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Operator’s Manual Page 9 of 89

OXY-2-USM-1, REV K

Section I. Introduction

A. Overview

The T.Ox™ Tissue Oximeter is an optically based device that non-invasively estimates the percent oxygen saturation (StO

2

%) in a

volume of tissue underneath the sensor. T.Ox™ Tissue Oximeter measurements are based on its proprietary technology called ODIS.
(See “The ODIS Technology” section, below.) The T.Ox™ Tissue Oximeter works by emitting two different wavelengths of near-
infrared (NIR) light into tissue at depths of 0–10 mm. The light is transmitted to the tissue by two light sources, and collected by four
photo detectors in each sensor.

As the light is collected and measured, the absorption and scattering coefficients of the tissue are calculated. Each tissue component has
a unique absorption spectrum or light “signature”. The T.Ox™ Tissue Oximeter uses two wavelengths (690 and 830 nm) of near-
infrared light specific to oxyhemoglobin (HbO

2

) and deoxyhemoglobin (Hb) for the noninvasive real-time measurements of StO

2

.

The ODIS Technology

Optical Diffusion Imaging Spectroscopy (ODIS) is a non-invasive tissue characterization method based on measurement of reflectance
or transmittance of near-infrared light shed onto tissue surface.

In biological tissue, near-infrared light is highly scattered and moderately absorbed. This allows photons to travel up to one meter in
tissue, in a random walk fashion, before being absorbed. Diffuse optical imaging is achieved by sending various optical signals to
various locations of tissue and measuring the corresponding diffuse reflectance or transmittance on tissue surface. ViOptix has
developed special source-detector patterns and algorithms, which make the measurements accurate, real-time and insensitive to external
factors. The system’s self-calibrating approach makes it possible to perform imaging and spectroscopy without a baseline data set.
This is particularly important in saving exam time.

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Содержание T.Ox OXY-2-USM-1

Страница 1: ...Tissue Oximeter Operator s Manual ViOptix Incorporated 39655 Eureka Drive Newark CA 94560 Phone 510 226 5860 Fax 510 226 5864 Website www vioptix com ...

Страница 2: ...roduct development ViOptix reserves the right to make changes and improvements to this manual and the products it describes at any time without notice or obligation Caution Federal law US restricts this device to sale by or on the order of a physician Caution Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure VIS...

Страница 3: ...t 2003 2022 Covered by one or more of the following US Patents and foreign equivalents www vioptix com patents ViOptix Incorporated 39655 Eureka Drive Newark CA 94560 Tel 510 226 5860 Fax 510 226 5864 ViOptix part number for this Operator s Manual OXY 2 USM 1 ...

Страница 4: ...2 4 Cautions 12 Section III System Setup 14 A System Configuration 15 1 Connecting the T Ox Tissue Oximeter 15 2 Turning on the T Ox Tissue Oximeter 15 B Using the T Ox Tissue Oximeter Controls 16 1 AC Power Switch 16 2 ON Standby Button 16 3 T Ox Tissue Oximeter Monitor Screen Display 17 4 Patch Sensor Probe Acquisition 19 6 Recording Patient Data 20 7 Oops Save Discard 21 Section IV System Opera...

Страница 5: ...tting Parameters in the Setup Screen 48 13 Setting the Date and Time 49 14 Setting the Date 53 15 Setting the Sound Level for Alarms 54 16 Performing Maintenance 56 17 Setting Up Organization Information 61 18 Open an Existing File for Review 64 19 Recording a New File Saving 66 20 Using the Help System 73 C Device Failure and Recovery 74 Section V Maintenance 77 Cleaning and Disinfecting 77 Secti...

Страница 6: ...Table 1 Control Bar Buttons 25 Table 2 System Status Bar 26 Table 3 Buttons and Tabs on the Main Screen 30 Table 4 Percentage of Zoom 38 Table 5 Alarm Messages 85 Table 6 Error Messages 86 Table 7 Status Messages 87 Table 8 Other Status Error and Warning Messages 88 ...

Страница 7: ...gure 13 Magnify StO2 Screen Single Mode 43 Figure 14 Magnify StO2 Screen Dual Mode 43 Figure 15 View Numerics Screen Single Mode 46 Figure 16 View Numerics Screen Dual Mode 47 Figure 17 Setup Screen 48 Figure 18 Set Up Current Date and Current Time Screen 50 Figure 19 Set Up Current Time Screen 51 Figure 20 Set Up Date Screen 53 Figure 21 Set Up Sound Level of Alarms 54 Figure 22 Maintenance Senso...

Страница 8: ...Operator s Manual Page 8 of 89 OXY 2 USM 1 REV K Figure 33 Discard Confirmation Screen 72 Figure 34 Help Index 73 Figure 35 Reboot Recovery Screen 75 Figure 36 Sensor Data Disposal 76 ...

Страница 9: ... 830 nm of near infrared light specific to oxyhemoglobin HbO2 and deoxyhemoglobin Hb for the noninvasive real time measurements of StO2 The ODIS Technology Optical Diffusion Imaging Spectroscopy ODIS is a non invasive tissue characterization method based on measurement of reflectance or transmittance of near infrared light shed onto tissue surface In biological tissue near infrared light is highly...

Страница 10: ...mits Low battery The T Ox Tissue Oximeter has visual alarms for Audio muted Sensor laser ON AC power OFF Low Battery The T Ox Tissue Oximeter consists of three parts Small computer console display module AC power cord Fiber optic sensor s The standard console configuration is two channels If the console has two channels both channels can be used at the same time Each channel samples and displays d...

Страница 11: ...or operator Inspect the sensors before each use for visible damage Make sure the lasers are off when inspecting in order to avoid damage to the eyes Do not use the sensor if it has visible damage Avoid direct exposure to the laser light beam in the sensor Looking at it directly could cause permanent damage to the eyes To prevent damage do not bend or apply torque on the fiber optic cables Use only...

Страница 12: ...eter battery in accordance with local requirements and regulations Do not use the sensor rest assembly or sensor cable wrap assembly as a handle Only connect the sensor cable plugs to the console channel connectors Device contains metal Do not use in a MR environment 3 Precautions Select alarm settings carefully using accepted clinical standards The audible alarm of the T Ox Tissue Oximeter is for...

Страница 13: ...atient assessment It must be used in conjunction with clinical assessment of signs and symptoms Do not block air vents of the unit Adequate cooling is required for proper operation of the unit Inaccurate readings may result if the sensor is not in proper contact with the skin or there is a leakage of light ...

Страница 14: ...ness Adjust Knob IR Printer Port Window LCD Display and Touch Screen Startup Shutdown Power Button Figure 1 Front Panel of T OxTM Tissue O Main Rear Panel Label Fuse Label AC power input AC power mains ON OFF switch 1 ON 0 OFF 1 Pole holding fixture Figure 2 Rear of ViOptix Tissue Oximeter Console Nurse call alarm output connector optional I V pole holding fixture ...

Страница 15: ...le bedside nurse call system jack To attach the cable press the cable s circular connector onto the rear panel connector and rotate until it clicks and locks To detach cable pull back on the cable connector s metal sleeve 2 Turning on the T Ox Tissue Oximeter Turn on the T Ox Tissue Oximeter by depressing the soft ON Standby power button on the right front of the console Refer to Figure 1 The main...

Страница 16: ...e AC Power switch is on the back of the console This switch routes AC power to the console s power supply 2 ON Standby Button Depressing the ON Standby power button on the right front of the console applies power to or removes power from the console electronics See Figure 1 To turn the unit off hold the ON Standby button in then release it after 3 seconds The console will perform a shutdown sequen...

Страница 17: ...sensor single channel operation The main T Ox Tissue Oximeter monitor screen includes these functional areas Control bar Sensor verification Numerical Data display Tissue StO2 trend graphs Status Alarms area System Status Figure 1 Main Screen Functional Areas Single Mode Sensor verification Tissue St02 trend graph Control bar Alarm limits in red System status bar Numerical data display area ...

Страница 18: ...REV K In two sensor dual channel operation the main screen provides separate sensor verification indicators Numerical Data displays and Tissue StO2 trend graphs for each channel as shown in Figure 2 Figure 2 Main Screen Functional Areas Dual Mode ...

Страница 19: ...Acquisition Small Patch Sensor Note During sampling laser light will be emitted from two of the apertures in the sensor head Avoid direct eye exposure Patch probe acquisition starts when the Main Screen s channel Paused Sampling button is activated to the Sampling position ...

Страница 20: ...e permanently saved in the console and available for review and off loading using the Control Bar s Open and Setup Send files buttons If the Stop Recording button is tapped and no patient data has been acquired the console performs no operation and retains the current screen You can review the current session s StO2 data from the Main Screen by tapping the appropriate channel s Review StO2 soft bu...

Страница 21: ...anual Page 21 of 89 OXY 2 USM 1 REV K 7 Oops Save Discard After pressing the Stop Recording button choose to save discard or continue recording These options are shown in Figure 3 Figure 3 Oops Save Discard Screen ...

Страница 22: ...sue somewhat greater pressure over adipose tissue 3 Check for good skin contact and no light leakage around the sensor contact point 4 Pause data collection when moving the sensor from one tissue site to another When using a patch sensor toggle the channel Sampling Paused button on the display monitor screen to pause data collection B Data Acquisition 1 Understanding the Display Monitor Screen Thi...

Страница 23: ...Operator s Manual Page 23 of 89 OXY 2 USM 1 REV K Figure 4 Main Screen with Control Bar at Top and System Status Bar at Bottom System Status Bar System status bar ...

Страница 24: ...l is being used to take readings Small Patch Sampling When using patch sensors Sampling Paused soft buttons with lights are displayed to indicate whether readings are actively being taken Sampling or if the system is in Paused mode When using the patch sensors press the on screen Ch1 Paused button in the upper right corner to start data sampling The Ch1 Paused button will change to Ch1 Sampling Wh...

Страница 25: ... 1 Control Bar Buttons Control Bar Button What the Button Does Main both single and dual mode Returns to the Main screen Open Displays the Open File screen Control Bar functions Open Record etc are disabled Stop Recording When tapped displays the Oops Save Discard screen if data has been acquired and saved Default mode is Recording of all acquired data Set up Displays the Setup screen menu Help Di...

Страница 26: ...g battery power when using the battery 3 Displays a Low Battery icon and alarm when low battery condition exists and the console prepares to automatically shutdown Errors and Alarms area Displays error and alarm messages in a flashing field of text Errors and Alarms are displayed in RED If more than one error and or alarm occurs messages will scroll to the next message after displaying each alarm ...

Страница 27: ...is button The flashing text field will continue to indicate the alarm condition Screen Lock and Unlock Allows the operator to lock the screen to prevent inadvertent touching Locking the screen might be appropriate during long term monitoring of a patient ...

Страница 28: ...e Oximeter auto detects the type of sensor s connected to the Oximeter The Main View screen is the first screen that is displayed when the system is turned on Its single mode automatically displays one channel if only one sensor is connected refer to Figure 5 Figure 5 Main Screen Single Mode ...

Страница 29: ... two sensors are attached refer to Figure 6 Figure 6 Main Screen Dual Mode The Main screen whether single or dual mode provides current numerical readings for StO2 This data is also displayed in trend graph format which indicates where the readings fall with regard to upper and lower alarm settings ...

Страница 30: ...ys a line graph of the real time data being gathered using the sensor Refer to Figure 5 During long term monitoring the graph advances to the left so that the current data is always being presented on the right side The y axis of the graph displays the percentage of StO2 range 0 100 in the tissue being measured The x axis displays a time scale and the data points as they are gathered in real time ...

Страница 31: ... range may be unreliable Therefore when the signal quality falls below this criterion the Oximeter suppresses StO2 values in its display and logging Although StO2 and signal quality are both measured as percentages keep in mind that they are distinct quantities The signal quality is a guide to the reliability of the StO2 reading The Oximeter s display reinforces this distinction by presenting the ...

Страница 32: ...Operator s Manual Page 32 of 89 OXY 2 USM 1 REV K Figure 7 Low Signal Quality Alarm ...

Страница 33: ...itions Because such readings could be unreliable the Oximeter suppresses their value and instead displays two dashes Figure 8 Low Signal Quality Suppresses StO2 Display The signal quality criterion for rejecting StO2 readings is normally locked at 80 This criterion helps ensure reliable readings in clinical use ...

Страница 34: ...s by lowering this 80 criterion or by defeating it entirely You access these options by entering a password in the Signal Quality Setup screen shown in Figure 9 If you are a researcher who needs to alter the signal quality criterion contact ViOptix to obtain a valid password for this screen Figure 9 Password Based Override of Signal Quality Criterion ...

Страница 35: ...splayed in the Messages and Alarms area at the bottom of the screen Also the current numeric reading is displayed as a large red number Figure 10 StO2 Alarm Set Screen 6 Setting the StO2 Alarm To set the StO2 alarm a On the Main screen press the Set Alarms button to the right of the StO2 graph Note In dual mode operation the Main screen provides a separate Set Alarms button for each channel This a...

Страница 36: ... Drop Rate Sound On box f Use the Clear button to clear the drop rate high alarm level then select tap the numeric buttons on the screen to set the drop rate alarm level The drop rate is defined as the drop in tissue oxygen saturation in St02 units per hour If the drop rate alarm level is exceeded for more than 30 minutes the alarm will sound g To change the sound level of the alarm press Change S...

Страница 37: ...Operator s Manual Page 37 of 89 OXY 2 USM 1 REV K Figure 11 Review StO2 Screen ...

Страница 38: ...o adjust The x axis displays the data points as they are gathered and represents the time scale The red dotted line s across the graph indicates the alarm level s and indicates where the data points fall with regard to the alarm level s The set alarm level is presented numerically to the left of the graph Use the Zoom buttons to display the data in different time increments Press the up or down ar...

Страница 39: ...ound where cursor is focused The large number in the upper left corner is the reading for the moment in time represented by where the cursor is on the graph The highest and lowest numbers displayed indicate the highest and lowest readings for StO2 during the total elapsed time of the reading ...

Страница 40: ...f the data to the present cursor position To print a Summary Report of the data press the top Control Bar s Print button Refer to the Printing Data section The Summary Report will print the entire collection of StO2 data values in numerical table format To print a Snapshot Report Print Screen of the data press the Print Screen button The Snapshot Report will only print the segment of data presente...

Страница 41: ...view Data Screen The Review Data screen provides the ability to scroll through all the data in a chronological format table Use the arrows to move up and down through the table The single arrows move from line to line The double arrows move through a page of lines at once Click the Top button to go to the most recent data gathered Click the Bottom button to go to the oldest data gathered ...

Страница 42: ...ssing the Review StO2 button Use the Time Interval Zoom buttons to select a time interval to view As an example selecting 2 Minutes will display incremented 2 minute averaged StO2 data 10 Magnifying the StO2 View Pressing the Magnify StO2 tab when using one sensor displays the screen in single mode refer to Figure 13 ...

Страница 43: ...rs displays the screen in dual mode refer to Figure 14 Figure 14 Magnify StO2 Screen Dual Mode Whether in single or dual mode the Magnify screen displays a line graph of the real time data as it is being gathered During long term monitoring the graph will slide to the left so that the real time data is always being presented on the right side ...

Страница 44: ...le with time periods displayed in 24 hour or AM PM format Because the Magnify screens are auto scaled the alarm levels are not displayed However if the readings are out of bounds an audible alarm will sound and a warning will be displayed in the Status and Alarms area From the Magnify StO2 screen press the Review StO2 button to view a graph of the StO2 data collected from the time data was acquire...

Страница 45: ...n single mode the following numerics are displayed The current StO2 reading The highest StO2 reading during the sampling period The lowest StO2 reading during the sampling period View Numerics will display the single mode or dual mode results depending on the number of sensors attached to channels The Highest and Lowest are the highest and lowest StO2 readings from the current sampling period ...

Страница 46: ...Operator s Manual Page 46 of 89 OXY 2 USM 1 REV K Figure 15 View Numerics Screen Single Mode ...

Страница 47: ...l Page 47 of 89 OXY 2 USM 1 REV K When in dual mode the same numerics as described for single mode are displayed for the two sensors that are collecting data refer to Figure 16 Figure 16 View Numerics Screen Dual Mode ...

Страница 48: ...tup Screen Figure 17 Setup Screen Go to the Setup screen by pressing the Set up button in the Control Bar The Setup screen provides soft buttons to define or change the following options Date and time Sound level Peripherals printers Maintenance Organization Information Delete Files ...

Страница 49: ...Sampling and Recording of channel data is in progress 1 Press the Set up button in the Control Bar to display the Setup screen 2 Press the Change Time Settings button 3 For date and time changes In the Set Up Current Date and Current Time screen press the Change date and time button located to the right of Current Time 4 Time zone changes In the Set Up Current Date and Current Time screen press th...

Страница 50: ...tor s Manual Page 50 of 89 OXY 2 USM 1 REV K Figure 18 Set Up Current Date and Current Time Screen 5 The Set Up Current Time screen appears as shown in Figure 19 Tap the arrows to scroll to the current time ...

Страница 51: ...red time with the 12 hour time display using AM PM 7 Press Cancel to return to the previous Set Up Current Date and Current Time screen Figure 18 without making changes Or Press OK to update the Current Time to the New Time then return to the previous Set Up Current Date and Current Time screen Figure 18 ...

Страница 52: ...creen 8 Select the desired time zone 9 Press Cancel to return to the previous Set Up Current Date and Current Time screen Figure 18 without making changes Or Press OK to update the Current Time Zone then return to the previous Set Up Current Date and Current Time screen Figure 18 ...

Страница 53: ...Up Date Screen 1 In the Set Up Current Date and Current Time screen press the Calendar to set the correct date as shown in Figure 20 2 Press Cancel to return to the previous Set Up Current Date and Current Time Figure 18 screen without making changes Or Press OK to save the selections ...

Страница 54: ...Change sound setting button The Set Up Sound screen is displayed as shown in Figure 21 2 Press a number from 1 to 5 to select the preferred alarm sound level The higher the number selected the louder the volume of the alarm The new setting is displayed in the box at the top right of the screen Note The audio alarm sound cannot be turned off except using the Mute button ...

Страница 55: ...Operator s Manual Page 55 of 89 OXY 2 USM 1 REV K 3 Press Cancel to not change the sound level and return to the Setup screen Figure 17 Or Press Done to save the setting and return to the Setup screen ...

Страница 56: ...screen press the Maintenance button The Maintenance Sensor Test screen will be displayed as shown in Figure 22 ViOptix recommends that you perform a self test of the console if a reading cannot be obtained The test sensors and phantom mold are required to perform a self test Press Cancel to return to the Setup screen Figure 17 Or ...

Страница 57: ...ntenance Screen Step 1 The Test Wizard moves through the following steps Step 1 Place the sensor on the phantom mold ensuring that the sensor face is flat on the mold allowing no light to leak from the sensor Note The start button on a pen or flashlight probe does not need to be activated for the self test to be completed ...

Страница 58: ...return to the Setup screen Or Press Back to return to the previous screen Or Press Next to continue the self test Figure 24 Maintenance Screen Step 2 Step 2 Figure 24 shows that both channels have sensors attached If only one channel has a sensor a test will be available only for that channel ...

Страница 59: ...rn to the previous screen Or Press the selected channel s Test button to perform that channel s self test During channel self test the console will display the test progress in the Status and Alarms area of the screen After a successful self test the instrument will display the screen shown in Figure 25 Figure 25 Maintenance Screen Step 3 ...

Страница 60: ...cates whether the sensor self test was successful To perform another sensor self test tap the Back button The Sensor Test screen shown in Figure 24 will be displayed When you are finished with sensor self tests tap the Done button to return to the Setup screen shown in Figure 17 ...

Страница 61: ...screen shown in Figure 26 appears 2 Using the on screen keyboard tap the keys to enter the name of the hospital or doctor s office Tap the TAB key to move from field to field Tap the Back key to delete a character Enter the organization street address using two lines if needed 27 characters maximum per field 3 Enter the city state and zip code 4 Enter the phone number Only numbers are accepted 17 ...

Страница 62: ...es and display the next screen Note The information that is entered in these fields will be displayed in the Summary and Snapshot Report 6 You will see a confirmation screen Figure 27 displaying the Organization information that you entered Figure 27 Organization Information Confirmation Press Edit to make any changes to the information ...

Страница 63: ...Operator s Manual Page 63 of 89 OXY 2 USM 1 REV K Or Press Save to save and exit to the Setup screen The Organization information will be displayed on the review screens and printed in the print reports ...

Страница 64: ... the Open button on the Control Bar at the top of the Main screen After the Open button is tapped you will see the Open File screen shown in Figure 28 Figure 28 Open File Screen The most recently saved file is displayed on the top by default To sort files alphabetically by name touch the File Name button To sort by sate touch the Date Saved button ...

Страница 65: ...EV K The only other available options are the Cancel and Done buttons the Control Bar buttons are unavailable Use the arrows to scroll to the desired file Press Cancel to return to the Setup screen Or Press Done to display the file in Review mode ...

Страница 66: ... prompted to enter the file s name If you are recording two channels each channel s data will automatically be saved in a file with a unique extension For example if you entered filename the Oximeter would name the files filename Ch1 for channel 1 and filename Ch2 for channel 2 To stop recording data tap the Control Bar Stop Recording button The Oops Save Discard screen is displayed as shown in Fi...

Страница 67: ...ave Discard screen tap Discard to proceed to the Discard Confirmation screen Figure 33 for a confirmation to delete the data Select Oops to cancel and return to the Main screen Figure 4 to continue data sampling Or Select Save to save the data in a file You will see the on screen keyboard as shown in Figure 30 Figure 30 Save File Screen ...

Страница 68: ...the Save or Discard screen without saving data Or Tap Done to save the data in the named file and return to the Main screen Note If both channels are being sampled the console will create a separate file for each channel It will give both channels the same file name that you entered but will automatically give each channel s file a unique filename extension Ch1 versus Ch2 Duplicate Filename Entere...

Страница 69: ...ilename Warning Selecting Overwrite File will delete the old saved file Saving Data When Disk Space Is Limited There are 200 Megabytes MB of disk storage for data log files This is equivalent to three months of continuous recording of data for two channels If the operator tries to save a logged file that would exceed the 200 MB limit the console will display the Free Disk Space for File Save scree...

Страница 70: ...disk Note the size of the file that you wish to save and delete enough files to free at least that much disk space You must delete each file individually by using the arrow buttons to select the file and then tapping the Delete button Once enough space is available the Save button will become accessible Tapping the Return button will return to the Oops Save Discard screen Figure 29 ...

Страница 71: ...tion of the temporary log files Figure 33 shows the Discard Confirmation screen Selecting the Yes button here will delete the temporary log files and return to the Main screen Figure 4 where recording will be stopped Selecting No will return to the Oops Save Discard screen without deleting files Selecting Oops will return to the Main screen without deleting files and continue recording of data ...

Страница 72: ...Operator s Manual Page 72 of 89 OXY 2 USM 1 REV K Figure 33 Discard Confirmation Screen ...

Страница 73: ...elp Index 1 Press the Help button The Help Index and current software version is displayed as shown in Figure 34 2 Use the arrows to scroll up and down through the Help text Double arrows scroll through the text page by page Single arrows scroll through the text line by line Holding an arrow down scrolls through several pages or lines at once 3 Press the mini screen in the upper left corner to dis...

Страница 74: ... to restore the state the instrument was in before the failure occurred The following device parameters settings are stored and retained Channel 1 Sampling or Paused Channel 2 Sampling or Paused Recording Mode On or Off If the device was sampling and recording when the failure occurred the screen shown in Figure 36 will be displayed after the Okay button shown in Figure 35 is tapped The screen sho...

Страница 75: ...Operator s Manual Page 75 of 89 OXY 2 USM 1 REV K Figure 35 Reboot Recovery Screen ...

Страница 76: ...Operator s Manual Page 76 of 89 OXY 2 USM 1 REV K Figure 36 Sensor Data Disposal ...

Страница 77: ...eter unit from any power sources prior to cleaning To clean the LCD screen dilute a household water based glass cleaner with 50 water Spray a small amount on a soft clean cloth and gently wipe the screen The T Ox Tissue Oximeter console exterior can be wiped down with a soft cloth dampened with water Make sure excess water has been squeezed out The connector ends should periodically be cleaned wit...

Страница 78: ...d Precision Parameter Range Precision Precision With Motion StO2 80 100 2 7 3 1 60 80 2 3 2 7 40 60 5 2 5 6 10 40 13 3 13 7 System control System will perform self test when power is turned on Alarms visual and audio Adjustable Low StO2 Adjustable High StO2 Adjustable StO2 Drop Rate Low battery Alarms visual Inadequate patient contact Sensor laser ON AC power ON Alarm Volume 50 to 80 dbA at 30 cm ...

Страница 79: ... oxide Transport and Storage Temperature 10 C to 40 C Humidity 20 to 80 non condensing Atmospheric Pressure 700hPa to 1060hPa Dimensions 27 5 cm x 38 1 cm x 17 8 cm 11 in x 15 in x 7 in Weight 4 3 kg 9 5 lbs Sensors Available in flexible styles 5 mm x 5 mm Flexible sensors are used for continuous monitoring Laser System Two pairs of solid state diode lasers 690 nm and 830 nm per pair 3 mW max outp...

Страница 80: ... single patient one time use DO NOT REUSE DO NOT RE STERILIZE Sterilized by Ethelyne Oxide Use by expiration date stamped Fuse marking identifies location type and rating of safety circuit component replacement fuse Type BF equipment Attention consult accompanying documents Protective Earth Ground REPLACE FUSE AS MARKED 2X T3A 250V ...

Страница 81: ... s Manual Page 81 of 89 OXY 2 USM 1 REV K ON Standby Button Off Power On Power Non ionizing radiation Model Number Catalog Number Lot Number DANGER Explosion risk if used with flammable anesthetics REF LOT A P ...

Страница 82: ...abels Laser warning labeling Rear Panel Product Label VISIBLE AND INVISIBLE LASER RADIATION AVOID DIRECT EYE EXPOSURE CLASS 3R LASER PRODUCT 690 nm and 830 nm 3 mW max IEC60825 1 1993 A1 A2 P N 89179 Rev 5 ViOptix Inc 39655 Eureka Drive Newark CA 94560 ...

Страница 83: ...Operator s Manual Page 83 of 89 OXY 2 USM 1 REV K Rear Panel Fuse Label Sensor Channel Labels for single channel or dual channel option as applicable Front Panel Label ...

Страница 84: ...Operator s Manual Page 84 of 89 OXY 2 USM 1 REV K ...

Страница 85: ...n readings have exceeded the set alarm levels Errors Alarms area Numbers will be displayed in red until the alarm is cleared Ch 1 High StO2 Exceeded alarm limit Patient s oxygen saturation readings have exceeded the set alarm levels Errors Alarms area Numbers will be displayed in red until the alarm is cleared Ch 2 Low StO2 Exceeded alarm limit Patient s oxygen saturation readings have exceeded th...

Страница 86: ...sensor on the patient and hold it firmly in place while sampling Run maintenance sensor test if failure persists CH2 Inadequate signal Check the contact sensor One of returned channel 2 detector readings is exactly zero indicating a defective sensor or source Errors Alarms area Pause if sampling Reposition the sensor on the patient and hold it firmly in place while sampling Run maintenance sensor ...

Страница 87: ...ampling Occurs after power level adjustment returned data analyzed to determine if readings are within limits Errors Alarms area Status message no corrective action needed CH1 Adjusting power level Auto adjusting power level for channel 1 Errors Alarms area Status message no corrective action needed CH2 Adjusting power level Auto adjusting power level for channel 2 Errors Alarms area Status messag...

Страница 88: ...eft empty StO2 Alarm Set screen Enter StO2 Low alarm level HIGH level must be greater than LOW level User input high value less than or equal to low value StO2 alarm set screen If High required StO2 High alarm level field s value must be greater than Low alarm level field s value StO2 Alarm Set screen Enter new StO2 alarm levels Open Screen File Format Error Device cannot open file because of form...

Страница 89: ...l alarm to notify that sampling has been interrupted Reboot screen Figure 34 Tap the Okay button if sampling and recording was previously being performed the operator will be given the option Figure 36 to save or discard the previous pre failure logged data The operator can also select Continue Logging to continue logging once the device restores its pre failure mode Data Screen Invalid new date P...

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