection
Electrical Safety Inspection The following electrical safety tests are recommended as part of a comprehensive preventive maintenance program. They are a proven means of detecting abnormalities that, if undetected, could prove dangerous to either the patient or the operator. Additional tests may be required according to local regulations.
Page 228: Device Enclosure And Accessories
Device Enclosure and Accessories C.2.1 Visual Inspection Test Item Acceptance Criteria The enclosure No physical damage to the enclosure and accessories. and accessories No physical damage to meters, switches, connectors, etc. No residue of fluid spillage (e.g., water, coffee, chemicals, etc.). No loose or missing parts (e.g., knobs, dials, terminals, etc.).
Page 229: Patient Leakage Current
1000 μA in Single Fault Condition Patient Leakage Current Patient leakage currents are measured between a selected applied part and metal foil placed on the TM80 (Normal condition only). All measurements have a true RMS only response. LIMITS For CF applied parts ■...
Page 230 For CF applied parts ■ 10μA in Normal Condition For BF applied parts ■ 100μA in Normal Condition NOTE • Make sure the safety analyzer is authorized comply with requirement of IEC60601-1. • Follow the instructions of the analyzer manufacturer. C - 4...
Page 231: D Electronic Interface
Electronic Interface The technical descriptions of the telemetry monitor, with a wireless or wired electronic interface, are as follows: Electronic Interface Specification Mindray SpO interface Mindray ECG interface Wi-Fi TCP/IP protocol bottom layer. Mindray Private Protocol MD2. Calibration protocol of TCP/IP. The intended information flow is from the equipment to the AP.
Page 232 This page intentionally left blank. D - 2...
Page 233: E Symbols And Abbreviations
Symbols and Abbreviations Units ampere ampere hour beats per minute °C centigrade cubic centimeter centimeter decibel dyne. second °F fahrenheit gram hour hundred pascal hertz inch kilo kilogram kilopascal litre pound meter milligrams minute milliliter millimeters millisecond millivolt milliwatt nanometer part per million E - 1...
Page 234: Symbols
second volt volt ampere Ω μA microampere μm micron μV microvolt watt Symbols minus percent per; divide; or power plus equal to < less than > greater than ≤ less than or equal to ≥ greater than or equal to ±...
Page 235 left arm augmented lead right arm augmented lead channel CISPR International Special Committee on Radio Interference central monitoring system Central Station central venous pressure DHCP Dynamic Host Configuration Protocol electrocardiograph European Economic Community electromagnetic compatibility error electrosurgical electrosurgical unit heart rate height International Electrotechnical Commission Internet protocol address...
Page 236 RA(R) right arm RL(N) right leg read-only memory arterial oxygen saturation from pulse oximetry S, SYS systolic pressure temperature difference V (C) precordial lead (chest) VLAN Virtual LAN E - 4...
Page 237 Declaration of Conformity F - 1...
Page 238 This page intentionally left blank. F - 2...
Page 240 P/N: 046-007479-00 (16.0)

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