T-Stat® VLS Tissue Oximeter Specifications |
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1. Physical Specifications |
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1.1 Size: | 11” Wide x 7 ” High x 9.5” Deep |
1.2 Weight: | 11 lbs (5 kg) |
1.3 Color: | Light Blue Case Ivory Front and Rear Panels |
1.4 Front Panel: | Back-Illuminated touch-screen VGA display screen Type SPEC-1 Female Sensor socket |
1.5 Rear Panel: | Power switch Power socket and fuse access USB (Type II) data port |
1.6 Top: | Flexible carrying handle |
1.7 Bottom: | Folding tilt-up stand |
2. Value and Accuracy Specifications: |
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2.1 Values Displayed |
| StO2% rHemoglobin (relative hemoglobin) Signal intensity Optional trend graph |
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2.2 Tissue Hemoglobin Saturation (StO2%) |
a. range: | 0-99% |
b. resolution: | 1% |
c. reproducibility: | ± 2% (SD, single site, x 5 over 1 minute, ex vivo) |
d. stability: | ± 2% (SD, single site x 1 day, ex vivo) |
e. accuracy: | ± 2% (SD @ 100% at 100uM, ex vivo) ± 2% ([email protected] 0%, in vivo |
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2.3 Relative 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. Alarm/Warning Specifications |
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Alarms 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 95%) rHemoglobin < 5 uM (analysis suppressed, “no tissue” error) rHemoglobin >100 uM (“bloody tissue” error) Signal < 500 counts in 500 ms Signal > 4000 counts in 5 ms Signal strength changes >20% between sample |
Result Blanking: (blanks to “- - -“) | Invalid data x 6 seconds Out of range data x 6 seconds No tissue seen x 6 seconds |
Alarm Indicator: | Red/Yellow/Green Status Indicator White error message on flashing red background Audible alarm (silenceable) |
Alarm Silencing: | Audible alarm silenced x 2 min Visual alarm cannot be turned off |
System Collecting: | Sequential illuminated squares when data collecting |
Good Data Indicator: | Green status indicator when data good |
Self-Diagnostics: | Automatic Self-Test at Power on Visual display of self-test progress Validation of software versions Validation of software integrity Validation of algorithm successful operation Test of optical spectrometer Test of optical socket reader Test of memory storage space Test of microprocessor system Red/Green self-test success indicators Halt at Start up if errors in self-test |
4. Microprocessor Specifications:
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Operating System: | Windows Embedded XP SP1 |
Internal Memory: | 64 Mb (minimum) |
CPU: | 1GHz P3 (minimum) |
Oximetry Software: | T-Stat® operating software 1.05.022.00 (clinical release CR4) or later |
5. Optical Specifications: |
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Probe Input: | 150 uM fiber return line |
Probe Output: | Current-limited 5V output source |
Connector: | Female, Type 1 Spectros Light-Jack Connector |
6. Electrical/Emissions Specifications: |
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Input Voltage: | 100-240 V~, 50-60Hz Electrically isolated US/Canada: Green-dot (hospital grade) 3 m grounded cord |
Power Required: | 100 VA (typical) |
Battery: | None |
Fuse: | T3A/250V |
Patient/Operator Protection: | Medical-grade Isolated power supply Isolated DC supply to probe socket Dual-Fuse Power Supply (external (user-replaceable), and internal fuse) Dual current limit resistor (limit resistor in socket AND limit resistor in each probe) |
Approvals: | UL 2601-1, EN60601-1-2:2001, CE, FC, EMC 89/336/EEC, Medical Directive 93/42/EEC |
7. Operating Specifications: |
Environment: | Intended for Indoor Hospital Use 5-40 degrees Celsius 5%-95% humidity (non-condensing) |
Start-Up | Warm-up and self test requires up to 2 minutes |
Shut Down | Power off using switch; no shutdown time required |
8. Optional Software: |
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Research Options (not for clinical use) | Optional data collection to internal flash Optional data export to external disk via USB port Optional analysis scripting for user-specific analysis |
9. Probe Specifications: |
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Sterile | Human probes are available sterile for single use. |
Sensor Types: | CTH-060-REC --- Rectal T-Stat® Sensor CTH-060-END 2M & .5M--- Endoscopic T-Stat® Sensor CTH-060-ORA & ORA/MINI --- Oral Buccal T-Stat® Sensor |