Single channel coagulometer with turbo-photometric

clot detection principle with an opto-mechanical

measuring system which improves sensitivity of

detecting weak fibrin polymers. Hemostar XF has 10

open locations which enables to perform PT, APTT, TT,

fibrinogen assays and factors assays. This walk away plug

and play system has been designed to make complicated

clotting analysis of hemostasis system into a simple error

free task (Fig. 10.2).

¾ Single-channel coagulometer, fully-controlled by builtin microprocessor

¾ Turbophotometric detection of fibrin polymer

formation (clots)

¾ Solid state thermostat set at 37°C

¾ Keyboard for programing and data entry

¾ Digital control and results display

¾ Integral printer for easier transcription of results

¾ Enables performance of all types of hemostasis plasma

phase studies and particularly: Quick, APPT, TT,

fibrinogen, factor studies

¾ Optics: Low voltage photometry lamp

¾ Truncated cone reading cell

¾ Photofeed detection

¾ Magnetic stirrer motor

¾ Thermostat: Metal block thermostated to 37 ± 0.1°C by

solid state elements

¾ Capacity for 10 cells and a reagent bottle

¾ Programing: The CLOT 1A has a permanent memory

for programing the parameters for each coagulation

FIG. 10.2: Hemostar XF

(Courtesy: Tulip Group of Companies)

Clinical Hematology: Bleeding Disorders 307

technique. These parameters remain stored in the

memory until they are reprogramed, even when the

unit is switched off

¾ The keypad enables the user to sequentially access the

programing and speeds up to date entry during routine

use of the instrument

¾ The digital display functions as a programing and

results monitor

¾ Results: Displayed on the screen and in printout

form, containing all parameters and the relevant

identification number

¾ Size: 36 × 15 × 35 cm

¾ Weight: 3.7 kg

¾ Power supply: 220 V 50 Hz 100 VA.

Technical Features

System Microprocessor controlled automatic single

channel coagulometer based on turbophotometric clot detection system

Measurement Opto-mechanical measuring system

Automatic start of measurement on addition

of reagent/ sample for precise result

On screen digital chronometer to measure

tenth of a second accurately

Sensitivity Highly-sensitive in all measuring range because of opto-mechanical measuring system (combination of optical controls with

mechanical movement of magnetic stirrers).

Incubator Inbuilt Incubator (solid state) fixed at 37°C.

Having 19 incubation positions

Testing Mode PT, APTT, TT, fibrinogen and factor assays

General

Programing 10 Locations for programing parameters

Key board Key board for programing and data entry

Printer Built-in quiet thermal printer for direct

reporting of result in INR, per cent activity,

PTR and APTT ratio

Serial output RS 232 standard

Lamp source Low voltage tungsten lamp

Detector IR detector

Motor For stirring action of magnetic stirrer

Display Back illuminated LCD with 4 rows of

20 characters

Working temperature

15 to 35° C

Power supply 220 V, 50 Hz, 60 Hz

Power consumption 100 VA

Dimensions 31 × 15 × 35 cm

Weight 3.7 kg

CoaLAB 6000

Fully automated compact and versatile bench top

coagulation analyzer for clotting assays based on the

patented turbodensitometric principle of clot detection.

CoaLAB 6000 is engineered to operate in random access

mode for PT, APTT and fibrinogen with an option for batch

and stat mode. CoaLAB 6000 has the agility for throughput

of 130 PT tests per hour. CoaLAB is an ideal coagulation

analyzer designed to simplify complicated coagulation

analysis into a walkway task for laboratories with high and

medium throughput (Fig. 10.3).

Compact

¾ Bench top coagulation analyzer

¾ Built-in computer with display and keypad

¾ Internal thermal printer

¾ On-board waste box for used cartridges.

Versatile

¾ Single and double determination adjustable

¾ Primary and secondary tubes can be used

¾ All reagent positions can be stirred

¾ On or off switch option allowing real time or patient

oriented printing of results

¾ Stat-program

¾ Automatic reagent level control

¾ All test parameters can be reprogramed and/or

changed by the user.

User Friendly

¾ Easy installation of the analyzer

¾ Optimal user guidance through routine software

FIG. 10.3: CoaLAB 6000

(Courtesy: Tulip Group of Companies)

308 Concise Book of Medical Laboratory Technology: Methods and Interpretations ¾ Easy method of change via chip cards

¾ Optimized cuvette cartridge consumption

¾ Preprogramed method settings and evaluation

procedures for: PTT, aPTT and fibrinogen assays

¾ Updating and/or upgrading via chipcards.

Technical Specifications

CoaLAB 6000 Fully automated coagulation analyzer for clotting assays

Measuring

principle

Turbodensitometric. This opto-mechanical

principle is able to measure lipemic and turbid plasma samples and reagents containing

kaolin

Measuring station 6 measuring channels (parallel working mode)

Loading station 18 sample positions (for primary and special

cups), 6 reagent positions (for 4 mL/10 mL

vials) at room temperature. All reagent positions can be stirred. 6 positions for cuvette cartridges, each cartridge includes 6 cuvettes

Cuvette Cuvette cartridges with 6 cuvettes including

mixers, reagent vials, sample-cups. Test volume: max 250 µL

Traverse Movement into 2 directions X-Z, for pipetting and transport of plasma and reagent

Pipettor heated to 37°C. A level sensor

detects the presence of liquid

Dilutor 250 µL syringe, 1 pipetting tube

System liquid Distilled water for washing and cleaning of

pipettor

Washing solution Special washer to avoid carry-over of thrombin

Display Alphanumeric LCD-display, 2 lines, 20 characters each

Operating mode Random access mode for PT/aPTT and

fibrinogen, batch mode selectable

Throughput >120 PT tests/hour

Printer Built-in thermal printer

Printout Patient and result oriented (selectable)

Barcode reader Optional, for fast introduction of patient/sample numbers

Interfaces 1 × RS232 C host/service, 1× barcode scanner

Power supply 100–240 V, 57–s63 Hz, 150 VA

Dimensions 72 × 45 × 55 cm (~28.3 × 17.7 × 21.7 in)

Weight 17 Kg (~ 35 pounds)

Software features Optimal user guidance through routine software

Method menu for PT, aPTT and fibrinogen

Additional assays evaluated on the analyzer:

Factor II, V, VII, VIII, IX, X, XII and thrombin

time. Documentation of all test parameters,

e.g. calibration curves, date, time, conversions

of percent, g/L, mg/dL, ratio, INR and incubation time can automatically be loaded via chipcard

Easy method change via chipcard

Two software languages (German/English) on

board

Consecutive award of sample/patient ID’s or by

optional barcode scanner or manually by user

External service and research program

Special features Single and double determination adjustable

On board waste box for used cartridges, for hygienic disposal of used cuvette cartridges

Plasma or reagent start (can be configured).

Optimized cuvette cartridge consumption to

avoid waste of unused cuvettes

On or off switch option allowing “real time” or

patient oriented printing

User oriented result management (print-out,

LCD and host)

Advanced paper feed button. Wide range power supply 100 - 240 V, 47-63 Hz

Easy installation of analyzer (“plug and play”)

Highlighted status/error messages in printout

Special check of liquid level in washing station.

Optimized liquid check at pipettor

Optimized cuvette cartridge guidance

Software controlled cuvette cartridge detection

Acoustic status signals of analyzer for convenient user information. Easy change of analyzer

tubings

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Clinical Hematology: Bleeding Disorders 309

TROUBLESHOOTING

General Instructions for Coagulation Test

Possible causes Solutions

Preparation of patients

1. Patients heavily exercised Although no special preparation of patients is required prior blood collection, fasting patients

before blood colletction or patients on a light non-fatty meal are preferable. Fasting samples collected provide desirable lower opacity, which improves the sensitivity of clot detection especially when photooptical instruments are being used

2. Erroneous results are obtained Turbid, lipemic or grossly hemolyzed samples vary in opacity and therefore, generate

due to varying opacity erroneous results

Sample collection techniques

1. Frothing of blood Blood should be withdrawn without undue venous stasis and without frothing into a plastic

syringe with a short needle of 19 to 20 SWG. The venepuncture must be a ‘clean’ one besides the tourniquet should not be placed too tightly or for extended lengths of time. Patting

the venepuncture site should also be avoided

2. Delay in mixing blood with anticoagulant Distribute blood into test tubes after detaching the needle from the syringe. Mix blood with

the anticoagulant immediately by gentle inversion of the tube

3. Formation of microclots leading to Clean’ venepuncture is essential to avoid formation of microclots at the site of

artificially prolonged results venepuncture and consumption of factors, which will lead to artificially prolonged

 results.

4. Use of improper needle for With smaller bore longer needles blood will remain in contact with metal surface for a

withdrawal of blood longer time leading to initiation of clotting or partial consumption of factors being

assayed causing error in results. Therefore, short bigger bore needles are recommended

since it allows free flow of blood within the syringe and reduces blood contact with metal

surface.

Sample preparation

1. Choice of anticoagulant The anticoagulant used for most coagulation procedures is sodium citrate or preferably

buffered sodium citrate

2. Shift in the ratio of citrate to blood The optimum ratio of citrate to blood is 1 part of anticoagulant to 9 parts of blood

• More blood, less citrate: Leads to formation of clots, consumption of factors and subsequent prolongation of results during test

• More citrate, less blood: Consumption of calcium from the reagents giving prolonged test

results

Sample processing and storage

Possible causes Solutions

1. Improper containers used for Containers for blood collection and processing should be clean and dry, free of

blood collection and processing detergents; acids and alkalies ideally made of plastic or siliconized glass tubes

2. Samples used for a long time Fresh samples should be used for testing. If specimen are kept at 22–24°C then they

are used for testing must be tested within 2 hours and kept at 2–4°C, then within 3 hours

3. Sample not stored properly Samples stored for future testing should be capped tightly to ensure accuracy of results

4. Centrifugation time and speed Excessive centrifugation may destroy clotting factors due to heat generation.

not maintained Maintain proper centrifugation speed and time to avoid erroneous results

Contd...

310 Concise Book of Medical Laboratory Technology: Methods and Interpretations Calibration of instruments/equipments

1. Water baths not preset properly To achieve accuracy and reproducibility, preset water bath at 37 ± 0.5° C

2. Improperly calibrated pipettes Prior to testing, check whether the pipettes so used are being regularly calibrated or not

Storage and procedure

1. Deterioration of reagents due to Most coagulation reagents are extremely delicate. For them to maintain their sensitivity

thermal stress and high ambient and performance over the usage period recommended storage temperatures

temperatures must strictly adhered to

2. Error in performing the test Ensure that the procedure and addition sequence is followed as indicated in the

 procedure package insert