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TCM4/40 operator`s manual

1. 5 4 pO alarm pO parameter only 3 20 Polysomnograph 6 21 Power socket 2 4 Power switch 2 4 PPMS monitor 6 24 configuration 6 27 Print reports 6 43 Printer setup 3 17 Printer type 3 18 Printing 6 38 Printouts 3 18 Index Proprietary name 1 2 Pulse alarm 3 12 lO Wi as 3 12 Pulse oximetry measuring principles 9 16 Pulse rates 6 4 Pure text messages 7 8 R Rear view 2 4 Recharging battery 4 7 Relative humidity 4 2 Remembraning 4 10 Removal of wraps 6 10 Report CUI VE pe deridet oe 6 41 table tees 6 39 Requirements ambient temperature 4 2 environmental 4 2 4 2 relative humidity 4 2 ventilation esses 4 2 Response time 8 9 DO d ideae ote tesis 8 9 Results Normal 6 16 Trend curve view 6 19 Trend table view 6 18 S SatSeconds 3 12 6 36 safety net 6 37 Saturation 6 4 9 16 Saturation monitoring 6 8 Screen general elements 2 5 Inenuanc cenae ehe erts 2 5 ta ERE TRES 2 5 VIC Wu ctus tiet 2 5 when not activated for 30 5 3 2 3 5 Screensaver 3 6 3 21 Sensor E3480 dc tente endis 6 6 S
2. Analog Wire Range output color Ground Blue N A Alarm Pink Activated 1000 mV 10 mV Not activated 0 mV 10 mV Heat Brown 1 mV mW 10 1000 mW 10 mV 10 mW lt 10 mW 0 mV Temp Green 20 mV C 10 50 C 10 mV 0 50 C tcpCO Grey 10 mV mmHg 0 100 mmHg 10 mV 1 mmHg 5 mV mmHg 0 200 mmHg 10 mV 2 mmHg Yellow 5mV mmHg 0 200 mmHg 10 mV 2 mmHg 1 mV mmHg 0 800 mmHg 10 mV 10 mmHg SpO gt White 10 mV SpO 0 100 1 SpO Pulse Red 4 mV bpm 20 250 bpm 10 mV x 3 bpm On the monitor press Setup Technical Enter the password and press Enter and Tech settings Use the Down arrow to select the pCO analog range and choose the 0 100 or 0 200 range Use the Down arrow to select the pO analog range and choose the 0 200 or 0 800 range Press OK to accept the changes and return to the main screen NOTICE To test the analog output calibrate the monitor When the calibration is complete the analog output will correspond to the tcpCO and tcpO readouts on the display 6 21 6 Patient monitoring TCM4 40 operator s manual Continuous data output standard Introduction The monitor is equipped with a continuous data output for direct connection to an external PC Connecting to Step Action externa PG 1 Connect the TCM4xx ETX Serial Adapter code no 636 649 to the serial port on the monitor and to the PC The RS232
3. ener ener enne 4 7 Preparation and maintenance of the tc sensors eee eee esee ee eee eene neenon 4 9 General information about remembraning 4 10 Cleaning the sensor head of the E5480 sensor sssssessesseeeeee 4 11 Membraning the E5480 0 1 ene eene entren 4 12 Membraning the E5280 and E5260 sensors 4 13 Cleaning disinfection and storage of sensors sssssssssseeeeeneene 4 15 Maintenance of the SpO sensors eese ceres ee 4 16 4 Installation and maintenance TCM4 40 operator s manual Operating requirements Environmental requirements Ventilation requirements 4 2 WARNING Risk of incorrect measurements Do not use the monitor adjacent to or stacked with other equipment as these can cause electromagnetic interference and thereby result in incorrect measurements If stacking or use adjacent to other equipment is necessary the monitor should be observed to verify normal operation before used on patients See the section EMC approvals and compliance in chapter 8 WARNING Risk of incorrect measurements When installing operating or servicing the monitor special consideration should be given to the information regarding the electromagnetic precautions for this equipment given in t
4. 4 3 Shutting down the monitor esses enne nnns 4 5 Contents TCM4 40 operator s manual Cleaning the monitor oett err erem ed eed eae egeo 4 6 Maintenance of the monitor esses 4 7 Preparation and maintenance of the tc sensors eere sees etes eene eee ense ne enaetn 4 9 General information about membraning 4 10 Cleaning the sensor head of the E5480 sensor ssssssssseeee 4 11 Membraning the E5480 Sensor cccesccesscssscessceeeeeeeeeeseeeseeescecsaecaecnaeenseenseenes 4 12 Membraning the E5280 and E5260 sensors 4 13 Cleaning disinfection and storage of sensors sse 4 15 Maintenance of the SpO sensors 4 eee eee eese eene eee n sense ta seta setas etes sns tn use 4 16 ctv eoe oti ee fe rep ade pde dd nud 5 1 General information e eiin o a TRE Rep ens eT RETO 5 2 Calibration eee een eo PRI RE ee VET Eie cede 5 3 Checking zero current and sensitivity essen 5 4 Patient monitoring esee eee sete seta states tons toss tas ease rapon soosoo ossos 6 1 General information ey EC tre 6 2 Application and removal of tc sensors sess 6 6 Application of SpO sensors ener 6 8 Patient monitoring In vivo monitoring 6 11 Patent DMS 5 2 E ONE SPUR EUN RE INE a RI
5. EA A E E 3 5 Trend table Vie Wenst e a eerte 3 7 THONG CURVE A AAA E E E E AE A E 3 8 3 4 TCM4 40 operator s manual 3 Menu structure and setup programs Normal view Introduction Accessing the program Selecting Normal view options In the Normal view setup it is possible to select which parameters will be shown in Normal view to set the time span of the graphical display and to activate the screen saver NOTICE If no touch key is activated for 30 seconds the main screen Normal view is displayed To access the Normal view setup press Setup Normal Normal view setup on TCM40 monitor View Parameter Technical Calibration Printer r View pCO SpO A SpO r Curve ranges Screen ae Time span Normal Trend table Trend curve Normal view setup on monitor View Parameter Calibration Printer Technical r View Time span Normal Trend table Trend curve ft t r Curve ranges Screen pCO Power EN dis Step Action 1 Use the Up and Down arrows to select the curves that are to be shown in the curve area in Normal view NOTICES e Parameter values will always be shown e The number of parameters to choose from depends on the sensor type installed combined pCO pO or pCO only and whether the pO parameter is set to
6. 9 16 measuring principles 9 16 AOTRE TO cise eas teet 9 16 sensor performance 1 6 5 SpO alarm lorum 3 12 dad scores 3 12 SpO module 2 3 SpO monitoring required materials 6 8 TCM4 40 operator s manual Stabilization time of patient 6 11 Standard calibration gas 5 4 Standard data output 6 22 Storage of sensor 4 15 Symbols used in the manual 1 6 used on the monitor 1 4 T Table report 6 39 6 40 TCMA Series monitoring system 1 2 TCM4 40 monitoring systems 1 2 TCM40 performance considerations 6 4 TCM40 SpO module 9 16 electrolyte solution 9 10 Technical alarms 6 34 Technical settings 3 20 Technical setup 3 19 Temperature sensor 6 2 Time settings 3 22 Touch key glossary 2 9 Touch screen 2 3 Traceability certificates 9 11 Trend curve view 3 8 6 19 Trend table view 3 7 6 18 Troubleshooting cause of 7 2 dialog box messages 7 6 error 7 3 7 2 pure text messages 7 8 recommended operator actions 7 2 symptoms eeseeeen 7 2 Tutorials 2 6 2 8 U USB 6 33 USB ports 2 4 6 38 Valve key 8 15 Ventilation requirements 4 2 View screen configuration 2 5 touch keys
7. Membraning the sensor Step 1 2 3 LAS XY Y E lt Y 4 Y vY 5 4 12 To membrane the sensor use a membraning kit code no 905 805 Action Apply two drops of electrolyte solution to the membraning tool NOTICE Ensure that there are no air bubbles in the electrolyte solution If air bubbles are present wait a few seconds and check again Place the sensor without the protection cap in the sensor slot a To remove the old membrane grip the membraning tool firmly at both ends b Pull in the direction of the arrows until only one arrow is visible in the sensor slot To click on the new membrane pull forcefully in the direction of the arrows until the tool locks and no arrows are visible in the sensor slot Remove the sensor and wipe off the surplus electrolyte solution with cleaning paper TCM4 40 operator s manual 4 Installation and maintenance Membraning the E5280 and E5260 sensors Membraning the To membrane the sensor use a membraning kit code no 904 892 sensor Step 2 On Or Action Remove the protection cap Then remove the old O rings by sliding the O ring remover under the O ring just above the arrow on the sensor house Turn the O ring remover clockwise to release the two O rings Peel off the old membranes Clean the sensor surface Absorb the old electrolyte solution wi
8. Normal VIEW ID 21012009 0000 pCO pO pCO mmm Corr Power 253 mW Ready Tena 430 5 mmHg pO A NE Pulse bpm _ Spo mm mm mm HI OFF Site time i i pie Tutorial Calibrate Setup om 15 56 2 Normal view o pCO pO pCO A mmm Corr Power 244 mW Ready SEE 430 C mmHg A mmm Power mW Site time i i Tutorial Calibrate A Setup NOTICE In Measuring mode the Event touch key replaces the Tutorial key Gives access to Patient DMS Site time xx xx Tutorial Event Calibrate Print Setup Alarm silence Resets the site timer to its preset value see Parameter setup Gives access to instruction videos when not monitoring Marks an event during monitoring Starts a calibration of the sensor and the SmartCal period if the function is set to ON in the setup Gives access to the Printer start stop time screen Gives access to all the setup menus and submenus Silences resets the alarm system Continued on next page TCM4 40 operator s manual 2 What is what The screen general elements Continued Menu screen The menu screens are divided into the following fields configuration Menu tabs Submenus settings Touch keys The menu screens contain the following tabs which give access to the setup menus and submenus View Parameter Calibration Printer and Technical password protected Ex
9. sss 2 6 View setup 3 4 Views Normal sseeee 3 5 Trend 3 8 Trend 3 7 VueLink 6 24 Waste of Electrical and Electronic Equipment 1 4 WEEE 1 4 What is what 2 1 Z Zero current 5 4 Index TCM4 40 operator s manual TCM4 40 operator s manual Date of issue Date of issue Radiometer representative If you have any questions or need assistance please contact your local Radiometer representative Manufacturer RADIOMETER Radiometer Medical ApS Akandevej 21 2700 Br nsh j Denmark www radiometer com TCM4 40 monitoring systems operator s manual from software version 3 00 Publication 201101 Edition C Code number 994 041 0459
10. Recommen Check the barometer of the monitor against a known calibrated barometer dation periodically See ranges in chapter 8 Specifications and ordering information 5 2 TCM4 40 operator s manual 5 Calibration Calibration Calibrating the If the SmartCal function is OFF the sensor must be calibrated manually using the sensor manually procedure below WARNING Risk of incorrect measurements When performing a gas calibration make sure the calibration gas mixture is set to 7 5 for pCO and 20 9 for pO as incorrect calibration values may cause incorrect measurements See Technical settings in chapter 3 Menu structure and setup programs Step Action 1 Make sure the sensor is placed in the calibration chamber 2 Press Calibrate A bar appears on the screen showing the progress of the calibration Furthermore the screen contains information on barometric pressure and if there is 10 or less gas left in the gas cylinder a bar will show the gas level NOTICES e If SmartCal has been activated in the setup pressing the Calibrate touch key will start the SmartCal period e During calibration it is not possible to reactivate the Calibrate touch key which will be grayed out 3 When the calibration is complete the Ready screen appears NOTICES e Ifthe sensor has been remembraned or if it has not been used for 24 hours or more it must be calibrated twice Either calibrate the sensor leave it in the
11. Accessing the program pO settings Selecting pO settings To access the pO setup press Setup Parameter gt ON OFF NOTICE The alarm is triggered if the parameter value exceeds or is equal to the alarm limit high or low It consists of a visual part the parameter value and an alarm text will be flashing and an acoustic part a discontinuous tone pO alarm high 1 800 mmHg in steps of 1 0 1 99 9 kPa in steps of 0 1 0 99 mmHg in steps of 1 0 0 9 9 kPa in steps of 0 1 Alarm sound 1 5 1 is minimum level Sensor temp 37 0 45 0 C in steps of 0 5 NOTICE If the set sensor temperature is changed during measurement a new calibration is required SmartHeat ON OFF NOTICE If SmartHeat is set to ON it adds 1 C max temp 45 C to the set sensor temperature for 5 minutes after the sensor has been removed from the calibration chamber OFF 5 12 hours in steps of hour Site time heat ON OFF NOTICE If Site time heat is set to OFF the sensor heat is switched off when the site timer reaches zero if set to ON the heat continues The setting of this option is common to pO and The settings of these options are common to pCO and pO Step Action 1 Select the relevant option with the W touch key 2 Choose the settings of that option with the Up or Down arrow key 3 Follow steps 1 2 for the remaining options 4 Press OK to accept the ch
12. Power mW SpO2 Pulse bmp 10 15 25 30 30 11 07 38 42 0 227 98 71 11 15 25 40 30 11 07 38 42 0 227 97 12 15 25 50 30 11 07 38 42 0 228 13 15 26 00 30 11 07 38 42 0 228 14 15 26 10 30 11 07 38 42 0 227 15 15 26 20 30 11 07 38 42 0 228 16 15 26 30 30 11 07 38 42 0 228 17 15 26 40 30 11 07 38 42 0 227 18 15 26 50 30 11 07 227 cc 4 Ready 7 Save Log Excel worksheet 6 32 TCM4 40 operator s manual 6 Patient monitoring Data export USB Introduction With this option patient information and a dump of the trend data can be exported to a memory stick through one of the USB ports Exporting data Step Action 1 Connect memory stick to one of the USB ports monitor 2 Press Setup Technical enter password and press Enter Tech Settings 3 Set Data export to USB and Data export interval to 2 10 30 or 60 seconds Then press OK Press ID to access Patient DMS Select the patient ID s session s to export and press Export The selected data will be exported to the USB port NOTICES e f a memory stick is not connected to the monitor a dialog box will be displayed asking the user to insert a USB storage device The user can either cancel the data export by pressing Cancel or insert a memory stick and press OK to initiate the data export While data is being exported a status dialog will be displayed It will no
13. is released from the skin it diffuses through the membrane into the electrolyte where it reacts with water forming carbonic acid which immediately dissociates into HCO and according to the following equation H O CO 2 H CO 2H HCO The changes in the electrolyte imply changes in pH As the pH in the electrolyte changes the voltage between the glass electrode and the reference electrode changes The pH change is converted to a pCO reading on the basis of the linear relationship between pH and log pCO as expressed by the Henderson Hasselbalch equation pH pK log COS ax pCO where pK dissociation constant of carbonic acid concentration of HCO a solubility coefficient of dissolved CO pCO partial pressure of CO As no charged molecules can penetrate the membrane the change in pH is strictly due to the carbon dioxide diffusion into the electrolyte The potential measured across the combined electrode chain is fed into the pCO channel where it is digitized The digitized signal is then passed on to the microcomputer where it is converted to display pCO in mmHg or kPa The monitor is based on a microcomputer system in which all data obtained by the sensor are collected processed and compared with the alarm limits preselected in the monitor s setup programs prior to presentation on the screen In most clinical settings transcutaneous pCO monitoring is performed using t
14. 2 What is what TCM4 40 operator s manual Touch key glossary Continued Touch keys continued Touch key Accepts the changes made in the settings and returns to the main screen In the Parameter menu it gives access to the pCO parameter setup In the Trend curve setup it gives access to the pCO curve range screen In the Parameter menu it gives access to the pO parameter setup In the Trend curve setup it gives access to the pO curve range screen Resets the site timer to its preset value see Parameter setup SmartCal Keeps the electrode ready for use 1 e calibrated for max 12 hours SpO7Pulse In the Parameter menu it gives access to the SpO Pulse parameter setup In the Trend curve setup it gives access to the SpO Pulse curve range screen Part of the Service setup only for service purposes Tech settings Gives access to the Technical settings password protected Part of the Service setup only for service purposes Touch screen Part of the Service setup only for service purposes calibration Gives access to the Trend curve setup Trend table Gives access to the Trend table setup Gives access to instruction videos Continued on next page 2 10 TCM4 40 operator s manual 2 What is what Touch key glossary Continued keys A v Scrolls the displayed screen parameters upward or or downward lt p Scrolls the displayed screen parameters forward or or backwar
15. At the time of printing the manual is in conformity with the systems All rights are reserved for instruments circuits techniques and names appearing in the manual The TCMA monitoring system is intended for continuous transcutaneous monitoring of carbon dioxide tcpCO and oxygen tcpO partial pressures It is indicated for use on neonates pediatrics and adults not under gas anesthesia The TCM40 monitoring system is intended for continuous transcutaneous monitoring of carbon dioxide tcepCO and oxygen partial pressures as well as of oxygen saturation of arterial hemoglobin SpO and pulse rate It is indicated for use on neonates pediatrics and adults not under gas anesthesia The sensors are provided non sterile and are intended for reuse For information on site locations see the relevant section about application of sensors in chapter 6 In vivo monitoring In hospital clinical environment Only trained health care personnel are permitted to use the monitor Transcutaneous monitoring is intended only as an adjunct in patient assessment and must be used in conjunction with clinical signs and symptoms WARNING Risk of incorrect measurements tcpCO tcpO monitoring should not be used on patients in a compromised hemodynamic state as this may cause incorrect measurements WARNING Risk of incorrect measurements The DS100A SpO sensor is contraindicated for use on active patients or for prolonged use
16. Henderson Hasselbalch equation 9 5 High frequency electrical signals 6 3 Hyperbaric chamber 4 2 6 3 HyperTerminal 6 22 6 30 Hyperthermia 6 3 Importing data files into Microsoft Excel 6 31 In vivo calibration 3 20 6 45 In vivo monitoring 6 11 Inaccurate measurements 6 4 6 5 8 11 Installation 4 3 Intended use 1 2 Interference from ambient light 6 5 known 8 11 K Keyboard 6 15 L Latching alarm 6 34 Light absorption 9 16 Line fuse 2 4 Linking session 6 12 Local vasodilation 9 4 Loss of pulse signal 6 4 6 5 8 11 TCM4 40 operator s manual M Main screen when not activated for 30 5 3 2 3 5 Markings normal 1 6 17 trend 6 20 trend table 6 18 Measurement DGQOs i eiu 9 5 DO 9 6 SpO ui opere e optio ed 9 16 Measuring principle dtd ES 9 5 DOK 9 6 SpOsai ictum aedis 9 16 Measuring sites 6 2 Membraning 4 10 E5260 4 13 E5280 4 13 E5480 4 12 Menu screen configuration 2 7 touch keys 2 7 Menu structure 3 2 Meta corr factor 3 20 Module release 2 4 Modules aun dus 2 3 tepCO tcpO gt E
17. Index Index A randier 2 3 4 7 Accessories recharging sess 4 7 additional items 8 15 Biocompatibility 8 12 8 14 Blood gas comparison 6 44 line cords 8 15 Blood gas values membraning Kit 8 14 calibrating transcutaneous SpO starter kits 8 14 measurements against 3 13 6 45 TCM4 40 documentation 8 14 comparing transcutaneous TCM4 40 systems 8 14 measurements with 3 13 6 44 Accuracy DGO sip eie rs 8 9 DOS aie tiere its 8 9 CALI 9 10 pulse ate tdt gets 8 10 CAL2 9 10 SPO ire te e nete nito 8 10 Calibration Alarm 5 2 DCO eese 3 10 frequency 5 2 DOS etsi 3 11 In VIVO Be 6 45 PulSe sien 3 12 5 3 TESCU Aus e eT 6 35 materials esses 5 2 SatSeconds 6 36 patient 5 9 9 5 6 35 process 9 8 SpO3 x sus 3 12 recommendation 5 2 6 35 SpO 9 17 VueLink 6 27 with calibration gas 5 3 Alarm mode Calibration chamber 2 3 latching sheer 3 20 Calibration gas 9 10 non latching 3 20 Calibration setup 3 14 Alarm sound leve
18. 8 Specifications and ordering information Specifications Continued EMC approvals and compliance continued Other approvals and compliance Recommended separation distances between portable and mobile RF communications equipment and the TCM monitor The monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the monitor as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter in meters Rated output power of 150 kHz to 80 MHz to 800 MHz to malls aioe d 124P d 234P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at an output power not listed above the recommended separation distance d in meters can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in the corresponding column NOTICES e At 80 MHz and 800 MHz the higher frequency range applies e These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Pati
19. Capture text Stop The following shows a screen from HyperTerminal File Edit View Call Transfer Help 21581 al3 ele cs 158 8 mmHg 74 bpm 158 8 mmHg 74 bpm 158 8 mmHg 73 bpm 158 8 mmHg 73 bpm 158 8 mmHg 72 bpm 158 8 mmHg 72 bpm 158 8 mmHg 74 bpm 158 8 mmHg 74 bpm 158 8 mmHg 74 bpm 158 8 mmHg 74 bpm 158 8 mmHg 75 bpm Disconnected auto detect 96008 1 SCROLL CAPS Capture Print echo NOTICES e Data is easily imported into other programs e g Microsoft Excel see the procedure under Data export serial e It is possible to have analog and serial output at the same time The analog wires are short circuit proofed 6 23 6 Patient monitoring TCM4 40 operator s manual Continuous data output VueLink Introduction Required items Possible PPMS monitors Connecting to PPMS monitor 6 24 With a VueLink interface module type B parameter values and attached alarm limit values can be exported from a TCM monitor to a Philips Patient Monitoring System PPMS The presentation of the data corresponds to Normal view NOTICE Only the parameter values are displayed on the PPMS The alarm limit values can only be used by a data management system connected to the PPMS e TCM4 40 monitors software version 2 10 or newer e PPMS monitor connected to one or more module racks e VueLink interface module type B M1032A A05 e Connecting ca
20. enne 1 6 Whialis Iri P S TCM4 A40 monitoring 2 2 Monitor top and nennen ener enne enne 2 3 teat MES 2 4 The screen general elements sse 2 5 Online eant 2 8 To ch key glossary ce DR e E ERR nete 2 9 Menu structure and setup programas 4 e cesse esee ee eee eese en esso seen ss enseenseenseesseesses J L Str ctute 3 2 List of setup enne enne nnne innen 3 3 VIEW E ue 27 Normalsview deett eie eese iet ee ee 3 5 teet aet et dt et Tes tastier edt Dee eta deti gon 3 12 Blood gas Ud pe EU REG LEES 3 13 Calibration set Presses osason saisi SmartCal EE 3 15 Calibration status ee deletae eset fee tede e dieta ie 3 16 SECU Py p E LT Technical Setup m D Technical set ngs 2 595 2 0S WE ct tee uie 3 20 Date time d te EROR REG UTR RE iC SR es 3 22 Default values 3 23 Installation and maintenance eeeeee sees ee esee ee seen enses sese sssees sees 4 1 Operating requirements iere rere etate 4 2 Installing the monitoring
21. 02 33 00 02 03 04 34 158 33 97 72 02 34 00 02 03 04 34 158 37 97 72 02 35 00 02 03 04 34 158 97 72 02 36 00 02 03 04 158 40 97 72 02 37 00 02 03 04 34 158 43 97 72 02 38 00 02 03 04 34 158 46 97 72 02 39 00 02 03 04 34 158 51 97 72 02 40 00 02 03 04 34 158 52 97 72 02 41 00 02 03 04 34 158 52 97 72 Printed 02 53 07 02 03 2004 Page 1 Continued on next page 6 39 6 Patient monitoring TCM4 40 operator s manual How to print Continued Example of RADIOMETER TCM4 SERIES table report Connie Transcutaneous measurement tcpCOztcpO SpO Pulse Facility name Patient name ID Comments Physician s signature Date Printed 02 53 07 02 03 2004 Page 2 Continued on next page 6 40 TCM4 40 operator s manual 6 Patient monitoring How to print Continued Example of RADIOMETER TCM4 SERIES curve report Transcutaneous measurement tepCO tepO SpO Pulse Measuring unit tepCO tepO mmHg Sensor temperature 42 0 C Power mW Last calibration 01 27 07 02 03 2004 SpO2 Last calibration value pCO 80 mmHg Pulse bpm 160 mmHg Facility name Patient name ID amp Blood gas event mark n vivo calibration 800 mmHg tcpOz 400 Ck ck ck ck ck ck ck 0 0 T T I T 02 27 02 31 02 35 02 39 02 23 00 02 03 2004 02 41 00 02 03 2004 200 mmHg tcpC O2 100 4 0 T T T T 02 23 00
22. 1 6 38 TCM4 40 operator s manual Action Shut down the monitor by following the procedure described in chapter 4 Installation and maintenance Connect an HP printer with PCL3 protocol to one of the USB ports on the rear of the monitor Switch on the monitor Action If required go into Printer setup to change the printer settings see chapter 3 Menu structure and setup programs Press Print and set the printer start and stop times NOTICES e The monitor must be connected to a printer with PCL3 protocol e The memory function holds a total of 48 hours of monitoring data e The printed report will be performed in accordance with the printer settings selected in the printer setup e The time span selected in the printer setup will influence the start time of the Printer start stop time screen as the interval between the printer start and stop times corresponds to the time span 1 e if the time span is set to 1 hour the interval between the printer start and stop times will also be 1 hour See Printer setup in chapter 3 The scroll interval depends on the time span selected in the printer setup If the time span is set to less than 1 hour the scroll interval will correspond to the exact time span e g 5 15 or 30 min If the time span is set to 1 hour or more the scroll interval will be 1 hour e The stop time is set to current time and then adjusted to match the time of the latest data record The stop time c
23. AUXILIARY PLUS 1 connection to the module has already been established e t is possible to insert several VueLink interface modules in the PPMS monitor and they will then be called VueLink B 2 VueLink B 3 etc Wait for the text Connect device or switch to new device to disappear NOTICE If the text has not disappeared after 30 seconds check the cable connection If the cable connection is okay see chapter 7 Troubleshooting for further operator actions Select the Setup VueLink softkey The AUXILIARY PLUS 1 tab containing the parameter values from the TCM monitor appears Example of task The task window AUXILIARY PLUS 1 is displayed automatically when window on connection between the TCM and the PPMS monitors has been established PPMS monitor Parameter Asterisk Unit lt AUMILLARY PLUS 1 gt Device type Device name Device Alarms Accepted Alarm status indication Receiving Data since 20 JAN 04 8 08 Time Update Values Only one of these two functions is accessible at a time Continued on next page 6 25 6 Patient monitoring TCM4 40 operator s manual Continuous data output VueLink Continued Example of task NOTICES window on e Transmission of data from the TCM monitor to the PPMS monitor may be PPMS monitor delayed with up to four seconds continued e Printout of data from the TCM monitor may cut off the connection between the TCM and the PPMS
24. It is not designed for long term monitoring Using this sensor for long term monitoring may result in incorrect measurements Continued on next page TCM4 40 operator s manual 1 Introduction Names intended use and limitations Continued WARNING Risk of allergic reactions The OXIband A N SpO sensors are contraindicated for use on patients who exhibit allergic reactions to the pressure sensitive adhesive on the wraps CAUTION US federal law restriction Federal law restricts this device to sale by or on the order of a physician NOTICE This equipment is not a blood gas device Legal notices e Instruments should be repaired by authorized service personnel or by Radiometer certified representatives only e Purchase of the TCM40 monitoring system confers no express or implied license under any Nellcor patent to use this instrument with any oximetry sensor that is not manufactured or licensed by Nellcor 1 3 1 Introduction TCM4 40 operator s manual Symbols used on the monitor Symbol Explanation CSA approved S Caution consult accompanying documents Temperature limitation Indicates that the product complies with the requirements of the Medical Device Directive 93 42 EEC June 1993 This product is a class IIa device Type BF equipment body floating USB Waste of Electrical and Electronic EEE WEEE The symbol indicates that e Radiometer Medical ApS and its distrib
25. NTC resistors Local vasodilation 9 4 am U LINZ SSS NOTICE The single tcpCO sensor E5260 is identical to the tepCO tcpO sensor E5280 except that it does not contain an active platinum cathode the pO part Component NTC resistors temperature sensors Platinum cathode pO part OO O oO C e orines o seue me menas O O i The temperature of the sensor is measured by the NTC resistors incorporated in the Ag AgCl reference electrode Due to the high thermal conductivity of the silver body the NTC resistors respond quickly to any changes in temperature The thermostatting system will keep the sensor at the preset temperature When the sensor is attached to the skin the generated heat is transferred from the heating element via the silver body to the skin surface The heat produces local vasodilation and increases the permeability of the skin to oxygen and carbon dioxide thus making a measurement on the skin surface possible TCM4 40 operator s manual 9 Functional description pCO measuring principle Definition Measuring principle Severinghaus temperature correction The measurement of pCO is defined as the partial pressure or tension of carbon dioxide It is performed by means of a Stow Severinghaus electrode based on an electrochemical electrode chain consisting of a pH glass electrode the sensor electrode and a silver chloride reference electrode As
26. appears Press OK to change all parameter and monitor settings to factory defaults or Cancel to exit without changing settings List of default Settings Default settings Normal view Curve selection TCM40 monitor pCO pO SpO TCMA monitor pCO pO Power Time span 1 hour Table view Time interval 15 minutes Curve view Time span 8 hours Curve selection TCM40 monitor pCO and SpO TCM4 monitor pCO and pO Curve range 60 mmHg 8 0 kPa Continued on next page 3 23 3 Menu structure and setup programs TCM4 40 operator s manual Default values Continued PS Aum sun evel 2 pO alarm high 95 mmHg 12 7 kPa Alarm sound level Sensor temp SmartHeat OFF SpO Pulse ON Calibration SmartCal OFF sd Continued on next page 3 24 TCM4 40 operator s manual 3 Menu structure and setup programs Default values Continued List of default Settings Default settings continued Report type Table and curve Technical 7 mmHg 1 0 kPa output 3 25 3 Menu structure and setup programs TCM4 40 operator s manual 3 26 4 Installation and maintenance Operating requirements ette eee er n 4 2 Installing the monitoring system eese entente 4 3 Shutting down the monitor sese nnne E 4 5 Cleaning the monitor tnn nee dente medien D IRR es 4 6 Maintenance of the
27. e et eere OR eere e eerte Ginnie es 9 7 Solutions and calibration gases eene 9 10 Traceability certificates sess enne 9 11 Pulse oximetry measurement sete setae s snae eaa 9 15 Measuring principle enne enne 9 16 Calibration of Sensor E te etre ette ee eee EFE TIN eden 9 17 9 Functional description TCM4 40 operator s manual 9 2 tcpCO tcpO2 measurement Construction Of Sensors o ear e EUER ORE 9 3 PEO Measuring principle ree e tete iere 9 5 pO measuring nennen entren 9 6 Calibration OF SENSO eet pierre eg eo Rr c terere OR Pe Eo dia 9 7 Solutions and calibration gases sess eren ener 9 10 Traceability certificates eere 9 11 TCM4 40 operator s manual 9 Functional description Construction of sensors Sensor The tcpCO tcpO sensors E5480 and E5280 combine a heating element two components temperature sensors a Clark type oxygen electrode and a Severinghaus type carbon dioxide electrode in a single unit E5480 sensor components Ag AgCl reference electrode Electrolyte reservoir Reinforced solid state glass electrode pCO part Continued on next page 9 3 9 Functional description TCM4 40 operator s manual Construction of sensors Continued E5280 sensor components
28. 00 00 22 01 36 157 260 13 45 00 22 01 36 157 258 13 30 00 22 01 36 157 262 13 15 00 22 01 36 157 262 13 00 00 22 01 36 157 263 12 45 00 22 01 36 157 259 12 30 00 22 01 36 156 258 12 15 00 22 01 36 157 261 12 00 00 22 01 36 157 263 11 45 00 22 01 36 157 266 11 30 00 22 01 36 157 266 11 15 00 22 01 36 157 268 NOTICE SpO and pulse are available on the 40 monitor only 2 Press A VT to move up or down one line in the list of results or press A to see the most recent results 3 To print the results press Print See also How to print later in this chapter Markings in The following markings can be seen in the Trend table Trend table Blood gas values have been entered An in vivo calibration has been performed No value is available An event mark number has been added 6 18 TCM4 40 operator s manual 6 Patient monitoring Results in Trend curve view Viewing results Step Action in trend curve AS 1 Press Setup View gt Trend curve gt OK The following is an example of a trend curve on a TCM40 monitor A ae m 2 Press lt or to see more results to the left or the right 3 Press Cursor to add a cursor to the screen This will also change the function of the Left and Right arrow keys they now move the cursor instead of time If the cursor is moved all the way to one side the time axis moves which
29. 02 03 2004 02 27 02 31 02 35 02 39 02 41 00 02 03 2004 Printed 02 53 07 02 03 2004 Page 1 Continued on next page 6 41 6 Patient monitoring How to print Continued Example of curve report continued 6 42 TCM4 40 operator s manual RADIOMETER TCM4 SERIES Transcutaneous measurement tepCO tepO SpO Pulse Facility name Patient name ID 7004 mW Power ye 3004 7 0 T T T T 02 27 02 81 02 35 02 39 02 23 00 02 03 2004 02 41 00 02 03 2004 SpO 100 4 96 2 50 0 T T T 02 27 02 31 02 35 02 39 02 23 00 02 03 2004 02 41 00 02 03 2004 Pulse 250 bpm 125 0 T T T T 02 27 02 31 02 35 02 39 02 23 00 02 03 2004 02 41 00 02 03 2004 Printed 02 53 07 02 03 2004 Page 2 Continued on next page TCM4 40 operator s manual 6 Patient monitoring How to print Continued Example of RADIOMETER TCM4 SERIES curve report Transcutaneous measurement tcpCO 2 tcpO SpO2 Pulse Facility name Patient name ID Comments Physician s signature Date Printed 02 53 07 02 03 2004 Page 3 6 43 6 Patient monitoring TCM4 40 operator s manual Blood gas comparison Introduction It is possible to key in the pCO and pO blood gas values of a patient to compare these with transcutaneous measurements from the same patient The blood gas values are displayed as blood drops in
30. 117 Traceability to the Primary Reference Standards at Radiometer available from Radiometer Radiometer is a trademark of Radiometer A S ORadiometer A S DK 2700 Br nsh j Denmark 2003 All Rights Reserved RADIOMETER inm 989 853 0303A COPENHAGEN TCM4 40 operator s manual 9 Functional description Pulse oximetry measurement Measuring principle Calibration of sensor 9 15 9 Functional description TCM4 40 operator s manual Measuring principle Introduction Measuring principles Oxygen saturation vs oxyhemoglobin fraction 9 16 The monitor uses pulse oximetry to measure functional oxygen saturation in the blood Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed such as a finger or toe The sensor contains a dual light source and a photodetector Bone tissue pigmentation and venous vessels normally absorb a constant amount of light over time The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations The ratio of light absorbed is translated into a measurement of functional oxygen saturation SpO Because a measurement of SpO 1s dependent upon light from the sensor excessive ambient light can interfere with this measurement Specific information about ambient conditions sensor application and patient conditions is contained throughout this manual Pulse oximetry is based on two principles that oxyhemoglobin and de
31. Normal view continued pCO pO The pCO pO display also contains the following information display continued Metabolic or Severinghaus corrections are enabled Current power delivered to the sensor Temp Current sensor temperature NOTICE If the sensor temperature is flashing the sensor temperature differs from the set sensor temperature with 0 6 C SmartHeat has been enabled in the setup In vivo calibration Current pCO pO values are in vivo calibrated active Pulse SpO In Normal view it is possible to change the Pulse SpO setup during measurement display by pressing the Pulse SpO display Pulse 60 bpm A Spo HI OFF The Pulse SpO display contains the following information Pulse rate in beats per minute bpm Saturation level of oxygenated hemoglobin in HI OFF SpO alarm high limit is disabled Markings in The following markings can be seen in Normal view Normal view Blood gas values have been entered An in vivo calibration has been performed An event mark number has been added 6 17 6 Patient monitoring TCM4 40 operator s manual Results in Trend table view Viewing results Step Action in Trend table vi w 1 Press Setup View Trend table gt OK The following is an example of a trend table on a TCM40 monitor Papa Trend table view ID 22012009 0014 pCO pos Power Spo Pulse mmHg mmHg mW Events Current 36 156 260 97 64 14
32. ON or OFF in Technical setup Continued on next page 3 5 3 Menu structure and setup programs TCM4 40 operator s manual Normal view Continued Selecting Step Normal view 2 options gt continued 3 4 5 6 3 6 Action Use the Up and Down arrows to select the time span NOTICE The time span selection only applies to the pCO pO and Power curves Select the curve range options of the individual parameters by pressing each of the parameters and in the appearing screens selecting the high and low values Press OK to accept the changes and return to the Normal view setup screen or press Cancel to return to the Normal view setup screen without saving changes If required select 7 the screen saver NOTICES e To activate the screen saver it is necessary to press OK before leaving the Normal view setup e The option is only visible if it has been activated in Technical settings e The screen saver is primarily meant for sleep labs to reduce the backlight from the display e Touching the screen deactivates the screen saver and to reactivate it the option must be selected in Normal view setup Press OK to accept the changes and return to the main screen e Apply to accept the changes without leaving the Normal view setup e Cancel to return to the main screen without saving changes TCM4 40 operator s manual 3 Menu structure and setup programs Trend table view Introduction In the Tren
33. Patent Application Nos EP1753343 EP2007272 e Japanese Patent Application No JP2007 537799 e Chinese Patent Application No CN1988849 e International Patent Application No WO2007 115568 Other patents pending Materials and Item Description accessories All materials and All materials and accessories are latex free accessories Dimensions Diameter e Sensor housing 15 mm e Silver body 8 1 mm Height 7 81 mm Weight 2 6 g Length Continued on next page 8 12 TCM4 40 operator s manual 8 Specifications and ordering information Specifications Continued E5260 sensors Dimensions Diameter e Sensor housing 15 mm e Silver body 9 mm Height 11 3 mm Weight 29g Length OxiMax sensors Item Description Dissipation 52 5 mW Wavelength The wavelength range of the light emitted is near 660 nm and 890 nm 8 13 8 Specifications and ordering information Accessories TCM4 40 systems accessories SpO 2 starter kits TCM4 40 documentation 8 14 Description E5480 tcpCO tcpO sensor tinyTeddy E5280 sensor E5260 sensor Membraning kit for E5480 sensor containing e tcpCO tcpO electrolyte solution e 10 membraning tools e Cleaning paper bag with 5 pieces Membraning kit for E5280 and E5260 sensors containing e tcpCO tcpO electrolyte solution e 12 green membrane units with PP membrane e O ring remover key e Cleaning paper bag
34. SpO then drops to 86 for 3 seconds and then to 84 for 8 seconds The resulting SatSeconds are SpO Seconds SatSeconds 2x 2 4 4x 3 12 6 x 8 48 Total SatSeconds 64 Continued on next page TCM4 40 operator s manual 6 Patient monitoring Alarms Continued TCM40 After approximately 13 seconds the SatSeconds alarm will sound because 60 SatSeconds SatSeconds will have been exceeded See arrow 1 in the figure below continued 60 second SatSeconds alarm point 0123452578 910111213 Seconds Saturation levels may fluctuate rather than remain steady for a period of several seconds Often SpO levels may fluctuate above and below the alarm limit re entering the non alarm range several times During such fluctuation the TCM40 monitor integrates the number of SpO points both positive and negative until either the SatSeconds limit SatSeconds setting is reached or the SpO level returns to within a normal range and remains there SatSeconds The SatSeconds safety net is for patients whose saturation levels frequently safety net exceed the high or low alarm limit but do not stay outside the limit long enough for the SatSeconds setting to be reached When three or more limit violations occur in 60 seconds an alarm will sound even if the SatSeconds setting has not been reached 6 37 6 Patient monitoring How to print Connecting a Step printer 1 2 3 Printing reports Step
35. a check mark to an external PC or a memory stick see the sections Data export serial and Data export USB later in this chapter NOTICE The Export touch key is only active if Data export has been selected in Technical settings Loads sessions with a check mark into the Trend table and Trend curve views NOTICES e Only sessions with the same patient ID can be loaded into the same view e If changes are made to the sessions that have been loaded into a view all the sessions will have to be loaded into the view again Returns to the view screen Continued on next page page 6 14 TCM4 40 operator s manual 6 Patient monitoring Patient DMS Continued On screen The following screen shows the basic keyboard layout alphanumeric keyboard 223 21012008 0012 B To switch between general and language specific character sets Placed in the upper right corner of the screen NOTICE Not applicable in English Backspace To delete one character at a time from right to left Shift To shift between different keyboards in the same character set To scroll left right in the text edit field or Space To add a space Enter To accept the changes made in the text edit field and return to the Patient DMS screen 6 15 6 Patient monitoring TCM4 40 operator s manual Results in Normal view Example of Normal view screen during monitoring Curve display pCO pO display 6
36. alarm is made up of visual indications the parameter value and an alarm text will be flashing and an acoustic indication a discontinuous tone 14 10 Nep Alarm 22012009 0014 0 mmH amp 0 eiu ai PCO2 ee 0 410 Power 259 mW 13 22 13 34 13 46 13 58 14 10 Temp 43 0 C mmHg pO mmHg 200 Alarm limit symbols 100 0 5 0 NJ fv Site time 00 54 Pulse 70 bpm A 5 0 A HI OFF Event Calibrate Continued on next page TCM4 40 operator s manual 6 Patient monitoring Alarms Continued Alerts Alarm silence Alarm reset Alarm tone An alert cannot be turned off but disappears automatically when the alert condition ceases to exist An alert is made up of visual indications Alert displayed in the headline field and a text explaining the problem in the curve view field of the affected parameter and an acoustic indication a discontinuous tone 16 55 21 01 2009 Alert pCO pO Calibration required mmHg 5 0 Spo Site time 04 00 e Tutorial Calibrate It is possible to silence an alarm or an alert for two minutes by pressing the Alarm silence touch key A progress bar will then be displayed on the Alarm silence touch key showing the progress of the alarm silence period However if an alarm alert is activated for another parameter during the silence period this will discontinue the silenc
37. all views as well as on all printed reports Keying in Step blood gas value 1 2 5 6 44 Action Make sure that the sensor is placed on the patient and that the tepCO and values are stable Before drawing the blood sample press Setup Parameter Blood gas Sample time The monitor will store the tc values at that time and the pCO and pO input fields and the numeric keypad are now accessible Draw the blood sample and perform a blood gas analysis When the blood gas results are ready enter the Blood gas setup press the pCO input field and key in the value with the numeric keypad NOTICES e The key deletes one character at a time from the right e Ifthe pCO or pO input field is dimmed the parameter is not available either because of the sensor type or because pO is disabled in Technical setup Press the pO input field and key in the value with the numeric keypad and then press OK The blood gas values will be displayed as blood drops in Normal view as in the following example 1517 i PEDIS vlew ID 22012009 0014 Hi En pCO mmHg nl pCO LI 30 0 3LO Power 249 mW 1429 1441 14 53 15 05 15 37 Temp 43 0 C mmHg pO mmHg 200 100 0 8 0 Pulse 60 bpm A cow Soo A HI OFF Site time amp 03 43 Event Calibrate 7 Setup TCM4 40 operator s manual 6 Patient monitoring In vivo calibration Introdu
38. cautions and instructions Incorrect use can cause incorrect measurements WARNING Risk of incorrect measurements Use only the DOC 10 pulse oximetry cable and do not increase the length of the sensor by connecting an extra sensor cable Use of another sensor cable or more than one cable will have an adverse effect on performance WARNING Risk of skin damage Use only Nellcor oximetry brand wraps designed for use with the SpO sensor Do not use tape Use of additional tape or various other types of wraps can cause skin damage NOTICES e Radiometer provides a starter kit containing sensor Nellcor DS100A Nellcor Oxiband A N or Nellcor Oxiband P I wraps and cable New sensors or other Nellcor sensors than the one in the starter kit wraps and cables must be ordered from your local Nellcor agent e When selecting an sensor consider the patient s weight and activity level the adequacy of perfusion and the available sensor sites the need for sterility and the anticipated duration of monitoring e When selecting a sensor site priority should be given to an extremity free of an arterial catheter blood pressure cuff or intravascular infusion line Before applying the sensor clean and remove any substances such as nail polish from the application site Continued on next page TCM4 40 operator s manual 6 Patient monitoring Application of SpO sensors Continued Application of Step Action DS100A
39. changes Select at least one report type Table and or Curve Select printer type color or B W i e black and white NOTICES e tis only possible to connect a local printer to the monitor Printing over the network is not supported e Radiometer recommends that you use an HP printer with PCL3 protocol Press OK to accept the changes and return to the main screen e Apply to accept the changes without leaving the Printer setup e Cancel to return to the main screen without saving changes TCM4 40 operator s manual 3 Menu structure and setup programs Technical setup Technical Setini See morenn pend dir e p dede ge eet etd 3 20 IBEX DH CRRRRRRRRRERRRERRMREEEEEMMEMEEEEEEMMMMEEEEEEEEEEEEEM 3 22 Default values eter tere ect 3 23 3 Menu structure and setup programs TCM4 40 operator s manual Technical settings Accessing the To access the Technical settings press Setup Technical enter password and program press Enter Tech Settings settings ve Meta corr 0 15 mmHg Defines the metabolic correction factor in steps of 1 mmHg factor To indicate that CO values 0 1 kPa have been corrected Corr is in steps of 0 1 kPa displayed together with the pCO value in Normal view Severinghaus ON OFF If set to ON all CO values are COIT corrected with the Severinghaus correction factor and Corr is displayed together with the pCO value in Normal view In vivo ON OFF Enables disabl
40. container into fire or incinerator as it may cause an explosion WARNING Risk of explosion Before discarding an empty CAL2 gas cylinder remove the safety valve using the valve key code no 922 509 If you do not do this the calibration gas cylinder may burst if exposed to heat 9 10 TCM4 40 operator s manual 9 Functional description Traceability certificates Certificate of Traceability Product name CALI standard calibration gas Type 7 5 CO 20 9 balance 180 mL Code 962 187 Traceability of parameters Expanded Primary gravimetrically prepared standards Traceable to NIST traceable 0 07 Primary gravimetrically prepared standards Traceable to NIST traceable 0 03 weights Certification Each lot of this product has been tested and the nominal values specified on the label of this product have been established with the above traceability jene Keres H B Kristensen Head of Chemical Reference Laboratory The traceability of the above parameters is fully described in booklet AS 117 Traceability to the Primary Reference Standards at Radiometer available from Radiometer Radiometer is a trademark of Radiometer A S RADIOMETERS Radiometer A S DK 2700 Brenshej Denmark 2004 All Rights Reserved XT 990 346 200409A COPENHAGEN 9 Functional description 9 12 Certificate of Traceability Product name CALI standard calibration
41. field and key in the pO value Press In vivo calibration and OK Continued on next page TCM4 40 operator s manual 6 Patient monitoring In vivo calibration Continued Performing an in vivo calibration continued Step Action The curves will now be marked with indicating that the measured values are in vivo calibrated and no longer show the original transcutaneous values 16 54 A Normal view 022120080017 50 pCO mmHg pCO a A rel Corr 0 Power 255 mW 18 42 18 45 16 48 16 51 16 54 Temp 430 C 200 ma In vivo calibration active P 0 Spo Pulse 52 bpm A 98 HI OFF Site time pei 03 37 Event Calibrate i Setup LJ NOTICES e The in vivo calibration procedure can be repeated during the monitoring period if you wish to alter the values again according to the results of new blood samples e To return to the original tc values simply put the sensor back in the calibration chamber 6 47 6 Patient monitoring TCM4 40 operator s manual 6 48 7 Troubleshooting The TCM4 40 systems 7 Troubleshooting TCM4 40 operator s manual The TCM4 40 systems Introduction The monitor contains Radiometer developed software that has been developed tested and released according to our certified Quality Assurance System in order to minimize hazards arising from the software Furthermore the status of the system is continuously monitor
42. high or low It consists of a visual part the parameter value and an alarm text will be flashing and an acoustic part a discontinuous tone pCO alarm high 6 200 mmHg in steps of 1 0 8 26 7 kPa in steps of 0 1 pCO alarm low 5 99 mmHg in steps of 1 0 7 9 9 kPa in steps of 0 1 Alarm sound 1 5 1 1s minimum level Sensor temp 37 0 45 0 C in steps of 0 5 NOTICE If the set sensor temperature is changed during measurement a new calibration is required SmartHeat ON OFF NOTICE If SmartHeat is set to ON it adds 1 C max temp 45 C to the set sensor temperature for 5 minutes after the sensor has been removed from the calibration chamber OFF 2 12 hours in steps of hour Site time heat ON OFF NOTICE If Site time heat is set to OFF the sensor heat is switched off when the site timer reaches zero if set to ON the heat continues The setting of this option is common to pO and The setting of this option is common to pCO and Step Action 1 Select the relevant option with the W touch key 2 Choose the settings of that option with the Up or Down arrow key 3 Follow steps 1 2 for the remaining options 4 Press OK to accept the changes and return to the main screen e Apply to accept the changes without leaving the pCO setup e Cancel to return to the main screen without saving changes TCM4 40 operator s manual 3 Menu structure and setup programs pO
43. maximum 10 minutes or until the change in the sensor signal is below 1 compared with the signals registered one minute earlier If following this the stability criterion is still not fulfilled the monitor will reject the sensor and the error message Calibration error Sensor drift during calibration will be displayed If the stability is accepted the monitor will then display Ready Continued on next page TCM4 40 operator s manual 9 Functional description Calibration of sensor Continued Patient safety In order to satisfy the requirements for patient safety the circuitry that is interconnected with the sensor is galvanically insulated from the rest of the system The monitor is equipped with an extensive safety system for controlling and monitoring sensor temperature e The microprocessor program gives an audiovisual alert if the sensor temperature deviates 0 3 C from the preset value e The sensor power consumption is permanently supervised If it exceeds maximum effect for more than two minutes the heat switches off e If the sensor temperature reaches 46 C or falls below 5 C this could indicate a short or an open circuit in the thermostatting control loop In this case the monitor utilizes one of several hardware and software controls to immediately and permanently switch off the sensor heating e If there is a temperature difference of more than 0 6 C between the two thermistors heating switches
44. monitors while printing The connection will be re established automatically e For examples of other PPMS monitors please refer to the user instructions for the relevant PPMS monitor The task window contains the following information Device type The type of connected module e g AUXILIARY PLUS 1 for the VueLink B 1 module AUXILIARY PLUS 2 for the VueLink B 2 module etc The name of the connected TCM monitor e g TCM4 Alarm status Whether alarms on the TCM monitor have been activated indication The parameters exported from the TCM monitor Asterisk That data for the following parameter is accessible on the main screen and in external databases Unit The parameter units NOTICE Units are only shown in the task window Time At which time the PPMS monitor started receiving data from the TCM monitor Main screen on The main screen is displayed by pressing the Main Screen key on the PPMS PPMS monitor monitor The parameters are displayed at the bottom right hand corner of the PPMS monitor screen Parameter on PPMS Color on PPMS Unit on PPMS and TCM monitor TCM monitor TCM monitors tcpCO tcpCO Green Blue mmHg kPa tcpO Green Red mmHg kPa SpO SpO Green Magenta PULSE Pulse Green Brown bmp NOTICE It is not possible to change the colors on the PPMS monitor Continued on next page TCM4 40 operator s manual 6 Patient monitoring Continuous da
45. not monitoring measuring mode You cannot enter this menu Data error Shut RAM failure on the PC unit down system immediately Data export Export of data to the USB storage device has been completed completed Data export failed Export of data to the USB storage device has failed E g due to missing USB storage device Data from more than The user has tried to load sessions from different patient one patient cannot be IDs into a view selected into a view Date and time cannot The user has tried to enter the Date time setup during be set during measurement measurement Exporting data Data is being exported to the USB storage device Please wait Incorrect password The user has tried to enter the Technical setup with an Try again incorrect password Incorrect time Try The user has entered an incorrect time again Insert USB storage Export to USB port was selected without a memory device stick being connected to the USB port Monitor temperature The temperature in the CPU is too high too high Please shut down system immediately Continued on next page 7 Troubleshooting TCM4 40 operator s manual The TCM4 40 systems continued messages in 3 ETE SPESE No sessions selected The user has tried to view session information in alphabetical Select one or more Patient DMS without selecting a session order continued sessions One or more sessions The user has selected one
46. or more sessions in Patient will be deleted from DMS and pressed Delete or Delete all the system This action cannot be undone pO pCO not e The pO parameter is disabled in Technical setup and enabled You cannot the user is trying to enter the pO parameter setup enter this menu e A tcpO sensor is connected and the user is trying to enter the pCO parameter setup Saving data Please The monitor is saving data before shutting down wait The monitor is The user has tried to delete the session in progress measuring Current session cannot be deleted The monitor is The user has tried to select one or more sessions other measuring No other than the one in progress into a view sessions can be loaded into the view The sensor mustbe The user has tried to change the sensor temperature recalibrated if the during Ready or Measuring state temperature is changed Do you want to change the temperature alphabetical alphabetical Calibrating The sensor is being calibrated order The sensor has been calibrated and is ready for use 7 8 8 Specifications and ordering information Specifications e emi er eo EH EE PEU ure n EP REFER Eee gta ACGeSSOTIQSU a d eto deri etre ee eet dme meu ete ei ee tdv eee imu 8 Specifications and ordering information TCM4 40 operator s manual Specifications monitor specifications tcpCO tcpO SpO pulse rate and sensor heating power Displa
47. 0 operator s manual Calibration setup SmartCal Calibration status 3 14 TCM4 40 operator s manual 3 Menu structure and setup programs SmartCal Purpose The SmartCal function makes sure that the monitor is always ready for monitoring by calibrating the sensor when needed Accessing the To access the SmartCal setup press Setup Calibration gt SmartCal program SmartCal Settings Options Function gees SmartCal ON OFF Enables disables the SmartCal function NOTICES e When enabled the monitor will calibrate auto matically The calibration interval may vary from 5 minutes to 2 hours and the maximum measuring time will be reduced accordingly e Although the option is enabled it is necessary to press Calibrate to start a SmartCal period SmartCal Forever Defines the duration of the SmartCal period duration 1 12 hours NOTICE If set to forever the monitor will calibrate whenever the sensor is placed in the calibration chamber if set to 1 12 hours the monitor will calibrate within the selected period and after a SmartCal period it will be necessary to press Calibrate to start a new SmartCal period Elapsed 0 00 12 00 Shows how much time has elapsed of the active time hours minutes SmartCal period Selecting Step Action SmartCal 1 v settings Select the relevant option with the touch key 2 Choose the settings of that option with the Up or Down arro
48. 00A Nellcor Oxiband A N or Nellcor Oxiband P I NOTICE For ordering information see the section Accessories in chapter 8 TCM4 40 operator s manual 2 What is what Monitor top and front Front view Touch screen Handle Calibration chamber ae tcpCO2 tcpO2 module Battery indicator Monitor support and holder for sensor cable Monitor elevating support functions For carrying the monitor For easy communication between operator and monitor Calibration For storage and calibration of tepCO tcpO sensor chamber For transcutaneous measurements of tepCO and and module calibration of the sensor Monitor support For supporting the monitor and holding the sensor cable and holder for sensor cable Monitor elevating For supporting the monitor at an elevated angle support For turning the monitor ON and OFF ON OFF button qo For indicating whether the battery is being recharged or not If the light is on the battery is being recharged NOTICE Only possible if the power switch on the back of the monitor is in the ON position Battery indicator SpO module For measurements of SpO and pulse rate TCM40 monitor only 2 3 2 What is what TCM4 40 operator s manual Monitor rear Rear view tcpCO tcpOs SpO sensor sensor socket Socket Module release Battery Line fuse Ventilator Power switch Power socket Ethern
49. 1 Place the patient s index finger over the sensor window of the DS100A sensor with the fingertip against the stop If the fingernail is long the nail tip will extend over the finger stop Spread open the rear tabs of the sensor to provide even force over the length of the pads Check the position of the sensor If an index finger cannot be positioned correctly or is not available a smaller finger can be used or use another sensor NOTICE Do not use the DS100A on a thumb or toe or across a child s hand or foot The sensor should be oriented in such a way that cable is positioned along the top of the hand Application of Step Action 1 Place the wrap on a flat surface adhesive sticky and sensors j 2 i side up with the tab on the left 2 Mee Remove the small piece of paper backing and TCI enough of the large piece of backing to expose both alignment holes 3 Nr DRE Position the sensor on the wrap so the alignment EX a Be bumps protrude through the holes Press down i firmly in the center of the sensor to ensure that the wrap adheres tightly 4 Remove the remainder of the paper backing from the wrap The sensor and wrap are now ready to be applied to the patient Select an appropriate site as described previously in this chapter under General information Continued on next page 6 9 6 Patient monitoring TCM4 40 operator s manual Application of SpO sens
50. 16 14 02 1 Aa UE Normal view 10 220120080014 pCO mmHg 60 30 o 410 Power 256 mW i314 1326 1338 1350 1402 Temp 430 C mmHg pO mmHg 200 100 96 0 5 0 a 60 bpm z NOTICES e The SpO plethysmograph displays data at a speed of 25 mm s in Normal view JMN po Site time vont fs OFF Calibrate 01 02 eue e The visual indication of the plethysmograph curve is not proportional to the pulse volume e The pCO pO SpO and Pulse parameter values are updated every 2 seconds e SpO and pulse are available on the TCM40 monitor only e On the TCM4 monitor the lower part of the curve display will either show the power curve or be empty and the Pulse SpO display will always be empty In Normal view it is possible to change the curve ranges setup and the time span setup during measurement by pressing the respective areas in the curve display pCO mmHg A HI i xin LO qM nm et _ 1850 atts Time span setup ranges o e y setup ME am ES SpO In Normal view it is possible to change the parameter setup during measurement by pressing the respective areas in the pCO pO display t Common to pCO and pO 4 pO parameter setup Continued on next page TCM4 40 operator s manual 6 Patient monitoring Results in
51. 2 21 01 2009 17 19 02 121012009 0001 21 01 2009 17 12 00 em 121012009 0000 21 01 2009 17 09 36 v Scroll between the patient IDs session numbers in the list and v Adds a check mark to the highlighted patient ID session no NOTICE Only patient IDs session numbers with a check mark can be viewed deleted printed and exported Continued on next page 6 13 6 Patient monitoring TCM4 40 operator s manual Patient DMS Continued GORGE Shows detailed information about the highlighted patient ID session number Change ID Enables changing the highlighted patient ID session number with the on screen alphanumeric keyboard see next page Maximum 64 characters NOTICE When changing a patient ID session number make sure to change it to something unique for each patient If the same ID is used for two patients the DMS will not be able to tell them apart Delete Deletes the patient IDs session numbers with a check mark NOTICES A dialog warns users that the action cannot be undone e The session in progress cannot be deleted Delete all Deletes all patient IDs session numbers in the list NOTICES A dialog warns users that the action cannot be undone e The session in progress cannot be deleted Print Prints a report one or more report types for the patient IDs session numbers with a check mark Export Exports the patient information and measuring data for the patient IDs session numbers with
52. 2 3 MonLink 6 29 N Name 1 2 Nominal dry gas calibration values 9 7 Non latching alarm 6 34 Non linearity and hysteresis DGOS sn share 8 8 8 9 Normal view 3 5 6 16 NTC resistors 9 4 On screen keyboard 6 15 Operating requirements 4 2 Operator profile 1 2 O ring 4 13 O ring remover 4 13 Oxygen saturation fractional sss 9 16 functional 9 16 Oxygenated hemoglobin 9 16 Oxyhemoglobin fraction 9 16 Index P Parameter setup 3 9 Parameters DC Osh PS 3 10 DO ctis aiid 3 11 Pulses sacs ndun 3 12 3 12 Parts and functions ene NGA 2 4 top and 2 3 Patents 8 12 Patient DMS 6 12 6 13 Patient ID 6 12 6 13 Patient monitoring 6 11 Patient movement 6 5 Patient safety 8 7 Patient stabilization time 6 11 PCL compatible PC printer 6 38 pCO measurement 9 5 measuring principle 9 5 sensitivity essen 5 4 pCO 3 10 pCO alarm iei eret tds 3 10 lO Wi 3 10 Performance considerations sensors 6 5 TCMAO monitor 6 5 Philips Patient Monitoring System 6 24 Photodetector 9 16 Photodiode 9 16 Physiological alarms 6 34 Plethysmography 9 16 pO 3 11 measurement 9 6 measuring principle 9 6 Zero
53. 6 12 TCM4 40 operator s manual 6 Patient monitoring Patient DMS Session Accessing Patient DMS Touch keys The Patient DMS Data Management System manages all session patient ID data and it helps avoiding the risk of patient data mix up From the Patient DMS screen it is possible to e change the automatically generated session number to a unique patient ID e view data from one or more sessions with the same ID in the Trend table or Trend curve view e print one or more sessions export one or more sessions e delete sessions e see detailed information about a session A session is a collection of data starting when the sensor is removed from the calibration chamber and ending when the sensor is placed back in the calibration chamber Each session gets a unique number which can be linked to a specific patient ID at any time It is thereby possible to link several sessions to the same patient ID Press ID in the top right corner of the view screens to enter the Patient DMS Patient DMS Patients available 21 01 2009 17 23 12 Change ID 21 01 2009 17 23 02 A 121012009 0010 21 01 2009 17 22 14 121012009 0009 21 01 2009 17 21 58 Delete 1210120090008 21 01 2009 17 21 26 v 121012009 0007 21 01 2009 17 21 04 121012009 0006 21 01 2009 17 20 32 Delete all 1210120090005 21 01 2009 17 20 02 121012009 0004 21 01 2009 17 19 46 E 1210120090003 21 01 2009 17 19 24 E 121012009 000
54. C Fixed width Fields are aligned in columns with spaces between each field Start import at row fi File origin Windows ANSI J Preview of file M BOX Pil CAPTURE txt a ime date Cancel Back Finish Continued on next page 6 31 6 Patient monitoring TCM4 40 operator s manual Data export serial Continued Importing data files into Step Action Microsoft Excel 4 Select the following settings and click Finish continued 21 This screen lets you set the delimiters your data contains You can see how your text is affected in the preview below T Treat consecutive delimiters as one Tab 5 Space Other Text qualifier zi ata preview Cancel Back gt Finish 5 Select the following settings and click OK Where do you want to put the data Existing worksheet Cancel C New worksheet Properties PivotTable report Parameters 6 Data is imported to Excel The following shows an extract of a screen from Excel E3 Microsoft Excel TCM40 txt DER File Edit View Insert Format Tools Data Window Help OsGS BBS BK AA WA SHE Scc EEEE _2 TCM4 40 Data Export 3 15 25 25 30 11 07 15 26 56 30 11 07 4 5 Patient ID 30112007 0015 6 7 Last calibration 15 24 53 30 11 07 O2 157 mmHg CO2 56 mmHg 8 9 Time Event 02 mmHg CO2 mmHg Temp
55. EF ON Eden 6 13 Results in Normal view 6 16 Results in Trend table view sess ener 6 18 Results in Trend curve view sss 6 19 Analog output hee ens rd ee e 6 21 Continuous data output standard 6 22 Continuous data output VueLink essere 6 24 Continuous data output 6 29 Data export serial r ninina i rani inori eisene 6 30 Data export USB ie eure a a a a ae 6 33 Alarms oasis err CO on e e Re rey 6 34 6 38 Blood gas comparison srecetina a 6 44 In vivo calibration seite cae set re dos 6 45 Meridie 7 1 The TCMA 40 Systems tete me eee e be ee 7 2 Specifications and ordering information c eee eee e eee e eene eee seen setas nato 8 1 Specifications ont inier e eite dis a eR ERO e Pe EE UI o e b 8 2 IATA eo toe eere eee docete ere e e ne EE FEE ence tree 8 14 TCM4 40 operator s manual Contents 9 Functional description cccccccscscssssscsssssscssccsssssccssscssscsecssccsscssscssecsscssscsssesssssssseees J L tcp CO tcpO enne ense seen seen seesseessees 0 2 Construction of sensors ee RR eter tee td c bes eee 9 3 pCO measuring principle nen
56. If two parameters are selected one of these must be deselected in order to be able to select a new parameter 3 Select the curve range options of the individual parameters by pressing each of the parameters and in the appearing screens selecting the high and low values using the arrow keys 4 Press OK to accept the changes and return to the Trend curve setup screen or press Cancel to return to the Trend curve setup screen without saving changes 5 In the Trend curve setup screen press e OK to accept the changes and return to the main screen e Apply to accept the changes without leaving the Trend curve setup e Cancel to return to the main screen without saving changes TCM4 40 operator s manual 3 Menu structure and setup programs Parameter setup WARNING Risk of incorrect monitoring Make sure to select the alarm limits carefully Setting alarm limits to extreme values can render the alarm system useless i 3 10 DOS apes 3 11 SpO Pulse eee etit eee et etc Coe e ete etes 3 12 Blood EE 3 13 3 9 3 Menu structure and setup programs TCM4 40 operator s manual pCO Accessing the program pCO settings Selecting p CO settings To access the pCO setup press Setup Parameter gt pCO alarm ON OFF NOTICE The alarm is triggered if the parameter value exceeds or is equal to the alarm limit
57. L APPLY EVEN IF ANY REMEDY FAILS OF ITS ESSENTIAL PURPOSE IN NO EVENT SHALL MS BE LIABLE FOR ANY AMOUNT IN EXCESS OF U S TWO HUNDRED FIFTY DOLLARS U S 250 00 Limitations on Reverse Engineering Decompilation and Disassembly You may not reverse engineer decompile or disassemble the SOFTWARE except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation SOFTWARE TRANSFER ALLOWED BUT WITH RESTRICTIONS You may permanently transfer rights under this EULA only as part of a permanent sale or transfer of the Device and only if the recipient agrees to this EULA If the SOFTWARE is an upgrade any transfer must also include all prior versions of the SOFTWARE EXPORT RESTRICTIONS You acknowledge that SOFTWARE is of US origin You are to comply with all applicable international and national laws that apply to the SOFTWARE including the U S Export Administration Regulations as well as end user end use and country destination restrictions issued by U S and other governments For additional information on exporting the SOFTWARE see http www microsoft com exporting 1 2 3 4 Contents Hr ero RE Names intended use and eene 1 2 Symbols used on the enne 1 4 Symbols used in the
58. LIED UPON Radiometer Medical ApS TO CONDUCT SUFFICIENT TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR SUCH USE NO WARRANTIES FOR THE SOFTWARE THE SOFTWARE is provided AS IS and with all faults THE ENTIRE RISK AS TO SATISFACTORY QUALITY PERFORMANCE ACCURACY AND EFFORT INCLUDING LACK OF NEGLIGENCE IS WITH YOU ALSO THERE IS NO WARRANTY AGAINST INTERFERENCE WITH YOUR ENJOYMENT OF THE SOFTWARE OR AGAINST INFRINGEMENT IF YOU HAVE RECEIVED ANY WARRANTIES REGARDING THE DEVICE OR THE SOFTWARE THOSE WARRANTIES DO NOT ORIGINATE FROM AND ARE NOT BINDING ON MS Note on Java Support The SOFTWARE may contain support for programs written in Java Java technology is not fault tolerant and is not designed manufactured or intended for use or resale as online control equipment in hazardous environments requiring fail safe performance such as in the operation of nuclear facilities aircraft navigation or communication systems air traffic control direct life support machines or weapons systems in which the failure of Java technology could lead directly to death personal injury or severe physical or environmental damage Sun Microsystems Inc has contractually obligated MS to make this disclaimer No Liability for Certain Damages EXCEPT AS PROHIBITED BY LAW MS SHALL HAVE NO LIABILITY FOR ANY INDIRECT SPECIAL CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING FROM OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THE SOFTWARE THIS LIMITATION SHAL
59. NING Risk of infection Due to the nature and seriousness of diseases such as the Human Immunodeficiency Virus HIV the causative agent of AIDS and Hepatitis B always regard equipment and accessories that can come into contact with human or animal tissues or fluids particularly blood as contaminated and potentially hazardous to avoid the risk of infection Disinfection of the sensor is carried out with a membraned sensor and normally prior to calibration Disinfection of the sensor and the cable can be carried out by immersing the sensor and the cable in a water based disinfection solution such as a germicidal water based solution e g one based on n alkyl dimethyl benzyl ammonium chloride with isopropanol WARNING Risk of incorrect measurements sensor failure Do not immerse the sensor plug in disinfection solution Immersing the sensor plug in disinfection solution will cause the sensor to fail 71 WARNING Risk of incorrect measurements sensor failure Do not heat sterilize as the sensor cannot tolerate temperatures exceeding 70 C Heat sterilization of the sensor will cause it to fail As the number of disinfection solutions is increasing and may vary from country to country and from hospital to hospital it is not possible to come up with a complete list of water based disinfection solutions that may be used However Radiometer proposes that one of the following water based disinfection solutions 1s used e Ma
60. SB 6 33 CE 6 34 lei rV PER E 6 38 Blood gas comparisons iuis ioter 6 44 In vivo ealiDrationa reete iet ee ert vari 6 45 6 Patient monitoring TCM4 40 operator s manual General information Measuring sites tcpCOtcpO sensor temperature General alerts 6 2 tcpCO tcpO measurements Clinical studies have shown the abdomen and chest to be the best measuring sites for both neonates and adults Saturation measurements e Nellcor Durasensor DS100A sensor e Patient gt 40 kg The preferred site is the index finger or alternatively a smaller finger but not the thumb e Nellcor Oxiband A N sensor e Adult gt 40 kg The preferred site is around an index finger with the cable positioned along the top of the finger Alternatively use a thumb or another finger with the cable positioned along the palm or around a great toe with the cable positioned along the sole of the foot Neonate 3 kg The preferred site is the foot below the toes with the cable positioned along the sole of the foot Alternatively place the sensor around the palm of a hand below the fingers with the cable positioned along the palm e Nellcor Oxiband P I sensor e Pediatric 15 40 kg The preferred site is around an index finger with the cable positioned along the top of the finger Alternative sites are around the thumb or another finger with the cable positi
61. TCM4 40 operator s manual TCM4 40 operator s manual TCM4 40 monitoring systems Operator s manual From software version 3 0 RADIOMETER 1 Table of contents Introduction What is what Menu structure and setup programs Installation and maintenance Calibration In vivo monitoring Troubleshooting Specifications and ordering information Functional description Index Date of issue System performance The procedures described in this manual must be observed in order to ensure proper system performance and to avoid hazards Radiometer cannot provide or verify system performance characteristics if the system is not installed used and maintained in accordance with Radiometer procedures or if accessories not meeting the specifications provided by Radiometer are used Radiometer warrants that the data media on which the software included in the system is furnished is free from defects in material and workmanship under normal use for three 3 months from the date of delivery as evidenced by a copy of invoice or receipt Third party software and trademarks The TCM4 40 monitoring systems comprise the Microsoft Windows CE 5 0 program By using the system you accept the terms of the Software License Agreement s of the provider s of the above software as shown in the End User License Agreement s included in this manual If you cannot accept the terms of the Software License Agreement s you should not use
62. a new one Calibration error The selected sensor Calibrate the sensor Sensor temperature temperature value cannot be error during reached calibration This may be due to an error in the sensor module If error remains the sensor is defective Replace with a new one Calibration required e The last calibration has Perform a calibration been aborted e 12 hours have passed since the last successful calibration e SmartCal has timed out Continued on next page 7 4 TCM4 40 operator s manual 7 Troubleshooting The TCM4 40 systems continued te error Recommended action SEE r Communication For unknown reasons e If error remains try with r nent error communication between the another module MN Sensor module monitor and the tc module f continued e If error remains on the disconnected Call service General error Call service Heater failure Invalid sensor connected No sensor connected pCO out of range pO out of range Site time end has not been satisfactory The tc module or sensor is not functioning e The measured sensor power is outside the measuring range new module contact authorized service personnel Try with another module or sensor If error remains contact authorized service personnel Unplug the sensor from the sensor socket at the rear of the module and then reconnect it Calibrate the sensor If error remains the sensor is defec
63. ach the battery from the connector 3 Attach a new battery to the connector 4 Reattach the battery cover Continued on next page 4 7 4 Installation and maintenance TCM4 40 operator s manual Maintenance of the monitor Continued Changing the Step calibration gas 1 2 Changing the Step gasket in the 1 calibration chamber 2 3 4 8 Action Unscrew the old calibration gas cylinder WARNING Risk of explosion Calibration gas cylinder Contents under pressure Do not puncture Do not use or store near heat or open flame Exposure to temperatures above 54 C for CAL2 and 50 C for CAL 1 may cause contents to vent or cause bursting Never discard container into fire or incinerator as it may cause an explosion Screw the new calibration gas cylinder clockwise as far as possible into the socket NOTICE Excessive force may damage threads and result in a leakage and thereby an increase in consumption Action Remove the gasket from the calibration chamber Clean the calibration chamber with a soft cloth moistened with skin antiseptic e g 70 alcohol Mount a new gasket into the calibration chamber NOTICE Be sure to align the gasket correctly TCM4 40 operator s manual 4 Installation and maintenance Preparation and maintenance of the tc sensors General information about membraning essen 4 10 Cleaning the sensor head of the E5480 4 11 Membra
64. actual date and time Otherwise correct them in Technical setup Membrane the tcpCO tepO sensor as described later in this chapter Connect the tcpCO tcpO sensor plug to the sensor socket at the rear of the tc module and place the sensor in the calibration chamber at the front Continued on next page 4 3 4 Installation and maintenance TCM4 40 operator s manual Installing the monitoring system Continued Procedure Step Action feonbuted 10 Check that the tc module is functioning The message Calibration required is displayed on the screen Leave it until step 12 11 Change View or Setup settings if required by pressing Setup See chapter 3 Menu structure and setup programs NOTICE The monitor is delivered with default settings see these in the section Default values in chapter 3 12 Calibrate the sensor as described in chapter 5 Calibration 4 4 TCM4 40 operator s manual 4 Installation and maintenance Shutting down the monitor Shutting down Step Action the monitor 1 Press the button on the front of the monitor The following system message will be displayed System shutdown Shut down system Cancel 2 Press OK to shut down the monitor the message Saving data Please wait will be displayed or Cancel to return to the main screen without shutting down the monitor 4 5 4 Installation and maintenance TCM4 40 operator s manual Cleaning the monitor Clea
65. ample of View menu screen Parameter Calibration Printer Technical r View Normal pCO Spo Menu tabs Trend table Submenus Settings pO SpO A y Touch keys NOTICE is available on the TCM40 monitor only touch keys 7 Accepts the changes and returns to the main screen Accepts the changes without leaving the menu screen Returns to the main screen without saving changes 2 7 2 What is what TCM4 40 operator s manual Online tutorials Tutorials Touch keys 2 8 The tutorials are short video sequences of commonly used procedures To access the tutorials press Tutorial NOTICE In Measuring mode the Event touch key replaces the Tutorial key TCM tutorials Je Change of Fixation of sensor calibration gas Membraning Cleaning 945 660 sensor head iz Select tutorial and press Play JAM o NOTICE The DS100A sensor tutorial can only be selected on the TCM40 monitor Touch key Function Wo Pauses the selected tutorial IINE Plays the selected tutorial lan 4 gt Scroll backward forward one step in the selected tutorial Returns to the TCM tutorials screen Exits the tutorial and returns to Normal view TCM4 40 operator s manual 2 What is what Touch key glossary Touch keys In the text touch keys are written in bold italic throughout the manual The gloss
66. an therefore differ from current time with up to 2 hours depending on the time interval selected in the printer setup Press OK to make a printout or press Cancel to exit the dialog box without making a printout NOTICES e The different kinds of event marks are only shown on the printout if they are actually present e Even if both report types are selected in Printer setup there will only be one Comments page Continued on next page TCM4 40 operator s manual 6 Patient monitoring How to print Continued Example of table report RADIOMETER TCM4 SERIES Transcutaneous measurement tceCOz2 tcpO2 SpO gt 2 Pulse Measuring unit tepCO tepO mmHg Sensor temperature 42 0 C Power mW Last calibration 01 27 07 02 03 2004 SpO2 Last calibration value pCO 80 mmHg Pulse bpm pO 160 mmHg Facility name Patient name ID Blood gas event mark n vivo calibration No value available Time date Event tcepCO Power SpO Pulse 02 23 00 02 03 04 34 158 3 97 71 02 24 00 02 03 04 34 158 7 97 71 02 25 00 02 03 04 1 34 158 11 97 71 02 26 00 02 03 04 34 158 97 71 02 27 00 02 03 04 158 16 96 70 02 28 00 02 03 04 2 34 158 19 96 70 02 29 00 02 03 04 34 158 23 97 72 02 29 13 02 03 04 5 97 72 02 30 00 02 03 04 34 158 26 97 72 02 31 00 02 03 04 3 34 158 30 97 72 02 32 00 02 03 04 34 158 31 97 72
67. anges and return to the main screen e Apply to accept the changes without leaving the pO setup e Cancel to return to the main screen without saving changes 3 11 3 Menu structure and setup programs TCM4 40 operator s manual SpO Pulse Accessing the To access the SpO Pulse setup press Setup Parameter SpO Pulse program tti SpO alarm NOTICE The alarm is triggered if parameter value exceeds or is equal to the alarm limit high or low It consists of a visual part the parameter value and an alarm text will be flashing and an acoustic part a discontinuous tone SpO alarm OFF 86 100 in steps of 1 high WARNING Risk of patient injury Make sure to select the upper alarm limit for oxygen saturation carefully and in accord with accepted clinical standards High oxygen levels may predispose a premature infant to develop retinopathy NOTICE SpO alarm high can be disabled HI OFF will be displayed beneath the alarm symbol while SpO alarm low is kept active 1 SpO alarm low 85 99 in steps of 1 OFF 10 100 in steps of 10 Alarm sound 1 5 in steps of 1 level Pulse alarm 35 240 bpm in steps of 5 high Pulse alarm low 30 235 bpm in steps of 5 The setting of this option is common to pCO pO and SpO Selecting Step Action SpO Pulse Men 1 Select the relevant option with the W touch key 2 Choose the settings of that option with the Up or Down arrow k
68. ary of all the touch keys used in the software with their description is given in alphabetical order in the table below Touch key v Adds a check mark to the highlighted patient ID session number in Patient DMS Displays detailed information about the highlighted patient ID session number in Patient DMS Silences resets the alarm system Apply Accepts the changes made in the settings without leaving the respective menu screen Blood gas Gives access to the Blood gas setup where blood gas values can be keyed in Cal status Gives information about the last calibration Calibrate Starts a calibration of the electrode Cancel Returns to the main screen without saving the changes made in the settings Adds removes a cursor in the Trend curve view Date time Gives access to the Date time setup password protected Default values Changes all settings to Radiometer default values password protected Delete config file Part of the Service setup only for service purposes Registers the entered password Event Marks an event during monitoring Export Exports the patient information and measuring data for the patient IDs session numbers with a check mark in Patient DMS Gives access to Patient DMS In vivo calibration Starts an in vivo calibration i e a correction of the measured tcpCO tcpO values with the keyed in blood gas values Normal Gives access to the Normal view setup Continued on next page 2 9
69. ation between the another module order SpO module monitor and the SpO If di e disconnected module has not been Piera n Call service satisfactory nis res p authorized service personnel General error SpO module or sensor is e Try with another module Call service not functioning Or sensor e f error remains contact authorized service personnel No sensor e No SpO sensor Connect an SpO sensor to connected connected to the monitor the monitor e Invalid sensor connected to the monitor Dialog box A number of messages system messages and alerts appear in dialog boxes Systemmessage Cause alphabetical System message Cause order Battery level Less than 5 minutes running time on battery critically low Battery level is The user has made changes in the setup while the critically low Setup battery level was critically low changes cannot be saved Continued on next page 7 6 TCM4 40 operator s manual 7 Troubleshooting The TCM4 40 systems continued Dialog box messages in alphabetical order continued Battery not connected No battery is connected to the monitor For data safety reasons a proper battery must always be connected Battery not connected The user has made changes in the setup while the Setup changes cannot battery was not connected Blood gas setup is The user has tried to enter the Blood gas setup while the only available in monitor is
70. ble Philips code no M1032 61654 and TCM4xx ETX VueLink Adapter Radiometer code no 636 651 for connecting the VueLink interface module to the TCM monitor NOTICE In the following the term PPMS includes the VueLink interface module The following patient monitors are supported e CMS software version C or newer e IntelliVue MP40 50 60 70 90 all software versions e Agilent V24 V26 all software versions NOTICE Older HP systems are often called CMS instead of PPMS TCM VueLink VueLink PPMS Module monitor cables interface module monitor rack Step Action 1 Insert a VueLink interface module in the PPMS monitor module rack 2 Connect the VueLink interface module to the TCM monitor with the connecting cable and the VueLink interface cable Turn on both monitors On the TCM monitor press Setup Technical enter password gt Tech settings set Continuous data output to VueLink and press Apply or OK NOTICE Changing settings for Unit will cause a temporary disconnection of communication of up to 60 seconds The connection will be reestablished automatically Continued on next page TCM4 40 operator s manual 6 Patient monitoring Continuous data output VueLink Continued Verification of Step connection 1 between TCM and PPMS monitors Action s On the VueLink interface module press the VueLink key The VueLink B 1 tab appears on the PPMS monitor screen NOTICES e If the tab name is
71. calibration chamber for 30 minutes and then calibrate it again or enable the SmartCal function press Calibrate and then leave the sensor in the calibration chamber for 30 minutes e If SmartCal is OFF and the sensor is not removed from the calibration chamber within 30 minutes after Ready the heat to the sensor will be switched off and a new calibration will be required 5 3 5 Calibration TCM4 40 operator s manual Checking zero current and sensitivity Recommen dations Items required Checking pO zero current and pCO sensitivity 5 4 The zero current of pO and the sensitivity of pCO should be checked if the sensor performance appears to deteriorate The following items are required e CAL2 standard calibration gas 10 CO with as balance e Gas adapter for CAL2 gas Step 1 Action Before calibrating the sensor set the metabolic correction factor to zero and the Severinghaus correction factor to OFF in the Technical setup Calibrate the sensor Attach the adapter to the CAL2 gas cylinder and place the sensor in the calibration chamber of the gas adapter The pCO reading is displayed on the screen It should be within 73 79 mmHg 9 7 10 5 kPa within 10 minutes after the sensor has been placed in the calibration chamber of the gas adapter Read the tcpO value on the screen e If under 5 mmHg 0 7 kPa the sensor is in good condition e If equal to or above 5 mmHg 0 7 kPa the sensor
72. ch as tissue bone and venous blood The monitor measures oxygen saturation also called functional saturation oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen It does not detect significant amounts of dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin To compare oxygen saturation measurements with those from an instrument that measures oxyhemoglobin fraction also erroneously called fractional saturation oxygenated hemoglobin expressed as a percentage of all measured hemoglobin including measured dysfunctional hemoglobins oxyhemoglobin fraction must be converted as follows oxyhemoglobin fraction 100 100 carboxyhemoglobin methemoglobin TCM4 40 operator s manual 9 Functional description Calibration of sensor Description Because light absorption by hemoglobin is wavelength dependent and because the mean wavelength of LEDs varies an oximeter must know the mean wavelength of the sensor s red LED to accurately measure SpO During monitoring the monitor s software selects coefficients that are appropriate for the wavelength of that individual sensor s red LED these coefficients are then used to determine SpO Additionally to compensate for differences in tissue thickness the light intensity of the sensor s LEDs is adjusted automatically 9 17 9 Functional description TCM4 40 operator s manual 9 18 TCM4 40 operator s manual
73. ction It is possible to perform in vivo calibrations i e alterations in the transcutaneous readings using the results from an arterial blood gas analysis In vivo calibrations can either be performed on pCO pO or both parameters When the blood gas values have been entered on the TCM4 40 monitor the new calibration lines are calculated The following formulas are used tepCO corr tepCO pCO a tepCO t tepO corr tepO x pO a tepO t where is either the measured CO value or the measured CO value with correction if corrections are selected in Technical settings e pCO a and pO a are the measured arterial values e tcpCO t and tcpO t are the transcutaneous values measured at time t which is the approximate time when the arterial sample was taken and the Sample time touch key was pressed On the pCO part the corrected CORR value line will have the correct 45 slope The in vivo calibration therefore gives an offset for all values i e it moves the line just as changing the metabolic factor in Technical settings would do Signal On the pO part of the sensor the in vivo calibration changes the sensitivity the slope of the pO signal just as with normal calibrations Signal Continued on next page 6 45 6 Patient monitoring TCM4 40 operator s manual In vivo calibration Continued Introduction continued Performing an in vivo cal
74. d Scrolls quickly to the most recent result Deletes one character at a time lt lt gt gt Moves one character at a time to the left or the right or keys y EH d Pauses the selected tutorial IE Plays the selected tutorial b d P Scroll backward forward one step in the selected tutorial Returns to the TCM Tutorials screen Exits the tutorial and returns to Normal view 2 What is what TCM4 40 operator s manual 2 12 3 Menu structure and setup programs Men structure i n ete ade tecto 3 2 List of setup programs leet a t ti nee dirti ede depot verita 3 3 ade 3 4 ING IMAL s tert los itches creates 3 5 Trend table view gestit et ER cete i e iei eripe 3 7 rend Curve VIEW tede on mise de ode re ONE abodes 3 8 Parameter Setup moe P 3 9 tees 3 10 DOS ctae dedi teuren 3 11 SpO Pulse eiae ttt eee se tte Re 3 12 ES CAE E ASS 3 13 iS os 3 14 SUELOS 3 15 Calibration Status zem cvs p roe 3 16 Printer 3 17 Technical 3 19 Technical settfgsiuinai es D STEPS ESSERE UI ENT NEN 3 20 Date Se tele AEE tv ite ten
75. d N Date time settings Tech settings 05 01 2009 14 30 18 7 8 9 Date time Date format 4 4 MM DD Y Y YY E Ea Service menu Default values Enter date time DD MM YYYY NOTICE Date and time cannot be set during measurement Trying to do so will result in an alert The Date time settings input field reflects the current settings Step 1 Action Select date format e MM DD YYYY month day year e DD MM YYYY day month year Move one character at a time in the Date time settings input field with the lt lt and gt gt touch keys Enter the new settings with the numeric keypad Press OK to accept the changes and return to the main screen e Apply to accept the changes without leaving the Date time settings e Cancel to return to the main screen without saving changes TCM4 40 operator s manual 3 Menu structure and setup programs Default values Introduction The Default values function changes all parameter and monitor settings to factory defaults The default values are listed below NOTICE When changing all settings to factory defaults all kPa settings will change to mmHg Changing Step Action settings to factory defaults 1 Press Setup Technical enter password and press Enter gt Default values 2 A dialog box with the text This will return the monitor into default setup and current setup will be lost
76. d table setup it is possible to select the time interval between each record in the Trend table Accessing the To access the Trend table setup press Setup Trend table program Selecting Step Action Trend table 1 Use the Up and Down arrows to select the time interval options 2 Press OK to accept the changes and return to the main screen e Apply to accept the changes without leaving the Trend table setup e Cancel to return to the main screen without saving changes 3 7 3 Menu structure and setup programs TCM4 40 operator s manual Trend curve view Introduction Accessing the program Selecting Trend curve options 3 8 In the Trend curve setup it is possible to set the time span of the graphic display and the ranges for pCO pO Power and SpO Pulse and to select which parameter s maximum two should be displayed on the Trend curve NOTICE Spo and pulse are available on the TCM40 monitor only To access the Trend curve setup press Setup Trend curve View Technical Time span View max 2 curves 34 Normal A pCO O Power Trend table Parameter Calibration Printer v O 5 0 Pulse Curve ranges pCO Power SE Step Action 1 Use the Up and Down arrows to select the time span 2 Select maximum two parameters to be displayed as trend curves NOTICE
77. daCide FD MADA Inc e Control III Maril Products Inc e Hi Tor Plus Ecolab Inc e 3 2 aqueous glutaraldehyde solution Surgikos Johnson amp Johnson Medical Solutions solely based on isopropanol propylalcohol should be avoided as frequent use of isopropanol propylalcohol may damage the electrode cable NOTICE To establish the correct disinfection procedure for your hospital it is important that you consult the hygiene committee at your hospital You may keep the sensors stored in the calibration chambers For longer periods of storage keep the sensors mounted with a protective cap NOTICE Add two drops of electrolyte solution to the cap 4 15 4 Installation and maintenance TCM4 40 operator s manual Cleaning the SpO sensors Wipe method procedure Soak method procedure 4 16 Maintenance of the SpO2 sensors The SpO sensors may be surface cleaned with a solution such as 70 isopropyl alcohol If low level disinfection is required use a 1 10 bleach solution Do not use undiluted bleach 5 5 25 sodium hypochlorite or any cleaning solution other than those recommended here because permanent damage to the sensor could occur AN AN WARNING Risk of incorrect measurements sensor failure Do not expose connector pins to cleaning solution as this may damage the SpO sensor WARNING Risk of incorrect measurements sensor failure Do not sterilize the SpO sensor by irradiation steam or ethylene ox
78. derate injury to the user or the patient or damage to the equipment or other property It may also be used to alert against unsafe practices This includes the special care necessary for the safe and effective use of the device and the care necessary to avoid damage to the device that may occur as a result of use or misuse NOTICE Addresses practical information that is not related to personal injury need to know information _ ni C Indicates that the product complies with the 0459 requirements of the Medical Device Directive 93 42 EEC June 1993 This product is a class IIa device 1 6 2 What is what TCM4 A40 monitoring 11 enne 2 2 Monitor top and front ette eer dert 2 3 Monitor otras EROR 2 4 The screen general elements eror o t p Eee ge 2 5 ete tei 2 8 TOUCH key glossary esee etis e diet e ik eR e 2 9 2 What is what TCM4 40 operator s manual TCM4 40 monitoring systems Introduction 2 2 The TCM4 monitoring system includes e Base unit e tcpCO tcpO module e Combined tcpCO tcpO sensors or single tcpCO sensor The TCM40 monitoring system includes e Base unit e tcpCO tcpO module and SpO module e Sensors for tepCO tcpO2 module Combined tepCO tepO sensors or single sensor e Sensors for SpO module SpO sensors Nellcor DS1
79. differ from the setting of the test device For a properly functioning monitor this difference will be reproducible over time and from monitor to monitor within the performance specifications of the test device Accuracy 3 bpm over 20 250 bpm range Continued on next page 8 10 TCM4 40 operator s manual 8 Specifications and ordering information Specifications Continued and compliance continued Known sources of tepCOtcpO interference After an hour s exposure halothane 4 96 evaporated into carrier gas will interfere with the tcpO readings of the sensor and thereby also influence the combined effects of non linearity and hysteresis beyond 6 mmHg 0 8 kPa Furthermore if the patient is treated with Halothane this may cause changes in the skin blood flow and in this way interfere with the tcpO readings Halothane does not affect the tepCO readings The following substances have been tested and shown not to influence the combined effects of non linearity and hysteresis within 6 mmHg 0 8 kPa e Nitrous oxide in a gas mixture of 60 0 5 20 9 Oy balance In the following referred to as carrier gas Enflurane 5 evaporated into carrier gas Isoflurane 5 evaporated into carrier gas Sevoflurane 5 evaporated into carrier gas Desflurane 12 evaporated into carrier gas SpO Inaccurate measurements can be caused by prolonged patient movement ve
80. e M MES 3 22 Default derat iet etu eR e etes te esee 3 23 3 Menu structure and setup programs Menu structure TCM4 40 operator s manual Menu structure The following diagram illustrates the menu structure of the TCM4 40 monitors Parameter pCO pO O Pulse Blood gas Sp View Ti Time span r Curve ranges Trend table me interval pCO pO Pow er Screen saver Technical settings se tti Date Available on the TCM40 monitor Available on the TCM4 monitor Date time Date time Enter password SmartCal T Cal status Printer ime interval Time span Report type Curve ranges Printer type Trend curve r Time span r Curve ranges pCO pO Power SpO Pulse L Select curves Service menu Default values For service ngs personnel format only only only NOTICE If no touch key is activated for 30 seconds the main screen Normal view is displayed 3 2 TCM4 40 operator s manual 3 Menu structure and setup programs List of setup programs Accessing the Press the Setup touch key to get access to the Setup menus Setup menus e View e Parameter e Calibration e Printer e Technical Detailed information about the five main Setup menus is given in the following sections 3 3 3 Menu structure and setup programs TCM4 40 operator s manual View setup
81. e calibration value to be within the normal physiological range for tcpCO Radiometer uses 7 5 concentration in the calibration gas for the TCM4 40 monitors The 7 5 CO calibration gas will give the following CO calibration value at a barometric pressure of 760 mmHg 0 805 760 im 57 mmHg 100 100 When the Severinghaus temperature correction factor is activated Severinghaus corr ON the above pCO calibration value will result in the following temperature corrected pCO values pCO CAL Bx Sensor temp C 37 38 39 40 41 42 43 44 45 Temperature corr factor 1 00 1 04 1 09 1 14 1 19 1 24 1 30 1 36 1 42 Temperature corr value mmHg 57 55 52 50 48 46 44 42 40 57 Temp corr factor Temperature corr pCO value Temp corr factor 10 9 019 T737 The monitor calculates the nominal dry gas tcpCO calibration values relative to the barometric pressure in accordance with the following formula 96 CO pCO CAL Bx where 100 B the barometric pressure in mmHg or kPa CO the percentage of CO in the calibration gas i e 7 5 The monitor calculates the nominal dry gas tcpO calibration values relative to the barometric pressure in accordance with the following formula Or O gt CAL Bx where p Ox CAL i06 B the barometric pressure in mmHg or kPa the percentage of O in the ca
82. e percentage point an audible alarm immediately sounds When the SpO level fluctuates near an alarm limit the alarm sounds each time the limit is violated Such frequent alarms can be distracting Therefore the TCM40 SpO module utilizes SatSeconds alarm management With the SatSeconds technique upper and lower alarm limits are set in the same way as traditional alarm management However the clinician also sets a SatSeconds limit that allows monitoring of SpO below the selected lower alarm limit and above the selected upper alarm limit for a period of time before an audible alarm sounds The SatSeconds limit controls the time that the SpO level may violate the alarm limits before an audible alarm sounds SatSeconds is enabled disabled in SpO parameter setup The method of calculation is as follows The number of percentage points that the SpO falls outside the alarm limit is multiplied by the number of seconds that the SpO level remains outside that limit This can be stated as an equation points x seconds SatSeconds where e points SpO percentage points outside of the limit e seconds number of seconds that SpO remains at that point outside of the limit The alarm response time assuming a SatSeconds limit set at 60 and a lower alarm limit set at 90 is described and illustrated below In this example the SpO level drops to 88 2 points and remains there for period of 2 seconds 2 points 2 seconds 4 The
83. e period and activate the alarm alert sounds NOTICE When affixing the sensor to the patient i e when the monitor goes from Ready to Measuring mode the alarm silence period starts automatically and lasts for 10 minutes When the alarm silence period times out the alarm system is reset The alarm system can also be reset by pressing the Alarm silence touch key twice or once if the alarm silence is already activated If the alarm alert condition is still present when the alarm system is reset the visual indications will remain for both types of alarms whereas the acoustic indication will be reactivated for an alarm condition only An alarm tone consists of bursts of 10 short pulses Between two bursts there is a 3 second pause The alarm tone continues until the alarm condition ceases to exist or Alarm silence is activated Continued on next page 6 35 6 Patient monitoring TCM4 40 operator s manual Alarms Continued Alert tone End of calibration tone TCM40 SatSeconds 6 36 An alert tone consists of two pulses followed by a 5 second pause The alert tone continues until the alert condition ceases to exist or Alarm silence is activated arene TES An End of calibration tone consists of two pulses gt With traditional alarm management upper and lower alarm limits are set for monitoring oxygen saturation During monitoring as soon as an alarm limit is violated by as little as on
84. ective film 2 Apply the fixation ring to the measuring site by pressing the center of the fixation ring onto the measuring site with a finger and then running a finger around the rim circumference NOTICE Press firmly to prevent leaks Fill the center of the fixation ring with 3 5 drops of the contact liquid Remove the sensor from the calibration chamber align the arrow on the sensor with one of the marks on the fixation ring and turn the sensor a quarter of a turn clockwise to fasten it in the fixation ring Removal of Step Action sensor aE a 1 Remove the sensor from the fixation ring by turning it anticlockwise 2 Remove the fixation ring by lifting the tab 3 Clean the sensor surface carefully with an alcohol swab 4 Then place the sensor in the calibration chamber 6 7 6 Patient monitoring TCM4 40 operator s manual Application of SpO2 sensors Required materials for SpO 2 monitoring 6 8 Saturation monitoring is only available on the TCM40 monitor The following items are required to apply an SpO sensor to a patient e Nellcor SpO sensor e Adhesive wrap model ADH A N or FOAM A N for Oxiband A N and Oxiband P I sensors e Nellcor DOC 10 pulse oximetry cable N AN WARNING Risk of incorrect measurements Use only Nellcor oximetry brand SpO sensors and sensor cables And before use carefully read the sensor directions for use including all warnings
85. ed during operation Should a problem or error occur it is automatically recorded and presented to the operator on the screen This chapter describes possible errors their causes and the recommended operator actions NOTICE The monitor cover should be removed only by authorized service personnel There are no user serviceable parts inside Error Recommended action s symptoms ymp Monitor not e Monitor is defective e Check the connections operational e Battery is exhausted e Contact authorized e Monitor is not connected service personnel to mains Measured values Insufficient removal of e Remembrane the sensor drift when sensor is old electrolyte during measuring on cal membraning procedure gas in vitro e Check sensor zero current and sensitivity e Air bubbles in electrolyte e The sensor membrane has not been changed regularly e Defective sensor mem brane holes or scratches e Defective O rings one or both O rings are broken Measured values Improper attachment of e Detach the sensor and drift constantly the sensor reapply correctly without any clinical cause when sensor is mounted on patient in vivo Improper attachment of e Detach the fixation ring the fixation ring and reapply correctly e An inappropriate e Check sensor zero current measurement site has and sensitivity been selected nadequate vasodilation e Hole in the membrane Remembrane the sensor e Air under the me
86. eeded Details about the specific alarm condition can be seen on the TCM monitor Alerts Alerts are caused by errors related to the TCM monitor or its accessories An alert is displayed as a text on a green background at the top left hand corner of the PPMS monitor screen The following alerts may be displayed on the PPMS monitor screen SEE TC MONITOR Details about the specific alert condition can be seen on the TCM monitor TC BAT LOW Necessary to connect to mains Continued on next page 6 27 6 Patient monitoring TCM4 40 operator s manual Continuous data output VueLink Continued Alerts Depending on the alert parameter values may be displayed in the following ways Canned Parameter reading Interpretation parameter value Data may be wrong Provided data is wrong Blank No data can be provided NOTICE Alarm alert delays between the PPMS and TCM monitors are less than two seconds Troubleshooting Symptom Recommended action s It is not possible Error related to to establish physical contact between connection the TCM and PPMS monitors Incorrect installation of TCM monitor Incorrect installation of PPMS monitor 6 28 Check that both monitors are ON Check the cable connection If error remains contact authorized service personnel Check that the TCM monitor is set up for VueLink transmission If error remains contact authorized service perso
87. emoglobin methemoglobin and sulfhemoglobin are unable to carry oxygen SpO readings may appear normal however a patient may be hypoxic because less hemoglobin is available to carry oxygen Further assessment beyond pulse oximetry is recommended Anemia causes decreased arterial oxygen content Although SpO readings may appear normal an anemic patient may be hypoxic Correcting anemia can improve arterial oxygen content The monitor may fail to provide an SpO if hemoglobin levels fall below 5 g dL Saturation The monitor displays saturation levels between 1 and 100 Pulse rates The monitor displays pulse rates between 20 and 300 beats per minute Detected pulse rates outside the range of 20 to 300 beats per minute are displayed as the closest value within the range Continued on next page TCM4 40 operator s manual 6 Patient monitoring General information Continued SpO sensor performance considerations Inaccurate measurements may be caused by e incorrect application of the sensor e placement of the sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line e ambient light e prolonged patient movement Loss of pulse signal can occur for the following reasons e The sensor is applied too tightly e A blood pressure cuff is inflated on the same extremity as the one with the sensor attached e There is arterial occlusion proximal to the sensor Use only Radiometer recommended s
88. ensor DSTOQOA iter 6 9 85260 nu eue 6 7 E3280 5 utes deti 6 7 Oxiband 6 9 Oxiband 6 9 SLOTA ge cs derer 4 15 TCM4 40 operator s manual 6 2 Sensor application procedure 100 6 9 5260 0 6 7 E3280 6 7 E5480 cce 6 6 Oxiband A N and P I 6 9 Sensor components E5200 nitet ctt edes 9 4 E5280 9 4 Sensor components E3480 scite amete 9 3 Sensor socket SpO siete ent alte 2 4 tepCO tepO E 2 4 Sensor temperature 3 10 3 11 Serial port RS232 2 4 Session 6 12 6 13 Session number 6 13 Setting up analog 6 21 Setup programs 3 3 etes 3 17 Severinghaus corr 3 20 Severinghaus temperature correction 9 5 Shutting down 4 5 Site time 3 10 3 11 6 11 Site time heat 3 10 3 11 SmartCal 3 15 5 2 SmartHeat 3 10 Solutions 9 10 stability uses 9 10 SUOTA GES ccce e eeclesie 9 10 USt receta a 9 10 Specifications E5260 8 13 E5280 8 13 E5480 8 12 isset ree 8 2 OxiMax 8 13 Spectrophotometry 9 16 SpO measurement
89. ensors and sensor cables Select an appropriate sensor apply it as directed and observe all warnings and cautions presented in the directions for use accompanying the sensor Clean and remove any substances such as nail polish from the application site Periodically check to ensure that the sensor remains properly positioned on the patient A WARNING Risk of skin damage Inspect the sensor site as directed in the sensor directions for use Incorrect application or inappropriate duration of use of an SpO sensor can cause skin damage AX WARNING Risk of incorrect measurements Make sure the sensor is applied correctly Incorrect application of the SpO gt sensor can cause incorrect measurements High ambient light sources such as surgical lights especially those with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps and direct sunlight can interfere with the performance of an SpO sensor To prevent interference from ambient light ensure that the sensor is properly applied and cover the sensor site with opaque material If patient movement presents a problem try one or more of the following remedies to correct the problem e Verify that the sensor is properly and securely applied e Move the sensor to a less active site e Use an adhesive sensor that tolerates some patient motion e Use a new sensor with fresh adhesive backing 6 5 6 Patient monitoring TCM4 40 operator s manual Application and re
90. ent safety e The instrument complies with IEC 60601 1 and IEC 60601 2 23 e The following test house has approved the instrument CSA in Canada according to CAN CSA C22 2 No 601 1 M90 601 181 94 601 1B 98 601 2 23 02 and UL std No 60601 1 Continued on next page 8 7 8 Specifications and ordering information TCM4 40 operator s manual Specifications Continued and compliance Compliance The monitor complies with continued e EC 60601 1 Medical Electrical Equipment Part 1 General requirements for safety IEC 60601 1 2 Medical Electrical Equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility requirements and tests IEC 60601 1 4 General requirements for safety and design of programmable electrical medical systems IEC 60601 2 23 Medical Electrical Equipment Part 2 23 Particular requirements for the safety including essential performance of transcutaneous partial pressure monitoring equipment IEC 60601 2 49 Medical Electrical Equipment Part 2 49 Particular requirements for the safety of multifunction patient monitoring equipment IEC 60601 3 1 Medical Electrical Equipment Part 3 1 Essential performance requirements for transcutane ous oxygen and carbon dioxide partial pressure monitoring equipment ISO 9919 Medical Electrical Equipment Particular requirements for the basic safety and essential performance o
91. es access to the In vivo calibration calibration touch key in the Blood gas setup Cal gas mix 0 0 100 0 A calibration constant pO in steps of 0 1 Cal gas mix 0 0 10 0 A calibration constant pCO in steps of 0 1 Unit mmHg kPa Defines the pCO pO unit pCO pO pO ON OFF Defines whether to display the pO parameter parameter or not NOTICE This option only has an effect when a combined tcepCO tepO sensor is connected to the monitor Alarm mode Latching Defines whether the alarm is latching non latching the monitor remains in alarm status even though the alarm condition ceases to exist or non latching the monitor resets itself as soon as the alarm condition ceases to exist Continuous OFF Standard VueLink Gives four possibilities for data data output MonLink or Raw data output standard VueLink MonLink and raw data See chapter 6 for detailed information NOTICE Raw data is for service purposes only For more information see the TCM4 Series service manual Continued on next page 3 20 TCM4 40 operator s manual 3 Menu structure and setup programs Technical settings Continued tti NLIS d Data export OFF USB or Serial Enables access to the Export touch key in Patient DMS which is used to export a dump of the trend data to a memory stick or an external PC NOTICE Serial is only available if Continuous data output is set to OFF Data export 2 10 30 or 60 seconds De
92. esconcecececcessesececcescocvessencesecesesscossenecees Calibration Checking z ero current and sensitivity eene 5 Calibration TCM4 40 operator s manual General information To ensure accurate and safe performance of the sensor it must be calibrated according to the recommendations below Calibration To calibrate the sensor use the CALI standard calibration gas mixture 7 5 CO material 20 9 balance N SmartCal The SmartCal function makes sure that the monitor is always ready by calibrating when needed for a period of time that is defined by the operator 1 12 hours or forever Calibration SmartCal Explanation If SmartCal is ON and the duration is set to forever or 1 12 hours a calibration will be performed automatically every 4 hours 1 e whenever the sensor is placed in the calibration chamber and within the selected SmartCal period NOTICE If the duration is set to 1 12 hours it will be necessary to press Calibrate to start a new SmartCal period after the first period ended If SmartCal is OFF Radiometer recommends performing a manual calibration e every time the sensor has been remembraned e prior to each monitoring period e when changing measuring sites e every 4 hours NOTICE If the sensor was not in use for an extended time period it is recommended to select SmartCal ON and to allow at least 4 hours for stabilization of the sensor in the calibration chamber
93. et for Serial port 2 USB ports authorized service analog output personnel only functions Battery For allowing monitoring during transport and power failure SpO sensor socket For connecting an SpO sensor to the monitor TCM40 monitor only Line fuse 1 25 AT For preventing a short circuit WARNING Risk of fire Replace fuse only as recommended by Radiometer Otherwise you risk that the monitor catches fire For connecting a power cord to the monitor Serial port RS232 For connecting the monitor to an external computer Analog output For connecting the monitor to a peripheral device such as a polysomnograph USB ports For connecting the monitor to an external printer and a memory stick NOTICE It is only possible to use one of the ports at a time Module release For releasing the sensor module from the monitor with a release key tepCO tcpO For connecting a tcpCO tcpO sensor to the monitor sensor socket Power switch For turning the power supply to the monitor ON and OFF NOTICE If the power supply is ON the battery will be recharged when needed 2 4 TCM4 40 operator s manual 2 What is what The screen general elements Screen types View screen configuration There are two types of screens on the TCM4 40 monitors view i e Normal Trend table and Trend Curve and menu screens The view screens are divided into the following fields Time Date System view statu
94. ey 3 Follow steps 1 2 for the remaining options 4 Press OK to accept the changes and return to the main screen e Apply to accept the changes without leaving the SpO Pulse setup e Cancel to return to the main screen without saving changes 3 12 TCM4 40 operator s manual 3 Menu structure and setup programs Blood gas Introduction Accessing the program Procedures In the Blood gas setup it is possible to e key in the blood gas values of a patient to compare these with transcutaneous measurements from the same patient The blood gas values are displayed as blood drops in all views as well as on all printed reports e calibrate the transcutaneous measurements against the blood gas values in vivo calibration and all results will then be displayed as red stars To access the Blood gas setup press Setup Parameter Blood gas NOTICE The system must be monitoring View Parameter Calibration Printer Technical Blood gas values pCO Sample time pCO mmHg Blood gas In vivo calibration OK Apply Cancel NOTICE The In vivo calibration touch key is only visible if the option has been activated in Technical settings see Technical settings later in this chapter For the procedures on how to key in a blood gas value and how to perform an in vivo calibration see Blood gas comparison and In vivo calibration in chapter 6 3 Menu structure and setup programs TCM4 4
95. f pulse oximeter equipment for medical use IEC 60601 1 8 Medical Electrical Equipment Part 1 8 General requirements for safety Collateral standard General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Class II Special Controls Guidance Document Cutaneous Carbon Dioxide tcpCO and Oxygen tcpO Monitors Guidance for Industry and FDA December 13 2002 e Draft Guidance for Industry and Staff Pulse oximeters premarket notifications submissions 510 k s Non linearity and hysteresis The requirement to non linearity and hysteresis 5 mmHg is fulfilled for gas concentrations between 5 and 10 Drift The requirement to drift lt 10 of initial reading over the calibration interval is fulfilled Continued on next page 8 8 TCM4 40 operator s manual 8 Specifications and ordering information Specifications Continued compliance pCO continued The following drift per hour has been measured at a sensor continued oc temperature of 43 C Max drift per hour at 5 2 Max drift per hour at 10 CO 2 96 Calibration interval 4 hours Accuracy The device indicates the partial pressure of carbon dioxide cutaneous pCO to within 5 mmHg over the measurement range Response time 10 to 90 response The following max response times have been measured at a sensor temperature of 43 C E5280 E5260 26 second
96. f the monitor Battery Changing the battery The following battery type must be installed on the monitor Standard 12 V 2 Ah lead acid battery code no 431 018 available from Radiometer Contact your local battery supplier for available type CAUTION Risk of patient not being monitored For data safety reasons a battery must always be connected to the system A CAUTION Risk of patient not being monitored Replace battery only with the types recommended by Radiometer AN CAUTION Handling of biohazardous waste Dispose of the battery according to local procedures to avoid personal injury or pollution of the environment The monitor can function for approx one hour on battery supply depending on battery type When the monitors run on battery it is indicated on the display and the battery level indicator shows the battery level If the battery level is low an alert sound is heard and the battery level indicator is flashing If the battery level is critically low an alert message will furthermore be displayed CAUTION Risk of patient not being monitored Make sure the battery level never becomes critically low as this will prevent data from being saved onto the disk To avoid a complete discharge of the battery reconnect the monitor to the mains as soon as possible to recharge the battery Recharging the battery takes approximately 8 hours Step Action 1 Unscrew the battery cover at the rear of the monitor 2 Det
97. fines the interval between the interval export of data 10 100 Defines the backlight brightness of the in steps of 10 display NOTICE Full backlight reduces the lifetime of the display Screen saver ON OFF Makes a screen saver option available in Normal view setup pO analog 0 200 or 0 800 mmHg Defines the pO analog output range range 0 0 26 7 or 0 0 99 9 kPa pCO analog 0 100 or 0 200 mmHg Defines the pCO analog output range range 0 0 13 3 or 0 0 26 7 kPa Selecting Step Action technical settings 1 Select the relevant option with the W touch key 2 Choose the settings of that option with the Up or Down arrow key 3 Follow steps 1 2 for the remaining options 4 Press OK to accept the changes and return to the main screen e Apply to accept the changes without leaving the Technical settings e Cancel to return to the main screen without saving changes 3 21 3 Menu structure and setup programs TCM4 40 operator s manual Date time Accessing the program Changing date time settings 3 22 To access the Date time settings press Setup Technical enter password and press Enter Date time View Parameter Calibration Printer Technical TCM 3 00 OK Apply Cancel WARNING Risk of data loss If the Date time settings are changed backward in time only the measurements that have been performed prior to the new date time will be kept in the memory Other data will be delete
98. gas US and Canada 7 5 CO 20 9 balance 180 mL 962 188 Type Code Traceability of parameters Expanded Primary gravimetrically prepared CO mol standards Traceable to NIST traceable 220 07 weights Primary gravimetrically prepared mol 96 standards Traceable to NIST traceable 0 03 weights Certification Each lot of this product has been tested and the nominal values specified on the label of this product have been established with the above traceability H B Kristensen Head of Chemical Reference Laboratory The traceability of the above parameters is fully described in booklet AS 117 Traceability to the Primary Reference Standards at Radiometer available from Radiometer Radiometer is a trademark of Radiometer A S RADIOMETER Radiometer A S DK 2700 Br nsh j Denmark 2004 Rights Reserved 990 347 200409A COPENHAGEN TCM4 40 operator s manual TCM4 40 operator s manual 9 Functional description NOTICE The below mentioned CAL2 calibration gas is not applicable to Germany For information on the CAL2 calibration gas that applies to Germany see next page Certificate of Traceability Product name CAL2 standard calibration gas Type 10 CO balance 999 mL Code 962 096 Traceability of parameters Expanded Primary gravimetrically prepared standards Traceable to NIST traceable 0 02 weights Primary gravimetrically
99. he Severinghaus temperature correction factor This means that the tcpCO readings are corrected to 37 C normal body temperature using the following formula tcpCO pCO 37 x 19 0 019 T 37 C where T is the set sensor temperature C 9 5 9 Functional description TCM4 40 operator s manual pO measuring principle Definition Measuring principle 9 6 The measurement of pO is defined as the partial pressure or tension of oxygen It is performed as a direct polarographic measurement based on an electrochemical electrode chain consisting of the platinum cathode the sensor electrode and the silver anode the reference electrode The sensor tip is covered with a thin membrane which stabilizes the conditions of pO diffusion to the sensor Oxygen diffuses through this membrane to the cathode where a reduction of oxygen occurs as a result of the current generating process 2 4 40H At the anode the following reaction takes place 4Ag 4Cl 4AgCl 4e The reduction of oxygen at the platinum cathode generates a current which is fed into the pO channel where it is converted into a voltage and digitized This digi tized signal is then passed on to the microcomputer where it is reconverted to display in mmHg or kPa TCM4 40 operator s manual 9 Functional description Calibration of sensor Temperature corrected pCO values Gas calibration values In order for th
100. he data export option a dump of the trend data can be exported to an external PC and presented in spreadsheet format Exporting data In this example HyperTerminal version 690170 with Excel version 97 SR 2 is to PC used Step Action 1 Connect the TCM4xx ETX Serial Adapter code no 636 649 to the serial port on the TCM monitor and to the PC 2 On the PC select Start Programs Accessories gt Communications HyperTerminal and open the EXE file Type in a name for the connection e g TcData and click OK 4 six TcData Enter details for the phone number that you want to dial Country region 4 Area code Phone number Ni Connect using Cancel Connect using COMI and click OK 5 Select the following port settings and click OK Port Settings Bits per second n Parity Noe Stop bits Flow control Restore Defaults Cancel Apply Continued on next page 6 30 TCM4 40 operator s manual 6 Patient monitoring Data export serial Continued Exporting data to PC continued Importing data files into Microsoft Excel Step Action 6 Collect the data in HyperTerminal by selecting Transfer Capture text Then name the file e g CAPTURE txt and click Start 7 On the TCM monitor press Setup Technical enter password and press Enter and Tech settings 8 Set Continuou
101. he section EMC approvals and compliance in chapter 8 Otherwise the monitor may be affected by electromagnetic interference causing incorrect measurements WARNING Risk of fire Do not place the monitor in an enriched oxygen atmosphere or inside a hyperbaric chamber as it may cause a fire hazard WARNING Risk of explosion Do not use the monitor in the presence of flammable anesthetics or gases as it may cause an explosion WARNING Risk of fire Do not cover the ventilator as this may cause it to seize up WARNING Risk of electrical shock Do not use the monitor if it is damaged as this may result in electrical shock gt The following environmental requirements must be observed at all times e ambient temperature 5 40 C e relative humidity 20 80 96 NOTICE Do not operate the monitor at ambient temperatures below 5 C or above 40 C and relative humidity below 20 or above 80 Operating the monitor outside these limits may affect the readings of the device The monitor must be located in a well ventilated dust free atmosphere TCM4 40 operator s manual 4 Installation and maintenance Installing the monitoring system Procedure Step Action 1 NOTICE While installing the modules the monitor must be turned off Install the relevant module s i e tc and SpO by pressing each module completely into the base unit until a click is heard NOTICE If using an E5480 sensor the gasket in the calibra
102. ibration 6 46 NOTICES e In vivo calibration should not be performed on hemodynamically unstable patients because the arterial blood gas value and the tc value may fluctuate considerably In vivo calibration of a tc value will bring the displayed value closer to the arterial sample reading But the correlation between the tc and the arterial values will remain unchanged In vivo calibration does not make the TCM monitor read arterial values Nor does it eliminate the blood flow dependence on the tc value or any of the other determinants It gives the same information as the original tc value only on another level see the graph below tepO2 sample Step 1 sample result calculation in vivo cal note 50 pOx a 70 mmHg 30 4 icpOs 40 mmHg 50 40 x 1 4 56 mmHg is the adiusted value Action Make sure that access to the In vivo calibration touch key has been enabled in Technical settings that the sensor is placed on the patient and that the tc values are stable Before drawing the blood sample press Setup Parameter Blood gas Sample time The monitor will register the blood sampling time and the pCO and pO input fields and the numeric keypad are now accessible Draw the blood sample and perform a blood gas analysis When the blood gas result is ready enter the Blood gas setup press the pCO input field and key in the value with the numeric keypad Then press the pO input
103. ide as this may damage the sensor There are two recommended cleaning disinfection methods e The wipe method for all three SpO sensors e The soak method for Oxiband A N and P I sensors only Step 1 Action Saturate a clean dry gauze pad with the cleaning solution Wipe all surfaces of the sensor and cable with this gauze pad Saturate another clean dry gauze pad with sterile or distilled water Wipe all surfaces of the sensor and cable with this gauze pad Dry the sensor and cable by wiping all surfaces with a clean dry gauze pad For Oxiband A N and sensors only Step 1 e WARNING Risk of incorrect measurements sensor failure Do not immerse or wet the DS100A sensor as this may damage the sensor Action Place the sensor in the cleaning solution such that the sensor head s and desired length of cable are completely immersed WARNING Risk of incorrect measurements sensor failure Do not immerse the connector end of an SpO sensor cable as this may damage the sensor Dislodge air bubbles by gently shaking the sensor and cable Soak the sensor and the cable for 10 minutes Remove from cleaning solution Place the sensor and the cable in room temperature sterile or distilled water for 10 minutes Remove from the water Dry the sensor and cable by wiping all surfaces with a clean dry gauze pad 5 Calibration General information c s seccccceccsseesesecccscecesvs
104. ifications Continued EMC approvals and compliance continued 8 Specifications and ordering information magnetic field IEC 61000 4 8 Immunity IEC 60601 Compliance Electromagnetic environment test test level level guidance Voltage dips lt 5 Ur N A as the None short gt 95 drop monitor has interruptions in for 0 5 battery and voltage cycle backup dei ka 40 Ur aa Y 60 drop input lines in for 5 IEC 61000 4 11 cycles 70 Ur 30 drop in for 25 cycles lt 5 Ur gt 95 drop in for 5 seconds Power 3 A m 3 A m None frequency 50 60 Hz NOTICE Uzis the AC mains voltage prior to application of the test level Continued on next page 8 5 8 Specifications and ordering information TCM4 40 operator s manual Specifications Continued EMC approvals Immunity IEC 60601 Compliance Electromagnetic environment and compliance test test level level guidance continued Portable and mobile RF communi cations equipment should be used no closer to any part of the monitor including cables than the recom mended separation distance calcu lated from the equation appropriate for the frequency of the transmitter Recommended separation distance d 124P 150kHz to 80 MHz Conducted RF 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz d 1 2VP 80 MHz to 800 MHz Radiated RF 3 V m 80 MHz to UE 2 5 GHz where P is the output power rating of the
105. l 3 12 Calibration status 3 16 Alarms 6 34 Calibration values 9 7 Alert Certificates of traceability 9 11 6 36 Changing Mule bank 2 ote tes 6 27 battery cte iet aas 4 7 Alerts 6 34 6 35 gas bottle 4 8 rights reserved 1 2 gasket in calibration chamber 4 8 Ambient light sources 6 5 Cleaning Ambient temperature 4 2 cable 4 15 Analog output 2 4 6 21 E5480 sensor head 4 11 Analog range exterior 4 6 PCOS 3 21 sensor 4 15 POs Hiei Ga 3 21 SpO sensors 4 16 Anemia 6 4 soak method 4 16 Application of sensor wipe method 4 16 D S100A eese 6 9 touch 4 6 E5200 7 tt teu desides 6 7 Combi module 2 3 E5280 iubes 6 7 Common name 1 2 E5480 titii 6 6 Compliance 8 8 Oxiband A N and P I 6 9 Connecting to B external chart recorder 6 21 external equipment 4 3 Battery 2 4 4 7 external PC 6 22 6 30 change 4 7 polysomnograph 6 21 Index PPMS monitor 6 24 printer creer oed 6 38 Construction of sensors 9 3 Contact liquid 6 7 9 10 Continuous data output 3 20 6 22 6 29 standa
106. libration gas 1 20 9 Continued on next page 9 7 9 Functional description TCM4 40 operator s manual Calibration of sensor Continued Calibration process 9 8 The calibration process includes the stages described in the table below CALIBRATION max duration 16 min If OK Cal Value on display Electrode READY Lamp goes on 4 Signal mV Acceptance v Range X Mean Value ifX X2 lt 1 READY if not OK then X2 X1 READY if not OK then Heat on El Signal Stability If not used for 30 min Press CAL iRangeCheck i Check Calis asked for i 2 i i 1 3 Heating The sensor is typically heated to the preset temperature within one minute If it has not reached this temperature within three minutes the computer will reject the sensor and the error message Calibration error Sensor temperature error during calibration will be displayed Check of When the sensor reaches the preset temperature the monitor sensor checks the sensor pCO and pO signals If these are not within a signal range specified range within one minute the monitor rejects the sensor and the error message Calibration error Sensor sensitivity error during calibration will be displayed NOTICE The sensor may also be rejected because of an incorrect calibration value Check of After heating and acceptance of the sensor signal range the stability monitor checks the sensor stability for
107. makes it possible to go back and forth in time Cursor The cursor values pCO2 pO Power SpO2 Pulse Time and Date are shown in the lower right part of the screen whereas current values are shown in the upper right part of the screen Press Cursor again to remove the cursor from the screen Continued on next page 6 19 6 Patient monitoring TCM4 40 operator s manual Results in Trend curve view Continued Viewing results Step Action in trend curve i view continued 4 To change the high or low values of the parameter ranges press 5 To print the results press Print See also How to print later in this chapter Markings in The following markings can be seen in the Trend curve view Trend curve 73 Blood gas values have been entered An in vivo calibration has been performed ec No value is available 1 99 An event mark number has been added 6 20 TCM4 40 operator s manual Analog output Introduction Setting up analog output 6 Patient monitoring The monitor is equipped with an output for direct connection to an external chart recorder or polysomnograph Follow the steps below to connect the TCM4 40 monitor to an external chart recorder or polysomnograph Step 1 Action Connect the TCM4xx ETX Analog Adapter code no 636 650 to the analog port NOTICE Do not use other adapters than 636 650 Connect the wires as follows
108. mark the event or press Cancel to return to Normal view without marking the event NOTICE It is possible to mark up to 99 events Continued on next page 6 11 6 Patient monitoring TCM4 40 operator s manual Patient monitoring In vivo monitoring Continued Patient monitoring Step Action continued 4 To link the session i e the measurement in progress to a specific patient ID press ZD in the top right corner of the view screens and make the necessary changes in the Patient DMS For more information see Patient DMS later in this chapter 5 View the readings and adjust the settings if necessary See chapter 3 Menu structure and setup programs WARNING Risk of skin damage Sensors must be moved to a new site at least every four hours Because individual skin condition affects the ability of the skin to tolerate sensor placement it may be necessary to change the sensor site more frequently with some patients If skin integrity changes move the sensor to another site JN WARNING Risk of incorrect measurements Always keep protection caps on the tepCO tepO sensors except when applied to skin placed in the calibration chamber or during handling and maintenance Exposing sensor membranes to light for example light from incubators may cause elevated pCO values NOTICE After removing the sensor from the patient make sure to wipe it clean from contact liquid before placing it in the calibration chamber
109. mbrane Continued on next page 7 2 TCM4 40 operator s manual The TCM4 40 systems continued Error symptoms R Measured values e Patient status unstable continued not stable or out of range 20 minutes after application e Inadequate vasodilation e Improper attachment of the sensor e Sensor exposed to high ambient light e Hole in the membrane e Air under the membrane Measured values e Inaccurate result due to change suddenly patient movements without any clinical e Air leakage under cause otis fixation ring e Self adhesive ring does not stick to the skin e Hole in the membrane e Air under the membrane 7 Troubleshooting Recommended action s e Evaluate patient status e Remount the sensor Remembrane the sensor Recalibrate and reapply sensor to the skin possibly selecting a new measuring site Remembrane the sensor Noise appears on Interference from nearby Increase the distance from the tension readout equipment the interfering equipment message Battery level low Battery level is low Connect Recommend acon _ monitor to the mains tc error Error message Cause messages in alphabetical order Calibration error Barometer value invalid Barometer error when collected at start of during calibration calibration Calibration error e Calibration chamber is Gas flow out of blocked range e Calibration unit is defective Recommended action
110. moval of tc sensors Required The following items included in the fixation kits are required to apply the tc materials for sensors to a patient application of Fixation ring sensors WARNING Risk of infection and inaccurate results Reuse of single use devices may lead to infection of patients and inaccurate results e Contact liquid Prior to sensor Step Action application 1 Calibrate the sensor as described in chapter 5 Calibration 2 Clean the selected measuring site with alcohol or other skin preparation solution 3 Dry the site well with a gauze pad Application of Step Action 1 Take a fixation ring and remove the protective film 2 Apply the fixation ring to clean and dry skin by pressing the center of the fixation ring onto the measuring site with a finger and then running a finger around the rim circumference to ensure a good seal 3 X 2 Apply 2 drops of contact liquid in the center of the ring NN g oy 4 P2 Place the sensor without the protection cap in the fixation ring with the sensor cord pointing in the opposite direction of the tab on the ring Then turn the sensor a quarter of a turn clockwise to fasten it in the fixation ring Continued on next page 6 6 TCM4 40 operator s manual 6 Patient monitoring Application and removal of tc sensors Continued Application of Step Action E5280 and NE E5260 sensors 1 Take a fixation ring and remove the prot
111. must be remembraned and recalibrated Then repeat steps 1 3 of this procedure NOTICE If the tcpO reading is still equal to or above 5 mmHg 0 7 kPa the sensor is defective After zero current and sensitivity have been checked unscrew the CAL2 gas cylinder from the gas adapter Remember to reset the metabolic correction factor to 7 and the Severinghaus correction factor to ON in the Technical setup NOTICE Lack of sensitivity may be due to insufficient removal of used electrolyte solution during the membraning procedure In such cases it is recommended to remembrane the sensor according to the procedure described in chapter 4 Installation and maintenance 6 Patient monitoring General information reaa ra 6 2 Application and removal of tc sensors sese 6 6 Application of SpO sensors enne nnne nennen 6 8 Patient monitoring In vivo een 6 11 Patient DMS PE 6 13 Results in Normal ect ertet 6 16 Results in Trend table view ener enne 6 18 Results in Trend curve 1 nne 6 19 Analog output te cn tdt aed o deiecit tet e Eae det 6 21 Continuous data output standard sess 6 22 Continuous data output VueLink esses 6 24 Continuous data output MonLink esee 6 29 Data export serial tee ree reo cen e t e e RS d 6 30 Data export U
112. nen nnne 9 5 measuring principle esee eene eene nennen nnne 9 6 Calibration of sensor sse eere 9 7 Solutions and calibration gases ssssssssesesee eee 9 10 T raceability Certificates onte eoo n eh ER OTRA ea a 9 11 Pulse oximetry measurement esee esee eee eee enses ense ense ease enses sees sess sees ssesscesse 9 15 Measuring principle nnne entren entren 9 16 Calibration of sensor sse ener enne entren nentes 9 17 Index Date of issue Contents TCM4 40 operator s manual 1 Introduction Names intended use and limitations seen eene Symbols used on the enne Symbols used in the manual 1 Introduction TCM4 40 operator s manual Names intended use and limitations Proprietary names Common names TCMA series monitors Reference All rights reserved Intended use Sensors Environment of use Operator profile Limitations 1 2 TCM4 monitor and TCM40 monitor Transcutaneous pCO pO monitoring system TCM4 and Transcutaneous pCO pO SpO Pulse monitoring system TCM40 The TCM4 and TCM40 monitoring systems are part of the TCM4 Series monitoring system This operator s manual for the TCM4 40 monitoring systems is intended for use as a reference It provides detailed operating instructions and answers to relevant questions about your monitoring systems
113. ning the exterior Cleaning the touch screen Disinfection of outer surfaces NOTICE 4 6 When cleaning the monitor e Shut down the monitor by following the procedure described earlier in this chapter e Use a cloth that is lightly dampened with soapy water e Do not use abrasive cleansers or pads the finish may become damaged Do not use aggressive detergents Extensive use may cause the plastic to become brittle and cracks may occur A dry or lightly dampened soft lint free cloth may be used to clean the monitor s touch screen Simply wipe the screen gently to remove fingerprints and or dirt To avoid streaking an approved screen cleaner is recommended Disinfection of the monitor exterior and touch screen is performed when appropriate The disinfection frequency depends on local requirements and the use of the monitor NOTICE Follow legal requirements and local rules for safe work practices with chemicals The following disinfectants dissolved in water may be used to disinfect the monitor exterior and touch screen e 70 isopropyl alcohol e 70 ethanol e 4 Diversol BX solution To disinfect the monitor exterior and touch screen wipe the surfaces using one of the above disinfectants on a paper towel or tissue Do not spray pour or spill any liquid on the monitor or any of the accessories connectors switches or openings in the chassis TCM4 40 operator s manual 4 Installation and maintenance Maintenance o
114. ning the E5480 501 eene nennen nnns 4 12 Membraning the E5280 and E5260 4 13 Cleaning disinfection and storage of sensors sse 4 15 4 9 4 Installation and maintenance TCM4 40 operator s manual General information about membraning To obtain reliable measurements remembrane the sensor every week WARNING Risk of incorrect measurements sensor failure After remembraning the sensor check that the membrane has been clicked completely and centrally onto the sensor housing Otherwise it may cause the sensor to fail When a sensor has been remembraned connect the sensor plug to the sensor socket at the rear of the monitor Check that the system shows Calibration required and calibrate the sensor twice as described in chapter 5 Calibration 4 10 TCM4 40 operator s manual 4 Installation and maintenance Cleaning the sensor head of the E5480 sensor Cleaning the NOTICE Once a month the sensor head must be cleaned to remove old electrolyte sensor head before the sensor is remembraned Step Action 1 Slide the sensor into the end of the membraning tool 2 Pull the sensor upwards to remove the membrane 3 Clean the sensor head with cleaning paper and remembrane the sensor as described on next page 4 Installation and maintenance TCM4 40 operator s manual Membraning the E5480 sensor
115. nnel Reset the PPMS to factory defaults or Select Module Setup and set AUXILIARY PLUS 1 or VueLink to ON If error remains contact authorized service personnel TCM4 40 operator s manual 6 Patient monitoring Continuous data output MonLink Introduction Available measured parameters Detailed Enables TCM transmission of real time data to external equipment Any interaction is initiated by host request that includes System parameter status Measuring values and system parameter status Analog ranges selected alarm ranges and parameter alarm status Parameter TCM configuration pCO pO SpO PR Power TCM4 monitor X x 40 monitor X X X x x Detailed alarm and alert notifications are not communicated but have to be revealed on the TCM monitor display All data values are updated every 2 seconds How status and measured values are presented is decided by and is under the responsibility of the vendor of the external equipment NOTICE For information on alarm delay and source identification on external equipment please refer to the user instructions for the relevant external equipment For the detailed communication protocol please see the document TCM communication Communication Protocol Specifications code no 994 038 from Radiometer protocol 6 29 6 Patient monitoring TCM4 40 operator s manual Data export serial Introduction With t
116. nous pulsations intravascular dyes such as indocyanine green or methylene blue defibrillation incorrect application of the sensor placement of the sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line ambient light Loss of pulse signal can occur for the following reasons The sensor is applied too tightly A blood pressure cuff is inflated on the same extremity as the one with the sensor attached There is arterial occlusion proximal to the sensor Continued on next page 8 11 8 Specifications and ordering information TCM4 40 operator s manual Specifications Continued Biocompatibility Fixation ring and compliance tinued The suitability of the fixation ring adhesives for use on intact human skin is supported by a series of in vitro and in vivo evaluations The fixation ring adhesives meet the requirements of ISO 10993 1 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing for surface devices contacting intact human skin The evaluations include cell cytotoxicity skin irritation and sensitization potential Nellcor SpO sensors TCM40 only The sensors have passed the recommended biocompatibility testing and are therefore in compliance with ISO 10993 1 Patents One or more of the following patents and patent applications may apply e US Patent No US7 474 908 e US Patent Application No US2007 0238943 e European
117. off immediately and permanently e f a software error occurs a watchdog circuit in the monitor immediately and permanently switches off the sensor heating 9 9 9 Functional description Solutions and calibration gases TCM4 40 operator s manual Solutions The following solutions are used with the TCM4 40 systems Solution Description tepCO tcpO Use To be applied on the clean sensor surface n e Composition 1 2 propanediol propanetriol potassium 10 mL chloride potassium hydrogen carbonate and deionized water Storage At room temperature or below Stability Expiration date and lot no are printed on a separate label on the bottle Contact liquid Use To establish contact between the skin and 20 mL the sensor during in vivo measurements Composition 1 2 propanediol and deionized water Storage At room temperature or below Stability Expiration date and lot no are printed on a separate label on the bottle NOTICE Keep the bottle caps on when bottles are not in use Calibration e CALI standard calibration gas 7 5 CO 20 9 with N as balance gases e CAL2 standard calibration gas 10 CO with as balance WARNING Risk of explosion Calibration gas cylinder Contents under pressure Do not puncture Do not use or store near heat or open flame Exposure to temperatures above 54 C for CAL2 and 50 C for CAL1 may cause contents to vent or cause bursting Never discard
118. on the printout e choose whether to print out the report as a table a curve or both adjust the set curve ranges e connect a color or a black and white B W printer to the monitor To access the Printer setup press Setup Printer Parameter Calibration Printer Report type Table Curve ranges 5 0 OK Apply Cancel NOTICE SpO and pulse are available on the TCM40 monitor only Step Action 1 Select the time interval with the Up and Down arrow keys 2 Select the time span with the Up and Down arrow keys NOTICE The selected time span will influence the start time of the Printer start stop time screen as the interval between the printer start time and the printer stop time corresponds to the time span i e if the time span is set to 1 hour the interval between the printer start time and the printer stop time will also be 1 hour see also How to print in chapter 6 In vivo monitoring 3 To change the curve range for pCO pO Power or SpO Pulse press the relevant parameter touch key and select the high and low values using the Up and Down arrows Continued on next page 3 17 3 Menu structure and setup programs TCM4 40 operator s manual Printer setup Continued Selecting printer Step settings 4 continued Action Press OK to accept the changes and return to the Printer setup or press Cancel to return to the Printer setup without saving the
119. oned along the top of the finger or a great toe with the cable positioned along the sole of the foot e Infant 3 15 kg The preferred site is around a great toe with the cable positioned along the sole of the foot NOTICE The monitor must only be connected to sensors for one patient at a time For neonates a sensor temperature between 42 and 44 C is recommended For adults a sensor temperature between 43 and 45 C is recommended N WARNING Risk of burns Do not allow the tcpCO tcpO sensor temperature to exceed 43 C for neonates and 44 C for adults if sensors are attached to skin for more than four hours as this may otherwise cause burns N WARNING Risk of incorrect measurements Do not use the sensors during MRI scanning Conducted current may cause burns Also the sensors may affect the MRI image and the MRI unit may affect the accuracy of oximetry measurements N WARNING Risk of strangulation As with all medical equipment carefully route and affix patient cabling using the cable clip to reduce the possibility of patient entanglement or strangulation WARNING Risk of skin damage To avoid the risk of skin damage make sure to set SmartHeat to OFF before applying the sensor to a neonate Continued on next page TCM4 40 operator s manual 6 Patient monitoring General information Continued General alerts continued gt WARNING Risk of incorrect measurements Remove the sensors from
120. orrectness of the information provided in this document as changed from time to time Radiometer disclaims any liability for errors and omissions Radiometer the Radiometer logo ABL AQT TCM RADIANCE PICO and CLINITUBES are trademarks of Radiometer Medical ApS 2011 Radiometer Medical ApS All rights reserved End user license agreement for Microsoft Software You have acquired a device TCM4 40 monitor that includes software licensed by Radiometer Medical ApS from Microsoft Licensing Inc or its affiliates MS Those installed software products of MS origin as well as associated media printed materials and online or electronic documentation SOFTWARE are protected by international intellectual property laws and treaties The SOFTWARE is licensed not sold All rights reserved IF YOU DO NOT AGREE TO THIS END USER LICENSE AGREEMENT EULA DO NOT USE THE DEVICE OR COPY THE SOFTWARE INSTEAD PROMPTLY CONTACT Radiometer Medical ApS FOR INSTRUCTIONS ON RETURN OF THE UNUSED DEVICE S FOR A REFUND ANY USE OF THE SOFTWARE INCLUDING BUT NOT LIMITED TO USE ON THE DEVICE WILL CONSTITUTE YOUR AGREEMENT TO THIS EULA OR RATIFICATION OF ANY PREVIOUS CONSENT GRANT OF SOFTWARE LICENSE This EULA grants you the following license You may use the SOFTWARE only on the DEVICE NOT FAULT TOLERANT THE SOFTWARE IS NOT FAULT TOLERANT Radiometer Medical ApS HAS INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE AND MS HAS RE
121. ors Continued Application of Oxiband A N Step and P I sensors 5 continued Action Position the sensor so that the notches are centered on the side of the measuring site The cable end must be positioned along the appropriate surface as described previously in this chapter under General information Wrap the sensor around the measuring site so the optical components and alignment bumps oppose each other across the site Press the sensor to ensure that it adheres snugly Wrap the remaining portion of the sensor wrap around the site loosely enough to ensure good circulation Removal of The disposable wraps used with the Oxiband A N and P I sensors should be wraps removed by peeling them away from the sensor 6 10 WARNING Risk of sensor damage Do not use excessive force when removing the disposable wrap from the sensor as it may damage the sensor TCM4 40 operator s manual 6 Patient monitoring Patient monitoring In vivo monitoring Patient Step Action monttoring 1 Apply the sensor s as described earlier in this chapter and wait for a stable reading NOTICES e The physiological stabilization time of a patient is 10 20 minutes for the tcpO reading Longer time may indicate incorrect sensor application or a poorly selected measuring site The physiological stabilization time of a patient is 5 10 minutes for the tcpCO reading Longer time may indicate incorrect sensor application or a poorly selec
122. output from the monitor is transmitted continuously every 2 seconds in ASCII code in the following format Timestamp O5 CO Heater power Temperature SpO Pulse 2 On the monitor press Setup Technical enter the password and press Enter and Tech settings 3 Use the Up and Down arrows to select Continuous data output and choose the option Standard 4 Press OK to accept the changes and return to the main screen 5 On the PC select Start Programs Accessories Communications HyperTerminal and open the EXE file Type in a name for the connection e g TcData and then click OK 7 6 22 2 TcData Enter details for the phone number that you want to dial Country region Denmark 45 Area code Phone number Connect using 7 Cancel Connect using COMI and click OK Continued on next page TCM4 40 operator s manual 6 Patient monitoring Continuous data output standard Continued Connecting to Step Action external PC 1 8 Select the following port settings and click OK Port Settings Bits per second 9 rl Data bits fe H Parity oe rl Stop bits nh nn Flow control Restore Defaults Cancel Apply 9 Collect the data in HyperTerminal by selecting Transfer Capture text Then name the file e g CAPTURE txt and click Start 10 Stop the collection of data to the file in HyperTerminal by selecting Transfer
123. ows CE 5 0 Interface connection Serial output EIA232 RS232 Printer output USB 2 0 compliant with USB 1 1 Analog output 0 1 V Power supply 100 240 V 50 60 Hz Battery Rechargeable Under normal conditions the battery can Pb battery operate for 1 hour before recharging is needed Dimensions of Height 16cm 6 3 in monitor Width 30 8 cm 12 1 in Depth 23 cm 8 7 in Weight 4 kg 8 8 Ibs Dimensions of tc Height 10 7 cm 4 2 in module Width 14 5 cm 5 7 in Depth 14 8 cm 5 8 in Weight 0 6 kg 1 3 lbs Dimensions of SpO Height 3 5 cm 1 4 in module Width 14 5 cm 5 7 in Depth 14 8 cm 5 8 in Weight 0 21 kg 0 5 Ib Alarm sound At highest Alarm tone 83 dBA pressure alarm sound Alert tone 73 dBA level End of calibration tone 64 dBA At lowest Alarm tone 65 dBA alarm sound Alert tone 58 dBA level End of calibration tone 51 dBA Continued on next page 8 3 8 Specifications and ordering information TCM4 40 operator s manual Specifications Continued EMC approvals and compliance The monitor is intended for use in the electromagnetic environment specified in the tables below The customer or user of the monitor should assure that it is used in such an environment The monitor complies with IEC 60601 1 2 Guidance and manufacturer s declaration electromagnetic emissions 8 4 Emissions test Compliance Electromagnetic environment guidance RF emission
124. oxyhemoglobin differ in their absorption of red and infrared light spectrophotometry and that the volume of arterial blood in tissue and hence light absorption by that blood changes during the pulse plethysmography A pulse oximeter determines SpO by passing red and infrared light into an arteriolar bed and measuring changes in light absorption during the pulsatile cycle Red and infrared low voltage light emitting diodes LED in the oximetry sensor serve as light sources a photodiode serves as the photodetector NOTICE Information about the range of wavelength can be useful to clinicians in particular For information on the range of wavelength see OxiMax sensors in the section Specifications in chapter 8 Because oxyhemoglobin and deoxyhemoglobin differ in light absorption the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation To identify the oxygen saturation of arterial hemoglobin the monitor uses the pulsatile nature of arterial flow During systole a new pulse of arterial blood enters the vascular bed and blood volume and light absorption increase During diastole blood volume and light absorption reach their lowest point The monitor bases its SpO measurements on the difference between maximum and minimum absorption measurements at systole and diastole By doing so it focuses on light absorption by pulsatile arterial blood eliminating the effects of non pulsatile absorbers su
125. prepared standards Traceable to NIST traceable 0 03 weights Certification Each lot of this product has been tested and the nominal values specified on the label of this product have been established with the above traceability Parae as kusan _ H B Kristensen Head of Chemical Reference Laboratory The traceability of the above parameters is fully described in booklet AS 117 Traceability to the Primary Reference Standards at Radiometer available from Radiometer Radiometer is a trademark of Radiometer A S Radiometer A S DK 2700 Br nsh j Denmark 2004 All Rights Reserved RADIOMETER z 990 348 200409A COPENHAGEN 9 13 9 Functional description TCM4 40 operator s manual 9 14 NOTICE The below mentioned CAL2 calibration gas applies to Germany only Certificate of Traceability Product name Cal 2 Gas 10 CO Type Gas mixture 1 L Code 962 154 Traceability of parameters ncertainty Primary gravimetrically prepared CO mol standards Traceable to NIST traceable 0 02 weights Primary gravimetrically prepared standards Traceable to NIST traceable 0 02 weights Certification Each lot of this product has been tested and the nominal values specified on the label of this product have been established with the above traceability Oma Katte St Kristensen Head of Chemical Reference Laboratory The traceability of the above parameters is fully described in booklet AS
126. r membranes to light for example light from incubators may cause elevated pCO values WARNING Risk of incorrect measurements Do not use the monitor adjacent to or stacked with other equipment as these can cause electromagnetic interference and thereby result in incorrect measurements If stacking or use adjacent to other equipment is necessary the monitor should be observed to verify normal operation before used on patients See the section EMC approvals and compliance in chapter 8 WARNING Risk of incorrect measurements When installing operating or servicing the monitor special consideration should be given to the information regarding the electromagnetic precautions for this equipment given in the section EMC approvals and compliance in chapter 8 Otherwise the monitor may be affected by electromagnetic interference causing incorrect measurements WARNING Risk of incorrect measurements The use of sensors cables and accessories other than those specified may result in increased emission and or decreased immunity and inaccurate readings of the monitor Continued on next page 6 3 6 Patient monitoring TCM4 40 operator s manual General information Continued General alerts continued TCM40 performance considerations 6 4 AN WARNING Risk of incorrect measurements tcpCO tcpO monitoring should not be used on patients in a compromised hemodynamic state as this may cause incorrect measurements WARNING Ri
127. rd 6 22 VueLink esses 6 24 CSA 8 7 Cursor 6 19 Curve report 6 41 6 43 D Data dump 6 30 6 33 Data export 6 30 Sepala souder tibi 6 30 USB 6 33 Data Management System 6 13 Date time settings 3 22 Default values 3 23 Dialog box messages 7 6 Disinfection outer surfaces 4 6 SENSORS AAA eee ee 4 15 Disinfection solutions 4 15 Display brightness 3 21 Documentation 8 14 Drift je ord 8 8 itia isses 8 9 Dysfunctional hemoglobins 6 4 E E5260 sensor components 9 4 E5280 sensor components 9 4 E5480 sensor membraning 4 12 E5480 sensor components 9 3 E5480 sensor head 1 4 11 Electrocautery 6 3 Electrolyte solutions 9 10 EMC approvals and compliance 8 4 Enriched oxygen atmosphere 4 2 6 3 Environment of use 1 2 Environmental requirements 4 2 Error messages 7 3 7 6 7 3 Event 6 11 Excel6 23 6 30 Exporting data to memory 5 1 6 33 TCM4 40 operator s manual External chart recorder 6 21 F Factory defaults 3 23 Fixation kit 6 6 Fixation rng 6 7 Flammable anesthetics 4 2 Front view 2 3 Functional oxygen saturation 9 16 G Gas adapter 8 15 Gas bottle maintenance 4 8 Gas calibration values 9 7 Gas level 3 16 5 3 Gas status 5 3 Gasket change of 4 8 H Handle 2 3
128. s e Start a new calibration e f error remains contact authorized service personnel e Check chamber sealing e Contact authorized service personnel Calibration error Less than 10 calibrations Change gas bottle Gas level low left Continued on next page 7 3 7 Troubleshooting TCM4 40 operator s manual The TCM4 40 systems continued tc error Error message Cause Recommended action s messages in alphabetical Calibration error There is a leak in the Check that a gasket is Grder Leak error in calibration chamber present and positioned calibration chamber correctly in the chamber e Check that the sensor is positioned correctly in the chamber Calibration error No sensor detected in the Place a tepCO tepO sensor No sensor calibration chamber at start in the chamber connected to the of or during calibration chamber Calibration error The sensor has been e Start a new calibration Sensor drift during rejected during the drift i z calibration check If error remains remem brane the sensor and start a new calibration If error remains the sensor is defective Replace with a new one Calibration error The sensor sensitivity is If the sensor has just been Sensor sensitivity outside the specifications remembraned start a new error during calibration calibration Otherwise remembrane the sensor and start a new calibration Sensor is defective Replace with
129. s E5480 83 seconds Non linearity and hysteresis The requirement to non linearity and hysteresis 5 mmHg is fulfilled for gas concentrations between 2 and 20 9 Drift The requirement to drift lt 5 of initial reading over the calibration interval is fulfilled The following drift per hour has been measured at a sensor temperature of 43 C Max drift per hour at 10 O5 1 Max drift per hour at 20 9 1 96 Calibration interval 4 hours Accuracy The device indicates the partial pressure of oxygen cutaneous pO to within 5 mmHg over the range from 0 96 to 20 9 In the range from 20 9 to full scale the accuracy is better than 10 Response time 10 to 90 response The following max response times have been measured at a sensor temperature of 43 C E5280 18 seconds E5480 26 seconds Continued on next page 8 9 8 Specifications and ordering information TCM4 40 operator s manual Specifications Continued and compliance tem Description continued Accuracy over 70 to 100 Sensor model Weight range Accuracy DS100A gt 40 kg 3 5 Oxiband A N adults gt 40 kg 3 SpO Oxiband neonates lt 3 kg 4 SpO gt Oxiband 3 40 3 SpO Test considerations and oximeter accuracy Functional testers and patient simulators Some models of commercially available bench top functional testers and patient simula
130. s Bat ID Curve display pCO pO display pCO pO Pulse SpO displ Power SpO a Touch keys NOTICE SpO and pulse rate are available on the TCM40 monitor only On the TCMA monitor the lower part of the curve display will either show the power curve or be empty and the Pulse SpO display will always be empty see examples on next page The real time 24 hour cycle and date System view Normal view Trend table view Trend curve view New status patient Alert or Alarm Bat The battery level when the monitor is running on battery Full i almost full low and critically low 0 HD Patient identification number Gives access to Patient DMS ID Curve display TCM4 monitor pCO pO and power TCM40 monitor pCO pO and SpO Sensor status e g Calibrating and gas level only displayed during calibration and if there is 10 or less gas left in the gas cylinder Barometric pressure only displayed during calibration pCO pO pCO pO Corr Power Temp SmartHeat In vivo calibration Pulse SpO2 HI OFF SpO alarm high is disabled A alarm is ON and alarm 1s OFF Continued on next page 2 5 2 What is what TCM4 40 operator s manual The screen general elements Continued Example of Normal view screen on TCM40 monitor Example of Normal view screen on TCM4 monitor Touch keys in Normal view 2 6 17 11 j
131. s Group 1 The monitor s RF emissions are very low CISPR 11 and they are not likely to cause any interference in nearby electronic equipment RF emissions Class A The monitor is suitable for use in all CISPR 11 establishments other than domestic and ia those directly connected to the public Harmonic emissions N A low voltage power supply network that IEC 61000 3 2 supplies buildings used for domestic Voltage fluctuations N A purposes flicker emissions IEC 61000 3 3 Guidance and manufacturer s declaration electromagnetic immunity Immunity IEC 60601 Compliance Electromagnetic environment test test level level guidance Electrostatic 6 6 Floors should be wood discharge contact contact crete or ceramic tile If floors ESD 48 kV air 48 kV air are covered with synthetic IEC 61000 4 2 material the relative humidity should be at least 30 96 Electrical fast 2 kV for 2 kV for Mains power quality should be transient burst power supply power supply that of a typical commercial IEC 61000 4 4 lines lines and or hospital environment 1 kV for 1 kV input output input output lines lines Surge 1 kV 1 kV Mains power quality should be IEC 61000 4 5 differential differential that of a typical commercial mode mode and or hospital environment 2 2 mode mode Continued on next page TCM4 40 operator s manual Spec
132. s data output to OFF Data export to Serial and Data export interval to 2 10 30 or 60 seconds Then press OK The data 1s exported to HyperTerminal and can be seen on the PC 9 On the PC stop the collection of data to the file in HyperTerminal by selecting Transfer Capture text Stop The following shows an extract of a screen from HyperTerminal TCM4 40 Data Export 15 25 25 30 11 07 15 26 56 30 11 07 Patient ID 30112007 0015 Last calibration 15 24 53 30 11 07 O2 157 mmHg CO2 56 mmHg Time Event O2 mmHg CO2 mmHg Temp C Power mW SpO2 Pulse bmp 15 25 30 30 11 07 70 38 42 0 227 98 71 15 25 40 30 11 07 71 38 42 0 227 97 72 15 25 50 30 11 07 71 38 42 0 228 98 71 15 26 00 30 11 07 71 38 42 0 228 98 72 15 26 10 30 11 07 70 38 42 0 227 98 71 15 26 20 30 11 07 70 38 42 0 228 98 72 15 26 30 30 11 07 71 38 42 0 228 97 71 15 26 40 30 11 07 70 38 42 0 227 98 72 15 26 50 30 11 07 70 38 42 0 227 98 71 Step Action 1 Open Excel and select Data Get External Data Import Text File 2 Select the file CAPTURE txt and click Import 3 Select the following settings and click Next Al xl The Text Wizard has determined that your data is Delimited If this is correct choose Next or choose the data type that best describes your data riginal data type Choo ile type that best describes your data 1 Characters such as commas or tabs separate each field
133. sk of incorrect measurements Using the SpO sensors in the presence of high ambient light may result in inaccurate measurements In such cases cover the sensor site with an opaque material WARNING Risk of incorrect measurements Remove any intravascular dyes or externally applied coloring such as nail polish dye or pigmented cream as they may lead to inaccurate pulse oximetry measurements WARNING Risk of incorrect measurements Pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions sensor application errors and certain patient conditions See the appropriate sections of the manual for specific safety information WARNING Risk of incorrect measurements Always select the measuring site carefully to avoid selecting a site with low perfusion or low signal quality which can cause incorrect measurements WARNING Risk of patient not being monitored Do not use a NIBP cuff or other constricting devices on the same appendage as the sensor A NIBP cuff will interrupt the patient s circulatory blood flow and result in no pulse found or loss of pulse pop p Certain patient conditions can affect the measurements of the monitor and cause the loss of the pulse signal Inaccurate measurements can be caused by e prolonged patient movement e venous pulsations e intravascular dyes such as indocyanine green or methylene blue e defibrillation Dysfunctional hemoglobins such as carboxyh
134. t be possible to operate the monitor until the export of data has been completed Removing the memory stick before the data export has been completed will result in incomplete data export 6 33 6 Patient monitoring TCM4 40 operator s manual Alarms Purpose Definitions Alarms 6 34 The alarm system informs the user about physiological and technical errors or it gives text messages about recommended actions NOTICE Every time the monitor is turned on it performs a test of the alarm system to check that the sound is working The alarm system contains three different alarms e Alarms physiological alarms one or more of the parameter values have exceeded or are equal to the high or low alarm limits e Alerts technical alarms inform the user if e g an error has been detected during calibration e Messages pure text e g Ready Alarms are enabled disabled in Parameter setup NOTICE If the X symbol is displayed on the screen all visual and acoustic alarm indications are disabled Alerts are not affected It is possible to choose between two modes see Technical settings in chapter 3 Menu structure and setup programs e Latching The monitor remains in alarm status even though the alarm condition ceases to exist So even if all parameter values are back within the alarm limits the user must reset the alarm Non latching The monitor resets itself as soon as the alarm condition ceases to exist An
135. ta output VueLink Continued Configuration Some features keys or softkeys may vary from one monitor system to another but of PPMS the principles are basically the same If you encounter differences between your monitor system and what we describe in this manual please see the technical documentation for the particular PPMS monitor The following configuration procedure is based on an Agilent V24C monitor Follow these steps to define how you want data presented on your PPMS monitor Step Action 1 Select the following softkeys Module Setup TCM should have appeared when the TCM monitor was connected Select Data 2 Mark the module number Num you wish to change with the up down arrow keys Select the Select Signal softkey 4 Select the Select Signal softkey again or use the left right arrow keys to turn the signal ON by selecting a parameter or OFF Select the Next Channel softkey Repeat steps 2 5 for other modules you wish to change Press the Main Screen key to finish and to display the selected signals Alarms VueLink defines two types of alarms red and yellow but a TCM monitor only gives yellow alarms A yellow alarm indicates a situation where a response of the medical staff is necessary but which is of less critical importance than a red alarm An alarm is displayed as a text on a yellow background at the top center of the PPMS monitor screen e g TC ALARM which means that an alarm limit has been exc
136. ted measuring site e Excessive motion may compromise performance In such cases try to keep the patient still or change the sensor site to one with less motion e If SmartHeat is set to ON it adds 1 C max temp 45 C to the set sensor temperature for 5 minutes after the sensor has been removed from the calibration chamber If the SpO sensor does not track the pulse reliably it may be incorrectly positioned or the sensor site may be too thick thin or deeply pigmented or otherwise deeply colored for example as a result of externally applied coloring such as nail polish dye or pigmented cream to permit appropriate light transmission If any of these situations occurs reposition the sensor or choose an alternate sensor for use on a different site e The visual indication of the plethysmograph curve is not proportional to the pulse volume 2 Press Site time to reset the site timer to the value selected in Parameter setup if required The site timer applies to tepCO tcpO only NOTICES e The site timer will count down to zero at 1 minute intervals and when it reaches zero the message Site time end will be displayed on the screen e If Site time heat is set to OFF in the setup the sensor heat is switched off when the site timer reaches zero and the monitor stops monitoring if set to ON the heat continues 3 To mark an event press Event The text Set event mark number x will be displayed Press OK to
137. th the cleaning paper Rub the sensor measuring surface carefully two or three times to remove the thin layer of silver that has precipitated on the sensor Apply two drops of the tepCO tepO electrolyte solution on the surface of the sensor NOTICE Check that the electrolyte solution covers the entire surface without air bubbles Continued on next page 4 13 4 Installation and maintenance TCM4 40 operator s manual Membraning the E5280 and E5260 sensors Continued Membraning the Step sensor 7 continued 4 14 Action e Place the membrane unit on a hard and stable surface e Turn the sensor slowly so that the measuring surface faces downwards Insert the sensor head into the top of the green membrane unit e Press the sensor firmly into the unit until a click is heard Remove the sensor from the unit and wipe off the surplus electrolyte solution with the cleaning paper TCM4 40 operator s manual 4 Installation and maintenance Cleaning disinfection and storage of sensors Cleaning the sensors Disinfection Storage Wipe the following parts gently with a soft cloth moistened with skin antiseptic e g 70 alcohol e the sensor head e the cable NOTICE Constant use of hand lotion containing isopropanol propylalcohol and alcohol prior to handling the sensor may damage the cable To avoid transferring lotion to the cable dry hands prior to handling the sensor WAR
138. the patient immediately if the system or patient is exposed to a defibrillator electrocautery or other high frequency electrical signals as these may affect the device and may cause injury to the patient WARNING Risk of fire Do not place the monitor in an enriched oxygen atmosphere or inside a hyperbaric chamber as it may cause a fire hazard WARNING Risk of personal injury Make sure to select the upper alarm limit for oxygen saturation carefully and in accord with accepted clinical standards High oxygen levels may predispose a premature infant to develop retinopathy WARNING Risk of skin damage Long term hyperthermia may blister skin When producing local hyperemia by means of hyperthermia a certain risk of applying temperatures harmful to the skin is always present although the risk is limited due to the control system of the instrument Always pay attention to the use of hyperthermia for special patients e g patients in shock patients with low blood pressure and patients with vascular constrictions WARNING Risk of bruises When applying a fixation ring to a patient make sure to place it so that the patient does not lie on top of it as this may cause the fixation ring to leave bruises on the patient WARNING Risk of incorrect measurements Always keep protection caps the tcepCO tcpO sensors except when applied to skin placed in the calibration chamber or during handling and maintenance Exposing senso
139. the system but immediately contact your provider for a return of the system and a refund of the purchase price Microsoft and Windows are trademarks of Microsoft Corporation Warranties and disclaimer Radiometer makes no warranties express or implied other than expressly stated Any warranties expressly stated in this document are conditional upon the system being installed used and maintained in accordance with Radiometer procedures including that only accessories meeting the specifications provided by Radiometer are used Radiometer disclaims any liability for system performance if the system is not installed used and maintained in accordance with Radiometer procedures or if accessories not meeting the specifications provided by Radiometer are used Further Radiometer disclaims any liability for loss of data and direct consequential or other damages including loss of profit or loss of business whether such claim for damages is based upon contract negligence or tort including strict liability and even if Radiometer has knowledge of the possibility of the potential damage or loss Confidentiality The contents of this document shall not be reproduced or communicated to any third party without the prior written consent of Radiometer Changes This document is subject to change without notice and you are urged to contact Radiometer to verify whether the document has been changed While every effort is made to ensure the c
140. tion chamber must be code no 837 488 and if using an E5280 or E5260 sensor the gasket in the calibration chamber must be code no 837 159 see package insert for instructions 2 For TCM40 monitor only Plug the SpO sensor into the monitor NOTICE It is not necessary for the monitor to be turned off while the sensor is being connected 3 Install the calibration gas cylinder and the battery according to the procedures described later in this chapter under Maintenance of the monitor 4 Connect the monitor power cord to e the power socket at the rear of the monitor and e an appropriate power supply 5 Connect the system to external equipment if required WARNING Risk of personal injury Before connecting other equipment to the TCM monitor the manufacturer of the equipment or a qualified engineer must be consulted to ensure that the equipment is compatible and that the safety of the patient the operator or the environment will not be impaired The resulting combined system must comply with EN 60601 1 1 6 Turn on the monitor by pressing the power switch to the ON position at the rear of the monitor and then pressing the ON OFF button on the front of the monitor NOTICE Every time the monitor is turned on a beep sounds indicating that it has been checked that the sound of the alarm system is working If the sound 1s not working an error message is shown 7 Check that the date and time in the display correspond with the
141. tive Replace with a new one The selected sensor temperature cannot be reached Check if the patient or the surroundings are very cold No tcpCO tcpO sensor Change the sensor detected e No sensor detected in the calibration chamber e The sensor in the calibration chamber is not functioning e The measured pCO value is outside the measuring range e The pCO sensor 15 low on battery power The measured pO value is outside the measuring range The site time counter has reached zero Connect a functional sensor e Change the membrane e Change the sensor e Change the membrane e Change the sensor e Reposition the sensor on the patient e Recalibrate the sensor Continued on next page 7 5 7 Troubleshooting TCM4 40 operator s manual The TCM4 40 systems Continued te error Recommended action s MESSAGES I Temperature failure e Measured temperature 15 e Calibrate the sensor Alphabetical outside the measurin order 8 e If error remains the continued rangs sensor is defective e The two sensor Replace with a new one thermistors give different temperatures e The sensor temperature is too high Temperature indi The selected sensor Wait until it is reached cation is flashing temperature has not yet No text is shown been reached messages in alphabetical Communication For unknown reasons the If error remains try with error communic
142. tors can be used to verify the proper functionality of Nellcor pulse oximeter sensors cables and monitors See the individual testing device s operator s manual for the procedures specific to the model of tester being used While such devices may be useful for verifying that the pulse oximeter sensor cable and monitor are functional they are incapable of providing the data required to properly evaluate the accuracy of a system s SpO measurements Fully evaluating the accuracy of the SpO measurements requires at a minimum accommodating the wavelength characteristics of the sensor and reproducing the complex optical interaction of the sensor and the patient s tissue These capabilities are beyond the scope of known bench top testers including known devices which claim to measure sensor LED wavelength SpO measurement accuracy can only be evaluated in vivo by comparing pulse oximeter readings with values traceable to SaO2 measurements obtained from simultaneously sampled arterial blood using a laboratory CO oximeter Many functional testers and patient simulators have been designed to interface with the pulse oximeter s expected calibration curves and may be suitable for use with Nellcor monitors and or sensors Not all such devices however are adapted for use with the Nellcor OXIMAX digital calibration system While this will not affect use of the simulator for verifying system functionality displayed SpO measurement values may
143. transmitter in watts W according to the transmitter manu facturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range d 23VP 800MHzto2 5 GHz Interference may occur in the vicin ity of equipment marked with the following symbol Kp Field strengths from fixed transmitters such as base stations for radio cellular cordless tele phones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the monitor is used exceeds the applicable RF compliance level above the monitor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the monitor Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m NOTICES e At 80 MHz and 800 MHz the higher frequency range applies b e These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Continued on next page 8 6 TCM4 40 operator s manual
144. utors within the European Union EU and associated states have taken the necessary steps to comply with the directive 2002 96 EC on waste electrical and electronic equipment WEEE The instrument when reaching its end of life must be collected and recycled separately from other waste according to national requirements Please contact your local Radiometer distributor for instructions Environmental implications WEEE contains materials that are potentially hazardous to the environment and to human health Continued on next page 1 4 TCM4 40 operator s manual 1 Introduction Symbols used on the monitor Continued Symbol Explanation Ein Ethernet interface connection to network Not for phone connection Off Power disconnection from the mains Power connection to the mains mE RE 7 1 5 1 Introduction TCM4 40 operator s manual Symbols used in the manual This manual contains alerts which are important and should be read carefully before performing the related procedures The manual also contains non safety information Symbol Signal word Explanation WARNING A warning alerts the reader about a situation which if L not avoided could result in death or serious injury It may also describe potential serious adverse reactions and safety hazards CAUTION A caution alerts the reader about a potentially AN hazardous situation which if not avoided may result in minor or mo
145. w key 3 Follow steps 1 2 for the remaining options 4 Press OK to accept the changes and return to the main screen e Apply to accept the changes without leaving the SmartCal setup e Cancel to return to the main screen without saving changes 3 Menu structure and setup programs TCM4 40 operator s manual Calibration status Introduction Accessing the program Calibration status information The Calibration status screen shows the status of the last calibration To access the Calibration status screen press Setup Calibration Cal Status Shows the time of the last calibration Set temp C Shows the sensor temperature during the last calibration Barometer mmHg kPa Shows the barometric pressure during the last calibration Cal value mmHg kPa Shows the O calibration value Cal value CO mmHg kPa Shows the CO calibration value Gas level Shows how much calibration gas is left in the cylinder NOTICE The level will be displayed as High until there is less than 10 left in the gas cylinder and then as a percentage Press OK or Cancel to return to the main screen TCM4 40 operator s manual 3 Menu structure and setup programs Introduction Accessing the program Selecting printer settings Printer setup In the Printer setup it is possible to e set the time interval between two values on the table printout set the time span of the measurements that are to be shown
146. with 20 pieces Fixation kit for E5480 sensor containing e 4 x 25 disposable fixation rings e 4 x 20 mL contact liquid Fixation kit for E5280 and E5260 sensors containing e 4 x 25 disposable fixation rings e 4 x 20 mL contact liquid TCM4 40 operator s manual 905 805 904 892 905 836 904 891 Large fixation ring for E5480 tepCO tcpO sensor tinyTeddy 905 901 TCM4 40 operator s manual English 990 277 Continued on next page TCM4 40 operator s manual 8 Specifications and ordering information Accessories Continued CALI standard calibration gas 7 5 CO 20 9 balance 962 187 180 mL CALI standard calibration gas 7 5 CO 20 9 balance 962 188 180 mL US and Canada CAL2 standard calibration gas 10 CO balance 999 mL 962 096 NOTICE Not applicable in Germany CAL2 standard calibration gas 10 1 L 962 154 NOTICE Only applicable in Germany 8 15 8 Specifications and ordering information TCM4 40 operator s manual 8 16 9 Functional description tcpCO tcpO measurement eee esee ee eee eee eese en ee 9 2 Constrictor Of SENSOTS re FU E e ERREUR FE bes etis 9 3 PCO measuring principle ee iea Eie e EE EE nennen 9 5 pO measuring PLINCIpPle ee eeccsccsseesseceseceteceeeceeeceeseeeeeeeseeeeeeeecsaecseceeeeeeeeeeas 9 6 Calibration OF SENSOR oe
147. y update period SpO plethysmograph 25 mm sec Numerical values 2 sec pCO pO gt graphs 2 sec Display range tcpCO 0 200 mmHg or 0 0 26 7 kPa tcpO gt 0 800 mmHg or 0 0 99 9 kPa SpO2 0 100 Pulse rate 0 and 20 300 beats per minute bpm Measuring range tcpCO 5 100 mmHg or 0 7 13 3 kPa 0 800 mmHg 0 0 99 9 kPa SpO2 70 100 Pulse rate 20 250 bpm Sensor heating power 10 650 mW 3 of reading lt 10 mW 0 mW range Temperature settings 37 0 45 0 C in steps of 0 5 C Barometer Built in 375 825 mmHg or 50 110 kPa Accuracy 5 mmHg or 0 67 kPa Calibration gas 7 5 CO 20 9 balance Ambient relative 20 80 humidity Ambient temperature Monitor tc sensors 15 40 C NOTICES e The ambient temperature must always be at least 3 C lower than the set sensor temperature e If SmartCal is selected the maximum ambient temperature is 34 C SpO gt sensors 5 40 C Transport and storage The monitor and modules can be transported and stored at conditions 20 to 60 C and lt 95 RH Data storage Up to 48 hours of monitoring data in 2 second data intervals Continued on next page 8 2 TCM4 40 operator s manual 8 Specifications and ordering information Specifications Continued ren it ons Computer Screen 6 color touch TFT full VGA 640 x 480 continued CPU AMD ETX LX800 500 MHz Pentium Class Software platform Wind

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