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TOSCA 500 Operating Manual

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1. h SEN oR AN CAPY 8 es 100 120 VAC TO2AL cil love 5 TO1AL 5060Hz20VA Hz 20 VA MONITO INPUT MONITEUR ENTREE MARCHE EA Q A DANGER Possible bzard if used POWER in the presente of flammable anaesthetics SECTEUR Degree of protection against ingress to solids and water by the enclosure CAUTION FEDERAL LAW USA RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Handle of the monitor 2 Connector for printer interface see section 15 External Connections only with same type and rating of fuse WARNING Risk of fire Replace 3 Sensor input socket 4 Type BF applied part defibrillator proof Attention Physiological effects sensor connection Note that the sensor has a heated surface Operate strictly in accordance with section 3 2 of this manual 4 Connector for system interface including RS 423 analog output for monitored parameter and nurse call relay see section 15 External Connections AC power compartment containing line cord plug fuses and voltage selector Attention Read the instructions before using the connector adjacent to this symbol 6 Container with screw connector for Radiometer Basel CAL Gas cylinder Protective bar 8 Monitor On Off switch On 6 Off 24 TOSCA 500 DESCRIPTION OF THE MONITOR 9 Connector for external 12 24 V battery see section 15 9 10 Connect
2. hypothermia during surgery use of vasoactive drugs The Perfusion Index PI value may be used to qualify the above listed situations Reference Use of a peripheral perfusion index derived from the pulse oximetry signal as a non invasive indicator of perfusion Critical Care Medicine 2002 Vol 30 No 6 1210 1213 skin anomalies skin edema It should be regarded that transient skin edema at the ear lobe may occur during the early recovery phase after anesthesia or when a patient is in the Trendelenburg position 20 TOSCA 500 CLINICAL APPLICATION 3 3 2 SpO measurement Like the transcutaneous technique pulse oximetry relies on the existence of intact transport mechanisms of arterial blood to the measurement site Whenever such transport is impaired to the extent that a sufficiently large pulse signal cannot be detected SpO2 monitoring is no longer feasible Such a condition may occur in cases of circulatory centralization shock peripheral vasoconstriction venous congestion or generally at low local tissue perfusion Furthermore the pulse oximetric measurement may not be valid under the following conditions excessive ambient light severe electrical interference excessive patient movement such as shivering significant levels of dysfunctional hemoglobin e g COHb and metHb presence of intravascular dyes skin pigmentation very low hemoglobin levels venous puls
3. OFF no feedback tone when any key is pressed Selection ON OFF Default ON HEATING POWER DISPLAY The heating power display mode can be turned on or off ON enabled OFF disabled ON the HEATING POWER display mode and the heating power TREND PWR mode are activated OFF these two modes are not available Selection ON OFF Default OFF disabled COMMUNICATION Selection of the communication protocol for the serial interface of the Systems Connector Selection EASYLINK VUELINK MONLINK Default EASYLINK For detailed description see Section 15 59 SYSTEM PARAMETERS MESSAGES TOSCA 500 TEACHING MODE 1 HOUR selection of the teaching mode ON During parameter setting the selected display mode remains for up to one hour The alarm functions of the monitor are turned off but they are activated when no key is pressed for 15 seconds This function can be used e g during a demonstration of the system or for training purposes OFF The display returns automatically to the last chosen display mode when the parameter setting is completed and no key is pressed for 15 seconds Selection ON OFF Default OFF MAIN X XX DBG X XX Display of the installed software revision levels MS11 DSPXXXX MCUXXXX ENGLISH Selection of the display language selection ENGLISH DEUTSCH FRANCAIS ITALIANO ESPANOL SWEDISH Default ENGLISH RETURN TO To return to the main menu MAIN MENU 7 2 6 U
4. The TOSCA 500 system is intended for use in the electromagnetic environment specified below The customer or the user of the TOSCA 500 system should assure that it is used in such an environment Immunity test IEC 60601 Compliance level Electromagnetic test level environment guidance Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 1 1 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Note 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ut gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ut 30 dip in Ur for 25 cycles lt 5 Ut gt 95 dip in Ur for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ut gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ut 30 dip in Ur for 25 cycles lt 5 Ut gt 95 dip in Ur for 5 sec Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospita
5. use before date as it will result in incorrect measurement CAUTIONS Certain types of mobile telecommunication equipment could potentially interfere with equipment operation Mobile telecommunication equipment should not be used within five meters of the monitoring equipment This unit needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the section 13 of this document The equipment can be used during defibrillation but the readings may be inaccurate during defibrillation but will rapidly recover When this equipment ts used with a defibrillator the user must precisely follow the instructions given in the defibrillator operating manual To ensure protection of patient operator and equipment from the effects of defibrillation and diathermy electro surgery cables manufactured by Radiometer Basel must be used SAFETY INFORMATION TOSCA 500 The equipment is protected against electrostatic discharge The tcPCO display may be temporarily affected during discharge to chassis ground but will rapidly recover For use during electro surgery the monitor sensor and their cables must be physically separated from the electrosurgical equipment The sensor must not be placed in the electrical pathway between cutting and counter electrode Electro surgery will produce at most a minimal transient disturbance in the reading and will not affect the system c
6. Electrical shock hazard The monitor must be switched off and disconnected from the AC mains power supply before cleaning it The plugs and connectors must be kept meticulously clean and dry No liquid should enter the equipment CAUTION Follow the instructions given above to clean the monitor and sensor Do not use any abrasive agent or any chemical that is not recommended in this manual 19 MAINTENANCE TOSCA 500 10 2 Check of monitor and sensor functions System check The operator may perform the following check of some important monitor functions Press both and when no parameter setting is in progress Verify that the alarm tone sounds with the selected loudness level the alarm suspended indicator lamp EX is lit all segments of the LED displays are lit all dots of the middle LCD display are visible Alarm check During patient monitoring the alarm functions may be tested by setting the alarm limits so that the current parameter reading is outside the alarm limit range Barometric pressure check When the barometric pressure is set to AUTO the indicated value may be checked against the local reference barometric pressure Select the menu PCO2 PARAMETERS Move to AUTO BAROMETRIC PRESSURE and compare the indicated value with the reference barometric pressure The acceptable deviation is 20 mmHg 27 hPa Safety check At normal use of the monitor there is no internal adj
7. Power failure alarm If the energy supplying the monitor is no longer sufficient to guarantee safe functioning i e internal battery almost empty the power is automatically switched off and an independent alarm tone sounds for at least two minutes 8 2 Alarm messages Note In the alarm messages PCO2 stays for tcPCOo 8 2 1 Physiological alarm messages high priority PCO2 TOO HIGH ALARM LIMIT xxx mmHg The tcPCQOz2 value is equal to or higher than the defined maximum alarm limit PCO2 TOO LOW ALARM LIMIT xxx mmHg The tcPCOz2 value is equal to or lower than the defined minimum alarm limit SP02 TOO HIGH ALARM LIMIT XX The SpOz value is equal to or higher than the defined maximum alarm limit SP02 TOO LOW ALARM LIMIT XX The SpOz value is equal to or lower than the defined minimum alarm limit PULSE RATE TOO HIGH ALARM LIMIT xxx BPM The pulse rate PR value is equal to or higher than the defined maximum alarm limit PULSE RATE TOO LOW ALARM LIMIT xxx BPM The pulse rate PR value is equal to or lower than the defined minimum alarm limit 69 ALARMS AND MESSAGES TOSCA 500 8 2 2 Technical alarm messages medium priority MONITOR FAULT NUMBER XX Switch the monitor off and on again to try to reset this message If the message disappears and the monitor can be restarted check all parameter settings and readjust if required A faulty function of the monitor is
8. SYSTEM PARAMETERS MESSAGES PRINT MODE IS SELECTED TREND TIME RETURN TO MAIN MENU 7 2 8 PRINTING STARTED PRESS 2 SEC TO STOP PRINTING PRINTING STOPPED PRESS 2 SEC TO START PRINTING STOP PRINTING FIRST TO CHANGE ANY PRINTER SETTINGS PRESS 2 SEC TO STOP CURRENT PRINTING FIRST NO PRINTING IN PROGRESS PRINTER FAULT Print messages Display of the print mode Appears only if the trace to be printed is SELECTED TREND To return to the main menu Appears when printer is started with selected parameter s and print mode Printing can be stopped by pressing for two seconds Appears when printing is stopped The printer can be restarted by pressing for two seconds Appears when printing is in progress and the parameter PRINT MODE or SELECTED TREND is selected to change the print settings Press to return to the status display mode and press _ for two seconds to stop printing Appears when printing is in progress and when is pressed for two seconds Press for two seconds to stop current printing before a parameter can be changed Appears when _ is pressed for two seconds and the printer is not operating Appears when the printer is started but the printer is off line no paper is available or no printer is connected Turn printer on insert a new paper roll or press _ for two seconds stop printing 63 SYSTEM PARAMETERS MESSAGES TOSC
9. 12 hours Interferences by anesthetic gases in vitro 15 N20 negligible 2 Halothane negligible 2 Enflurane negligible 2 Isoflurane negligible SpO Measurement range 0 100 Resolution 1 Accuracy saturation range 70 100 3 digits The SpOz accuracy is expressed as plus or minus 3 digits oxygen saturation percentage points between saturation of 70 and 100 This variation equals plus or minus one standard deviation 1SD which encompasses 68 of the population The accuracy specification is based on tests performed with the TOSCA 500 monitor compared with arterial 83 SPECIFICATIONS TOSCA 500 blood sample and the reference is measured with a CO oximeter on healthy adult volunteers in induced hypoxia studies across the specified range 1 Since pulse oximeter measurements are statistically distributed it can be expected that only about two thirds of the measurements fall within the specified accuracy compared to CO oximeter measurements 2 If there is independent demonstration that a particular calibration curve is accurate for the combination of a pulse oximeter monitor and a pulse oximeter probe then a functional tester can measure the contribution of a monitor to the total error of a monitor probe system The functional tester can then measure how accurate a particular pulse oximeter monitor is reproducing that calibration curve Pulse Rate Measurement range 25 240 bpm Resol
10. CONTACT A PERSON AUTHORIZED TO RESTORE THE FACTORY SETTINGS RETURN TO To return to the main menu MAIN MENU 61 SYSTEM PARAMETERS MESSAGES TOSCA 500 7 2 1 Print settings These settings apply when a printer with an IBM proprinter emulation mode is connected see section 5 7 START PRINTING Press for two seconds to start printing The message PRINTING STARTED PRESS 2 SEC TO STOP PRINTING is displayed to confirm the action STOP PRINTING Press for two seconds to stop printing The message PRINTING STOPPED PRESS 2 SEC TO RESTART PRINTING is displayed to confirm the action PARAMETER TO PRINT selection of the trace to be printed Options PCO2 amp SPO2 PR amp SPO2 PULSE SIGNAL SELECTED TREND The SpOz and pulse rate parameters are not available when SPO2 PR is disabled PRINT MODE Selection of the print mode Appears only if the selected trace is PCO2 PCO2 amp SPO2 or PR amp SPO2 Options ONLINE FAST ONLINE SLOW SELECTED TREND TIME with the time windows LAST 1H LAST 12H LAST 24H or LAST 72H Default LAST 24H Print resolution ONLINE FAST 20 dots min 34 cm hour ONLINE SLOW 2 dots min 3 4 cm hour LAST 1H 20 dots min 34 cm hour LAST 12H 24H 72H 2 dots min 3 4 cm hour SELECTED TREND TIME max 500 dots 14 cm PRINT MODE IS Display of the print mode Appears only if the trace to be LAST 12 S printed is PULSE SIGNAL 62 TOSCA 500
11. PCOz2 is measured by determining the pH of an electrolyte solution A change in pH is proportional to the logarithm of the PCO2 change The pH is determined by measuring the potential between a miniature glass pH electrode and an Ag AgCl reference electrode The electrolyte is provided within a thin hydrophilic spacer which is placed over the sensor surface and is coupled to the skin via a highly gas permeable hydrophobic membrane The membrane is protected with a thin golden plate to eliminate any mechanical damage The sensor is calibrated in a gas of a known CO gt 2 concentration The slope change of potential with PCOz is preset in the sensor memory The electrical power needed to heat the sensor to a constant temperature depends to a small fraction on the local tissue perfusion At constant ambient temperature deviations of the heating power from a stored reference value relative heating power may indicate changes in perfusion PCO Temperature corrections In general a high correlation between transcutaneous PCO tcPCOz and arterial PCO2 PaCOz is found in patients of all ages However due to the elevated temperature of the sensor the transcutaneous PCO is higher than the arterial value It has therefore become a common practice to apply a correction to the transcutaneous value to provide a monitor readout which corresponds as close as possible to arterial PCOz The shift of tcPCOz2 towards higher values is attributed to two ma
12. 50 C 10 to 50 C 10 to 95 wT aH Kan O O oe O O L co O oe O N 09 10 to 30 C 85 COMPATIBILITY DECLARATION TOSCA 500 13 COMPATIBILITY DECLARATION WARNING The use of accessories sensors and cables other than those specified with the exception of sensors and cables sold by the manufacturer of the TOSCA 500 system as replacement parts may result in increased emissions or decreased immunity of the TOSCA 500 system 13 1 Electromagnetic emissions The TOSCA 500 system is intended for use in the electromagnetic environment specified below The customer or the user of the TOSCA 500 system should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions The TOSCA 500 system uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The TOSCA 500 system is suitable for use in all CISPR 11 establishments including domestic establishments and those directly connected to the public low voltage Harmonic emissions Class A power supply network that supplies buildings used for domestic purposes IEC 61000 3 2 Voltage fluctuations Complies Flicker emissions IEC 61000 3 3 86 TOSCA 500 COMPATIBILITY DECLARATION 13 2 Electromagnetic immunity
13. TOSCA Sensor Electrolyte 10 ml 560 1300 Attachment Clips including 40 Attachment Clips 1 Contact Gel 10 ml 560 1500 TOSCA Fixation Rings 32 mm including 1 Dispenser of 60 TOSCA Fixation Rings 1 Contact Gel 10 ml WARNING The use of accessories sensors and cables other than those specified above with the exception of parts sold by the manufacturer of the TOSCA 500 system as replacement parts for internal components may result in increased emissions or decreased immunity of the TOSCA 500 system 91 EXTERNAL CONNECTIONS TOSCA 500 15 EXTERNAL CONNECTIONS 15 1 Overview Patient data can be obtained mainly through the serial interface and analog outputs of the Systems Connector on the back of the TOSCA 500 monitor by connecting it to a Personal Computer PC or a Component Multiparameter System CMS When connecting the TOSCA 500 monitor to a PC or CMS verify proper operation before clinical use Both the TOSCA 500 monitor and the PC or CMS must be connected to a grounded AC outlet The communication protocol setting must be set as described in the section System Parameter Configuration paragraph Communication Protocol of the TOSCA 500 Operating Manual Any PC or non medical device connected to the Systems Connector must be certified according to IEC EN 60950 Standard All combinations of equipment must be in compliance with IEC EN 60601 1 1 Standard systems requirements Anyone who
14. and the speed timing and behavior of each The stability of the readings over time is affected by the averaging mode being used The longer the averaging time the more stable the readings tend to be become This is due to a dampened response as the signal is averaged over a longer period of time than shorter average times However longer average times delay the response of the oximeter and reduce the measured variations of SpO2 and PR Pulse rate values The pulse rate display on TOSCA 500 may differ slightly from the heart rate displayed on the ECG monitor due to the differences in averaging times There may also be a discrepancy between cardiac electrical activity and peripheral arterial pulsation Significant differences may indicate a problem with the signal quality due to physiological changes in the patient or one of the instruments or application of the sensor The pulsation from intra aortic balloon Support can be additive to the pulse rate displayed on TOSCA 500 18 TOSCA 500 CLINICAL APPLICATION Signal IQ The Signal IQ is a Signal Identification and Quality indicator and a special feature of the Masimo SET technology and displayed on the plethysmogram display of the TOSCA 500 The signal IQ is a visual indicator of the plethysmogram signal quality and an alert when the displayed SpO value is not based on adequate signal quality The signal IQ can be used to identify the occurrence of a patient s pulse and the associated signa
15. connects a PC or a CMS to the TOSCA 500 Systems Connector configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of system standard IEC EN 60601 1 1 and the electromagnetic compatibility system standard IEC EN 60601 1 2 15 2 Connecting to the Systems Connector The TOSCA 500 Systems Connector may be connected to the PC or CMS by using a cable terminated with a shielded DB 37 connector The cable should be no more than 3 meters in length The cable used must have a braided shield providing 100 coverage The shield must have a 360 degree connection to the metal shell on the DB 37 connector and to the connector on the PC or CMS Do not create sharp bends in the cable as this may tear or break the shielding See section 15 4 EasyLink section 15 5 VueLink and section 15 6 Monlink for details 92 TOSCA 500 EXTERNAL CONNECTIONS 15 2 1 Systems Connector pinouts lt D In Reserved NOT CONNECT Oog utput RS423 O lt ut RS423 22 GND ut RS423 23 GND utput RS423 NO N Q DlalSlQlDlalV aloOlalAlal Alald alazala Z 2 2Z2 S 2 9 2 8 Z a Z J Z X Z X Z 2 a U E 0 552 O ZSS 7 7 yu lt S o D D D o S Q tel a Q O 5 0 5 5 5 D N 3 O O N lt 3 D 2 j Jel jal e lt O o 5 Ol IS e 2 J 2 O a lt A O D Z D utput 5 V ON 0 V OFF GND NOT CONNECT utput 10 to 26 V max 20
16. from the ear lobe and that the patient does not lie on the sensor Monitoring start Press to start monitoring and site time clock The message MONITORING STARTED PCO2 ALARM SUSPENDED UNTIL ARTERIALIZATION IS COMPLETED appears alternating with the selected display mode If the key is not pressed within five minutes monitoring is started automatically The SpOz2 and PR values are displayed immediately after the application The SpO2 and PR alarms are activated when the monitoring is started 36 TOSCA 500 OPERATION Arterialization During the first five minutes after the start of monitoring the PCOz2 alarm detection is suspended to allow sufficient time for arterialization Thereafter the alarm is automatically activated The display mode can be changed at any time by pressing HOME see section 6 1 Pulse tone During monitoring a short tone sounds synchronous with the pulse if a pulse rate value is available for setting loudness level see section 7 2 4 The frequency of the tone changes with the SpOz2 value A high frequency represents a high SpOz2 value e g 900Hz 100 and a decreased frequency indicates a low SpOz e g 5 0Hz 70 The tone is suppressed while any parameter is changed CAUTION To ensure accuracy check for adequate signal strength and repeatable pulse waves on the bar graph display Inaccurate measurement may be caused by incorrect sensor application or use significant levels
17. laboratories that deal with patients who have highly infectious disease Disease can enter by the following routes Through broken skin Needle or other sharp object Contamination of cuts abrasions or burns Ingestion placing a contaminated object in or near the mouth e g pen finger Direct contact with mucous membranes e g eyes Inhalation of contaminated dust or aerosols Experience has proven that when proper precautions are taken the risk of infection is very small and certainly of a lower order of magnitude than other risks that are taken routinely in daily life 11 4 DO s and DON Ts When working in a contaminated area observe the following rules DO avoid any contact with sharp edged objects DO wear a laboratory coat apron and gloves DO disinfect tools after use DO wash your hands thoroughly before leaving the contaminated area DO dispose of gloves and aprons immediately after use or if damaged DO treat any cut or abrasion immediately DO keep cuts and abrasions covered with a waterproof dressing DO encourage any cut to bleed and then wash it under running water DON T put hands near mouth eyes ears or nose DON T eat drink or smoke in any contaminated area DON T blow surfaces to remove dust use a vacuum cleaner 11 5 Equipment requiring service When equipment or accessories are to be returned to the supplier or factory for s
18. or suspended the remote alarm is deactivated Remote alarm The alarm signals available at the nurse call and serial communication interface are activated during an alarm condition which is not muted or suspended with a delay of max 0 3 seconds Automatic suspension of alarms The auditory and or visual alarm signals are automatically suspended in situations in which a particular alarm is not relevant Those alarms which are automatically suspended are listed below along with the related situations 1 All high priority auditory and visual alarm The sensor is in the calibration chamber signals The sensor has been taken out of the 2 Medium priority auditory and visual alarm calibration chamber but monitoring has signals related to SpOz e g TOO MUCH not yet been started e g during sensor AMBIENT LIGHT application When the key is pressed the alarms are automatically activated except for tcPCO2 see below High priority visual and auditory alarm During the first five minutes after the start of signals related to tcPCO gt 2 monitoring to allow sufficient time for arterialization Thereafter the alarms are activated automatically All visual alarm signals except flashing of The home key has been pressed during the parameter display past 15 seconds All visual and auditory alarm signals except During adjustment setting of any parameter flashing of parameter display 68 TOSCA 500 ALARMS AND MESSAGES
19. period is elapsed Remove the sensor from the patient place it into the calibration storage chamber and reapply the sensor at the other ear if required PLACE SENSOR IN CALIBRATION CHAMBER The sensor has been exposed to air for more than three minutes Place sensor into the calibration storage chamber or reapply it to the patient if it was detached CALIBRATE SENSOR The sensor needs to be calibrated Place sensor into the calibration storage chamber REMEMBRANE SENSOR The date of the last sensor preparation is older than 14 days or the sensor characteristics are out of specifications Remembrane sensor as described in section 5 4 NO GAS FLOW The installed CAL Gas bottle is empty or no gas bottle is RENEW GAS BOTTLE installed Install a new bottle 8 3 Monitoring messages PRESS START KEY TO START MONITORING The sensor has been removed from the calibration storage chamber and applied to the patient Press to start monitoring and site time clock The alarm functions for tcPCO2 SpO2 and PR are alternating with suspended until monitoring is started PCO02 SP02 PR ALARMS ARE SUSPENDED These two messages appear periodically alternating with UNTIL MONITORING IS the selected display mode until monitoring is started STARTED Note Monitoring is automatically started after five minutes if the key has not been pressed by the operator T1 ALARMS AND MESSAGES TOSCA 500 MONITORING START
20. place Open the cover remove sensor and discard preparator 31 OPERATION _ SENSOR REMEMBRANED 7 YES NO SETTING MENU pow UP HOME TOSCA 500 Clean excess electrolyte from the side of the sensor Press to confirm the new sensor remembraning The date is stored in the sensor memory Lift up the lever of the calibration chamber and insert the sensor with its surface pointing downwards as far as it will go Release the lever The message CALIBRATING SENSOR 38 mmHg CAL Gas appears When the calibration is completed the message READY TO USE with date and time appears The sensor is now ready to be applied to a patient 5 5 Sensor application The Clinical Application in section 3 should be carefully read before starting monitoring The recommendations on sensor temperature and application time is given in section 3 2 2 The sensor is applied to the ear lobe by using the Attachment Clip Ref 5601300 see section 5 5 1 or to alternative measuring sites using the TOSCA Fixation Rings Ref 560 1500 refer to section 5 5 2 32 TOSCA 500 OPERATION 5 5 1 Application at the ear lobe with the Attachment Clip Clean the ear lobe with an alcohol swab amp Alcohol aper Take a TOSCA Attachment Clip out of the package open the P M clip jaws and remove the white cover LS U 4 Attach the clip with the retainer ring pointing outwards to the fleshy part
21. second While the sensor is in the calibration storage chamber this display is switched off as long as no key is pressed Line connected indicator lamp 22 TOSCA 500 DESCRIPTION OF THE MONITOR 5 Monitor ON indicator lamp ON OFF switch on rear panel LED display indicating the pulse rate PR in beats per minute bpm between 25 and 250 bpm or if no value is available or if SPO2 PR is disabled see section 7 2 4 The value is updated once per second The LED bar graph display 10 segments indicating the pulse waveform For a Perfusion Index PI value of less than 1 the amplitude of the bar graph is proportional to this value the Perfusion Index value is defined in section 3 2 3 For example an amplitude of 7 segments represents a PI value of 0 7 At values above 1 the waveform is displayed over the full range of the bar graph and is therefore not proportional to the Perfusion Index This display is switched off when the sensor is in the calibration storage chamber 7 Keys to enter the parameter setting menu and to select the adjustable parameters Key to return to the last chosen display mode during a parameter setting procedure or to select one of the display modes Status Trend Plethysmogram and Heating power during monitoring By pressing this key for one second one may return directly to the last chosen display mode during a parameter setting procedure or to the message displa
22. temperature of 42 C which has been found to be tolerated by the skin for up to twelve hours When higher sensor temperature is used the exposure time should be shorter see specification section 12 2 Note The sensitivity of the skin to heat may not only be different from patient to patient but may also vary in an individual patient In particular any clinical situation resulting in reduced skin blood flow will increase the sensitivity to heat and the risk of skin burn Also excessive mechanical pressure against the sensor will provoke such a condition tcPCO in anesthesia There is no measurable interferences in nitrous oxide halothane isoflurane and enflurane with the transcutaneous PCO2 measurement see section 12 3 3 2 3 SpO measurement At high saturation the oxyhemoglobin dissociation curve becomes almost flat so that small changes in the measured SpOz represent large changes in PO2 Pulse oximetry is therefore of limited use to quantify the degree of hyperoxemia The shape of the oxyhemoglobin dissociation curve can differ from patient to patient Therefore the SpOz2 alarm limits should be selected specifically for each patient after comparing SpO gt 2 readings with arterial PO2 data obtained by laboratory analysis The stability of the SpO2 readings may be a good indicator of signal validity Although stability is a relative term experience will provide a good feeling for changes that are artifactual or physiological
23. the sensor with its surface pointing downwards as far as it will go Release the lever The message CALIBRATING SENSOR 38 mmHg CAL Gas When the calibration is completed the message READY TO USE with date and time appears The sensor is now ready to be applied to a patient 40 TOSCA 500 OPERATION 5 7 3 Removal of the sensor from the TOSCA Fixation Ring Hold the outer part of the adhesive ring while removing the sensor head from the ring The TOSCA Fixation Ring may remain on the skin and a second Fixation Ring may be attached in order to alternate the sensor application site Clean sensor surface carefully with an alcohol swab Lift up the lever of the calibration chamber and insert the sensor with its surface pointing downwards as far as it will go Release the lever The message CALIBRATING SENSOR 38 mmHg CAL Gas o B 100 When the calibration is completed the message READY TO USE with date and time appears The sensor is now ready to be applied to a patient 5 8 Operation with a printer The TOSCA 500 monitor is equipped with a parallel interface to connect a printer with an IBM proprinter emulation mode 41 OPERATION TOSCA 500 Note The monitor incorporates insulation to protect the patient against accidental exposure to high voltage from the printer However most printer types with IBM proprinter emulation are not designed for medical applications Therefore local regulati
24. to the other An application site time of 8 hours at a sensor temperature of 42 C is recommended The clip may remain on the ear lobe and re used for a further sensor application However it is recommended to remove and discard the clip every 24 hours so that the ear lobe is free of the adhesive for one monitoring period e g 8 hours proceed as described in section 5 7 1 Short term monitoring or spot check When the patient monitoring is completed and the sensor should be removed with the clip proceed as described in section 5 7 2 5 7 1 Removal of the sensor from the clip Grip the sensor at the cable neck and detach it from the clip while retaining the clip with a finger Clean the sensor surface carefully with an alcohol swab Lift up the lever of the calibration chamber and insert the sensor with its surface pointing downwards as far as it will go Release the lever The message CALIBRATING SENSOR 38 mmHg CAL Gas o i 100 When the calibration is completed the message 39 OPERATION TOSCA 500 with date and time appears The sensor is now ready to be applied to a patient Apply the sensor to the other ear lobe as described in section 5 5 Sensor application 5 7 2 Removal of the sensor and the clip from the ear Open the sensor clip and remove it from the ear lobe by turning it sidewise Clean sensor surface carefully with an alcohol swab Lift up the lever of the calibration chamber and insert
25. 0 mA Reserved NOT CONNECT cPCO2 analog output tput O 5 V 0 125 mmHg or 0 25 kPa pO2 analog output tput 0 5 V 0 100 olololololgolololololololololol5l ols lt lt S lt jO lt lt O lt lt lt S lt d OUO Z Z U U C O ulse Rate analog output utput 0 5 V 0 250 BPM UIO w lt O ulse wave analog output utput 0 5 V auto scaled N O Z O 0 0 7 O J served NOT CONNECT O NOT CONNECT O NOT CONNECT O NOT CONNECT served served eserved ot Connected ot Connected ot Connected urse Call relay common urse Call relay normally closed urse Call relay normally open O Q olg g ogo lt O lt mmon pin max 0 5 A 30 VDC 50 VAC horted to Common if NOT calling horted to Common if calling OO N Z U N con IN OO NO Co N O Ql P OO N O OO OO Q9 OO OO OO OO N N N N N N N O Ql gt OO NO O Co N O Ql r Z O CO Oo EXTERNAL CONNECTIONS TOSCA 500 15 3 Communication protocol Through the menu Configuration Communication see section 7 2 5 the following communication protocols are available on the serial interface EASYLINK Unconditionally real time data transmission Memory dump download functions can be request from the host device PC or CMS see section 15 4 for details VUELINK Compatible with the Philips VueLink Open Interface see section 15 5 for details MONLINK Transmis
26. 3 1999 IEC 60601 2 49 2001 ISO 9919 2005 IEC 60601 3 1 1996 CSA C22 2 No 601 1 M90 and UL 60601 1 2003 This equipment is fully in conformance with the requirements of the Council Directive 93 42 EEC of June 14 1993 concerning Medical Devices Masimo patents of the integrated Masimo SET technology This device is covered under one or more of the following U S A patents 5 758 644 5 823 950 6 011 986 6 157 850 6 263 222 6 501 975 and other applicable patents listed at www masimo com patents htm TOSCA 500 No implied license Purchase or possession of this device does not convey any express or implied license to use the device with replacement parts which would alone or in combination with this device fall within the scope of one or more of the patents relating to this device TOSCA is a registered trademark of Radiometer Medical ApS Denmark Masimo SET is a federally registered trademark of Masimo Corporation Signal IQ APOD and FastSat are trademarks of Masimo Corporation All rights reserved The information contained in this publication may not be used for any purpose other than that for which it was originally supplied The publication may not be reproduced in part or in whole without the written consent of Radiometer Basel AG In order to maintain and improve standards of manufacturing methods of functioning and to increase reliability Radiometer Basel equipments are periodically reviewed For this rea
27. 8 TOSCA 500 COMPATIBILITY DECLARATION 13 4 Recommended separation distances The TOSCA 500 system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the TOSCA 500 system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the TOSCA 500 system as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance according to frequency of transmitter power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz ue d 2 3 VP m a a er anes a iokedbiat 1 2 m 3 94 ft 1 2 m 3 94 ft 2 3 m 7 55 ft as 7 i246 3 8m 1246 7 3 m 23 95 ft 12 m 39 36 12m 39 36 23 m 75 46 ft For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m 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 watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 89 COMPATIBILITY DECLA
28. A 500 7 3 Default parameter settings Note In the settings PCO2 stays for tcPCOz2 The TOSCA 500 monitor is provided with default factory parameter settings These settings can be restored if required in the submenu USER SETTINGS as described in section 7 2 6 ALARM LOUDNESS LEVEL 3 PCO2 MAXIMUM 50 mmHg 6 6 kPa PCO2 MINIMUM 25 mmHg 3 3 kPa SPO2 MAXIMUM SPO2 MINIMUM 85 PRMAXIMUM 150 BPM PRMINIMUM 50 BPM AUDITORY ALARM MODE suspension 2 min SENSOR TEMPERATURE 42 C SITE TIME 4H00 MANUAL BAROMETRIC PRESSURE 750 mmHg 1000 hPa if selected PCO2 TEMP CORRECTION FACTOR AUTO PCO2 METABOLIC CONSTANT 5 mmHg 0 7 kPa IN VIVO PCO2 CORRECTION OFF IN VIVO AUTOMATIC RESET ON BAROMETRIC PRESSURE AUTO PCO2 UNIT mmHg SPO2 PR ON PULSE AVERAGING TIME 8s SENSITIVITY NORMAL FASTSAT OFF AUDIO PULSE LOUDNESS LEVEL 3 DATE 01 01 2001 TIME 12 00 DISPLAY CONTRAST 10 DISPLAY BACKLIGHT ON KEY FEEDBACK TONE ON HEATING POWER DISPLAY OFF COMMUNICATION EASYLINK TEACHING MODE OFF LANGUAGE English PARAMETER TO PRINT PCO2 amp SPO2 PRINT MODE last 24H 64 TOSCA 500 ALARMS AND MESSAGES 8 ALARMS AND MESSAGES 8 1 Description of the alarm functions The TOSCA 500 monitor is equipped with an alarm system which corresponds to in
29. BPM OO HPWR gt 5N 0 1000mW 5 REFHPWR 500mW 102 TOSCA 500 EXTERNAL CONNECTIONS 15 6 3 Legend of codes Carriage Return code 0x0D Line Feed code 0x0A Space code 0x20 00 Request message ok 01 Request code not recognized 02 Invalid specifier in request message 03 Request message corrupt configuration code number of monitor between 00 and 99 PO PCO2 P02 EO PCO2is waveform 2 PCO2 is waveform 2 SPO2 is waveform 3 PR is waveform 4 HPWR is waveform 5 some parameter is in alarm high priority alarm parameter in alarm and silenced auditory alarms have been switched off inhibited auditory alarms have been suspended W normal operation Standby and Calibration Fault medium and low priority alarm Normal Direct real time data pean g eRe PCO2 measurement value in mmHg or kPa PCO2 50 100 mmHg kPa PCO2 low and high alarm limits 0 1000mW 5 analog output range 0 to 1000 mW 0 to 5V End of message 103 EXTERNAL CONNECTIONS TOSCA 500 15 7 Analog outputs PCO analog output on pin 10 0 to 5 V 0 to 125 mmHg 40mV mmHg or 0 to 25 kPa 20 mV 0 1 kPa SPO analog output on pin 11 0 to 5 V 0 to 100 50 mV SPO2 Pulse Rate analog output on pin 12 0 to 5 V 0 to 250 BPM 20 mV BPM Pulse Wave analog output on pin 13 0 to 5 V auto scaled 15 7 1 Calibration of an analog recording system The analog output signals can be used for th
30. ED PCO2 ALARM SUSPENDED UNTIL ARTERIALIZATION The tcPCQOz2 alarm detection is disabled for five minutes after monitoring has been started The alarm detection is automatically activated after that time This message IS COMPLETED SITE TIME REMAINING xx MIN SEARCHING PULSE SIGNAL ALARMS MUTED AUDITORY ALARMS SUSPENDED FOR 2 MINUTES READY TO USE with date and time CALIBRATING SENSOR 38 mmHg CAL Gas with bar graph EXTENDED CALIBRATION WEAK OPTICAL TEST SIGNAL CONNECT UNIT TO MAINS POWER CHARGE BATTERY MINIMUM 12 HOURS 12 appears periodically during these five minutes Indication of the remaining time of the selected monitoring time period This message is displayed when the remaining monitoring time site time is 10 of the preset site time The sensor detects no pulse signal The sensor may not be correctly applied to the patient This message will not appear while the sensor is in the calibration storage chamber is pressed when the auditory alarm is sounding during an alarm fault condition The auditory alarm is muted See section 8 1 is pressed when no auditory alarm is sounding The auditory alarm is suspended for two minutes even if an alarm condition should arise during this time See section 8 1 The TOSCA sensor 92 is ready for patient monitoring Calibration of the sensor is in progress The calibration value is indicated The calibration value depends on the sensor te
31. NING SCIVICE epia 19 12 SPECIFICATION S iiaa a a 80 121 TOSCA 500 IMOnNON aena a a a a a i eGe oi tate Geo ti 80 12 2 TOSCA SENSO OZ arrari E T A EE 82 123 SYSTEMMF SMOMMANCS sere E E 83 IZA ENVIonNmMmenalcoNANION Saprene nn EN 84 13 COMPATIBILITY DECLARATION ieesiteecks Gaede ee 86 15a HEICCIROMAGNEIC CINISSIONS ercsi E 86 19 2 BICCIFOMAGNETC IMMUN V 15355 c3 say sees a a a dap race Gaeenceeeaseneens 87 13 3 Electromagnetic immunity RF portable equipment cece cece eee eeeeeeeeeeeeeeeeeeeeees 88 13 4 Recommended Separation CIStANCES ccccccceccecceeceeeeeeeeeeeeeeseeseeseeseeseeseeseeseeneeeees 89 139 CADICS ICM O enie tole tae Se lOc seed cte tatiana Saal Maicentarea eter coe 90 14 ACCESSORIES AND ORDERING INFORMATION cccccceceseeeseeeeeeeeeeeeeseeeeees 91 15 EXTERNAL ONIN GOIN os aise ieee cee a ctree anode neddemecsetawesnodtene sna dtemeenaceeece 92 Me NST WY a estes gate necteseonad atsuasasien E ashen dampens et raat beelenaenaameaes auenaaeaaeaaaan 92 15 2 Connecting to the Systems Connector ccccccceccceceeeeceeeceeeceeeceeeceeeeeeseueceeeeeeseeeaes 92 15 2 HOVStCINS CONECO DINOULS atectecics tected dee treed deetuced dun Svenddentuend duntieadduladtir addindeeuddupiededtaediics 93 15 9 GOMMUMICATON DIOlLOCOM i i5 5i2i 5 jeatokes date a aa a aa a auras 94 A Ea VAK Gone Re A ee ee ee ee ate er eee ener te 94 tO VUEN Keenen aa dadha ls tinladtalnaisdentataniad 97 Too LM aO ea n
32. PI is defined as the ratio of the amplitudes of the pulsatile AC and the non pulsatile DC infrared signals expressed in percent The TOSCA 500 displays this value on the status display The PI is a relative number and varies from patient to patient as physiologic conditions vary A low value indicates weak pulse strength and a high value a strong pulse strength The message of Low Perfusion Index is displayed when there are very low amplitude arterial pulsation CAUTION If the message Low Perfusion Index is frequently displayed assess the patient and if indicated verify oxygenation status through other means If the accuracy of any measurement does not seem reasonable first check the patient s vital signs by alternate means and check the monitor for proper functioning 19 CLINICAL APPLICATION TOSCA 500 FastSat The FastSat enables rapid tracking of arterial oxygen saturation changes It is a special feature of the Masimo SET technology Rapid changes in arterial oxygen saturation are typically smoothed out by pulse oximeter averaging algorithm yielding blunted readings FastSat captures and reports these rapid oxygen saturation changes FastSat feature is automatically enables when an averaging of 2 or 4 seconds is selected see section 7 2 4 for parameter definition Sensitivity The sensitivity level enables the clinician to tailor the response of the TOSCA 500 to the needs of the particular patient si
33. R RADIOMETER RADIOMETER BASEL AG RAO OMETER MA autocal SMe TOSCA 500 X MUTE START DOWN UP HOME TOSCA 500 Operating Manual for USA Software Version MAIN 1 33 and upwards TOSCA 500 TOSCA 500 Operating Manual CAUTION FEDERAL LAW USA RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Publ No 520 81 009 9 Issued July 2010 Part No 520 0918 TOSCA 500 The TOSCA 500 Operating Manual is intended to provide the necessary information for proper operation of the TOSCA 500 system General knowledge of transcutaneous measurement and pulse oximetry and an understanding of the features and functions of the TOSCA 500 system are a prerequisite for proper use Do not operate the TOSCA 500 system without completely reading and understanding these instructions Manufactured by Your contact for sales and service of TOSCA 500 in the USA Radiometer Basel AG Austrasse 25 Radiometer America Inc Tel 1 800 736 0600 CH 4051 Basel 810 Sharon Drive Toll free Switzerland Westlake OH 44145 Tel 4161 278 8111 USA www radiometer com Fax 4161 278 81 81 email info radiometer basel ch The equipment has been designed and manufactured to meet the requirements of the following safety standards IEC 60601 1 1988 A1 1991 A2 1995 IEC 60601 1 2 2001 A1 2004 IEC 60601 1 4 1996 A1 1999 IEC 60601 1 6 2006 IEC 60601 1 8 2003 A1 2006 IEC 60601 2 2
34. RATION TOSCA 500 13 5 Cables length WARNINGS The use of accessories sensors and cables other than those specified may result in increased emission and or decreased immunity of the TOSCA 500 monitor Cables and sensor Maximum length Complies with TOSCA sensor 92 3 m 10 ft RF emissions CISPR 11 part no 562 1000 Class B Group 1 Harmonic emissions TOSCA PC Interface Cable 2 m 6 6 ft IEC 61000 3 2 part no 500 0101 Voltage fluctuations flicker emission IEC 61000 3 3 Electrostatic discharge ESD TOSCA VueLink Adapter 0 5 m 1 6 ft Cable IEC 61000 4 2 part no 500 0100 Electric fast transient burst IEC 61000 4 4 PHILIPS VueLink Interface 2 m 6 6 ft Surge Cable IEC 61000 4 5 25 pin D to 10 pin Philips Voltage dips short interruptions and shielded voltage variations on power supply input lines IEC 61000 4 11 ee Som Power frequency 50 60 Hz magnetic field 25 pin D to 36 pin re Centronics shielded IEC 61000 4 8 Conducted RF IEC 61000 4 6 poeta pet hid end interface 2 m 6 6 ft Radiated RF part no 500 0115 IEC 61000 4 3 TOSCA Open end interface 2 m 6 6 ft cable 1V FS part no 500 0116 TOSCA Open end nurse 2 m 6 6 ft call cable part no 500 0117 90 TOSCA 500 ACCESSORIES AND ORDERING INFORMATION 14 ACCESSORIES AND ORDERING INFORMATION 562 1000 TOSCA Sensor 92 560 1100 TOSCA Preparation Supplies including 12 TOSCA Sensor Preparators 1
35. TERS CONFIGURATION USER SETTINGS PRINT SETTINGS CLOSE MENU Submenus Press to enter a selected submenu Press or to move to the requested parameter and Press or to change it Select RETURN TO MAIN MENU and press or HOME to return to the main menu ALARM LOUDNESS LEVEL PCO2 MAXIMUM PCO2 MINIMUM SPO2 MAXIMUM SPO2 MINIMUM 50 TOSCA 500 SYSTEM PARAMETERS MESSAGES The submenu PCO2 PARAMETER has one lower level menu the SPECIAL PCO2 PARAMETERS To select and change a parameter at this level proceed in the same way as for a submenu Note The display will automatically return to the last chosen display mode if no key is pressed for more than 15 seconds 7 2 Description of parameters Note In the menu Alarm parameters 7 2 1 PCO parameters 7 2 2 Special PCO2 parameters 7 2 3 User settings 7 2 6 and Print settings 7 2 7 PCO2 stays for tcPCO2 7 2 1 Alarm parameters ALARM LOUDNESS LEVEL Selection of the loudness level of the alarm tone Range 1 to 6 in steps of 1 Default value 3 AUDITORY ALARM MODE The auditory alarms suspension is set to suspension 2 min A change of this mode may be requested for special applications e g in sleep centers This mode can be changed only by an authorized Radiometer representative ALARM LIMITS The alarm limits for SpO2 and pulse rate are available when SPO2 PR is enabled in the SpO2 menu But if SPO2 PR is d
36. The in vivo PCO correction is not active during calibration Range 7 to 7 mmHg 1 0 to 1 0 kPa in steps of 1 mmHg 0 1 kPa Default value 0 WARNING The function IN VIVO PCO2 CORRECTION may be used only if a systematic difference between the transcutaneous and arterial PCO value is clearly established by several arterial blood gas analyses The entered correction value must be checked periodically and adapted in case of changes The transcutaneous PCO value remains an estimate of arterial PCO also after the in vivo correction SENSOR Selection of the sensor temperature The recommended TEMPERATURE temperature is 42 C Range 37 0 to 44 0 C in steps of 0 5 C Default value 42 C Note When changing the sensor temperature a change of the site time may become necessary Be cautious when using a temperature above 42 C Read recommendations given in section 3 2 2 53 SYSTEM PARAMETERS MESSAGES TOSCA 500 SITE TIME Selection of the duration of a monitoring period Range 30 minutes to 24 hours in steps of 30 minutes and unlimited H Default value 4HOO Note When changing the site time a change of the sensor temperature may become necessary See section 3 2 2 AUTO BAROMETRIC This parameter is activated when the BAROMETRIC PRESSURE PRESSURE mode is set to AUTO at the level of SPECIAL PCO2 PARAMETERS section 7 2 3 The barometric pressure measured by the monitor is ind
37. There are three different request codes possible which TOSCA 500 can understand The format of these codes and the corresponding replies are described below Request code no 1 status Monitor status record Request format CRLFO1 Reply format CRLFrrnin2 C U CRLF 00 gt N O ND vn Z Pp CRLF Example 0000 00 gt N ND Request code no 2 values Value and status record Request format CRLFO2 Reply format CRLFrrnin2 EE EkPa A EEEmmHg F 10 4kPa A CRLFO0 PCO2 tc43 0 gt 2 N PCO2 078mmHg gt N S S A F A CRLF00 SPO2_ gt 3 N _SPO2 078PERCNT gt N S S 101 EXTERNAL CONNECTIONS TOSCA 500 A F A CRLFOO PR gt 4 N _PR 088BPM gt N S S A F CRLF00 HPWR_ gt 5 N _HPWR 0589mW gt N S S CRLF Example 0000 00 PCO2 tc43 0 gt 2N PCO2 048mmHg gt N OO SPO2 gt 3N SPO2 076PERCNT gt N OO PR gt 4A PR 128BPM gt N OO HPWR gt 5N HPWR 1000mW gt N Request code no 3 limits Range and limits record Request format CRLFO3 Reply format CRLFrrnin2 A F kPa 6 7 13 3kPa CRLF00 PCO2_ gt 2 N 0 125 mmHg 5 PCO2 50 100mmHg S A F CRLFOO SPO2 gt 3 N _ 0 100PERCNT_5 _SPO2 95 PERCNT S A F CRLFOO PR_ gt 4 N_ 0 250BMP 5 PR 60 180BPM S A F CRLFOO HPWR_ gt 5 N 0 1000mW_5 REFHPWR 500mw S CRLFS Example 0000 00 PCO2 gt 2N 0 125mmHg 5 PCO2 50 100mmHg OO SPO2 gt 3N 0 100PERCNT 5 SPO2 95 PERCNT OO PR gt 4A 0 250BMP 5 PR 60 180
38. aciwndthaciandehadianciantandiaadiandehadieadinanieadiaadiandahacenchanaxt 44 62 TRENDOPAY iene sete eee ee ee ee 44 BZ 1 DESCIIDUON sicseccsscevaceaseaanceareenciannaancaaanaaadannaansaeanseandaangaanenaneseacdaiddaisdaaatnandaniaddeaeataaan 45 OZ SRA ANECS IDI Scere ahr ee Bg te ee teat Baers 45 Oo PEE re OMI GISAINE CISDIAY sresti EA 47 B23 WISSCHIDUOIT ssatccee sets nan one onecause seat aeearia aia gear 47 6 3 2 Parameten SCMING Sascenctnceecsstceceenatasaeenctenaeoneecaceenctanaeenanse sees eraacesnsean sexs aneeceanacansesnazeecesees 47 04 REATINGI POWER GISDIAY ciccuntacetesttaeiesetdeacid teste ete ntidertestaleree stad wien eteteeenents 48 BAe 1 ID SSCHIDUON eoan E Ee 48 04 2 Farameter SSHNS ee E E a E 49 T SYSIEM PARAMETERS MESSAGES panisso teint eines 50 fol iHPalaMmeler SCHING Sanese e TE 50 LZ WESChIDUOMVOF parameter S sanea a 51 Cede Alap ammel S aaraa A EES 51 kee WOOF Al O aa a a 53 122 0 Opel FCO Dal IM lE riaa T E aa 55 kA ODO PR Dal GIMeClelS an AEAN 5 1220 GOMMOUPAL OM caccratacaconatcaaeseatenaeenaaccearatancemncasdeanatacqeseaimccassatescecuateasadanatsendaasdacadanatacadan 58 eO IS CT SC UNG S sorcerer ts ates sashes aa aes aa ee sn Nata estes 60 F2 ENES OUNO S acts a 62 k2O PINUS SSA CS oeie E E E S 63 7 0 Delault parameter SCHINGS sorrera i a E 64 8 ALARMS AND MESSAGES encnniei es r ee 65 8 1 Description of the alarm functions ccc cccceccsecceeeeeeseeeeeeeeeceeeeeeeeeeseesueeeeeeeeeeeeaee
39. alibration If any function fails to operate correctly consult an authorized service technician When the equipment has been wetted accidentally it must be wiped dry externally and allowed to dry thoroughly before further use 10 TOSCA 500 INTRODUCTION 2 INTRODUCTION 2 1 Intended use The TOSCA 500 system is used for noninvasive monitoring of transcutaneous PCO 2 tcPCOz2 functional oxygen saturation SpO2 and pulse rate using a single sensor It is indicated for use on adult and pediatric patients Environment of use In hospital clinical environment Operator profile Only licensed health care professionals are permitted to use the monitor 2 2 TOSCA 500 monitor The Radiometer TOSCA 500 system combines the best technologies of Radiometer transcutaneous PCO with the Masimo SET for SpO2 and pulse rate The integrated calibration unit allows a fully automatic calibration and provides also a storage facility for the sensor These features ensure that the sensor is always READY TO USE High quality standard TOSCA 500 is a compact and portable unit which operates by AC power and for transport inside a healthcare facility The monitor is microprocessor based and incorporates most advanced circuit design and user friendly software The monitor is equipped with an extensive built in self check program ensuring a reliable and safe system performance Easy operation All settings and adjustments are made with a few fu
40. and the selected time period is indicated between two arrows To recall trend values from the past 72 hours define the time period and the end time The start time is then automatically set A time period of up to 12 hours can be selected from the 72 hours memory Time period The time period may be changed as follows Range 5 10 30 minutes and 1 2 4 8 12 hours Default value 1 hour End time The end time of the trend graph can be selected in steps whereby the width of a step is identical with the selected time period The start time is always automatically adjusted Range up to 72 hours Default value actual time 46 TOSCA 500 DISPLAY MODES 6 3 PLETHYSMOGRAM display tcPCO ALARM FTE MENU SETTING S POWER ON 6 3 1 Description The PLETHYSMOGRAM display mode allows the presentation of the actual pulse waveform The pulse wave is displayed over the full range and is therefore not proportional to the Perfusion Index PI value The PI value is indicated at the bottom line for definition of Perfusion Index value see section 3 2 3 The signal IQ is showed as vertical line coinciding with the peak of the pulse wave for definition see section 3 2 3 The Plethysmogram display mode and the PI value are not available when SPO2 PR is disabled in the SpO2 menu 6 3 2 Parameter settings Press to select the current PLETHYSMOGRAM display mode Press to access the parameter setting mo
41. appears during calibration sensor operating time has been exceeded last remembraning gt 14 days sensor has been stored in air for a prolonged period of time the sensor is new or has been stored unprepared for a prolonged period of time the sensor was just remembraned but this was not confirmed by pressing YES SENSOR REMEMBRANED remembrane sensor Initiate a new calibration and allow few hours for sensor stabilization in the cal storage chamber allow at least 4 hours for sensor stabilization in the cal storage chamber confirm sensor remembraning by selecting the parameter SENSOR REMEMBRANED YES and then press YES is TROUBLESHOOTING TOSCA 500 9 3 Monitor Sensor SENSOR FAULT appears _ the sensor is defective SENSOR FAULT appears _ safety circuitry in monitor switch off monitor allow during selection of a lower detects too high sensor sensor to cool down and sensor temperature temperature switch on monitor again Excessive gas consumption gas cylinder is not screwed in tighten up cylinder tightly system is leaking consult technical service MONITOR FAULT appears a faulty function of the monitor switch OFF ON the monitor with an identification number is detected to reset the message If the message disappears and the monitor can be restarted check all parameter settings and readjust if required a faulty function of the monitor If the message cannot be is detect
42. ar panel The monitor can be operated at 100 120V or 200 240V 50 60 Hz Connect the monitor to the mains n rooms classified as cardiac protected electrical areas connect the equipotential ground of the monitor to the equipotential earthing system Install the CAL Gas cylinder Switch on the monitor at the rear Connect the TOSCA sensor 92 Prepare the sensor Allow the sensor to stabilize for at least 4 hours prior to use Check the parameter settings CAL Gas installation Install the CAL Gas cylinder in the appropriate position at the rear of the monitor by turning it in a clockwise direction Tighten it firmly but do not over screw Power connection Connect the power cable to the power source and switch monitor on switch at the rear panel Check that the Line connected and Monitor on indicator lamps at the front panel are illuminated Self check The monitor performs an extensive self check after it has been switched on The relevant functions of the microcomputer system are checked the display segments are illuminated and the alarm tone sounds If any fault is detected in the course of this self check program a message is displayed see sections 8 2 2 and 9 for details After completion of the self check the message SYSTEM TEST MAIN DBG MS DSP MCU CONNECT SENSOR appears followed by along with an audible alarm 28 TOSCA 500 OPERATION Disp
43. arge after long term power interruption 42 TOSCA 500 DISPLAY MODES 6 DISPLAY MODES The TOSCA 500 system provides four display modes two of them in different versions STATUS TREND 4 versions PLETHYSMOGRAM HEATING POWER 2 versions The heating power display mode must be enabled in the configuration menu see section 7 2 9 The display modes can be selected and changed at any time also during monitoring by pressing HOME To select the TREND PLETHYSMOGRAM or HEATING POWER display modes see sections 6 2 6 3 or 6 4 6 1 STATUS display K ur Ga SETTING A POWER ON 6 1 1 Description The values of the following parameters are displayed and can be changed in this mode alarm limits for SpOz2 alarm limits for pulse rate bpm alarm limits for tcPCO2 mmHg or kPa remaining site time hours minutes 43 DISPLAY MODES TOSCA 500 The values of the following parameters are only displayed and cannot be changed in this mode unit of tcPCO2 mmHg or kPa sensitivity mode MAX or APOD NORMAL is not displayed sensor temperature C PI Perfusion Index in Note When SPO2 PR are disabled the alarm limits for SpOQz2 and pulse rate are not available and displayed as see section 7 2 4 6 1 2 Parameter settings The displayed values of the alarm limits and site time can be directly changed at any time in this mode These parameter
44. ars on the display Press or to move to the parameter which should be changed Press or to change it Display version selection of one of the two versions of the heating power display Options HEATING POWER or RELATIVE HEATING POWER Default RELATIVE HEATING POWER Reset of heating power reference value Press or to move to the message RESET REL HEATING POWER REFERENCE Press to reset Display range Selection of the RELATIVE HEATING POWER graphic display range Range 50 100 200 500 mW Default 100 mW 49 SYSTEM PARAMETERS MESSAGES TOSCA 500 T SYSTEM PARAMETERS MESSAGES 7 1 Parameter settings The TOSCA 500 system is delivered with factory default parameter settings as listed in section 7 3 These parameters can be changed modified stored and restored at any time CAUTION The auditory alarm signal and the SpO pulse tone are automatically suspended during parameter setting Access to main menu Starting from any display mode Press to access the parameter setting mode MENU appears on the display inverted and the sign flashing Press to enter the main menu Main menu The main menu consists of six submenus arranged in a loop which can be selected with or UP The selected submenu is inverted and the sign flashes Select CLOSE MENU and press or to exit the main menu Example ALARM PARAMETERS ALARM PARAMETERS PCO2 PARAMETERS SP02 PR PARAME
45. ata are stored whenever values are displayed e g during patient monitoring The memory will indicate blank spaces for those time intervals in which no values are displayed e g while the sensor is placed in the calibration storage chamber or while the monitor is turned off The results can be downloaded to a printer or to a personal computer PC Communication interface The TOSCA 500 monitor is equipped with a Parallel Interface and a Systems Connector The Parallel Interface is used for connecting a printer The Systems Connector allows the connection to any patient monitoring system or to a computer The protocol is selectable through the menu of the system parameters 2 3 TOSCA sensor 92 The TOSCA sensor 92 employs the most advanced technology for combining two measurement methods It determines transcutaneous PCOz oxygen saturation and pulse rate at the ear lobe The sensor is heated to a constant temperature to achieve local arterialization of the skin which is required for the transcutaneous measurement The increased perfusion of the ear lobe produced in this way serves also to augment the pulse oximetric signal strength Sensor memory The TOSCA sensor contains an electronic memory to store PCO calibration values and other relevant sensor data such as date of last sensor preparation or light intensities of LEDs By evaluating these data on the monitor an irregularity of the sensor characteristics or the need for a new se
46. ation at the frequency of the patient s arterial pulse venous return when the sensor is applied to the forehead or cheek on a patient in Trendelenburg position head lower than the heart WARNING The TOSCA 500 monitoring system is not a device for blood gas analysis It is recommended that prior to any decisive therapeutic measures an accurate arterial blood gas analysis is carried out The use of the TOSCA 500 monitoring system cannot replace a permanent supervision of the patient by medical personnel 21 DESCRIPTION OF THE MONITOR TOSCA 500 4 DESCRIPTION OF THE MONITOR 4 1 Overview 4 1 1 Front panel MENU SETTING e Ne Ge LED display indicating the oxygen saturation SpO2 between 0 and 100 or if no value is available or if SPO2 PR is disabled see section 7 2 4 The value is updated once per second This display is switched off when the sensor is in the calibration storage chamber Illuminated LCD display which serves to guide the user through the programming of the system and to show text messages During operation one of the four display modes can be selected Status Trend Plethysmogram and Heating power The tcPCO2 unit mmHg or kPa is indicated at the upper right corner LED display indicating the tcPCO2 value between 0 and 200 mmHg 0 0 and 25 0 kPa or if no value is available or EEE if PCOz value is higher than 200 mmHg 25 0 kPa The value is updated once per
47. d user parameter settings are automatically reset to the factory default parameter settings 10 4 Disposal of equipment Dispose the TOSCA 500 monitor in accordance with your country s laws for disposal of equipment containing electrical and electronic parts For disposal of accessories follow local regulations regarding disposal of hospital waste CAUTION The battery contains lead and acid in gel form Dispose of safely according to the local waste regulations DO NOT INCINERATE EQUIPMENT GAS CYLINDER a DECONTAMINATION TOSCA 500 11 DECONTAMINATION 11 1 Requirements Due to the nature and seriousness of infectious diseases such as AIDS and Hepatitis B it is important that equipment and accessories which can come into contact with human or animal tissues or fluids particularly blood should always be regarded as contaminated and potentially hazardous Contaminated equipment and accessories must be decontaminated by the procedures described below Decontamination must be carried out by a properly trained person If you are in any doubt regarding contamination or decontamination consult your local infection control authority 11 2 Decontamination procedures CAUTION Do not autoclave pressure sterilize or sterilize this equipment by irradiation steam or ethylene oxide Do not soak or immerse the monitor in any liquid Use the cleaning solution sparingly Excessive solution can flow into the monitor and ca
48. de MENU appears on the display Press or to move to the parameter which should be changed Press or _ to change it Time period selection of the time window of the plethysmogram display Range 2 4 6 8 seconds Default value 4 seconds 41 DISPLAY MODES TOSCA 500 6 4 HEATING POWER display tcPCO RELATIVE HEATING PHR 85 mi ALARM 700 vo X MENU SETTING S POWER 0N 6 4 1 Description The HEATING POWER display mode is available only when it is enabled in the CONFIGURATION menu see section 7 2 5 It includes two versions allowing the display of the value and the graphical presentation of the HEATING POWER and the RELATIVE HEATING POWER The HEATING POWER is the absolute value of the actual electrical power needed to heat the sensor The RELATIVE HEATING POWER is the difference between the actual heating power and a reference value which has been previously stored It is necessary to reset this reference value to the actual heating power i e after the sensor is warmed up at the patient prior to displaying the RELATIVE HEATING POWER For the interpretation of this parameter see section 3 2 2 No value is displayed and the bar indicates 0 while the sensor is within the calibration storage chamber 48 TOSCA 500 DISPLAY MODES 6 4 2 Parameter settings Press to select the current HEATING POWER display mode Press to access the parameter setting mode MENU appe
49. detected If this message appears alternating with a sensor fault message as described below disconnect the sensor to check the cause of the fault If the message cannot be reset note the indicated number and consult your service technician SENSOR FAULT A failure of the TOSCA sensor 92 is detected Disconnect and reconnect the sensor If the message cannot be reset replace the defective sensor UNKNOWN SENSOR The connected sensor is not the TOSCA sensor 92 Connect TOSCA sensor 92 CONNECT SENSOR No sensor is connected The message is automatically reset when the TOSCA sensor 92 is connected BATTERY IS LOW The internal battery is at a very low charge level and needs to be recharged Connect the monitor to mains LOW SIGNAL IQ Low signal quality is detected Check the fixation of the sensor and reapply if needed see section 5 5 for details SENSOR OFF PATIENT The sensor is detached Check the fixation of the sensor and reapply it if requested TOO MUCH The measurement is affected by light AMBIENT LIGHT Make sure that the sensor is not exposed to bright light INTERFERENCE Outside signal or energy preventing reading Remove outside interference 10 TOSCA 500 ALARMS AND MESSAGES LOW PERFUSION INDEX The signal is too low Move the sensor to the other ear lobe see section 5 5 for details 8 2 3 Operating alarm messages low priority SITE TIME ELAPSED The selected monitoring time
50. detection of hypoxemic events and of critically high or low levels of carbon dioxide tension as compared to conventional arterial blood gas analysis Also it can be of assistance in deciding the timing of arterial blood gas sampling and may therefore considerably reduce the frequency of sampling Measuring sites The TOSCA sensor is applied to the ear lobe using the Attachment Clip Ref 560 1300 It can also be applied to the forehead or to the cheek using the TOSCA Fixation Ring Ref 560 1500 or to other measuring sites for tcPCO2 only measurement refer to section 5 5 3 2 Points to be regarded during monitoring 3 2 1 General Monitoring during surgery For use during electro surgery the monitor sensor and their cables are to be physically separated from the electrosurgical equipment The sensor must not be placed in the electrical pathway between cutting and counter electrode Electro surgery will produce at most a minimal transient disturbance in the reading but it will not affect the system calibration 17 CLINICAL APPLICATION TOSCA 500 3 2 2 Transcutaneous PCO measurement Recommended sensor temperature and application time The quality of the correlation between arterial and transcutaneous PCOz has been found to be similar at sensor temperatures between 41 C and 44 C With decreasing sensor temperature however the in vivo response time to rapid arterial PCO2 changes increases It is recommended to use a sensor
51. e calibration of any analog recording system e g polysomnograph in sleep labs The analog outputs on the System Connector are set to full scale of 5V 15mV during the system check To perform a system check Press both and when no parameter setting is in progress see section 10 2 The analog outputs are set to zero when the connected sensor is placed into the calibration chamber no PCO value is displayed 15 8 Nurse call The nurse call feature is activated if any of the following conditions are true One or more alarms are active and not muted The auditory alarm is not suspended The auditory alarm is not inhibited Relais Shorts pin 19 to pin 18 common if calling Shorts pin 37 to pin 18 if not calling 104 TOSCA 500 EXTERNAL CONNECTIONS 15 9 Connection to external battery Connector type Redel SA Type PAG M02 GLAC GSG Polarity WARNING If the external battery is connected to a battery recharging device this device must be medical grade double isolation 105
52. e repeated every 10 seconds The melody generated represents the Oxygen cause of alarm related to Oxygen as defined in the international standard IEC 60601 1 8 Timing representation of a HIGH PRIORITY ALARM Os 5s 10s 15s 20s 25s 30s The alarm tone of a MEDIUM PRIORITY ALARM consists of 3 pulses and is repeated every 25 seconds The melody generated represents a General cause of alarm as defined in the international standard IEC 60601 1 8 Timing representation of a MEDIUM PRIORITY ALARM oO Os 5s 10s 15s 20s 25s 30s The alarm tone of a LOW PRIORITY ALARM consists of 2 pulses and is repeated every 25 seconds The melody generated represents Any cause of alarm as defined in the international standard IEC 60601 1 8 Timing representation of a LOW PRIORITY ALARM 66 TOSCA 500 ALARMS AND MESSAGES Os 5s 10s 15s 20s 25s 30s Monitoring message tone Every monitoring message described in section 8 3 is announced once by an auditory signal as follows PO Os 5s 10s 15s 20s 25S 30s This signal is not generated if a parameter adjustment is in progress Alarm muting There are two possible situations Situation 1 The MUTE key is pressed when the auditory alarm is sounding during an alarm fault condition The auditory alarm is muted The visual alarm flashing parameter value and or alarm fault message remains active ALARM MUTED appears below the alarm fault message in the middle LCD disp
53. e used on patients less than one year of age Sensor temperature Recommended temperature 42 C Selectable between 37 C and 44 C in steps of 0 5 C Reliable safe control by two independent circuits Accuracy 0 2 C Sensor LED characteristics LED wave lengths red 658 nm infrared 880 nm Maximum LED energy 50 mW Note Information about the range of wavelength can be useful specially to clinicians Sensor memory Built in memory for storage of calibration preparation and test data 82 TOSCA 500 SPECIFICATIONS Sensor preparation Remembraning required after two weeks at normal use Protection Degree of protection against ingress of solids and water IP64 Physical specifications Dimensions 15 mm 0 6 diameter 8 mm 0 3 high Cable 3 m 10 ft long highly flexible shielded and polyurethane coated latex free Biocompatibility TOSCA sensor 92 and accessories are in compliance with the biocompatibility testing recommended in ISO 10993 1 Biological Evaluation of Medical Devices 12 3 System Performance tcPCO Measurement range 1 200 mmHg 0 1 25 0 kPa Resolution 1mmHg 0 1kPa Response time in vitro 10 90 at 42 C lt 60 sec Drift in vitro lt 0 5 h Linearity in vitro at 1 COz better than 1 mmHg at 10 COz better than 1 mmHg at 33 COz better than 3 mmHg Calibration interval recommended after each patient monitoring session or after max
54. ed reset note the indicated identification number and consult technical service 14 TOSCA 500 MAINTENANCE 10 MAINTENANCE 10 1 Routine maintenance The routine maintenance should be performed monthly according to the following procedure Monitor Switch monitor off and disconnect it from AC power Clean housing front and rear panel with a soft cloth lightly moistened with warm soapy water Use only mild soap or detergents Allow to dry completely before use See section 11 for Decontamination Inspect power cord assembly for any signs of mechanical damage to cable or connector If damaged replace with a genuine Radiometer Basel replacement part Do not attempt to repair Connect monitor to AC power Switch monitor off and on again Verify that during the following self check all display segments and control lamps are illuminated that all dots of the middle LCD are visible and that a tone sounds Check parameter settings and readjust if required Sensor Check sensor and cable assembly for any signs of mechanical damage In case of a damage replace sensor Do not attempt to repair Clean the prepared sensor and the cable with a soft cloth moistened with alcohol carefully avoid damaging the delicate sensor surface Allow to dry completely before use Remembrane sensor if required Consumables Check expiration date of all consumables Replace if necessary WARNINGS
55. ee meee Re eee as ee Re es E E A E eee ae 99 15 5 2 VueLink Task Window CXaMple ccccceccecceeceeceeteeteeceeceeeeeeaeceeeseeseesueceeceeseeseesaes 100 O VO MUM erase cetcsasteea satan asea taste astas A sue aiag ines usb aae eae 101 196 SEN lal POR COMNGUIATION sosen aE E 101 196 2 COMMUNICATION DlOlOGC Ol viicscnsasisicininnautsanplnsausadedanientelesnuienaunsanisaauetanienaeaunuteadpedoubaneednelentewbannt 101 15 6 3Legend Of CodeS sninen ecco io ei elect ae eta elie tes ecard Seca eee 103 Wat ANOTOU US arcs etree sce nesecee ered E aoauadaysewacden seaneden E seaceeun aeaceassenes 104 15 7 1 Calibration of an analog recording SYStOM ccccceccceecceeeceeeeeeeseeeeeeeeeeseeseeeaeeeaees 104 ho AUSE Rae Ree eee See E AA eee nee ee 104 15 9 Connection to external battery ccc ccccceccseeceeeceeeseeeceeecaeeeseseuecaeeceeesaeeseesseesanes 105 SAFETY INFORMATION TOSCA 500 1 SAFETY INFORMATION The instructions regarding precautionary measures given in this operating manual must be followed carefully It is mandatory that these instructions are read prior to installation of the monitor Definition A WARNING indicates that there is a risk of injury to the patient or user A CAUTION refers to a condition that may lead to damage or malfunction of the equipment A Note provides additional information WARNING The TOSCA 500 system is to be operated by qualified personnel only T
56. enous oxygen saturation This is referred to as stereo saturation measurement since it separates the arterial from the venous information instead of mixing them together as is done with conventional pulse oximeters 15 INTRODUCTION TOSCA 500 The pulse oximetric signal strength Perfusion Index PI is displayed on the status and plethysmogram screen The Perfusion Index PI is a qualitative indicator of tissue perfusion and the value is defined as the ratio of the amplitudes of the pulsatile and the non pulsatile infrared signals expressed in percent 16 TOSCA 500 CLINICAL APPLICATION 3 CLINICAL APPLICATION 3 1 Indications The need to monitor simultaneously carbon dioxide tension and arterial oxygen saturation exists in various fields of medicine such as anesthesia preoperative monitoring intensive critical care diagnostic procedures such as bronchoscopy sleep studies and apnea testing exercise testing pulmonary stress testing respiratory research Monitoring of transcutaneous PCO2 and SpO2 with TOSCA 500 is of particular value in following up the immediate effect of any therapeutic measures which have a direct or indirect influence on the patient s degree of oxygenation and ventilatory efficiency The information on trends provided by TOSCA 500 permits an instantaneous qualitative assessment of the effect of the therapy Monitoring with TOSCA 500 allows in general a more rapid
57. er Data line Possible modes are C calibrating R ready to use P pre measurement M measurement other connect sensor monitor fault etc CO 6 TOSCA 500 EXTERNAL CONNECTIONS Column pos 13 General status Heading line Status lt CR gt lt LF gt No heading parameter Status This is the last column of the heading line ending with CR LF OxOD Ox0A bytes Data line lt code gt lt CR gt lt LF gt Possible codes are N no alarm A at least one alarm active S at least one alarm muted U alarm suspended or inhibit This is the last column of the data line ending with CR LF OxOD Ox0A bytes Bytes per line heading line 133 bytes data line 53 bytes Column heading line example 2006 07 31 PCO2 kPa _01 2 12 3 PCO2s SPO02 88 100 SPO2s PR bpm 050 150 PRs HPWR mW 541 Perf Index Temp C 44 0 Timer Mode Status Data line example 1 1 22 33 12 3 N 100 N 245 N 999 12 3 44 3 12 34 M A 15 5 VueLink As part of a Philips Patient Monitoring Systems Philips V24 26 Philips CMS and Philips IntelliVue here after called Philips Monitor the TOSCA 500 monitor is compatible with the following VueLink Open Interface module Module type Philips VueLink module M1032A A05 K6B type B Auxiliary plus with Open Interface cable Ordering information M1032A A05 VueLink Open Interface Module type B auxiliary plus M1032A K6B VueLink Ope
58. ered Equipment when supplied by the internal battery Applied part type BF protected against the effects of defibrillation Degree of protection against ingress of solids and water IP21 Electromagnetic compatibility EMC The equipment complies with IEC 60601 1 2 2001 and the relevant particular standards for emission and immunity see section 13 Electromagnetic Compatibility Declaration External connections 1 x 37 way connector with analog output RS 423 communication and nurse call 1 x 25 way connector with Centronics parallel interface for printer with IBM Proprinter emulation 1 x 2 way connector for connecting an external battery see section A 9 Equipotential ground Physical Specifications Height 135 mm 5 3 Width 266 mm 10 5 81 SPECIFICATIONS TOSCA 500 Depth 300 mm 11 8 Weight 5 28 kg 11 6 Ibs including gas cylinder 12 2 TOSCA sensor 92 Principle of measurement Stow Severinghaus type PCO sensor combined with pulse oximeter sensor Application time The application time of the sensor on the patient depends on sensor temperature The recommended maximum application time along with the sensor temperature is indicated in the table below Age of patient Sensor core Corresponding Recommended temperature maximum sensor maximum application skin interface time temperature WARNING Temperature settings greater than 42 C skin interface temperature greater than 41 C must not b
59. ervice repair the clinical user may be required to ensure that the device has been properly decontaminated A certificate of decontamination may be completed by the person responsible for the device and this certificate must accompany the device on its return for service or repair For full decontamination procedures see Service Manual Where equipment is to be serviced on site a certificate of decontamination may also be required by the service engineer 19 SPECIFICATIONS TOSCA 500 12 SPECIFICATIONS 12 1 TOSCA 500 monitor Display Three times 3 digit LED displays for PCO2 SpO2 and pulse rate 10 segment LED bar graph for pulse wave Graphic LCD 128 x 64 dots with LED back light and adjustable contrast for selectable parameter visualization modes messages and alarms User selectable display modes for status trend plethysmogram and heating power Patient Data Memory Automatic storage of measured patient data over the last 72 hours using to the FIFO First In First Out principle see also section 2 2 Sensor heating Sensor core temperature selectable between 37 C and 44 C in steps of 0 5 C Calibration Fully automatic calibration Typical calibration time in routine use 2 min Integrated calibration chamber with one gas calibrator CAL Gas cylinder Composition 12 0 Os 7 0 CO balance No Volume nominal 0 5 liter Filling pressure 10 8 bar at 21 C Typical function time 2 months Site timer Cl
60. ervision of the patient by medical personnel TOSCA 500 SAFETY INFORMATION The TOSCA 500 pulse oximetry should NOT be used as an apnea monitor The pulse oximetry should be considered an early warning device As a trend towards patients deoxygenation is indicated by pulse oximetry blood samples should be analyzed by a laboratory co oximeter to completely understand the patient s condition Interfering substances to SpO measurement Carboxyhemoglobin may erroneously increase readings The level of increase is approximately equal to the amount of carboxyhemoglobin present Dyes or any substance containing dyes that change usual arterial pigmentation may cause erroneous readings Do not reuse any sensor fixation accessories to prevent contamination and cross infections and because the adhesive will not correctly adhere to the skin resulting in incorrect measurements Do not reprocess any sensor fixation accessories by exchanging the adhesive part as it may result in incorrect measurements and biocompatibility inconvenience Do not reuse or reprocess any membraning kits as it may result In incorrect measurements Do not refill any cal gas cylinders because of the risk of explosion related to the refilling process and for preventing inaccurate gas concentration resulting in incorrect measurements Do not use calibration gas cylinder other than the original Radiometer calibration gas and do not use the calibration gas with an expired
61. g during patient monitoring The memory will indicate blank spaces for those time intervals in which no values are displayed e g while the sensor is placed in the calibration storage chamber or while the monitor is turned off Heading and data lines content Column pos 1 Date and time Heading line lt date gt Date of the next data line format yyyy mm dd 2006 30 07 Data line lt time gt Time of the actual data line format hh mm ss 11 22 33 Column pos 2 PCO2 value Heading line PCO2 lt unit gt lt limit gt Indication of the PCO2 unit in mmHg or kPa_ PCO2 mmHg and alarm limits low high valid for the next data 0012 0123 lines PCO2 kPa 01 2 12 3 Data line lt value gt PCO2 value in mmHg out decimal point or in 0123 kPa with decimal point Indication of or if no value is available EEE Indication of EEE or EE E if the value is out of 23 4 range EE E Column pos 3 PCO2 alarm status Heading line PCO2s No heading parameter Data line lt code gt Possible codes are N no alarm A alarm active S alarm muted reset Column pos 4 SPO2 value Heading line SPO2 lt limit gt Indication of the SPO2 alarm limits low high SPO2 90 098 valid for the next data lines SPO2 90 Data line lt value gt Indication of if no value is available 087 Column pos 5 SPO2 alarm status Headi
62. gaes 65 o2 PIARIMIMNG SSAC eas i a E E EE 69 8 2 1 Physiological alarm messages high priority cee cece cecceeeeeeseeeeeeseeeeeeaeeseeeaeeaees 69 8 2 2 Technical alarm messages medium POF ity ccc cecc eee seeceeeeeeseeeeeeseeseeeeeeseeeaeeaees 70 8 2 3 Operating alarm messages low PIlOFity c cccccccceccceeeseeceeeee cece eeseeeseeeeeeseeeseeeseeeaes 71 Boe MONOMONO Sel Oe S e E A ance nes qoeaacies ER 11 9 TROUBLESHOOTING wxrestectacectcchacestoerle pos dne alta thos oah ode oe ode ak odeeteedee eres 73 91 D ring MONITORING A DDIICAUION erreien E 13 ae BUMD MUON ere eagees ete scarcer A aces aches auiae ashe nes E gene 73 O53 WOMMOR SCNSON sirasi ee 14 10 MAINTENANCE sconce ene E a ee ee ee ee ee 75 TORT Roue MANEA O asyees cits cees tise ea a a es baeeaceiGeeencesaaeeaees 15 TOSCA 500 10 2 Check of monitor and sensor FUNCTIONS ccccec cece eeeceeceeeeeeceeeeeeeeeeeeeeeeeaeeeeeeeeeeeenaes 76 10 3 Battery Refresh Charge ronronner nee a r e E r et 76 t04 DISPOSal Ol CQUIDING ML civiccenteumutantenontontesnntantenmmantbecwndicheanninaaeceaiauhneennacheamasianeenetesawenis ai 11 DECONTAMINATION sicictsaetaicntnetncatenatainabnentaunbueatanstiadtobddunaiudeduatdonidabtiunddwadtunduantaudiens 78 IET ERC GUIFGIIG INS errana E 78 112 DECONTAMINATION DFOCCOUICS aerae a A 78 Vc RISKS opisi an aAA aE 19 led ince a DO FEDON eee eee eee en ener ec eee enn eee eee ee ere 19 io JSQUIDMENE FEQUI
63. here P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as deter mined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol io NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones 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 TOSCA 500 system is used exceeds the applicable RF compliance level above the TOSCA 500 system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the TOSCA 500 system 3 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 8
64. his manual accessory directions for use all precautionary information and specifications should be read before use Explosion and flammability hazards Do not use the monitor in the presence of flammable anesthetics or other flammable substance in any combination with air oxygen enriched environments or nitrous oxide Do not use the equipment in a hyperbaric environment Do not use TOSCA 500 monitor and sensor on patients undergoing magnetic resonance imaging MRI scanning Induced current could potentially cause burns The TOSCA 500 monitor may affect the MRI image and the MRI unit may affect the accuracy of the measurement Electrical shock hazard Do not remove the monitor cover Only a qualified operator may perform maintenance procedures specially described in this manual Failure of operation If TOSCA 500 monitor fails any part of the setup procedures remove the monitor from the operation until qualified service personnel have corrected the situation Patient safety If a sensor is damaged in any way discontinue use immediately As with all medical equipment carefully rout patient cabling to reduce the possibility of patient entanglement or strangulation The TOSCA 500 tcPCO monitoring is not a device for blood gas analysis It is recommended that prior to any decisive therapeutic measures an accurate arterial blood gas analysis is carried out The use of the TOSCA 500 monitoring system cannot replace a permanent sup
65. ic pressure must be entered manually Only when this mode is selected can the MANUAL BAROMETRIC PRESSURE be entered at the level of tcPCOz Parameters see section 7 2 2 Selection AUTO MANUAL Default AUTO LAST SENSOR PREP deh elites Bip The date of the last sensor preparation is displayed with date aa eer SENSOR REMEMBRANED Option to set the preparation date of the sensor to the current date by pressing YES This function can be used when the sensor has been remembraned on the same day without being connected to the monitor The current date is stored in the memory as last sensor preparation date PCO2 UNIT Selection of the tePCO gt unit mmHg or kPa Default unit mmHg RETURN TO PCO2 To return to the submenu PCO PARAMETERS PARAMETER RETURN TO To return to the main menu MAIN MENU 06 TOSCA 500 SYSTEM PARAMETERS MESSAGES 7 2 4 SpO PR parameters Sp02 PR The SpOz and pulse rate parameters may be turned off ON the SpOz2 and pulse rate values and the corresponding alarm limits are available and displayed The SpOz and PR trend can be selected in the TREND display mode and the PLETHYSMOGRAM display mode is selectable OFF the SpOz pulse rate values and the corresponding alarm limits are not available and displayed as The Plethysmogram display is not selectable and the Perfusion Index value is not available Therefore the SpO2 pulse rate and perfusion values cannot be reca
66. icated in mmHg when this unit is selected for the tcPCO gt value and in hPa when kPa is selected for tcPCOz MANUAL BAROMETRIC This parameter is activated when the BAROMETRIC PRESSURE PRESSURE mode is set to MANUAL at the level of SPECIAL PCO2 PARAMETERS section 7 2 3 The actual barometric pressure must be entered manually The value of the barometric pressure is indicated in mmHg when this unit is selected for the tcPCO2 value and in hPa when kPa is selected for tcPCObz Range 450 to 800 mmHg 600 to 1067 hPa in steps of 1 mmHg 1 hPa Default value 750 mmHg 1000 hPa 54 TOSCA 500 SYSTEM PARAMETERS MESSAGES 7 2 3 Special PCO parameters While in the submenu PCO2 PARAMETERS select the lower level menu SPECIAL PCO2 PARAMETERS PCO2 TEMP CORRECTION Selection of the temperature correction factor for FACTOR calculating the tcPCOd2 calibration value This factor is used in combination with the tcPCO2 metabolic constant see section 2 4 1 for details When AUTO is selected the correction is automatically adjusted to the sensor temperature When a specific value is selected this adjustment is not made and the sensor must be recalibrated after a change of the sensor temperature Also the correction parameters should then be adjusted if necessary Range AUTO 1 00 to 2 00 in steps of 0 01 Default AUTO PCO2 METABOLIC Selection of the metabolic constant for calculating the CONSTANT tcPCOz calib
67. iguena aonais oa onnie 8 INTRODUC THON rrinin a 11 mMiended US C norr EEE EEEE EDENE e 11 TOSCA SGOMONNO vaaan a a aTa Ta TAINA 11 TOSCA SENSO OZ ivinsiocatavetaieiduabatebivebavedivabaratiupbarebiualaiebsnabainiausbsiadeelieinataninaewaiion 12 COINS LOU OO CI AU OM errai A tmnfc cateet lente tea laacltiwacleatles 13 Transcutaneous PO Odes convsmiarsusiaeramiierseiaseinicuniaiaeniae ico 13 XV OSM SALUPAUON SD Oo versie sacs i E htatlcusheetloutltedl E 14 CLINICAL APPLICATION procona aaa aaa a AAAA 17 ge ors 6 9 S ae a E nn ee ee eee S ee 17 Points to be regarded during MONItOLING cccceccecc secs eee eeeceeceeeseeseeeeeeseeeaeeaeeeeeaeeees 17 Generalean a a AE AE AEE EEEE 17 Transcutaneous PCOs measuremeNtirristeret ioi 18 SPOzMeaSr eme Ni geroaren aaa ETATE 18 PANY MACNN S ain aa aa Gung exee ounbawen puaee wed oven eee wanna 20 TranscutaneOuS PCO2 measurement orreee EAERI ARTEN 20 DP OME ASUS IMENE e ENA EN 21 DESCRIPTION OF THE MONITOR annsan 22 OVE VIEW ccasceancasscasnaiescaweceaaea seca caaanecicanimneraieuanananganaansieaaaontaadenindatadoniacadanaaatadadndseadadaian 22 PIOME Dane saicuetete a iete cee a hG De La ie ta Uae aa are 22 ate lOG Weare ten arn ern eRe earn E een ena eer eee 23 Redal Daneler estas sere as 24 OPERATION meena basement E cutee acne apn tanecaneincecieet acne nat eunesmoneaceushesates 26 mMuaksetup orne Sy EN eeemee renin sree tet ner ae se ater terme ae are meer ete OTe An ean a ele eae ae 26 F
68. in factors First the elevated temperature raises local blood and tissue PCO2 by approx 4 5 C anaerobic factor secondly the living epidermal cells produce carbon dioxide which contributes to the capillary COz level by a constant amount metabolic constant This metabolic contribution may change with age skin thickness and other variables A generally accepted estimation is that skin metabolism raises the transcutaneous PCO by approx 5 mmHg Taking into account both effects the relationship between tcPCO2 and PaCO can be expressed by the following equation tcPCO2 10exp 0 019 T 37 PaCO2 SmmHg or tcPCOz2 Fr PaCO2 Cy whereby Fr temperature correction factor 13 INTRODUCTION TOSCA 500 Cm metabolic constant The theoretical basis of this algorithm is described by J W Severinghaus in his paper Transcutaneous blood gas analysis Respiratory Care 1982 27 2 152 159 The correction of tcPCOz2 is combined with the sensor calibration i e the sensor is calibrated to a value which is adjusted to compensate for both effects The correction parameters Fr and Cm can be selected by the operator as described in section 7 2 3 In the AUTO mode Fr is automatically adjusted to the sensor temperature according to the above equation In this case it is recommended to use Cy 5 mmHg Alternatively specific values for both correction parameters may be used for example Fr 1 5 and Cy 0 at a senso
69. isabled the alarm limits are not selectable and displayed as Alarm limit ranges 0 99 mmHg 0 13 0 kPa 5 200 mmHg 0 7 25 0 kPa 1 mmHg 0 1 kPa SpO2 50 95 70 100 PR 25 150 bpm 50 240 bpm 51 SYSTEM PARAMETERS MESSAGES TOSCA 500 Default values 25 mmHg 3 3 kPa 50 mmHg 6 6 kPa SpO PR 50bpm 150 bpm 1 Note The difference between the maximum and the minimum alarm limit is automatically adjusted so that it corresponds to at least 5 step values Note The maximum SpO alarm limit can be made inactive by selecting one step above 100 This will be indicated as 52 TOSCA 500 SYSTEM PARAMETERS MESSAGES 1 2 2 PCO parameters IN VIVO PCO2 This parameter is activated only if the IN VIVO PCO2 CORRECTION CORRECTION mode is enabled at the level of SPECIAL PCO2 PARAMETERS section 7 2 3 This function provides the possibility of adjusting the tcPCOz2 value displayed by the TOSCA 500 monitor to the arterial PCO2 value as determined by an arterial blood gas analysis for details see section 2 4 1 The entered correction value is added or subtracted to the measured tcPCOz2 value during patient monitoring A triangle A will appear automatically next to the tcPCOz unit to indicate that a correction 0 is applied to this value The automatic reset of the entered correction value can be turned ON or OFF see section 7 2 3 IN VIVO AUTOMATIC RESET
70. l environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the TOSCA 500 system requires continued operation during power mains interruptions it is recommended that the TOSCA 500 system be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Uris the a c mains voltage prior to application of the test level 87 COMPATIBILITY DECLARATION TOSCA 500 13 3 Electromagnetic immunity RF portable equipment The TOSCA 500 system is intended for use in the electromagnetic environment specified below The customer or the user of the TOSCA 500 system should assure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment guidance test level Portable and mobile RF communications equipment should be used no closer to any part of the TOSCA 500 system including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms d 1 2 VP IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m IEC 61000 4 3 80 MHz to d 1 2 VP 80 MHz to 800 MHz 2 5 GHz d 2 3 VP 800 MHz to 2 5 GHz w
71. l quality of the measurement With motion the plethysmographic waveform is often distorted and may be obscured by artifact The Signal IQ shown as a vertical line coincides with the peak of an arterial pulsation Even with a plethysmographic waveform obscured by artifact the TOSCA 500 locates the arterial pulsation The pulse tone when enabled coincides with the vertical line of the Signal IQ The height of the vertical line of the signal IQ indicates the quality of the measured signal High vertical bar indicates a good quality signal Low vertical bar indicates a low quality signal When the signal quality is very low the accuracy of the SoO2 measurement may be comprised and a Low Signal IQ message is displayed When this message appears proceed with caution and check the following Assess the patient Check the sensor and ensure proper sensor application Determine if an extreme change in the patient s physiology and blood flow at the ear lobe occurred e g an inflated blood pressure cuff severe hypotension vasoconstriction in response to hypothermia medication or a spell of Rynaud s syndrome After performing the above and if the Low Signal IQ message is displayed frequently or continuously it may be considered to verify the oxygen saturation value by a co oximetry analysis Low perfusion PI The Perfusion Index PI is a relative assessment of the pulse strength at the monitoring site The
72. lay The message If more than one alarm is active all of them are muted The auditory alarm remains muted until the alarm fault condition is discontinued The auditory alarm will be reactivated by any new alarm fault condition Each new alarm can be muted the message ALARM MUTED appears below each corresponding alarm fault message in the middle LCD display Situation 2 The MUTE key is pressed when no auditory alarm is sounding no alarm condition or an auditory alarm has been muted The auditory alarm will be temporarily suspended for two minutes for all alarm fault conditions The message AUDITORY ALARMS SUSPENDED FOR 2 MINUTES appears during two seconds and the alarm suspended indicator lamp EN flashes during two minutes 67 ALARMS AND MESSAGES TOSCA 500 If during these two minutes an alarm fault condition occurs only the visual alarm flashing parameter value and or alarm fault message will be displayed The auditory alarm Suspension can be switched off within the 2 minutes by pressing the MUTE key a second time After the suspension period of 2 minutes the alarm suspended indicator lamp LX is switched off the auditory alarm is again active for all alarm fault conditions except for those which are muted WARNING If an alarm condition occurs while the auditory alarm is suspended the only alarm indication will be visual no alarm tone will sound While the auditory alarm is muted
73. lay contrast Before continuing set the optimal contrast for your viewing angle by pressing or while holding pressed see also section 7 2 5 Sensor Connect the sensor to the input socket at the rear of the monitor The label of the sensor plug must face upwards If the sensor was remembraned within the previous 14 days the message CALIBRATE SENSOR appears in this case skip the next step and proceed with calibration If the sensor is new or if the date of the last sensor preparation is older than 14 days the following message is displayed SENSOR REMEMBRANED _ NO Remembrane the sensor as described in section 5 4 Keep the sensor connected to the monitor during preparation with the monitor turned on When finished press to confirm the new preparation and to store the date in the sensor memory If the sensor is not remembraned at this time press the key If the date of the last sensor preparation is older than 14 days the message REMEMBRANE SENSOR will immediately appear when trying to start a calibration Calibration When confirmed with the message cattarare sensor SENSOR Place the sensor into the calibration chamber The calibration is now automatically initiated and the display shows appears CALIBRATING SENSOR 38 mmHg CAL Gas 29 OPERATION TOSCA 500 The figure identifies the PCO calibration value in mmHg or kPa see section 7 2 3 The bar indicates the
74. lected Selection OFF ON Default OFF AUDIO PULSE Selection of the loudness level of the auditory pulse signal LOUDNESS LEVEL The level cannot be set higher than the selected alarm loudness level This parameter is not selectable and is displayed as when the SpO2 PR parameter is disabled Range OFF 1 to 6 in steps of 1 Default value 3 RETURN TO To return to the main menu MAIN MENU Configuration YEAR MONTH DAY Setting of the current date HOUR MINUTE Setting of the current time DISPLAY CONTRAST Selection of the optimal contrast of the LCD display for a given viewing angle Range 1 to 20 in steps of 1 Default value 10 The display contrast can also be set at any time by pressing and while holding pressed 08 TOSCA 500 SYSTEM PARAMETERS MESSAGES DISPLAY BACKLIGHT Selection of the LCD display backlight mode ON the backlight is unconditionally switched on AUTO the display backlight is switched off if one of the following events persists for more than 5 seconds otherwise it is switched on No message is displayed or the sensor is in the calibration storage chamber No parameter selection is in progress No key is pressed No alarm is active Default ON KEY FEEDBACK TONE selection of the key feedback tone mode ON a tone sounds each time a key is pressed The volume of the key feedback tone is the same as that of the alarm tone
75. lled or downloaded Selection ON OFF Default ON PULSE AVERAGING TIME Selection of the pulse averaging time When 2 or 4 is selected the FastSat algorithm is automatically activated This parameter is not selectable and is displayed as when the SPO2 PR parameter is disabled Range 2 4 8 10 12 and 16 seconds Default value 8 s Note See section 3 2 3 for potential implications of a long averaging time SENSITIVITY Selection of the sensitivity mode of the pulse signal NORMAL sensitivity setting is for normal patient monitoring this mode is not displayed APOD Adaptive Probe Off Detection setting should be selected when the sensor is in danger of detaching from the patient due to wet skin severe motion or other circumstances MAX setting is for improved sensitivity performance on patients with extremely low perfusion The sensitivity settings APOD and MAX is displayed on the status screen if selected The sensitivity mode is not stored in user settings and is automatically reset to NORMAL after monitor was turned off Selection NORMAL APOD MAX Default NORMAL of SYSTEM PARAMETERS MESSAGES TOSCA 500 FASTSAT Selection of the FastSat algorithm ON the FastSat algorithm is activated In the 2 and 4 seconds pulse average mode the FastSat algorithm is automatically enabled OFF the FastSat algorithm is deactivated when 8 10 12 14 or 16 seconds of pulse average time is se
76. methemoglobin To convert fractional saturation to functional saturation the fractional saturation measurements must be converted according to Fractional saturation Functional saturation x100 100 carboxyhemoglobin methemoglobin Masimo SET The TOSCA 500 system incorporates the Masimo Signal Extraction Technology for SpO2 measurement The Masimo SET s signal processing differs from conventional pulse oximeters Conventional pulse oximeters assume that arterial blood is the only blood moving pulsating in the measurement site During patient motion however the non arterial blood also moves which causes conventional pulse oximeters to read low values because they cannot distinguish between the arterial and venous blood movement sometimes referred to as noise Masimo SET utilizes parallel engines and adaptive digital filtering Adaptive filters are powerful because they are able to adapt the varying physiologic signals and or noise and separate them by looking at the whole signal and breaking it down to its fundamental components The Masimo SET signal processing algorithm Discrete Saturation Transform DST reliably identifies the noise isolates it and using adaptive filters cancels it It then reports the true arterial oxygen saturation for display on the monitor Although venous saturation is not displayed TOSCA 500 with Masimo SET measures and calculates the values of both the arterial and v
77. mperature and barometric pressure The bar indicates the remaining gas level 100 full gas bottle Calibration of the sensor could not be completed within ten minutes and is continuing While the sensor is in the calibration storage chamber a potential malfunction is detected Clean sensor surface with an alcohol swab If the message reappears consult your service technician The TOSCA 500 monitor is not connected to mains and the battery runs low Connect the monitor to mains to recharge the battery TOSCA 500 TROUBLESHOOTING 9 TROUBLESHOOTING 9 1 During Monitoring Application After sensor application on the patient it takes longer than specified to reach a stable value After sensor application the tcPCO gt value does not increase within 5 minutes Sudden and unexpected decrease of tcPCO2 the message TOO MUCH AMBIENT LIGHT is displayed and no SpO2 amp PR values are displayed 9 2 physiological cause e g edema of the skin arteriovenous shunts etc too much Contact Gel no Contact Gel sensor is loosely attached air is between sensor and ear lobe the measurement is affected by light During Calibration evaluate the status of the patient reapply sensor using only one little drop of Contact Gel remove sensor from clip and apply one small drop of Contact Gel reattach sensor securely make sure that the sensor Is not exposed to bright light REMEMBRANE SENSOR
78. n Interface Cable 2m Standard 25 pin male connector Connection Connect the VueLink module to the TOSCA 500 Systems Connector with the VueLink Open Interface cable available from Philips and the TOSCA VueLink adapter cable Linde part No 500 0100 Operation When the VueLink protocol is selected see section 7 2 5 the VueLink module plugged in to the Philips Monitor Module device will automatically recognize the TOSCA 500 monitor and will appear as TOSCA on the VueLink module setup menu see section VueLink of the Philips Monitor documentation for setting and configuration of the VueLink module 97 EXTERNAL CONNECTIONS TOSCA 500 Available data The following real time data are available on the Philips Monitor through the VueLink Interface Numeric values and settings tcpCO2 tcPCO gt with alarm status SpO SpO gt 2 with alarm status PR with alarm status absolute HPWR PERF Perfusion Index PI sOxilv Pulse averaging time oximeter averaging interval Temp Sensor temperature TemSet Sensor temperature set Site time set format hh mm Barom Barometric pressure Bmode Barometric pressure mode Wave forms tcepCO 2 tcpCO tcPCO gt analog value SpOz analog value PR analog value PLETH PERF Pulse wave analog value 98 TOSCA 500 EXTERNAL CONNECTIONS 15 5 1 Messages Alarm messages TOSCA SPO2 LOW SpOz too low highest pri
79. n of being capable of to hear the auditory alarm signals to see which of the LED display and or LCD displays is flashing during alarm manifestation The operator should be capable to read the alarm messages on the LCD display during manifestation of medium and low priority visual alarm in order to determine the event of the alarm 65 ALARMS AND MESSAGES TOSCA 500 Visual alarm indication For physiological alarms see 7 2 1 the tcPCO2 SpO2 or Pulse Rate LED display is flashing and a corresponding alarm message is indicated on the middle LCD display For technical and operating alarms see 7 2 2 and 7 2 3 a corresponding alarm message is indicated on the middle LCD display and the LCD display backlight is flashing For each alarm message on the middle LCD display the first line of the display indicates the priority of the corresponding alarm as follows high priority 2 f f medium priority low priority l Example of high priority alarm message SP02 TOO LOW ALARM LIMIT XX The visual alarms are always active they cannot be switched off The visual alarm indications remains as long as the alarm conditions exists If more than one alarm is active all corresponding alarm messages will be displayed alternating Auditory alarm tone The type of alarm tone is different for each level The alarm tone of a HIGH PRIORITY ALARM consists of two bursts of five short pulses which ar
80. nction and control keys which are arranged in a straightforward and easily understandable manner Display The values of the three parameters tcPCOz SpO2 and PR pulse rate are displayed on three clearly visible bright LED windows Additionally the trend can be displayed on the middle screen during patient monitoring Together with the pulse rate value a bar graph indicates the pulse waveform In the center a wide backlit LCD window serves to guide the user through the selection of parameters and to show text messages during alarm and fault situations Four different display modes are available during operation Status Trend Plethysmogram and Heating power Patient safety The monitor fulfills the requirements of the Medical Device Directive 93 42 EEC The inputs are fully isolated and filtered so that the monitor can be used with defibrillators and diathermy apparatus Particular emphasis has been placed on the reliability of the sensor heating circuitry which incorporates full temperature control redundancy based on the proven dual thermistor approach In order to prevent excessively long exposure of the sensor to the skin a built in site timer alerts the user when the preset application time has elapsed 11 INTRODUCTION TOSCA 500 Storage of patient results The TOSCA 500 monitor incorporates a memory to store automatically all measured patient results for the last 72 hours using the FIFO First In First Out principle D
81. ndicated as a dotted line 6 2 2 Parameter settings Press to select the current TREND display mode Press to access the parameter setting mode MENU appears on the display Press or to move to the parameter which should be changed Press or to change it Trend parameter selection tcPCO2 SpO2 PR or PWR Default parameter tcPCOz2 For the heating power trend PWR the heating power display must be enabled in the configuration menu see section 7 2 5 For SpOz2 and pulse rate PR the SPO2 PR parameter must be enabled in the SoO2 menu see section 7 2 4 Parameter range values The maximum and minimum values may be changed to the values as indicated in the below table The difference between the maximum and minimum values is automatically adjusted so that it corresponds to at least three step values Parameter Minimum tcPCO gt 2 0 150 mmHg 0 20 kPa 50 200 mmHg 5 25 kPa 10 mmHg 1 kPa SpO gt 0 90 50 100 5 0 200 bpm 100 240 bpm 10 bpm PWR 0 800 mW 250 999 mW 50 mW A D Q 2 49 DISPLAY MODES TOSCA 500 Default values Parameter Minimum tcPCO2 O mmHg 0 kPa 80 mmHg 10 kPa SpO2 100 PR 150 bpm 999 mW Time window The time window of the trend graph can be defined by selecting the time period and the end time To display the actual trend define the time period and select the actual time as end time The start time is then automatically set
82. nditions Temperature 10 C to 40 C 50 F to 104 F Humidity lt 90 Ambient pressure 525 to 800 mmHg 700 to 1060hPa The ambient temperature must be at least 3 C lower than the set sensor temperature 5 2 Precautions The instructions regarding precautionary measures given below must be read prior to the installation of TOSCA 500 For electromagnetic compatibility see section 13 26 TOSCA 500 OPERATION WARNING The TOSCA 500 system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the TOSCA system should be observed to verify normal operation in the configuration in which it will be used When operated by AC power the monitor must only be connected to a three wire grounded hospital grade receptacle The three conductor plug must be inserted into a properly wired three wire receptacle if this is not available a qualified electrician must install one in accordance with the governing electrical code Do not under any circumstances remove the grounding conductor from the power plug Do not use extension cords or adapters of any type The power cord and plug must be intact and undamaged If there is any doubt about the integrity of the protective earth conductor arrangement operate the monitor on internal battery power until the AC power supply protective conductor is fully functional The correct type and rating of live and neutral fuses mu
83. ng line SPO2s No heading parameter Data line Possible codes are N no alarm A alarm active S alarm muted reset 95 EXTERNAL CONNECTIONS TOSCA 500 Column pos 6 PR value Heading line PR bpm lt limit gt Indication of the PR alarm limits low high valid PR bpm 050 150 for the next data lines Indication of if no value is available Data line lt value gt 087 Column pos 7 PR alarm status Heading line No heading parameter Data line Possible codes are N no alarm A alarm active S alarm muted reset Column pos 8 HPWR value Heading line HPWR mW lt HPWRref Indication of the lt HPWRref gt relative heating gt power reference valid for the next data lines HPWR mW 256 Data line lt value gt Indication of if no value is available 252 Column pos 9 Perfusion Index PI Heading line Perf Index l No heading parameter Data line Indication of if no value is available 12 3 Column pos 10 Sensor temperature Heading line Temp C lt set gt Indication of the temperature set valid for the next Temp C 42 0 data lines Data line lt value gt Indication of if no value is available 41 9 Column pos 11 Site timer Heading line No heading parameter Data line lt timer gt Site time left of the actual data line format 02 15 hnh mm Column pos 12 Mode Heading line No heading paramet
84. nsor preparation is detected In addition the memory feature allows the operator to change the sensor from one monitor to another without the need for a new preparation Easy remembraning For fast and easy new preparation remembraning of the sensor a convenient fit amp click preparator is provided which allows a reproducible sensor preparation within seconds A message is displayed when the sensor needs to be remembraned This is required once every 14 days A specially designed thin golden plate protects the sensor measurement surface from mechanical damage to the membrane This enhances the function time of the sensor and ensures a high reliability of the measurement 12 TOSCA 500 INTRODUCTION 2 4 Concept of operation 2 4 1 Transcutaneous PCQ Principle of measurement Transcutaneous measurement of PCO makes use of the fact that carbon dioxide gas is able to diffuse through body tissue and skin and can be detected by a sensor at the skin surface By warming up the sensor a local hyperemia is induced which increases the supply of arterial blood to the dermal capillary bed below the sensor The transcutaneous PCO value tcPCOz2 has to be interpreted primarily as the PCO partial pressure prevailing at the level of the arterialized skin tissue In general this value correlates well with the corresponding arterial PCOz2 partial pressure The PCO part of the TOSCA sensor consists of a Stow Severinghaus type electrode
85. ock triggers an alarm when the selected measuring duration has elapsed Indication of remaining site time Sensor fault Automatic shut down of heating in case of sensor fault triggered by one of the following conditions actual temp gt set temp 1 C for 4 sec actual temp lt set temp 1 C for tmax maximum time tmax is normally 30 sec but 5 min during warming up of the sensor actual temp set temp gt 0 3 C for tmax difference between thermistors gt 0 6 C for 4 sec difference between thermistors gt 0 3 C for tmax 80 TOSCA 500 SPECIFICATIONS Alarms Adjustable low and high limits for PCO2 SpO2 and pulse rate PR Audio and visual alarm indication Audio alarm loudness adjustable from level 1 to 6 corresponding to the following sound pressure range High priority 52 to 72 dB A 5 dB Medium priority 46 to 66 dB A 5 dB Low priority 43 to 63 dB A 5 dB Sound pressure level measured at 1m according to IEC 60601 1 8 clause 201 3 3 2 Power supply Either by AC line voltages of 200 240 V 410 and 100 to 120 V 410 50 60 Hz or by an external battery 12 24 V 20 VA max consumption Internal battery Lead acid cell 12 V 1 8 Ah rechargeable Typical operating time 1 hour Complete charging time if empty 24 hours Protection Protection against electrical shock Class I when connected to AC line voltage 100 120 or 200 240 Vrms Internally Pow
86. of the dysfunctional hemoglobin e g carboxyhemoglobin or methemoglobin intravascular dyes such as indocyanine green or methylene blue expose to excessive illumination such as surgical lamps especially ones with xenon light source bilirubin lamps fluorescent lights infrared lamps or direct sunlight exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material excessive patient movement venous pulsations Loss of pulse signal can occur in any of the following situations there is too much pressure on the sensor e g the patient lies on the sensor there is excessive illumination from light source such as a surgical lamp a bilirubin lamp or sunlight the patient has hypotension severe anemia or hypothermia there is arterial occlusion proximal to the sensor the patient is in cardiac arrest or is in shock 37 OPERATION TOSCA 500 WARNINGS Effect of temperature on skin Effect of temperature on skin prolonged exposure to the heated sensor may cause a skin burn The recommendations on sensor temperature and exposure time given in section 3 2 2 should be read carefully before using the instrument on a patient Failure of operation If the monitor fails to operate as described do not use it until the problem has been corrected by an authorized service technician Failure of sensor function In spite of the extensive measures for automa
87. of the ear lobe Squeeze gently to ensure that the adhesive area sticks firmly to the ear lobe Make sure that no air is under the adhesive area Apply a small drop of Contact Gel to the visible skin area in the center of the retainer ring just enough to slightly wet it Remove the sensor from the calibration chamber and insert it into the retainer ring of the clip Press slightly until it snaps in Twist the sensor into the best position Make sure that the sensor cable is loose and will not be stretched during monitoring Route the sensor cable properly to avoid strangulation 33 OPERATION TOSCA 500 l Attach the sensor cable with the black cable clip on an appropriate site of the patient clothing After the sensor has been applied the following message is displayed for up to five minutes PRESS START KEY TO START MONITORING alternating with PC02 SP02 PR ALARMS ARE DISABLED UNTIL MONITORING IS STARTED and alternating with the selected display mode 5 5 2 Application with the TOSCA Fixation Ring Measuring sites The choice of the measuring site depends on the parameter to be measured Parameters Measuring sites SpO2 PR and tcPCO2 Forehead simultaneously Contraindications The use of those measuring sites are contraindicated for patients who exhibit allergic reactions to adhesive tapes 34 TOSCA 500 OPERATION tcPCO2 only Thorax left and right side below the clavicles Abdomen Uppe
88. ons concerning the use of line operated printers in close proximity to patients must be considered CAUTION The resulting electrical medical system must comply with EN 60601 1 1 Printing Connect printer to monitor Access the MENU PRINT SETTINGS Select PARAMETER TO PRINT and define the requested parameter to be printed Select PRINT MODE and define the requested print mode Select START PRINTING and press for two seconds to start the printer When the recording is completed Select STOP PRINTING and press _ to stop the printer see section 7 2 7 for printer settings 5 9 Power supply interruption If the TOSCA 500 monitor is switched on and the energy supply of the monitor is no longer sufficient to guarantee safe functioning i e internal battery is almost empty and the monitor is not connected to the mains supply the power is automatically switched off and an alarm tone sounds see section 8 1 for power failure alarm In this case switch off the TOSCA 500 monitor connect it to the mains supply and switch it on again The parameter settings and patient data are stored in memory as long as the internal battery is not completely empty even if the TOSCA 500 monitor is switched off internationally or automatically and disconnected from the mains supply When the monitor is switched on again the data and settings are available as previously stored See section 10 3 for battery refresh ch
89. ority TOSCA PCO2 HIGH _ PCO too high TOSCA PCO2 LOW PCOz2 too low TOSCA SPO2 HIGH SpOz too high TOSCA PR HIGH PR too high TOSCA PR LOW PR to low lowest priority Note The following alarm philosophy is used on the Philips Monitor with the TOSCA 500 VueLink Module The alarm messages described above are yellow priority alarms The alarm signals are indicated on the display of the Philips Monitor by an alarm message on the center of the upper line and by the blinking of the related measured value if displayed The alarm signals disappear on the Philips Monitor if the related auditory alarm signals on the TOSCA 500 monitor are muted Only one of the alarm messages described above is displayed at time If more than one alarm condition is present only the alarm message with the highest priority is displayed INOP messages TOSCA MONIT FAULT Monitor fault highest priority TOSCA SENSOR FAULT sensor fault CONNECT TOSCA SENS Connect sensor or Unknown sensor or Update software TOSCA SENSOR OFF Sensor off patient TOSCA AMBI LIGHT Too much ambient light interference Searching pulse signal Site time elapsed No gas flow renew gas bottle lowest priority 99 EXTERNAL CONNECTIONS TOSCA 500 Note The following INOP philosophy is used on the Philips Monitor with the VueLink Module An INOP message is indicated on the lef
90. ors for equipotential ground Equipotential ground connector adjacent to this symbol Equipotential earthing in treatment areas used for cardiac procedures is intended to minimize any voltage differences between earthed parts of the equipment and any other exposed metals in the room A Attention Read the instructions before using the connector adjacent to this symbol 25 OPERATION TOSCA 500 5 OPERATION 5 1 Initial setup of the system The TOSCA 500 system is delivered with following items 1 TOSCA 500 monitor 1 Power Cord 2 Mains Fuses 1 TOSCA Sensor 92 1 Starter Kit including 2 Sensor Preparators 1 TOSCA Sensor Electrolyte 10 ml 1 Contact Gel 10 ml 20 Attachment Clips 1 CAL Gas cylinder 1 Operating Manual English 1 Sensor application and preparation card Unpacking Unpack the TOSCA 500 monitor the TOSCA sensor 92 and the accessories Inspect the monitor and sensor for visual damage and clean if necessary Follow local regulations regarding disposal of packaging waste Location The monitor should be located so that the sensor cable is close enough to the patient and will not be unduly stretched by movements of the patient The alarms produced by the monitor should be clearly audible from the operator s position Lighting on and around the monitor should be such that the displays and indicator lamps are clearly legible and visible Operating environmental co
91. r FS SACI ONS areri cpr avec eco 9a ne cnc nc ns Sampo a este ee 26 neyo 10 og 6 a 921 Oe MR OT IPTC erro E AE 28 DENSON DIED alallO Mrasisusencesandctce cas cntinsand entehonseiehtunssathandiatebauabalesa diate sale aa 31 nyo Ac gers 1 ele 010 EEA eT eet eno ne E AERE ENE NE ENEN Oe SENEE SEEE SE S 32 Application at the ear lobe with the Attachment Clip ccc ccccceeeeeeeeeeeeeeee esse eens 33 Application with the TOSCA Fixation RING c cccsecceeeseeseeeeeeeeceeeeseeeeeeeeeeeeeeneeees 34 Fale AU MOUMONIN GO scccchacerc chactatera ctstebe ccatscatutdidiet siete etotehoehcishouhieehoehatdhocshoteral arc auad 36 ROMOV el pala SENSO inner aT re nn eee ee 39 Removal of the Sensor from the clip cccccceccceeceeceeeceeeeeeeseteeeseeceeeeeeeseseeeseetaeeseeees 39 Removal of the sensor and the clip from the eaf ccc cccccecceceeeeceeeeeeeeeeeeeeeeeeeeeeeees 40 Removal of the sensor from the TOSCA Fixation RING ccccececeeeseeeeeeeeeeeeeeeeeees 41 ODES FAL GH WIS DINU ecnsinctanniarisazesinvansraucaaviirtiwaraanysntateabuatvatcloauibrdivalbrb Ea 41 TOSCA 500 99 POWer SUDDIV INTERMUDUOMN cierre E AE AA 42 6 DISPLAY MODE Ssss E reseed suenendunrenety testes 43 01 STATUS GISDIAY scs cesratescesnatenccenatenteanatasteanatacmennaecetaenanscsace sieaeennancaccieauseaanonaiasmeaneenaadan 43 Oli DESIDI anne Ree a Cn eee eon eee ee ee ee 43 6 1 2 Ff alameten Selg Si sextuzaiuenicasthavinaceh
92. r application Proceed to section 5 5 for sensor application 30 TOSCA 500 OPERATION Stand by conditions The monitor must always be turned on and the sensor must be stored in the calibration chamber even when the system is not in use The system automatically performs a calibration every 4 hours while the sensor is in the chamber This ensures that the sensor is always in good operating condition and READY TO USE 5 4 Sensor preparation 1 Ensure that the sensor is connected to the monitor which must be turned on Remove the membrane retainer ring assembly using the V shaped notch of the preparator base Discard the old retainer ring assembly Note A new sensor Is delivered without membrane In this case start with step 2 Clean the sensor surface with a tissue soaked in clean water This will also remove the spacer Dry the sensor surface and make sure that no fibers remain from the tissue Note Do not leave unprepared sensor in air Proceed immediately with the next steps SENSOR REMEMBRANED i This message appears Leave unanswered until step 8 Lift up the cover of the preparator and place two drops of TOSCA sensor electrolyte into the center of the retainer ring assembly Insert the sensor with its surface pointing downwards into the preparator base until it is slightly locked Do not apply pressure Close the cover of the preparator and press it down until the new retainer ring clicks into
93. r arm Thigh WARNING The measurement of SpO and PR are not reliable on these sites In order to avoid erroneous readings and false alarms of SpO and PR these parameters must be turned off in the SPO2 PR Parameter menu of the monitor Sensor application Clean the skin at the monitoring site with an alcohol swab and dry it Pull out one TOSCA Fixation Ring and remove it from the paper strip Attach the Ring to the measuring site and press gently onto the Ring Then run a finger around the rim circumference to ensure a good seal Apply two drops of Contact Gel to the skin area in the center of the ring Remove the sensor from the calibration chamber and insert it into the TOSCA Fixation Ring Press the sensor gently against skin until it snaps In Twist the sensor into the best position 39 OPERATION TOSCA 500 Secure the sensor cable with an adhesive tape WARNING Do not use the TOSCA Fixation Ring at the ear lobe This would lead to unreliable readings After the sensor has been applied the following message is displayed for up to five minutes PRESS START KEY TO START MONITORING alternating with PCO2 SP02 PR ALARMS ARE DISABLED UNTIL MONITORING IS STARTED and alternating with the selected display mode 5 6 Patient monitoring The application site ear lobe should be checked periodically during the monitoring It is important to check that the sensor does not become detached
94. r temperature of 42 C In this case Fy is not automatically adjusted to the sensor temperature When selecting Fr 1 and Cy 0 no correction is applied For calculating the PCO calibration values the barometric pressure is taken into account in both cases PCO In vivo correction In addition to the temperature correction the tcPCOz2 value can be adjusted based on the result of an arterial blood gas analysis This possibility is provided for special applications or when a systematic difference between tcPCOz and PaCOsz is clearly established by several arterial blood gas measurements When this correction is made it must be checked periodically and adapted in cases of changes 2 4 2 Oxygen saturation SpO General description Pulse oximetry is a continuous and non invasive method of measuring the level of arterial oxygen saturation in blood The measurement is taken by attaching the sensor at the ear lobe of the patient The sensor collects signal data from the patient and sends it to the monitor The monitor displays the calculated data in three ways asa percent value for arterial oxygen saturation SpO2 asa pulse rate PR and asa plethysmographic waveform Principle of measurement Pulse oximetry is governed by the following principles Oxyhemoglobin oxygenated blood and deoxyhemoglobin non oxygenated blood differ in their absorption of red and infrared light spectrophotometry The amount of a
95. ration value This constant is used in combination with the tcPCO 2 temperature correction factor see section 2 4 1 for details Range 0 to 8 mmHg 0 0 to 1 0 kPa in steps of 1 mmHg 0 1 kPa Default value 5 mmHg 0 7 kPa It is recommended to select the following settings tcPCO2 temperature correction factor AUTO tcPCOz2 metabolic constant 5 mmHg IN VIVO PCO2 Selection of the option to adjust the tcPCOz to the arterial CORRECTION blood gas value Only when ON is selected the IN VIVO PCO2 CORRECTION mode is activated at the level of PCO2 PARAMETERS and the correction value can be entered there see section 7 2 2 Selection ON OFF Default OFF 99 SYSTEM PARAMETERS MESSAGES TOSCA 500 IN VIVO AUTOMATIC This parameter is active only when the IN VIVO RESET CORRECTION parameter is ON and allows to turn ON or OFF the automatic reset feature ON The entered in vivo correction value is automatically reset to zero after a sensor calibration OFF The entered in vivo correction value remains active even after a sensor calibration Four dashes are displayed when the IN VIVO CORRECTION is turned OFF disabled Selection ON OFF Default ON BAROMETRIC The barometric pressure is used to calculate the tcPCOz PRESSURE MODE calibration value Selection of the options AUTO or MANUAL AUTO the barometric pressure measured by the monitor is automatically set MANUAL the barometr
96. remaining gas level in the CAL Gas bottle If the calibration cannot be completed within ten minutes the message EXTENDED CALIBRATION 38 mmHg CAL Gas o B 100 appears and the calibration continues If the calibration is not possible this will be indicated by the message REMEMBRANE SENSOR In the case of a new sensor or an unprepared sensor stored in air before remembraning ignore this message and leave the sensor in the calibration storage chamber for at least four hours preferably overnight This time is required for stabilization of the PCOz2 part of the sensor Thereafter initiate a new calibration by pressing for four seconds Ready to use When the calibration is successfully completed the message READY TO USE with date and time appears The sensor is now ready to be used for patient monitoring Parameter settings The TOSCA 500 monitor is delivered with default parameter settings Check the settings as described in section 7 and change them as required At least check and define following parameters Arterialization mode see section 3 2 2 and 7 2 2 Sensitivity see section 3 2 3 and 7 2 4 Sensor temperature 42 C recommended see section 3 2 2 Site time see section 3 2 2 Alarm limits see section 7 2 1 Note During patient monitoring the alarm functions may be tested by setting the alarm limits so that the current parameter reading is outside the alarm limit range Senso
97. rterial blood in tissue changes with the pulse photoplethysography Therefore the amount of light absorbed by the varying quantities of arterial blood changes as well The TOSCA 500 uses a two wavelength pulsatile system to distinguish between oxygenated and deoxygenated blood Signal data is obtained by passing red 658 nm wavelength and infrared 880 nm wavelength light through a capillary bed and measuring changes in light absorption during the pulsatile cycle The TOSCA sensor 92 utilizes red and infrared light emitting diodes LEDs that pass light through the site to a photodiode photodetector The 14 TOSCA 500 INTRODUCTION photodetector receives the light converts it into an electronic signal and sends it to the TOSCA 500 monitor for calculation TOSCA Sensor 92 LEDs photodiode i o i a earlobe b vascular bed N attachment clip Once the TOSCA monitor receives the signal from the sensor it utilizes Masimo SET signal extraction technology for calculation of the patients functional oxygen saturation and pulse rate Functional vs fractional saturation The TOSCA 500 measures and displays functional saturation the amount of oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen The TOSCA does not measure fractional saturation oxygenated hemoglobin expressed as a percentage of all measured hemoglobin including measured dysfunctional hemoglobin such as carboxyhemoglobin or
98. s may also be changed in the main menu The alarm limits for SpO2 and pulse rate are available when SPO2 PR is enabled The sensor temperature the PCO2 unit and the mode of arterialization can only be changed in the main menu See section 7 2 for parameter description Press to access the parameter setting mode MENU appears on the display Press or to move to the requested value Press or to change it Note A change of the remaining site time will also change the setting of the total site time 6 2 TREND display autocal ALARM K ur Go MENU SETTING POWER ON 44 TOSCA 500 DISPLAY MODES 6 2 1 Description This mode allows the graphical presentation of the trend of one of the four parameters tcPCO2 SpO2 PR and PWR heating power if the Heating Power parameter is enabled in the CONFIGURATION menu Trend graphs The trend of the selected parameter is displayed within a defined time window It is possible to display the actual trend or the trend of max 12 hours during selectable time periods within the previous 72 hours patient data memory Blank spaces indicate those time intervals in which no values are available e g while the sensor is placed in the calibration storage chamber or while the monitor is turned off Alarm limits The active low and high alarm limits are indicated as two dotted lines Heating power reference The relative heating power reference value is i
99. ser settings WARNING A potential hazard can exist if different alarm settings are used for several TOSCA 500 monitors and or similar devices in a single area It is recommended to check the alarm settings before starting monitoring See parameter settings in section 5 3 Setup for operation ERASE PATIENT DATA Option to erase the complete contents of the 72 hours patient data memory Press for two seconds to erase these data The message PATIENT DATA ERASED is displayed to confirm the action 60 TOSCA 500 SYSTEM PARAMETERS MESSAGES STORE USER SETTINGS Option to store the current parameter settings as user settings This function can only be executed by an authorized person who is responsible for the operation of this equipment Press for two seconds and the following message is displayed CONTACT A PERSON AUTHORIZED TO STORE THE USER SETTINGS RESTORE USER SETTINGS Option to restore the last defined user settings and those default factory parameter settings which are not available in the user settings memory Press for two seconds to restore the settings The message USER SETTINGS RESTORED is displayed to confirm the action RESTORE FACTORY Option to restore the factory parameter settings This SETTINGS function can only be executed by an authorized person who is responsible for the operation of this equipment Press for two seconds only the following message is displayed
100. sion of real time data on host request see section 15 6 for details Note In the messages Heading and Data lines PCO stays for tcPCOz2 15 4 EasyLink Easy operation When the EASYLINK communication protocol is set the TOSCA 500 monitor sends automatically real time data The data format used is ASCII CSV Coma Separated Values which simplify the treatment of data by the PC or CMS host device Easy connection To connect the PC or CMS to the TOSCA 500 Systems Connector you need only a 3 wire shielded cable Example of connection to a PC serial COM port TOSCA 500 DB 37 PCDB 9 pin2 TxD pin 2 RXD _ pin 3 RxD pin 3 TxD pin 20 GND pin 5 GND pin 21 GND Shielding pin 5 GND Principle Real time data is continuously sent to the serial port A new line of data is send every second Column heading line will be send after every 60 data lines or if one of the values in the column heading changes Serial port settings Baud rate of 19200 8 bit data even parity 1 stop bit without handshaking 94 TOSCA 500 EXTERNAL CONNECTIONS Memory dump download The host device can request a memory dump download of the last 72H patient data Also the results can be downloaded to a printer or to a personal computer PC The monitor automatically stores the measured patient data over the last 72 hours according to the FIFO First In First Out principle Data are stored whenever values are displayed e
101. son the contents of this publication are subject to change without notice Copyright 2010 Radiometer Basel AG TOSCA 500 QUALITY RELIABILITY AND SAFETY This equipment is designed with an emphasis on QUALITY RELIABILITY AND SAFETY but Radiometer Basel AG will accept responsibility for these aspects only when the following conditions are met Electrical installations of the room or building in which the equipment is to be used must comply with regulations specified by the country in which the equipment is to be used The equipment is used in accordance with the instructions for use provided by Radiometer Basel All modifications and repairs to the equipment must be carried out by Radiometer Basel or by authorized service technicians Modifications must not be carried out unless they conform with approved Engineering service Information issued according to the appropriate Radiometer Basel procedure Equipment installation must be carried out in accordance with local requirements regarding responsibility and warranty Only original sensors and accessories of Radiometer Basel must be used Other sensors and accessories may cause improper monitor performance TOSCA 500 TABLE OF CONTENTS 2 1 2 2 2 3 2 4 2 4 1 2 4 2 3 1 3 2 3 2 1 3 2 2 3 2 3 3 3 3 3 1 3 3 2 4 1 4 1 1 4 1 2 4 1 3 5 1 9 2 9 3 5 4 5 5 9 5 1 9 9 2 5 6 W Iaa 9 1 2 9 7 3 5 8 SAFELY INFORMATION icorcrsien n
102. st always be used The monitor has no mains switch Disconnect the mains plug to isolate the monitor from the supply mains Note Do not connect to an electrical outlet controlled by a wall switch or dimmer When connecting other equipment to TOSCA 500 the manufacturer of the equipment or a qualified engineer must be consulted to ensure 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 When the monitor is operated by an external battery which is connected to a battery recharging device this device must be medical grade double isolation To ensure patient electrical isolation connect only to other equipment with electronically isolated circuits As with all medical equipment carefully rout patient cabling to reduce the possibility of patient entanglement or strangulation Do not place the monitor in any position that might cause it to fall on the patient Do not lift the monitor by the power supply cord or sensor cable use the handle of the monitor CAUTION Do not expose the monitor to high humidity or heat for details see specifications in section 12 3 2 OPERATION TOSCA 500 5 3 Setup for operation Main steps to setup In the following the main steps and processes required to setup the system are summarized The details of each step are described below Check the monitor for the correct mains voltage setting re
103. t of the upper line on the Philips Monitor display as long as the related visual message is displayed on the TOSCA 500 monitor Only one of the INOP messages described above is displayed at time If more than one INOP condition is present only the INOP message with the highest priority is displayed Auditory alarms The above described VueLink messages do not generate auditory signals on the Philips Monitor Calibrating sensor Ready Ready to use Applic Sensor application monitoring not started Monit Monitoring in progress 15 5 2 VueLink Task Window example AUXI LI ARY PLUS tcpCO 100 tepco Monit on 0 Mode Monit Device Alarms Accepted tcpco 39 mmHg Spo 97 s PR 67 bpm HPwr 275 _ mi PERF 1 2 Temp 41 9 c Barom 769 mmHg Timer 3 24 HM TemSet 42 0 c Bmode auto TimSet 4 00 Hm 100 TOSCA 500 EXTERNAL CONNECTIONS 15 6 MonLink TOSCA 500 Transmission of real time data on host request 15 6 1 Serial port configuration Baud rate 9 6 kBd ASCII 7 bit Parity even 1 Stop bit Pins 2 3 4 5 15 6 2 Communication protocol The monitor is always assumed to be slave in the sense that it cannot transmit information unless it has been requested to do so The messages are always transmitted in ASCII To initiate a communication the requesting device pulls RTS true and waits until the monitor replies with CTS true Transmission can then proceed
104. ternational regulations The alarm system employs three levels high priority physiological alarm medium priority technical alarm low priority operating alarm They are defined as follows High priority alarm Signal indicating that immediate operator response is required in the situation of Physiological alarms A physiological alarm is activated if a monitoring value equals or falls outside the set alarm limits The triggering delay of the high priority physiological alarm signal is one to five seconds depending on monitor conditions Medium priority alarm Signal indicating that prompt operator response is required for the following situations Monitor fault and sensor fault Technical alarms which prevent measurement or accurate measurement of a physiological parameter i e no sensor no signal Low priority alarm Signal indicating that operator awareness is required for the following situations Site time elapsed Other technical alarms e g no gas flow request to calibrate sensor All alarm messages are indicated by an auditory and visual signal flashing of the parameter or of the middle display dependent on the alarm level The alarm indications auditory and visual disappear automatically when the alarm condition is ceased See section 8 2 for description of alarm messages Operator s position In order to respond to alarm signals the operator should be in a positio
105. tic error recognition certain sensor failures may not always be detected by the device e g deactivation of the surface It is therefore referred to the possibility of performing a simplified function test of the sensor see section 10 2 Application failure The recommendations given in this manual concerning the selection of the measuring site and the application of the sensor should be read carefully An incorrect application or handling of the sensor can entail false measured values Monitoring end Before the preset site time of a monitoring session is elapsed the message SITE TIME REMAINING xx MIN indicating the remaining time 10 of the preset site time appears When the monitoring time site time is elapsed the message SITE TIME ELAPSED appears along with an audible alarm Remove the sensor from the clip See section 5 7 Clean the sensor surface with alcohol Place it into the calibration chamber When the calibration is completed reapply the sensor to the other ear lob of the patient if requested proceed as described in section 5 5 step 1 when a new clip is used or section 5 5 step 4 when the clip is at the ear 38 TOSCA 500 OPERATION 5 7 Removal of the sensor The sensor must be removed from the ear lobe when the site time of the patient monitoring period is elapsed Long term monitoring For continuous and long time monitoring of a patient the sensor can be moved from one ear
106. tuation The sensitivity level can be selected in the parameter menu of TOSCA 500 and includes the options of APOD Normal and Max The APOD Adaptive Probe Off Detection technology is a special feature of the Masimo SET technology It is a suite of complex and powerful signal processing algorithm that carefully analyze the incoming signal to determine if the TOSCA sensor is on or off the patient The following sensitivity levels can be selected in the parameter settings of TOSCA 500 APOD is the least sensitive in picking up on patients with low perfusion Normal sensitivity provides the best combination of sensitivity and sensor off detection performance and is recommended for the majority of patients Max sensitivity is reserved for the sickest patients where obtaining a reading is most difficult Max sensitivity is designed to interpret and display data for even the weakest of signals and is recommended during procedures and when clinician and patient contact is continuous If low perfusion combined with movement inhibits the TOSCA 500 monitor from readings switch from APOD to Normal or Max sensitivity see section 7 2 4 for parameter settings 3 3 Limitations 3 3 1 Transcutaneous PCO measurement Under the following clinical situations there is according to current knowledge limited or no correlation between transcutaneous and arterial PCOz profound peripheral vasoconstriction circulatory centralization shock
107. use damage to internal components Do not touch press or rub the display panels with abrasive cleaning compounds instruments brushes rough surface materials or bring them into contact with any that could scratch the panel Do not use petroleum based or acetone solutions or other harsh solvents fo clean the monitor These substances attack the device s materials and device failure can result Cleaning Where an equipment has been used but is not visibly contaminated first wipe its surface with cotton wool swabs soaked in isopropyl alcohol 70 and then dry the surface with a disposable cloth Disinfecting Where surfaces of an equipment or accessories are visibly contaminated wipe the surfaces with cotton wool swabs soaked in a surface disinfection solution containing e g quaternary ammonium derivatives to remove all visible traces of soiling Then apply the disinfection solution to the surfaces keeping them wet according to the recommendation of the disinfecting solution manufacturer Rinse the surfaces with water and then dry them using disposable cloths Take care that liquids do not enter the equipment or connectors Dispose of swabs in the receptacle for biological waste immediately after use 78 TOSCA 500 DECONTAMINATION 11 3 Risks All human or animal tissues or fluids in the hospital and laboratory environment are capable of transmitting infection Therefore special precautions must be taken in hospitals and
108. ustment or new calibration of the monitor required It is recommended to perform a safety check at regular intervals or in accordance with local and governmental regulations see Service Manual for details The safety check must be done by a trained and authorized service technician only CAUTION If one of the above tests should fail call an authorized service technician Sensor A simplified function test of the PCOz part of the sensor may be carried out as follows Following a calibration expose the sensor for approximately one to two minutes to ambient air The displayed tcPCO2 value should drop to a value below 5 mmHg 0 7 kPa If this value is not reached remembrane the sensor and repeat the test After a renewed missing of this value consult an authorized service technician 10 3 Battery Refresh Charge The TOSCA 500 monitor incorporates a battery which is recharged automatically while the monitor is connected to mains When the monitor is not in use and not connected to mains 16 TOSCA 500 MAINTENANCE for more than 3 months the battery charge must be refreshed This ensures the functional capability of the battery and prevents the loss of the parameter settings For a full charge connect the TOSCA 500 monitor to mains power for 24 hours CAUTION If the monitor stays without any electrical energy monitor disconnected from the mains supply and internal battery is empty the patient data are cleared and the current an
109. ution 1 bom Accuracy 3 bpm The pulse rate accuracy has been validated in bench testing against a Bio Tek Index 2 SpOz Simulator with a signal strength set to 1 SpO and Pulse Rate Signal averaging over 2 4 8 10 12 14 and 16 sec Sensitivity APOD normal or maximum Perfusion Index PI Range 0 02 9 99 and 10 0 20 0 Low perfusion accuracy In low perfusion situations the SoO2 and Pulse Rate accuracies mentioned above have been validated in bench testing against a Bio Tek Index 2 SpO2 Simulator with a signal strength set to 0 03 Heating Power Resolution 1mW Range 0 999 mW 12 4 Environmental conditions Operating conditions Temperature 10 to 40 C Relative humidity lt 90 Ambient pressure 525 to 800 mmHg 700 to 1060 hPa The ambient temperature must be at least 3 C leaver than the set sensor temperature 84 TOSCA 500 Transport and storage conditions in original factory packaging Designation Temperature Relative Ambient humidity pressure Storage Transport Storage Storage 2 weeks Transport Transport 520 100X TOSCA 500 Monitor 562 1000 TOSCA Sensor 92 500 0101 TOSCA PC Interface Cable 500 0100 TOSCA VueLink Adapter Cable 500 0115 TOSCA Open End Interface Cable 5V FS 500 0116 TOSCA Open End Interface Cable 1V FS 500 0117 TOSCA Open End Nurse Call Cable 560 1100 TOSCA Sensor Preparator Supplies 1 bottle of 10 ml 10 to
110. y if a message is displayed Keys to decrease increase the value of a selected parameter If no parameter setting is in progress pressing or for more than 2 seconds will start or stop the printer See section 7 2 7 for details 10 Alarm suspended indicator lamp to indicate that the auditory alarm is suspended flashing See section 8 1 for details Auditory alarm mute key to mute or suspend the auditory alarm See section 8 1 for details for PCO2 which is enabled only after five minutes and the site time clock is started See section 8 3 for details By pressing this key for four seconds a calibration can be activated when the sensor is within the calibration chamber During this calibration the PCO2 value is displayed Key to start monitoring of a patient The parameter alarm detection is enabled except 13 Calibration and storage chamber for the TOSCA sensor 92 An automatic calibration of the sensor is executed when the sensor is placed into the chamber Spool for sensor cable 4 1 2 Underside Adjustable feet Labels indicating Warning statements Device type CE mark Serial number Service status of instrument ESI Software revision status Masimo patents 23 DESCRIPTION OF THE MONITOR TOSCA 500 4 1 3 Rear panel eee PARALLEL INTERFACE SYSTEMS CONNECTOR INTERFACE WARALLELE INTERCONNEETEUR E S e00000000000 O oo00000000000000006 oooc090000Gc0000 oocococoooooooooo0o0o0o0o0

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