User Manual biobas 10 - Material de Laboratorio Clínico y ...User Manual biobas 10 Content 5 6.6.1.2 Load default 72 6.6.1.3 Copy method 74 6.6.1.4 Exchange method 76 6.6.1.5 Read

User Manual

biobas 10

For in-vitro diagnostic use only!

User Manual biobas 10

Revision History 2

Revision History:

Version Manual

(Art.-No.)

Date

(yyyy/mm/dd)

Analyser Software-Version - Release -

Comment

01.00

(105-96-510-00) 2019-07-31

V1.0, Feb. 8, 2019

Initial version


Content 3

Content

1 IMPORTANT INFORMATION 8

Definition OEM / PLD 8

Liability Disclaimer 8

Software Copyrights 9

Intellectual Property 9

Warranty 9

Exclusions of manufacturer’s warranty 10

Guidelines for getting service assistance 11

2 TERMS, ABBREVIATIONS AND SYMBOLS USED IN THIS MANUAL 13

3 SAFETY 16

Duty of care of the user 17

Intended use 17

Reagents 19

Safety instructions 19

Electrical safety 19

Mechanical safety 20

Reasonable foreseeable and remaining risks 20

Emergency and first aid 21

Fire fighting 21

4 INSTALLATION 22

Name Plate (Serial no.) 22

Component overview 23

Software 23

Mounting and connecting the analyzer 24

Thermal block and User interface 26


Content 4

External printer 28

Connection to an external Printer (Port A) 28

Activate and deactivate the external printer 30

CuvCARDs - Load a cuvette balance (optional) 31

ChipCARDs – Store or load methods 36

Connection to a HOST (Port B) 37

Connecting an external Barcode Scanner 38

5 ANALYZER AND METHOD PARAMETERS 41

Instrument parameters 41

Method memory positions and Default Method Parameters 42

6 OPERATION 44

Measuring principle 44

User qualification 45

Switch on the analyzer 45

STANDBY 47

Method selection 48

Measuring Mode (= “cuvette in”) 48

Measuring Mode (= “Patient ID”) 49

Carry out a PT Measurement 51

Carry out an aPTT Measurement 54

Carry out a Fibrinogen Measurement g/l 58

Parameter configuration - Access WITHOUT PIN 61

Calibration curve 61

Set calibration curve points for PT 62

Set calibration curve points for Fibrinogen 64

Set MNP value 66

Save parameters 67

Parameter configuration - Access WITH PIN 68

Menu <General> 69

6.6.1.1 Method name 69


Content 5

6.6.1.2 Load default 72

6.6.1.3 Copy method 74

6.6.1.4 Exchange method 76

6.6.1.5 Read from ChipCARD 78

6.6.1.6 Write to ChipCARD 80

Menu <1st conversion> 83

6.6.2.1 <None> 85

6.6.2.2 Set <Reference curve> 85

6.6.2.3 Set <Unit> 86

6.6.2.4 Set <Decimal place> 86

6.6.2.5 Set Min/Max value (Conversion limits) 87

6.6.2.6 Set calibration points 87

6.6.2.7 Set <Time Interpolation> 89

6.6.2.8 Set <Value Interpolation> 89

Menu <2nd conversion> 90

6.6.3.1 Select <INR> and set the ISI value 92

6.6.3.2 Select <RATIO> and set MNP 93

6.6.3.3 Set <none> 93

Menu <Measurement> 94

6.6.4.1 Set Start Reagent Volume/ Reagent Lot. Number

95

6.6.4.2 Set Incubation time 96

6.6.4.3 Set Start number for Print out 96

6.6.4.4 Set Mixer function 97

6.6.4.5 Set <min value> 98

6.6.4.6 Set <Learn-/Lag times> 98

6.6.4.7 Set Minimum and maximum time 99

6.6.4.8 Set measuring time 99

UTILITIES 101

SubMenu <Printer> 103


Content 6

SubMenu <Port A> 105

SubMenu <Port B> (virtual com port via USB) 106

SubMenu <Beeper> 110

SubMenu <Language> 111

SubMenu <Date/Time> 112

SubMenu <PIN Code> 114

SubMenu <Cuvette-test> 116

SubMenu <Parameter import> 118

SubMenu <Parameter export> 121

SubMenu <Info> 123

Sample print-outs PT and calibration 124

7 TROUBLESHOOTING 126

Application errors 126

Cancel incubation / measurement 127

Status messages CuvCARD (in alphabetical order) 128

Error messages (in alphabetical order) 130

Errors during operation 135

Warnings 136

8 MAINTENANCE AND HYGIENE 140

Safety 140

Operating and auxiliary materials 141

Disinfectant 141

Hand protection 141

Eye protection 141

Other 141

9 TRANSPORT 142

Prepare the analyzer for packaging 142

Pack the analyzer for shipment 143

10 SERVICE INFORMATION SHEET (CUSTOMER COMPLAINT) 145

11 DECOMMISSIONING AND STORAGE 146


Content 7

12 DISPOSAL OF THE ANALYZER 147

13 APPENDIX 148

Technical data 148

System related 148

Electrical data 149

Environmental requirements 150

Disposables 150

Materials supplied 151

Optional equipment 151

Supplier documentation 151


1 Important Information 8

1 IMPORTANT INFORMATION

Definition OEM / PLD

OEM (Original Equipment Manufacturer)

LABiTec®

LAbor BioMedical Technologies GmbH

An der Strusbek 6

D 22926 Ahrensburg

Tel.: +49-4102 47950

Fax.: +49-4102 479535

Email: [email protected]

Website www.labitec.de

PLD (Private Label Distributor)

SPINREACT, S.A.

Ctra Sta Coloma, 7

17176 St. Esteve d'en Bas (Girona) Spain

Liability Disclaimer

The OEM makes no express or implied warranty regarding this manual, its quality, performance, or appropriate use regarding any type of specific procedure. Furthermore, this manual may be modified by the OEM without notice and without implying any obligation or liability on the part of the company.

mailto:[email protected]

http://www.labitec.de/



Software Copyrights

All software used with the analyzer is the intellectual property of the OEM. Intellectual property rights shall remain with the OEM. You are entitled to use the software and the printed accompanying material at a place of work that cannot be transferred. Any violation of property rights or copyright or trademark or using conditions may be subject to legal action. The OEM reserves the rights to modify the software, documentation as well as this operator manual without prior written notice and without prior agreement from the PLD.

Intellectual Property

biobas 10 is a product name of the PLD. All rights reserved by OEM.

No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translation into any language (human or computer) in any form, or by any means whatsoever, without the prior written permission of the OEM.

Any reference to products, documentation, articles within this publication not expressly described as property of OEM shall be considered as intellectual property of the publishing company of this certain product, documentation and or article.

Warranty

The OEM, the PLD or his authorised sub-distributor warrant this analyzer against defects to the original purchaser in accordance with legal requirements or other mutual agreements after the date of supply in material and workmanship and defects arising from failure to conform to specifications applicable on the date of supply, provided they are properly installed, operated and used with accessories and consumables in accordance with the operating and service instructions.

The OEM, the PLD or his authorised sub-distributor further agree to correct, either by repair, or, at its election, by replacement, any such defect found on examination to have occurred, under normal use and service, during one-year period, provided The OEM, the PLD or his authorised sub-distributor is properly notified in writing upon discovery of such defect.



Exclusions of manufacturer’s warranty

The use of none permitted peripheral devices, e.g. printer.

Improper use/operating faults and non-adherence to the user instructions.

Attempted repairs by the customer or third-parties without authorization by manufacturer.

Faulty maintenance by third parties without authorization by manufacturer.

Defects caused by power failure, like wrong main voltage, overvoltage, wrong frequency of main voltage or similar reasons.

Accidents, storms, lightening, fire, water/other liquids, other natural catastrophes, theft, riots, plundering, the effects of war or other instances of acts of god.

Defects caused by transportation/shipping.

The use of third party components, unauthorized consumables or accessories which do not comply to manufacturers specifications.

Defects caused by non-authorised analyzer and software changes.

Defects caused by bypass of safety functions, deletion of passwords etc.

Loss of customer data or software from repair and installation processes.

Defects caused by improper use of analyzer.

Defects caused by inappropriate environmental conditions.

Analyzer were information or analyzer parts have been removed or changed necessary for a clear identification

Parts of the analyzer which are subject to natural wear and tear.

Defects which are the result of breaks and scratches, dirtying on e.g. LCD displays, membrane keypads or dirtying of the measuring channel.

Defects which are caused by use of improper printer paper.



Guidelines for getting service assistance

NOTE

Supporting our service department with the basic information as detailed as possible will help us to give you the needed assistance. Thank you in advance.

Customer identification

Customer

Name

Address

Country

Email

Phone

Fax

Distributor / Enduser (in case of enduser, please state the distributor)

Analyzer identification

Type of analyzer

Serial-Number (SN)

Reference number (REF)

Software version



Problem description

Describe the problem as detailed as possible. This may clarify the situation.

Display Messages

Printouts

Screenshots

Photos

Analytical data

In case of analytical problems further information will be needed.

Describe the problem as detailed as possible.

Test type: eg. PT, aPTT, Fibrinogen, ….

Sample (Patient sample, Control N, Control P, dilution, ….)

Reagent Manufacturer, Name of reagent, Order number, Lot Number, date of expire.

Leaflets

Actual measured results, raw value in seconds, converted values.

Conversion, Conversion table, ISI, …


2 Terms, abbreviations and symbols used in this manual 13

2 TERMS, ABBREVIATIONS AND SYMBOLS USED IN

THIS MANUAL

Table 2-1 Symbols used in this Manual, on the analyzer itself, and on available accessories and consumables

Symbol Meaning Symbol Meaning

Manufacturer

Date of manufacture

Batch Code

Serial Number

CE Conformity

Do not use if packaging is damaged

Refer to Operators Manual

Do Not Reuse

Protect From Sunlight.

Caution

Danger

Warning

Temperature Limitation.

Traceblility number according to customer.

Humidity Limitation.

Important Information.

Electric Shock Warning

Biological Risk.



Symbol Meaning Symbol Meaning

Fuse

This side up.

Keep dry!

Separate collection, handling and disposal for waste electrical and electronic equipment and its components

Do not throw

Observe Precautions for handling electrostatic sensitive devices (ESD) / Warning of damages by electrostatic discharge

In vitro Diagnostica



Table 2-2 Explanations of styles used in this manual

Symbol Meaning

● Instructions that have to be followed

Explanations to the given context

Things, that are required, have to be checked or fullfilled

Chapters

Steps that have to be carried out in the given order.


3 Safety 16

3 SAFETY

This analyzer conforms with the European Directives for in vitro diagnostica .

The analyzer type described in this manual bears an IVD and CE mark, which confirms the compliance with essential requirements of the Directive 98/79/EC of the European Parliament on in vitro diagnostic medical devices.

Table 3-1 Explanation of safety symbols and signal words according ISO 3864-1

Symbol Signal Word

Meaning

DANGER Indicates a direct hazard with high risk, which will have as consequence death or grievous bodily harm if it isn't avoided.

WARNING Indicates a possible hazard with medium risk, which will have as consequence death or (grievous) bodily harm if it isn't avoided.

CAUTION Indicates a hazardous situation, which, if not avoided, could result in minor or moderate injury.

NOTICE Indicates a Damage Message only device-related.

NOTE Indicates an important note in the manual. Duty of care of the operator


3 Safety 17

Duty of care of the user

This User manual describes the analyzer and is directed to all users of the device.

This User manual gives all information necessary for the implementation, maintenance and packing of the analyzer.

Careful observation of all information, especially of hazards and precautions will ensure the correct and safe operation of the analyzer. Therefore, it is absolutely necessary to read the User manual completely.

This User manual was prepared with greatest care. Should you have any questions or recommendations please refer to your distributor or the manufacturer.

Intended use

WARNING

For in-vitro diagnostic (IVD) use only!

The biobas 10 (Model CD12-1-17) named hereafter as analyzer, is a semi-automated 1-channel in-vitro diagnostic analyzer for coagulation of blood plasma. The type of the light source is an infrared LED.

The analyzer is capable to perform a wide range of coagulation tests such as Prothrombin time, activated and partial Thromin time, Fibrinogen.

The analyzer is intended for the use by trained operators in coagulation labs for in-vitro diagnostics.

Only use the analyzer according to the required ambient

conditions.

Do not use sharp objects to operate the buttons of the

anaylzer.

Protect the measuring channel from direct sunlight or other

light sources.


3 Safety 18

Only use pipettes which are being validated in regular

intervals.

Close the light protection cap prior to each measurement.

Make sure that pipetting does not cause any air bubbles.

Use a new tip after every pipetting operation to prevent

reagent/sample carry-over.

Only use pipette tips that fit the pipette (e.g. eppendorf

pipettes with eppendorf tips), otherwise secure handling is not

guaranteed.

Always place a cuvette in the measuring channel before

pipetting. Ensure each cuvette is equipped with a mixer.

Pipetting reagent or sample into the measuring channel can

significantly contaminate the analyzer and could even render

it faulty, so that expensive cleaning or repair might become

necessary.

Only use the original manufacturer’s cuvettes and mixers as

they are subject to strict quality control. The use of 3rd party

products and any associated analyzer problems as a result,

will invalidate your guarantee.

Use cuvettes once only. Multiple use of cuvettes (e.g.

cleaned) may produce incorrect results; this in turn can

become an indirect hazard for the patient.

Perform regular quality control checks. Refer to the guidelines

of use provided by the reagent manufacturer and the local

law.

Before use make sure that the reagents, controls and

disposables are not yet past their expiration date.

We recommend NOT to set the analyzer to silent mode.


3 Safety 19

Reagents

For proper coagulation analysis we recommend to use reagents, controls and buffers supplied by PLD.

Always read the information leaflet in the package and observe the instructions given by the reagent manufacturer.

NOTE

Utilize reagents and controls only according to directions as provided by the reagent manufacturer to avoid incorrect measuring results or malfunction of the analyzer.

Safety instructions

Electrical safety

DANGER - ELECTRICAL SHOCK

Never remove protective covers or secured components.

The stated input voltage of the wide-range power supply has to comply with the local mains voltage.

Never place the analyzer on a moist surface (floor, worktable or countertop), nor place containers of liquids on top of the analyzer. Liquids leaked out into the analyzer may cause an electrical shock.

Even after a device has been switched off, components can be still under voltage as a result of electrical charge and represent a risk of an electrical shock.


3 Safety 20

Mechanical safety

WARNING - MECHANICAL SAFETY

Put the analyzer out of operation and secure it against inadvertent use if you come to the conclusion that it can no longer be operated safely.

This is to be assumed in the following cases:

The analyzer shows visible damage.

The analyzer does not longer work.

The analyzer has been stored or transported for

a prolonged period under unfavorable

conditions.

Reasonable foreseeable and remaining risks

WARNING – BIOLOGICAL RISKS

Use disposable nitrile rubber gloves to avoid any hand contact with potentially infectious material.

Wear goggles as splashes of reagent, plasma or disinfectant might enter the eye.

WARNING - LASER LIGHT

Be careful when using the external barcode scanner.

Avoid direct eye contact with the laser beam.

Follow the manufacturer’s instructions.


3 Safety 21

Emergency and first aid

CAUTION

In case of emergency immediately interrupt the operation of the analyzer and pull out the external power supply from the socket.

Relevant actions to rescue personnell are given in the operational rules determined by the company.

Following procedure is recommendatory, not binding.

1. If the risk of injury remains when staying where the accident

happenend, bring the person immediately out of the danger

zone.

2. Otherwise take care of the person.

3. Provide first aid.

4. Call for help (colleagues, manager, doctor, ambulance…).

5. Take care of the injured person until further help arrives.

Fire fighting

There are no special measurements necessary for fire fighting.

We recommend to use common CO2 fire extinguisher.

Please consider the instructions defined by your company regarding fire protection and fire fighting.


4 Installation 22

4 INSTALLATION

Name Plate (Serial no.)

The name plate can be found on the bottom of the analyzer.

Information (signs) given on the plate is explained in the following.

Manufacturer according to IVD

Manufacture date

Type: Analyzer name (according to customer)

Traceblility number according to customer

Serial number of analyzer

Refers to the User manual with further information

Separate collection, handling and disposal for waste electrical and electronic equipment and its components

CE Conformity

In vitro Diagnostica

Input: Information about voltage and current

Fuse characteristic 1.25 AT


4 Installation 23

Component overview

Thermal block +37.4°C +/- 0.4°C

4 x cuvette positions

1 position for reagent bottles (NO stirring implemented)

1 measuring channel with light protection cap

Display 2 lines, 20 characters each

Membrane keypad with keys (0 - 9, Mode, Enter, ESC, <,>, Start and Reset)

ChipCARD / CuvCARD reading unit

Secure Digital Memory Card (SD Card)

Power supply socket

1x 6-pin Mini DIN RS232-C

1x USB interface (Type B)

Software

The analyzer software is stored in a memory chip and activated as soon as the analyzer is connected to the plug-in power supply attached to the mains supply.

The software controls the analyzer via start functions for the analytic program. Visual communication between the analyzer and the user is accomplished via a liquid crystal display with two rows and a 20 character string each.

Via the display the user is lead through all measurement steps. The user will confirm these steps either by key strokes or by pipetting start reagent. Thus, correct handling of the system is guaranteed.


4 Installation 24

Mounting and connecting the analyzer

Upon receipt remove the analyzer from its packaging check

the content for damage and completeness and verify that the

accessory kit is complete.

Immediately inform your distributor in the event that the

shipment was damaged or incomplete. Otherwise it results in

a loss of claims.

Upon unpacking keep all package material (e.g. membrane

packaging and card boards) stored at a dry place. You might

need them later on to send back the analyzer to the

manufacturer for repair or maintenance purposes.

Proceed as follows to install the analyzer:

1. Prior to installation of the analyzer read chapter 3, page 16.

2. Compare the input range of the plug-in power supply with the local mains voltage. Make sure that the external power supply meets the local mains voltage.

3. Place the analyzer in a location that is not exposed to excess humidity, any explosive gases, magnetic influences and direct light, e.g. sun and other light sources.

4. Place the analyzer on a stable and level surface with at least 150 mm space for ventilation at all sides.

5. Make sure to meet the environmental requirements, see chapter 13.1.3, page 150.

Figure 4-1 External Power supply


4 Installation 25

NOTICE

The analyzer is delivered with an external power supply.

The analyzer has to be connected exclusively with the delivered external power supply. Make sure to have a protected ground at the main socket. Otherwise a safe operation can not be guaranteed.

We do not warrant against a defect of the analyzer in case another plug-in power supply than the delivered has been used.

6. Connect the cable of the power supply to the analyzer and the external power supply itself to a socket outlet without voltage surges produced by heavy power users, e.g. lifts and centrifuges.

7. Ensure easy accessibility of the power plug at the analyzer rear side and/or at the external power supply at the wall socket to disconnect the device in case of an emergency.

Interfaces on the rear side

1 USB Port B

2 Serial interface for Barcode-Scanner or external Printer

3 Power supply socket

4 SD card-Slot

Figure 4-2 Interfaces on the analyzer rear side

1 2 3 4


4 Installation 26

Thermal block and User interface

Figure 4-3 Thermal block (left area), User interface (right area) and ChipCARD / CuvCARD reader slot on the right side of the analyzer

The operation area of the analyzer consists of the heated Thermal block with

Reagent position

Cuvette positions

Measuring channel

… and of the User interface with

Number keys

Mode / Esc / Enter keys

Start / Reset key

Arrow keys (for navigation)

Display

The function of the keys is described in the following table.


4 Installation 27

Table 4-1 Key description of the interface

Arrow-key left, right

Left = 1. select display to the left

2. delete

Right = 1. select display to the right, 2. set decimal point

Esc-key

1. Switch from measuring to STANDBY

2. Exit a submenu

3. Quit parameter change

4. Exit a menu or save entered or modified data.

Enter-key

1. Confirm selection

2. Confirm parameter change

Mode-key

1. Calibration

2. Menu selection, analyzer settings and method parameterization

Number-keys = Enter parameters

0-Key = A print-out of the respective

parameters for the selected method is generated by pressing 0 during measuring.

Start-key: manual start of measuring

- Start sample incubation timer

- Sample adjustment

- Manual test start

- Manual test stop

Reset key: manual stop of measurement,

Break of run, adjustment of sample

+

Current measurement is cancelled if keys are pressed simultaneously. Display: "break"


4 Installation 28

External printer

NOTE

Please read the suppliers manual carefully.

Connection to an external Printer (Port A)

For software activation of the external printer, see chapter 6.7.1, page 103.

1 Serial interface RS-232-C) / Barcode-Scanner / external printer (Port A)

Figure 4-4 Serial interface for an external printer

Serial interface data for external printer:

9600 baud

8 bit

no parity

1 stop bit

no Handshake

1


4 Installation 29

NOTE

Never operate the printer without paper!

Without inserted paper or if the printer function is deactivated you may not be able to print results and parameters.

We recommend to purchase and use the printer exlusively with the thermal paper offered by the manufacturer.

Operating the printer with another paper might result in malfunction of the printer with the following effects:

No paper transport.

Paper abrasion.

No print out.

Damage of the printing unit.

These effects may have the following reasons:

The paper is too thick / thin

The paper is too wide or small.

No thermal paper is used.

Paper is inserted upside down.

NOTICE

We do not warrant against a defect of the printing unit if the use of printer paper other than recommended is the is the cause of the defect.

NOTE

Mind proper storage conditions for the thermal printer paper:

Dry environment.

Protect from light.

Protect from heat.


4 Installation 30

Activate and deactivate the external printer

The printer is connected to the analyzer as well as to a power supply with a seperate cable.

The printer function in the analyzer is preset to "Off" by the manufacturer.

In case no thermal printer paper is available or necessary you can deactivate the printer.

To set the printer to <Off> proceed as described.

1. Press or and select UTILITIES.

2. Press and enter the PIN (default = 11111).

3. Press and select Port A.

4. Press to enter Port A Submenu.

5. Press and select „Printer <On>“ or „Printer <Off>“.

6. Press to confirm the selection.


4 Installation 31

7. Press if you want to adjust more parameters.

8. Press to switch to measuring mode.

If you have changed the settings following display appears:

9. Press to save parameters or to leave the menu without saving.

If parameters are unchanged an according message appears

and the analyzer turns to STANDBY automatically.

CuvCARDs - Load a cuvette balance (optional)

Without a cuvette balance no measurements can be carried out.

In this chapter it is described how to load a cuvette credit balance of original cuvettes by means of a cuvette card, so-called CuvCARD.

The individually loaded cuvette credit balance enables the user to perform coagulation measurements in the same quantity of cuvettes as loaded to the analyzer.

NOTE

Upon delivery the analyzer is preloaded with a cuvette balance that corresponds to the quantity of cuvette as delivered in the accessory box.

NOTE

Disposal of the CuvCARD may be done in the domestic waste. Ensure in your own interest that no balance remains on the CuvCARD.


4 Installation 32

Each unit of original cuvettes, suitable for the analyzer, is also

equipped with a corresponding CuvCARD. This CuvCARD

carries the same quantity of cuvettes as you will find in the

box.

Using the CuvCARD you can select, whether the total cuvette

credit balance shall be loaded to the analyzer. Otherwise, if

more analyzers of the same type are available, you can also

load only the necessary number to each analyzer.

Once the cuvette credit balance is fully used, meaning, if

measurements of the same quantity as the loaded cuvette

balance have been performed, the analyzer automatically

requests to re-load (reminder to order new cuvettes if used

up).

NOTE

We recommend to load the total credit balance on either one analyzer or, if more analyzer are in the laboratory, split it and load the necessary amount.

REASON: If the CuvCARD gets lost or is damaged the remaining balance is lost.

If you do not want to load the total balance, store the CuvCARD at a dry and safe place.

1. Set the analyzer to STANDBY.

Only in this state the analyzer can recognize CuvCARDs.


4 Installation 33

Figure 4-5 Insertion of CuvCARD with memory chip face up

2. Insert the CuvCARD face up into the reader slot (memory chip in the direction of insertion). Leave the CuvCARD in the reader.

The following display appears.

Display Meaning

<bookable> Displays the quantity of cuvette balance still remaining on the CuvCARD

<debit> Quantity of cuvettes on the CuvCARD which shall be loaded to analyzer.

3. Press to to enter the desired quantity of cuvettes.

The following entries are possible:

Minimum quantity

= 100 cuvettes (if e.g. 99 is entered, a beep indicates the automatic input of a balance of 100)

Maximum quantity

= as displayed at <bookable>


4 Installation 34

Entries between 100 and the maximum available quantity may

be done in steps of 10 cuvettes, for example 100, 110, 120,

…200 etc.

The display shows the remaining balance of cuvettes still

available on the analyzer.

This menu section only appears as long as the cuvette credit

balance on the analyzer is larger than or equals 100 cuvettes.

4. Press or to select between the following options:

Selection Meaning

<keep> Remaining cuvette balance on the analyzer shall be kept, no loading from CuvCARD.

<overwrite> Remaining cuvette balance on the analyzer shall be overwritten by loading a cuvette balance from the CuvCARD.

NOTE

When loading a cuvette balance from the CuvCARD to the analyzer, the remaining balance eventually still on the analyzer will be overwritten. Make sure the balance on the analyzer is fully used prior to loading a new balance from the CuvCARD!


6. Wait until the message appears to remove the CuvCARD.


4 Installation 35

7. Remove the CuvCARD from the reading unit and the analyzer automatically turns to the measuring mode “cuvette in”.

An automatic printout follows if the printer is set to «On»

NOTE

To print a short overview of method relevand data e.g. Lot Number, remaining cuvette balance, select

the desired method, press to enter the

measuring mode and then press . The printout starts automatically.

As soon as the cuvette balance has been loaded, the analyzer automatically prints the following information.

CuvCARD balance

loaded to

biobas 10 Type of analyzer

Vxx.xx

SerNo. Axxxxxxx

Actual software version of the analyzer

Serial number of analyzer

Date/Time: Date and time of loading process

dd:mm:yyyy, hh:mm:ss

--CuvCARD Info--

Lot Number = xxxxxxxx Lot Number of loaded cuvette/mixer

Balance = xxx Loaded balance on analyzer

Remaining balance

on CuvCARD = xxx

Remaining balance on CuvCARD


4 Installation 36

ChipCARDs – Store or load methods

ChipCARDs are used to load or store method-specific

information in or from the analyzer.

Storage of the Methods on a ChipCARD is helpful, if the user

has changed the parameters inadvertendly and wants to

restore the default parameters.

The operator has the possibility to store method-specific data

and parameters from the analyzer on the ChipCARD in case

they are unitentionally changed and have to be reloaded. In

this case, the method stored on the ChipCARD can be

transferred/ written to another analyzer.

Unless a measurement is currently running, a ChipCARD can

be inserted into the reading unit to read a method from the

ChipCARD or to safe a method to a ChipCARD at any time.

If a ChipCARD has been read-in, no further adjustments need

to be carried out on the analyzer, because the analyzer

processes the data automatically.

The method-specific data on the analyzer will be overwritten

by the ChipCARD data.

Only one method can be stored at the time on the ChipCARD.

The operator has the possibility to set customized methods

not stored as default by the manufacturer and write them onto

a ChipCARD.

ChipCARDs can be ordered at any time. Please contact our

sales department.

For further information how to enter the menu, read chapter

6.6.1.5, page 78 and chapter 6.6.1.6, page 80.

For troubleshooting see chapter 7, page 126.


4 Installation 37

Connection to a HOST (Port B)

For software activation of the HOST connection, see chapter 6.7.3, page 106.

To connect the analyzer to the HOST a special USB cable with USB-A (for HOST) and USB-B (for analyzer) connection.

Figure 4-6 USB cable with USB-A (for HOST) and USB-B (for analyzer)

Figure 4-7 USB cable connected to the analzyer via USB-B

Figure 4-8 USB cable connected to HOST via USB-A


4 Installation 38

Connecting an external Barcode Scanner

1 USB-B Port (PORT B)

2 Serial interface RS 232-C / external Barcode-Scanner / Printer (PORT A)

Figure 4-9 Interface for External Barcode scanner, Printer and Host connection

If the analyzer is connected to a HOST via Port B, the software requests to scan a barcode (= patient-ID) or a manual input of the patient-ID number.

For software activation of the external Barcode Sanner see chapter 6.7.3 SubMenu <Port B> (virtual com port via USB), page 106.

The Barcode scanner can be connected via the RS 232-C interface (2).

Hardware adaption of the scanner cable might be required.

The power supply of the analyzer for the barcode is 5V DC

max. 150 mA.

The number input of the patient-ID can either be carried out by

entering the number manually (numerical data) or with a

barcode scanner (alpha numerical).

For functionality of the external BC Scanner the analyzer has

to be set to Port B = HOST to enable the communication.

1. Connect the analyzer to HOST via the USB-B Port (1)

2 1


4 Installation 39

2. Connect the Barcode scanner to serial interface RS 232-C (2).

3. Switch on the HOST and wait at least 30 sec.

4. Switch on the analyzer.

5. Select UTILITIES with or .

6. Press and enter the PIN (default = 11111).

7. Press or , select <Port B> and set Port B to HOST.

8. Press .

9. Press .

10. Press to save parameters or to leave the menu without saving.

The display shows “Patient ID” to indicate, that a number is

requested.

11. Press and manually enter the Patient-ID or scan the

barcode.


4 Installation 40

Automatically “cuvette in” appears to indicate, that the

measuring procedure can be started.

See chapter 6.4.3, page 49, to start e.g. a PT measurment.


5 Analyzer and Method parameters 41

5 ANALYZER AND METHOD PARAMETERS

Parameters are stored in the EEPROM memory. The parameters of the analyzer are preset by the manufacturer.

NOTE

Before routine tests can be performed, the user must change certain reagent- specific parameters such as Lot Number and calibration curve.

Otherwise results have no correct relation to the actual reagent.

Instrument parameters

The following default parameters are preset:

Program version: V x.xx Release mm.dd.yy

Printer Off

Port A Off

Port B Off

Beeper On

Language English

PIN Code 11111



Method memory positions and Default Method Parameters

The analyzers provide up to 15 method memory positions, whereas some are already preset with method parameters (factory defaults). The following overview in

Table 5-1 Default method parameter (for 1-channel), no parameters are deposited in Memory positions 8-15

on the next page, shows the preset method parameter and memory positions.

Before you start with your analysis the method parameters must be updated for the respective reagent as described in chapter 6.5, page 61 and chapter 6.6, page 68.

<empty>

The method memory positions <empty> are free positions where new methods can be entered manually or installed and modified by copying existing methods or using a ChipCARD, see chapter 6.5, page 61 and 6.6.1.5.




6 Operation 44

6 OPERATION

Measuring principle

The analyser operates according to the opto-mechanical measuring principle. This measuring principle is especially suited for lipemic and/or icteric colored samples as well as reagents with kaolin.

A light beam passes through the cuvette containing the test plasma onto a photo detector. Any change in the intensity of the transmitted light, that is light increase or decrease, is converted into an electric signal. Hence, even the most unstable clot can be detected.

The period from adding the start reagent until clot formation is measured. It then can be converted into the appropriate units (%, ratio, INR, mg/dl, g/l).

Once the start reagent has been added, the measuring channel is adjusted, that is the lamp intensity automatically adjusts up or down depending on the turbidity of the test sample. In this process the turbidity of the sample plasma and the reagent are adjusted.

A mixer is located in the cuvette. During the measuring process the mixer provides homogeneity of the reagent-plasma medium. At the same time a small whirl emerges through the mixer movement which assures that even the smallest fibrin clot is formed in front of the photo detector.

This stirring action combined with the optical measurement constitutes the basic features of the "turbodensitometric measuring principle".


6 Operation 45

User qualification

WARNING

It is absolutely necessary that only skilled personnel will access the parameter menu with a PIN Code as improper handling of the analyzer might cause inaccurate measuring results. (see chapter 6.7.7, page 114 <PIN Code>).

All settings in the parameter menu must be done in accordance with manufacturer requirements.

Upon alteration a parameter protocol must be printed in order to check all settings again.

Switch on the analyzer

NOTE

Communication with the analyzer is performed via the liquid crystal display. We assume that you are familiar with the function of the individual keys as described in chapter 4.5, page 26.

Contact your local distributor with regard to adjustment of display contrast if the display cannot be correctly read.

Connect the power supply plug to the analyzer and the socket,

respectively.

Following information appears on a “floating display”:

Analyzer name

Program version and date

Name of distributing company


6 Operation 46

Warm-up time

NOTE

The analyzer requires approximately 30 minutes to warm-up the thermal block to an operating temperature of 37.4°C.

During the warm-up no measurements are possible.

Only switching between menus is possible and settings can be adjusted.

The display shows the actual temperature of the thermal

block.

If the target temperature is reached, another 15 minutes serve

as temperature stabilizing time.

A timer counts down to 00:00 min. and displays the remaining

time until the analyzer is ready for measurements,

respectively.

Use the warm-up phase to load the analyzer with cuvettes and

reagents for testing. Ensure each cuvette is equipped with a

mixer.

Comply with the instructions of the reagent manufacturer.

Compare the method parameters with those stored in the analyzer.

For your own safety follow the instructions for hygiene.


6 Operation 47

STANDBY

When the analyzer has reached the required temperature the display turns automatically to STANDBY. The temperature of the thermal block as well as the last method used will be displayed.

PT Method is shown by default. However, always the last method set by the user will be displayed when switching on the analyzer.

1. Press .

2. Remove the cuvette from the measuring channel and close

the light protection cap.

NOTE

Make sure that the cuvette is removed out of the measuring channel prior to confirm the message, otherwise the automated cuvette detection and measuring channel adjustment may not work properly.

3. Press any key to confirm the message

The measuring channel is adjusted automatically.

4. The display shows “cuvette in” and the measurement can be

started.


6 Operation 48

Method selection

STANDBY is the level from where the user can switch between and select the necessary method or carry out settings in UTILITES menu

Press or to select a method or UTILITIES

After the required selection press and enter the PIN

(11111) to access the according menu.

You can also:

Press up to to quick select a test (method). Each

test is assigned to an according number (1 = PT; 2 = aPTT; 3

= Fibrinogen etc.).

Press to quick select UTILITIES.

To start the measuring see next chapter.

Measuring Mode (= “cuvette in”)

NOTE

Make sure the cuvette is removed from the measuring channel prior confirm the message and settings are correct.

Press to switch to the measuring mode of the according

method

The selected method has been initialized.


6 Operation 49

Only in this mode measurements can be carried out.

“cuvette in” requests the user to place the cuvette into the

measuring channel.

NOTE

For all tests you can do single determination measurement, with one result. A mean value calculation from two single values afterwards is not supported by the software.

Measuring Mode (= “Patient ID”)

If HOST is activated in the UTILITIES menu (chapter 6.7.3, page 106) the measuring is carried out the following.

1. From STANDBY press to enter the measuring mode (Patient ID).

2. Press .

3. Enter the patient ID manually (with number keys) or use the external barcode scanner.

4. Press within <30 sec.


6 Operation 50

NOTE

If you wait over 30 sec without entering the ID or with entering the ID but without pressing Enter to proceed, the following message appears:

<Read Pat-ID Time Out>

Then, the display automatically switches back to Patient ID display.

From this point (= “cuvette in”) the measurement can be

started as described in the next chapter.

When the measurement is finished (= result appears on the display) all information is also transferred to HOST via USB-B Port . See also chapter 4.9.1 Connecting an external Barcode Scanner, page 38.


6 Operation 51

Carry out a PT Measurement

NOTE

For the special preparation of Plasma and Reagents (reconstitution, prewarming) please see the according Plasma/Reagent leaflet.

Place the PT start reagent vial and a sufficient number of cuvettes in the thermal block at the same time as starting the analyzer (or at least 30 min before starting with the measurement). The temperature has to be constantly kept at 37,4°C in the reagent and cuvette positions.

Sample incubation

Sample incubation has to be carried out always in the measuring channel as the automatically started test-specific incubation time is necessary to get plausible and reproducible results.

1. Set the analyzer to STANDBY and select the PT method.

2. From STANDBY press to switch to the measuring

mode.

3. Pipette 50 µl plasma without air bubbles into a cuvette that

has been prewarmed in the thermal block to 37,4°C.

4. Open the light protection cap of the measuring channel, place

the cuvette into the measuring channel and close the light

protection cap.

The analyzer automatically recognizes the cuvette and starts

the timer for sample incubation (timer count down).


6 Operation 52

A 5 second period of intermitting beeps indicates, that the

measurement can be startet soon.

The display shows INCUBATION READY (incubat. ready) and

then AUTO ADJUST.

After the sample incubation the measuring channel will be

adjusted (zero adjustment) for the measurement (adjust).

Add start reagent

After the adjustment the following display appears for the PT-

Measurement and requests to add 100 µl start reagent.

5. Aspirate 100 µl pre-warmed start reagent and pipette it

vertically through the hole of the light protection cap of the

measuring channel into the cuvette.

The measurement starts automatically.

During the measurement the display shows the measuring

time until the clot is formed.


6 Operation 53

If the beeper is activated an acoustic signal indicates the

recognition of clotting in the cuvette and stops the timer.

The maximum measuring time is set for every method

individually in the parameter settings, thus if no clotting is

detected an acoustic signal indicates that the maximal

measuring time is reached without clotting detection.

If conversions are programmed the measured values will be

converted automatically and appear on the display.

Results

Results (time in sec, Conversion to % and INR) are displayed.

If a printer is connected and set to <Auto> the result is printed

automatically.

If the printer is set to <On> press to print the result.

PT

Patient _ _ _ _ _


No. = 1

Channel = 1

Time = 13.7 s

% = 74.4

INR = 1.18

Figure 6-1 Example print out of PT result

After the print out, “cuvette out” appears in the display.


6 Operation 54

Open the light protection cap, take out the cuvette, close the

cap and press

The display shows “cuvette in” again and the next

measurement can be started.

Carry out an aPTT Measurement

NOTE

For the special preparation of Plasma and Reagents (reconstitution, prewarming) we refer to the according Plasma/Reagent leaflet.

Place the reagent vial (CaCl2) in the thermal block at the same time as starting the analyzer (or at least 30 min before starting with the measurement). The temperature has to be constantly kept at 37,4°C.

Sample incubation

Sample incubation has to be carried out always in the measuring channel as the automatically started test-specific incubation time is necessary to get plausible and reproducible results!

1. Set the analyzer to STANDBY and select the aPTT method.

2. Press to switch to measuring mode.


6 Operation 55

3. Pipette 50 µl of plasma sample without air bubbles into a pre-warmed cuvette.

4. Add 50 µl aPTT reagent without air bubbles into the same

cuvette onto the plasma.

5. Open the light protection cap of the measuring channel and

place the sample cuvette into the measuring channel.

6. Close the cap of the measuring channel.


the timer for sample incubation (120 sec. timer count down).

A 5 seconds period of intermitting beeps indicates the

remaining incubation time and the display shows

INCUBATION READY and then AUTO ADJUST.

After sample incubation the measuring channel will be

adjusted (zero adjustment) for the measurement.

Add start reagent

After the adjustment the following display appears:


6 Operation 56

7. Pipette 50 µl of prewarmed start reagent (CaCl2) vertically

through the hole of the light protection cap of the measuring

channel into the sample cuvette.


During measurement the display shows the measuring time

until the clot is formed.





detected an acoustic signal indicates that the measuring time

is reached without clotting detection.


converted automatically.

Results

Results (time; Ratio) are displayed.


out automatically.


6 Operation 57


aPTT

Patient _ _ _ _


No. = 2

Channel = 1

Time = 31.5 s

Ratio = 1.13

Figure 6-2 Example print out of aPTT result



cap and press .




6 Operation 58

Carry out a Fibrinogen Measurement g/l

NOTE

For the special preparation of Plasma and Reagents (reconstitution, prewarming) we refer to the according Plasma/Reagent leaflet.

Sample incubation

Sample incubation has to be carried out always in the measuring channel as the automatically started test-specific incubation time is necessary to get plausible and reproducible results.

1. Set the analyzer to STANDBY and select the Fibrinogen method.

2. Then press to switch to measuring mode.

3. Pipette 100 µl of a pre-diluted (1:10) plasma sample without air bubbles in a prewarmed cuvette in the thermal block to 37,4°C.

4. Open the light protection cap of the measuring channel.

5. Immediately insert the cuvette into the measuring channel.

6. Close the light protection cap of the measuring channel.


the timer for sample incubation (60 sec. timer count down).


6 Operation 59

A 5 seconds period of intermitting beeps indicates the

remaining incubation time and the display shows

INCUBATION READY and then AUTO ADJUST.

After sample incubation the measuring channel will be

adjusted (zero adjustment) for the measurement.

Add start reagent

After the adjustment the following display appears:

7. Pipette 50 µl start reagent vertically through the hole of the light protection cap of the measuring channel into the sample cuvette.


During measurement the display shows the measuring time.





detected an acoustic signal indicates that the maximum

measuring time is reached without clotting detection.


converted automatically.


6 Operation 60

Results

Results (time; g/l) are displayed.


automatically.


Fib. g/l

Patient _ _ _ _ _


No. = 3

Channel = 1

Time = 5.7 s

g/l = 3.87

Figure 6-3 Example print out of Fibrinogen result



cap and press .




6 Operation 61

Parameter configuration - Access WITHOUT PIN

The following parameters can be accessed from the measuring mode (cuvette in) directly without entering the PIN Code.

1st conversion with calibration points

ISI

Start Reagent Lot Number

MNP value (depending on method)

2nd conversion (MNP value)

This chapter is a Quick Guide for adjustments of the calibration points according to the selected method and the Start Reagent Lot.No.

Calibration curve

Although method parameters of the analyzer do include preset values for the calibration curve (of PT and Fibrinogen; %, g/l, mg/dl and time in sec) it is necessary to adjust the parameters any time you change the Lot Number of the reagents.

The reason is, that the reagent has lot-specific properties, which could lead to wrong results when the settings do not match the reagents results.

Calibration curves are carried out with special calibration plasma and the new reagent.

NOTE

To set calibration curves /points all relevant methods have to be set to “ON” under column “Reference curve” in Table 5-1, page 42.

A dilution series is prepared to later on set the respective

measured values as calibration points in the analyzer.

We recommend to carry out a double measurement for each

dilution and calculate the mean.


6 Operation 62

Each mean is entered in the analyzer as calibration point as

described in the following chapters.

NOTE

Points on the reference curve that are not to be used must have the entries 0.0% or 0.0 s.

A minimum of 2 points must be defined. A maximum of 9 points can be entered.

We recommend defining 4 points (100%, 50%, 25%, 12.5%).

Set calibration curve points for PT

1. Select the required Method in STANDBY, here PT.

2. Press to set the analyzer to measuring mode.

3. Press from "cuvette in" directly without entering the

PIN Code.

The analyzer switches directly to the first calibration point.

(Point of highest activity and lowest coagulation time,

previously determined by the calibration curve measurement).

4. Use number keys to enter the activity of e.g. 100.0% and to set the decimal point.

5. Press to confirm and enter the next line.


6 Operation 63

6. Use number keys to enter the clotting time and to set the

decimal point for the respective activity.

7. Press to confirm and set values of the second

calibration points.

8. Continue the same way to set subsequent calibration points (50%, 25%, 12,5%)

9. Press to confirm and switch to the ISI.

10. Enter the ISI-value of the respective reagent as indicated in

the according reagent leaflet in the table of values with

number keys and to set the decimal point.

11. Press to confirm the entry.

12. Press to confirm and set the Lot Number with number

keys of the according Start reagent.

13. Press


6 Operation 64

14. Press to save parameters or to leave the menu

without saving.

The analyzer switches automatically back to the measuring

mode.

Set calibration curve points for Fibrinogen

1. Select required Method in STANDBY, here Fibrinogen g/l.


3. Press from " cuvette in" directly without entering the

PIN Code.

The analyzer switches directly to the first calibration point. (the

point with the highest concentration, thus the lowest time).

4. Use number keys to enter the activity of e.g. 6 g/l

and to set the decimal point.

5. Press to confirm and enter the next line.


6 Operation 65

6. Use number keys to enter the clotting time and

to set the decimal point for the respective activity

7. Press to confirm and set values of the second

calibration points.

Continue the same way to set subsequent calibration points.

8. Press to confirm and switch to set Lot.No. of the according Start reagent leaflet.

9. Use number keys to set numbers, press to

switch to the next entry position, and press or to enter characters or decimals).

10. Then press .


without saving.


mode.


6 Operation 66

Set MNP value

NOTE

MNP = Mean of Normal Plasma

1. Select required method in STANDBY, here aPTT.


3. Press from " cuvette in" directly without entering the

PIN Code.

4. Press and set the MNP value with number keys

and to set the decimal point.

5. Press to confirm and switch to set Lot.No. of the according Start reagent.

6. Use number keys to set numbers, press or

. to enter characters or decimals and press to switch to the next entry position and continue until the following message appears.


6 Operation 67

Press to save parameters or to leave the menu

without saving.


mode (cuvette in).

Save parameters

Generally, after finishing parameterization or when leaving the method menus the analyzer checks the parameters and the following sequence appears.

If no parameters were changed:

If parameters were changed:

Press to save parameters or to leave the menu

without saving.


6 Operation 68

Parameter configuration - Access WITH PIN

Detailed adjustments can only be accessed and set with a PIN code, respectively.

Method Parameter <General>

Method Parameter <1st conversion>

Method Parameter <2nd conversion>

Method Parameter <Measurement>

Adjustment of the settings are similar among the menus (PT, aPTT, Fibrinogen, etc.).


2. Press or to select the required method (here PT is

shown).

3. Press to enter respective method.

4. Enter the PIN Code (Default no. 11111) to access the method

parameter menu. See also chapter 6.7.7 SubMenu <PIN

Code>, page 114.

If the wrong number was entered STANDBY will be displayed again. As soon as the correct number has been entered, access to PT Method parameter settings is possible.

5. Press to enter the respective menu and its submenus.


6 Operation 69

Menu <General>

Press to access the Menu <General>.

The following submenus are available:

Selection Meaning

<Method name> Enter or change a method name

<Load default> Load a default method from memory

<Copy method> Copy a method

<Exchange method>

Exchange method memory positions

<Read from ChipCARD>

Read a method from a ChipCARD to the analyzer

<Write to ChipCARD>

Safe a method to a ChipCARD

6.6.1.1 Method name

The method name, as displayed in STANDBY, can be edited with

the character generator (with arrow keys or ).

The character generator comprises the following characters:

! " § $ % & /= ? + * # < > , . : _

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

a b c d e f g h i j k l m n o p q r s t u v w x y z.

To enter or modify a method name follow the description as shown below.


6 Operation 70

1. Select the necessary method, press and enter the PIN

with number keys to access the menu. The first

display “Method-Parameter <General> appears.

2. Press to confirm.

3. Press or to select <Method name>

4. Press to confirm selection.

The next display appears:

The cursor blinks on the first character position.

5. Press or to set the desired character.

6. Press to confirm the character position and to move to

the next position.

7. Repeat this process to enter more characters.

8. Once the last character is entered press until the final

position is reached.


6 Operation 71

9. Press to finally confirm your entry.

NOTE

If you keep the arrow-key pressed the characters will be displayed faster and you can speed up your selection.

If you keep the Enter-key pressed the cursor will move faster.

Delete character

Set the cursor with behind the character you want to

delete.

Press to delete the character to the left.

Every stroke means one deletion.


6 Operation 72

6.6.1.2 Load default

Some method memory positions of the analyzer have been preset by the manufacturer. In Table 5-1, page 42, you will find an overview of the default methods. These parameters are saved in the preset ROM of the analyzer and can be reloaded.

Either to restore adjusted parameters of e.g. <1 PT> or to load a default method to an empty memory position e.g. <14 empty> follow the instructions below.

This is an example to restore original PT settings to memory position <1 PT>.

1. Select <1 PT> in STANDBY.

2. Press and enter the PIN Code to access the parameter

menu.

3. Menu <General> appears, press to enter the menu.

4. Press or and select <Load default>


6. Press or to select the desired method, here

<1 PT>.

The following display appears:


6 Operation 73


Automatically the next display will be displayed.

8. Press to overwrite the actual method or to leave

the menu without overwriting the parameters.

Automatically the next submenu appears.

Either you enter more settings or return to STANDBY.

To return to STANDBY proceed with the following:

9. Press several times until the following display appears:

If parameters have been changed, the following display

appears:

10. Press to save the changes or press to leave the

menu without saving.

The analyzer automatically switches to STANDBY and the

user can proceed with the operation.


6 Operation 74

6.6.1.3 Copy method

If you want to load a method which is rather similar to an existing method you can copy it to the desired method memory position and modify the parameters where necessary.

Follow the instructions below to copy an existing method to another memory position. For example, method <1 PT> shall be loaded to an empty memory position.

1. When in STANDBY select the method memory position e.g. <11 empty>.

2. Press and enter the PIN Code to access the parameter menu.

3. Select the menu <General> and press or to select the submenu <Copy method>.

4. Press to confirm the selection. The following display

appears:

5. Press to select the desired method <1 PT>.


appears:


6 Operation 75

7. Press to overwrite the desired method or to leave

the menu without saving.

Automatically the next submenu appears.

Either you enter more settings or return to STANDBY.




appears:






6 Operation 76

6.6.1.4 Exchange method

Sometimes it might be useful to exchange method memory positions. Follow the instructions below to exchange two method memory positions. For example, the method on position <11 empty> shall be exchanged with method <1 PT>.

1. When in STANDBY select the method memory position

<11 empty>.

2. Press and enter the PIN Code to access the parameter

menu.

3. In the Menu <General> press or to select the

submenu <Exchange method>.


appears:

5. Press or to select the desired method in this

example e.g <1 PT> and then press to confirm and the

next display appears:

6. Press to exchange or to keep the settings.


6 Operation 77

When exchanging, all parameters will be exchanged.




appears:






6 Operation 78

6.6.1.5 Read from ChipCARD

Background information for the ChipCARD in general is given in chapter 4.8 ChipCARDs – Store or load methods, page 36.

To load method-specific data from a ChipCARD to the analyzer follow the next steps described.

1. When in STANDBY press or to select the memory

position you would like to overwrite with the ChipCARD data,

for example <11 empty>.

2. Press and enter the PIN Code to access the selected

memory position.

3. Press or and select <General> , press .

4. Press or and select <Read from ChipCARD> with

.

5. Insert the ChipCARD into the reader slot with the memory chip facing up. Leave the ChipCARD in the reader, see Figure 4-5, page 33 for correct insertion and chapter 4.8 ChipCARDs – Store or load methods, page 36 for more information.

If no ChipCARD is inserted or if the ChipCARD is not correct a

message “INVALID ChipCARD” as floating text appears:

6. Remove the incorrect ChipCARD and insert a correct one.

7. Leave the ChipCARD in the reader.



6 Operation 79

9. Press or to select between the following options:

10. Select <Yes> to start the loading process.



With “Reading parameters from ChipCARD “ the selected

method on the analyzer will be replaced by the new

parameters coming from the ChipCARD.

The following display with new method name and corresponding Lot.-No. appears. This is an example name of the method.

12. Remove the ChipCARD from the ChipCARD reader.

NOTE

Before starting measurements with the new method we recommend to set the new method name and enter the correct Lot.-No. of the reagent.

The next submenu <Write to ChipCARD> will be displayed automatically.

To return to STANDBY:


6 Operation 80

13. Press until the message "checking parameters please

wait" appears.

14. If there was no change in the parameters the analyzer

switches automatically to STANDBY.

15. If parameters have been changed the following message

appears:


without saving.

6.6.1.6 Write to ChipCARD

Apart from the possibility to load method-specific data from a ChipCARD, such data may also be saved from the analyzer onto a ChipCARD for later use.

The steps are the same between all methods.

Remember however, that only one method can be saved on one ChipCARD at a time.

A CuvCARD also a used CuvCARD – that means – a CuvCARD with no credit left cannot be used as a ChipCard to store method parameters.

Measurement results and measurement curves cannot be saved.

To save method-specific data on a ChipCARD follow the steps as decribed.

1. When in STANDBY, select the method memory position you would like to save on the ChipCARD, for example <1 PT>.

2. Press and enter the PIN to access the selected memory position.


6 Operation 81

3. Press or and select <General> , press .

4. Press or and select <Write to ChipCARD> with

.

5. Insert the ChipCARD into the reader slot with the memory chip facing up. Leave the ChipCARD in the reader, see Figure 4-5, page 33 for correct insertion and chapter 4.8 ChipCARDs – Store or load methods, page 36 for more information.


7. Press or to select among the following options:

8. Select <Yes> and and press to confirm.


then

With “Writing parameters to ChipCARD “ the parameters on

the ChipCARD will be replaced by the new parameters coming

from the analyzer.


6 Operation 82

9. Remove the ChipCARD from the ChipCARD reader.

Automatically, the next menu appears:

10. Press until “checking parameters please wait" appears,

then


without saving the changes.

12. Automatically STANDBY or the measuring mode is reached.


6 Operation 83

Menu <1st conversion>

NOTE

Evaluating the measurement results with the set 1st conversion parameters means that the results are calculated based on previously determined calibration points or calibration values given in the lot-specific PT reagent leaflet.

You have two options to change the <1st conversion> settings.

1. WITHOUT a PIN Code as described in chapter 6.5, Parameter configuration - Access WITHOUT PIN, page 61.

2. WITH a PIN Code as described in the following.

Method parameters are preset by the manufacturer. Before

you start with the analysis, certain parameters (Lot.-No.,

calibration points) must be updated for the respective reagent.

Table 6-1 Overview 1st conversion parameters

Selection Meaning

<Reference curve> <rising/falling>

Rising or falling reference curve

<Unit> Unit in % of reference curve to be entered by the text generator

<Decimal place> No. of digits after decimal point (format xxx.x)

<Min./Max. value> Ranges of activity/concentration

<Points> Entering a 9-point reference curve

<Time interpol.> Linear / Reciprocal / Logarithmic

<Value interpolation>

Linear / Reciprocal / Logarithmic

<None> No conversion


6 Operation 84

1. Set the analyzer to STANDBY <1 PT>.

2. Press enter the PIN Code (factory default: 11111).

See also chapter 6.7.7 SubMenu <PIN Code>, page 114.

If the number was incorrect STANDBY display appears again.

If the correct PIN Code was entered, the following display

appears:

3. Press or to switch to 1st conversion

4. Press .

5. Press to enter reference curve options


6 Operation 85

6.6.2.1 <None>

Press or and set 1st conversion to <None>.

Then press to confirm.

If <None> is selected instead of <Reference curve> under

<1st conversion> no conversion will be calculated.

6.6.2.2 Set <Reference curve>

1. Press the following display appears:

2. Press or to choose between falling and rising.


NOTE

Reference curves must be entered as follows:

Rising curves (inhibitors) start with the lowest value.

Falling curves (coagulation factors) start with the shortest measuring times (sec) and the highest converted value (%, g/l, mg/dl).

The software will support this procedure only!


6 Operation 86

6.6.2.3 Set <Unit>

Character format, e.g. mg/dl.

max.: 4 digits.

The fraction bar is fix.

Select the characters for the unit and press to confirm.

6.6.2.4 Set <Decimal place>

NOTE

Regardless of the language used a dot is always used as decimal instead e.g. a comma.

The display to enter the digits (decimal place) appears.

There are 4 alternatives:

1. <Format xxxx.>

2. <Format xxx.x>

3. <Format xx.xx> or

4. <Format x.xxx>

Press or to select the required format and press

to confirm.


6 Operation 87

6.6.2.5 Set Min/Max value (Conversion limits)

You can enter the minimum and maximum values for the calibration curve and conversion.

Set minimum and maximum value with number keys

and to set the decimal point and press to

confirm.

An error message (Min Value reached – no more points)

appears if the values are outside the ranges or only the time

but no converted result will be displayed.

6.6.2.6 Set calibration points

In the following sequence a 9-point reference curve can be entered.

A minimum of 2 points must be defined. We recommend

defining at least 4 points.

Points in the reference curve that are not used need entries of

0.0 % and 0.0 s. As soon as e.g. the 5th point has the entry 0.0

the next point (here the 6th) will not appear.

Before you save the adjustments and return to the measuring

mode, check all calibration points for proper entries.

Press to enter the first reference curve point.

For a “PT” the point of highest activity and lowest coagulation

time in the calibration is for example the following:


6 Operation 88

1. Press to confirm the activity of 100.0%, or

2. Press number keys to overwrite the actual values and to

set the decimal point.

3. Press to confirm the entry. The cursor changes to a time setting.

4. Enter the clotting time for the respective activity of 100.0%.

5. Press to confirm the entry, the field for the next point on

the reference curve appears automatically.

1. Verify or adjust the second calibration point as previously

described.

2. Proceed as described above to set the remaining calibration

points.


6 Operation 89

6.6.2.7 Set <Time Interpolation>

As soon as the last point on the reference curve has been confirmed the following display will appear:

In the following display you can select Time interpolation modes of the time axis the following options can be selected:

<linear>, <reciprocal>, <logarithmic>.

Press or to select e.g. <linear> and press to

confirm.

6.6.2.8 Set <Value Interpolation>

In the following display you can select Value interpolation modes for the activity/concentration: <linear>, <reciprocal>, <logarithmic>.

Press or to select e.g. <reciprocal> and press

to confirm.


Press to access measuring or to set or verify

more parameters.


6 Operation 90

Menu <2nd conversion>

NOTE

Results are calculated based on set MNP (= Mean Normal Plasma).

ISI values are given in the leaflet of the lot-specific PT-reagent.

RATIO = patient sample in sec is divided by MNP in sec.

INR = International Normalized Ratio

ISI = International Sensitivity Index according to package insert

1. Enter the settings WITHOUT a PIN Code as described in chapter 6.5, page 61.

2. Enter the settings WITH a PIN Code as described in the following.

NOTE

Only if <None> has been selected for <1st conversion> an input field to enter the MNP (Mean Normal Plasma) value will automatically be displayed for the INR/RATIO conversion under <2nd conversion>.

In case of the aPTT-Method, the 1st conversion is none and the MNP has to be entered.

If the <Reference curve> is selected under <1st conversion> and the reference curve consists of valid points, the MNP value is taken from the reference curve. Thus, there is no option to set the MNP.

The following sub-menus can be selected if <reference curve> or <none> was selected under 1st conversion.


6 Operation 91

Table 6-2 Overview 2nd conversion submenus

Selection Meaning

<INR> -→ MNP-→ ISI For calculation of the INR-value enter the ISI according the given in the PT reagent leaflet

<RATIO> -→ MNP To enter the MNP (only if <1st conversion> is set to <None>. e.g. Mean value of the normal plasma aPTT range.

<None> No conversion

Press to access the submenu <2nd conversion>.


6 Operation 92

6.6.3.1 Select <INR> and set the ISI value

1. Press and the following display appears:

2. Press to confirm and enter the next display.

3. Use number keys to enter the ISI-value and to set the decimal.


5. Press to access measuring or to set or verify

more parameters.


6 Operation 93

6.6.3.2 Select <RATIO> and set MNP

If for <1st conversion> <none> is selected, the following display appears to enter the MNP time value.

1. Select 2nd conversion and press to confirm. The

following display appears:

2. Use number keys to enter the MNP, use to set the decimal point.

3. Press to confirm the entry of normal time value.

NOTE

If the 1st conversion is active, the MNP value is not accessible in the RATIO submenu.

6.6.3.3 Set <none>

If <none> is selected no INR and no Ratio will be calculated. The result is only displayed as the clotting time in seconds.


6 Operation 94

Menu <Measurement>

CAUTION

Any modifications within this menu can cause different measuring results!

To avoid incorrect measuring results only authorized personnel should have access to the method parameterization!

After each entry a parameter protocol must be printed in order to check the entry again!

Press to access menu <Measurement>.

The following selections are available.

Table 6-3 Overview Measurement parameter

Selection Meaning

<Start reagent> To enter the start reagent volume and reagent Lot Number

<Incubation> To enter the 1st and 2nd incubation time

<Printout No.> To enter a Start-No. for print-outs

<Mixer> Mixer starting speed - period of reduction until final speed is reached - mixer final speed

<learn, lag> To enter learn and lag times

<Meas.time> Total measuring time


6 Operation 95

6.6.4.1 Set Start Reagent Volume/ Reagent Lot. Number

Example for Method <PT> reagent and Lot Number.

NOTE: Entry range: 1-250 µl.

The Lot. No. can have an maximum of 12 characters.

1. Enter the volume for the start reagent with the number keys

, for example 100 µl.


3. Enter the reagent Lot Number manually the same way.


NOTE

Alternatively, if a barcode scanner is connected:

Scan the barcode label of the reagent vial (a

maximum of 12 alphanumeric digits is imported

as string). The Software automatically displays

the next menu after the string was imported and

displayed for 3 seconds.


6 Operation 96

6.6.4.2 Set Incubation time

NOTE

For the PT method, the first incubation time is set to 0 by definition. The according value is assigned to the second incubation. If another parameterization is set, the analyzer might change the measuring procedure which could lead to missleading results and interpretation.

See according reagent leaflet for correct incubation times.

Example for PT-Method Incubation time of Start reagent.

NOTE: 0 s = no incubation, Max.: 600 s.

1. Enter the method-dependend 1st sample incubation time for

1st = 0 s and 2nd =xxx s with the number keys .


6.6.4.3 Set Start number for Print out

The next display appears.

NOTE: Max.: 3-digits (1-999).

Enter the start number for print out by using the number keys

.

Press to confirm the entry.


6 Operation 97

6.6.4.4 Set Mixer function

NOTE

The mixer function is implemented to gently and properly mix the sample (and reagent).

Information to method-specific settings are given in chapter 5, page 41, Table 5-1.

Before modification consult your local distributor.

Example for Method Fibrinogen mg/dl

1. Enter the time period in sec = time from rpm1 to rpm2.

2. Enter the starting speed (0, 200 - 800 rpm).

3. Enter the end speed (0, 200 - 800 rpm).

In this example the measurement will start with 500 rpm (rpm1) and reaches 200 rpm (rpm2) after 40 seconds.

Figure 6-4 Exemplary function of mixer speed reduction


6 Operation 98

6.6.4.5 Set <min value>

Here you can enter the (individual evaluated) mininum value

(as digits) for the light that has to pass to the sample.

In case the sample is very turbid due to e.g. lipemic samples

the passing light goes below this minimum value.

As a result a "Break Dark" message appears on the display.

‘0’ means off, the detection of a mininum value is deactivated.

The curser is blinking and the value can be entered with

number keys.

Press to continue (to the next display).

6.6.4.6 Set <Learn-/Lag times>

Example for PT-Method

Here you can enter parameters for the optical detection of the

sample.

Learn 1…60 sec phase: Thresholds definition phase

Lag 0…60 sec phase: Time phase without measuring curve

analysis.

NOTE

Before any modification consult your local distributor.


6 Operation 99


2. Press to access measuring or to set or verify more parameters.

6.6.4.7 Set Minimum and maximum time

Here the minimum time after which a clot can be detected and the upper limit of clotting detection can be set.

1. The cursor blinks on the first entry position for “min. time”.

2. Enter the “min. time” with number keys or confirm and proceed.

3. Press to confirm the entry and jump to “max. time”.

4. Enter the “max. time” with number keys or confirm and proceed.


You jump automatically to the “meas. time” display.

6.6.4.8 Set measuring time

Here the total measuring time, depending on the test method (here aPTT), can be set.


6 Operation 100

1. Enter the measuring time with number keys or confirm and proceed.


3. Automatically the next display appears.

4. Press until “checking parameters please wait" appears,

then:


without saving the changes.

Automatically STANDBY or the measuring mode is reached.


6 Operation 101

UTILITIES

Parameter access WITH PIN Code only

The menu UTILITIES includes a group of submenus in which analyzer settings can be adjusted.

A "PIN Code" (default PIN 11111) is necessary to enter. It can be changed user-specific later on in UTILLTIES submenu <PIN Code>.

Table 6-4 Overview UTILITIES Submenus

Selection Meaning

<Printer> Select: AUTO / ON / OFF and print parameter protocol

<Port A> Activates functions at the RS232-C.

<Port B> Sends measuring results to HOST if “ON”.

Enables BC-Reader at Port A

If “OFF” the measuring results will not be sent to the HOST

<Beeper> Select: ON / OFF / CLICK

<Language> Select analyzer language

<Date/Time> Entry of Date and Time

<PIN Code> Enter a personal PIN Code (secret number)

Entry range is from <00001> to <59999>

00000 = Off/ disable

<CUVETTE-Test> Verification of automatic cuvette detection.

< Param.im/export > Service: Load parameter from a SD-Card, Save parameter onto SD-Card

Info Shows name of analyzer, software version with corresponding date.


6 Operation 102


2. In STANDBY press or until <UTILITIES> appears.

3. Press and enter the PIN Code (factory default: 11111).

NOTE

If the number was incorrect STANDBY display appears again. The following display appears, provided the correct PIN Code was entered.

Generally, after a SubMenu has been selected and adjusted,

respectively, you are asked to adjust more parameter or

change to the measuring mode.

According display will appear:

4. Press to access the measuring mode (cuvette in) or

press to set or verify more parameters.


6 Operation 103

SubMenu <Printer>

In this SubMenu you can select the print-out of different data, e.g. test results, method- or analyzer parameters as well as error messages via the external printer.

Table 6-5 Printer selections

Selection Meaning

<On> Printer is activated, Press for print-out.

<Auto> Print of results automatically, as soon as the test result is available.

<Parameter protocol>

Print of Method- and global analyzer parameter

<Actual Method>

Print of method parameter of a selected method

<All Parameter>

Print of all analyzer- and method parameter

<Global> Print of global analyzer parameter

<Off> Printer is deactivated

Printout e.g. <Parameter protocol> Actual method

Very often it is of interest, to have a look at the actual method parameters in order to verify the measuring results.

The easiest way is to make a print-out as described in the following.

1. Enter UTILITIES and press or to switch to <Printer>.


6 Operation 104

2. Press to enter the <Printer> menu.

3. Press or to select <Parameter-Protocol>.

4. Press to enter the <Parameter-Protocol> menu.

5. Press or to select <Actual Method>.

6. Press to print out the actual method.

NOTE

To select and activate the actual method for the print out, the warm-up time of the analyzer after “switch on” must be finished. Then, select the

required method, press and change via UTILITIES to print out the actual method.


6 Operation 105

SubMenu <Port A>

The analyzer model is equipped with a 6-pin RS 232-C interface at the backside of the analyzer (= Port A). This interface can be used for external data communication, to connect an external printer or barcode scanner.

Table 6-6 Port A - Selections

Selection Meaning

<Off> RS 232-C interface (Port A) is deactivated

<ext. printer> Serial output of data to external printer

1. Enter UTILITIES and press or to switch to

<Port A>.

2. Press to enter the Port A submenus.

3. Press or to select among following options:

4. Press to confirm and activate respective option.

5. Press to return to the measuring mode or press

to set or verify more parameters.


6 Operation 106

SubMenu <Port B> (virtual com port via USB)

To link the analyzer to a HOST see chapter 4.9, page 37 to connect the HOST to the analyzer.

NOTE

If not already made available by the HOST operating system a USB driver has to be installed previously on the HOST in order to use the USB port.

The analyzer offers an USB interface (USB Type B connector

/ Port B) at the backside. This interface will be acknowledged

as virtual COM-Port at the HOST side (see also chapter 4.9

Connection to a HOST (Port B), page 37.

The USB interface can only be used to connect the analyzer

to a HOST. It is not possible to connect an external printer.

Table 6-7 Port B - Selections

Selection Meaning

<OFF> Interface is switched off

<HOST>

Serial Port B is activated for HOST communication.

The analyzer changes into a state that a barcodescanner can be connected to the RS232 interface.

If a HOST is activated/connected to the analyzer the software requests a patient barcode number. The number input can either be carried out by entering the number manually (numerical data) or by a barcode scanner (alpha numerical).


6 Operation 107

If a LIS application is installed on your HOST, the following order is necessary.

1. Switch on the HOST and wait until it is booted.


Wait approx. 30 sec. until the HOST has detected the USB

connection. If available and activated a sound indicates the

identification of the analyzer.

3. Then open the LIS or other software application at HOST start the user software.

If the analyzer has been switched off in the meantime and has to be switched on again, follow the described order.

1. Stop the user software (close the program).


3. Wait until the computer has identified the analyzer (beeps if sound are “on”).

4. Then start the user software.

Options in the analyzer settings

1. Off

2. HOST – measured results to be send in a formatted string to HOST.

Output example general:

<STX> Analyzer; S/N; Date; Time; Patient ID; Method_Name; Channel No; Raw Value1; R_Unit1; Raw Value2; R_Unit2; 1st Conversion; 1_Unit; 2nd Conversion; 2_Unit; 3rd Conversion; 3_Unit; Flags; CRC;<CR><LF>

Output example for PT method with normal Plasma:

<STX>biobas 10; G1560001; dd:mm:yyyy, hh:mm:ss; 147; PT; 1; 12,3;s; 89,7;%; 1,06;Ratio; void;void; OK; CB90;<CR><LF>

Output example for aPTT method with pathological Plasma

<STX>biobas 10; G1560001; dd:mm:yyyy, hh:mm:ss; 1895; aPTT; 1; 88,2;s; void;void; 3,15;Ratio; void;void; OK; D334;<CR><LF>.


6 Operation 108

HOST output Flags

o M = Mixer Motor (measurement stops, critical error)

o T = Temp (warning)

o OK = no flag

Set respective interface parameters in the User software (see “Options to set the analyzer settings”, point 3) as described in the following:


<Port B>.

2. Press to Port B submenus.

3. Press or to select among following options:

4. In this case select HOST and press to confirm.

Automatically the next display appears:

5. Press to set more parameters or to return to STANDBY and measuring mode.


6 Operation 109

The analyzer checks the parameters.

If parameters had been changed and saved, the following

message appears:

If parameters are unchanged the following message appears:

If parameters are different to the previous ones:

6. Press to save new parameters and continue with the measurments.

7. Press to return to the measuring mode without saving the changes.

Automatically the next display appears

At this point the measuring can be started.


6 Operation 110

SubMenu <Beeper>

The beeper acoustically confirms:

Key functions upon confirmation.

An incorrect process.

The finished sample incubation.

The coagulation recognition.

1. Enter UTILITIES and press or to switch to <Beeper>

2. Press to enter the Beeper submenus.

Table 6-8 Beeper selctions

Selection Meaning

<On> Activates the beeper.

Each action is confirmed by the beeper

<Off> Deactivates the beeper.

<Click> Only keystrokes will be confirmed by the beeper


6 Operation 111

SubMenu <Language>

This menu allows you to select different analyzer software languages.

The Default language is English.

Table 6-9 Language selections

Selection Meaning

<English> Set analyzer language to English

<German> Set analyzer language to German

<Español> Set analyzer language to Spanish

<French> Set analyzer language to French

<Portuguese> Set analyzer language to Portuguese

<Russian> Set analyzer language to Russian

1. Enter UTILITIES and press or to switch to <language>.

2. Press

3. Press or to select the required language.


6 Operation 112

4. Press to confirm the selected language.

5. Press to save the selection or to return without

changes.

After that:

6. Press to return to the measuring mode.

7. Press to set more parameters.

SubMenu <Date/Time>

In this menu you can set the actual date and time of the analyzer.


<Date/Time>

2. Press


6 Operation 113

The cursor blinks on the first character, the format is fix

(dd.mm.yy, and hh:mm:ss)

3. Press respective number keys to enter date and time (from left

to right).

4. Press to jump to the next number/ character.

The cursor automatically blinks on next number/ character.

There is no need to enter a decimal point.

5. Proceed with the adjustments until the last entry is reached.

6. Press

8. Press to return to the measuring mode, the analyzer

checks the parameters .

9. Press to save or to return to the measuring mode.

The analyzer switches to the measuring mode of the last

method set.


6 Operation 114

SubMenu <PIN Code>

A PIN Code can be entered to prevent inadvertent parameter changes of non-authorized personnel.

Without entering a PIN Code it is possible to:

Perform all tests.

Select the test method.

Set / adjust the conversion parameter and reagent Lot Number.

With a PIN Code it is possible to:

Perform all tests.

Select the test method.

Have full access to all method parameters.

Set / adjust the conversion parameter and reagent Lot Number.

Have full access to all parameter in the menu <UTILITIES>.

This menu allows you to select a PIN Code (secret number) of

5 digits to access the parameter and UTILITIES menu.

Entering <00000> will disable the PIN request.

Entry range is from <00001> to <59999>.

After the PIN Code has been entered, the following display

appears:


6 Operation 115

The default PIN set by the manufacturer (11111) can be overwritten at this point.

1. Enter the PIN Code with number keys.

2. Press to confirm the entry, parameters are checked.

3. Press to confirm the entry or to return to the measuring mode.

If changes are saved a print out will follow if a printer is

connected and the printer-mode is set to <Auto>.

-----------------------------

<Analyzer name>

Ser. No. B1770711 Example print-out!

PIN No. =xxxxx x = Number

-----------------------------

NOTE

If 5 times a 0 “zero” is entered and saved, the PIN Code is not required to enter the parameter or UTILITIES menu.

In any case, the PIN Code must have 5 characters.

The analyzer switches automatically to STANDBY of the last

method set.


6 Operation 116

SubMenu <Cuvette-test>

This menu checks the function of the automatic cuvette recognition.

The thermal block has to be warmed up to operating

temperature.

1. Enter UTILITIES and press or to switch to <Cuvette-test>.

2. Press to select <Cuvette-test> and the following display appears:

3. Insert a cuvette into the measuring channel

The transmission threshold value is used to decide whether a

cuvette is inserted or the light path is free of a cuvette.

If a cuvette is inserted into the measuring channel, the display

shows “cuvette” in case of cuvette detection.

When removing and inserting the cuvette alternately the

display must show the appropriate status “cuvette” and “- - -“.

In case the function does not operate as described above:

1. Remove all cuvette from the measuring channel.


6 Operation 117

2. Switch OFF the analyzer.

3. Wait about 1 minute.

4. Switch ON the analyzer.

5. Repeat all the steps described above a second time.

If the CUVETTE-test is carried out but the thermal block has not reached its final temperature the following info appears:

Wait until the temperature of 37.4°C is reached and the

adjustment of the measuring channel is finished. Then carry

out the step again.


6 Operation 118

SubMenu <Parameter import>

It is possible to import reagent and method data by use of a SD-card.

An already defined method with the same name is overwritten automatically.

At the end of this procedure modifications can be saved or skipped.

All parameters can be imported from a file named PARIMP.TXT to the analyzer.

To execute this function a fat32 formatted SD-Card must be inserted into the analyzer SD-Card slot.

Formatting of the SD-Card is only possible with a special software because windows does not support the formatting process properly.

Please visit: www.sdcard.org/downloads

NOTE

Make sure the SD-Card does not carry any additional adhesive stickers this could harm the card reading unit.

The write protection of the SC-Card has to be unlocked otherwise no data can be exported.

IF the SD-Card is protected the analyzer shows a P-FLAG. In this case remove the SD-Card, unlock it and insert it again

http://www.sdcard.org/downloads


6 Operation 119

Insert the SD-card

1. Insert a SD-Card into the card reading unit located on the rear

side of the analyzer.

2. Ensure that the SD-Card latches in the card reader.


<Param. im/export>.

4. Press .

5. Select < Import <-SD-Card>.

6. Press .

The parameter import starts automatically with according

message.

The parameter file of the SD card is imported automatically.

Subsequently, the display shows the next submenu.

7. Press to return to STANDBY of the respective method.



6 Operation 120


If parameters are different to the previous ones the display

shows.


9. Press to return to STANDBY without saving the changes.

Remove the SD-card

Slightly press the outer visible face of the SD-Card into the

analyzer.

The pressure causes the internal ejector mechanism to

release the SD-Card.


6 Operation 121

SubMenu <Parameter export>

All parameters can be exported to a file named PAREXP.TXT onto SD-Card.

To execute this function a fat32 formatted SD-Card must be inserted into the analyzer SD-Card slot.

Formatting is only possible with a special software because windows does not support the formatting process properly.

Please visit: www.sdcard.org/downloads

Another possibility is to use a camera to format the SD-Card. See corresponding User manual to carry out the formatting.

NOTE

Make sure the SD-Card does not carry any additional adhesive stickers this could harm the card reading unit.

The write protection of the SC-Card has to be unlocked otherwise no data can be exported.

If the SD-Card is protected the analyzer shows a P-FLAG. In this case remove the SD-Card, unlock it and insert it again

1. Insert a SD-Card into the card reading slot located on the back

side of the analyzer.

2. Ensure that the SD-Card is inserted and pushed into the card

reader as far as possible.

3. Enter UTILITIES and press or to switch to <Param. im/export>

4. Press .

5. Select < Export - > SD-Card>.

http://www.sdcard.org/downloads


6 Operation 122

6. Press .

The parameter export starts automatically with according

message.

Export of parameter from the analyzer to the SD-Card.

The parameter file of the SD card is exported automatically.

Subsequently, the display shows the next submenu.

7. Press to return to STANDBY of the respective method.



If parameters are different to the previous ones the display shows.



6 Operation 123

9. Press to return to STANDBY without saving the changes.

Remove the SD-card

Slightly press the outer visible face of the SD-Card into the

analyzer.

The pressure causes the internal ejector mechanism to

release the SD-Card.

SubMenu <Info>

This submenu has the purpose to show the user

Name of the analyzer

Current software version

Date of release of software version

Serial number of the analyzer

Parameter ID number

Number of NTC-T

Press or to switch between lines.


6 Operation 124

Sample print-outs PT and calibration

General print-outs

Once a method has been selected the programmed calibration curve parameters will be printed out followed by the results.

The print-out is done automatically as soon as a result has been obtained by the measuring channel.

Each method has its own counter. As soon as the analyzer has been switched on, the counter starts with "1".

This feature can be set in menu <Method-Parameter>, <Measurement>, <Printout No.>.

Print-out of all parameters

A print-out of all programmed test parameters can be generated as described in chapter 4.3 UTILITIES.

Print-out of method parameters

To generate a parameter print-out for the selected method, press “0” when the analyzer is in the measuring mode.

However, the printer must be set to <On> or <Auto> in the UTILITIES menu <Printer>.


6 Operation 125

Print-out of method PT (Example):

Conversions via a 4-point calibration curve in % and INR.

- method store 1 - `PT´ Date dd.mm.yyyy Meas time = 420 s Gain_idx = 0 Cuv in ON

Reagens_sens ON

Automated cuvette detection

Start Reagent: Lot = 1 Reagent-Lot. No. Volume = 100 ul Reagent Start Volume incubat. = 60 s Incubation time 1st convers

INTERPOLAT.

1. conversion, calib. curve / interpolation

97.0%= 11.5 s Calibration curve points 43.0%= 20.1 s 23.0%= 31.9 s 12.0%= 57.0 s 2nd convers INR 2. conversion INR ISI = 1.05 ISI-constant

Results: PT Method Patient

___________

Patient name

dd:mm:yyyy,

hh:mm:ss

Date, Time

No. = 1 Print.-out no. Channel = 1 Channel No. 1 Time = 12.0s Measuring time % = 90.4 Conversion to PT % INR = 1.06 Conversion to INR


7 Troubleshooting 126

7 TROUBLESHOOTING

Faults may caused by actions during use and/or by the system itself. The analyzer displays error messages and warnings in the display.If an external printer is attached and activated the information are printed out.

Application errors

Application errors may cause error messages. Possible causes are:

Air bubbles were created during pipetting.

Pipetting was performed directly into the measuring channel

without cuvette.

The wrong pipette tips were used.

The pipetted volume is incorrect (e.g. variable Pipets).

The pipetting process was too slow or the pipetting angle

incorrect.

The temperature of the start reagent deviates from 37,4°C.

Cuvettes are not prewarmed / too cold for plausible

measuring.

The sample, control or reagent is too old.

No mixer has been placed into the cuvette.

Reagent carry over (e.g. PT reagent).

A reagent with the wrong Lot Number has been used.

The reagent has not been used according to the package

insert.

The reagent used does not correspond to the method

selected.

Start reagent has not been mixed properly.



No or an incorrect calibration curve is available.

Errors appeared during the sample collection or centrifugation.

Method parameters relevant for measuring are incorrect.

Should any of these errors occur and they are recognized in time, solve them immediately.

Cancel incubation / measurement

If you realize wrong handling and want to interrupt the measurement stop the measurement with the following key combination.

Press and at the same time to stop the

measuring process on the respective channel.



Status messages CuvCARD (in alphabetical order)

Status message (display/print)

Cause Action

Balance and reserve fully used.

The cuvette balance and reserve quantity is now fully used, no further measurement possible

Insert new CuvCARD and load new balance to analyzer, once the cuvette balance and reserve quantity is fully used.

Balance fully used!

The cuvette balance on the analyzer is now fully used, no further measurements possible.

Insert new CuvCARD and load new balance to analyzer, once the cuvette balance is fully used. Make sure always having enough cuvettes on stock.

CuvCARD devalued!

Cuvette balance on CuvCARD is fully used, CuvCARD is empty!

Use new CuvCARD delivered with cuvettes boxes.

Make sure enough cuvettes are available.

Only xx measurements remaining.

Message shows the remaining quantity of measurements left to utilize.

Perform remaining number of measurements, when used, insert new CuvCARD and load new balance.




Only xx reserve measurements remain possible.

Message provides information, that only a certain reserve quantity is left to utilize.

Insert new CuvCARD and load new balance to analyzer, once the reserve quantity is fully used.


Only a few measurements remain possible.

Message provides information, that only a small reserve quantity is left to perform.

Insert new CuvCARD and load new balance to analyzer, once the cuvette balance is fully used.


Please order new cuvettes.

Note; balance and reserve will run short soon.

Timely order new cuvettes to be able continuing measurements.



Error messages (in alphabetical order)

Error message (Display)

Cause Action

break time Possibly no clotting;

The maximum measuring time has been exceeded.

Optical test for clots; repeat test

break top Exceeded measuring range (too high) possibly caused by air bubbles

Repeat test

break bott(om) Exceeded measuring range (too low) preparation becomes turbid

Repeat test

break moto(r) Mixer motor error occurred

Contact technical service

break nois(e) Signal too noisy after sample adjustment

Check for air bubbles or other particles, e.g. mixer fallen out of the cuvette into the channel.

break drft (drift) Measured curve drifted after reagent has been added or start pipette error.

Check sample for air bubbles or if start pipette is activated in soft-ware but not linked to analyzer

break adj(ust) Light value is too low during adjustment phase (too little light

Check sample and try again




Cause Action

passes the channel)

break Measurement cancelled with

and

Intentionally done by user!

Bright value failed

Channel is not free, e.g. remaining cuvette, dust or other debris disturbs the light path

Remove the cuvette

Clean the channel

Then press ENTER to retry or ESC to go to the next channel

If necessary call the technical service.

Channel

locked!

A measuring channel is locked due to no remaining cuvette balance available.

Error during adjustment

Load new cuvette balance to analyzer.

Switch OFF the analyzer and ON again to repeat the adjustment.

CuvCard or ChipCARD

Checksum error!

Parameter checksum on inserted card type is incorrect


CuvCard or ChipCARD

Read error!

Inserted card type may be defect.

Re-insert card and repeat process, otherwise contact technical service




Cause Action

illegal card! please remove it.

Utilized CuvCARD may not carry cuvette credit or is a wrong card.

Try another CuvCARD or contact technical service.

Invalid customer ID

No booking done!

Customer ID number on CuvCARD does not correspond to cuvette type used.

Contact distributor

Empty/invalid card

Inserted ChipCARD could not be read due to possible incorrect or no data being on the card.

Repeat process or use other ChipCARD. Contact distributor.

card write error. NOT booked!

An error occurred while writing data to card.


Wrong cuvette type

No booking done!

Cuvette type on cuvette card does not correspond to cuvette type on analyzer.

Contact distributor

Warning: ChipCARD Error!

Read Error

ChipCARD is inserted upside down

Wrong blank ChipCARD has been inserted

Wrong Method ChipCARD has been inserted

Invalid version of ChipCARD has been inserted

Insert the ChipCARD with the correct direction

Insert correct blanko ChipCARD

Insert correct Method ChipCARD




Cause Action

WARNING: Please remove ChipCARD!

A card still remains in the card reading unit

Remove card and press ENTER to continue

WARNING: incompatible

method

Wrong ChipCARD with incompatible method data was inserted into the analyzer.

Use ChipCARD with method data compatible to the analyzer software.

SD-CARD is write-protected

The SD-Card is locked

Unlock the write-protection of the SC-Card

CD12 BOOTLOADER V1.0

Inserted SD-Card is locked after connecting the analyzer to the power = starting.

Remove the power supply cable, then remove the SD-Card, unlock the SD-Card, insert the SD-Card and attach the power supply cable to start the analyzer again.

Invalid method param

Method parameters entered are incorrect.

Check method parameters

New name cancelled

Method name was entered incorrectly.

Enter method name again.

No card! There is no ChipCARD or CuvCARD inserted in the card reader.

Insert correct Card to card reader.

No SD-Card detected.

SD-card could not be read.

Check SD-Card, perhaps use another card instead.




Cause Action

No SD-Card found.

While trying to access the SD-Card card was not found.

Insert SD-Card to analyzer.

Blinking P in the right upper corner of the display.

Write protection of the SD-Card is activated.

Remove the SD-Card Remove the SC-Card, unlock the write portection and insert the SC-Card again.

Parameter error!

set to defaults

While loading parameters an error occurred. System default parameters loaded instead.

Check parameters and re-enter if necessary.

SD-Card write-protected!

The write protection on the Memory Card has been activated.

Deactivate write protect on the Memory Card and repeat the operation.

SD-Card: Init. error!

Initialization error while writing data to a card.

Repeat process, perhaps use other card instead.

SD-Card: Root directory error!

SD-Card defective or incorrectly formatted.

Use other card or try to initialize.

Write Error! Data cannot be written to SD-card.

Card defect, wrong card used or not correctly inserted. Retry. Contact technical Service if




Cause Action

problem persists.

WARNING: HOST not connected

PC is not connected.

USB driver is not installed.

PC and analyzer are switched on in the wrong order.

1. Switch on the HOST / PC.



4. Install a USB driver.

Errors during operation

Error Cause Action

Cannot start analyzer

Power supply failure.

Loose power cable.

Mains power failure.

Check the function of the power supply.

If the power supply is ok but the analyzer does not work, contact your local distributor or the technical service.

Analyzer fails during operation

Power supply failure.

Loose power cable?

Mains power failure.

Check the function of the power supply.

If the power supply is ok but the analyzer does not work, contact your local distributor or the technical service



of the manufacturer.

Measuring cells contaminated with liquids

Additional pipetting of plasma or reagent into the measuring cell without cuvette.

Remove liquid with pipette, clean with appropriate absorbent cloth and disinfectant.

Warnings

Warning Meaning Action

Cool down This message will appear when it is determined while no measurements are running that the thermal block is too warm. No other measurements can be started during cool down.

Might occur due to direct sunlight, place the analyzer to another place with lower light input.

Contact technical service.

WARN: Temp. instabile

(TEMP WARN)

If during a measurement the temperature of the thermal block deviates significantly from the set value, the measurement is not cancelled. Instead this warning appears in the display and is also printed out via the active printer.

Might occur due to direct sunlight.

Place the analyzer to another place with lower light input.


ERR over

(calculation overflow)

This message appears if a calculated measuring value cannot be

Check conversion

If the err over message is displayed check the




(in display and printout)

displayed (calculation overflow) because of size overflow.

The err over message can appear during:

Extrapolation of the

100 % calibration

curve value

Interpolation of a

measuring value

based on the

calibration curve

Calculation of the

coefficient of

variation.

parameterization of the calibration curve parameters

ERR div0 Measurement calculation detetced a negative value.

Check adjustments on Time Interpolation and Value interpolation.

Repeat measurement and check reference curve.

ERR no clot No clotting detected during measurement.

Check sample and method parameter settings, repeat measurement.

ERR log0 Measurement calculation detetced a negative value.

Check adjustments on Time Interpolation and Value interpolation

Repeat measurement and




check reference curve.

ERR bright-calib ch%u:

Bright calib failed!

An error has been detected during bright calibration.

Remove all cuvettes from measuring channel and repeat adjustment. Might occur due to direct sunlight, place the analyzer to another place with lower light input.

Close light protection cap.

Contact technical service if problem persists.

ERR dark-calib ch%u:

Dark calib failed!

An error has been detected during dark calibration.

Remove all cuvettes from measuring channel and repeat adjustment. Might occur due to direct sunlight, place the analyzer to another place with lower light input.

Close light protection cap.

Contact technical service is problem persists.

min-value reached

- no more points

or

max-value reached

During the input of the calibration curve, the range of values (%, g/l, mg/dl) is limited for each method due to factory settings. In addition the points must increase or

Check the Range for the calibration and enter the values again.




- no more points

decrease depending on the presetting. If the largest or smallest permitted value for a point has been entered, no additional points can be entered. Input will be blocked when this message appears.


8 Maintenance and Hygiene 140

8 MAINTENANCE AND HYGIENE

Safety

CAUTION

Do not use organic acids to clean the analyzer.

Do not spray or pour on any liquids, as they can

affect the correct function of the analyzer or

damage it.

Keep the analyzer free from dust and liquid

spillages. When not used over a longer period

of time, place a dust cover over the analyzer or

place it into a cabinet.

If liquid has been spilled on the analyzer.

Remove the contamination with a clean,

absorbent non-woven cloth considering all

applicable hygienic requirements.

If liquid has accidentally entered, or been pipetted into a measuring channel:

Remove the liquid with a pipette, then clean the

measuring channel with a lint-free cloth.

Consider all applicable hygienic requirements!

Contact our technical service if subsequent control measurements do not produce the expected result.

NOTE

The analyzer is fitted with a lithium battery type Li-Mn CR 2430 (life approx. 5 years). It should be replaced by an authorised service operator after 5 years at the latest. Otherwise a faultless operation can not be guaranteed.

BIOLOGICAL RISK

The light protection cap is considered to be potentially contaminated. Therefore, the manufacturer recommends to replace it once a year. Contact your local distributor for further information.


8 Maintenance and Hygiene 141

With the application of different reagents, and here especially reagents containing thrombin, there is a risk of reagent carry-over.

If liquids or dried-on remnants can be seen on the rim of the opening of the light protection cap, remove them with laboratory disinfectant solution and lint-free cotton buds.

Operating and auxiliary materials

Disinfectant

96% Ethanol, denatured.

To clean and disinfect the analyzer (Thermal block, working

area)

Hand protection

Disposable nitrile rubber gloves.

Avoid any hand contact with potentially infectious material.

Eye protection

Safety eye glasses.

Splashes are likely to occur, there is a risk of infection.

Other

Lint-free cloth.


9 Transport 142

9 TRANSPORT

If you should have thrown away the packaging material, please contact the manufacturer, see chapter 1.1, page 8.

See also chapter 4.3 for further information.

Prepare the analyzer for packaging

NOTE

Please clean and disinfect the analyzer at first.

Take care when moving the analyzer.

Secure the analyzer against slipping and tilting.

There are no special signs regarding the transport of the analyzer.

1. Remove cuvettes incl. mixer.

2. Remove all vials and adapters (if inserted).

NOTE

Do not leave any loose parts inside the analyzer!


9 Transport 143

Pack the analyzer for shipment

1. Fold the flat card box, insert the analyzer and secure it as shown in the following pictures.


9 Transport 144

2. Open the box 3. Insert film-card

secured analyzer onto the botton of the box.

4. Take power supply plug and the accessory box and put them into the box.

5. Turn down the side flaps.

6. Close the cover of the box and seal it with packaging tape.


10 Service Information Sheet (Customer Complaint) 145

10 SERVICE INFORMATION SHEET (CUSTOMER

COMPLAINT)

NOTE

Please request a Return Authorization Number prior to any return shipment.

For proper handling of a complaint please make sure the following information is available.

AnalyzerType (Name Plate)

Serial Number of the analyzer (Name Plate)

Model (Name Plate)

Problem Description

If available a picture of the defective part

Furthermore, we recommend to keep a service log book to document maintenance work with information about date, reason and operator/ responsible person.

This makes the life cycle of the analyzer clearly visible and traceable.


11 Decommissioning and storage 146

11 DECOMMISSIONING AND STORAGE

If you intend not to use the analyzer over a longer period of time follow the instructions as described.

CAUTION

1. Remove the external power supply from the socket.

2. Remove the power supply from the analyzer.

3. Remove all loose items as cuvettes or vials from the analyzer.

4. Dispose vials with reagents and/or plasma according to given disposal specifications.

5. Clean / desinfect the analyzer surface properly with Ethanol (96%, denatured).

6. Let the analyzer dry for a certain time to get rid of any possible remaining liquid.

7. Insert red cuvettes (the same when delivered) into the measuring channel as dust protection.

8. Put the analyzer into a film bag.

9. Put the external power supply and power cable into a film bag.

10. Store the analyzer and additional items at a safe, dry place.


12 Disposal of the Analyzer 147

12 DISPOSAL OF THE ANALYZER

CAUTION

For the safety of the operating personnel make sure the analyzer has been disinfected before disposal.

All parts parts must be disposed of in accordance with national

directives for disposal.

Do not dismount and recylcle the analyzer by yourself

For disposal send the analyzer to a registered waste disposal

authority or contact your local distributor.

1. Remove the power supply from the socket and remove the power supply cable from the analyzer.

2. Remove all loose items, e.g. cuvettes or vials from the analyzer.

3. Clean / disinfect the analyzer properly with Ethanol (96%, denatured).

4. Let the analyzer dry for a certain time to get rid of any possible remaining liquid.

5. Put the analyzer into a film bag.

6. Put the power supply plug and power supply cable into a film bag.

7. Prepare the analyzer for transport as described in Chapter 9 Transport, page 142.

Do not dismount and recylcle the analyzer by yourself.

All parts parts must be disposed of in accordance with

national directives for disposal

For disposal send the analyzer to a registered waste

disposal authority.


13 Appendix 148

13 APPENDIX

Technical data

System related

Characteristics Description

Type of analyzer Semi-automated 1-channel in-vitro diagnostic analyzer for coagulation

Application Clotting tests

Operation Described in this User Manual

Measuring principle Turbodensitometric

Sensitivity ~ 1 g/l Fibrinogen

Test throughput ~30/h PT, ~15/h aPTT

Cuvette volume min. 150 µl, max. 200 µl (suspension)

Calibration Manual input of calibration points, method dependent

Software Stored in memory

Programmed methods PT, in sec, %, Ratio, INR (combinations)

aPTT, in sec, and Ratio

Fibrinogen, in sec, g/l and mg/dl

Thrombin Time, in sec

Intr. Factor, in %, Extr. Factor, in %

Light source LED approx. 875 nm

Display Liquid crystal display, 2 lines with 20 characters each

Thermal block Temperature controlled at 37.4°C +/- 0.4°C

Measuring channel 1


13 Appendix 149

Light protection caps: 1 (designed for yellow pipette tips by Eppendorf)

Reagent positions 1 á 22 mm diameter

Cuvette positions 4

Measuring time max. 420 sec

Interfaces RS232-C, USB-B, SD-Card, Card reader

System time Real time clock for time and date

Dimensions Approx. 160 x 210 x 80 mm (LxWxH)

Weight Approx. 0.80 kg

Electrical data

External power supply characteristics

Specification

Input voltage 100 – 240 VAC

Rated input current Approx. 0.4 A

Rated input frequency 50-60 Hz +/- 3Hz

Output voltage +12 VDC

Output current Max. 1.25 A

Power consumption Max. 15 VA

Analyzer characteristics Specification

Input voltage 12 VDC

Max. input current Max 0.8 A

Overvoltage category I


13 Appendix 150

Pollution degree 2

Means of protection Class III

Lithium battery type Li-Mn CR 2430

+3V

Environmental requirements

Parameter Specification

Installation site Inner rooms only, dry environment

Altitude 2.000 meters

Mains voltage fluctuation

Max. 10% of rated voltage

Temperature During operation; +15°C - +30°C

During transport and storage; +2°C - +50°C

Humidity 10% - < 85%, non-condensing

Disposables

Type Quantity Description

Cuvettes

5 x 100 Micro Cuvettes / Dispo-System with Mixer 1,0x4,0 mm

1x CuvCARD

1 x 500 Micro Cuvettes / Mixer 1,0 x 4,0 mm in plastic bag

1x CuvCARD


13 Appendix 151

Materials supplied

Quantity Description

1 x biobas 10

1 x 10 single cuvettes with mixer in plastic bag

1 x User manual on USB stick

1 x External power supply.

Optional equipment

Barcode scanner

External printer

USB driver (if not already available at HOST)

Cable for printer and scanner

Supplier documentation

Barcode scanner instruction

External printer instruction

USB driver information

Documents

User Manual biobas 10 - Material de Laboratorio Clínico y ...User Manual biobas 10 Content 5 6.6.1.2 Load default 72 6.6.1.3 Copy method 74 6.6.1.4 Exchange method 76 6.6.1.5 Read