MaestroCoag User GB V 11

H 007298 - 03.
05
Micro Typing System
User Manual
Maestro Coagulation
Caution
Before using your Maestro
Coagulation software, read this
User Manual and take special
note of all safety instructions
Identification
Document
Maestro Coagulation User

Manual
Version Date Comment
Version 1.1 / 03.05
Document No. : H 007298 1.0 24.01.05 First issue (draft)
Reference for order : 1.1 04.03.05 Small corrections

009985V Maestro Coagulation
MasterSoft Box / User Manual
Copyright ©
The reproduction, even partially, of this document is forbidden. No part may be copied in
any form, and it may not be used, edited nor transmitted by any electronic means
(photocopy, photography, magnetic supports or other recording processes), without the
written authorization of DiaMed AG. All rights and particularly reproduction, translation,
edition, distribution and also industrial property and recording are reserved.
Printed in Switzerland
M Coagulation User Manual

Table of Contents
1 General........................................................................................................ 1
1.1 Appropriate use ............................................................................... 1
1.1.1 Warranty limitation ........................................................... 1
1.2 Glossary .......................................................................................... 2
1.2.1 Persons ............................................................................ 2
1.2.2 Product ............................................................................. 2
1.3 Typographical conventions ............................................................. 3
1.3.1 Description ....................................................................... 3
1.3.2 Command ........................................................................ 3
1.3.3 Procedure ........................................................................ 3
1.3.4 Cross reference ............................................................... 4
1.3.5 List of items ...................................................................... 4
1.3.6 Trouble-shooting .............................................................. 4
1.3.7 Warnings .......................................................................... 4
1.3.8 Recommendation and Note ............................................. 6
2 Safety and handling................................................................................... 7

2.1 Introduction ..................................................................................... 7
2.1.1 Principles ......................................................................... 7
2.1.2 Importance of the safety instructions ............................... 7
2.1.3 Non-compliance with the safety rules .............................. 7
2.2 Environmental conditions ................................................................ 8
2.3 General safety instructions .............................................................. 9
2.3.1 Observations and informations ...................................... 10
2.4 Special safety instructions ............................................................. 10
2.5 Storage conditions ........................................................................ 11
2.5.1 Storage .......................................................................... 11
2.5.2 Handling and transportation ........................................... 12
Doc N° H 007298 03.05 V1.1

Table of Contents
3 Generalities............................................................................................... 13
3.1 Hardware .......................................................................................13
3.1.1 Instrument overview .......................................................13
3.2 Software ........................................................................................14
3.2.1 Description of the interface .............................................14
3.2.2 Hide the Maestro Coagulation interface (in the tray).......14
3.2.3 Minimize the Maestro Coagulation interface ..................14
3.2.4 Close the Maestro Coagulation interface .......................14
3.2.5 Launch the online help ...................................................14
3.2.6 Stop the program ............................................................15
3.2.7 Set the Stay On Top option ............................................15
3.2.8 Set the Auto Close option ...............................................16
3.2.9 Move the Maestro Coagulation interface ........................16
3.2.10 Move a tool bar ...............................................................16
4 Samples module....................................................................................... 17
4.1 Filter the samples ..........................................................................18
4.1.1 By sample information ....................................................18
4.1.2 By patient data ...............................................................19
4.2 View sample details .......................................................................20
4.2.1 Sample Info window .......................................................20
4.2.2 Patient Details window ...................................................22
4.3 Export data ....................................................................................23
4.3.1 Procedure .......................................................................23
4.4 Import data ....................................................................................24
4.4.1 Procedure .......................................................................24
4.5 Add samples ..................................................................................25
4.5.1 Add patient data to a sample ..........................................26
4.6 Print reports ...................................................................................28
4.6.1 Procedure .......................................................................28
4.7 Perform a selected backup ............................................................29
4.8 Perform a selected restore ............................................................30

Table of Contents
5 CD-X module ............................................................................................ 31

5.1 Hardware ....................................................................................... 32
5.1.1 Description ..................................................................... 32
5.1.2 Main characteristics ....................................................... 34
5.1.3 Measurement principle ................................................... 37
5.1.4 Instrument preparation ................................................... 38
5.2 Software description ...................................................................... 40
5.2.1 CD-X module main screen ............................................. 40
5.2.2 CD-X main menu ........................................................... 41
5.3 Operation ...................................................................................... 42
5.3.1 Perform a test ................................................................ 42
5.3.2 Setting the communication parameters ......................... 44
5.3.3 Emergency operations ................................................... 45
5.4 Trouble-shooting ........................................................................... 46
5.4.1 General remarks ............................................................ 46
5.4.2 Causes and remedies .................................................... 46
5.5 Services ........................................................................................ 47
5.5.1 Assistance to the users .................................................. 47
6 Appendix................................................................................................... 49
6.1 Graphical symbols ......................................................................... 49
6.1.1 Instrument related symbols ............................................ 49
6.1.2 Package-related symbols ............................................... 51
6.2 Quality system ............................................................................... 52
6.2.1 Decontamination procedure ........................................... 52
6.2.2 Decontamination certificate ............................................ 52
6.2.3 Maintenance record ....................................................... 54
! compliance (directives and norms) ......................................... 56

6.2.4 Performance variation .................................................... 56
6.3
6.4 Spare parts ordering ..................................................................... 56
6.5 Device disposal ............................................................................. 56
6.5.1 General warnings ........................................................... 56
6.5.2 Disposal ......................................................................... 57
6.6 List of documents .......................................................................... 58
6.6.1 Maestro Coagulation User Manual ................................ 58
6.6.2 Service Manuals (english only) ...................................... 58
6.6.3 Configuration Manual (english only) .............................. 58
6.7 Barcode specifications .................................................................. 59
Doc N° H 007298 03.05 V1.1

Table of Contents

General 1
Chapter overview
This chapter gives basic information on system functions, specifications and
documentation.
1.1 Appropriate use

The M Coagulation is an interface to control DiaMed Coagulation Analyzers and
to manage the data for the patients, the tests and the working list.
Its intended use is restricted to Haemostasis operations in a controlled environment,
away from the patients. The equipment and the software may only be operated with duly
trained personnel.
The indications in the present manual, in particular, the safety instructions must be
complied with.
1.1.1 Warranty limitation
Although the software has been tested, it is highly recommended to perform a backup of
the computer before any installation and use of the software.
DiaMed AG denies any responsibility in case of:
• wrong use of the software;
• unauthorized modification (willingly or unwillingly);
• not complying to the instructions contained in the manuals provided with the
instruments and software;
• not complying to the safety instructions contained in the manuals;
• damages linked with the use of the software, in particular any data loss or any
financial loss which could possibly be attached to the use of the software.
When the instrument is connected to a host, the user takes the entire responsibility for
an errorless transmission of the results (hardware, software, firmware, etc...) to this
system.
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1 General
1.2 Glossary
The following terms, among others, are used in this User Manual.
1.2.1 Persons
Manufacturer
The manufacturer of the M Coagulation is DiaMed SA, CH-1785 Cressier sur
Morat.
Operator
The operator is the respective proprietor of the M Coagulation or the respective
instrument, regardless of whether he operates it as the owner or transfers it on to third
parties.
Technician personnel
Technical personnel refers to all persons who are authorized, bases on their training, to
carry out specific activities with the M Coagulation or the respective instrument.
1.2.2 Product
1.2.2.1 Software
This is the M Coagulation distributed by DiaMed SA, CH-1785 Cressier sur Morat.
1.2.2.2 Hardware
The differents product names used in this User Manual are the following :
Name Logo
Maestro Coagulation M Coagulation
CD-X
2 M Coagulation User Manual

General 1
1.3 Typographical conventions

The following styles are used in this User Manual.
1.3.1 Description
This style, use in conjunction with illustration numbers, is preceded with the
corresponding numbers:
Example:
(1) First element
(2) Second element
(3) Etc...
1.3.2 Command
Any software command, button, function key, window, icon, option, tab, checkbox,
selection box, article, menu, tool bar, field and section used in this document is
represented by a bold italic font.
Example:
The Exit command allows to quit the software.
1.3.3 Procedure
Each procedure step to be carried out step-by-step by the user is preceded by a letter.
Example:
A. Open the drawer.
B. Put the microplate into position as shown.
C. Close the drawer.
1.3.3.1 Procedure result
A procedure result is shown by the following symbol ".

Example:
A. Click on the Parameters button.
# The parameter window is displayed.
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1 General
1.3.4 Cross reference
This style is used to help the user find complementary information linked to the current
subject.
Example:
$ See section “4.2.4 Configure import settings” on page 27
1.3.5 List of items
This style is used in order to display a list of elements.

Example:
• item 1;
• item 2;
• item 3.
1.3.6 Trouble-shooting
The complete description along with the error message, the explanation and the
remedy appears as follows:
Problem
- Explanation, possible cause
Remedy
1.3.7 Warnings
In relation to the importance of the warning and its related risks, three warning styles
are defined.
The safety aspects are used in accordance with the requirements contained in the
following norms :
• ANSI Z535.4;
• ISO 3864 and ISO 3864-1:2002.

General 1
1.3.7.1 Danger
Used to designate an imminent and dangerous situation which, if not avoided, may lead
to death or serious injury.
The primary risk is given in capital letter below the % symbol. However,
mentioning a specific risk does not exclude the presence of subsidiary risks.
Example:
&
Electrocution
Never touch an exposed electrical wire. A contact with an electrical wire may
cause an electrocution.
1.3.7.2 Warning
Used to designate a potentially dangerous situation which, if not avoided, may lead to
death or serious injury.
Example:
'
Always disconnect the electrical cord before opening the instrument. A
contact with an exposed electrical wire may cause an electrocution.
1.3.7.3 Caution
Used to designate a potentially dangerous situation which, if not avoided, may lead to
light injury or cause material damage.
Example:
(
Do not manipulate a broken mirror with bare hands as this operation may
result in cuts.
The use of the ) sign without the warning triangle means that the only risk
consists in material damage.
Example:
)
The use of other cleaning agents or hard objects may damage the
instrument. Do not use other cleaning agents or products without obtaining
first the authorisation of the manufacturer.
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1 General
1.3.8 Recommendation and Note
When complementary information is required and if their non-compliance only leads to

minor inconveniences, recommendations and notes are given.
1.3.8.1 Recommendation
Used to designate a prefered procedure or a recommended practice. DiaMed AG

denies any responsibility in case of non-compliance with the recommendations.
Example:
* Recommendation: Check that the instrument’s drawer is closed before switching it on.
1.3.8.2 Note
Used to accompany a general remark or an purely informative comment.

Example:
+ Note: The reassembly of the instrument is performed in the opposite order of its
disassembling.

Safety and handling 2
Chapter overview
This chapter sets out safety instructions for ensuring safe and trouble-free operation of
the M Coagulation and its associated instruments. It also describes the handling
and storage conditions.
2.1 Introduction
2.1.1 Principles
Before carrying out any operation whatsoever on any instrument, it is imperative to read
this chapter and fully understand it.
In case of any doubt, consult the manufacturer or your DiaMed representative.
2.1.2 Importance of the safety instructions
All the safety instructions in this User Manual must be complied with in order to prevent
accidents to persons, damage to equipment or pollution of the environment.
Similarly, statutory legal regulations, accident prevention and environmental protection
measures, together with recognised technical regulations concerning appropriate and
safe working methods in force in the country and place of use of any instrument must be
obeyed.
2.1.3 Non-compliance with the safety rules
Any non-compliance with the safety instructions or with existing legal and technical
regulations may lead to accidents to persons, damage to equipment or pollution of the
environment.
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2 Safety and handling
2.2 Environmental conditions
'
As with any other electrical device, the instrument may not be located near a
water tap.
Any equipment may only be used indoors and never in the immediate vicinity
of patients.
The electrical safety is guaranteed only if the electrical installation of the

building complies with national regulations applicable to buildings for
medical purposes or laboratories and if this installation is functioning
perfectly.
The instruments may not be used in buildings prone to fire and explosion
hazards.
)
The instruments and computer must be kept away from potential sources of
interference.
The instruments may not be exposed to direct sunlight, heat, dust or

excessive humidity (use only in a clean laboratory environment).

2.3 General safety instructions
&
ELECTROCUTION
During maintenance work, any instrument, when powered and uncovered, may
not be left unmonitored.
&
CLASS 2 LASER
PERMANENT EYESIGHT INJURY
- Never look directly into the barcode reader laser beam.
- Never modify, open or remove any protections of the laser beam.
- Never interrupt the laser beam with a reflecting object.
Most metals reflect the laser beam.
'
Repair and service operations must only be performed by qualified staff
appointed by the manufacturer.
The sole possession of the service manual does not allow personnel to
perform any repairs on any instrument.
Take into account all the warnings and follow all instructions provided on any
instrument and in the documentation.
The instruments may only be connected to the electrical power sources

specified.
It is imperative to use the liquids specified in the manual to clean any

instrument. If you intend using a different liquid, do so only after consulting
the manufacturer and receiving his approval.
The use of materials other than those defined in the user’s manual
(unauthorized hazardous substances, for example) is forbidden. Any
infringement of this rule will be considered by the manufacturer as guilty
negligence.
Never attempt to use spare parts other than those supplied by the
manufacturer.
Doc N° H 007298 03.05 V1.1 9

)
The instruments may only be used on an appropriate table.
Ensure that the ventilation around any instrument is sufficient to avoid any
excessive heating. A space of 300 mm behind the instrument must be left
clear of any obstacle.
The instruments may only be operated with the software supplied and with
the accessories approved by the manufacturer (example: external barcode
reader).
It is imperative to obtain the manufacturer’s approval before using any

instrument in combination with other devices.
Do not allow any liquid to penetrate inside the housing of any instrument. In
case of major spillages of liquid inside any instrument, proceed immediately
as follows:
A. Switch off any instrument at the power switch.

B. Disconnect the plug.
C. Dry the instrument.
D. Clean and decontaminate the instrument.
E. Check all electrical functions.
+ Note: For more information, contact either the DiaMed AG representative or the
manufacturer directly.
2.3.1 Observations and informations
In case of malfunction or any other technical incident for which a remedy has not been
described in the User Manual, please contact the manufacturer immediately.
2.4 Special safety instructions

Appropriate safety instructions associated with special risks which will occur only in
specific situations can be found in the section of this User Manual corresponding to
each specific instrument.

2.5 Storage conditions

One must distinguish between short term and long term storage.
If an instrument must be stored for a short duration in laboratory conditions, it is usually
not necessary to perform a complete wrapping.
In any other case when the instrument must be stored for a prolongated period of time,
it is recommended to wrap completely the instrument.
2.5.1 Storage
2.5.1.1 Short term storage
Short term storage may only be performed when the storage conditions are as follows :
• temperature : +5°C to 30°C (41°F to 86°F);
• relative humidity : 5% to 95% (non condensing);
• protected from direct sunlight and dust.
2.5.1.2 Long term storage
)
Packing the instrument is mandatory in case of long term storage.
* Recommendation: Use the original packing material provided by the manufacturer.
The storage room must be a place protected from water sprays and provide the
following conditions :
• temperature : +5°C to 30°C (41°F to 86°F);
• relative humidity : 5% to 95% (non condensing).
Doc N° H 007298 03.05 V1.1 11

2.5.2 Handling and transportation
2.5.2.1 Packing
Packing the instrument is essential before shipping or for long-term storage.

• before packing, a complete shut-down of the instrument must be performed;
• group together all the essential accessories (cables, technical documentation
and PC card);
• place in the package all the documents accompanying the instrument :
- delivery bill with all the necessary information;
- decontamination certificate.
• place the instrument with its packing material and the accessories box in the
package.
2.5.2.2 Transportation recommandation
For domestic transportation, it is recommended to use : car, truck, postal parcel and
train.
For international and overseas transportation, it is recommended to use a professionnal
shipping company.
+ Note: During transportation, make sure that all the instructions on the parcel are
adherred to.
• always carry upright;

• do not throw nor let the
instrument fall down; 12
• do not use a handle to

carry;
• protect from moisture and
water sprays; Fig. 2-1: Handling instructions
• do not stack more than xx

(12 in the example beside)
identical packing on the
first one.

Generalities 3
Chapter overview
This Generalities help module will give you some general information about the
navigation with the M Coagulation interface.
3.1 Hardware
3.1.1 Instrument overview
The M Coagulation software is concieved to be the common basis for the

following IVD equipment:
• DiaMed CD-X Coagulation Analyzer
The CD-X is designed to carry out coagulometric tests such as PT, PTT, TT,
fibrinogen, single factor tests, chromogenic and immunoturbidimetric tests (for
instance Antithrombin-III, D-dimer etc.).
Doc N° H 007298 03.05 V1.1 13

3 Generalities
3.2 Software
3.2.1 Description of the interface

(1) (2) (3) (4)
(1) Icon to launch the Generalities
online help
(2) Icon to hide the interface
(3) Icon to minimize the interface
(4) Icon to close the interface
(5)
(5) Icon to launch the Samples module
(6) Icon to launch the CD-X module (6)
(used to drive the Coagulation
Analyzer)
(7)
(7) Icon to launch the System module
(8) Icon to stop the software (8)
3.2.2 Hide the Maestro

Coagulation interface
(in the tray)
A. Click on the "." button (2) at the right

top of the interface. Fig. 3-1: M Coagulation interface
3.2.3 Minimize the Maestro Coagulation interface
A. Click on the "_" button (3) at the right top of the interface.
3.2.4 Close the Maestro Coagulation interface
A. Click on the X icon (8) at the bottom of the interface or on the small x button (4) at the
right top.
3.2.5 Launch the online help
A. Click on the ? icon (1) at the right top of the interface.

Generalities 3
3.2.6 Stop the program
A. Click on the X icon at the bottom (8)

or on the small x (4) at the right top
of the Maestro Coagulation
interface.
# The Finish the Coagulation

window appears.
+ Note: You also can close the

M Coagulation interface
Fig. 3-2: Finish the M Coagulation
automatically when you close the
last running module.
$ See section “3.2.8 Set the Auto

Close option” on page 16.
+ Note: You have the possibility to

finish the system or to log on as a
different user (see below).
3.2.6.1 To quit the Maestro Coagulation Interface
A. Select Finish the system option and click on the OK button.
3.2.6.2 To log on as a different user
A. Select Login as a different user option and click on the OK button.
3.2.7 Set the Stay On Top option
Used to force the M (9)

Coagulation interface to be always
on top of all windows.
A. Right click anywhere on the M
Coagulation interface.
B. Click on the Stay On Top (9) option.
Fig. 3-3: "Stay On Top" option
Doc N° H 007298 03.05 V1.1 15

3 Generalities
3.2.8 Set the Auto Close option
Used to close the M

Coagulation interface automatically (10)
when closing the last running
module.
A. Right click anywhere on the M
B. Click on the Auto Close (10) option.
Fig. 3-4: "Auto Close" option
3.2.9 Move the Maestro

Coagulation interface
A. Click and drag with the left button of

the mouse anywhere on the M
3.2.10 Move a tool bar
A. Click and drag with the left button of

the mouse anywhere on a toolbar, Fig. 3-5: Samples module toolbar
but not on an icon.
+ Note: The toolbar can be placed at

the top, bottom, left or right of the
window.

Samples module 4
Chapter overview
This help module will help you to
work with the Samples module
used to manage samples and
patient data. The following functions
are available :
(1) Samples Filter icon (1) (2) (3) (4) (5)
$ See section “4.1 Filter the samples”

on page 18.
Fig. 4-1: Samples menu
(2) Add Samples icon
$ See section “4.5 Add samples” on

page 25.
(3) Selected Backup icon
$ See section “4.7 Perform a selected

backup” on page 29.
(4) Selected Restore icon

restore” on page 30.
(5) Samples Module Exit icon

To close the Samples module.
Doc N° H 007298 03.05 V1.1 17

4 Samples module
4.1 Filter the samples
This command allow you to search

one or more sample(s) using
criterias. There are two possibilities
to filter your data :
• by sample information;
• by patient data.
4.1.1 By sample information
A. Launch the command File -

Samples Filter.
B. Select the tab Sample Info
(default). In this screen, it is
possible to set up the filtering
criteria by means of the differents
fields and check boxes.
C. Click on Apply Filter or press F3.
#
Fig. 4-2: Filtering samples, sample info
The results of the query
appears in a list (Fig. 4-3).
D. From this screen, you can :

• return to the samples filter
(Filter button or F4);
• view the sample(s) information
and patient details (if existing)
for the selected sample(s).
(Details button or F6);
$ See section “4.2 View sample

details” on page 20.
• export data (Export Data

button or F12);
Fig. 4-3: Filtering samples, result list
$ See section “4.3 Export data” on
page 23.
• print the selected processed

sample(s). (Print button or F5);
$ See section “4.6 Print reports” on

page 28.
• delete the selected sample(s).

(Delete button or Ctrl + Del ).

Samples module 4
4.1.2 By patient data
A. Launch the command File -

Samples Filter.
B. Select the tab Patient Details. In
this screen, it is possible to set up
the filtering criteria by means of the
differents fields and list boxes.
C. Click on Apply Filter or press F3.
# The results of the query

appears in a list (Fig. 4-5).
Fig. 4-4: Filtering samples, patient details
D. From this screen, you can :

• return to the samples filter
(Filter button or F4);
• view the sample(s) information
and patient details (if existing)
for the selected sample(s).
(Details button or F6);

• export data (Export Data

button or F12);
Fig. 4-5: Filtering samples, result list
page 23.
• print the selected processed

sample(s). (Print button or F5);

page 28.
• delete the selected sample(s).

(Delete button or Ctrl + Del ).
Doc N° H 007298 03.05 V1.1 19

4 Samples module
4.2 View sample details

From the result list, it is possible to
see the details of a sample in 3
manners :
• by double-clicking on a sample
(1);
• by selecting a sample (1) then
clicking on Details (2);
• by selecting a sample (1) then
pressing the F6 key.
(1) (2)
4.2.1 Sample Info window Fig. 4-6: Filtering samples, result list
From this screen, the operator has

several possibilities which are (3) (4) (5) (6) (7) (8) (9)
described below :
(3) Left arrow used to select the
previous sample
(4) Right arrow used to select the next
sample
(5) Patient Details tab :
To display the patient data for the
selected sample (6)
$ See section “4.2.2 Patient Details

window” on page 22
(6) Selected sample

(7) Scroll button : (10) (11) (12) (13) (14) (15) (16)
To scroll the diagram contents :
Fig. 4-7: Samples Data
• drag mouse to perform the
scrolling.
(8) Zoom button :
To select the diagram zoomin tool :
• drag mouse to right bottom to
zoom;
• drag mouse to left top to
unzoom.
(9) Button used to display the diagram
in a new pop-up window (Fig. 4-8).
The same buttons (7), (8), (13) and
(14) are also available in this new
window
Fig. 4-8: Signal Diagram

Samples module 4
(10) Filter (F4) button :

To return to the filter utility (3) (4) (5) (6) (7) (8) (9)

on page 18
(11) Export Data (F12) button :

To export the data of the selected
sample

page 23
(12) Print (F5) button :

To make a report of the selected
sample

page 28
(10) (11) (12) (13) (14) (15) (16)
Fig. 4-9: Samples Data
(13) Reset button :
To put the display of the diagram
contents to its default view
(14) Get Value button :
To get the exact values (time and
signal) along the curve :
• move the mouse on the curve
to get the values.
(15) Double Test Details button :
(17) (18) (19)
To display a new pop-up window
(Fig. 4-10). Click on the (17), (18)
and (19) tabs to display the average
result, the result of the first test and
the result of the second test. Then,
click on (20) to close the pop-up
window.
(16) Back (Esc) button :
To return to the Result List window
(20)
Fig. 4-10: Double Test Details
Doc N° H 007298 03.05 V1.1 21

4 Samples module
4.2.2 Patient Details window

(21) (22)
From this screen, the operator has
several possibilities which are
described below :
(21) Sample Info tab :
To display the sample information
for the selected sample
$ See section “4.2.1 Sample Info

window” on page 20
(22) Information fields concerning the

patient for the selected sample
(23) Filter (F4) button :
To return to the filter utility
(23) (24)

on page 18
Fig. 4-11: Patients Data
(24) Back (Esc) button :

To return to the Result List window

Samples module 4
4.3 Export data

Through this feature, the processed Patient’s data can be exported in one file format -
Delimited (txt) - to one determined directory.
+ Note: It also can be exported through Serial Link.
+ Note: Several parameters can be configured through the Export tab of the File -
System Settings command of the System module.
$ See section “Configure export settings” in the M Coagulation Configuration

Manual.
4.3.1 Procedure
A. From the Result List screen, select

the processed sample(s) you want
to export with Ctrl and mouse click.
B. Press on the F12 function key or
click on Export Data <F12>.
# The selected data will be

exported and the status will
change from Processed to
Sent.
Fig. 4-12: Filtering samples, task list
+ Note: If the export settings are not

or wrong completed, the message It
is not possible to perform the
exportation. You must set the
parameters in the System
Settings appears.
$ See section “Configure export

settings” in the M Coagulation
Configuration Manual.
Fig. 4-13: Exporting data
Doc N° H 007298 03.05 V1.1 23

4 Samples module
4.4 Import data

Through this feature, the processed data can be imported from a Delimited (txt) text
file format to the database.
+ Note: The selection of the fields to import, the separator char, the path and the file
name are defined through the Import tab of the File - System Settings command of
the System module.
$ See section “Configure import settings” in the M Coagulation Configuration

Manual.
4.4.1 Procedure
A. Launch the command File - Import

Data.
+ Note: If the import settings are not

or wrong completed, the Import
button (1) is disable.
$ See section “Configure import

settings” in the M Coagulation (1)
Fig. 4-14: Importing data
B. Click on Import (1) to import the
data automatically.

Samples module 4
4.5 Add samples (1) (2) (3) (4) (5)

Adding samples allows the user to
insert samples, the tests to be
performed for these samples and
the patient's data associated with.
A. Select the test(s) you want to
perform (5) from the Tests list.
B. Type the sample identification in the
Enter with Sample Identification
field (1) and press the Enter key.
C. If you want to delete the sample you
have entered, select it (2) then click
on Delete Sample (3). (6) (7) (8) (9) (10) (11)
D. If you want to associate a patient Fig. 4-15: Add samples
with the sample, select it (2) then
click on Patient (4).
$ See section “4.5.1 Add patient data

to a sample” on page 26.
E. Click on Add (7) to continue.

F. Check the Double Test (10) option
if you want to perform 2 test.
G. If you want to remove a test for a
sample, select it (6) and click on
Remove (8).
H. Repeat the steps A. to G. for each
sample you want to add.
I. Click on Finish (9).
# The samples and their

corresponding tests are now
present in the task list.
J. Click on Close (11) to quit the

window.
Doc N° H 007298 03.05 V1.1 25

4 Samples module
4.5.1 Add patient data to a sample (1) (2)
This function allow you to enter

patient data (birth date, sex, etc.) to
a sample.
A. Select the sample (1) for which you
want to add patient data in the
Samples list.
B. Click on the Patient button (2).
Fig. 4-16: Add patient data to a sample
# The Patients window appears.
C. Enter the patient's data in the

differents fields.
+ Note: It is mandatory to fill the

Patient ID and Name fields with
valid informations. The other fields
are optionnal.
D. Click on Save button (3) to accept

the entry or Cancel (4) to abort the
command.
+
(3) (4)
Note: Cancelling the command
Fig. 4-17: Add patient data to a sample
allows to associate an existing
patient to a sample.
$ See section “4.5.1.1 Link existing

patient data” on page 27.

Samples module 4
4.5.1.1 Link existing patient data
If you want to assign existing patient

data to a new sample, proceed like
described below.
A. Perform the steps A. to B. of the
previous procedure.
$ See section “4.5.1 Add patient data

to a sample” on page 26.
B. Click on Cancel (2).

C. Click on Search (1)
(1) (2)
Fig. 4-18: Searching for patient data
# The window beside appears.
D. Select a patient (3) in the list.

E. Click on Select (4) to link it.
(3) (4)
Fig. 4-19: Select a patient in the list
Doc N° H 007298 03.05 V1.1 27

4 Samples module
4.6 Print reports

This function allow you to print a
report for the processed samples.
The pre-defined layout files can be
selected in the Report part of the
System Settings window of the
System module.
$ See section “Configure report

4.6.1 Procedure (1) (2) (3) (4) (5) (6)
A. Select the result(s) you want to print Fig. 4-20: Select the report layout
(1) from the Result List.
B. Click on Print (5) or press F5.
# The Selected Report window

appears.
C. Select the pre-defined report layout

in the list (6).
$ To define the list of pre-defined

layouts, see section “Configure
report settings” in the M
Coagulation Configuration Manual.
(7)
D. Check the Print diagram option (2) Fig. 4-21: Diagram
if you want that a diagram (7)
appears in the report.
E. Check the Print single
measurings of double test option
(3) if you want to print only the
average measure of each test.
F. Click on Print (4).
# The Report Preview window

appears.
G. Click on the printer icon (8) to print

the report.
(8) (9)
H. Click on the export icon (9) to export
the report in another formats (for Fig. 4-22: Report preview window
example, Acrobat Format (PDF) or
Crystal Reports (RPT)).

Samples module 4
4.7 Perform a selected backup (1) (2) (3)

A. Launch the command Security
Routine - Selected Backup.
# The Selected Backup window

appears.
B. Click on the down arrow (2) and

select the drive name in the list.
C. Double-click on the desired
directory path (3) in the list.
D. Select the backup Initial Date in the (4) (5) (6)
calendar (4).
Fig. 4-23: Selected backup
E. Select the backup Final Date in the
calendar (6).
F. Type the backup name in the
Backup file name field (1).
Fig. 4-24: Backup file name too long
+ Note: The maximum length for this

name is 15 characters. Otherwise,
the message of the Fig. 4-24
appears.
G. Click on the Backup button (5) to (7)

start the selected backup and
Fig. 4-25: Selected backup confirmation
confirm the command with Yes (7).
# All the samples with the status

"processed" for the selected
time period will be saved in a
file and erased from the
samples list.
H. Confirm the end of the process (8).
+ Note: To restore these processed

samples in the database, use the
Selected Restore function.

restore” on page 30.
$ See also section "Configure security

settings" in the M Coagulation
(8)
Configuration Manual to define all Fig. 4-26: Selected backup completed
parameters for the backup.
Doc N° H 007298 03.05 V1.1 29

4 Samples module
4.8 Perform a selected restore (1) (2) (3)

A. Launch the command Security
Routine - Selected Restore.
# The Selected Restore window

appears.
B. Click on the down arrow (2) and

select the drive name in the list.
C. Double-click on the desired
directory path (1) in the list.
(4)
D. Select the backup file to restore (3)
in the list. Fig. 4-27: Selected restore
E. Click on the Restore button (4) to

start the process and confirm the
command with Yes (5).
(5)
Fig. 4-28: Selected restore confirmation
# All the samples contained in

the backup file will be added to
the samples list.
F. Confirm the end of the process (6).
(6)
Fig. 4-29: Selected restore completed

CD-X module 5
Chapter overview
This help will help you to use the
CD-X module used to read the tests
performed by the Fig. 5-1: CD-X menu
instrument.
Doc N° H 007298 03.05 V1.1 31

5 CD-X module
5.1 Hardware
5.1.1 Description
The is an automatic turbidimetric coagulation analyzer equipped with 4-

channel optics for use in a coagulation laboratory. The CD-X is designed to carry out
coagulometric tests such as PT, PTT, TT, fibrinogen, single factor tests, chromogenic
and immunoturbidimetric tests (for instance Antithrombin-III, D-dimer etc.).
5.1.1.1 Front view
Pipetting arm Protective bar Lid Sample

rack
Cuvette tower
Keybord Reagent
block
Left-hand Screen Cuvette rotor System block Right-hand

device drawer device drawer
(cuvette wastes) (liquid wastes)
Fig. 5-2: Instrument front view

CD-X module 5
5.1.1.2 Rear view
Printer
cover
Rinsing
solution
tank
ID-plate Mains switch RS232 service RS232 debug interface for

and power interface for updating error analysis (reserved
input and data transmission for manufacturer)
(115K, 8,1,N)
Fig. 5-3: Instrument rear view
Doc N° H 007298 03.05 V1.1 33

5 CD-X module
5.1.2 Main characteristics
5.1.2.1 Performances
• determination of all clotting, chromogenic and immunologic tests (D-Dimer);

• throughput :
- 160 PT/h;
- 80 PTT/h;
- 60 PT, PTT and Fibrinogen/h.
• batch or random access;
• 4 optic channels;
• integrated barcode reader;
• positive identification for samples;
• level detection for samples and reagents;
• cap piercing;
• emergency function;
• autocalibration for PT and Fibrinogen;
• autodilution for Fibrinogen and Factors;
• calculation units %, INR, R, mg/dL, g/L;
• integrated printer for standard curves and results;
• host connectivity.
5.1.2.2 Physical caracteristics
Voltage 85 - 264 VAC at 45-60 Hz

120 - 340 VDC
Frequency 45-60 Hz
Fuses Input 94,5-240VAC
Nom: 5A, 47-63Hz
or 133-330VDC
Nom: 3.4A
For IEC/EN60601-1
94,5-240VAC
Nom: 5A, 47-63 Hz
or 133-300VDC
Nom: 3.4A
Power Max. 200 VA

CD-X module 5
5.1.2.3 Dimensions and mass
Width 850 mm
Depth 600 mm
Height 700 mm
Weight Approx. 50 kg (incl. packaging)
5.1.2.4 Temperature limits and performance limitations
To ensure a failure-free and safe operation, the following environmental conditions must
be respected :
• operating temperature : +18°C to +30°C (64.4°F to 86°F);
• operating relative humidity : max 80%, non condensing;
• storage temperature : +10°C to +40°C (50°F to 104°F);
• elevation above NN sea level : 0 - 3’000 m.
&
DEFLAGRATION
The CD-X is not antideflagrant. Sparks may cause a fire or an explosion.
Do not install the CD-X in the vincinity of inflammable or explosive products.
&
ELECTRICAL HAZARD
The CD-X is not protected against water penetrations. Water penetrating the
instrument may cause an electrical discharge.
Do not install the CD-X in the vincinity of water or in any place where a risk of
water penetration is possible.
(
Never touch moving parts such as the measurement rotor or pipetting arm
during device operation.
(
Never try to pull a cuvette block out of the measurement rotor during test
processing operation.
Doc N° H 007298 03.05 V1.1 35

5 CD-X module
)
Use only the cleaning and rinsing liquids approved by the manufacturer.
Failure to do so could result in faulty measurements or malfunctions of the
CD-X. Prevent reagents from leaking into the Analyzer. Failure to do so may
make expensive maintenance work necessary!
)
Carry out control measurement runs at regular intervals to ensure that the
Analyzer continues to function faultlessly.
)
Use only citrate plasma for test analysis runs: Mix 9 parts venous blood with
1 part 3.8% or 3.13% sodium citrate and centrifuge the mixture at 1500 – 2000
g (~ 3.000 rpm) for approx. 10 minutes.
)
The CD-X must be operated by a specialist trained in clinical laboratory
techniques who has also received instruction and training in operation of the
CD-X and has read and understood this User Manual.
)
Use other than the intended use of the CD-X or failure to comply with the
instructions in this User Manual shall result in exclusion of the manufacturer
from liability for any damages to the CD-X, patients or operating personnel
resulting therefrom.

CD-X module 5
5.1.3 Measurement principle
The CD-X is equipped with highly sensitive 4-channel LED optics at a wavelength of
400 nm, making precise and reliable measurements possible even with icteric or
lipaemic plasmas.
Once a reaction charge has been prepared, the optimum transillumination settings are
found using an amplifier that facilitates measurement of both clear and cloudy samples.
Recording of measurement process data is started automatically when the start reagent
is added. When coagulation begins, transmission is reduced, which changes the form of
the measurement curve. The time from measurement start to this change (turning point)
in seconds [s] is the result. The software then converts this datum into other units.
5.1.3.1 Mathematical principles
The conversion of coagulation time into a specific test unit is one using a linear, semi-
logarithmic or double-logarithmic interpolation of the stored calibration points. The
current mathematical model is printed out in "TEST SETUP". Values outside the
calibration range are calculated by extrapolation and flagged as " * ".
Doc N° H 007298 03.05 V1.1 37

5 CD-X module
5.1.4 Instrument preparation
Procedure
A. Make sure the CD-X is connected to the power mains.
B. Check for sufficient rinsing and cleaning fluid levels.
C. Move the mains switch to the position ON.
D. Switch on the standby switch.
# The following screens appear

in this order after the CD-X is
switched on.
The CD-X carries out a system
test as well as a rinsing and
cleaning cycle.
Fig. 5-4: CD-X Startup screen 1
+ Note: You can interrupt the startup

sequence by pressing ESC during
the "WARM-UP" phase. This
deactivates the needle system,
where upon the software
automatically switches to the
"SIMULATOR=1" mode.
Fig. 5-5: CD-X Startup screen 2

CD-X module 5
# At the end of the initialization

phase, the main screen
appears.
+ Note: After about 15 min. of warm-

up time (depending on the ambient
temperature), the lighting up of the
LED (Temp.) on the keypad
indicates the system is ready to
make measurements.
Fig. 5-6: CD-X Main screen
E. Switch on the computer.
F. Launch the M Coagulation
software.
# The instrument is ready for use.
$ See section “5.3.1 Perform a test”

on page 42.
Doc N° H 007298 03.05 V1.1 39

5 CD-X module
5.2 Software description
5.2.1 CD-X module main screen
After starting the CD-X module from the M Coagulation interface, the main screen
appears :
(1)
Fig. 5-7: CD-X module main screen
The commands of the CD-X main menu (1) are described below.
$ See section “5.2.2 CD-X main menu” on page 41.

CD-X module 5
5.2.2 CD-X main menu
(1) File menu
$ See section “5.2.2.1 File menu” on

page 41.
(1) (2)
Fig. 5-8: CD-X main menu

(2) Configuration menu
$ See section “5.2.2.2 Configuration

menu” on page 41.
5.2.2.1 File menu
(3) Exit command :

To close the CD-X module.
(4) Close command :
To close the active window.
(5) Reading command :
To perform tests with the
(3) (4) (5)
and bring them into the database.
$ See section “5.3.1 Perform a test” Fig. 5-9: CD-X File menu
on page 42.
5.2.2.2 Configuration menu
(6) Communication Settings

command :
To configure the com ports.
$ See section “5.3.2 Setting the

communication parameters” on
(6)
page 44. Fig. 5-10: CD-X Configuration menu
Doc N° H 007298 03.05 V1.1 41

5 CD-X module
5.3 Operation
5.3.1 Perform a test
A. Launch the File - Reading

command.
B. Put the samples tubes you want to

test on the sample rack.
Fig. 5-11: Scan sample request
C. Move the sample rack back (to the
right).
D. Slowly move the sample rack to the
left in order to scan all sample tube
barcodes.
# The scanning is performed and

the window beside appears.
E. Click on Continue (1) to confirm the

scanning.
(1)
Fig. 5-12: Scanning of the sample barcodes

(2) (3)
F. Select a sample (2) in the Samples
Read by CD-X list.
G. Select a test (3) in the Available
Tests list.
H. Click on Add Test (5) to put the test
in the working list (4).
+ Note: If you want to remove a test

from the working list, select it (4)
and click on Remove Test (7).
I. Check the Double Test option (8) if (4) (5) (6) (7) (8)
you want to perform 2 tests for the
selected sample. Fig. 5-13: Confirm samples to read
J. Repeat the steps F. to I. as much as
desired.
K. Confirm the working list with
Confirm (6).

CD-X module 5
# The batch is launched and the

window beside appears.
L. Wait until the process is finished.
Fig. 5-14: Performing measuring

(9) (10) (11)
+ Note: The navigation in the several

sample results (9) is made using the
arrows (10) and (11).
+ Note: The diagram tools (14) are

explained in the Samples module.

M. Click on Patient (12) if you want to

view the patient data for the
selected sample (9). (12) (13) (14)
N. To save the data, click on Save (13) Fig. 5-15: Results
and confirm the command by
clicking on Yes.
+ Note: If the Automatic Export

option is activated in the System
module, the data will also be
exported automatically (for
example, transferred to a host).
$ See section “Configure export

# You will be asked for printing (15)

the data.
Fig. 5-16: Print confirmation
O. To print the data, click on Yes (15).

page 28 for more information about
the printing.
Doc N° H 007298 03.05 V1.1 43

5 CD-X module
5.3.2 Setting the communication

(1)
parameters
This function permits to select the

com port.
A. Launch the command
Configuration - Communication
Settings.
B. Select the com port (1).
+ Note: The other fields are read only

values.
C. Click on OK. Fig. 5-17: Communication settings

CD-X module 5
5.3.3 Emergency operations
A. Switch off the "on/off" button (1) at the rear of the instrument.
(1)
Fig. 5-18: Instrument rear view
Doc N° H 007298 03.05 V1.1 45

5 CD-X module
5.4 Trouble-shooting
5.4.1 General remarks
+ Note: Most of the solutions to problems may be solved by the end-user, based on the
following instructions.
)
Do not perform any operation reserved to an authorized technician.
Comply with the safety instructions.
$ See section “2.3 General safety instructions” on page 9
5.4.2 Causes and remedies
5.4.2.1 Maestro Coagulation error messages
«Trying to store a string of length xx into a field that can only contain 15»
- By performing a selected backup, you have choosen a backup file name
too long.
Retype a shorter backup file name (< 16 characters).
5.4.2.2 CD-X error messages
«Replace needle»
- Useful life of pipetting needle exceeded.
Replace pipetting needle.
«Replace syringe»
- Useful life of syringe exceeded.
Replace syringe.

CD-X module 5
5.5 Services
5.5.1 Assistance to the users
Please contact your distributor.
$ You can find DiaMed representatives in over 80 countries of all continents on the
website www.diamed.com.
Doc N° H 007298 03.05 V1.1 47

5 CD-X module

Appendix 6
Chapter overview
This chapter covers non-standard operations on the instruments.
6.1 Graphical symbols

The following non-standard symbols may be found on the instruments, on their
packaging or in the documentation.
6.1.1 Instrument related symbols
Symbol Meaning
Caution, consult accompanying documents
Serial number
Manufacturer
In vitro diagnostic medical device
Biological risks
Doc N° H 007298 03.05 V1.1 49

6 Appendix
Symbol Meaning
Consult instructions for use
Patient number
For IVD performance evalutation only
, This symbol is used to warn of the danger of

injury caused by high-voltage. The label
should be sticked on the power supply unit.
-
This label is located in front of the barcode
reader windows.
This symbol is used to warn of the danger of
permament eyesight injury caused by laser
beam.

Appendix 6
6.1.2 Package-related symbols
Symbol Meaning
Fragile, handle with care
Keep dry
Keep upright
Do not use a handle to carry
Do not stack more than xx (12 in the example

12 beside) identical packing on the first one
Doc N° H 007298 03.05 V1.1 51

6 Appendix
6.2 Quality system
6.2.1 Decontamination procedure
The decontamination must be performed by an authorized technician in accordance

with the instructions contained in the corresponding user and service manuals.
6.2.2 Decontamination certificate
The instruments and their accessories must be cleaned and decontaminated before
performing any maintenance, revision task, before taking the instrument out of service
and when preparing for transportation.
+ Note: In case of transportation, the instruments must be purged.
+ Note: You can find the official decontamination certificate on the DiaMed website,
section "distributors - secet area - official forms".
'
Fill in a copy of the decontamination certificate and place it on the
instrument, in a conspicuous place.
The absence of decontamination certificate may extend the time needed for revision
and maintenance.
DiaMed SA will bill any cleaning and decontamination operation.
* Recommendation: The original certificate must remain in the present manual. When a
certificate is required, make a copy and fill in the latter sample.

Appendix 6
DECONTAMINATION C ERTIFICATE
DiaMed Instruments
Distributor /Customer:
Country:
E-mail:
Phone:
Herewith declares that the:
Instrument:
Material No
Serial No.:
has been cleaned and decontaminated according to the

procedure described in the user manual, paragraph
“maintenance”
Cleaning & decontamination performed by:
Date: _____________ Signature: __________________
E0303HDI-01
Doc N° H 007298 03.05 V1.1 53

6 Appendix
6.2.3 Maintenance record
* Recommendation: The original blank maintenance sheet must remain in the present
manual. When a maintenance record is required, make a copy and fill in the latter
sample.
Type Page
Serial number
Maintenance / Defect Action Operator Date

Appendix 6
Maintenance / Defect Action Operator Date
Doc N° H 007298 03.05 V1.1 55

6 Appendix
6.2.4 Performance variation
If any variation of the performance of the instrument performance is observed or

suspected, contact immediately your DiaMed representative.
6.3 ! compliance (directives and norms)

The instrument and its respective computer software comply with the
following EU directives :
• directive 98/79/EC on in vitro diagnostic medical devices, and directive 80/181/
EEC;
• standards EN 60601-1, EN 60601-1-2, DIN EN ISO 14971:3/2001, DIN EN 1041:4/
98 have been applied.
6.4 Spare parts ordering

To order spare parts, please refer to the service manual corresponding to the
instrument.
$ See section “6.6.2 Service Manuals (english only)” on page 58
6.5 Device disposal
6.5.1 General warnings
'
In order to protect the persons and the environment, any instrument and its
accessories must be disposed of in an appropriate way. Its is mandatory to
striclty apply laws and local bylaws relative to an appropriate disposal
procedure.
(
An instrument may only be dismounted and divided into its basic
components by a qualified technician.
Parts and sub-parts removed from an instrument may not be reused unless
after having been approved in writing by the manufacturer. Any future
application has to ben precisely described in the request.

Appendix 6
6.5.2 Disposal
The following components can be found in the various instruments :
Packing material
• paperboard;
• polyethylene foam;
• anti-static bag;
• class II fireproofedpolystyrene.
Instruments
• plastic materials :
- PVC;
- POM;
- nylon;
- rubber.
• electrical components :
motors, copper wires, plastic insulation;
• electronical components :
epoxy printed boards;
• optical components :
camera lens, camera body;
• metals :
copper electrical wires;
aluminium instrument base, holders, guides for electronics
boards, partitions, lids;
steel springs, holders, screws, bolts.
Doc N° H 007298 03.05 V1.1 57

6 Appendix
6.6 List of documents
6.6.1 Maestro Coagulation User Manual
English H 007298
6.6.2 Service Manuals (english only)
Service Manual
6.6.3 Configuration Manual (english only)
M Coagulation configuration H 010519

Appendix 6
6.7 Barcode specifications

The tubes used must bear a
barcode to be recognisable.
Their specifications are as follows :
Barcode Barcode Blank

Type of tube position length space
h min l max e min
Rounded end 7 mm 45 mm 3 mm
Fig. 6-1: Barcode dimensions
Minimum barcode resolution : ............... 3 mil

Barcode coding : ......................................... Code 128
Doc N° H 007298 03.05 V1.1 59

MaestroCoag User GB V 11

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H 007298 - 03.

Micro Typing System

Maestro Coagulation User

Reference for order : 1.1 04.03.05 Small corrections

M Coagulation User Manual

2 Safety and handling................................................................................... 7

Doc N° H 007298 03.05 V1.1

M Coagulation User Manual

5 CD-X module ............................................................................................ 31

! compliance (directives and norms) ......................................... 56

Doc N° H 007298 03.05 V1.1

M Coagulation User Manual

1.1 Appropriate use

1.1.1 Warranty limitation

Doc N° H 007298 03.05 V1.1 1

Maestro Coagulation M Coagulation

2 M Coagulation User Manual

1.3 Typographical conventions

1.3.3.1 Procedure result

A procedure result is shown by the following symbol ".

# The parameter window is displayed.

Doc N° H 007298 03.05 V1.1 3

1.3.4 Cross reference

$ See section “4.2.4 Configure import settings” on page 27

1.3.5 List of items

This style is used in order to display a list of elements.

4 M Coagulation User Manual

Doc N° H 007298 03.05 V1.1 5

1.3.8 Recommendation and Note

When complementary information is required and if their non-compliance only leads to

Used to designate a prefered procedure or a recommended practice. DiaMed AG

Used to accompany a general remark or an purely informative comment.

6 M Coagulation User Manual

2.1.2 Importance of the safety instructions

2.1.3 Non-compliance with the safety rules

Doc N° H 007298 03.05 V1.1 7

2.2 Environmental conditions

The electrical safety is guaranteed only if the electrical installation of the

The instruments may not be exposed to direct sunlight, heat, dust or

8 M Coagulation User Manual

2.3 General safety instructions

Most metals reflect the laser beam.

The instruments may only be connected to the electrical power sources

It is imperative to use the liquids specified in the manual to clean any

Doc N° H 007298 03.05 V1.1 9

It is imperative to obtain the manufacturer’s approval before using any

A. Switch off any instrument at the power switch.

2.3.1 Observations and informations

2.4 Special safety instructions

10 M Coagulation User Manual

2.5 Storage conditions

2.5.1.1 Short term storage

2.5.1.2 Long term storage

* Recommendation: Use the original packing material provided by the manufacturer.

Doc N° H 007298 03.05 V1.1 11

2.5.2 Handling and transportation

Packing the instrument is essential before shipping or for long-term storage.

2.5.2.2 Transportation recommandation

• always carry upright;

• do not use a handle to

• do not stack more than xx

12 M Coagulation User Manual

3.1.1 Instrument overview