T-Stat® VLS Tissue Oximeter Specifications

1. Physical Specifications

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:

2.1 Values Displayed

StO2%

rHemoglobin (relative hemoglobin)

Signal intensity

Optional trend graph

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

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

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:

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:

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:

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:

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:

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