Spectros T-Stat 2.0 User Manual
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Spectros T-Stat 2.0 User Manual

Microvascular tissue oximeter
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T-STAT 2.0 User Manual
T-Stat 2.0
User Manual
Rev B
Spectros Medical Devices Inc.

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  • Page 1 T-STAT 2.0 User Manual T-Stat 2.0 User Manual Rev B Spectros Medical Devices Inc.
  • Page 2 T-STAT 2.0 User Manual 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: Table Of Contents

    T-STAT 2.0 User Manual Table of Contents Contents Safety Information ..........................4 Table of Symbols ............................. 6 ® About the Spectros T-Stat Tissue Oximeter ..................7 Indications for Use ..........................8 Principle of Operation ..........................9 ® Understanding T-Stat Readings ......................9 Cautions and Notes ..........................

  • Page 4: Safety Information

    T-STAT 2.0 User Manual A. Safety Information NOTE: Federal Regulations in the United States restrict the sale of this device to or on the order of licensed medical practitioners. 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.
  • Page 5 T-STAT 2.0 User Manual Precautions The prospective clinical value of measurements made with the T-Stat ® Oximeter has not been demonstrated in disease states. The T-Stat ® Oximeter should not be used as the sole basis for diagnosis or therapy. While normal StO...

  • Page 6: Table Of Symbols

    T-STAT 2.0 User Manual B. Table of Symbols Caution: Consult this manual for a complete explanation Electrical Shock Hazard (AC). Alternating Current Type BF Equipment RX ONLY: US Federal regulations restrict the sale of this device to, or on the...

  • Page 7: About The Spectros T-Stat ® Tissue Oximeter

    T-STAT 2.0 User Manual C. About the Spectros T-Stat Tissue Oximeter ® ® The T-Stat Microvascular Tissue Oximeter provides a continuous, noninvasive, and localized measurement of the microvascular hemoglobin oxygen saturation, sensitive to regional and global reduced-flow or no-flow ischemia, as demonstrated in peer- reviewed human clinical studies.

  • Page 8: Indications For Use

    T-STAT 2.0 User Manual Monitoring is achieved by attaching the connector end of the selected sensor to the monitor and placing the patient end of the selected sensor near, on, or into the target tissue to be studied, depending upon the site selected.

  • Page 9: Principle Of Operation

    ® forms (oxy-, deoxy-, met-, carboxy-) has unique spectroscopic properties that allow StO2% to be determined based on measurements of the spectral characteristics of the reflectance of light from tissue. The Spectros T-Stat uses broadband, multi-wavelength illumination and ® monitoring to determine the relative amount of oxygenated and deoxygenated hemoglobin in the microvascular tissue spaces.
  • Page 10 T-STAT 2.0 User Manual Table 1 Normal Range of Oxygenation Values for pulse oximetry, central venous sampling, and VLS tissue oximetry Normal Value Description Range 95-100% Arterial hemoglobin saturation. Commonly i,ii estimated by Pulse Oximetry. iii,iv 65-75% Venous hemoglobin saturation. Commonly estimated by Central Venous Catheter sampling.

  • Page 11: Cautions And Notes

    T-STAT 2.0 User Manual G. Cautions and Notes 1. Capillary-weighted tissue oxygenation differs from arterial oxygenation as measured by pulse oximetry. Tissue oxygenation (StO %) is influenced by arterial blood oxygenation (SaO %), as well as by blood flow and blood hemoglobin content, and does not require a pulse in order to obtain a measurement.

  • Page 12: Feature Layout

    T-STAT 2.0 User Manual H. Feature Layout The T-Stat Tissue 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.

  • Page 13: Operation

    T-STAT 2.0 User Manual I. Operation Monitoring Oxygenation In order to use the T-Stat Tissue Oximeter, the monitor is placed 2meters or ® less from the bedside (limited only by the length of the sensor cable, not by any fundamental limitation of transmission). A disposable sensor is then placed at the target tissue site, either oral (buccal), skin, or through an endoscope.
  • Page 14 T-STAT 2.0 User Manual current data file, store it in the internal memory 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: Placement And Use Of The Oral Sensor

    T-STAT 2.0 User Manual Placement and Use of the Oral Sensor The oral sensor is placed in the following steps: Caution: If pouch integrity is compromised prior to removal, discard sensor. Possibility of contamination presents risk to patient 1. The sensor is connected to the monitor, and then the cable is routed to comfortably place the sensor alongside either the left or right cheek.

  • Page 16: Placement And Use Of The Endoscopic Sensors

    T-STAT 2.0 User Manual Placement and Use of the Endoscopic Sensors The endoscopic sensor is placed during an endoscopy procedure in the following steps: Caution: If pouch integrity is compromised prior to removal, discard sensor. Possibility of contamination presents risk to patient 1.

  • Page 17: Placement And Use Of The 1 Cm Surface Sensor

    T-STAT 2.0 User Manual Placement and use of the 1 cm Surface Sensor Preparation – Assure skin area to be measured is clean and free of blood. – Do not apply to open wound. Placement 1. Remove T-Stat Surface Sensor from Sterile Package ®...

  • Page 18: Placement And Use Of The 2.5 Cm Surface Sensor

    T-STAT 2.0 User Manual Placement and use of the 2.5 cm Surface Sensor Preparation – Assure skin area to be measured is clean and free of blood. – Do not apply to open wound. Placement Remove T-Stat Surface Sensor from Sterile Package.

  • Page 19: Changing The Alarm Settings

    T-STAT 2.0 User Manual Changing the Alarm Settings A flashing alarm can be set to display on the screen if saturation rises above or falls below a set value. This can be done on the main menu, which appears after power up, before plugging in the sensor, or can be reached by pausing the measurement and pressing “Done Monitoring”...

  • Page 20: Moving Stored Data

    T-STAT 2.0 User Manual In the example above, the T-Stat device serial number is: TS2.0D1000A. ® File Folders: T-Stat files are transferred to two folders: Data and Results. ® Data Files: T-Stat produces 3 types of output files in Windows PC format: ®...

  • Page 21: Changing Date And Time

    T-STAT 2.0 User Manual Changing Date and Time 1. From the main screen, press OPTIONS. 2. Press SELECT TIME 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...

  • Page 22: Instructions For Use Of On-Call Via Wi-Fi

    T-STAT 2.0 User Manual Instructions for Use of On-Call via Wi-Fi CAUTION: Do not touch or move antenna while the unit is transmitting or receiving CAUTION: Do not operate the radio or attempt to transmit data unless the antenna is connected; this behavior may cause damage to the radio.
  • Page 23 T-STAT 2.0 User Manual 6. Click on the WiFi Settings Tab. 7. Click on the button labelled Wifi - ON. This will give you a list of Wi-Fi networks available in the vicinity. If you do not see a list, hit the Refresh button on the top right.
  • Page 24 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 24 of 44 Rev B Spectros Medical Devices Inc.

  • Page 25: Instructions For Use Of On-Call Via Verizon Or Att

    T-STAT 2.0 User Manual Instructions for Use of On-Call via Verizon or ATT WARNING: Do not engage Wi-Fi or use cell modems in areas where emissions could interfere with critical wireless monitors. Follow hospital policy. 1. Power up the T2 and wait for the self-test to finish its checklist.

  • Page 26: At&T Access

    T-STAT 2.0 User Manual AT&T Access: Connect the AT&T Modem to the USB port at the back of T2 and wait for the LED to turn a solid green color. When the light is solid, click on the “AT&T Modem” tab on the OnCall Access page.

  • Page 27: Care And Maintenance

    T-STAT 2.0 User Manual J. Care and Maintenance Cleaning Disconnect the T-STAT system from AC power prior to ® CAUTION: cleaning Do not autoclave, gas-sterilize, or immerse the T-STAT system. WARNING: ® Disconnect the power cord before cleaning Use a soft cloth and mild, non-abrasive cleaners on the touch screen display.

  • Page 28: Messages

    T-STAT 2.0 User Manual K. Messages Table 2 T-Stat ® Messages T-Stat ® Message: Possible cause and course of action: Message: No Sensor Insure that probe is connected to monitor. Insure that probe connector is rotated clockwise to its full extent.

  • Page 29: Appendix A: Measured Values

    T-STAT 2.0 User Manual Appendix A: Measured Values 1. Normal Values Tissue optical saturation has been measured in a number of clinical studies. However, the validity and significance of these normal ranges of values for human use has not been established.
  • Page 30 T-STAT 2.0 User Manual 2. T-Stat Values During Hypoxemic Hypoxia (Low saturation): ® During hypoxemia induced by mixture of room air with nitrogen (breathe down study) in a pig, the relationship between arterial blood oxygen saturation as measured by pulse oximetry...
  • Page 31 T-STAT 2.0 User Manual 3. T-Stat Values During Ischemic Hypoxia (Low blood flow): ® During local ischemia in human colon polyps, induced by either epinephrine injection or suture ligation, the following values have been measured. Table A.2. Human Colon Polyp Tissue Oxygenation During Ischemia Oxygenation No.

  • Page 32: Appendix B: Sensor Specifications

    T-STAT 2.0 User Manual Appendix B: Sensor Specifications The T-Stat was designed to operate with multiple interchangeable T-Stat sensors, ® including surface sensors, endoscopic sensors, T-Stat sensors undergo 100% testing at manufacture. This testing produces an internal ® certification file (registration file) that is stored on an internal EEPROM memory chip located in the connector of each tissue oximeter sensor.
  • Page 33 T-STAT 2.0 User Manual The following sensors are available and have been approved by the FDA for human use. Table 3 T-Stat Sensor Types. ® Sensor Sensor Number Description CTH-060-ORA M Oral Sensor CTH-060-SUR 2.5 2.5 cm Surface Sensor CTH-060-SUR 1...
  • Page 34 – 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 operation ; IEC 60601-1-2 (2007), 4. Operating Specifications: Environment:...

  • Page 35: Appendix C: Self-Test And Errors

    T-STAT 2.0 User Manual Appendix C: Self-Test and Errors The T-Stat Tissue Oximeter performs comprehensive self-test upon power-up. This test consists of ® a verification of constancy of the program software, standards, algorithm, and support files, validation of the algorithm software using a known set of testing standards, and operation and functionality of the hardware.

  • Page 36: Appendix D: T-Stat ® 2.0 Specifications

    T-STAT 2.0 User Manual Appendix D: T-Stat 2.0 Specifications ® T-Stat® 2.0 Specifications 1. Physical Specifications 1.1 Size: 11” Wide x 5.5” High x 8.5” Deep 1.2 Weight: 6 lbs. (2.7 kg) 1.3 Color: Light Grey Case 1.4 Front Panel:...
  • Page 37 5. Optical Specifications: Sensor Input: 150 uM fiber return line Sensor Output: Current-limited 5V output source Connector: Female, Type 1 Spectros Light-Jack Connector 6. Electrical/Emissions Specifications: Input Voltage: 100-240 V~, 50-60Hz Electrically isolated US/Canada: Green-dot (hospital grade) 3 m grounded cord...

  • Page 38: Appendix E: Emc Information

    EMC information provided in the following tables. Warning: The use of ACCESSORIES, transducers and cables other than those provided by Spectros and specified, in this manual, may result in increased EMISSIONS or decreased IMMUNITY of the T- Stat®...
  • Page 39 T-STAT 2.0 User Manual Table 2 Guidance and manufacturer’s declaration – electromagnetic immunity The T-Stat® 2.0 is intended for use in the electromagnetic environment specified below. The customer or the user of the T-Stat®2.0 should assure that it is used in such an environment.
  • Page 40 T-STAT 2.0 User Manual Table 3 Guidance and manufacturer’s declaration – electromagnetic immunity The T-Stat® 2.0 is intended for use in the electromagnetic environment specified below. The customer or the user of the T- Stat®2.0 should assure that it is used in such an environment.

  • Page 41: Appendix F: Warranty Information

    Spectros’ sole discretion, replace the units that prove to be defective in material or workmanship. If Spectros determines that the Product is defective and that the claim was made within the warranty period, Spectros shall satisfy its obligations under this warranty by repairing or replacing the Product and returning it to the Customer at Spectros’...
  • Page 42 Spectros MDI makes no claim or warranty express or implied, related to the use of the Spectros T- STAT system as a ®...

  • Page 43: Appendix G: Service And Disposal Information

    Do not attempt to ® perform any service or tamper with the warranty seal unless you have been authorized to do so in writing by Spectros MDI. Performing unauthorized service or repairs during the warranty period will void the product’s warranty. Disposal...

  • Page 44: References

    T-STAT 2.0 User Manual References: 1. Levesque BM, Pollack P, Griffin BE, Nielsen HC. Pulse oximetry: what's normal in the newborn nursery? Pediatr Pulmonol. 2000 Nov;30(5):406-12. 2. Gries RE, Brooks LJ. Normal oxyhemoglobin saturation during sleep. How low does it go? Chest. 1996 Dec;110(6):1489-1492.

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