Firma:              Hoffmann La Roche

Modell:            Pentra 120

Kommentar:   Dokumente engl.

TECHNICAL SPECIFICATIONS

The PENTRA 120 is a medical device used to measure the characteristics of blood tested in laboratories.This device includes both hardware (mechanical and pneumatic) and software program technologies. The PENTRA 120 has the following characteristics:

General configuration

A - Given parameters

* 38 parameters :

- WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW

- PLT, MPV, PCT, PDW

- LYM#, LYM%, MON#, MON%, NEU#, NEU%, EOS#, EOS%, BASO#, BASO%, ALY# (atypic lymphocytes), ALY%, LIC# (Large Immature Cells), LIC%

- RET#, RET%, RETL%, RETM%, RETH%, RETLratio, RETMratio, RETHratio, IMM%, MFI%, MRV, CRC

* 22 parameters (US configuration) :

- WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW

- PLT, MPV

- LYM#, LYM%, MON#, MON%, NEU#, NEU%, EOS#, EOS%, BASO#, BASO%

- RET#, RET%

* High definition of WBC differentiation matrix

* High definition of RET repartition

* RBC and PLT histograms

* Qualitative and quantitative flags

* Pathology flags

B - Throughput analyses

C - Automatic mode (closed tubes)

* Vertical cassette loader

* 10 tubes per cassette

* Loader capacity: 15 cassettes

* Continuous loading capability

* Cassette selection, CBC or CBC + DIFF or CBC+RET or DIFF+RET or RET

D - Tube identification

* Closed tube mode:

- With the alphanumerical or front panel keyboard

- With barcode labels: tubes and cassette identifications

* Microsampling mode:

  - With the alphanumerical or front panel keyboard

- With barcode labels: tube identification

E - Memory capacity

* 90,000 patient results on hard disk with curves and matrix in 5DIFF analysis mode

* Backup on floppy disk available

F - Statistics and quality control

* Specific menus for statistics and quality control

* XB control

* Daily mean

* Westgard

* LJ graphs

G - Reagents

* 6 reagents, 4 integrated (*)

- ABX DILUENT

- BASOLYSE

- EOSINOFIX (*)

- ABXAL PHALYSE (*)

- ABX CLEANER (*)

- RETIX (*)

H - Display

* LCD black and white backlighted

* Optional color station for result validation (PC type)

I- Data processing

* 68340 type microprocessor

* Multifunction, multitask

* 350 to 500 Mb hard disk capacity

* 3.5" floppy disk drive

* RS232C output

* Mono or bidirectional connection

Software functional requirements

The software program has been developed with a 68340 type microprocessor and microcontrollers for key operation, computation and result output. This software was developed with the functional requirements given below:

A - Power on processing

* Boot and software initialization

* hardware initialization including compressor, printer and motors

B - Initialization processing

*           Startup cycle (includes an autocontrol cycle, a diluent rinse, a blank cycle check)

C - Operation with numerical keyboard and menus

* Result analyses

* Result review

* QC

* Calibration

* Maintenance

* Setup

D - Calibration

* Automatic procedure with open or closed tubes

* Direct entering of calibration coefficients

E - Measurements and computation

* Impedance change for WBC, RBC, PLT, BASO, HCT

* Spectrophotometry for HGB

* Impedance change and Iight scattering for LYM%, MON%, NEU%, EOS%, ALY% and LIC%

* Computation from stored data that was directly measured for MCV, MCH, MCHC, RDW, MPV, PCT, PDW, LYM#, MON#, NEU#, EOS#, ALY# and LIC#

* Impedance change, Iight scattering and fluorescence for RET# and RET%

F - Outputs

* Hard copy printing

* External output (RS232C)

G - Error/troubleshooting processing

* Error message display

* Sampling stop in automatic mode

* Fully automatic autocontrol cycle

* Maintenance and troubleshooting procedures

PHYSICAL SPECIFICATIONS

Power requirements

A - Instrument:

- Power supply:          100V, 110V, 220V, 240V, 50/60Hz

- Consumption:           650W (routine)

900W (startup)

B - Laser:                    800W in stand-by mode

2KW maxi

Operating temperature and humidity

- 18 - 32°C

- Up to 95% without condensation - Avoid exposure to direct sunlight

- Temperature gradient: 2°C per 3 hours

- Reticulocyte Option temperature range : ~ 8°C

Laser specifications

- Laser Spectra-Physics 163A, Argon type at 488nm

- Class IlIb

- Emission power: 25mW

- Power consumption: 2kW

Dimensions and weight

A - PENTRA 120 5DIFF

- Height: 67 cm

- Width: 117 cm

- Depth: 55 cm

- Weight: 90 kg

B - PENTRA 120 RET

- Height: 75 cm

- Width: 117 cm

- Depth: 55 cm

- Weight: 110 kg

C - Dot matrix printer

- Height: 17 cm

- Width: 46 cm

- Depth: 38 cm

- Weight: 10.5 kg

D - Laser printer

EPSON printer :

- Height: 217 mm

- Width: 352 mm

- Depth: 407 mm

- Weight: 5 kg

E - Laser power supply

- Height: 14 cm

- Width: 16 cm

- Depth: 28.5 cm

- Weight: 11.5 kg

Wastes

- Automatic disposal, level control

- Waste handled according to local/national regulations

Minimum sample volume

- Manual cycle:            130µI

- Automatic cycle:       200µl

Dilution ratlos

- WBC/HGB:    1:234

- RBC/PLT:      1:10 000

- BASO:           1:200

- LMNE:            1:80

- RETIC:          1:3125

Counting aperture diameters

- RBC chamber aperture:       50pm

- LMNE flowcell aperture:        60pm

- BASO chamber aperture:     80pm

- WBC chamber aperture:      100pm

- RET flowcell aperture:          60pm

HGB measurement

- Modified Drabkin method (cyanmethemoglobine) - Light source: Electroluminescent diode

- Wavelength: 550nm

- Bandwidth:10nm

Cycle durations

- STARTUP cycle : 229 to 341 seconds (depending on the blank cycle number)

- SHUTDOWN cycle : 121 to 131 seconds (depending on the compresseur Status : ON or OFF)

SUMMARY OF PERFORMANCE DATA

A total of 20 blood specimens were analyzed in three laboratories. These specifications can be taken into account only for a clean and well-maintained Instrument according to the procedures given in section 8 of this manual.

Within Run Precision

These specimens include normal and abnormal samples. The table below describes the range of %CV's for all samples. They are categorized as normal or abnormal samples based on the PENTRA 120 Normal Range given in section 9.3.7. Precision calculations were not performed for parameters which produced flags or error alarms.