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TCM400 operator`s manual - Radiometer America Inc.

1. Preparing a Follow the steps below to prepare the sensor for membraning sensor Step Action 1 Remove the protection cap Then remove the old O rings by sliding the O ring remover under the O rings just above the arrow on the sensor house Be 2 Turn the O ring remover clockwise to release the two O rings Ui oo O a 3 Peel off the old membrane and check that the entire membrane has been removed 4 Clean the sensor surface Absorb the old electrolyte solution with a piece of cleaning paper 5 Rub the sensor measuring surface carefully two or three times to remove the thin layer of silver that has precipitated on the sensor 6 Membrane the sensor as described in steps 1 3 in the membraning procedure on the next page Continued on next page 4 Installation and maintenance TCM400 operator s manual Preparation and maintenance of the sensor Continued Membraninga Use the D826 membraning kit and follow the steps below to membrane a sensor sensor Step 1 Action i Apply two drops of the tcpO electrolyte solution on the surface of the sensor NOTICE Check that the electrolyte solution covers the entire surface without air bubbles Place the membrane unit on a hard and stable surface Turn the sensor slowly so that the measuring surface faces downwards Insert the sensor head into the top of the white tcpO membrane unit Press the sensor fi
2. 1103 ji 4 cate Calibration required IO 23032005 0063 te pO Au tc pO mmHg mmHg Preset temp 44 0 C Frosettomo 44 0 C Calibration required Calibration required te pO mmHg Preset temp 440 C Calibration required tc pO mmHg Preset temp 44 0 C Calibration required Tutorial 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 as listed in the topic Default settings in chapter 3 Menu structure and setup programs Check that the time and date settings correspond with the actual time and date otherwise correct them Calibrate the sensor s as described in chapter 5 Calibration Reconfiguration IMPORTANT In order not to jeopardize the integrity of the patient data stored of sensor before the reconfiguration you must save your data by making a data export modules and or printout prior to reconfiguring the modules Follow the steps below to reconfigure the sensor modules Step 1 2 4 4 Action Turn the monitor off Install remove the necessary sensor module s see procedures on the previous page and the next page Turn the monitor on Continued on next page TCM400 operator s manual 4 Installation and maintenance Installing the monitor continued Reconfiguration of sensor Step Action modules 4 A dialog box will be displayed giving you the following options c
3. electromagnetic emissions Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 TCM400 system s RF emissions are CISPR 11 very low and they are not likely to cause any interference in nearby electronic equipment RF emissions Class A The TCM400 system is suitable for use CISPR 11 in all establishments other than domestic and those directly connected to the Harmonic emissions Not public low voltage power supply IEC 61000 3 2 applicable network that supplies buildings used for Voltage fluctuations Not domestic purposes flicker emissions applicable IEC 61000 3 3 Guidance and manufacturer s declaration electromagnetic immunity IEC 61000 4 2 Immunity IEC 60601 Compliance Electromagnetic environment test test level level guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete discharge or ceramic tile If floors are ESD Eee SEEN ae covered with synthetic material the relative humidity should be at least 30 Continued on next page 8 3 8 Specifications and ordering information Specifications Continued EMC approvals and compliance continued 8 4 TCM400 operator s manual Immunity IEC 60601 test Compliance Electromagnetic test level level environment guidance Electrical fast 2 kV for power 2 kV for power Mains power quality should transient burst supply l
4. Additional items In addition the following accessories are available Description CAL2 standard calibration gas 10 COs balance N 962 154 999 mL Protection cap for E5250 sensor white Color code kit 18 tags tcpO sensor module incl release key TCM4xx ETX serial adapter 12V 2AH lead acid battery Unassembled connector kit for hyperbaric chamber 905 660 Connector kit for ETC hyperbaric chamber 905 688 Passthrough cable 905 751 Extension cable for tepO sensor Length 3 meters 118 1 617 853 in NOTICE The total length of cable between the sensor and the TCM400 monitor must not exceed 10 meters Extension cable for tepO sensor Length 6 meters 236 2 617 864 in NOTICE The total length of cable between the sensor and the TCM400 monitor must not exceed 10 meters 8 13 8 Specifications and ordering information TCM400 operator s manual 8 14 9 Functional description Overview Introduction This chapter gives functional descriptions of e the construction of the tcpO sensor and the theory behind its calibration and measurement e the solutions used with the system and their approximate compositions In this chapter This chapter covers the following topics THEAE POS SENSOM E EEEE T ieee es AE E Stank ENEA E need A cee tua ores 9 2 Measurement sy roeines iaeaea aa aa ia esaa Ean 9 3 Calibration eenen e a e a a e gaayivedeastou dea daity Pon 9 4 Solutions and calibration gas ccccccccs
5. C Timer active only O RPI M Print in color O Power Cancel 2 Select one or more of the Advanced print options NOTICES o If Timer active only is selected only the values that have been measured while the timer was active will be printed e Only the Trend curve can be printed in color Select the parameter you wish to print Press OK to accept the changes and return to the Printer setup or press Cancel to return to the Printer setup without saving changes TCM400 operator s manual 3 Menu structure and setup programs Technical setup Accessing Technical setup The Technical setup is accessed by pressing Setup gt Setup gt Technical setup Technical setup password entry Password 4 TCM400 4 00 Te 0 NOTICE The software version is displayed on this screen Enter the password 19100 and press OK Technical setup Press to change Backlight Humidity correction factor pO unit Calibration gas mixture Date time or to select Bypass calibration Press to perform Self check or to Utilities restore Default settings Service r mode Press to enter Service mode From the Technical setup screen it is possible to access e Auxiliary setup incl Date time setup see next page e Utilities see the following pages e Service mode see the following pages Continued on next page 3 Menu structure and setup programs TCM400 operator s manual Technical setup Cont
6. 159 mmHg Printed 11 45 23 07 10 2001 Elec 1 Elec 2 Elec 3 Elec 4 Elec 5 Elec 6 200 mmHg 150 _ 100 0 T T T T T T 02 00 02 05 02 10 02 15 01 58 39 12 09 2001 02 17 23 Page 1 The above example shows a report in monochrome When the printout of the report is in color the colors of the lines are the same as on the display The trend curve report contains the following e Space for adding Signatures of physician and technologist e Information about Patient name ID from the Patient DMS Measuring unit Sensor temperature Value of the last calibration that was completed success fully before the session started Time and date of printout e Data versus Time graph of measurement data NOTICE If measurement data for a sensor is not available or if it is out of scale the line reflecting the results of that sensor will not be shown e Page number TCM400 operator s manual 6 In vivo monitoring Serial data output standard Introduction The TCM400 monitor is equipped with a continuous data output for direct connection to an external PC The transmitted data consists of the current values i e the values displayed in Normal view This means that values for sensors that are in Ready mode are also transmitted Procedure Follow the steps below to connect the monitor directly to an external PC Step Action 1 Connect the TCM4xx ETX serial adapter code no 636 649 to the
7. 7 Press OK to accept the new settings in Printer setup and return to the User setup screen or press Cancel to return to the User setup screen without saving changes Curve scales Follow the steps below to adjust the curve scales on the printout Step Action 1 From the Printer setup screen press Curve scales te pO upper scale 500 mmHg 400 mmHg 300 mmHg 100 mmHg 50 mmHg Continued on next page 3 9 3 Menu structure and setup programs TCM400 operator s manual User setup Continued Curve scales continued Advanced print Step 2 Action Use the Up and Down arrows to select the upper and or lower scales for the shown parameters e tcpO2 mmHg upper scale range is 50 2000 lower scale range is 0 1900 kPa upper scale range is 5 270 lower scale range is 0 260 e Power Upper scale range is 100 to 700 lower scale range is 0 to 600 e RPI Upper scale range is 0 1 to 3 0 NOTICE The selected scales determine the range on the printed Trend curve report In order for results to be printed data must be within the upper and lower scales Press OK to accept the changes and return to the Printer setup or press Cancel to return to the Printer setup without saving changes Follow the steps below to set the Advanced printer setup Step Action 1 From the Printer setup screen press Advanced Advanced printer setup Advanced print Parameters O Events only pO
8. Installing the monitoreo aai E E aay asada tended setae nanioeanas aa caeees 4 3 Shutting down the monitor seee n EE R E AE E EA E 4 8 Cleaning th monitor sesinin ei a a tates Ea A OE E EE E aS 4 9 Preparation and maintenance of the SCNSOL cescsseesceeecesecceeecesecaecaeeeseesecaeeasceeeseeeeeeaes 4 11 P Cara GhOM E EE TE E E EE EEN OEE ET EEE EEE E OVELVICW AE A E E E T 5 1 General information huen nis chads A A aN aare AGAO 5 2 Calibration with atmospheric airs sje cisctysesgyest nene n a e 5 3 Checking the sensor Zero c ret ennnen iano iseni iannis isei 5 7 6 In vivo monitoring esssessseessecssccsocssscessccesecssecssecesecesocesocesocesocssocssosssossssossssse L COV ET VIE Wisi r R E ad ety E Gt O E A A 6 1 Contents TCM400 operator s manual General Tnforiinati on sanea eaae dele tuecuscteis deat AE AE EEN ESATA 6 2 In vivo monitoring ee eeeeeeecceeceseeseeeecesecesecseesecssecesecseesecssecasecseeeecaecsaecseeseceaecasecseeeeseaeceaeeneees 6 4 Trend table view iz civsistecsscet cs chs stot en e e ale ones 6 13 Trend curve View si iii ni Su Hue AG ed Ae ae 6 14 How to printesa aseni shag duds cohesh EAE E EE ETA EEA tude ANENE eats 6 16 Setial dataoutp t stand rd dienn a a aer a a a a a aA 6 21 S rial datacoutputi data eXpPOrt siinon ei rn Err EE a EEIE E SE 6 25 Tee TEOUDIESHOOUINE dccsnsscessissctacecuacsesstecesnsedecccvscbesenesvestsvsdtesecascivsgerdssessancosesdessseces AL O
9. Specifications and ordering information Specifications Continued EE Known sources of After an hour s exposure halothane 4 evaporated into interference Carrier Gas will interfere with the tcpO gt readings of the E5250 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 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 N20 20 9 Oo 5 CO balance N2 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 Biocompatibility 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 the 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 Materials and All materials and All material
10. you should not use 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
11. 2 Install the battery according to the procedure described later in this section under Installing the battery 3 Connect the monitor power cord to the power socket at the rear of the monitor and to an appropriate power supply 4 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 5 Switch on the monitor by pressing the power switch to the ON position at the rear of the monitor The monitor will be initializing for a few seconds 6 Membrane the sensor s as described in Preparation and maintenance of the sensor later in this chapter 7 Connect the sensor plug to the sensor socket at the rear of the sensor module Then place the sensor in the calibration chamber at the front and swing the spring loaded sensor retainer into position over the sensor Continued on next page 4 3 4 Installation and maintenance TCM400 operator s manual Installing the monitor continued Procedure St continued ep 8 9 10 11 Action Check that all sensor modules are functioning The following screen is shown when six sensor modules are connected and calibration is required
12. 375 825 mmHg or 50 110 kPa Accuracy 5 mmHg or 0 67 kPa Ambient relative 20 80 humidity Ambient temperature Monitor 5 40 C tc sensors 15 40 C NOTICE The ambient temperature must always be at least 3 C lower than the set sensor temperature Data storage Up to 48 hours of accumulated measuring data from six tcpO sensor modules in 10 second data intervals Computer Screen 6 2 color touch TFT full VGA 640 x 480 CPU AMD ETX LX800 500 MHz Pentium Class Software platform Windows CE 5 0 Dimensions of monitor Height 16 cm 6 3 in Width 30 8 cm 12 1 in Depth 23 cm 8 7 in Weight 4 kg including battery 8 8 Ibs Dimensions of sensor Height 3 5 cm module Width 14 5 cm Depth 14 8 cm Weight 0 22 kg Power supply 100 240 V 50 60 Hz 8 2 TCM400 operator s manual Power consumption Interface connection Printer output Rechargeable Pb battery Serial output 8 Specifications and ordering information 70 VA EJA232 RS232 USB 2 0 Compliant with USB 1 1 Under normal conditions the battery can operate for 1 hour with three modules before recharging is needed EMC approvals The TCM400 system is intended for use in the electromagnetic environment specified in the tables below The customer or user of the TCM400 system should assure that it is used in such an environment The TCM400 system complies with and compliance IEC 60601 1 2 Guidance and manufacturer s declaration
13. 5 Select the following settings and click OK 6 In vivo monitoring New worksheet Properties f PivotTable report Existing worksheet Cancel Jee 6 Data is imported to Excel The following shows an extract of a screen from Excel ED pa pe pot fga jk Qes Dioer mri Oe er a re ICTA A LE O oae e DEGNI ae LM D u 5 7 a a x 2 3 u s y 9 a 2 a u AEA sheets Gate Rees 7 Save Log Excel worksheet Control signs 6 29 6 In vivo monitoring TCM400 operator s manual 6 30 Overview Introduction In this chapter 7 Troubleshooting This chapter describes the errors their causes and the recommended operator actions This chapter covers the following topics OY iEn 111 00 emer Rr ee nt rec SE Oo En SY EOP A ee EA 7 Troubleshooting The monitor Introduction TCM400 operator s manual The status of the system is continuously monitored during operation When problems or errors occur they are automatically recorded and presented to the operator on the screen This chapter describes the errors their causes and the recommended operator actions Error symptoms The following table lists the errors symptoms for the monitor Measured values drift when sensor is measuring on cal gas in vitro or air Measured values drift constantly without any physiological cause when sensor is mounted on patient in vivo Measured val
14. 64 17 10 12 2B 24 10 51 00 07 08 2005 12 64 17 10 12 13 24 10 52 00 07 08 2005 64 17 10 12 13 24 10 53 00 07 08 2005 64 17 10 12 13 24 10 54 00 07 08 2005 64 17 10 12 13 24 10 55 00 07 08 2005 64 17 10 12 2B 24 10 56 00 07 08 2005 15 64 17 10 12 13 24 10 57 00 07 08 2005 64 17 10 12 13 24 10 58 00 07 08 2005 64 17 10 12 13 24 10 59 00 07 08 2005 64 17 10 12 2B 24 11 00 00 07 08 2005 64 17 10 12 13 24 11 01 00 07 08 2005 18 64 17 10 12 13 24 11 02 00 07 08 2005 64 17 10 12 13 24 11 03 00 07 08 2005 64 17 10 12 13 24 11 04 00 07 08 2005 64 17 10 12 13 24 11 05 00 07 08 2005 81 64 17 10 12 2B 24 11 06 00 07 08 2005 64 17 10 12 13 24 Page 1 TCM400 operator s manual Signatures of physician and technologist Patient name ID from the Patient DMS Measuring unit Sensor temperature Value of the last calibration that was completed success fully before the session started Time and date of printout e Table of measurement data NOTICE If measurement data is not available for all sensors or if some measurements are missing for a specific sensor a dash is printed in the specific field s in the table e Page number if data stretch over more pages page headers and page numbers are added to all pages Continued on next page TCM400 operator s manual 6 In vivo monitoring How to print Continued Advanced Below is an example of an advanced trend table report for tepO gt trend table RADIOMETER TCH SERIES RADIOMETE
15. 9 60 20 9 oeanal Wop ik e ses a POKERY 100 pa aT This means that a calibration value of 156 5 mmHg would be right If the pO CAL value of 159 mmHg is used instead the inaccuracy will be inaccuracy m x 100 1 6 This means that the tcpO values during measurement will be 1 6 too high Continued on next page 5 5 5 Calibration TCM400 operator s manual Calibration with atmospheric air continued Saturated water The table below shows saturated water vapor pressure at different temperatures vapor pressure 5 6 Saturated water vapor pressure mmHg kPa 17 5 2 33 18 7 2 49 19 8 2 64 21 1 2 81 22 4 3 00 25 23 8 3 17 26 25 2 3 36 27 26 7 3 56 28 28 3 3 77 29 30 0 4 00 30 31 8 4 24 1 kPa 7 50 mmHg The humidity correction factor used in the TCM400 system is calculated by multiplying the saturated water vapor pressure found in the table with the relative humidity If for example the temperature is 22 C and the relative humidity is 70 the humidity correction factor to be used is Humidity correction factor 19 8 x 70 100 13 9 14 TCM400 operator s manual 5 Calibration Checking the sensor zero current Items required The following items are required to check the sensor zero current e CAL2 standard calibration gas 10 CO with N as balance e Gas adapter for CAL2 gas Recommen Check the sensor zero current d
16. Patient DMS To see detailed information about the highlighted patient ID session number in Patient DMS 3 To set the printer start time and stop time To select SmartPrint To print one or more reports from the Patient DMS Advanced To select printout of e Events only Timer active only and or Print in color e pO RPI or Power Auxiliary setup To change backlight calibration gas mixture humidity correction factor pO unit serial output and date time setup or to bypass calibration Bypass calibration To bypass the calibration in progress and force the monitor into Ready mode NOTICE If a calibration is bypassed the monitor will be monitoring with invalid data The option should therefore only be used for service purposes Calibrate To start a calibration of all sensors Cancel To return to the previous screen without making changes Change ID To change the highlighted patient ID session number in Patient DMS with the on screen keyboard Change view To change the view of your data to Normal Trend table or Trend curve view and to enter the view options Close To close the Timer dialog box Delete To delete the patient IDs session numbers with a check mark in Patient DMS Continued on next page TCM400 operator s manual 2 What is what The touch key glossary Continued Touch key symbols continued Touch key Delete all To delete all patient IDs session numbers in the list in P
17. cables For supporting the monitor at an elevated angle For turning the monitor ON and OFF Battery indicator 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 Continued on next page TCM400 operator s manual 2 What is what TCM400 monitor front Continued Sensor module configurations Automatic numbering Regional Perfusion Index The TCM400 monitor allows placement of the sensor modules in many different combinations Example Six sensor modules The TCM400 monitor will automatically give each module sensor a number when mounted The first module from the left will be given number 1 and this sensor will always be the reference for the other sensors when calculating the Regional Perfusion Index RPI This means that RPI can only be calculated if there is a module placed in position 1 Example Four sensor modules The Regional Perfusion Index RPI is calculated as follows RPI tcpO other module tcpO reference module 1 2 3 2 What is what TCM400 operator s manual TCM400 monitor rear Rear panel Sensor socket Battery Module release Line fuse Power switch Power socket Ethernet Serial port USB ports Parts and The following table lists the parts located on the rear of the TCM400 monitor functions For
18. change the view of the Main screen to Normal Table or Curve view and to change the options for the three different views Ed a To change to another view press one of the view selections and OK To change the options for the Normal Table and Curve views see the following pages Normal View cscs seis cciceaid cccbh A A A sue lessepogeabseigeyineaceecaane 3 4 Trend table VOW ivcccsiccocccsecesesvsavescecaedvteeuseececoostaeseovscdcececsedvssveceteessteuseacdbccdacveve 3 5 Trend curve VICW cccccesssssosscccccvsosscsssenscecevsosssssenecescessessssneeccessossessscnsecsceveess 3 6 3 3 3 Menu structure and setup programs TCM400 operator s manual Normal view Changing Follow the steps below to change the Normal view options Normal view options 3 4 Step 1 Action From the Change view screen press Normal view View options Normal view options Choice of second parameter in normal view Trend arrow OK cena Use the Up and Down arrows to select the second parameter to be shown on the screen during measurement e RPI e Power e Temperature e None Press the check box to activate check mark or deactivate blank Trend arrow The option is activated as default When activated an upward downward arrow will appear on the Normal view screen when an upward downward trend in measuring values is detected as in the example below Poke Measuring O 23032005 0063 ee 1102 s
19. critically low Data and setup changes cannot be saved on disk Battery not connect ed Data and setup changes cannot be saved on disk Changing date time backward in time results in loss of data Only data from before the new time will be available Data from more than one patient cannot be selected into a view Date and time cannot be set during measurement e Measured temperature is outside the measuring range The two sensor thermistors give different temperatures The selected sensor temperature cannot be reached The sensor temperature is too high The selected sensor temperature cannot be reached running time left on the battery No battery connected The date time settings are changed backward in time The user has tried to load sessions from different patient IDs into a view The user has tried to enter the Date time setup during measurement 7 Troubleshooting Recommended actions e Calibrate the sensor e If error remains the sensor is defective Replace with a new one Wait until it is reached A number of messages system messages and alerts appear in dialog boxes The following table lists these messages in alphabetical order Cause There is less than 5 minutes Recommended actions Connect monitor to the mains Attach a battery and connect the monitor to the mains e Press OK to accept the new settings e Press Cancel to abort Select only sess
20. decusca cases oss eeueseseseedcssine tase Gosesscvedseeebeseseseessinseec 2 E OV CLV Wadd fs cs ntenss E E ato eae et toe cage atin E N E A A fetes aap TCM400 monitor front TEM400 monitor Tear sosie secstetassucesde chia oseese E eE NENO Era KE EAEN Cove 2 4 The s reen general elements sasae it aieri r S E O wa dees 2 5 Onlin tutotalS nsien en EKE EEEE AE EEAO EA AEN EEANN S 2 7 Thetouch key slossa iaa a BEL a aa aN EAE a nS 2 8 3 Menu structure and setup programs sssscossssocsesooesesoocsssoossesooesesooesesoossssssse J L OVEIVIGW 2k ett ais e E E een E E Rie 3 1 Men Structure iieii oriei E A A EE OTE ET E ATERN OARE EEEE 3 2 The change view program sssssssssssessssrrn ttrt eens 3 3 Normal VIEW dine nna ennn e A A eases E O E E E A ARA 3 4 Trend table View asesi E E E EAE EEE ves E AES EE EAR 3 5 Trend Curve VEW an n Sects e AE E EAT estates de ab eaten bev de aslo uation EAEN 3 6 Thes t p programi siota nei Bed o hok Pe eed odd eee ee aed Shean ee ee ets 3 7 USEr SOUP EENE cesses codon tadagsueages cave dadestacexeenda duce de cous bdo EEA 3 8 Technical setups hunne dad nies eae cds bee hii ead a aaea aAa aaa 3 11 Default setting S aineensa ee ioa Er rE EAEE aetna ens 3 16 4 Installation and maintenance ese sssosooeosessosooooesssesosoocoeessesosooeosessososooseseessss A L OVEIVIEW ssi dons disso hie retin adele A sh ieee ass 4 1 Operating TEquire ments sanra e E E odes ced weeds ato ain eee ates 4 2
21. e Restore default if you want to set the system to Radiometer default settings A message will be displayed on the screen saying that current setup will be lost if the monitor is restored to default settings NOTICE If you want to use another temperature than the default sensor temperature 44 0 C you have to select it in the setup 3 Press OK to return to the previous screen Continued on next page 3 14 TCM400 operator s manual 3 Menu structure and setup programs Technical setup Continued Service mode Follow the steps below to enter the Service mode option NOTICE Service mode should only be entered by Radiometer service technicians Step Action 1 From the Technical setup screen press Service mode Service mode Module placement D z E Delete config file 2 Press one of the touch keys to check a module 3 Press Delete config file to delete the configuration file 4 Press OK to return to the previous screen See also For more information about Service mode please see the service manual 3 Menu structure and setup programs TCM400 operator s manual Default settings Introduction The Radiometer default settings for the Change view and Setup programs are presented below Access to default To restore defaults press Setup Setup Technical setup Utilities gt settings Restore default NOTICE Restoring defaults during calibration will end the calibrati
22. made to ensure the correctness 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 2010 Radiometer Medical ApS All rights reserved End user license agreement for TCM400 monitors The installed software comprises Microsoft Windows CE and Radiometer developed programs Each program is licensed not sold to you to be used only under the terms of this agreement and the Microsoft end user license agreement Radiometer Medical ApS and its licensor reserve all rights not expressly granted to you You may use the software only with the instrument in which it is installed for your internal purposes and only transfer the software to others as installed with the instrument and with the end user license agreements included in the operator s manual The software may not be copied You may not modify reverse engineer decompile or disassemble the programs By your use of the instrument you agree to the terms of this agreement and the Microsoft end user license agreement If you do not accept or agree to the terms you should switch off the instrument promptly and contact your Radiometer representative for a return of the instrument and a refund of your money End user license agreement for Microsoft Software You have acquired a device TCM400 m
23. 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 The CAL2 standard calibration gas Use To check the sensor zero current Composition 10 CO with N as balance gas Storage At room temperature Volume 1 L cylinder blue label Stability Expiration date and lot no are printed on a separate label on the 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 50 C may cause contents to vent or cause bursting Never discard container into fire or incinerator as it may cause an explosion AN WARNING Risk of explosion Before discarding an empty calibration 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 TCM400 operator s manual 9 Functional description Traceability certificate Certificate of Traceability Product name CAL2 standard calibration gas Type 10 CO balance N2 999 mL Code 962 096 Traceability of parameters Primary gravimetrically prepared standards Traceable to NIST traceable weights Primary gravimetrically prepared sta
24. settings for printer Start time Stop time for a session in progress are the last 60 minutes and for an older session they are the time of the last value in that session and 60 minutes backward The default settings for Print time interval is 1 min 2b To print a dump i e what you see is what you get of the actual view in Table or Curve view activate SmartPrint SmartPrint uses the view settings range span interval parameter etc and is only available in the Table and Curve views and if selected the Start and Stop time input fields are grayed Continued on next page 6 16 TCM400 operator s manual 6 In vivo monitoring How to print Continued Printing continued Printout of timer active measurements Step Action 3 Press OK to make a printout and return to the previous screen or press Cancel to return to the previous screen without making a printout NOTICES e It can take up to 30 60 seconds to generate the report s for printout and during this time the Print touch key is grayed e Even if several report types have been selected in Printer setup only one Comments page will be printed e If a report contains one or more events the event numbers and texts are listed on a separate page at the end of each report There are two ways to print only the values that have been measured while the timer was active e Inthe Advanced printer setup select Timer active only e Inthe Trend table or Trend cur
25. will result in an alert Step Action 1 From the Auxiliary setup screen press Date time Date time r Date time settings W3 23 2005 10 51 42 7 8 9 r Date format MM DD YYYY 4 9 DD MM YYYY 1 2 2 Select date format e MM DD YYYY month day year e DD MM YYYY day month year default The clock runs on a 24 hour cycle 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 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 deleted Press OK to accept the changes and return to the previous screen or press Cancel to return to the previous screen without saving changes Continued on next page 3 Menu structure and setup programs TCM400 operator s manual Technical setup Continued Utilities Follow the steps below to enter the Utilities options Step Action 1 From the Technical setup screen press Utilities Self check Press to perform Self check 2 Press one of the following touch keys e Self check for more information please see chapter 3 Checkout and Adjustment in the service manual NOTICE The Self check program should only be entered by Radiometer service technicians or
26. 2 7 print start stop time 3 17 print time interval 3 17 printer setup 3 7 3 9 printing 6 18 EVENS aaora etasan aea 6 19 parallel port eee 6 18 USB ports eeeeeeeesseeeeeees 6 18 R recharging the battery 4 8 reconfiguration of sensor modules 0 4 5 reference sensor9 2 Regional Perfusion Index 2 3 4 2 5 5 Relative humidity 4 3 reports advanced trend table 6 21 simple trend table 0 6 20 trend CUVE eese 6 22 Requirements ambient temperature 4 3 environmental 4 3 relative humidity cce 4 3 ventilation 4 3 restore default 3 15 restoring defaults 3 17 restricted use 6 2 rights reserved 1 2 S screen configuration 2 5 self check 3 15 sensor mod le esiiecscnsscssriieicsssreisse 2 2 module release 4 6 preparing to replace membrane 4 13 TCM400 operator s manual Signal range cceeseeseceteeeteees 9 4 SOCKEb E EEA AAE 2 4 SUOTING eeccecsseesseeseeeteeeneeenees 4 17 temperature 3 7 3 17 9 3 to MEMbrane ceeceeeeeee ees 4 14 sensor modules reconfiguration 4 5 serial data output 3 13 3 18 data expOrt ceeeeeeseereeees 6 27 Standard riase icin esias 6 23 serial port RS232 2 4 service mode 3 7 3 12 3 16 session 6 7 session number 6 8 setup programs 3 1 3 7 simple trend table report6 20 SmartPrint 6 15 6 17 6 18 solutions 9 6 specifications TCM400 monitor c
27. 400 system TCM4 Series The TCM400 system is part of the TCM4 Series monitoring system monitors Reference This operator s manual for the TCM400 Transcutaneous pO Monitoring System is intended for use as a reference It provides detailed operating instructions and answers to relevant questions about your transcutaneous system All rights At the time of printing the operator s manual is in conformity with the system All reserved rights are reserved for instruments circuits techniques and names appearing in the manual Intended use The TCM400 system is a device that uses up to six non invasive sensors placed on the patient s skin and that is intended to record transcutaneous oxygen partial pressures in adults not under gas anesthesia Do not use the TCM400 system in intensive care ICU NICU etc for unattended patient monitoring as the system has no alarms Measuring Transcutaneous measurements of tcpO can be performed at levels from 0 to 2000 range mmHg 0 to 266 7 kPa Operator profile Only trained health care personnel are permitted to use the monitor Limitations Transcutaneous monitoring is intended only as an adjunct in patient assessment and must be used in conjunction with clinical signs and symptoms AN WARNING Risk of incorrect measurements tepCO tcpO monitoring should not be used on patients in a compromised hemodynamic state as this may cause incorrect measurements A N CAUTION US federal law restricti
28. 7 10 12 B 34 11 01 00 07 08 2005 7 64 17 10 H B 24 11 02 00 07 08 2005 64 17 10 12 B 24 11 03 00 07 08 2005 64 17 10 12 B 24 11 04 00 07 08 2005 64 17 10 12 B E 11 05 00 07 08 2005 a 64 17 10 12 B TH 11 06 00 07 08 2005 64 17 10 T B TE Physician s signature Date Page 1 Page Z The advanced trend table report contains the following e Space for adding Signatures of physician and technologist e Information about Patient name ID from the Patient DMS Measuring unit Sensor temperature Value of the last calibration that was completed success fully before the session started Time and date of printout Table of measurement data NOTICE If measurement data is not available for all sensors or if some measurements are missing for a specific sensor a dash is printed in the specific field s in the table Body chart of entire body left leg and feet or right leg and feet on which the sensor sites can be marked Space for notes physician s signature and date Page number Continued on next page 6 19 6 In vivo monitoring TCM400 operator s manual How to print Continued Trend curve 6 20 Below is an example of a trend curve report tcpO2 RADIOMETER TCM4 SERIES Transcutaneous oxygen tension tcpO2 Patient name ID _ 123456789012345 _______ Physician Measuring unit mmHg Sensor temperature 45 0 C Last calibration value
29. 8 Go into the Patient DMS and add a check mark to the session s you want to export Press Export and wait for the data to be transmitted NOTICE During data transmission the Export touch key is grayed Continued on next page 6 26 TCM400 operator s manual 6 In vivo monitoring Serial data output data export Continued Procedure continued General information about exporting data to Microsoft Excel Step Action 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 115200 HyperTerminal Ele gdt Yiew Call Transfer Help Ds lB oo i eel TCH400 Data Expor al 15 22 56 23708705 15 24 47 23 08 05 Patient ID Hansen Last calibration 15 12 12 23 08 05 158 mmHg 00 1 01 44 0 27 5 4 r Ee est aT EA o pets C594 00 156 054 15 23 00 23708705 ail 0 15 23 10 23 08 05 Gee eee 18 23 20 29 08 05 4 0 10 4 ie 37 ig 16 ta 00 23 08 05 188 Pe 2h 16 23 08 05 o wee 189 Spe OO E M e ha Oe ho 15 24 26 23 08 05 158 159 id Ue 2 m Sere ee EEk a Connected 00 53 47 auto detect 115200 8 N 1 SCROLL CAPS NUM Cap Pri NOTICE If measurement data is not available for all sensors or if some measurements are missing for a specific sensor a dash is shown in the specific field s Before exporting da
30. 9 6 In vivo monitoring TCM400 operator s manual In vivo monitoring continued Starting and stopping timer Step continued 2 3 4 6 6 10 Action Press the desired countdown timer to start the timer counting down NOTICE When the timer reaches 00 00 the monitor will make a beep sound Or Press Start timer when the timer is at 00 00 to start the timer counting up NOTICES e When the timer has been started the text on the Start timer touch key will change to Stop timer e During the first hour the countup timer shows time in minutes and seconds 59 59 then it changes to hours and minutes The maximum countup time is 99 hours and 59 minutes e If the timer has been activated and one of the five countdown timers is selected this will cause the timer in progress to stop and the new one to start Press Stop timer to stop the countdown countup NOTICE The text on the touch key will change to Start timer If Start timer is pressed the timer will continue the countdown countup from where it stopped To change the timer configurations press Timer setup the Timer setup screen will appear See Timer setup in chapter 3 Menu structure and setup programs To reset the timer to 00 00 press Reset To close the dialog box press Close Continued on next page TCM400 operator s manual 6 In vivo monitoring In vivo monitoring continued Marking of Follow the steps below to mark an event while
31. Continued on next page 4 9 4 Installation and maintenance TCM400 operator s manual Cleaning the monitor continued Disinfection The need for disinfection of the monitor exterior and touch screen is governed by procedures and local requirements as well as monitor use frequency Disinfecting IMPORTANT It is important that you consult the hygiene committee at your outer surfaces hospital to establish the correct disinfection procedures for your hospital To disinfect the monitor exterior and touch screen Step Action 1 Shut down the monitor by following the procedure described earlier in this chapter 2 Use a soft cloth or tissue moistened with one of the recommended disinfection solutions to wipe the outer surfaces of the monitor NOTICE Follow legal requirements and local rules for safe work practices with chemicals 3 Use clean tissues moistened with water to remove any remaining disinfection solution from the surfaces 4 Use clean tissues to remove any remaining moisture 4 10 TCM400 operator s manual 4 Installation and maintenance Preparation and maintenance of the sensor General To obtain reliable measurements the sensor should be remembraned every week information After 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
32. NING 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 fire Do not place the TCM400 system in an enriched oxygen atmosphere or inside a hyperbaric chamber as it may cause a fire hazard gt B B gt WARNING Risk of incorrect measurements Do not use the TCM400 system 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 TCM400 system should be observed to verify normal operation before being used on patients See the section EMC approvals and compliance in chapter 8 gt B 6 2 TCM400 operator s manual 6 In vivo monitoring WARNING Risk of incorrect measurements When installing operating or servicing the TCM400 system special consideration should be given to the inf
33. R TCMA SERIES Transcutaneous oxygen tension tcpO2 Transcutaneous oxygen tension tcpO2 Patient name ID _ 123456789012345 Patient name ID _ 123456789012345 SRSA ER RES L Physician Technologist s comments Measuring unit mmHg Sensor temperature 45 0 C Last calibration value 159 mmHg Printed 11 45 23 07 08 2005 Time date Event _Elec 1 Elec 2 Elec 3 Elec 4 Elec 5 Elec 6 10 38 00 0770872005 65 5 B B 14 7 10 39 00 07 08 2005 3 6 16 B 14 14 a 10 40 00 07 08 2005 67 15 4 B 5 7 10 40 19 07 08 2005 125 E 2 T 35 53 10 41 00 0708 2005 17 EJ 5 T 1 5 10 42 00 07 08 2005 3 EJ 16 B 3 2 10 42 23 07 08 2005 H T T 7 i z 7 10 43 00 07 08 2005 65 18 TI 10 4 5 RISKEN Interpretation 10 44 00 07 08 2005 64 17 10 H B 24 10 45 00 07 08 2005 64 17 10 H B 24 10 46 00 07 08 2005 64 17 10 H B E 10 47 00 07 08 2005 64 17 10 H B 24 10 48 00 07 08 2005 64 17 10 H B 24 10 49 00 07 08 2005 64 17 10 12 B 24 10 50 00 07 08 2005 64 17 10 H B E 1051 00 07 08 2005 7 64 17 10 12 B 24 10 52 00 07 08 2005 64 T 10 H B 24 10 53 00 0708 2005 64 17 10 H B 24 10 54 00 07 08 2005 64 17 10 T B 24 10 55 00 07 08 2005 64 17 10 12 B 24 10 56 00 07 08 2005 5 64 17 70 T2 3 24 1057 00 0708 2005 6 17 10 T B 74 10 58 00 07 08 2005 64 17 10 H B TE 10 59 00 07 08 2005 64 17 10 12 B E 11 00 00 07 08 2005 64 1
34. RFERENCE 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 SHALL 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 pe
35. Scroll backward forward one step in the selected tutorial Returns to the TCM Tutorials screen Exits the tutorial and returns to Normal view Keyboard quer Escape To return to the Patient DMS screen without keys making changes To switch between different character sets Backspace To delete one character at a time from right to left Shift To shift between different keyboards in the same character set 3 To scroll left right in the text edit field Space To add a space Enter To accept the changes made in the text edit field and u return to the Patient DMS screen 2 10 Overview Introduction In this chapter 3 Menu structure and setup programs This chapter describes the view options and setup programs available on the TCM400 system This chapter covers the following topics Menu str ct r sninn dosesbeenestenecd aeae a iiaa a e aa a staves 3 2 The change view program ccccccccccecssccesseecsseceessecesseecsseesesseseesaeeeaes 3 3 Normal Va Cw erena aE sone ciseaseuavesjont ccdesaceuaguasesceuasesennsg nee aea e 3 4 PYEN tale VIC Wi EEEE A N N 3 5 Trend CUVE VISW faves tssoedec iauet tz ebactagactecustctadael a stink ta deavesten S a 3 6 The setup program 3 25 55 202825 sesazsha cadesos tersian ia R a ATS AROAN na aR 3 7 RA AAE E EAEE EEI EEATT A E 3 8 Technical setup an r a aa dy a a a iea 3 11 DePaul settings irea a e E E sah oe E T OA E 3 16 3 Menu s
36. Subtotals Validation Table Text to Columns Consolidate Group and Outline PivotTable and PivotChart Report 3B New Web Query a New Database Query t File 1 lt gt pi Sheeti Sheet Sheets dal Ready 1 I II NM O oT y 2 Select the file CAPTURE txt and click Import 3 Select the following settings and click Next Axi 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 iginal data type Choose the file type that best describes your data Characters such as commas or tabs separate each field dth Fields are aligned in columns with spaces between each field Start import at row fi File origin windows ANSI Preview of file E TCM400DataExport txt S Patient ID OZ24032005 0064 Cancel lt Back next gt Finish 4 Select the following settings and click Finish This screen lets you set the delimiters your data contains You can see how your text is affected in the preview below I Tab IV Semicolon I Comma I Space Other Text qualifier j zi Fe I Treat consecutive delimiters as one Continued on next page 6 28 TCM400 operator s manual Serial data output data export Continued Data files in Step Action Microsoft Excel continued Import Data Where do you want to put the data
37. TCM400 operator s manual TCM400 operator s manual TCM400 Transcutaneous pO Monitoring Systems Operator s manual from software version 4 2 RADIOMETER lt 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 TCM400 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
38. acters 00 6 29 general information 6 29 patient ID eeceeeeeeees 6 29 F fixation kit 6 4 fixation ring 6 4 Flammable anesthetics 4 2 fluctuations 5 5 functional description 9 1 Index H handle 2 2 headline field 2 5 heating element 9 2 holder for cable 2 2 humidity correction factor 3 13 3 18 5 6 4 2 Hyperbaric chamber 4 2 HyperTerminal 6 24 6 27 hyperthermia 6 2 6 3 IEC 8 7 in vivo monitoring 6 1 6 4 installation 4 1 installing TCM400 monitor 00 4 4 intended use 1 2 K keyboard 6 10 L legal notices 1 2 limitations 1 2 Line fuse 2 4 M main menu structure 3 2 maintenance 4 1 marking of event 6 13 measurement of pO 93 measurement principle 9 3 measuring site 6 2 7 3 measuring temperature 6 2 membrane replacement frequency 4 13 membraning a sensor 4 14 menu structure 3 1 module configurations 2 3 module release 2 4 N name 1 2 normal view 3 3 3 4 1 3 NTC resistors 9 2 o on screen keyboard 6 10 operating requirements 4 2 operator ACUDE Seconden rmah a eaea 7 2 proles aR 1 2 TCM400 operator s manual P parallel port 6 18 password 3 12 patient DMS 6 7 patient ID 6 8 in Excelyonrin eapi e 6 29 patient safety 9 3 platinum cathode 9 3 pO Cal Value oo ee eeceeeeteeneeeeeeeees 2 7 UDI aei a a 3 13 3 18 value adjustment 00 0 0 eee 9 4 power socket 2 4 power switch 2 4 precautions 1 3 preset temp
39. aia need 6 14 Ow to OI n tai EAA E E E E EE 6 16 Serial data output standard cceccecccescesscseeceeeeeeseeceeeseeesecssecsseceeceeeeeesaes 6 21 Serial data output data exPOrt ccccecscecscecssecsteeseceseceeecseeeeeeeeeeeeeeeeeeeseeeaaes 6 25 6 In vivo monitoring TCM400 operator s manual General Information Restricted use The use of the equipment is restricted to one patient at a time Measuring sites Clinical studies have shown the abdomen and chest to be the best measuring sites for adults Measuring A measuring temperature between 43 and 45 C is recommended for adults temperature P WARNING Risk of burns Do not allow the sensor temperature to exceed 44 C when sensors are attached to skin for more than four hours as this may otherwise cause burns General alerts AN WARNING Risk of incorrect measurements Remove the sensor s from the patient immediately if the TCM400 system or patient is exposed to a defibrillator electrocautery or other high frequency electrical signals as this may affect the device and may cause injury to the patient 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 incorrect measurements tcpO2 monitoring should not be used on patients in a compromised hemodynamic state as this may cause incorrect measurements WAR
40. alibration Radiometer recommends performing a calibration frequency e prior to each monitoring period e when changing measuring sites e every four hours e every time a sensor has been remembraned NOTICE After an eight hour monitoring period the monitor will go into Calibration required mode i e it will be necessary to perform a calibration in order to be able to monitor Recommen Check the monitor s barometer against a known calibrated barometer periodically dation See ranges in chapter 8 Specifications and ordering information 5 2 TCM400 operator s manual 5 Calibration Calibration with atmospheric air Procedure Follow the steps below to calibrate the tcpO sensor s with atmospheric air Step Action 1 Connect the tcpO sensor to the sensor socket on the monitor 2 Check that the calibration chamber is clean If it is not clean it See the procedure Cleaning the calibration chamber in Chapter 4 Clean the sensor See the procedure Cleaning the sensor in Chapter 4 Insert the membraned sensor into the calibration chamber on the monitor 5 Swing the sensor retainer into position over the sensor 6 Adjust the humidity correction factor if required by pressing Setup gt Setup gt Technical setup Auxiliary setup 7a To calibrate all connected sensors simultaneously press Calibrate If six sensors are connected the following screen appears 09 36 ibrati oe Calibrating D Calibrating Bar
41. an e g 1 hour and if held down they scroll normally but with built in acceleration When scrolling is activated the view becomes static and data will not automatically be updated when the monitor receives new data By scrolling to the latest results the view becomes dynamic and data will be updated when the monitor receives new data 2 To display the cursor press Cursor 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 makes it possible to go back and forth in time Cursor values as well as current values are shown to the right of the trend curve Cursor values are always static To remove the cursor from the screen press Cursor 3 To mark an event press Event and select from a list of textual events NOTICE Events can only be inserted during Measuring mode 4 To adjust the high and low values of the parameter ranges shown in the Trend curve view press the vertical arrow keys When leaving the view the monitor will remember the new range values Continued on next page TCM400 operator s manual 6 In vivo monitoring Trend curve view Continued Trend curve Step Action continued 5 To print the results press Print The printed report can be made in accordance with the Printer setup or as a SmartPrint see the section How to print later in this chapter and chapter 3 Menu stru
42. assistance please contact your local Radiometer representative Manufacturer RADIOMETER Q Radiometer Medical ApS Akandevej 21 2700 Br nsh j Denmark www radiometer com TCM400 Transcutaneous pO Monitoring System operator s manual from software version 4 2 Publication 201004 Edition N Code number 989 592 CE 0459
43. atient DMS Edit list To edit the list of textual events Sensor no To start calibration of a single sensor Event To mark an event during monitoring Function Normal view To change to Normal numerical view To accept the setting s change s and return to the previous screen 0 Printer setup To enter Printer setup e To see which text is connected to which event number Exp To export the detailed information for the patient IDs session numbers with a check mark in Patient DMS OK To reset the timer to 00 00 Restore default To restore all settings to default change the view or the sensor temperature To enter User setup Utilities To perform self check or to restore to default settings View options To change the options in the Normal the Trend table or the Trend curve view Continued on next page To start one of the countdown timers rt t Start stop timer To start or stop the timer 2 9 2 What is what TCM400 operator s manual The touch key glossary Continued k ss A y To scroll up down in a list and To scroll left right in a list Si n aa To add remove events in the Edit event list E To scroll to the top of the Trend curve lt lt gt gt To move left right one character at a time in the Date time and settings input field Tutorial touch Touch key Function k Sys WE Pauses the selected tutorial C Plays the selected tutorial lt q lan d j
44. atient DMS screen it is possible to change the automatically generated session number to a unique patient ID view data from a session in the Trend table or Trend curve view print one or more reports export one or more sessions delete sessions see detailed information about a session A session is a collection of data starting when the first sensor is removed from the C C alibration chamber and ending when the last sensor is placed back in the alibration 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 Continued on next page TCM400 operator s manual 6 In vivo monitoring In vivo monitoring continued Accessing Press the ID field in the top right corner of the view screens to enter the Patient Patient DMS DMS Data Management System Patient DMS Patients available Created E C Hansen 03 22 2005 09 6 Change ID vi 03 22 2005 09 A C 22032005 0047 03 22 2005 09 5 0122032005 0046 03 22 2005 09 5 Delete 1 22032005 0045 03 22 2005 09 5 v 1 22032005 0044 03 22 2005 09 4 1 22032005 0043 03 22 2005 09 4 Delete all 122032005 0042 03 22 2005 09 4 22032005 0041 03 22 2005 09 4 Y amp 22032005 0040 03 22 2005 09 4 Q C 22032005 0039 03 22 2005 09 4 C 22032005 0038 03 22 2005 09 T annans onaz n ans rafal Export A v Scroll between the patient IDs session nu
45. ation e once a month e if the sensor performance appears to deteriorate Procedure Follow the steps below to check the sensor zero current Step Action 1 Calibrate the sensor See the procedure in Calibration with atmospheric air in this chapter 2 Attach the adapter to the CAL2 gas cylinder and place the sensor in the calibration chamber of the gas adapter Wait 3 5 minutes for the tcpO gt reading to stabilize 4 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 must be remembraned and recalibrated Then repeat steps 1 to 3 of this procedure NOTICE If the tcpO2 reading is still e qual to or above 5 mmHg 0 7 kPa the sensor is defective 5 After zero current has been checked unscrew the CAL2 gas c ylinder from the gas adapter 5 7 5 Calibration TCM400 operator s manual 5 8 Overview Introduction In this chapter 6 In vivo monitoring This chapter describes the application of the tcpO sensor on a patient and in vivo monitoring Graphical presentations of the results are also described in this chapter This chapter covers the following topics General informations eass eniinn a anana a a ARE Ei 6 2 In vivo monitoring oo eee ecceesseesseenteceseceseceseceseceeeeeeeeeeeeeseesseecsaecsecsaecnseenaeees 6 4 Trend table View eisa eea i a e A as a aa E a e a 6 13 Trend C rve VIEW cie ouine an a a E
46. c interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the TCM400 system 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 vats d 1 2VP d 1 2VP d 23 P 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 NOTICE At 80 MHz and 800 MHz the higher frequency range applies NOTICE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Patient 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 1S1 94 601 1B 98 and UL std No 601 2 23 02 and 60601 1 Continued on next page TCM400 operator s manual 8 Specifications and ordering information Specifications Continued d li E ras Compliance The TCM400 system compl
47. cal sensor chain consisting of the platinum cathode the electrode sensor and the silver anode the reference sensor The sensor tip is covered with a thin membrane which stabilizes the conditions of 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 O 2H 0 4e 40H At the anode the following reaction takes place 4Ag 4Cl gt 4AgCl 4e The reduction of oxygen at the sensor s 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 pO2 in mmHg or kPa In order to satisfy the requirements for patient safety the circuitry that is interconnected with the sensor is galvanically isolated from the rest of the system The TCM400 system is equipped with an extensive safety system for controlling and for continuous surveillance of the sensor temperature e The microprocessor program gives an audiovisual alarm if the sensor temperature deviates 0 3 C from the preset value The error message Temp error is displayed e The sensor power consumption is permanently supervised If it exceeds maximum effect for more than two minutes during a measurement the heat switches off The error message Heater failure is displayed Although it is an effective safety feature it may cause problem
48. cations reading over the calibration interval is fulfilled continued The following max drift per hour has been measured at a sensor temperature of 43 C Max drift per hour at 10 O2 1 0 Max drift per hour at 20 O2 0 7 Response time 10 to 90 response The following max response times have been measured at a sensor temperature of 43 C 2 O to 20 9 Or 11 seconds 20 9 O to 2 Oz 11 seconds Test conditions All tests have been performed after preparation and calibration of the sensor according to the operator s manual The linearity tests have been performed using the calibration chamber as a test chamber The test gases used for the tests were dry gases fed to the calibration chamber at a flow rate of 10 15 mL min The drift tests have been performed simulating in vivo conditions i e with the sensor in contact liquid as during in vivo monitoring These test conditions have been obtained by placing the sensor in the sensor protection cap filled with contact liquid for four hours the calibration interval The drift value calculation is based upon the gas readings before and after the four hours The gas readings are obtained using the calibration chamber as test chamber feeding the dry test gas to the calibration chamber at a flow rate of 10 15 mL min The temperature of the test gases corresponds to the ambient temperature 21 23 C Continued on next page 8 8 TCM400 operator s manual 8
49. ceecseesteenees 4 7 CY PCr ce fecsstis we ieee chr eee 4 7 body chart 3 17 bypass calibration 3 13 byte format 6 29 C calculating the calibration value 5 5 calibration 5 1 ch mbert inisesin sissi 2 2 freg ene yaen n 5 2 PrOCESS enai 9 4 with atmospheric air 5 3 cathode 9 2 9 3 1 3 certificate of traceability 9 8 change view program 3 3 Clark type sensor 9 2 cleaning calibration chamber 4 11 the sensor and cable 4 14 the exterior eeeeeeseeeeeeees 4 1 touch SCLEEN cee esoeiseesssss 4 11 Index contact liquid 6 4 continuous data output 6 23 CSA 8 7 current generation 9 3 curve scales 3 9 D data dump 6 27 data export 6 27 Data Management System 6 8 data time setup 3 14 date time 3 18 date time setup 3 12 default settings 3 17 dialog box messages 7 7 disinfecting sensor and first part of cable 4 15 last part of sensor cable 4 17 disinfection frequency for exterior 4 12 Outer Surfaces sses 4 12 disinfection solutions recommended for sensor and cable DMS 6 7 E EMC approvals and compliance 8 4 Enriched oxygen atmosphere 4 2 4 2 Environmental requirements 4 3 error messages 7 3 Ethernet 2 4 event 2 7 2 10 marking 0 0 eeeeeseeeeeeteeeteeeees 6 13 event list configuration eee eeeeeeeeeneees 6 14 events in printed report eee 6 19 list of available 6 13 Excel 6 26 6 27 6 30 control char
50. cture and setup programs NOTICES e The monitor must be connected to an HP printer with PCL3 protocol e The memory function stores up to 48 hours of accumulated measuring data e To view data in the Trend curve view it is necessary to be monitoring or to select a patient ID session number into the view e If measurement data for a sensor is not available or if it is out of scale the line reflecting the results of that sensor will not be shown 6 15 6 In vivo monitoring TCM400 operator s manual How to print Connecting Follow the steps below to connect a printer to the monitor peter Step Action 1 Shut down the monitor by following the procedure described in chapter 4 Installation and maintenance 2 Connect an HP printer with PCL3 protocol to one of the USB ports on the rear of the monitor NOTICE It is also possible to connect a printer to a TCM400 monitor with parallel port 3 Switch the monitor on and select the printer settings in Printer setup see chapter 3 Menu structure and setup programs Printing Follow the steps below to make a printout Step Action 1 Press Print Printer start stop time Start time 15 09 2005 A 05 58 r Stop time 15 09 2005 A 06 58 y C SmantPrint 2a To get a printout using the printer settings set the Start and Stop time NOTICES e The memory function stores up to 48 hours of accumulated measuring data e The default
51. d Down arrows to select the Countdown timer setup e Select a Timer and the desired Start value for this timer configuration 1 60 minutes e Repeat the procedure for the four other timers 3 Use the Up and Down arrows to select Timer mode e Manual Timer must be started manually e Auto If the monitor is in Ready mode the timer will start automatically when the first sensor leaves the calibration chamber 4 Press OK to accept the changes and return to the previous screen or press Cancel to return to the previous screen without saving changes Continued on next page 3 8 TCM400 operator s manual 3 Menu structure and setup programs User setup Continued Printer setup Follow the steps below to change the Printer setup Step Action 1 From the User setup screen press Printer setup Printer setup Print time interval Curve ee Advanced Body chart Entire body C Advanced table Left leg and foot C Curve Right leg and foot Cancel 2 Use the Up and Down arrows to select the Print time interval i e the interval between the data on the printout 3 Press Curve scales to adjust the curve scales on the printout See the procedure below 4 Press Advanced to access the Advanced printer setup See the procedure on next page 5 Select one or more report types 6 Select a body chart NOTICE Only available if the advanced table report has been selected
52. e 8 2 tcepO2 Sensor eeeeceeseeeeeeees 8 10 stability check 9 5 standard data output 6 23 starting and stopping timer 6 11 storing the Sensor 4 17 symbols 8 11 T TCM400 monitor Honte nese e ea 2 2 POAT r i a e A ER 2 4 technical setup 3 7 3 12 temperature sensor 9 2 temperature setting 3 7 time span 3 6 timer mode 3 18 timer setup 3 7 3 8 timer active measurements only 3 5 3 6 3 17 timers 6 11 touch key field 2 7 touch key glossary 2 9 Index touch screen 2 2 traceability certificate 9 8 trend arrow 3 17 trend curve report 6 22 trend curve scale options 3 17 trend curve time span 3 17 trend curve view 3 3 3 6 6 16 trend table time interval 3 17 trend table view 3 3 3 5 6 15 troubleshooting 7 1 dialog box messages 7 7 pure text messages eee 7 9 the TCM400 monitor 7 2 tutorials 2 8 U Unicode characters 6 29 USB ports 2 4 6 18 user setup 3 7 3 8 utilities 3 7 3 12 3 15 vV 4 2 Ventilation requirements 4 3 view field 2 7 view options 3 3 pormal osten ar e 3 4 trend CUIV ssinsssscresesescssesssess 3 6 trend table 3 5 WwW warnings 1 3 Waste of Electrical and Electronic Equipment 8 12 WEEE 8 12 what is what 2 1 Z zero current 5 7 zero point check Index TCM400 operator s manual TCM400 operator s manual Date of issue Date of issue Radiometer representative If you have any questions or need
53. eeeseneeses 4 2 Installing the MOOK seiere e E E E E E a E E R ee 4 3 Shutting down the MOMItOL ccccesccesccesscsesceeeeeeeeeeseeeseecseecseecsaecnseeneeeeeesereeeeeeses 4 8 Cleaning the Monitor ecccecccesccesscesecseeeesseeeseeeseeeseeeseecsaecsaecsaecseceseeneeeeeesereseneeaes 4 9 Preparation and maintenance of the SCNSOL cccceccessceeseeeeceeeeeeeeeeseeeseeeseeeeeenaes 4 11 4 Installation and maintenance TCM400 operator s manual Operating requirements Environmental requirements Ventilation requirements 4 2 A gt gt gt P P 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 fire Do not place the monitor in an enriched oxygen atmosphere or inside a hyperbar
54. eft and Right arrows Press OK to accept the changes or press Cancel to return to the Events screen without saving changes TCM400 operator s manual 6 In vivo monitoring Trend table view How to viewa To view a Trend table press Setup gt Change view Table view gt OK trend table j If 14 56 i 0323 2005 Measuring ID 23032005 0065 tepO mmHg Be Em 26 Event Current 1907 241 575 908 1241 859 03 23 2005 14 56 00 1905 239 572 906 1239 861 03 23 2005 14 55 00 1893 228 561 894 1227 872 Bs 217 550 83 1216 883 206 539 872 1205 894 195 528 861 1194 905 184 517 850 1183 916 173 506 89 1172 928 162 495 828 1161 939 150 483 816 1150 950 140 472 805 1139 961 128 461 2 1128 972 117 450 73 1m6 383 106 439 72 105 994 95 428 761 1094 1005 B4 417 750 1083 106 73 406 733 1072 10x7 73 406 739 1072 1028 ge Setup Event NOTICE If the temperature of a sensor exceeds the preset temperature the sensor value will be flashing Step Action 1 To scroll through the results press the Up and Down arrows If the arrows are held down they scroll an entire screen When scrolling is activated the view becomes static and data will not automatically be updated when the monitor receives new data By scrolling to the latest results the view becomes dynamic and data will be updated when the monitor receives new data 2 To mark an event press Event and select from a list of textual events NOTICE Events ca
55. ensor status The status of the individual sensor e g Ready Calibration required Calibrating No sensor connected etc or an error status Touch key field The touch key field contains the following touch keys timer and its interval when active To enter the Setup and View programs Event To mark an event during monitoring Only visible in Measuring mode and in the Trend table and Curve views Tutorial To access instruction videos 2 6 TCM400 operator s manual 2 What is what Online tutorials Tutorials Touch keys 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 touch key TCM Tutorials Fixation of Membraning electrode Select tutorial and press play wt Pauses the selected tutorial er Plays the selected tutorial a ha 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 7 2 What is what TCM400 operator s manual The touch key glossary Touch key symbols 2 8 Touch keys are designated in bold italic throughout this manual The glossary of all the touch keys used in the software with their description is given in alphabetical order in the table below Touch key Y To add a check mark to the highlighted patient ID session number in
56. ep Action 1 Connect the TCM4xx ETX serial adapter code no 636 649 to the serial port on the TCM400 monitor and to the PC e g the COM1 port 2 On the PC select Start gt Programs Accessories gt Communications HyperTerminal Connection Description yy New Connection Enter a name and choose an icon for the connection Type in a name for the connection e g TcData and click OK 3 Connect To Enter details for the phone number that you want to dial Country region Area code Phone number Connect using ma Zi he Connect using COM1 and click OK Continued on next page 6 25 6 In vivo monitoring TCM400 operator s manual Serial data output data export Continued Procedure Step Action confined 4 Select the following port settings and click OK COM1 Properties Port Settings Bits per second Data bits Parity Stop bits Flow control Restore Defaults Cancel Apply 5 Collect the data in HyperTerminal e select Transfer Capture text e name the file e g CAPTURE txt e click Start 6 On the TCM400 monitor press Setup Setup Technical setup and enter password 7 Press Auxiliary setup select Data export and press OK Auxiliary setup Backlight rCal gas mix __ Hum cor factor lt gt Serial output Off ass O calibration Standard Date time Hild
57. erTerminal e select Transfer Capture text e name the file e g CAPTURE txt e click Start Continued on next page 6 23 6 In vivo monitoring TCM400 operator s manual Serial data output standard Continued Procedure Step Action continued 8 Stop the collection of data to the file in HyperTerminal by selecting Transfer Capture text Stop The following shows a screen from HyperTerminal 9600 0 4 Hyperterminal 1 mnh wi Temp 44 0 degC RPI P Tenp g ni nnlg nalig 3 H degl malig 7 degt mnHg A degl malig 0 mml J i malig RPI H Temp malig A Tenp nnlig Temp malig 4 Temp mnHg RPI A nll Tenp degl 3 mmHg RPI 1 00 Power 184 mW Temp 44 0 deal malig RPI Power all Temp degl malig RPI Power gt Temp degl antig gt Temp degl antig 3 Temp degC malg Temp degl _ NOTICE Data is easily imported into other programs e g Microsoft Excel see procedure under Data export 6 24 TCM400 operator s manual 6 In vivo monitoring Serial data output data export Introduction With the data export option a dump of the trend data can be exported to an external PC and presented in spreadsheet format Procedure Follow the steps below to export data from the TCM400 monitor to a PC In the example below HyperTerminal version 690170 with Excel version 97 SR 2 is used St
58. ers with a check mark see the section Serial data output data export later in this chapter Loads sessions with a check mark into the Trend table and Trend curve views e 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 Accessing Patient DMS _Touch key uae On screen The following screen shows the basic keyboard layout keyboard ry 123456 7890 E a E A a Ec EEE a eo o p x y t BA E N Escape To return to the Patient DMS screen without making changes Continued on next page 6 8 TCM400 operator s manual 6 In vivo monitoring In vivo monitoring continued keyboard ouch Key unction continued Backspace To delete one character at a time from right to left 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 Starting and Follow the steps below to start and stop the Timer stopping timer Step Action 1 Press Timer Countdown timers Start Start Start Start 1 min 3 min 5 min 10 min Timer Timer2 Timer3 Timer4 Timer5 Timer set Reset Close setup Continued on next page 6
59. formed on atmospheric air and the adjustment pO value is adjusted to the pO value of atmospheric air Continued on next page 9 4 TCM400 operator s manual 9 Functional description Calibration Continued ee d Sensor The TCM400 system checks the sensor stability for maximum stability 10 minutes until the change in the sensor signal is less than 1 check compared with the signals registered 1 minute and 30 seconds earlier If the stability criterion is not fulfilled the TCM400 system rejects the sensor and the error message Cal error drift is displayed If the stability is accepted the TCM400 system displays Ready The sensor signal range check continues during the stability check If during the stability check the pO signal exceeds the sensor signal range limits the error message Cal error drift will be displayed 9 5 9 Functional description TCM400 operator s manual Solutions and calibration gas Solutions Zero point check gas 9 6 The following solutions are used with the TCM400 system Solution Description tcpO Use To be applied on the clean sensor surface electrolyte Composition 1 2 propanediol potassium chloride sodium solution nie 10 mL 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 the 20 mL
60. full functionality the battery must be installed in the TCM400 monitor It enables monitoring and storage of data during transport and prevents data loss in the event of a power failure For connecting the sensor to the monitor For connecting a power cord to the TCM400 system 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 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 Ethernet serial For connecting the TCM400 system to the communication port system NOTICE Not yet available Serial port For connecting the TCM400 system to an external RS232 computer For connecting the TCM400 system to an external printer 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 2 4 TCM400 operator s manual 2 What is what The screen general elements The screen There are three types of view screen Normal Trend table and Trend curve and configuration they are all divided into the following fields Headline Sensor display Touch keys Example of Normal view screen in Ready mode Green Red Blue Yellow Orange Preset temp 44 0 C Purple Ready Touch key
61. ic 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 The following environmental requirements must be observed at all times e ambient temperature 5 40 C e relative humidity 20 80 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 TCM400 operator s manual 4 Installation and maintenance Installing the monitor Procedure Follow the steps below to install the monitor Step Action 1 IMPORTANT While installing sensor modules the monitor must be turned off Install the number of sensor modules needed for monitoring by pressing each module completely into the base unit until a click is heard NOTICES e To release a module see Releasing a sensor module on the next page e When interchanging the sensor modules note that the numbering of sensors modules changes too See Automatic numbering in TCM400 monitor front in Chapter 2 of this manual
62. ice 1 3 1 Introduction TCM400 operator s manual 1 4 Overview Introduction In this chapter 2 What is what The transcutaneous pO monitoring system includes e the TCM400 monitor e the tcpO gt sensor E5250 This chapter identifies the parts of the TCM400 monitor This chapter covers the following topics OV CTVICW AREE AT tat ah cactobs antege tts EEE A a Meet etettat on TCM400 monitor front TCM400 monitor rear The screen generalielement secie2s is sstitnideiebiens dbus teat ee aes Online titorials coches eiere eE ess ncte shes eaces EEE E EEE The touch key glossary 2 What is what TCM400 monitor front TCM400 operator s manual Handle Touch screen Sensor modules Battery indicator Button Monitor elevating support The following table lists the parts located on the front of the TCM400 monitor Front view Calibration chambers Monitor support and holder for sensor cables Parts and functions 2 2 Handle For carrying the monitor Calibration chambers For sensor storage and calibration Touch screen Facilitates communication between operator and monitor Sensor modules Monitor support and holder for sensor cable Monitor elevating support For transcutaneous measurements of tepO2 The TCM400 monitor can contain up to six modules see the configuration below The support of the monitor has the capability of holding the sensor
63. ies with continued e IEC 60601 1 Medical electrical equipment Part 1 General requirements for safety e IEC 60601 1 2 Medical Electrical Equipment Part 1 2 General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests e TEC 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 3 1 Medical Electrical Equipment Part 3 1 Essential performance requirements for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment e Class II Special Controls Guidance Document Cutaneous Carbon Dioxide tcpCO and Oxygen tcpO2 Monitors Guidance for Industry and FDA December 13 2002 IEC 60601 3 1 Linearity Performance The IEC 60601 3 1 requirement to linearity 5 mmHg Specifications 0 66 kPa is fulfilled for gas concentration between 2 O and 20 9 Oo At zero O the linearity is better than 1 mmHg At 90 O the linearity is better than 25 mmHg equal to 4 The above linearity data was obtained at an sensor temperature of 43 C Continued on next page 8 7 8 Specifications and ordering information TCM400 operator s manual Specifications Continued li and compilanee TEC 60601 3 1 Drift continued Ate Performance The IEC 60601 3 1 requirement to drift lt 5 of initial Specifi
64. ines supply lines be that of a typical IEC 61000 4 4 1 kV for input output lines 1 kV for input output lines commercial and or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial and or hospital environment Voltage dips lt 5 Ur Not applicable None short gt 95 drop in as the TCM400 interruptions Ur for 0 5 cycle monitor has and voltage 40 Ur battery backup variations z 60 drop in power SUPP Y Uz for 5 cycles input lines 70 Ur IEC 61000 4 11 Sone 30 drop in Ur for 25 cycles lt 5 Ur gt 95 drop in Ur for 5 seconds Power 3 A m 3 A m None frequency 50 60 Hz magnetic field IEC 61000 4 8 NOTICE UT is the AC mains voltage prior to application of the test level A 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 A WARNING Risk of incorrect measurements When installing operating or servicing the monitor special consideration should be g
65. inued Auxiliary setup Follow the steps below to change the Auxiliary setup 3 12 Step Action From the Technical setup screen press Auxiliary setup Bypass catbration Date tme Use the Up and Down arrows to select the settings for e Backlight NOTICE Full backlight reduces the lifetime of the display e Humidity correction factor see chapter 5 WARNING Risk of inaccurate results When performing an atmospheric air calibration make sure to set the calibration gas mixture to the percentage of oxygen in atmospheric air and the humidity correction factor as described in chapter 5 Failure to do so can cause inaccurate results Select the settings for e pO unit kPa or mmHg e Serial output Off Standard or Data export Press Bypass calibration if you want to bypass the calibration in progress NOTICE If a calibration is bypassed the monitor will be monitoring with invalid data The option should therefore only be used for service purposes Press Date time to adjust date and time see procedure next page Press OK to accept the changes and return to the previous screen or press Cancel to return to the previous screen without saving changes Continued on next page TCM400 operator s manual 3 Menu structure and setup programs Technical setup Continued Date and time Follow the steps below to change the Date time setup NOTICE Date and time cannot be set during measurement Trying to do so
66. ions linked to the same patient ID Press OK to abort Continued on next page 7 5 7 Troubleshooting The monitor Continued Dialog box messages continued System status messages 7 6 Incorrect password Try again Incorrect time Try again Monitor temperature too high Please shut down system immediately No sessions selected Please select one or more sessions One or more sessions will be deleted from the system This action cannot be undone The monitor is measuring Current session cannot be deleted The monitor is measuring No other sessions can be loaded into the view Calibrating Calibration required Measuring Ready Wrong password entered in Technical setup The user has entered an incorrect time format The PC has run out of memory The temperature in the CPU is too high possibly because the fan has stopped or is blocked The user has tried to view session information without selecting a session The user has selected one or more sessions in the Patient DMS and pressed Delete or Delete all The user has tried to delete the session in progress The user has tried to select one or more sessions other than the one in progress into a view TCM400 operator s manual System message Cause Recommended actions Try again or use 19100 Enter a valid time format see the topic Date and time in chapter 3 e Close irrelevant programs e Tur
67. is exhausted e Monitor is not connected to mains Battery low battery Battery level is low bar and High and Low are flashing Battery low battery bar and High and Low are flashing and a continuous alert sound is heard Battery level is critically low e Check the connection e Contact authorized service personnel Connect the monitor to the mains Connect the monitor to the mains immediately Error messages The following table lists the error messages for the monitor in alphabetical order Error message Cause Cal error barometer Barometer value invalid Cal error chamber Cal error drift when collected at start of calibration No sensor detected in the calibration chamber at start of or during calibration The sensor is rejected during the drift check Recommended actions e Start a new calibration e If error remains contact authorized service personnel Place a tcpO gt sensor in the chamber e Start a new calibration e If error remains remem brane the sensor and start a new calibration e If error still remains the sensor is defective Replace with a new one Continued on next page 7 3 7 Troubleshooting TCM400 operator s manual The monitor continued Error message Cause Error messages Recommended actions continued 7 4 Cal error sensitivity Cal error temperature Calibration required Heater failure Module disa
68. ithin 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 e 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 Store between the temperatures shown on the symbol Example shows the temperature range between 10 and 25 C Lot number Expiry date Do not use after this date See instructions for use 8 11 8 Specifications and ordering information TCM400 operator s manual Accessories D826 tcpO accessory kit that contains 904 308 e tcpO electrolyte solution e 12 white membrane units with PP membrane e O ring remover key e Cleaning paper bag with 20 pieces D282 Fixation kit that contains 904 891 e 4 x 25 disposable fixation rings e 4 x 20 mL contact liquid Line cords Description Line Cord 115 120V USA and JPN 615 407 Line Cord 230V UK Line Cord 230V ITA Line Cord 230V DK Line Cord 230V ISR Line Cord 230V CHE Line Cord 230V other 230V countries rem Continued on next page 8 12 TCM400 operator s manual 8 Specifications and ordering information Accessories Continued
69. itically low as this will prevent data from being saved onto the disk Reconnect the monitor to the mains as soon as possible after the battery level indicator starts to flash to recharge the battery Recharging the battery takes approximately eight hours TCM400 operator s manual 4 Installation and maintenance Changing the To change the battery follow the steps below battery Step Action 1 Using a 2 mm hex or Allen key remove the two screws from the battery cover at the rear of the monitor Remove the cover Detach the battery from the connector cable Attach a new battery to the connector cable Slide the battery onto the battery shelf in the monitor SS Oe S Reattach the battery cover 4 7 4 Installation and maintenance TCM400 operator s manual Shutting down the monitor Procedure Follow the steps below to shut down the monitor Step Action 1 Press the D button on the front of the monitor The following dialog box will be displayed System shutdown Shut down system Cancel 2 Press OK to shut down the monitor or Cancel to return to the main screen without shutting down the monitor 4 8 TCM400 operator s manual 4 Installation and maintenance Cleaning the monitor NOTICE Cleaning the exterior Cleaning the touch screen Cleaning the calibration chamber Recommended disinfection solutions Do not spray pour or spill any liquid on the monitor or any of the access
70. iven to the information regarding the electromagnetic precautions for this equipment given in the section EMC approvals and compliance Otherwise the monitor may be affected by electromagnetic interference causing incorrect measurements TCM400 operator s manual 8 Specifications and ordering information Specifications Continued EMC approvals and compliance continued Immunity IEC 60601 Compliance Electromagnetic environment test test level level guidance Portable and mobile RF communi cations equipment should be used no closer to any part of the TCM400 monitor including cables than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms d 12JP 150 kHz to 80 MHz IEC 61000 4 6 150 kHz to 80 MHz d 1 2JP 80 MHz to 800 MHz Radiated RF 3 V m IEC 61000 4 3 S0 MZ d 23VP 800 MHz to 2 5 GHz where P is the output power rating of the 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 Interference may occur in the vicin ity of equipment marked with the following symbol o Field strengths from fixed transmitters such as base stations for radi
71. m TOUTES PaCS 92 664 Timer ca G Setup Event Press OK to accept the changes and return to the previous screen or press Cancel to return to the previous screen without saving changes TCM400 operator s manual 3 Menu structure and setup programs Trend table view Changing Trend Follow the steps below to change the Trend table view options table view options Step Action 1 From the Change view screen press Table view View options Trend table view options Parameter in Trend table view _ Trend table time interval lt gt p A din 5 min Power Vv 10 min C View timer active measurements only Cancel 2 Use the Up and Down arrows to select one of the following e tcpO gt or RPI or Power the table will display values for each sensor used e Time interval i e interval between displayed values in trend tables 3 Press the check box to activate check mark or deactivate blank View timer active measurements only NOTICE If the option has been activated only the values measured while the timer was active will be shown If the option has not been activated then all measured values will be shown 4 Press OK to accept the changes and return to the previous screen or press Cancel to return to the previous screen without saving changes 3 5 3 Menu structure and setup programs TCM400 operator s manual Trend curve view Changing Trend Foll
72. mbers in the list and _ 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 Shows detailed information about the highlighted patient ID session number Session into Createc 03 22 2005 09 50 51 Jensen Start 09 50 51 Stop 10 53 13 atic 01 02 22 ast c 03 22 2005 09 41 00 Cal value 159 mmHg Change ID Enables changing the highlighted patient ID session number with the on screen 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 e A dialog warns users that the action cannot be undone e The session in progress cannot be deleted 6 7 6 In vivo monitoring TCM400 operator s manual In vivo monitoring continued Accessing Patient DMS _Touch key continued Delete all Deletes all patient IDs session numbers in the list NOTICES e 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 Exports the patient information and measuring data for the patient IDs session numb
73. monitoring event Step Action 1 Press Event rEvents available Event text 4 Start of measurement l 1 2 End of measurement 3 Change of measuring site 4 Provocational maneuver 1 5 Provocational maneuver 2 6 Provocational maneuver 3 7 Provocational maneuver 4 8 Elevation 9 Supine position 10 Start 02 11 Stop 02 2__ Work period 2 Select a textual event from the list 3 Press OK to mark the event or press Cancel to return to the previous screen without marking the event List of The following predefined events are available available events 1 Start of measurement 11 Stop O2 2 End of measurement 12 Work period 1 3 Change of measuring site 13 Work period 2 4 Provocational maneuver 1 14 Work period 3 5 Provocational maneuver 2 15 Stasis 6 Provocational maneuver 3 16 Stable point 7 Provocational maneuver 4 17 Change HBO condition 8 Elevation 18 Other 1 9 Supine position 19 Other 2 10 Start O2 20 Other 3 Continued on next page 6 11 6 In vivo monitoring TCM400 operator s manual In vivo monitoring Continued Configuration Follow the steps below to edit the list of events of event list Step Action 1 6 12 Press Edit list 2 End of measurement The available events are listed to the left and the events that have been selected are listed to the right Events are added to removed from the list to the right with the L
74. n only be inserted during Measuring mode 3 To print the results press Print The printed report can be made in accordance with the Printer setup or as a SmartPrint see the section How to print later in this chapter and chapter 3 Menu structure and setup programs NOTICES e The monitor must be connected to an HP printer with PCL3 protocol e The memory function stores up to 48 hours of accumulated measuring data e To view data in the Trend table view it is necessary to be monitoring or to select a patient ID session number into the view e If measurement data is not available for all sensors or if some measurements are missing for a specific sensor a dash is shown in the specific field s in the table 6 In vivo monitoring TCM400 operator s manual Trend curve view Trend curve 6 14 To view a Trend curve press Setup gt Change view Curve view gt OK 14 43 n y 03 23 2005 Measuring ID 23032005 0065 te pO mmHg Sensor 1620 w o values 1260 1080 900 m 70 F Cursor 540 a a 5 a 52 mmHg v 190 Time 14 40 30 0 Date 23 03 2005 14 38 14 39 14 40 14 41 14 42 lt gt Cursor G Setup Event NOTICE If the temperature of a sensor exceeds the preset temperature the sensor value will be flashing Step Action 1 To scroll through the results press the Left and Right arrows If the arrows are pressed they scroll an entire time sp
75. n the monitor off and on Turn off the monitor and contact authorized service personnel Press OK to abort e Press OK to delete the sessions e Press Cancel to keep the sessions Press OK to abort Press OK to abort The following table lists the system status messages in alphabetical order All sensors are being calibrated At least one of the sensors must be calibrated At least one of the sensors is measuring All sensors have been calibrated and are ready for use 8 Specifications and ordering information Overview Introduction This chapter contains the specifications and ordering information for the TCM400 transcutaneous pO monitoring system In this chapter This chapter covers the following topics Specifications scrcosictihacs ve tesohsd sca a a ada a dead a a a eves 8 2 Accessoi sne miie e se cei wed detent De wodetete Geet ccs EON tee Da ea aa Ae 8 12 8 Specifications and ordering information TCM400 operator s manual Specifications TCM400 The table below lists the specifications for the TCM400 monitor Parameters Measured tcpO and sensor heating power Pet e os en Accuracy Better than 2 mmHg or 0 2 kPa 0 1 of reading at 25 C excluding sensor Polarization voltage 680 mV 5 mV Sensor heating power 10 500 mW range Displayed accuracy 3 Temperature settings 37 0 to 45 0 C in steps of 0 5 C in C Accuracy better than 0 1 C excluding sensor Barometer Built in
76. ndards Traceable to NIST traceable weights Expanded 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 Biame lAts 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 fat 990 348 e 2004094 COPENHAGEN E 9 7 9 Functional description TCM400 operator s manual 9 8 TCM400 operator s manual Index A accessories 8 13 additional items 8 14 advanced print 3 11 3 17 advanced printer setup 3 9 advanced trend table report 6 21 4 2 Ambient temperature 4 3 anode 9 3 application procedure 6 4 approvals 8 7 arrow touch keys 2 11 automatic numbering 2 3 auxiliary setup 3 7 3 12 3 13 B backlight 3 18 barometer recommendation 5 2 barometric pressure 2 7 battery Changing 0 ceeceseesseeeteceteeeeees 4 9 FUNCTION ecirar ieis 2 4 indicator Gr 2 2 Installing eeeeseeeteceteeeteees 4 7 LEV El esvessspsestaseetzereecttspatvacsencatbae 4 7 level indicator eeeeeeeeeee 2 5 Hessel dead ctitecsdees E ee ia 4 7 4 8 running the monitor on battery power alone oo eee e
77. ng and Ready modes The monitor must be in Calibration required mode or be powered off and then on to change the temperature setting Continued on next page 5 4 TCM400 operator s manual 5 Calibration Calibration with atmospheric air continued Calculating the calibration value Causes of error Example relative humidity When using atmospheric air the tepO calibration value is calculated according to the following formula FO atm air pO CAL B pH O temp x Foam where B barometric pressure in mmHg or kPa FO atm air percentage of oxygen in atmospheric air default 20 9 pH 2O temp humidity correction factor actual water vapor pressure in mmHg or kPa in atmospheric air at room temperature temp C RH pH O temp o x pH O sat temp where RH is the actual percentage of relative humidity in atmospheric air pH O sat temp is the saturated water vapor pressure at room temperature Calibration can be performed in atmospheric air without compensating for fluctuations in relative humidity or barometric pressure However this may lead to some inaccuracies If no compensation for relative humidity is made the following inaccuracy can be estimated Barometric pressure B 760 mmHg Room temperature temp 21 C Relative humidity RH 60 Saturated water vapor pressure at room temperature pH O sat 21 C 18 7 mmHg Percentage of oxygen in atmospheric air FO2 atm air 20
78. nsor temperature see below e User setup Timer and Printer setup e Technical setup Auxiliary setup Utilities and Service mode See the menu structure on the second page of this chapter NOTICE It is always possible to return to the default values see the section Default settings later in this chapter The sensor temperature is adjusted with the Up or Down arrows Available sensor temperatures range from 37 0 to 45 0 C NOTICE The temperature cannot be adjusted while the monitor is in Measuring and Ready modes The monitor must be in Calibration required mode or be powered off and then on to change the temperature setting To change the User and Technical setup see the following pages User SQUID icoisassccchdecscsiesjexdecdancnscudaanvuacddssuedensaeataeidwnieeuabaea dienes deevaaaeuuncees ceeesdes 3 8 Technical setip isorinis e EE R E E E 3 11 3 7 3 Menu structure and setup programs TCM400 operator s manual User setup Accessing User The User setup is accessed by pressing Setup Setup User setup setup Printer setup Press to adjust Printer setup 1 Press to adjust Timer setup From the User setup screen it is possible to access e Timer setup see below e Printer setup see next page Timer setup Follow the steps below to change the Timer setup Step Action 1 From the User setup screen press Timer setup r Countdown timer setup A ase A Asab A 2 Use the Up an
79. o 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 TCM400 system is used exceeds the applicable RF compliance level noted above the TCM400 system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the TCM400 system b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m NOTICE At 80 MHz and 800 MHz the higher frequency range applies NOTICE 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 5 8 Specifications and ordering information TCM400 operator s manual Specifications Continued EMC approvals and compliance continued Other approvals and compliance 8 6 Recommended separation distances between portable and mobile RF communications equipment and the TCM400 system The TCM400 system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the TCM400 system can help prevent electromagneti
80. o pressure 760 mmHg pO Cal value 159 mmHg Calibrating Baro pressure 760 mmHg pO Cal value 159 mmHg Calibrating Baro pressure 760 mmHg pO Cal value 159 mmHg Continued on next page 5 3 5 Calibration TCM400 operator s manual Calibration with atmospheric air continued Procedure continued Step Action 7b To calibrate one sensor at a time press the number of the relevant sensor Calibrate single electrode Start calibration of electrode 1 Cancel Press OK to start calibration or press Cancel to return to the previous screen without initiating the calibration NOTICE While calibrating a single sensor it is possible to monitor with the other sensors 8 Wait for the calibration to finish RESULT There is a beep and the calibration values are displayed 0944 _ 03 23 2005 _ Preset temp 44 0 C Preset temp 44 0 C Ready Ready Preset temp 44 0 C Preset temp 44 0 C Ready Ready Preset temp 44 0 C Preset temp 44 0 C Ready amp Tutorial NOTICES e Ifthe sensor has been remembraned prior to the calibration leave the sensor in the calibration chamber for 30 minutes and then press Calibrate again e If the sensor is not removed from the calibration chamber within 30 minutes after Ready the heat to the sensor will be switched off minimizing electrolyte drying out A new calibration will be required e The temperature cannot be adjusted while the monitor is in Measuri
81. on 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 notice Instruments should be repaired by Radiometer service personnel or by Radiometer certified representatives only 1 2 TCM400 operator s manual 1 Introduction 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 AS hazardous situation which if not avoided may result in minor or moderate 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 wee 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 Hb dev
82. on of a sensor and the first part of the attached cable that closest to the sensor is carried out with a membraned sensor prior to calibration A N WARNING 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 A N 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 AN 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 Step Action 1 Immerse the sensor and only the first part of the cable in one of the recommended water based disinfection solutions 2 Use clean tissues moistened with water to remove any remaining disinfectant from the sensor and cable 3 Use clean tissues to remove any remaining moisture Continued on next page 4 13 4 Installation and maintenance TCM400 operator s manual Preparation and maintenance of the sensor continued Disinfecting the Disinfect the last part of the sensor cable the part closest to the plug as follo
83. on process and cause the monitor to go into Calibration required mode Change view The table below lists the default settings in the Change view program Setup defaults The table below lists the default settings in the Setup program Trend curve scale options tcpO2 upper scale value 200 mmHg tcpO lower scale value 0 mmHg Power upper scale value 600 mW Power lower scale value 0 mW RPI upper scale value 1 0 Advanced print Events only Timer active only Print in color Parameters Report type for printout Simple table Body chart for printout Entire body Continued on next page TCM400 operator s manual 3 Menu structure and setup programs Default settings Continued feontnued Start values of timers Timer 1 1 min Timer 2 3 min Timer 3 5 min Timer 4 10 min Timer 5 20 min 3 Menu structure and setup programs TCM400 operator s manual Overview Introduction In this chapter 4 Installation and maintenance This chapter describes the operating requirements and the installation of your transcutaneous pO monitoring system As this system requires minimal maintenance and since the installation procedure will cover most of the maintenance it is included in this chapter as well This chapter covers the following topics OVENI eWoe ae a dantiect ea a seeds wh cs EE eter ad dake whe EEr E EEE 4 1 Operating requirements cceecceeccessceseceeeeeeseeeseeeseecseecsaecsuecaecseceseenaeeeeees
84. onitor 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 gt gt 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 RELIED 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 INTE
85. ontinued 1 Shut down and revert to previous configuration to back up data 2 Delete all patient data and allow new configuration Select one of the options and press OK NOTICES e Incase you have not made a backup of the existing patient data it is possible to abort the configuration by selecting the first option Then save your data and follow steps 1 4 in this procedure e Reconfiguration of the electrode modules does not affect the setup Releasing a Follow the steps below to release a sensor module sensor module Step Ach n 1 Slide the release key into the module release at the rear of the module 2 Press the release key while releasing the module sideways 3 Remove the release key and pull out the sensor module Continued on next page 4 5 4 Installation and maintenance TCM400 operator s manual Installing the monitor continued Battery Installing the battery Running the monitor on battery power alone Recharging the battery 4 6 The following battery type must be installed on the monitor Standard 12 V 2AH lead acid battery code number 431 018 available from Radiometer Contact your local battery supplier for available type A CAUTION Risk of patient not being monitored For data safety reasons a battery must always be connected to the system CAUTION Risk of patient not being monitored Replace battery only with the types recommended by Radiometer AN CAUTION Handling of bioha
86. ories connectors switches or openings in the chassis To clean the monitor exterior Step Action 1 Shut down the monitor by following the procedure described earlier in this chapter 2 Use a soft cloth or tissue moistened with a mild detergent to wipe the exterior NOTICE Do not use abrasive cleaners or pads otherwise you may damage the finish NOTICE Do not use aggressive detergents as extensive use may cause the plastic to become brittle and crack 3 Use clean tissues moistened with water to remove any remaining detergent from the surfaces 4 Use clean tissues to remove any remaining moisture 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 The calibration chamber must be cleaned whenever it has been exposed to contact liquid The procedure is as follows Step Action 1 Use a soft cloth or tissue moistened with either water or a mild detergent to clean the chamber 2 If a mild detergent has been used use clean tissues moistened with water to remove any remaining detergent from the chamber 3 Use clean tissues to remove any remaining moisture from the chamber 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
87. ormation regarding the electromagnetic precautions for this equipment given in the section EMC approvals and compliance in chapter 8 Otherwise the TCM400 system may be affected by electromagnetic interference causing incorrect measurements e NOTICE The TCM400 system is not a blood gas device 6 3 6 In vivo monitoring In vivo monitoring Required materials Prior to sensor application Application procedure 6 4 TCM400 operator s manual The following items included in the fixation kit are required to affix a tcpO sensor to a patient e Fixation ring WARNING Risk of infection and inaccurate results Reuse of single use devices may lead to infection of patients and inaccurate results e Contact liquid Follow the steps below prior to affixing a sensor to a patient Step Action 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 Follow the steps below to affix a tcpO sensor to a patient Step 1 Action Take a fixation ring and remove the fixation ring from the protection film 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
88. ow the steps below to change the Trend curve view options curve view options Step Action 1 From the Change view screen press Curve view View options Trend curve view options Parameter in Trend curve view Trend curve time span I View tmer active measurements only coren Use the Up and Down arrows to select one of the following e tcpO gt or RPI or Power e Time span NOTICE When loading a session from the Patient DMS into a view and if the time span is set to e g 30 minutes the system will show the latest value of the selected session and 30 minutes backward The maximum trend curve time span is 12 hours Press the check box to activate check mark or deactivate blank View timer active measurements only NOTICE If the option has been activated only the values measured while the timer was active will be shown If the option has not been activated then all measured values will be shown Press OK to accept the changes and return to the previous screen or press Cancel to return to the previous screen without saving changes TCM400 operator s manual 3 Menu structure and setup programs Introduction Adjusting sensor temperature The setup program The Setup program is accessed by pressing Setup Setup Electrode temperature Technical Press to enter password protected setup Technical setup OK Cancel The Setup is divided into three options e Se
89. ppeared No sensor connected Out of range The sensor sensitivity is outside the specifications The selected sensor temperature value cannot be reached e The last calibration has been aborted e Eight hours have passed since the last successful calibration e The sensor has been subject to excessive heating e The measured power is outside the measuring range For unknown reasons the communication between the monitor and the module has not been satisfactory e No sensor detected in the calibration chamber e The sensor in the calibration chamber is not functioning The measured tcpO gt value is outside the measuring range e Remembrane the sensor and start a new calibra tion e The sensor is defective Replace with a new one e Calibrate the sensor e If error remains the sensor is defective Replace with a new one Perform a calibration e Calibrate the sensor e If error remains the sensor is defective Replace with a new one e Turn the monitor off and on e If error remains try with another module e If error still remains contact authorized service personnel Connect a functional tepO sensor e Replace the sensor with a new one e Recalibrate the sensor Continued on next page TCM400 operator s manual The monitor continued Error message Cause Error messages continued Temp error Temp warning Dialog box messages System message Battery level is
90. rmitted 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 TCM400 operator s manual Contents Contents Introduction This manual describes how to operate the TCM400 system and covers the following chapters and topics 1 THOU CEION iccsisccchstesccdcesesscntstesdavedsasecetstescsecsseseceevesdswesensocSetesdsecssesecedctesssvesss aL OV ELVIS Wess sh Sheds ape ss eovdede AOR See a BEB SE bo was Reds de Satie ATS bs OSG Cage Eases 1 1 Name intended use and limitations c ccccccccesscceessececessceceessececseeeceeeeceessececsseeeceeseeceesseeess 1 2 Symbols used in the manual 0 cccceescescceseesceeecesecceeseesecesecaaeeseeseceaecaeeeseeseseaecaeeseeseeeeseaeente 1 3 De WHat 18 WIA siscsede ccs occdscsesecs dass es
91. rmly into the unit until a click is heard Remove the sensor from the unit and wipe off the surplus electrolyte solution with the piece of cleaning paper Cleaning the Clean the sensor and cable as follows sensor and cable Step Action 1 Use a soft cloth or tissue moistened with water to wipe the sensor and cable 2 Use clean tissues to remove any remaining moisture Continued on next page 4 12 TCM400 operator s manual 4 Installation and maintenance Preparation and maintenance of the sensor continued Recommended disinfection solutions Disinfecting the sensor and first part of the cable As the number of available disinfection solutions is increasing and varies 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 to disinfect the sensor and cable However Radiometer suggests that one of the following water based disinfection solutions is used e MadaCide FD MADA Inc e Control III Maril Products Inc e Hi Tor Plus Ecolab Inc 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 IMPORTANT t is important that you consult the hygiene committee at your hospital to establish the correct disinfection procedures for your hospital Disinfecti
92. s Timer l Calibrate fe 2 Setup Tutorial NOTICE In Normal view the Event touch key replaces the Tutorial touch key during Measuring mode Headline field The headline field contains the following information The real time 24 hour cycle and date Ready Measuring Calibrating or Calibration required Battery level Shows the battery level The indicator is only visible when indicator the monitor is running on battery power alone For more details see Chapter 4 Installation and maintenance Full i almost full 5 low ul and critically low 0 ID Patient identification number Serves as a shortcut to the Patient DMS Continued on next page 2 5 2 What is what TCM400 operator s manual The screen general elements Continued Sensor display The sensor display field contains the following information field One to six sensor Data presented as modules A e Numerical values normal view e Trend tables e Trend curves Trend arrows An upward downward arrow will appear next to the result on the Normal view screen when an upward downward trend in measuring values is detected Preset temp The preset sensor temperature in each sensor display during Ready and Calibration required modes NOTICE If the sensor temperature exceeds the preset temperature a text message appears in the sensor display The measured barometric pressure during calibration pO cal value The calculated pO value for calibration S
93. s and accessories are latex free accessories accessories E5250 tcpO The table below lists the specifications for the tecpO sensor Dimensions Diameter e Sensor housing 15 mm 0 6 in e Silver body 91mm 0 36in Height 11 3mm 0 44in Weight 2 9g 0 1 oz Pressure on skin 0 015 g mm 0 05 4 b sq in Sensor cable length 2 25m 88 6 in 8 9 8 Specifications and ordering information Specifications Continued List of symbols 8 10 TCM400 operator s manual The following symbols are used with the TCM4 Series monitoring system Symbol Explanation Barcode eto 002 74135 0 G k CSA approved Gr US O COM communication port Printer Battery Ethernet interface connection to network Not for phone connection Power switch Standby Manufactured by ECER Type BF body floating equipment Continued on next page TCM400 operator s manual Specifications continued List of symbols continued 8 Specifications and ordering information Symbol Explanation Product complies with the requirements of the Medical 0459 Device Directive 93 42 EEC June 1993 This product is a class Ia device A Caution consult accompanying documents A Waste of Electrical and Electronic Equipment WEEE The symbol indicates that e Radiometer Medical ApS and its distributors w
94. s if the sensor has been immersed for more than 2 minutes in a cold disinfectant solution after calibration The only remedy is to raise the temperature of the solution e If the sensor temperature reaches 46 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 controls to shut off immediately and permanently 9 3 9 Functional description TCM400 operator s manual Calibration Calibration The calibration process includes the stages described in the table process CALIBRATION max duration 19 min READY is displayed Electrode Signal mV Acceptance Vv Vv v Range EES o _ ___e__ rr r r D gt 1 2 3 4 5 El Signal Stability Be ae ena deen ae wigs Press Cal Heat on Range Check Check If not used for 30 min 1 H 2 3 i Cal is asked for Heating of The sensor will typically be heated to the preset temperature the sensor within one minute If it has not reached this temperature within three minutes the computer will reject the sensor and the error message Cal error temperature will be displayed Checking the When the sensor has reached the preset temperature the sensor signal TCM400 system checks the sensor pO signals If they are not range within a specified range within 1 minute the monitor rejects the sensor and the error message Cal error sensitivity will be displayed pO value The pO measurement is per
95. scesseesseceseceseceseceeeeseeceeeeeeseeeeeeseeeeeeaaes 9 6 Traceability certificate 0 ee ceceeceesecseeseeeecesecseeeecesecaecaeeeeeeseceaeeaeeeceaeeaeeeneeaes 9 8 9 Functional description TCM400 operator s manual The tcpO2 sensor The sensor components The NTC resistors Local vasodilation 9 2 The E5250 tcpO sensor combines a heating element temperature sensors and a Clark type oxygen sensor in a single unit SO S S z Y ENTE ron emere sensos O2 permeable membrane Electrolyte reservoir Heating element The temperature of the sensor is sensed by the NTC resistors incorporated in the Ag reference sensor 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 heating produces local vasodilation and increases the permeability of the skin to oxygen thus making a measurement on the skin surface possible TCM400 operator s manual 9 Functional description Measurement Definition Measurement principle Patient safety features 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 electro chemi
96. serial port on the TCM400 monitor and to the PC e g the COM1 port The RS232 output from the TCM400 monitor is transmitted continuously every two seconds in ASCII code in the following format Timestamp Sensor no O2 RPI Heater power Temperature 2 On the TCM400 monitor press Setup Setup Technical and enter the password 3 Press Auxiliary setup select Standard and press OK Auxiliary setup Bypass calibration Date time Continued on next page 6 21 6 In vivo monitoring TCM400 operator s manual Serial data output standard continued Procedure continued Step Action 4 On the PC select Start gt Programs Accessories gt Communications HyperTerminal Connection Description uy New Connection Enter a name and choose an icon for the connection Name Icon Connect To Enter details for the phone number that you want to dial Country region Area code E E Phone number Comect using i Connect using COM and click OK Continued on next page 6 22 TCM400 operator s manual 6 In vivo monitoring Serial data output standard continued Procedure continued Step Action 6 Select the following port settings and click OK COM1 Properties Port Settings Bits per second Data bits Parity Stop bits 1 Flow controt Ei v Restore Defaults 7 Collect the data in Hyp
97. ta to Microsoft Excel please note the following Control characters The patient data has been prepared for data handling programs that separate and organize data It therefore contains control characters to mark the beginning and end of a session the patient ID etc This however causes a problem with regard to Excel as the control characters will not be filtered out of the exported data but be displayed as OOO see the screen in step 6 in the procedure below NOTICE After exporting data to Excel you have the option of deleting the Q characters from your Excel file Patient ID Patient IDs are Unicode characters exported in byte format Therefore they are displayed in Excel in one of the following ways e For languages based on a standard ASCII character set Basic Latin a space is added in front of each character e g S mith e For Japanese Greek and Russian all characters in the patient ID are replaced with non readable characters unless the patient ID is composed of numerical values only Continued on next page 6 27 6 In vivo monitoring TCM400 operator s manual Serial data output data export Continued Data files in Step Action Microsoft Excel z 1 Open Excel and select Data Get External Data Import Text File Ei Microsort excel Book E Bile Edit View Insert Format Tools Data RoboPDF Window Help 18 x D amp S SRB s sot ee ae Eiter Form
98. the hole in 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 Repeat steps 1 4 if more sensors are to be applied TCM400 operator s manual 6 In vivo monitoring In vivo Follow the steps below to start the in vivo monitoring with one or more sensors monitoring Step Action 1 Wait for a stable reading after the sensor has been affixed to the patient NOTICE The physiological stabilization time of a patient is 10 20 minutes for the tcpO2 reading Longer time may indicate an incorrect attachment of the sensor or a poorly selected measuring site 2 Press Timer if required See the procedure later in this topic NOTICE If Timer mode has been set to Auto in the Setup program the timer will start automatically when the first sensor is removed from the calibration chamber 3 Press Event if required See the procedure later in this topic NOTICE The Event touch key can among other things be used to record the time when starting a new monitoring period 4 Link the session in progress to a specific patient ID See the topics Accessing Patient DMS and Session on the following page 5 View the readings and adjust the settings if necessary See the topic Menu structure in chapter 3 Menu structure and set
99. tructure and setup programs TCM400 operator s manual Menu structure Main menu The following diagram illustrates the main menu structure of the TCM400 system structure Setup Change view Setup I Normal Table Curve view view view View View View options options options I I l Parameter Parameter Parameter i Trend arrow Time interval Time span i View timer active View timer active measurements only measurements only I I i I PAE OA SEE E E NTE REEE Ee E T 1 Setup Sensor User setup Technical setup temp Enter password st Auxiliary setup Backlight Timer setup Printer setup Cal gas mixture Hum cor factor Timer mode Print time interval pO unit Start value Report type Serial output Countdown Advanced Bypass calibration timer setup Advanced print Date time Parameters Body chart Utilities Curve scales Self check tepO upper scale Restore default tcpO lower scale Power upper scale Power lower scale Service mode RPI upper scale L For service personnel only 3 2 TCM400 operator s manual 3 Menu structure and setup programs Introduction Changing view Changing view options The change view program The Change view program is accessed by pressing Setup gt Change view Change view Table win Press to change to Trend table view Curve wom Press to change to Trend curve view vi options Change options on Normal view OK Cancel In this program it is possible to
100. ues not stable or out of limits 20 minutes after application 7 2 Recommended actions e Insufficient removal of Remembrane the sensor old electrolyte during membraning procedure Air bubbles in electrolyte The sensor membrane has not been changed regularly Sensor zero current check has not been performed regularly Defective sensor membrane holes or scratches Defective O rings one or both O rings broken e Detach the sensor and reapply correctly Improper attachment of the sensor e Detach the fixation ring and reapply correctly Improper attachment of the fixation ring An inappropriate measurement site has been selected Inadequate vasodilation Patient status unstable e Evaluate patient status Inadequate vasodilation e Remount the sensor Improper attachment of the sensor Continued on next page TCM400 operator s manual The monitor Continued Error symptoms continued Measured values change suddenly without any physiological cause Noise appears on the tension readout Monitor not operational e Artifact due to patient movements e Air leakage under fixation ring e Self adhesive ring does not stick to the skin 7 Troubleshooting Recommended Actions Recalibrate and reapply sensor to the skin possibly selecting a new measuring site Interference from nearby Increase the distance from equipment the interfering equipment e Monitor is defective e Battery
101. up programs 6 When the patient no longer needs to be monitored remove the sensor by turning it in an anticlockwise direction through a quarter of a turn until the arrow on the sensor aligns with one of the marks on the fixation ring and lift it out 7 Clean the sensor using a soft cloth or tissue moistened with water then use a dry tissue to remove any remaining moisture then place it in the calibration chamber WARNING Risk of skin damage The sensor 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 NOTICE After an eight hour monitoring period the monitor will go into Calibration required mode i e it will be necessary to perform a calibration in order to be able to monitor Continued on next page 6 5 6 In vivo monitoring TCM400 operator s manual In vivo monitoring continued Screen during monitoring Patient DMS Session 6 6 The following is an example of a screen picture during monitoring maag Measuring ID 23032005 0063 1595 159 1S es aah ale 159 ws 199 che 340 mw 690 mw Timer Calibrate 00 00 The Patient DMS manages all session patient ID data and it helps reducing the risk of patient data mix up From the P
102. ve view options select View timer active measurements only go into Trend or Curve view and make a SmartPrint Examples of table and curve reports are shown on the following pages Continued on next page 6 17 6 In vivo monitoring How to print Continued Simple trend table 6 18 Below is an example of a simple trend table report for tepO RADIOMETER TOMA SERIES Physician Transcutaneous oxygen tension tcpO2 Patient name ID __123456789012345 Measuring unit mmHg Sensor temperature 45 0 C Last calibration value 159 mmHg Printed 11 45 23 07 08 2005 The simple trend table report contains the following e Space for adding e Information about Time date Event Elec 1 Elec 2 Elec 3 Elec 4 Elec 5 Elec 6 10 38 00 07 08 2005 65 15 13 13 14 25 10 39 00 07 08 2005 63 66 16 13 14 14 24 10 40 00 07 08 2005 67 15 14 13 15 25 10 40 19 07 08 2005 125 29 22 16 35 53 10 41 00 07 08 2005 66 147 34 25 15 40 65 10 42 00 07 08 2005 93 26 16 2B 32 42 10 42 23 07 08 2005 65 2 2B 7 8 22 10 43 00 07 08 2005 65 18 11 10 14 25 10 44 00 07 08 2005 64 17 10 12 13 24 10 45 00 07 08 2005 69 64 17 10 12 13 24 10 46 00 07 08 2005 64 17 10 12 13 24 10 47 00 07 08 2005 64 17 10 12 2B 24 10 48 00 07 08 2005 64 17 10 12 13 24 10 49 00 07 08 2005 64 17 10 12 13 24 10 50 00 07 08 2005
103. verVie Wanna n E E E Sa Ly I i Ry OE 7 1 Themo ene a EE E T AE AE T O 7 2 8 Specifications and ordering information sessesssecssocesocesocesocesocssoossoossoossosee S L OVET VIEW issisissssees de enean nne aee aae a arae K aren a ree 8 1 Specification Si heina a a a a a a a a e a aae 8 2 A CESSOriE Sarasi ekanna an a e a reei 8 12 9 Functional description sesssessscsssecsocesocesccssccesecesecssccesccssocesocssocssocssoosssossssse J L Index OVETVI W ioari i i T E ATE VE NNE ATA E be tevaueevees 9 1 The tepO Sens OF iis or E e aa delete A E EES 9 2 Meas rement oiee n r E E E AERA EA AARE A RE TEE 9 3 Calibration ii enna Ea EAA EE EAA EAE ARE A 9 4 Solutions and calibration gaS eriei eai e aae ean EEE EEE a a ETAN Ea ERA 9 6 Traceability ceri neateina e EEE AA EE aE A A A E A 9 7 Date of issue 1 Introduction Overview Introduction This chapter describes the intended use of the TCM400 system It also contains the definitions of warnings cautions and notices In this chapter This chapter covers the following topics Name intended use and limitations cecceecceeseeseeeneeeseeesseeeecnsecesecneeeseees 1 2 Symbols used in the manual ccccecccescesscsseceeeeeeeeeeseesseceseceseesseeeeeeeeeeeeneennes 1 3 1 Introduction TCM400 operator s manual Name intended use and limitations Proprietary TCM400 Transcutaneous pO Monitoring System name Common name Multichannel tcpO monitor or TCM
104. ws last part of the Step Action sensor cable ao O A TRNrxXxxXY XYN z_ SxrYvxr ryvdydyr3oij jqq N 1 Use a soft cloth or tissue moistened with one of the recommended disinfection solutions to wipe the cable 2 Use clean tissues moistened with water to remove any remaining disinfectant from the cable 3 Use clean tissues to remove any remaining moisture Storing the If the sensor needs to be stored for less than one week it may be stored in the sensor calibration chamber However for storage periods longer than 1 week the sensor should be kept covered by its protective cap after placing 2 drops of electrolyte solution in it 4 14 Overview Introduction In this chapter 5 Calibration This chapter describes the calibration of the tcpO sensor s with atmospheric air The sensor zero current check is also described This chapter covers the following topics OVERVIEW AOE E oR AE EAEE a Oe a ea Tea Aas OS eae tena eee ade Tan done E EESE 5 1 General informati n oei seid ccc caces eh enscndecede a a a a bec ecssustevuctab ois eaten Ovvelenees 5 2 Calibration with atmospheric aif ccecccccseesseesseesceescecssecssecesecesecnseeseeeeeesereeneeeses 5 3 Checking the sensor Zero current c cecccecsceesseesceesceeseeesaecteceseceseceseeeseeeeeeeeeeeeneeses 5 7 5 Calibration TCM400 operator s manual General information Calibration To calibrate the tcpO2 sensor use atmospheric air room air materials C
105. zardous waste Dispose of the battery according to local procedures to avoid personal injury or pollution of the environment To install the battery follow the steps below Step Action 1 Using a 2 mm hex or Allen key remove the two screws from the battery cover at the rear of the monitor Remove the cover Clip the connector cable to the battery Slide the battery onto the battery shelf in the monitor GU ee Reattach the battery cover The monitor can function for approximately one hour on battery power alone The battery power level can be read from the battery level indicator on the monitor screen for more details see Headline field in The screen general elements in Chapter 2 What is what The battery level indicator on the screen starts blinking when the battery level is getting low If the monitor continues to be run on battery power alone the battery level will continue to fall and the monitor will sound an alarm and display an alert message about connecting the monitor to a mains power supply as soon as possible see Chapter 7 Troubleshooting If the monitor continues to be run on battery power alone the monitor will automatically switch off before the battery power reaches a critically low level This not only prevents loss of any measurement data it also prevents the battery being damaged by being completely discharged CAUTION Risk of patient not being monitored Make sure the battery level never becomes cr

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