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BeneVision TMS60, Operator'S Manual

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Cleaning and Disinfecting

Sterilization

TMS60 Operator’s Manual

15 - 9

15.6

Sterilization

Sterilization is not recommended for this equipment, related products, accessories or 
supplies unless otherwise indicated in the instructions for use delivered with the 
products, accessories or supplies.

15.7

Impact of Improper Cleaning or Disinfection

Using cleaning agents or disinfectants other than those recommended may have the 
following impact:

■

Product discoloration

■

Metal part corrosion

■

Brittle and breaking wires, connectors, and equipment housing

■

Reduced cable and leadwire life

■

Overall system performance degradation

■

Equipment malfunction or failure

Summary of Contents for TMS60

Page 1: ...BeneVision TMS60 Telemetry Monitoring System Operator s Manual ...

Page 2: ......

Page 3: ...indray Bio Medical Electronics Co Ltd All rights reserved Release time April 2019 Revision 4 0 WARNING Federal Law USA restricts this device to sale by or on the order of a phy sician or other practitioner licensed by U S state law to use or order the use of this device ...

Page 4: ...wned by Mindray in China and other countries All other 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 notice under 35 U S C 287 a for Mindray patents http www mindrayna com patents Manufacturer s Responsibility Contents of this manual are subject to cha...

Page 5: ...cturer 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 Distributor Mindray DS USA Inc Address 800 MacArthur Boulevard Mahwah New Jersey 07430 USA Tel 1 800 288 2121 1 201 995 8000 Website www min...

Page 6: ...ual 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 professionals who are expected to have a working knowledge of medical procedures practices and terminology as required for monitoring of critically ill patients Illustrations All illustrations in this manual ...

Page 7: ...3 3 3 3 Connecting the ECG Leadwire 3 4 3 4 Installing the Batteries 3 5 3 4 1 Installing the Lithium ion Rechargeable Battery Pack 3 6 3 4 2 Installing the AA Batteries 3 7 3 5 Powering On the Unit 3 8 3 6 Understanding Touch Gestures 3 9 3 7 Basic Operations 3 9 3 7 1 Understanding the Screen Display Orientation 3 10 3 7 2 Browsing the Screen Display 3 10 3 7 3 Switching the Screen Display Orien...

Page 8: ...Admitting a Patient 5 2 5 3 Changing the Patient Category 5 2 5 4 Placing a Device in Standby 5 3 5 5 Exiting the Standby Mode 5 3 5 6 Discharging the Patient 5 4 5 6 1 Selecting the Discharge Patient menu 5 4 5 6 2 Restarting the TD60 5 4 6 Alarms 6 1 6 1 Introduction 6 2 6 2 Alarm Categories 6 2 6 3 Alarm Levels 6 2 6 4 Alarm Indicators 6 3 6 4 1 Alarm Light 6 3 6 4 2 Alarm Tones 6 3 6 4 3 Alarm...

Page 9: ...3 1 Preparing the Patient s Skin 8 3 8 3 2 Positioning the Electrodes 8 3 8 4 Changing the Resp Settings 8 4 8 4 1 Configuring the Resp Setup 8 4 8 4 2 Configuring the Resp Waveform 8 5 8 5 Understanding the Resp Display 8 6 8 5 1 Resp Digital Area 8 6 8 5 2 About the Resp Digital Area 8 6 8 5 3 Resp Waveform Area 8 6 8 5 4 About the Resp Waveform Area 8 7 9 Monitoring Pulse Oxygen Saturation SpO2...

Page 10: ... 7 10 5 3 NIBP Operations at the TD60 10 7 11 Configuring the TD60 11 1 11 1 Introduction 11 2 11 2 Entering the Maintenance menu 11 2 11 3 Configuring the General Menu 11 2 11 4 Configuring the Alarms Menu 11 3 11 5 Quick Keys Menu 11 5 11 5 1 Changing the Quick Keys 11 5 11 5 2 Deleting a Quick Key 11 6 11 6 Configuring the Defaults Menu 11 6 11 6 1 Transferring a Configuration 11 7 11 7 Screen ...

Page 11: ...ing the Battery 13 4 13 6 Charging the Rechargeable Lithium ion Battery 13 5 13 7 Storing the Batteries 13 6 13 7 1 Storing Rechargeable Lithium ion Battery 13 6 13 7 2 Storing AA Batteries 13 7 13 8 Maintaining the Rechargeable Lithium ion Battery 13 7 13 9 Disposing of the Batteries 13 8 13 9 1 Disposing of the Rechargeable Lithium ion Battery 13 8 13 9 2 Disposing of the AA Batteries 13 8 14 Tr...

Page 12: ...iewing System Information 16 6 17 Accessories 17 1 17 1 ECG Accessories 17 2 17 1 1 ECG Electrodes 17 2 17 1 2 ECG Leadsets 17 3 17 2 SpO2 Accessories 17 3 17 2 1 Masimo SpO2 Module 17 3 17 2 2 Masimo SpO2 Sensor 17 4 17 2 3 Nellcor SpO2 Module 17 4 17 2 4 Nellcor SpO2 Sensor 17 4 17 3 NIBP Accessories 17 5 17 4 Miscellaneous 17 5 A Product Specifications A 1 A 1 Classifications A 2 A 2 Environmen...

Page 13: ...Patient Area Network MPAN Specification A 8 A 7 Measurement Specifications A 10 A 7 1 ECG A 10 A 7 2 Resp A 13 A 7 3 SpO2 A 14 B EMC B 1 C FCC Compliance C 1 D Symbols and Abbreviations D 1 D 1 Units D 2 D 2 Symbols D 3 D 3 Abbreviations D 3 ...

Page 14: ...8 TMS60 Operator s Manual This page intentionally left blank ...

Page 15: ...TMS60 Operator s Manual 1 1 1 Safety Safety Information 1 2 Equipment Symbols 1 7 ...

Page 16: ...afe practice that if not avoided could result in death or serious injury CAUTION Indicates a potential hazard or unsafe practice that if not avoided could result in minor personal injury or product property damage NOTE Provides application tips or other useful information to ensure that you get the most from your product ...

Page 17: ...injury and burns may occur due to the metal components of the equipment which can heat during MR scanning The equipment may present a risk of projectile injury due to the presence of ferromagnetic materials which can be attracted by the MR magnet core The leadwires and electrodes will generate artifacts in the MR image The equipment will not function properly due to the strong mag netic and radio ...

Page 18: ...d patients episodes of ventricular tachycardia may not always be detected Do not rely entirely upon the system s automated arrhythmia detection algorithm Keep pacemaker patients under close surveillance Do not operate the touch screen with wet hands Only use parts and accessories specified in this manual Route wrap and secure the cables to avoid inadvertent disconnection stumbling and entanglement...

Page 19: ...ent exists the telemetry equipment performance will be affected Exercise caution when selecting the operating frequency of all the wireless equipment in a hospital as this is very important to avoid mutual interference among them Magnetic and electrical fields are capable of interfering with the proper performance of the equipment For this reason make sure that all exter nal equipment operated in ...

Page 20: ...d to all other transmitters need to be considered to ensure that no two transmitters are programmed with the same frequency NOTE Put the equipment in a location where you can easily view and operate the equipment In normal use the operator shall stand in front of the equipment The software was developed in compliance with IEC60601 1 4 The pos sibility of hazards arising from software errors is min...

Page 21: ...rotection against fluid ingress Non ionizing radiation General warning sign Refer to instruction manual booklet Stand by Humidity limitation Atmospheric pressure limitation Temperature limitation Plastics identification symbol The presence of this label indicates the machine was certified by ETL with the statement Conforms to AAMI Std ES 60601 1 IEC Std 60601 1 6 IEC Std 60601 1 8 IEC Std 60601 2 ...

Page 22: ...Equipment Symbols Safety 1 8 TMS60 Operator s Manual NOTE Some symbols may not appear on your equipment ...

Page 23: ...TMS60 Operator s Manual 2 1 2 General Product Description Intended Use 2 2 Applied Parts 2 2 Key Features 2 3 Components 2 3 TD60 Physical View 2 5 Touch Screen Display 2 6 ...

Page 24: ... the TMS60 The telemetry monitoring system is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner 2 2 Applied Parts The applied parts of the TMS60 are ECG leadwires SpO2 cables SpO2 sensors NIBP tubes and cuffs WARNING Only skilled trained clinical professionals should operate the equip ment The equipment is not designed for mon...

Page 25: ...sp SpO2 NIBP parameter numerics and ECG SpO2 and Resp waveforms Battery options of two AA three AA or lithium ion battery pack are available Display supports parameter auto sizing 2 4 Components The TMS60 consists of the following components Telemetry transmitter TD60 Telemetry antenna array Telemetry receiver RC60 NIBP module BP10 Central charger Accessories 2 4 1 Telemetry Transmitter TD60 For i...

Page 26: ... the CMS to analyze and display For details about the general wireless communication problems refer to General Prob lems on page 14 2 For details about the frequency allocation and receiver connection refer to Telemetry Monitoring System Installation Guide P N 046 007624 00 For details about the RC60 refer to TMS60 Service Manual P N 046 007057 00 WARNING Authorized Mindray personnel are required ...

Page 27: ...econds to display the power off confirma tion menu 2 Nurse Call key Pressing this key will send a nurse call request to the CMS The alarm light indica tor 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 key when on the main screen will open the main menu Pressing this key when a menu is open will return to ...

Page 28: ...ts the ECG leadset 7 SpO2 cap Covers SpO2 connector when SpO2 is not in use 8 SpO2 connector Connects the SpO2 module 9 Speaker 10 USB connector It is only available for authorized service personnel 11 Battery compartment Contains the lithium ion battery pack or AA battery tray 2 6 Touch Screen Display Move your finger on the touch screen display to operate the TD60 For details about the supported...

Page 29: ...ne TD60 is not connected to another TD60 for configura tion transfer indicates that the TD60 is paired with the BP10 successfully or configu ration transfer of the TD60 is in progress 3 Alarm symbols indicates that the alarm system is reset indicates that the technical alarm audio is turned off 4 Battery symbol This symbol indicates the battery charge status For details about the battery sta tus s...

Page 30: ...rations on page 3 9 2 6 2 On Screen Keyboard The TD60 uses an on screen keyboard to enter alphanumeric information such as the device name and passwords 2 6 2 1 Alphabetic Keyboard 1 Alphabetic buttons tap to input the desired alphabetic text 2 Delete button tap to erase the text to the left of the cursor 3 Accept button tap to save the settings and exit the keyboard 4 Space button tap to input a ...

Page 31: ...tap to input the desired punctuation mark or symbol 3 Delete button tap to erase the text to the left of the cursor 4 Accept button tap to save the settings and exit the keyboard 5 Space button tap to input a space 6 Alphabetic switch button tap to switch to the alphabetic layout 7 More punctuation buttons tap to display the punctuation keyboard as shown below 1 2 3 4 5 6 7 ...

Page 32: ...Touch Screen Display General Product Description 2 10 TMS60 Operator s Manual This page intentionally left blank ...

Page 33: ...etting Started Unpacking and Checking 3 3 Environmental Requirements 3 3 Connecting the ECG Leadwire 3 4 Installing the Batteries 3 5 Powering On the Unit 3 8 Understanding Touch Gestures 3 9 Basic Operations 3 9 Using the Pouch 3 14 ...

Page 34: ...ipment s signal input output port is responsible for providing evidence that the safety certification of the devices has been performed in accordance to the IEC 60601 1 If you have any questions please contact Mindray If it is not evident from the equipment specifications whether a particu lar combination with other devices is hazardous for example due to summation of leakage currents please consu...

Page 35: ...e substances When the device 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 WARNING The TMS60 may be subject to microbacteria contamination during stor age transport or use Prior to use please verify that the packages are intact especially the packages of single use a...

Page 36: ... as indicated by the arrow in the following figure 2 Insert the ECG leadwire plug into the ECG connector as shown in the enlarged fig ure below NOTE The system 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 ...

Page 37: ...nce Do not use the ECG leadwire to move or lift the TD60 This may cause the device to fall which may damage the equipment or injure the patient NOTE ECG leadwires are used as the antenna for the TD60 To ensure good radio performance always connect the ECG leadwires to the ECG con nector while monitoring the patient Insert the SpO2 cap in the SpO2 connector when SpO2 is not in use NOTE Always keep ...

Page 38: ...lot on the battery compartment as indicated by the enlarged figure below 3 Press down the battery pack until it is installed firmly as indicated by the arrow in the following figure WARNING Only use specified lithium ion rechargeable batteries Use of other lith ium ion batteries will adversely affect the batteries Level reporting Low battery alarms Life performance NOTE The lithium ion rechargeabl...

Page 39: ...can hold three AA batteries To install the AA batteries 1 Make sure the battery compartment is empty 2 Insert two or three 1 5V alkaline AA batteries according to the diagram in the bot tom of the battery tray as shown in the images below 3 Align the hook on the upper part of the battery tray with the slot on the battery compartment as indicated by the enlarged part in the following figure Install...

Page 40: ...rms a self test 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 TD60 installed with the rechargeable lithium ion pack or AA battery tray is powered off press the key to turn it on Upon powering up there are two situations When the TD60 is turned on for the first time the device will request you to con...

Page 41: ...any monitoring procedure on a patient if you suspect the equipment is not working properly or if the equipment is mechanically damaged Contact your service personnel or Mindray Gesture Description Tap Briefly touch the surface with your fingertip to select a target Press and hold Touch the surface for extended period of time Drag Move your fingertip over the surface without losing contact Swipe Qu...

Page 42: ...en Display To scroll the screen display drag your finger up or down on the screen To quickly move through the parameters Swipe your finger up or down on the screen 3 7 3 Switching the Screen Display Orientation 1 Swipe your finger down from the top of the main screen to display the drop down menu 2 Tap the desired option to switch the screen display orientation For example to switch from portrait ...

Page 43: ... to enter the Discharge Patient menu Refer to Dis charging the Patient on page 5 4 for details Standby Tap the button to enter the Standby Mode menu Refer to Placing a Device in Standby on page 5 3 for details Change Lead Tap the button to change the current first ECG lead waveform to the next ECG lead waveform that is available in sequential order For example if the current first ECG lead wavefor...

Page 44: ...body contains menus buttons and other controls to configure and operate the device 4 exits the current menu and return to the previous menu or the main screen and saves any modified settings Controls Description Accesses a submenu to reveal more options or information Indicates that a password is required for access Submenus Contains more operations or information related to the corre sponding men...

Page 45: ...e 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 or key to turn the display on and access the Screen Locked menu 2 Input the passcode to unlock the screen Once the passcode is entered the screen is temporarily unlocked If the is pressed or the device times out the screen will lock again and a passc...

Page 46: ...ils about how to trigger a nurse call refer to TD60 Physical View on page 2 5 3 8 Using the Pouch The TD60 is not intended for direct contact with the patient s skin During normal use the TD60 should be worn over clothing in a pocket or in a pouch The waterproof pouch with a clear window front is an appropriate means for holding the TD60 Disposable pouches specified in this manual can be used for ...

Page 47: ... Pinch the snap fastener to close the pouch 3 Secure the pouch on the patient with ties around the patient s shoulder and under the arm as shown in the following figure CAUTION During showering do not let water enter or accumulate in the pouch Besides do not perform SpO2 or NIBP measurement When the patient is showering signal quality and leads off detection may be compromised due to significant m...

Page 48: ...ile using a pouch with the TD60 on the patient consider the patient s condition Be careful about the placement of the straps as the straps could present a strangulation hazard NOTE The pouch is used only for the TD60 The pouch cannot be used for carry ing other personal devices such as a mobile phone ...

Page 49: ...ltaneously follow steps in 3 8 1 Securing the Pouch for the TD60 to secure the pouch for the TD60 on the left or right side of the patient s body and follow steps in BP10 Operator s Manual to secure the pouch for the BP10 on the patient s waist Wearing the disposable pouches NOTE Do not secure the pouches for the TD60 and BP10 on the same side of the patient s body ...

Page 50: ...Using the Pouch Getting Started 3 18 TMS60 Operator s Manual This page intentionally left blank ...

Page 51: ...TMS60 Operator s Manual 4 1 4 User Configurations Introduction 4 2 Configuring the Display 4 2 Configuring the Audio Volume 4 4 ...

Page 52: ... 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 TD60 to apply the setting 4 2 2 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 of the...

Page 53: ...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 digital areas exist In this case the last digital parameter area shall have one tile on the left side and the right half will be blank 5 Digital areas shall be paired with the next available digital area to satisfy rule 4 This means that a digital area may be moved ahead of a wav...

Page 54: ...tly set the technical alarm volume touch screen click and systole beep volume The method for setting the three volumes are the same To change the volume settings 1 In the main menu tap Audio Volume 2 In the Technical Alarm Touch Screen Click or Systole Beep section drag the slider to the left or right to adjust the volume 3 Tap the icon to exit the Audio Volume menu NOTE The icon indicates that th...

Page 55: ... Operator s Manual 5 1 5 Patient Management Introduction 5 2 Admitting a Patient 5 2 Changing the Patient Category 5 2 Placing a Device in Standby 5 3 Exiting the Standby Mode 5 3 Discharging the Patient 5 4 ...

Page 56: ...he patient at the CMS you can directly admit next new patient at the TD60 by discharging the current patient Refer to Discharging the Patient on page 5 4 for details 5 3 Changing the Patient Category 1 In the main menu tap Patient Info 2 In the Patient Info menu tap Patient Category to select the desired patient cate gory The screen displays the Are you sure you want to change patient category mes...

Page 57: ...the CMS of the standby mode 5 5 Exiting the Standby Mode Press to exit the standby mode After exiting the Standby mode the system responds as follows Restores parameter measurement as previously configured Alarm system is activated Notifies the CMS of returning to normal monitoring NOTE When the device is connected to the CMS the patient category at the CMS is updated if the patient category is ch...

Page 58: ...60 and the CMS The patient s configuration is cleared and the default departmental settings are restored The discharged patient window of the CMS adds a record of the patient s history data 3 Press the key to start monitoring by applying the default departmental set tings 5 6 2 Restarting the TD60 1 If the TD60 is powered off press the key to turn on the device The device prompts whether this is a...

Page 59: ...TMS60 Operator s Manual 6 1 6 Alarms Introduction 6 2 Alarm Categories 6 2 Alarm Levels 6 2 Alarm Indicators 6 3 Configuring Alarms 6 5 Resetting Alarms 6 5 ...

Page 60: ... status patient status a device malfunction or a patient data distortion due to improper operation or mechanical problems Technical alarms are available both at the TD60 and the CMS In addition to the technical alarms the TD60 also displays informational message to inform the user of patient system status The TD60 will display informational messages in the message area at the top of the display 6 ...

Page 61: ...nd Mode 2 For each config uration the alarm tones enunciate the alarm levels as follows Low level Indicates a device malfunction or an improper operation which may compro mise a certain monitoring function but will not threaten the patient s life Alarm Levels Technical alarms NOTE When the TD60 display is off the user must activate the screen to view any local alarms High level alarms the lamp qui...

Page 62: ...ff indicates the alarm system is reset High level alarms Medium level alarms Low level alarms high pitched single beep double beep low pitched single beep Mode 2 High level alarms Medium level alarms Low level alarms high pitched triple beep double beep low pitched single beep NOTE When multiple technical alarms of different levels occur simultaneously the TD60 selects the alarm of the highest lev...

Page 63: ... enter the main menu and then tap Alarm Reset from the Commands section OR 1 Swipe your finger up at the bottom of the main screen to display the quick keys area 2 Tap the Alarm Reset quick key to reset the alarm system When the alarm system is reset depending upon the technical alarm there are several ways the alarm system may respond as follows The alarm sound will be silenced the alarm light wi...

Page 64: ...Resetting Alarms Alarms 6 6 TMS60 Operator s Manual This page intentionally left blank ...

Page 65: ...TMS60 Operator s Manual 7 1 7 Monitoring ECG Introduction 7 2 Safety 7 2 Preparation for Monitoring ECG 7 3 Maintaining Quality ECG Signal 7 11 Understanding the ECG Display 7 15 ...

Page 66: ...he conductive parts of electrodes and associated connectors for applied parts including the neutral electrode do not contact any other conductive parts including earth Periodically inspect the electrode application site to ensure skin quality If the skin quality changes replace the electrodes or change the applica tion site Do not touch the patient or any device connected to the patient includ ing...

Page 67: ...ntil it is raw or bleeding 7 3 2 Positioning the Electrodes NOTE After defibrillation the waveform recovers within 10 seconds applied in accordance with the manufacturer s instructions for use NOTE Prepare the electrode site with alcohol only if the skin is extremely greasy If alcohol is used as a drying agent always allow the skin to dry before placing the electrode on the skin NOTE Store electro...

Page 68: ... ensure direct contact Consult the electrode manufac turer s instructions for specific use 3 Secure the lead wires to the patient according to hospital practice NOTE Using a Transcutaneous Electrical Nerve Stimulator TENS Since a TENS unit transmits electrical impulses avoid placing ECG electrode near the TENS electrodes ECG electrodes may need to be repositioned and the ECG lead viewed may need t...

Page 69: ... significantly larger than other lower voltage waves on the ECG tracing the monitor may have some difficulty in identifying the appropriate waves On some patients electrode placement and or the viewed ECG lead may need to be adjusted in order to obtain a significant R wave NOTE It is recommended that the electrodes be changed at least every 24 to 36 hours to maintain proper contact with the skin a...

Page 70: ...vectors I II or III The recommended 3 wire lead placement is as follows AHA IEC Electrode Placement RA white R red At the patient s 2nd ICS mid clavicular line to the right of the sternum LA black L yellow At the patient s 2nd ICS midclavicular line to the left of the sternum LL red F green On the patient s lower left chest wall within the ribcage frame RA R LA L LL F ...

Page 71: ...ement RA white R red At the patient s 2nd ICS mid clavicular line to the right of the sternum LA black L yellow At the patient s 2nd ICS midclavicular line to the left of the sternum LL red F green On the patient s lower left chest wall within the ribcage frame RL green N black On the patient s lower right chest wall within the ribcage frame V brown C white V lead C lead position depicted in the f...

Page 72: ...non pacemaker patient Do not place an ECG electrode directly over the pacemaker generator Place the elec trode patches 2 to 3 inches away from the pacemaker generator area For example if the pacemaker generator is located in the right subclavian area relocate the Right Arm elec trode closer in towards the center of the chest 3 wire lead placement for a pacemaker patient AHA IEC RA R LA L LL F Pace...

Page 73: ...e area of the main screen In the main menu tap Lead Placement 7 3 5 2 Understanding the Lead Placement Instructions The Lead Placement window indicates the lead status 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 level A flashing circle indicates the disconnecte...

Page 74: ...form area of the Central Monitoring System s screen WARNING For paced patients you must set Paced to Yes If it is incorrectly set to No the CMS could mistake a pace pulse for a QRS and fail to alarm when the ECG signal is too weak On ventricular paced patients episodes of ventricular tachycardia may not always be detected Do not rely entirely on rate meter alarms when monitoring patients with pace...

Page 75: ...e the stress loop to the patient A secured stress loop prevents lead wire rotation about the electrode snap leadwire tugging at the electrode and ECG artifact WARNING In order to minimize the possibility of interference place electrodes leadwires and TD60 as far away from the pacemaker as possible False low heart rate indicators or false asystole calls may result with cer tain pacemakers because o...

Page 76: ...t Enters the Lead Placement window Refer to Checking the Lead Placement on page 7 9 for details Cable Type Selects the current ECG leadwire type Auto 3 Lead 5 Lead Refer to ECG Leadwire Types on page 7 13 for details Smart Lead Monitored Lead When Cable Type is set to Auto the option displays Smart Lead Drag the swtich to right or left to enable or disable the Smart Lead function When Cable Type i...

Page 77: ...ain screen 5 Lead the leadwire types is set to 5 lead All waveform leads display on the main screen 7 4 3 Configuring the ECG Waveforms 1 In the Waveform section of the ECG menu select the options described in the fol lowing table 2 Tap to exit the ECG menu Options Description Settings All Lead Size Selects the waveform size for all the leads To set the waveform size for a specific lead select tha...

Page 78: ...CG Waveforms on page 7 13 Options Description Settings Paced Selects the paced status Unspecified No Yes Unspecified is only available for the first time you set the paced sta tus Refer to Setting the Paced Sta tus on page 7 10 for details Markers Selects the pacer indicator Line A 1 cm line shows above each ECG wave form each time the pace pulse is detected Dot A 2 mm dot shows above each ECG wav...

Page 79: ...t 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 1 2 3 NOTE Both the HR value displayed on the TD60 s main screen and that at the Central Monitoring System can meet relevant standards and are reliable HR trended alarm checking and arrhythmia are based on the HR calcu lated at the Cen...

Page 80: ...form area provides scrolling real time waveform data and an erase bar to provide a time indicator of oldest and new data The ECG waveform area scrolls the waveform in the configured sweep speed The ECG waveform area rails the top most value when the waveform exceeds the upper scale limit for real time waveforms The ECG waveform area rails the bottom most value when the waveform exceeds the lower s...

Page 81: ...TMS60 Operator s Manual 8 1 8 Monitoring Respiration Resp Optional Introduction 8 2 Safety 8 2 Preparation for Monitoring Resp 8 3 Changing the Resp Settings 8 4 Understanding the Resp Display 8 6 ...

Page 82: ...ion level too low the monitor is more likely to detect cardiac activity and to falsely interpret cardiac activity as respira tory activity in the case of apnea If operating under conditions according to the EMC Standard IEC 60601 1 2 Radiated Immunity 3V m field strengths above 3V m may cause erroneous measurements at various frequencies Therefore it is recom mended to avoid the use of electricall...

Page 83: ...rom the electrode sites Never rub the skin until it is raw or bleeding 8 3 2 Positioning the Electrodes As the Respiration measurement adopts the standard ECG electrode placement you can use different ECG cables Since the respiration signal is measured between two ECG elec trodes if a standard ECG electrode placement is applied the two electrodes should be RA and LL of ECG Lead II For more informa...

Page 84: ...nates Some patients with restricted movements breathe mainly abdominally In these cases you may need to place the left leg electrode on the left abdomen at the point of maximum abdominal expansion to optimize the respiratory wave In clinical applications some patients expand their chests laterally causing a negative intrathoracic pressure In these cases it is better to place the two respiration el...

Page 85: ... TD60 will trigger the No Chest Move ment alarm if the patient has stopped breathing for longer than the set apnea time This alarm is displayed on the central monitoring system only 10s 15s 20s 25s 30s 35s 40s Color Selects the Resp waveform color 16 colors The default color is yellow The factory default settings are in bold Options Description Settings Gain Selects the waveform size x0 25 x 0 5 x...

Page 86: ...ys 1 Parameter name 2 Measurement unit 3 Respiration rate RR 8 5 2 About the Resp Digital Area The Resp digital 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 The Resp waveform area displays 1 Resp lead label 2 Resp waveform 3 Resp waveform gain 1 2 3 1 3 2 ...

Page 87: ...tanding the Resp Display TMS60 Operator s Manual 8 7 8 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 ...

Page 88: ...Understanding the Resp Display Monitoring Respiration Resp Optional 8 8 TMS60 Operator s Manual This page intentionally left blank ...

Page 89: ... 1 9 Monitoring Pulse Oxygen Saturation SpO2 Optional Introduction 9 2 Measurement Limitations 9 2 Safety 9 3 Connecting the SpO2 Module 9 4 Changing the SpO2 Settings 9 5 SpO2 Measurement 9 8 Understanding the SpO2 Display 9 9 ...

Page 90: ...ement Limitations If the SpO2 measurement seems out of range or inaccurate check the patient s vital signs Then check the equipment and SpO2 sensor The following factors may influence the accuracy of measurement Ambient light Physical movement Low perfusion Electromagnetic interference Dysfunctional hemoglobin such as carboxyhemoglobin COHb and methemoglobin MetHb NOTE A functional tester or SpO2 ...

Page 91: ...ples should be analyzed by a laboratory co oximeter to completely under stand the patient s condition Do not use SpO2 sensors during magnetic resonance imaging MRI Induced current could potentially cause burns The sensor may affect the MRI image and the MRI unit may affect the accuracy of the oximetry measurements Prolonged and continuous monitoring may increase the temperature of the sensor and c...

Page 92: ...O2 Optional 9 4 TMS60 Operator s Manual 9 4 Connecting the SpO2 Module Connect the SpO2 module to the TD60 The TD60 can auto detect the SpO2 module type when the SpO2 module is connected Connecting the Masimo SpO2 module SpO2 module SpO2 sensor SpO2 sensor connector ...

Page 93: ...pO2 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 to enter the SpO2 menu In the main menu tap Parameter Setup SpO2 to enter the SpO2 menu 1 In the Setup section of the SpO2 menu select the options described in the follow ing table NELLCO R SpO2 sensor SpO2 sensor co...

Page 94: ...patient motion High This mode should be used for the sickest patients where obtaining a reading is most diffi cult High Sensitivity is designed to interpret and display data for even the weakest of signals This mode is recommended during procedures and when clinician and patient contact is continu ous Normal This mode provides the best combination of sensitivity and probe off detection performance...

Page 95: ...e visibility to subtle desatura tions while also being long enough to minimize major changes in SpO2 due to quick transitory desaturations Although averaging timesgreater than 10 seconds are more likely to reduce visibil ity to rapid brief desaturations this may be desirable in care areas where brief desaturations that do not require clinician intervention occur more often such as NICU It is also ...

Page 96: ...an appropriate sensor according to the module type patient size and weight 2 Remove colored nail polish from the application site 3 Apply the sensor to the patient 4 Connect the sensor to the SpO2 module and the SpO2 module to the TD60 The SpO2 measurement displays when the TD60 detects that a sensor is con nected to the patient Options Description Settings Speed Selects the SpO2 pleth waveform sp...

Page 97: ...en equipped with a Masimo or Nellcor SpO2 module use only the sensors specified in this manual Use of other SpO2 sensors may cause improper oximeter performance If the sensor is too tight because the application site is too large or becomes too large due to edema excessive pressure for prolonged peri ods may result in venous congestion distal from the application site leading to interstitial edema...

Page 98: ... Area The SpO2 digital area displays in units of with a resolution of 1 The SpO2 PR value displays in units of bpm with a resolution of 1 bpm Displays Masimo PI 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 place of digits 1 2 3 6 7 9 5 4 8 ...

Page 99: ...Masimo SpO2 waveform area SIQ enabled Nellcor SpO2 waveform area 9 7 4 About the SpO2 Waveform Area Displays in the configured SpO2 color Provides scrolling real time waveform data Scrolls the waveform in the configured sweep speed Automatically scales the SpO2 waveform data area to maximize the vertical height of the Pleth waveform for the data range If using Masimo SpO2 the Signal Quality Index ...

Page 100: ... sensors or cables which would alone or in combina tion with this device fall within the scope of one or more of the patents relating to this device 9 9 Nellcor Information Nellcor Patents This posting serves as notice under 35 U S C 287 a for Covidien patents http www covidien com patents No Implied License Possession or purchase of this device does not convey any express or implied license to us...

Page 101: ...ing Noninvasive Blood Pressure NIBP Optional Introduction 10 2 Pairing the TD60 with the BP10 10 2 Unpairing the TD60 with the BP10 10 4 Screen Display after Pairing a TD60 with a BP10 10 5 Interactions after Pairing a TD60 with a BP10 10 6 ...

Page 102: ...the BP10 10 2 1 Pairing Procedure Before pairing the TD60 with a new BP10 first unpair the already connected BP10 by fol lowing steps in 10 3 1 Unpairing via the TD60 To pair a TD60 with a BP10 follow this procedure 1 Press the MPAN key on the right panel of the BP10 The Pairing message will dis play in the message area of the BP10 2 Press to enter the main menu of the TD60 3 Tap Wireless Modules ...

Page 103: ...d ongoing NIBP measurement for current patient will not stop No Patient related settings at BP10 comes from the TD60 Besides NIBP measurement for the patient monitored by BP10 will stop and the data his tory related to this patient will be cleared at BP10 When a BP10 in ABPM mode is not unpaired with a TD60 and needs to be paired with a new TD60 you must select No Otherwise chaotic patient data ma...

Page 104: ...ted settings displayed on the main screen of the TD60 will come from the BP10 The patient monitored by BP10 will be dis charged automatically and the data history related to this patient will be cleared Patient Category can be changed at the TD60 only A patient cannot be discharged from the BP10 and NIBP related settings are grayed out at BP10 To discharge a patient from BP10 you need to unpair th...

Page 105: ...nected previously will be changed to Disconnect under Devices on the TD60 The icon will be changed to in the top right corner of the TD60 s screen and of the BP10 Measured NIBP values on the main screen of the TD60 is displayed as indicating invalid values 10 4 Screen Display after Pairing a TD60 with a BP10 When a TD60 is paired with a BP10 successfully measured NIBP values will be displayed on t...

Page 106: ...e when NIBP measurement starts 10 5 Interactions after Pairing a TD60 with a BP10 10 5 1 Overview of Interactions Once a TD60 is paired successfully with a BP10 the interactions proceed as shown below Action At the TD60 At the BP10 Start NIBP measurement Yes Yes Stop NIBP measurement Yes Yes Stop All NIBP measurements Yes Yes NIBP STAT Yes Yes Set initial pressure Yes No Set NIBP measurement mode ...

Page 107: ...Operations at the TD60 In the Setup section of the NIBP menu at the TD60 you can Tap Mode to set NIBP measurement mode to one of the following Manual Auto Seq ABPM Tap ABPM to configure ABPM related settings Day Night Start Interval Tap Auto to set NIBP measurement interval to one of the following 1 min 2 min 2 5 min 3 min 5 min 10 min 15 min 20 min 30 min 1h 1 5h 2h 3h 4h 8h Tap Seq to configure ...

Page 108: ...Interactions after Pairing a TD60 with a BP10 Monitoring Noninvasive Blood Pressure NIBP Optional 10 8 TMS60 Operator s Manual This page intentionally left blank ...

Page 109: ... Entering the Maintenance menu 11 2 Configuring the General Menu 11 2 Configuring the Alarms Menu 11 3 Quick Keys Menu 11 5 Configuring the Defaults Menu 11 6 Screen Lock Menu 11 8 Changing the Passwords 11 9 Changing the Device Name 11 9 Demo Mode 11 9 Service Menu 11 9 ...

Page 110: ...nance menu tap General The current setting displays to the right of the option 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 system language ENGLISH FRENCH Location Changes the hospital and department names N A Notch Filter Configures the ECG No...

Page 111: ...een On Off This option is available only when your TD60 supports the Resp functionality Options Description Settings The factory default settings are in bold NOTE Mindray recommends the same SpO2 tone mode be used for the device within a monitoring area Section Options Description Settings Sounds Style Allows an authorized user to set the alarm tone pattern ISO Mode 1 Mode 2 Timeout Reminder Tone ...

Page 112: ...et to 0 the alarm sound is turned off and the symbol appears on the screen Off 1 2 3 4 5 6 7 8 9 10 Technical Alarm Priority ECG Lead Off Allows an authorized user to configure the alarm level Low Medium High SpO2 Sensor Off Allows an authorized user to configure the alarm level Low Medium High Section Options Description Settings The factory default settings are in bold Minimum value WARNING When...

Page 113: ... 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 you want to configure A list of options displays 3 Tap the desired option from the list of options to configure the selected quick key 4 Repeat steps 2 to 3 to configure other quick keys if needed A list of options ...

Page 114: ...lows an authorized user to manage the system configurations 1 In the Maintenance menu tap Defaults 2 Select the options described in the following table 3 Tap to exit the Defaults menu Options Description Save Departmental Defaults Allows an authorized user to save the current device settings for the selected patient category Export Device Settings Copies the current settings to the external devic...

Page 115: ...configurations The Downloading device settings message will be shortly displayed on the TD60 B s screen If an import is successful the Download complete message will be displayed on the TD60 B s screen The screen returns to the Defaults menu in 10 seconds The Complete message will be displayed on the TD60 A s screen If the import fails the Import attempt failed message will be displayed on the TD6...

Page 116: ...ain Screen is accessible without passcode entry The System Info menu is accessible by tapping the battery symbol on the main screen The Lead Placement menu is accessible by tapping an ECG Sensor Off message in the alarm area Ability to change display orientation Hardkeys are enabled 11 7 2 Setting the Screen Lock The initial enabling of screen lock mode requires a passcode to be entered immediatel...

Page 117: ...s to change the maintenance password Tap Service Password and follow the on screen instructions to change the service password 2 Tap the icon to exit the Edit Passwords menu 11 9 Changing the Device Name 1 In the Maintenance menu tap Device Name 2 Use the on screen keyboard to input the device name 3 Tap Accept to save the setting and exit the Device Name menu 11 10 Demo Mode Allows an authorized ...

Page 118: ...Service Menu Configuring the TD60 11 10 TMS60 Operator s Manual This page intentionally left blank ...

Page 119: ...TMS60 Operator s Manual 12 1 12 Monitoring with the TMS60 at the CMS Introduction 12 2 Monitoring at the CMS Version Earlier than 03 00 12 2 Monitoring at the CMS Version 03 00 or Above 12 30 ...

Page 120: ... Alarms At the CMS you can view and change the physiological alarm limits and alarm levels in the Alarm Setup menu The Alarm Setup menu contains three tabs Parameter Alarm Settings view and change the parameter alarm limits alarm levels and alarm responses Arrhythmia Alarms view and change the arrhythmia alarms levels and alarm responses Arrh Threshold Setup view and change the arrhythmia threshol...

Page 121: ... operator properly configure the alarm system and adjust alarm set tings as per the patient s condition Setting alarm limits to extreme values may cause the alarm system to become ineffective For example high oxygen levels may predispose a premature infant to retrolental fibroplasia If this is a consideration do NOT set the high alarm limit to 100 which is equivalent to switching the alarm off If ...

Page 122: ...mit 2 Default 50 For pediat ric 15 to high limit 2 Default 75 High Med On Off On Off On Off ST Single Unit of mea sure mV Invalid data On Off For adult and pediatric Low limit 0 2 to 2 00 Default 0 1 For adult and pediat ric 2 00 to high limit 0 2 Default 0 1 High Med Low ST Dual Unit of mea sure mV Invalid data QTc Unit of mea sure ms Invalid data For adult 200 to 800 Default 500 For pediatric 20...

Page 123: ...ult 90 High Med On Off On Off On Off SpO2 Desat Unit of mea sure Invalid data On Off For adult and pediatric None For adult and pediat ric 0 to 100 Default 80 High Parameters Activati on State Alarm High Limit Alarm Low Limit Alarm Priority Alarm Response Record on Alarm Print on Alarm Paging Switch Notes The factory default settings are in bold NOTE The SpO2 Desat alarm limit is restricted such t...

Page 124: ...n Alarm Print on Alarm Paging Switch Asystole On Off High On Off On Off On Off V Fib V Tach V Tach Vent Brady Extreme Tachy Extreme Brady PVCs min On Off High Med Low Message R on T Run PVCs High Med Low Message Couplet High Med Low Message PVC Vent Rhythm On Off High Med Low Message Bigeminy On Off Trigeminy Tachy Brady Pacer Not Pac ing High Med Low Message Pacer Not Cap ture Notes The factory d...

Page 125: ...Low Message Irr Rhythm Low Message Pauses min High Med Low Message Name Activation State Alarm Priority Alarm Response Record on Alarm Print on Alarm Paging Switch Notes The factory default settings are in bold NOTE When Paced is set to Yes the Missed Beat MIS alarm is reported as the Pacer Not Capture PNC or Pacer Not Pacing PNP alarm The priority of lethal arrhythmia alarms is always high It is ...

Page 126: ...Default Step Unit of measure PVCs High 1 to 100 10 1 minute Pauses min 1 to 15 8 1 None Asystole Delay 3 to 10 4 1 second Tachy High 60 to 300 Adult 120 Pediatric 160 5 bpm Brady Low 15 to 120 Adult 50 Pediatric 75 5 bpm Extreme Tachy 60 to 300 Adult 160 Pediatric 180 5 bpm Extreme Brady 15 to 120 Adult 35 Pediatric 50 5 bpm Multif PVCs Window 3 to 31 15 1 min V Tach Rate 100 to 200 130 5 bpm V Ta...

Page 127: ...f the ECG tab Options or Buttons Description Settings HR Activation State Configures whether or not to enable the HR alarm See Factory Default Parameter Alarm Settings on page 12 3 for details HR Alarm Priority Configures the HR alarm levels HR High Limit bpm Configures the HR high alarm limit HR Low Limit bpm Configures the HR low alarm limit Sweep Speed Configures the ECG wave speed 6 25 mm s 12...

Page 128: ...nalysis leads and displayed leads is On which means that the analysis leads are consistent with the displayed leads You can change the default setting as following steps if necessary 1 At the CMS select Admin Setup input the password select OK 2 In the Admin Setup menu select the Telemetry tab 3 On the left side of the Telemetry tab select Analysis Lead Setup The corresponding setting displays to ...

Page 129: ... the corresponding gain for ECG 2 I II III aVR aVL aVF V 0 125 0 25 0 5 1 2 4 ECG 3 Select the desired ECG lead and set the corresponding gain for ECG 3 I II III aVR aVL aVF V 0 125 0 25 0 5 1 2 and 4 The factory default settings are in bold Options Description Settings Lead Waveform size ECG 1 Select the desired ECG lead and set the corresponding gain for ECG 1 to display in the waveform area I I...

Page 130: ...te value 7 Pauses per minute label 8 PVCs threshold 9 PVCs per minute value 10 PVCs per minute label Options Description Settings Paced The option is unavailable at the CMS The paced status can be set at the TD60 only Refer to Setting the Paced Status on page 7 10 for details Pacer Reject Configures whether or not to reject the pace pulses On the pace pulses are not counted as extra QRS complexes ...

Page 131: ... ECG Waveform Area The ECG waveform area displays 1 ECG Lead 2 ECG waveform size 3 ECG filter setting 4 Notch filter setting 5 ECG waveform 6 ECG scale ECG waveform area 1 2 3 4 5 6 7 8 9 10 NOTE If the Activation State for HR PVCs or Pauses alarm is set to Off the symbol displays to the right of corresponding parameter 1 2 3 4 5 6 ...

Page 132: ... QT interval in an ECG lead is the time interval from the onset of the earliest deflec tion in the QRS complex to the end of the T wave QT monitoring can assist in the detec tion of prolonged QT interval syndrome 12 2 3 1 Measurement Limitations QT QTc values are calculated with 3 leadwire or 5 leadwire ECG cables 12 2 3 2 QT Settings The following table lists the QT settings in the QT Analysis se...

Page 133: ...ked with a vertical line The QTc value is equal to the current QTc value minus the template QTc value QTc Formula Configures the QTc formula used Bazett Fridericia Framingham Hodges QT Alarm Setup Configures the QT alarms For details about the QT alarms limits See Factory Default Parameter Alarm Settings on page 12 3 for details For details about the QT alarms responses See Factory Default Paramet...

Page 134: ...nfigure the desired items Buttons Description Settings Lead Select the desired lead to display on the QT View menu screen II I III aVR aVL aVF V Set as Ref Replaces the template waveform and QT QTc values with the current waveform and QT QTc values None The QT template updated time displays at the bottom of the screen Print Prints the template and current wave forms and QT QTc values for all leads...

Page 135: ...tal area displays 1 Parameter label 2 QTc value 3 High QTc alarm limit 4 Activation State Off symbol for QTc alarm 5 QTc label 6 QTc value 7 High QTc alarm limit 8 Activation State Off icon for QTc alarm 9 QT value 10 QT label 11 QTc label 12 QT HR label 13 QT HR value Example QT digital area 1 2 3 4 5 6 7 8 10 11 9 CAUTION Updating QTc reference affects QTc value and alarm ...

Page 136: ... is a fixed distance from the J point at the end of the QRS complex The ST point can be configured to 40 60 or 80 milliseconds past the J point independent of the heart rate By default the ST point is positioned as follows At 80 milliseconds for heart rates less than or equal to 120 beats per minute At 60 milliseconds for heart rates greater than 120 beats per minute All available ECG leads are an...

Page 137: ...ment data The significance of the ST segment changes need to be determined by a clinician Options or Buttons Description Settings ST Analysis Enables or disables ST analysis On Off If ST Analysis is set to On the Filter option from the Other Settings menu is automatically set to ST Display ST Segments Select whether or not to display the ST segments in the waveform area On Off ST Alarm Setup Confi...

Page 138: ... follow this procedure 1 In the ST Analysis section of the ECG tab select Define ST Point The Define ST Point menu displays as shown in the following figure Define ST point menu 2 Adjust the parameter using the buttons described in the following table WARNING Always make sure that the ST measurement points are appropriate for your patient Buttons Description Settings Lead Select the desired ECG le...

Page 139: ...ment depression 4 Units of measure 5 Lead identifier Example 5 lead ST digital area ISO J Selecting Auto fixes the ISO and J ST points Selecting Manual allows the clinician to manually adjust ISO and J ST points Auto Manual ISO left arrow If ISO J is set to manual the button adjusts the ISO reference line to the left ISO right arrow If ISO J is set to manual the button adjusts the ISO reference li...

Page 140: ...arrhythmia analysis program is intended to detect ventricular arrhythmias It is not designed to detect atrial or supraventricular arrhythmias It may incorrectly identify the presence or absence of an arrhythmia Therefore a physician must analyze the arrhythmia infor mation with other clinical findings Heart rate reading may be affected by cardiac arrhythmias Do not rely entirely on heart rate alar...

Page 141: ... be available Therefore closely monitor the patient s condition during the learning phase after the learning phase to allow the algorithm to reach optimal detection performance 12 2 5 2 Understanding the Arrhythmia Events Arrhythmia message Description Category Asystole No QRS detected within the set time threshold in absence of ven tricular fibrillation or chaotic signal Lethal arrhythmia V Fib V...

Page 142: ...cer Not Pacing No pace pulse detected for 1 75 x average R to R intervals following a QRS complex for paced patients only Pacer Not Capture No QRS complex detected for 300 milliseconds following a pace pulse for paced patients only Missed Beats No beat detected for 1 75 x average R R interval for HR 120 or No beat for 1 second with HR 120 for non paced patients only or No beat detected for more th...

Page 143: ...changes Selecting the Relearn button in the Arrhythmia Analysis section Selecting the the Relearn button in the Arrhythmia Analysis section is recommended after one or more of the following ECG electrodes have been repositioned Eight hours have passed since the last relearn Significant changes occurred to the patient QRS complex Significant changes occurred to the patient ECG rhythm Options or But...

Page 144: ... be made Using the commands provided move the minimum detection threshold up or down to ensure it is above the level of the P waves but below the peak of the R wave Since the P wave height could vary a little from beat to beat do not set the hori zontal line representing the minimum detection threshold at or barely above the level of the peak of the P wave Ensure that it is at least one or two mil...

Page 145: ... can view and change the SpO2 settings in the SpO2 tab of the Parame ter Setup menu To enter the SpO2 tab follow this procedure 1 Select the SpO2 digital area or waveform area to enter the Parameter Setup menu 2 Select the SpO2 tab 12 2 7 Measurement Limitations See Measurement Limitations on page 9 2 for details Buttons Description Settings Gain Select the desired ECG waveform size X1 X2 X4 Refre...

Page 146: ...ly The option is not configurable The option setting is synchronous with the set ting at the TD60 See Configuring the SpO2 Setup on page 9 5 SpO2 High Limit Configures the SpO2 high alarm limit Low limit 1 to 100 The default is 100 SpO2 Low Limit Configures the SpO2 low alarm limit 0 to high limit 1 The default is 90 PR High Limit bpm Configures the PR high alarm limit Low limit 2 to 300 The defau...

Page 147: ...gital area displays 1 Parameter label 2 High SpO2 alarm limit 3 PR label 4 PR value 5 High PR alarm limit 6 SpO2 unit of measure 7 Low PR alarm limit 8 Masimo perfusion index value 9 PI label 10 Low SpO2 alarm limit 11 SpO2 value Masimo SpO2 digital area 1 2 3 4 5 6 7 8 9 10 11 NOTE When HR Source of the ECG tab is set to Both the PR value displays on the SpO2 digital area ...

Page 148: ...ersion is 03 00 or above you can view physiological alarms for ECG Resp SpO2 and NIBP param eters change parameter settings and perform related operations 12 3 1 Physiological Alarms At the CMS you can view and change the physiological alarm limits and alarm levels in the Alarm Setup menu For details on how enter the Alarm Setup menu refer to Ben eVision Central Monitoring System Operator s Manual...

Page 149: ...ngle Unit of mea sure mV Invalid data On Off For adult and pediatric Low limit 0 2 to 2 00 Default 0 1 For adult and pediat ric 2 00 to high limit 0 2 Default 0 1 High Med Low ST Dual Unit of mea sure mV Invalid data QTc Unit of mea sure ms Invalid data For adult 200 to 800 Default 500 For pediatric 200 to 800 Default 480 For adult and pediat ric None QTc Unit of mea sure ms Invalid data For adult...

Page 150: ... mea sure mmHg Invalid data For adult Low limit 5 to 270 Default 160 For adult 40 to high limit 5 Default 90 High Med NIBP D Unit of mea sure mmHg Invalid data For adult Low limit 5 to 210 Default 90 For adult 10 to high limit 5 Default 50 NIBP M Unit of mea sure mmHg Invalid data For adult Low limit 5 to 230 Default 110 For adult 20 to high limit 5 Default 60 Parameters Activati on State Alarm Hi...

Page 151: ...Priority Alarm Outputs Asystole On Off High On Off V Fib V Tach V Tach Vent Brady Extreme Tachy Extreme Brady PVCs min On Off High Med Low Prompt R on T Run PVCs High Med Low Prompt Couplet High Med Low Prompt PVC Vent Rhythm On Off High Med Low Prompt Bigeminy On Off Trigeminy Tachy Brady Pacer Not Pacing High Med Low Prompt Pacer Not Capture Notes The factory default settings are in bold ...

Page 152: ...rompt A Fib High Med Low Prompt Irr Rhythm Low Prompt Pauses min High Med Low Message Name Activation State Alarm Priority Alarm Outputs Notes The factory default settings are in bold NOTE When Paced is set to Yes the Missed Beat MIS alarm is reported as the Pacer Not Capture PNC or Pacer Not Pacing PNP alarm The priority of lethal arrhythmia alarms is always high It is unchange able Button Descri...

Page 153: ...VCs min 1 to 100 10 1 minute Pauses min 1 to 15 8 1 None Asystole Delay 3 to 10 4 1 second Tachy HR High 60 to 300 Adult 120 Pediatric 160 5 bpm Brady HR Low Adult 15 to 115 Pediatric 15 to 120 Adult 50 Pediatric 75 5 bpm Extreme Tachy 60 to 300 Adult 160 Pediatric 180 5 bpm Extreme Brady Adult 15 to 115 Pediatric 15 to 120 Adult 35 Pediatric 50 5 bpm Multif PVCs Window 3 to 31 15 1 beat V Tach Ra...

Page 154: ...rties See Factory Default Parameter Alarm Settings on page 12 3 12 3 2 2 Changing ECG Wave Settings To change ECG waveform related settings follow this procedure 1 From the ECG tab select the Setup section 2 Set the desired items Options or Buttons Description Default Setting ECG 1 Select the desired ECG lead and set the corresponding gain for ECG 1 II ECG 2 5 lead I ECG Gain Configures the size o...

Page 155: ...ion 2 From the ECG tab select the QRS Threshold section 3 Select the arrow buttons to adjust the QRS threshold Selecting Default resets the QRS threshold to the default value 0 16 mV Options or Buttons Description Default Setting Paced The option is not configurable at the CMS The paced status can be set at the TD60 only See Setting the Paced Status on page 7 10 for details None Pacer Reject Confi...

Page 156: ...a displays 1 HR unit 2 Parameter label 3 HR value 4 Low HR alarm limit 5 High HR alarm limit ECG digital area ECG Waveform Area The ECG waveform area displays 1 ECG Lead 2 ECG waveform size 3 ECG filter setting 4 Notch filter setting 5 ECG waveform 6 ECG scale 1 2 3 4 5 NOTE If an alarm for a parameter is disabled the symbol is displayed on the right of this parameter ...

Page 157: ...ted with 3 5 leadwire ECG cables for the TMS60 12 3 3 2 Setting QT Alarm Properties To set QT alarm properties follow this procedure 1 From the QT tab select the Alarm section 2 Set the desired alarm properties For the default alarm properties See Factory Default Parameter Alarm Settings on page 12 3 12 3 3 3 Changing QT Settings To change QT related settings follow this procedure 1 From the QT ta...

Page 158: ...hat the QT algorithm detects correct Q and T points 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 yellow The Q and T points are marked with a vertical line The QTc value is equal to the current QTc value minus the template QTc value QT View menu Set Baseline Configures the ...

Page 159: ...QTc alarm is off the alarm off symbol is displayed Buttons Description Settings Left or right arrow Select the desired lead to display on the QT View menu screen by selecting the left or right arrow II I III aVR aVL aVF V Set Baseline Set an ST baseline when ST values become stable None The QT template updated time displays at the bottom of the screen Hide Baseline Hides the reference baseline Non...

Page 160: ...set ST alarm properties follow this procedure 1 From the ST tab select the Alarm section 2 Set the desired alarm properties For the default alarm properties See Factory Default Parameter Alarm Settings on page 12 3 12 3 4 3 Changing ST Settings To change ST related settings follow this procedure 1 From the ST tab select the Setup section 2 Set the desired items Options or Buttons Description Defau...

Page 161: ...itions of ISO point and J point are automatically adjusted accordingly Disabled you need to manually adjust the position of ISO point and J point by selecting the arrows at the right sides of ISO and J ST Alarm Setup Configures the ST alarm settings For details about the ST alarms limits See Factory Default Parameter Alarm Settings on page 12 3 for details For details about the ST alarms responses...

Page 162: ...irority of ΔST alarm 12 3 4 6 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 1 Select the ECG digital area or waveform area to enter the ECG menu on the ViewBed...

Page 163: ...ter label 2 ST unit 3 ST alarm off symbol 4 Lead labels 5 ST numerics a positive value indicates ST segment elevation and a negative value indicates ST segment depression Example 5 lead ST digital area 12 3 4 8 ST Segment Display The ST segments display in the waveform area 1 Lead labels 2 ST markers ISO J ST 3 Current ST value 4 Baseline ST value 5 ST unit 5 lead ST segments 1 3 4 5 2 1 2 3 4 5 ...

Page 164: ...on page 12 23 12 3 5 2 Understanding the Arrhythmia Events Arrhythmia message Description Category Asystole No QRS detected within the set time threshold in absence of ven tricular fibrillation or chaotic signal Lethal arrhythmia V Fib V Tach A fibrillatory wave for 6 consecutive seconds A dominant rhythm of adjacent Vs and a HR the V Tach HR limit V Tach The consecutive PVCs V Tach PVCs limit and...

Page 165: ...r Not Pacing No pace pulse detected for 1 75 x average R to R intervals following a QRS complex for paced patients only Pacer Not Capture No QRS complex detected for 300 milliseconds following a pace pulse for paced patients only Missed Beats No beat detected for 1 75 x average R R interval for HR 120 or No beat for 1 second with HR 120 for non paced patients only or No beat detected for more than...

Page 166: ...eshold an alarm will be triggered To do so follow this procedure To change arrhythmia settings follow this procedure 1 From the Arrhythmia tab select the Threshold section 2 Set the desired items 12 3 5 5 Setting PVC Related Alarms Threshold PVC related alarms are detected on the basis of the current ventricular heart rate and the number of consecutive PVCs To set the threshold of PVC related alar...

Page 167: ...dy PVCs limit 5 and the Vent Rate is lower than the V Brady limit 40 a Vent Brady alarm is generated ƾ If both the V Brady PVCs and V Brady Rate are lower than the limits but V Brady PVCs is greater than 2 a Run PVCs alarm is generated ƾ If the V Brady PVCs and V Brady Rate are greater than or equal to limits but the Vent rate is is lower than V Tach Rate 130 a Vent Rhythm alarm is generated 12 3 ...

Page 168: ...l area or waveform area on the ViewBed screen of the CMS to enter the Resp menu 12 3 6 1 Setting Resp Alarm Properties To set Resp alarm properties follow this procedure 1 In the Resp menu select the Alarm tab and PR Alarm tab respectively 2 Set the desired alarm properties For the default alarm properties See Factory Default Parameter Alarm Settings on page 12 3 12 3 6 2 Changing Resp Settings To...

Page 169: ...RR value 3 RR source 4 Low RR alarm limit 5 High RR alarm limit 6 RR unit 12 3 7 SpO2 Monitoring At the CMS you can view and change the SpO2 settings in the SpO2 menu Select the SpO2 digital area or waveform area on the ViewBed screen of the CMS to enter the SpO2 menu Options Description Default Setting Gain Configures the Resp waveform size x2 Speed Configures the Resp wave speed 6 25mm s 1 2 3 4...

Page 170: ... ECG waveform related settings follow this procedure 1 In the SpO2 menu select the SpO2 Setup tab 2 Set the desired items 12 3 7 4 SpO2 Display SpO2 Digital Area The SpO2 digital area displays 1 Parameter name 2 High SpO2 alarm limit 3 PR label 4 PR value 5 High PR alarm limit 6 SpO2 unit of measure Options Description Settings Sensitivity Masimo only The option is not configurable The option sett...

Page 171: ... Manual 12 53 7 Low PR alarm limit 8 Masimo perfusion index value 9 PI label 10 Low SpO2 alarm limit 11 SpO2 value Masimo SpO2 digital area Nellcor SpO2 digital area 12 3 7 5 SpO2 Waveform Area The SpO2 waveform area displays 1 Parameter label 2 Pleth waveform SpO2 waveform area 1 2 3 4 5 6 7 8 1 2 ...

Page 172: ...u select the Alarm tab 2 Set the desired alarm properties For the default alarm properties refer to Factory Default Parameter Alarm Settings on page 12 3 12 3 8 3 Changing NIBP Settings To change NIBP related settings follow this procedure 1 In the NIBP menu select the Setup tab 2 Set Interval 12 3 8 4 NIBP Display The NIBP area displays numerics as shown below 1 Parameter label 2 Systolic pressur...

Page 173: ...ual 12 55 12 3 8 5 NIBP List When NIBP List is selected to display in the Tile Layout the NIBP list area displays multi ple sets of most recent NIBP measurements The displayed PR is derived from NIBP 1 9 2 3 10 4 5 7 8 6 NOTE NIBP List cannot be displayed on some screens such as the big numerics screen ...

Page 174: ...Monitoring at the CMS Version 03 00 or Above Monitoring with the TMS60 at the CMS 12 56 TMS60 Operator s Manual This page intentionally left blank ...

Page 175: ...y 13 2 Installing the Battery 13 4 Checking the Battery Charge Status 13 4 Removing the Battery 13 4 Charging the Rechargeable Lithium ion Battery 13 5 Storing the Batteries 13 6 Maintaining the Rechargeable Lithium ion Battery 13 7 Disposing of the Batteries 13 8 ...

Page 176: ...sing other 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 battery Unspecified lith ium ion battery can give unacceptable performance Use caution when handling the lithium ion rechargeable battery pack Misuse or abuse may cause bodily injury or device dam...

Page 177: ...r replacing the rechargeable lithium ion battery charge it in time Do not store the lithium ion battery whose batter power is depleted but is not charged yet To eliminate the risk of electrical shock or burn do not carry loose bat teries on your person such as placing the battery in clothing pockets CAUTION Remove the battery before transporting the device or if the device is not in use or is bein...

Page 178: ...N Some failure conditions such as short circuits can 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 Then remove the battery from the device and contact your service personnel to identify the cause of over heating Avoid scraping the metal contactor i...

Page 179: ...s designated by Mindray Only use the approved power cord with the grounded mains plug to firmly connect the central charger to a grounded AC mains socket Never refit the mains plug to fit an ungrounded AC mains socket Do not use the Multiple Portable Socket Outlets MPSO or AC mains extension cords Use an IEC 60601 1 approved isolation separation transformer otherwise it may result in leakage curre...

Page 180: ...inated Storing batteries in a cool place can slow the aging process Stored batteries should be charged to about 50 of their capacity every six months The battery should be fully charged prior to first use NOTE Remove the lithium ion battery from the device if the device is not used for a prolonged time for example several weeks and keep the device in clean place to avoid the dust or liquid enterin...

Page 181: ... of failure may increase with battery ser vice life due to the accumulated stresses of daily use Therefore Mindray strongly recom mend that lithium ion battery should be replaced after two years or 500 complete charge discharge cycles Using the outdated battery may cause the device abnormity and unacceptable performance NOTE Replace the AA battery tray on the battery compartment after removing the...

Page 182: ...has been used for more than two years or 500 complete charge dis charge circles Discharge the battery and insulate the terminals with tape before disposal Properly dis pose of the batteries according to local regulations 13 9 2 Disposing of the AA Batteries The batteries may be subject to local regulations regarding disposal Dispose of batteries in approved containers Follow local regulations if a...

Page 183: ...TMS60 Operator s Manual 14 1 14 Troubleshooting General Problems 14 2 Physiological Alarm Messages at the CMS 14 3 Technical Alarm Messages at the TD60 14 6 ...

Page 184: ...lication site If the error persists replace the sensor The SpO2 data is not displayed on the CentralStation 1 The SpO2 module is not con nected to the TD60 2 There may be error in the SpO2 module 1 Connect the SpO2 module to the TD60 2 If there is an error in the SpO2 module replace the SpO2 mod ule with a new one ECG noise ECG waveforms are overlapped with the noise interference Check if the ECG ...

Page 185: ...e prone to offline in certain area As there are many WiFi devices in this area communication between the TD60 and BP10 is interfered seriously Contact your service personnel Some TD60 or BP10 is prone to offline Device malfunction Symptom Possible cause Solution NOTE Physiological alarm messages for Resp and NIBP functionalities of the TMS60 telemetry monitoring system are only available at the CM...

Page 186: ... Brady High R on T Med Run PVCs Low Couplet Prompt Multiform PVC Med PVC Prompt Bigeminy Med Trigeminy Med Tachy Med Brady Med Pacer Not Cap ture Prompt The pacer appears abnormal Check the pacer Pacer Not Pac ing Prompt Missed Beats Prompt The ECG signal is so weak that the TD60 can t per form ECG analysis Check the patient s con dition and the ECG con nections Nonsus V Tach Med Vent Rhythm Med P...

Page 187: ...2 value has fallen below the desaturation alarm limit Check the patient s con dition and check if the alarm limit settings are correct No Pulse High The pulse signal was so weak that the TD60 can not perform pulse analy sis Check the patient s con dition SpO2 sensor and measurement site NIBP NIBP Sys Too High High The NIBP systolic pressure is higher than the upper alarm limit Check the patient s ...

Page 188: ...Alarm message Alarm level Alarm Indication Possible cause Solution ECG ECGLead Off Low B The electrode has become detached from the patient or the lead wire has become discon nected from the adapter cable Check the connec tions of the elec trodes and leadwires ECGXX Lead Off Low B ECG Module Error High A An error occurred to the ECG module There is a problem with the communications between the mod...

Page 189: ...pO2Too Much Light Low A There is too 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 signal Move the sensor to a site with better per fusion SpO2 Unplugg ed Low C SpO2 module connector is disconnected from the TD60 Reconnect the SpO2 module to the TD60...

Page 190: ...or occurs Check the airway NIBP Weak Signal Low C The patient s pulse is weak or the cuff is loose Check the patient s condition and change the cuff application site If the error persists replace the cuff NIBP Over range Low C The measured NIBP value is not within the specified range Contact your service personnel NIBP Exces sive Motion Low C Patient s arm moves too much Check the patient s condit...

Page 191: ... Replace the cuff NIBPCuff and Patient Mis match 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 not set Set the intervals NIBP NIBP S Over range Low A The measured NIBP value is not within the mea surement range Contact your service personnel NIBP Dia Over range Low A NIBP M Over...

Page 192: ...equired Med A The lithium ion battery is aging Power Low Bat tery Med A The battery charge is low Replace with a known good battery Critically Low Bat tery High A The battery charge is almost depleted Battery Mainte nance Required Med A The lithium ion battery is aging Battery Error Med A The lithium ion battery communication is error Battery Type Error Med A The battery contacts are in bad contac...

Page 193: ...dule communication or initialization Restart the TD60 If theproblempersists contact your service personnel Restor ing Last Defaults Failed Low C Restoring the last default configuration is error Loading Defaults Failed Low C Loading the default con figuration is error No CMS Low A The TD60 is disconnected from the CMS Check the network connection Measurement Alarm message Alarm level Alarm Indicat...

Page 194: ...Technical Alarm Messages at the TD60 Troubleshooting 14 12 TMS60 Operator s Manual This page intentionally left blank ...

Page 195: ...Introduction 15 2 Safety Information 15 2 Cleaning and Disinfecting the Equipment 15 3 Cleaning and Disinfecting ECG Leadwires and SpO2 Sensors 15 7 Cleaning and Disinfecting Other Parts 15 8 Sterilization 15 9 Impact of Improper Cleaning or Disinfection 15 9 ...

Page 196: ...evel of protection against electrical 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 hospital shall carry out all cleaning and disinfection procedures specified in this chapter Avoid use of cleaners materials or chemicals that may damage equipment surfaces labels...

Page 197: ...eroxide Hydrogen peroxide 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 ammonium chloride 8 704 n Alkydimethyl benzyl ammonium chloride 8 190 Virex TB n Alkyl dimethyl benzyl ammonium chlorides 0 105 n Alkyl dimethyl ethylbenzyl ammonium chlorides 0 105 Rely...

Page 198: ...17 2 PDI Sani Cloth 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 Hypochlorite 0 63 other ingredients 99 37 PDI Sani Cloth HB Germicidal Disposable Wipe n Alkyl dimethyl ethylbenzyl ammonium chlorides 0 07 n Alkyl dimethyl benzyl ammonium chlorides 0 07 PDI ...

Page 199: ...ing the equipment make the following preparation Install the battery pack or battery tray and firmly close to seal the battery compartment Insert the SpO2 cover in the SpO2 connector when SpO2 is not in use Insert the ECG leadwire plug into the ECG connector NOTE For equipment with the symbol all the listed cleaning and disinfecting agents are available for use For equipment without the symbol onl...

Page 200: ... place CAUTION Always dilute according the manufacturer s instructions or use lowest possible concentration Take extra care when cleaning the display screen because it is more sensitive to rough cleaning method Never allow the cleaning solutions to spill or enter the plug connector or battery compartment If liquid has accidentally entered the equipment or its parts shut down the equipment and have...

Page 201: ...Leadwires and SpO2 Sensors To clean and disinfect reusable ECG leadwires and SpO2 sensors refer to the instructions for use delivered with the accessory CAUTION To maximize effectiveness and minimize buildup of residual disinfectants please strictly adhere to disinfectant manufacturer s instructions for use Wring excess disinfectant from wipe before using Never allow the disinfectants to spill or ...

Page 202: ... servicing schedule To clean and disinfect other parts follow this procedure 1 Shut down the device 2 Remove the lithium ion battery pack or battery tray from the TD60 3 Unplug the ECG leadwire and SpO2 cable from the TD60 4 Clean and disinfect other parts with a soft cloth moistened with alcohol During cleaning and disinfection always avoid metallic objects 5 Wipe off the alcohol residue with a d...

Page 203: ...uctions for use delivered with the products accessories or supplies 15 7 Impact of Improper Cleaning or Disinfection Using cleaning agents or disinfectants other than those recommended may have the following impact Product discoloration Metal part corrosion Brittle and breaking wires connectors and equipment housing Reduced cable and leadwire life Overall system performance degradation Equipment m...

Page 204: ...Impact of Improper Cleaning or Disinfection Cleaning and Disinfecting 15 10 TMS60 Operator s Manual This page intentionally left blank ...

Page 205: ...ety 16 2 Regular Check 16 3 Maintenance and Testing Schedule 16 4 Power on Test 16 4 Verifying the ECG at the TD60 16 5 NIBP Accuracy Test 16 5 NIBP Leakage Test 16 5 Nurse Call Test 16 5 Electrical Safety Tests 16 5 Battery Check 16 6 Viewing System Information 16 6 ...

Page 206: ...al employing the use of this equipment to implement a satisfactory maintenance sched ule may cause undue equipment failure and possible health hazards The safety checks or maintenance involving any disassembly of the equipment should be performed by service personnel Otherwise undue equipment failure and possible health hazards could result No modification of this equipment is allowed Do not open ...

Page 207: ...epaired 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 environment and power supply meet the requirements Inspect the devices and their accessories for mechanical damage Inspect all plugs connectors leadwires for damage and make sure that their insulation is in goo...

Page 208: ...ing any repairs or replacement of rele vant component ECG verification Performance test 1 If the user suspects that the measurement is incorrect 2 Following any repairs or replacement of rele vant module 3 Once every two years Note NIBP test should be performed at least once a year Verification Resp test Performance test SpO2 test NIBP test Pressure check Leakage test Nurse call test If the user s...

Page 209: ...contact your service personnel 8 After completing the verification disable Calibrate ECG 16 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 16 8 NIBP Leakage Test The NIBP leakage test checks the integrity of the system and of the valve It is required at least once a...

Page 210: ...ery Check For details about the battery charge check and maintenance refer to Maintaining the Rechargeable Lithium ion Battery on Page 13 7 16 12 Viewing System Information To view the system information of the TD60 such as battery tap System Info from the main menu ...

Page 211: ...TMS60 Operator s Manual 17 1 17 Accessories ECG Accessories 17 2 SpO2 Accessories 17 3 NIBP Accessories 17 5 Miscellaneous 17 5 ...

Page 212: ...in this chapter Using other accessories 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 accuracy Check the accessories and their packages for any sign of damage Do not use them if any damage is detected Use the accessories before the expiry date if indicate...

Page 213: ...New Telemetry AHA Snap 36 009 004771 00 3 Lead New Telemetry AHA Pinch 24 009 004772 00 3 Lead New Telemetry AHA Pinch 36 115 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 Snap 24 Reusable Adult Pediatric 009 004783 00 5 Lead New Telemetry AHA Snap 36 009 004786 00 5 Lead New Telemetry ...

Page 214: ...tx Adult Single Patient Adhesive Sen sors 30 kg 20 box Disposable Adult 0600 00 0122 LNCS Pdtx Pediatric Single Patient Adhesive Sensors 10 50 kg 20 box Pediatric 0600 00 0126 LNCS DCI Adult Reusable Finger Sensor 30 kg Reusable Adult 0600 00 0127 LNCS DCIP Pediatric Reusable Finger Sensor 10 50 kg Pediatric PN Description Applicable property Applicable patient 115 054978 00 Nellcor SpO2 module Re...

Page 215: ...Description 022 000196 00 Li ion battery 3 8V 3800mAh 0000 10 10902 Alkaline 1 5 V AA battery for service personnel to perform debug ging only 0146 00 0077 10 L91 AA battery 045 001698 00 TP 2AA battery tray 045 001699 01 TP 3AA battery tray 115 032957 00 Disposable pouch 25 box DA8K 10 14452 US power cord 009 005409 00 USB upgrade cable 115 026852 00 Main unit of the central charger ...

Page 216: ...Miscellaneous Accessories 17 6 TMS60 Operator s Manual This page intentionally left blank ...

Page 217: ... 1 A Product Specifications Classifications A 2 Environmental Specifications A 2 Power Supply Specifications A 3 Physical Specifications A 4 Hardware Specifications A 5 Wireless Specification A 7 Measurement Specifications A 8 ...

Page 218: ...Mode of operation Continuous Degree of protection against harmful ingress of water TD60 IPX7 RC60 IPX0 Central Charger IPX0 Degree of protection against hazards of explosion Not suitable Equipment not suitable for use in the presence of a flammable anesthetic mixture with air with oxygen or nitrous oxide Degree of protection against hazard of dropping for the TD60 No damage by dropping from a heig...

Page 219: ...apacity for lithium ion battery 3500 mAh Charge time for lithium ion battery At the room temperature 5 hours to 90 charge Safety and authentication for lithium ion battery UL2054 IEC62133 UN38 3 Battery run time at 25 C 5 C with dis play off no sound and light as default no alarms display lit for one minute every two hours using L91 AA batteries P N 0146 00 0077 10 Two AA batteries Three AA batter...

Page 220: ...battery charge is full Size Weight TD60 126 mm 64 mm 23 mm 140 g without batteries SpO2 module ECG lead wires or accessories 210 g with two AA batteries and 3 lead ECG cable without the SpO2 module and any other accesso ries 140 g without batteries SpO2 module ECG lead wires or accessories 229g with a rechargeable lithium ion battery without SpO2 module ECG leadwires or accesso ries 233g with thre...

Page 221: ...een Screen size 3 5 Resolution 480 pixels 320 pixels Display Activation Power On Off key The switch time is less than or equal to two seconds LED Alarm lamp 1 three colors red yellow and cyan Audio Indicator Speaker 1 Sound Pressure Range 45 dBA to 85 dBA Keys Nurse call 1 Power On Off 1 Main menu 1 External Connectors ECG connector 1 SpO2 connector 1 ...

Page 222: ...nd communications status Power indicator 1 green indicates the power status Audio Indicator Buzzer 1 indicates internal abnormity External Connectors Ethernet connector 1 standard RJ45 connector Antenna connector 2 Charger slot 10 LED 10 which indicates the battery charge status AC power indicator 1 Installation mode Place on the desktop or mount on GCX wall channel ...

Page 223: ... and receiver box The receiver box can measure RSSI from TD60 and send it to the CMS A 6 1 3 Function Specification Protocol Private protocol Modulation mode GFSK Operating frequency band 608 MHz to 614 MHz Channel spacing 25 KHz Wireless baud rate 8 kbps 3 Transmit power 10 mW Receiver sensitivity 110 dBm Bit error rate 1 Data security Private protocol WARNING Do perform all network functions of ...

Page 224: ...rmal when the following conditions exist simultaneously The distance between interfering devices and the transmitter is greater than 20 centimeters The distance between interfering devices and the receiver antenna is greater than 100 centimeters 118dBm co channel WMTS interference exists at the receiver antenna Note The interfering devices include but are not limited to wire less devices operated ...

Page 225: ...riority All communication data type shall have the same priority Transmission distance Distinct vision distance between the TD60sTD60s is no less than 3 m Distinct vision distance between the TD60sTD60s and the BP10 is no less than 3 m System capacity OneTD60 can synchronously transport the device configuration to at least other five the TD60sTD60s in a 10 m2 space Five pairs of the TD60sTD60s and...

Page 226: ... 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 MΔ Bandwidth 3dB Monitor mode 0 5 Hz to 40 Hz ST mode 0 05 Hz to 40 Hz Common mode rejection ratio with Notch off Monitor mode 105 dB ST mode 105 dB Notch 50 60 Hz rejection capacity 20 dB Polarizing voltage scope 500...

Page 227: ...350 bpm Resolution 1 bpm Accuracy 1 bpm or 1 whichever is greater Sensitivity 160μV accuracy 0 1mV or 25 whichever is greater and the abso lute amplitude of signal is greater than 0 15mV HR averaging method In compliance with the requirements in Clause 201 7 9 2 9 101 b 3 of IEC60601 2 27 the following method is used If the last 3 consecutive RR intervals are greater than 1200 ms the 4 most recent...

Page 228: ... 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 Segment Analysis Measurement range 2 0 mV to 2 0 mV RTI Resolution 0 01 mV Accuracy 0 8 mV to 0 8 mV 0 02 mV or 10 whichever is greater Beyond this range Not specified Arrhythmia Analysis Arrhythmia analysis classificati...

Page 229: ... bpm to 150 bpm Pediatric 15 bpm to 180 bpm Resp Technique Trans thoracic impedance Lead Lead II Respiration excitation waveform 300 μA RM 32kHz 10 Baseline impedance range 200 Δ to 2500 Δ Bandwidth 0 2 Hz to 2 5 Hz 3 dB Sweep speed 3mm s 6 25 mm s 12 5 mm s 25 mm s Respiration Rate Measurement range Adult 0 rpm to 120 rpm Pediatric 0 rpm to 150 rpm Resolution 1 rpm Accuracy 7 rpm to 150 rpm 2 rpm...

Page 230: ...y testing on healthy adult volunteers in the range of 60 to 100 SpO2 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 collected over range of 70 100 SaO2 with a resultant accuracy of 2 9 SpO2 The following table shows the accuracy Arms for the SpO2 sensors...

Page 231: ...ology in a clinical study Adtx Pdtx PR Measurement range 25 bpm to 240 bpm Resolution 1 bpm Accuracy 3 0 bpm measured without motion 5 0 bpm measured with motion PI Measurement range 0 02 to 20 Least resolution 0 01 use three valid digits Response Time 25 s PR 75 bpm average time 8 s no disturbance SpO2 value rises from 50 to 100 20 s SpO2 value 98 average time 8 s no disturbance PR value rises fr...

Page 232: ...r s Manual DCI DCIP A 7 3 3 Nellcor SpO2 Module 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 Accuracy 20 bpm to 250 bpm 3 bpm 251 bpm to 300 bpm Not specified ...

Page 233: ...17 A 7 3 4 Fitting Curve for Nellcor SpO2 Sensors SpO2 Accuracy for Nellcor Sensors vs Co Oximeters Arms Modified Bland Altman for SpO2 DS 100A Sensor SpO2 SaO2 vs SaO2 SpO2 Range 100 to 70 100 to 90 89 to 80 79 to 70 DS 100A 1 64 1 16 1 67 2 25 D YS OXI P I 2 41 1 38 2 50 3 60 ...

Page 234: ...Measurement Specifications Product Specifications A 18 TMS60 Operator s Manual Modified Bland Altman for SpO2 D YS OXI P I Sensors SpO2 SaO2 vs SaO2 ...

Page 235: ...TMS60 Operator s Manual B 1 B EMC ...

Page 236: ...lectromagnetic interference of nearby equipment It may be necessary to take mitigation measures such as re orienting or relocating the non ME EQUIPMENT or shielding the location This device is intended for use in professional healthcare facility envi ronment If it is used in special environment such as magnetic reso nance imaging environment the equipment system may be disrupted by the operation o...

Page 237: ... precautions regarding EMC and needs to be installed and put into service according to the EMC information pro vided below Other devices may affect this device even though they meet the require ments of CISPR When the inputted signal is below the minimum amplitude provided in technical specifications erroneous measurements could result The EMISSIONS characteristics of this device make it suitable ...

Page 238: ... than 3 m Mains power quality should be that of a typi cal commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Voltage dips and Voltage interruptions IEC 61000 4 11 0 UT for 0 5 cycle 0 UT for 1 cycle and 70 UT for 25 30 cycles 0 UT for 250 300 cycle 0 UT for 0 5 cycle 0 UT for 1 cycle and 70 UT for 25 30 cycl...

Page 239: ...watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site sur veyb should be less than the compliance level in each frequency rangec Interference may occur in the vicinity of equipment marked with the following sym bol 6 Vrms in ISM bands and amateur radio bandsa bet...

Page 240: ...ges 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 intended for use in an electromagnetic environment in which radiated RF disturbance are con trolled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum di...

Page 241: ...TMS60 Telemetry Monitoring System Operator s Manual C 1 C FCC Compliance ...

Page 242: ... with each other Therefore we don t suggest that the equipment can be installed or operated within 80 kilometers of 1 National Astronomy and Ionosphere Center Arecibo Puerto Rico 18 20 38 28 North Latitude 66 45 09 42 West Longitude 2 National Radio Astronomy Observatory Socorro New Mexico 34 04 43 North Lat itude 107 37 04 West Longitude 3 National Radio Astronomy Observatory Green Bank West Virg...

Page 243: ...ng System Operator s Manual C 3 The radio device used in this product is in compliance with the essential requirements and other relevant provisions of Directive 1999 5 EC Radio Equipment and Telecommu nications Terminal Equipment Directive ...

Page 244: ...FCC Compliance C 4 TMS60 Telemetry Monitoring System Operator s Manual This page intentionally left blank ...

Page 245: ...TMS60 Operator s Manual D 1 D Symbols and Abbreviations Units D 2 Symbols D 3 Abbreviations D 3 ...

Page 246: ... 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 meter mg milligrams min minute ml milliliter mm millimeters ms millisecond mV millivolt mW milliwatt nm nanometer ppm part per million s second V volt VA volt ampere Δ ohm μA microampere μm micron ...

Page 247: ...minus multiply copyright AAMI Association for Advancement of Medical Instrumentation AC alternating current AHA American Heart Association ANSI American National Standard Institute ARR arrhythmia ART arterial AUX Auxiliary output aVF left foot augmented lead aVL left arm augmented lead aVR right arm augmented lead CH channel CISPR International Special Committee on Radio Interference CMS central m...

Page 248: ... ISO International organization for standardization MRI magnetic resonance imaging LA L left arm LAP left atria pressure LED light emitting diode LL F left leg Loop loop read write test fail M MEAN mean pressure O2 oxygen P power PR pulse rate QRS interval of ventricular depolarization QRS complex RA R right arm RL N right leg ROM read only memory SpO2 arterial oxygen saturation from pulse oximetr...

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