Anleitg_OxyTrueA_ENG 1.1.indd
Contents
1. OT CHECK MONITORING OF FUNCTIONAL ARTERIAL OXYGEN SATURATION SPO2 AND PULSE RATE PRODUCT No 1020112001 conforms with the essential requirements of Annex of the Council Directive 93 42 EEC of 14 June 1993 concerning medical devices In accordance with Annex IX of the Directive 93 42 EEC the product has been classified as Class IIb Application of the CE marking Issuer bluepoint medical GmbH amp Co KG An der Trave 15 D 23923 Selmsdorf Germany Place Date Selmsdorf 12 Nov 2007 va 1 hj Legally binding signature eee ieee anne Bernd Lindner Managing Director OxyTrue A User Manual bluepoint MEDICAL GmbH amp Co KG 2007 bluepoint MEDICAL GmbH amp Co KG An der Trave 15 23923 Selmsdorf Germany Phone 49 38823 548 8000 Fax 49 38823 548 8029 E mail info bluepoint medical com www bluepoint medical com OxyTrue A User Manual Version EN 1 12. and duration of the recording The SpO2 reading is shown in green and the pulse reading in red The yellow lines repre sent the respective alarm limits 4 1 3 Submenu Device Setup 4 1 3 1 General Information Volume SpO2 Averaging Date Time Brightness Language Service Exit This submenu offers access to various device set tings confirm selection by pressing the lt button 4 1 3 2 Adjusting Settings Adjust the pulse tone volume using the AV buttons Confirm new setting by pressing the lt button C Stable EM Standard C Sensitive Exit Stable When this setting is selected any strong and sudden variations in data will not immediately affect the reading data incorporated over time minor ir regularities have little or no effect on the displayed reading Standard Averaging parameters used for this setting are between those of the stable and sensitive settings Sensitive The reading is more sensitive to irregulari ties but reacts very quickly to any changes in measu red parameters OxyTrue A User Manual bluepoint MEDICAL GmbH amp Co KG 2007 Y M D Date 2007 08 07 Time 17 36 Exit First select between 12h mode and 24h mode then set date and time Settings for date and time are not erased when the batteries are temporarily removed Adjust display brightness using the AV buttons Confirm new setting by pressing the lt button Please note Very high brightness set
3. bluepointmeo caL AZ Table of Contents W 1 Intended Use Warnings 2 Controls Symbols Display Modes 2 1 Controls and User Interfaces 2 2 Display Modes and Displayed Data 2 3 Symbols and Indicators 2 4 Audible Indicators 2 4 1 Pulse Tone Beep 2 4 2 Audible Warning Signal 2 4 3 Alarm Signals IQ NHS RA J 3 Preparation for Use 4 Screen Contents Menu Structure 4 1 Main Menu 4 1 1 Submenu Alarm Settings 4 1 1 1 General Information 4 1 1 2 Adjusting Settings 4 1 2 Submenu Data Management 4 1 2 1 General Information 4 1 2 2 Data 4 1 3 Submenu Device Setup 4 1 3 1 General Information 4 1 3 2 Adjusting Settings 4 2 Other 4 2 1 Volume Control Shortcut 4 2 2 Brightness Control Shortcut 4 2 3 Power Save Mode O O XD X X 0 N N NN O O O O NO 5 Error Messages Problems Corrective Actions 10 5 1 General Information 10 5 2 Error Messages Causes 10 5 3 Failure Cause Corrective Action 10 6 Maintenance Cleaning 12 7 Symbol Definitions 12 8 Technical Specifications 12 9 Packing List Accessories and Replacement Parts 13 10 OxyTrue A PC Software 13 11 Declaration of Conformity 14 Contact address 15 OxyTrue A User Manual bluepoint MEDICAL GmbH amp Co KG 2007 1 Intended Use The OxyTrue A handheld pulse oximeter is indicated for continuous or spot check monitoring of functio nal arterial oxygen saturation SpO2 and pulse rate of adult pe
4. ction o Sensor Port Port for the SpO2 sensor Dez A Arrow Buttons Vv up down USB USB 2 0 interface To turn on the device press and hold power button briefly To turn off the device press and hold power button for approx 3 seconds Multifunction buttons used for 1 scrolling through menu items and 2 increasing decreasing parameters 3 From monitoring display modes can be used as shortcuts to volume brightness control Diplo oe Tesh aid ms a acs FH eRe Cm Da nana OxyTrue A User Manual bluepoint MEDICAL GmbH amp Co KG 2007 2 2 Display Modes and Displayed Data Toggling Between Display Modes The operator can toggle between various display mo des by pressing the amp button 6 15 28 9 _ 15 43 Display 1 Display 2 Display 3 to 5 Example of 15 minute trend Display mode showing trend data for 15 30 or 240 minute time interval parallel to ongoing measurement 1 The SpO2 value shows the blood oxygen 5 Time interval trends saturation level expressed as a percentage The small numbers shown immediately above 6 Trend waveform for SpO2 with continuous upper and below the measured value on the right side and lower alarm limits in yellow indicate the upper and lower alarm limits 7 Trend waveform for pulse rate with continuous 2 Pulse rate in beats per minute The small numbers upper and lower alarm limits in yellow immediately above and below the measured value on the right side indicate the upp
5. diatric and newborn patients in hospital hospital type facilities transport emergency care and mobile environments as well as in the home care en vironment A Warnings Warnings are identified by the WARNING sym bol shown above Warnings alert the user to po tential serious outcomes such as death injury or adverse events to the patient or user A Do not make any clinical judgments based solely on the OxyTrue A The monitor is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms The interpretation of the measurement values should be done only by trained health care professionals A Explosion hazard Do not use OxyTrue A in the presence of flammable anesthetics mixture with air oxygen or nitrous oxide A Routinely monitor the patient to make sure the OxylIrue A is functioning and the sensor is correctly placed A Pulse oximetry measurements and pulse signals can be affected by certain environmental conditions sensor application errors and certain patient conditi ons See the appropriate sections of this manual for specific safety information A If you are uncertain about the accuracy of any measurement check the patient s vital signs by alter nate means then make sure the OxyTrue A is func tioning correctly A The use of accessories sensors and cables other than those specified may result in increased emission and or create invalid readin
6. e measured SpO2 value A higher pitch s indicative of a higher oxygen saturation The pulse tone volume can be adjusted under the menu item Volume The pulse tone can be also silenced using the X but ton Pressing the button a second time will reactivate the pulse tone 2 4 2 Audible Warning Signal Beep Beep 5 Seconds Beep Beep Error or warning messages for example the Oxy True A device will indicate that the sensor has slip ped off the finger by sounding an audible warning signal 2 4 3 Alarm Signals When an alarm is triggered the device will emit a loud high pitched pulsating tone in addition to the visual alarm The alarm volume is not adjustable however it is possible to silence the alarm for a period of two minu tes using the A button Once triggered an alarm will only reset if the cause of the alarm has been resolved Individual alarm limits can also be completely deacti vated if necessary 3 Preparation for Use Battery Installation e Slide down the cover of the battery compartment on the rear panel of the device e Insert three batteries 1 5 volt AA e Ensure correct orientation of batteries in accordance with polarity markings e Slide battery compartment cover closed Connecting the SpO2 Sensor Plug the sensor cable into the sensor port located on the top edge of the device The markings on the plug and port must match and face upward Turning on the Device Pre
7. e with the monitor s ability to detect and display accurate measurements include e Incorrect applications of the sensor e Placement of the senor on an extremity with a blood pressure cuff arterial catheter or intravascular line e Excessive patient activity e Intravascular dyes e Externally applied colouring agents such as nail polish e Failure to cover the sensor site with opaque OxyTrue A User Manual bluepoint MEDICAL GmbH amp Co KG 2007 10 material in high ambient light conditions e Venous pulsation e Dysfunctional haemoglobin e Low perfusion 5 2 Error Messages Causes No sensor The sensor is not connected properly to the device Check sensor connection Probe off The sensor has been removed from the monitoring site Check that the sensor is properly attached to the patient Low battery battery symbol blinking red The battery is almost completely discharged Replace batteries immediately Sensor fault The connected sensor is either defective or not com patible with the device check sensor Device defective Fatal device error e g resulting from improper hand ling such as use with computed tomography The device must be sent in to the Service Department Too much ambient light High ambient light sources near the sensor e g surgi cal lights Shield sensor more effectively from ex ternal light Bad signal qualit
8. er and lower 8 Pulse indicator alarm limits 9 Start and end times 3 Bar graph for pulse amplitude Indicates the dynamic pulse amplitude and rate As the detected pulse becomes stronger more bars light with each pulse The reverse is true for weak pulses 4 Pulse waveform plethysmogram The reading is automatically adjusted to the pulse strength therefore a waveform with strong amplitude should be visible at all times OxyTrue A User Manual bluepoint MEDICAL GmbH amp Co KG 2007 2 3 Symbols and Indicators Battery level indicator The three segments represent the battery charge level The symbol flashes red when the battery capacity is low o 10 07 Current time displayed in 12h or 24h format KR Alarm silenced indicator The audible alarm can be silenced for a maximum period of two minutes a renmn The colour of the bar graph is an indicator for signal quality Green good signal quality very accurate measurement Yellow average signal quality measurement may be inaccurate Red poor signal quality unreliable measurement Memory symbol gt The device s memory for measurement data is full p No new data can be stored Old data can be erased or overwritten OxyTrue A User Manual bluepoint MEDICAL GmbH amp Co KG 2007 2 4 Audible Indicators 2 4 1 Pulse Tone Beep During monitoring a pulse beep is sounded for every detected pulse The pitch of the pulse tone s depen dent on th
9. gs of the OxyTrue A A Failure to cover the sensor site with opaque ma terial in high ambient light conditions may result in inaccurate measurements OxyTrue A User Manual bluepoint MEDICAL GmbH amp Co KG 2007 Do not silence the audible alarm function or decre ase the audible alarm volume if patient safety could be compromised A The OxyTrue A is a prescription device to be ope rated only by trained personnel The monitor is for attended monitoring only A The OxyTrue A is not defibrillator proof Howe ver it may remain attached to the patient throughout defibrillation or while an electrosurgical unit is in use The measurements may be inaccurate throughout the defibrillation or use of an electrosurgical unit and shortly thereafter To avoid shock the caregiver should not hold the OxyIrue A while using a defib rillator on a patient A Disconnect the OxyTrue A and sensor from the patient throughout magnetic resonance imaging MRI scanning Induced current could potentially cause burns A Do not use a sensor or cables that appear dama ged Do not use sensors where optical components lie open A Ensure that the speaker is clear of any obstruction and that the speaker holes are not covered Failure to do so could result in an inaudible alarm tone 2 Controls Symbols Display Modes 2 1 Controls and User Interfaces OxyTrue A Front view Side view Symbol Feature Button Fun
10. n Speaker audio has malfunctioned Signal is corrupted OxyTrue A has stopped functioning Call Service Department Other problems EMI Electromagnetic Interference Caution This device has been tested and found to comply with the limits for medical devices according to EN 60601 1 2 second edition and the Medical Device Directive 93 42 EEC These limits are desig ned to provide reasonable protection against harmful interference n a typical medical installation Due to the proliferation of radio frequency transmit ting equipment and other sources of electrical noise in healthcare environments it is possible that high levels of such interference due to close proximity or strength of a source may result in disruption of per formance of this device Examples of noise sources in healthcare environments that could cause electromag netic interference are e Electrosurgical units e Cellular phones e Mobile two way radios e Electrical appliances e High definition televisions HDTV s The monitor is designed for use in environments in which the pulse can be obscured by electromagnetic interference During such interference measurements may seem inappropriate or the monitor may not seem to operate correctly Disruption may be evidenced by erratic readings ces sation of operation or other incorrect functioning If this occurs the site of use should be surveyed to de termine the source of disr
11. pproval OxyTrue A User Manual bluepoint MEDICAL GmbH amp Co KG 2007 12 8 Technical Specifications Measurement Range SpO2 45 to 100 Pulse Rate 20 to 300 beats per minute bpm Accuracy SpO2 2 70 to 100 Pulse Rate 1 digit lt 100 bpm 1 gt 100 bpm Display e OLED colour graphic display 262 000 colours 128 x 160 pixels e Data displayed oxygen saturation pulse rate plethysmogram bar graph short term and long term trends e Indicators signal quality pulse amplitude battery status alarm silenced sensor detection sensor disconnection Trend Information e Long term Trends up to 48 hours Short term Trends 15 min 30 min 4 hrs Environmental Conditions e Operating conditions 0 to 50 C 15 to 95 RH 600 to 1300 hPa e Storage conditions 20 to 70 C 10 to 95 RH 600 to 1500 hPa Other e Class IIb Product e Water resistant construction e Type BF e Dimensions Ixwxh 11 8 cm x 6 cm x 2 5 cm e Weight approx 160 g with batteries without sensor e Power Supply 3 batteries 1 5 volt AA e Battery Life gt 2 days of continuous operation or approx 5 days in power save mode Order Number 1020112001 Applied Standards EN 60601 1 EN 865 ISO 9919 2005 9 Packing List Accessories and Replacement Parts Packing List e OxyIrue A main unit e SC 6500 SoftCap Sensor e OxylIrue A PC Software e USB data cable e Silicone protecto
12. r e 3 AA batteries Accessories and Replacement Parts e SoftCap Sensor SC 6500 P N 1020132001 3rd generation SoftSensor 1 2m cable length silicone cable e SoftFlap Finger Sensor SF 6500 P N 1020132002 finger clip sensor 1 2m cable length PVC cable e Extension Cable XT 6500 P N 1020122057 1 2m cable length PVC cable e Extension Cable XT 6501 P N 1020122058 2 4m cable length PVC cable e Universal Mounting Kit P N 1020122059 V adapter with female pole mount thread e Universal Pole Mount Adapter P N 1020122060 Adapter with vertical and horizontal adjustment e Carrying Bag P N 1020122061 Carrying bag for main unit and sensor with shoulder strap e OxyTrue A Silicone Protective Cover P N 1020122056 e USB Data Cable P N 1020122057 e CD ROM OxyTrue A PC Software P N 1020410001 Additional sensors available upon request OxyTrue A User Manual bluepoint MEDICAL GmbH amp Co KG 2007 13 10 OxyTrue A PC Software With the user friendly OxyIrue A PC Software all saved data can be stored on a PC via the USB inter face This software offers a multitude of functions for more advanced analysis and archiving of the measu red data For more information please read the enclosed soft ware manual 14 11 Declaration of Conformity EC Declaration of Conformity We hereby declare under our sole responsibility that the product OXYTRUE A HANDHELD PULSE OXIMETER FOR CONTINUOUS AND SP
13. rn to the mo nitoring screen 4 1 1 Submenu Alarm Settings 4 1 1 1 General Information With the OxyTrue A device the alarm limits for SpO2 and pulse can be set individually The current alarm limits are shown as small numbers above and below the measured values on the right side If a measured value either exceeds the upper limit or falls below the lower limit visual and audible alarms will be trigge red immediately Visual alarm When an alarm has been triggered the critical value will flash red together with the violated alarm limit 17 35 Figure Visual alarm which was triggered by a violation of the lower SpO2 alarm limit An alarm will also be triggered if the sensor slips off the patient if the signal quality remains poor over a longer period of time or if a sensor is disconnected from the device provided that valid measurement data have been recorded beforehand 4 1 1 2 Adjusting Settings Selection with AW buttons Selection confirmation with lt d buon Alarm Settings menu The upper and lower alarm limits for SpO2 and pulse rate can be adjusted using this menu Off deactiva tes the alarm limit Default limits Limit changes are in effect only as long as the monitor remains on When it is turned off the default limits are stored When the monitor is turned on the default limits will be in effect 4 1 2 Submenu Data Management 4 1 2 1 General Information Recording Data The Ox
14. ss and hold button briefly until an opening splash screen appears After the power on self test OxyTrue A User Manual bluepoint MEDICAL GmbH amp Co KG 2007 is successfully completed the device is ready for monitoring Beginning Monitoring As soon as a sensor 1s connected and correctly positi oned on the patient monitoring begins automatically Turning Off Device Press and hold button for several seconds The OxyTIrue A device will also power off automatically after 5 minutes when not in use 4 Screen Contents Menu Structure 4 1 Main Menu Alarm settings All important and frequently used settings are accessible through the main menu which can be opened by pressing the button Data management Setup Exit Navigating the Menu Use the AV buttons to scroll through menu items The currently selected menu item is highlighted by a coloured frame Press the lt a button to confirm your selection Entering Data In some submenus it is possible to adjust a certain parameter In this case the parameter can be increased or decreased using the 4W buttons The value will in crease or decrease more quickly when the respective button is held down Press the lt button to confirm the new value Exiting Menu and Returning to Display Select the menu item EXIT to return immediately to the monitoring display If no button has been pressed for more than 30 se conds the device will automatically retu
15. tings will shor ten battery life considerably English Deutsch I Francais Espa ol Exit Depending on the firmware up to nine different lan guage options are available here for selection All messages and menus will be displayed in the selected language PIN Code Enter Exit Service The Service submenu is protected by a PIN code only authorised service personnel can access this menu 4 2 Other 4 2 1 Volume Control Shortcut If the 4 button is pressed during any monitoring dis play mode the volume control screen will open Adjust volume using the AY buttons Confirm new setting by pressing the lt button 4 2 2 Brightness Control Shortcut If the W button is pressed during any monitoring dis play mode the brightness control screen will open Adjust brightness using the A amp W buttons Confirm new setting by pressing the lt button 4 2 3 Power Save Mode Display OFF Press any key for ON Power Safe Mode The device s display can be turned off to save power and extend battery life This can be accomplished by pressing and holding the W button until Countdown Display appears on the screen The display can be tur ned on again by pressing any button If an alarm is triggered the display will be turned on automatically 5 Error Messages Problems Corrective Actions 5 1 General Information Physiological conditions medical procedures or ex ternal agents that may interfer
16. ulse Remove the source of interference Problem After a valid measurement the pulse sig nal can not be found anymore Cause Corrective Action Check the patient Check the sensor directions for use to determine if an appro priate sensor 1s being used and if it is applied properly Check sensor and extension cable connections Test the sensor on another subject Try another sensor or extension cable Perfusion may be too low for the monitor to track the pulse Check the patient Test the monitor on yourself Change the sensor site Try another sensor Interference due to patient activity may be preventing the monitor from tracking the pulse Keep the patient still if possible Verify that the sensor is securely applied and replace it if necessary Change the sensor site The sensor may be too tight there may be interference due to ambient light or the sensor may be on an ex tremity with a blood pressure cuff arterial catheter or intravascular line Reposition sensor as necessary Electromagnetic interference may be preventing the monitor from tracking the pulse Remove the source of interference OxyTrue A User Manual bluepoint MEDICAL GmbH amp Co KG 2007 11 Problem No pulse tone Cause Corrective Action Continue to listen for the pulse beep tone as the monitor is used If it does not sound with each pulse it indicates one of the follo wing Pulse beep volume is off Switch volume o
17. uption and the following actions taken to eliminate the source e Turn equipment in the vicinity off and on to isolate the offending equipment e Reorient or relocate the interfering equipment e Increase the distance between the interfering equipment and this equipment The monitor generates uses and radiates radio fre quency energy If t s not installed and used in ac cordance with these instructions the monitor may cause harmful interference with other devices in the vicinity 6 Maintenance Cleaning Maintenance and cleaning There are no user serviceable parts inside the Oxy True A The cover should only be removed by quali fied service personnel The monitor requires no calibration If service is ne cessary contact qualified service personnel or your local sales representative Caution Do not spray pour or spill any liquid on the Oxy True A its accessories connectors switches or ope nings in the enclosure as this may damage the moni tor Surface clean Use a soft cloth dampened with either a commercial nonabrasive cleaner or a solution of 70 alcohol in water Lightly wipe the surface of the monitor Desinfection Use a soft cloth saturated with a solution of 10 chlo rine bleach in tap water 7 Symbol Definitions N Attention See instructions for use Tu oA Date of manufacture R Type BF X Observe applicable waste disposal regulations European Union a
18. y Poor quality pulse signal for example as a result of low perfusion Move the sensor to a different site on the patient or provide more effective monitoring conditions 5 3 Failure Cause Corrective Action Problem There is no response to the Power button Cause Corrective Action Ensure that the Power button is fully depressed The batteries may be mis sing discharged or oriented incorrectly Install new batteries Problem No pulse signal found Cause Corrective Action Check the patient Check the sensor directions for use to determine if an appro priate sensor 1s being used and if it is applied properly Check sensor and extension cable connections Test the sensor on another subject Try another sensor or extension cable Perfusion may be too low for the monitor to track the pulse Check the patient Test the monitor on yourself Change the sensor site Try another sensor Interference due to patient activity may be preventing the monitor from tracking the pulse Keep the patient still if possible Verify that the sensor is securely applied and replace it if necessary Change the sensor site The sensor may be too tight there may be interference due to ambient light or the sensor may be on an ex tremity with a blood pressure cuff arterial catheter or intravascular line Reposition sensor as necessary Electromagnetic interference may be preventing the monitor from tracking the p
19. yTrue A device can store up to 48 hours of monitoring data Each individual data set regardless of its actual length uses at least 15 minutes of memo ry space A new data set is generated automatically each time the device is turned on When the device is turned off all of the measurements that were taken are OxyTrue A User Manual bluepoint MEDICAL GmbH amp Co KG 2007 automatically stored in the devices memory together with the respective alarm limits date and time The device warns the user when the memory is almost full by displaying the Y symbol A maximum of 50 data sets can be stored in the memory After this maximum has been reached the oldest data set 1s overwritten upon confirmation by the user Stored data sets can be retrieved and erased under the menu item Data management The data sets can also be stored and processed with the user friendly OxyIrue A PC Software 4 1 2 2 Data Stored data Delete all data Exit Use Data Management menu to e view remaining recording time in minutes e access list of stored data sets e delete all data in memory 07 08 07 15 11 07 08 07 15 14 07 08 07 15 16 Exit Stored Data menu List of all stored data sets Retrieve selected data set by pressing the lt 8 button Select Back to return to the list of stored data or Delete to erase the data set shown The stored measurements are displayed in graphic form together with the date start time
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