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Spectros T-Stat 2.0 Скачать руководство пользователя страница 38

Spectros Medical Devices Inc. 

Page 38 of 44 

Rev B 
 

 

 

T-STAT 2.0 User Manual 

 

Appendix E: EMC Information 

 

 

 

 
 
 

 

The following tables apply to all T-Stat® 2.0 sensors offered by Spectros 

 

Table 1 

 

Guidance and manufacturer’s declaration –

 electromagnetic emissions 

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. 

Emissions test 

Compliance 

Electromagnetic environment 

–

 guidance 

RF emissions 

CISPR 11 

Group 1 

The T-Stat® 2.0 uses RF energy for its internal function 
and optional Wi Fi or cell modem.  Therefore, its RF 
emissions without the RF options are very low and are 
not likely to cause 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 
purposes 

Harmonic emissions 

 

IEC 61000-3-2 

Class A 

Voltage fluctuations/ flicker 
emissions 

 

IEC 61000-3-3 

Complies 

Warning: MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to 
be installed and put into service according to the 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® 2.0 system. 

Содержание T-Stat 2.0

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

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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 ...

Страница 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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