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Spectros T-Stat 2.0 User Manual Download Page 4

Spectros Medical Devices Inc. 

Page 4 of 44 

Rev B 
 

 

 

T-STAT 2.0 User Manual 

A.

 

Safety Information 

 

 

 

Warnings 

 

WARNING: Explosion hazard. Do not operate the monitor in the presence of flammable gases or 
anesthetics, such as high concentrations of oxygen or nitrous oxide. 

 

WARNING: Electric shock hazard. The monitor’s cover is to be removed only by qualified service 

personnel. There are no user-serviceable parts inside. 

 

WARNING: Use only the medical-grade AC power cord provided by the manufacturer. If in doubt 
about the integrity of the mains supply connection, cease the operation of the monitor. 

 

WARNING: Do not look directly into light source for extended periods of time. 

 

WARNING: T-Stat sensors are designed for single use only and may not be re-used. Do not 
autoclave or gas-sterilize any of the T-Stat sensors. 

 

WARNING: Use only T-Stat sensors in conjunction with the T-Stat monitor. Connecting other 
sensors may result in damage to the T-Stat monitor, or compromise its safety or performance. 

 

WARNING: Do not autoclave, gas-sterilize, or immerse the T-Stat

®

 monitor. This may create an 

electric shock hazard, or damage internal components. 

 

WARNING: Do not connect any accessories to the USB port on the rear panel of the monitor when the 
system is in use on a patient other than the approved AT&T or Verizon modems. 

 

WARNING: When monitoring on neonates or infants, check site every 4 hours for pressure necrosis 
and change site every 24 hours. 

 

WARNING: Reuse of Sterile Sensors can result in infection due to cross contamination. 

 

WARNING: Sensors are designed for single use. Reuse can result in intermittent operation due to 
contamination of the receiving connection in the T-Stat. 

 

WARNING: When monitoring on adults, check site every 12 hours for pressure necrosis and change 
site every 24 hours. 

 

WARNING: Lithium Battery: Replacement by inadequately trained personnel could result in a HAZARD 

(such as excessive temperatures, fire or explosion). 

NOTE: Federal Regulations in the United States restrict the sale of this device to or on the order of 
licensed medical practitioners. 

Summary of Contents for T-Stat 2.0

Page 1: ...Spectros Medical Devices Inc Rev B T STAT 2 0 User Manual T Stat 2 0 User Manual ...

Page 2: ...ual T Stat 2 0 Microvascular Tissue Oximeter User Manual Spectros Medical Devices Inc 2211 Norfolk St 1110 Houston TX 77098 www spectros com T Stat monitor and sensors are protected by the following patents issued US6711426 US7062306 US7427165 For Prescription Use Only ...

Page 3: ...Surface Sensor 17 Placement and use of the 2 5 cm Surface Sensor 18 Changing the Alarm Settings 19 Saving Data to Internal Disk 19 Data File Naming Convention 19 Moving Stored Data 20 Changing Date and Time 21 Checking Software Version Numbers 21 Instructions for Use of On Call via Wi Fi 22 Instructions for Use of On Call via Verizon or ATT 25 Verizon Access 25 AT T Access 26 J Care and Maintenanc...

Page 4: ...e T Stat monitor or compromise its safety or performance WARNING Do not autoclave gas sterilize or immerse the T Stat monitor This may create an electric shock hazard or damage internal components WARNING Do not connect any accessories to the USB port on the rear panel of the monitor when the system is in use on a patient other than the approved AT T or Verizon modems WARNING When monitoring on ne...

Page 5: ...stablished in disease states The T Stat Oximeter measures regional StO2 and may not reflect changes in oxygenation that occur in regions outside of that monitored by the T Stat sensor The T Stat Oximeter used alone at a single site cannot differentiate between local and global conditions Use of the T Stat during high output shock states such as sepsis has not been evaluated During these conditions...

Page 6: ...planation Electrical Shock Hazard AC Alternating Current Type BF Equipment RX ONLY US Federal regulations restrict the sale of this device to or on the order of licensed medical practitioners Off On Audible Alarm Sounding Do not re use No Latex Battery Indicating Charge Level Battery Exhausted Shutdown will begin soon Battery Charging ...

Page 7: ...2 0 Each single use patient sensor contains a visible light source for illuminating the tissue and glass optical fibers for transmitting light remitted from tissue along the sensor fiber and back to the monitor There are five different T Stat sensor sensors available The clinical choice of sensor is determined by the target site of monitoring either oral buccal endoscopic via endoscopy or surface ...

Page 8: ...s of T Stat 2 0 Sensors D Indications for Use The Spectros T Stat 2 0 Microvascular Tissue Oximeter is intended for use as an adjunct monitor of the localized hemoglobin oxygen saturation of blood in the microvascular tissue spaces StO2 in infants children or adults at risk for reduced flow and no flow ischemic states The prospective clinical value of measurements made with the T Stat Oximeter has...

Page 9: ... sensor placement F Understanding T Stat Readings The T Stat Tissue Oximeter measurements differ from conventional pulse oximetry in several important ways Capillary weighted Hemoglobin oxygen saturation of blood in the microvascular tissue is typically lower than pulse oximetry saturation SpO2 and arterial saturation SaO2 Whereas pulse oximetry measures arterial saturation tissue oxygenation is c...

Page 10: ...issue is reduced both pulse oximetry and tissue optical oximetry report low values Sensitive to low flow or no flow Ischemia Reduced blood flow ischemic states are detected by tissue oxygen saturation StO2 but are not detected by pulse oximetry During reduced blood flow ischemia such as from tissue ablation thrombosis or cardiac failure the arterial saturation remains unchanged but the reduced blo...

Page 11: ...in such as introduced by trauma or surgery Thin mucosa such as the intestinal wall can also absorb oxygen directly through the mucosa and read as more highly oxygenated during open surgical procedures 3 Tissue oxygenation is affected by tissue compression which locally reduces blood flow and produces local ischemia Care must be taken that local tissues are not madeartificially ischemic by direct p...

Page 12: ...ssue Oximeter parts and features are illustrated below Figure 3 T Stat 2 0 Physical Layout Menu buttons 1 Graph StO2 rHb 2 Sensor Probe Socket 3 Saturation 4 Relative Hemoglobin rHb 5 Color Status Dot and Message 6 On Off Button 1 Power Switch 2 Electrical Supply 3 USB Port 4 Wi Fi Antenna Port 1 4 2 3 ...

Page 13: ... on the monitor located to the lower right of the monitor display Align the red line on the sensor connector with the red arrow on the front panel 12 00 insert the connector into the connection port until it hits a hard stop and rotate turn clockwise to lock in place 3 00 Sensor identification and calibration will begin automatically when sensor is plugged in 5 When the T Stat completes its self t...

Page 14: ...and no longer display this file on the visual screen chart 12 When finished monitoring remove from the patient and discard sensor 13 Make sure to turn the power off from the front of the monitor If you wish to keep the monitor charging make sure it is plugged in the back power switch is on and the front power button is off ...

Page 15: ...behind the ear if desired to stabilize the sensor Figure 4 Placement of the Oral Sensor in an Adult The sensor can be placed against either cheek left or right Note that the sensor end is located against the inner oral mucosa Caution Ensure that the illuminated portion of the sensor is not in contact with the cheek Excess pressure on the inner cheek at the sensor site can alter local blood flow an...

Page 16: ...on contact sensor All that is required for measurement is a view of the mucosal tissue to be monitored The placement of the endoscopic sensor is illustrated in the following figure Figure 6 Placement of the Endoscopic Sensor Caution Ensure that the illuminated portion of the endoscopic sensor is not in contact with the mucosal tissue Excess pressure on mucosal tissue at the sensor site can alter l...

Page 17: ...2 00 on the monitor then rotating one quarter turn clockwise after insertion to the locked position When locked into position the white light sensor will illuminate and will automatically go through recognition and calibration If this does not happen this step is incomplete 3 Hold sensor flat on skin surface being careful not to apply pressure so as to cause local ischemia FIGURE 7 1 cm surface se...

Page 18: ...osition When locked into position the white light sensor will illuminate and will automatically go through recognition and calibration If this does not happen this step is incomplete Remove the white sticker tape from the face of the surface sensor disk 2 Place sensor flat on skin surface being careful not to apply too much pressure so as to not cause local ischemia 3 Surgical tape or Tegaderm can...

Page 19: ...Auditable alarms can be silenced permanently by pressing DISABLE ALARM 4 When done press HIDE ALARM SCREEN When setting the alarms the real time values measured continue to be displayed at the bottom of the screen Saving Data to Internal Disk 1 From the main screen select 2 To save discard future displayed results select Save Patient Results 3 To save discard future raw data select deselect Save R...

Page 20: ...the T Stat system Stored data can be transferred to a Zip or other USB Storage Device as follows 1 Connect storage device to the USB data port on rear panel of monitor 2 From the main screen select OPTIONS 3 Select TRANSFER DATA There will be a brief pause before copying data is complete 4 Wait until copying is done and OK to Remove Disk is displayed before removing the disk Press DONE WITH OPTION...

Page 21: ...3 Use the arrows to change the time date and time units 12h vs 24h AM or PM 4 Press SAVE or DO NOT SAVE Checking Software Version Numbers You may view the software versions and view the results of a system integrity check using the Versions screen as follows 1 From the main screen select OPTIONS 2 Press ABOUT 3 When finished viewing press OPTIONS DONE ...

Page 22: ...ded with the T2 Refer to image below 3 Turn the antenna until it is pointing upwards 4 On the home screen click on OPTIONS In the following page there will be a number of options on the left panel 5 Click on the button that says ONCALL ACCESS This will be the 4th from the top CAUTION Do not touch or move antenna while the unit is transmitting or receiving CAUTION Do not operate the radio or attemp...

Page 23: ...ord 5 Enter the password using the on screen keyboard and click on OK when done 6 Click on the x located on the on screen keyboard to close the keyboard 7 The connection should now be established The name of the network will now appear right next to Current Connection on the top of the page If the connection has failed try re typing the password or connect to a different network 8 To verify that t...

Page 24: ... Inc Page 24 of 44 Rev B T STAT 2 0 User Manual 9 Once the connection has been established the device is ready to transmit 10 To turn off the wifi connection navigate to OnCall Access in the OPTIONS menu and click on Wifi OFF ...

Page 25: ...turn into a solid green light 2 When the light is solid click on the Verizon Modem tab on top of the page 3 Wait for a few seconds while Verizon establishes a connection The following page will appear when the modem is ready to transmit 4 To verify check the internet connection icon at the bottom of the page It should be green if there is an active connection and grey when the connection is lost 5...

Page 26: ...lished the following page will appear 4 To verify check the internet connection symbol at the bottom of the page It should be green if the connection is active and grey when it is inactive 5 Once the connection has been established the device is ready to transmit To disconnect navigate to the connection page above and click on Off and then Apply NOTE If the LED on the modem doesn t become a solid ...

Page 27: ...the monitor Fluids and dried substances will impair light collection and may impart color to the returning light which may result in inaccuracies o Allow unit to dry completely prior to re connecting AC power Storage and Transport o Do not drop o Do not store in humid condensing or wet environments o Short term exposure to 20C to 60C 5 95 RH is permissible o For sensors storage we recommend the WH...

Page 28: ...nsor has expired Message Pause Monitor is ready to capture and display incoming data Message Check Sensor Sensor may be improperly placed Re position sensor Sensor may be picking up excess light from an external light source Re position sensor external light source or cover sensor to shadow it from room light Tip of sensor may be obscured by blood Remove sensor and clean tip Message Check Contact ...

Page 29: ...nsive systolic blood pressure below 90 mmHg A total of 786 measurements in oral and GI system tissues were performed in 111 healthy patients Normal values are as follows Table A 1 T Stat mucosal oxygenation values measured in healthy patients Region Oxygenation Mean SD Number of Subjects n 95 C I Reference Buccal Mucosa 77 3 n 21 71 83 6 Colon 69 4 n 40 61 77 6 Small Intestine 71 3 n 10 65 77 6 St...

Page 30: ... is shown in Figure A 2 The relationship between pulse oximetry and tissue oxygenation during acute hypoxemia is linear 6 Figure A 2 Tissue oximetry versus pulse oximetry in a porcine hypoxemia model measured in leg muscle 90 85 80 75 70 65 60 55 50 45 40 0 20 40 60 80 Muscle Oxygenation StO2 Note that during hypoxemia the difference between SaO2 and StO2 in muscle is typically less than 35 though...

Page 31: ... that during hypoxemia with a normal pulse oximetry reading of 90 94 the difference between SaO2 and StO2 in muscle raises to as high as 77 well above the hypoxemia range of 15 35 Thus the difference between the pulse oximetry estimate of SaO2 and the tissue oximetry measure of StO2 may allow for discrimination of ischemia from pure hypoxemia 4 Discriminating Between Ischemia Hypoxemia or mixed Hy...

Page 32: ... sensors are provided in Section G of this manual User reparable errors are identified and displayed by the monitor system during measurement including testing for sensor placement proper total hemoglobin seen light level appropriate sensor movement unstable total hemoglobin or unstable light levels sensor failure no or insufficient returning light and insufficient or excess returning light Import...

Page 33: ...and have been approved by the FDA for human use Table 3 T Stat Sensor Types Sensor Number Sensor Description CTH 060 ORA M Oral Sensor CTH 060 SUR 2 5 2 5 cm Surface Sensor CTH 060 SUR 1 1 cm Surface Sensor CTH 060 END 2M Endoscopic T Stat 2 m Catheter Figure B 1 Four Basic Sensors 1 CM Surface Sensor 2 5 CM ...

Page 34: ...rrent limit resistor socket and sensor Memory Internal EEPROM 1kB memory with the following information Lot Number Serial Number Mfg Date Sensor Name Sensor Type Compatibility Version Expiration Date Expiration Flag Reuse Flags Concentration and or wavelength calibration factor Approvals Tested with T Stat 2 0 to the following specifications UL 2601 1 EN60601 1 2005 Class 1 Type BF continuous oper...

Page 35: ...tine is checked for consistency with the initial installation and or software updates Software Integrity A bit by bit comparison is performed to ensure that each software script and database component has not been altered since installation Algorithm Integrity A full test of the data handling and calculation using an internal database to ensure calculation is accurate Storage Maintenance A self cl...

Page 36: ...ative Hemoglobin rHemoglobin a range 0 0 99 mM b resolution 0 01 mM c reproducibility 5 uM SD single site x 5 over 1 min ex vivo d stability 5 uM SD single site x 1 day ex vivo e accuracy 5 uM SD 100 at 100uM ex vivo 3 Informational Warning Specifications Warning levels Low StO2 User settable 0 99 preset Low 40 High StO2 Low Heme High Heme Too Dim Too Bright Unstable User settable 0 99 preset High...

Page 37: ...ital grade 3 m grounded cord Power Required 70 VA typical Battery 11 25V 6400mAh 72 0Wh Lithium Ion Rechargeable Smart Battery Pack Fuse T3A 250V Patient Operator Protection Medical grade Isolated power supply Isolated DC supply to sensor socket Dual Fuse Power Supply external user replaceable and internal fuse Dual current limit resistor limit resistor in socket AND limit resistor in each sensor ...

Page 38: ...se any interference in nearby electronic equipment Likewise the emissions outside the Wi Fi or Cell modem bands are very low when these options are available RF emissions CISPR 11 Class b The T Stat 2 0 is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic pur...

Page 39: ... Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT...

Page 40: ... in metres m Field strengths from fixed RF transmitters as deter mined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propaga...

Page 41: ...ndling diagnostics and repair of the system Limited Warranty a THE T STAT SHALL BE DELIVERED FREE FROM MANUFACTURING DEFECTS AND SPECTROS MDI WILL REPAIR OR REPLACE ANY PART IDENTIFIED AS DEFECTIVE TO SPECTROS BY THE CUSTOMER FOR THE FIRST YEAR FOLLOWING DELIVERY OF THE T STAT b SPECTROS SHALL NOT BE RESPONSIBLE FOR ANY FAILURE OF THE T STAT SYSTEM THAT IS DUE TO NEGLECT MISUSE OR ABUSE c TO THE K...

Page 42: ...OR ANY SPECIAL INDIRECT INCIDENTAL OR CONSEQUENTIAL DAMAGES OR PUNITIVE DAMAGES OF ANY KIND OR FOR THE LOSS OF REVENUE LOSS OF BUSINESS OR OTHER FINANCIAL LOSS OR THE COST OF SUBSTITUTE GOODS OR SERVICES HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY ARISING OUT OF THIS AGREEMENT THESE LIMITATIONS SHALL APPLY NOTWITHSTANDING THE FAILURE OF ANY LIMITED REMEDY PROVIDED HEREIN Purpose of Product This ...

Page 43: ...ials Shipping materials can be obtained by contacting Spectros Customer Service Department Before shipping call Spectros Customer Service Department and obtain a Return Materials Authorization RMA number When returning a system include the following information Description of problem RMA number Contact information for person to contact at your facility Return address Unauthorized Repair There are ...

Page 44: ...entral venous and mixed venous oxygen saturation in critically ill patients Respiration 2001 68 3 279 285 4 Macmillan CS Andrews PJ Cerebrovenous oxygen saturation monitoring practical considerations and clinical relevance Intensive Care Med 2000 Aug 26 8 1028 1036 5 Friedland S Benaron DA Parachikov I Soetikno R Measurement of mucosal capillary hemoglobin oxygen saturation in the colon by reflect...

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