Manual Analizador Pirogenio Ellab Man - Py - SW - 20090626 - 3.0 PDF

PyroMon™ Manual
2.9.6
TM
Equipment supported by software:
IF9600 (comminication module)

UI128 (user interface)
TM9616 (temperature module)
Version 3.00 Juni 2009
ELLAB A/S
Trollesmindealle 25, DK-3400 Hilleroed, Denmark.

Telephone: +45 44 52 05 00
Fax: +45 44 53 05 05
E-mail: info@ellab.com
Web Site: www.ellab.com
Edition 3.00
Number: MAN_PY_SW_20090617_3.0
PyroMon Manual Version 2.9.6.
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Contents
PyroMon Manual 2.9.6 .........................................................................................................1
1 Safety Information............................................................................................................6
1.1 Warnings......................................................................................................................6
1.2 General ........................................................................................................................6
1.3 Electrical Hazards.........................................................................................................6
1.4 Directives .....................................................................................................................7
2 Definitions ........................................................................................................................8
3 Introduction......................................................................................................................9
3.1 The Program ................................................................................................................9

3.2 Setup / Training demand:............................................................................................10
3.2.1 Hardware setup..................................................................................................10
3.2.2 Network .............................................................................................................10
4 Hardware Description ....................................................................................................11
4.1 Content ......................................................................................................................11

4.1.1 IF9600 ...............................................................................................................11
4.1.2 PA9600 ..............................................................................................................12
4.1.3 PS24V ...............................................................................................................12
4.1.4 TM9616 .............................................................................................................12
4.1.5 UI128.................................................................................................................13
5 Component Check List ..................................................................................................15
6 Install the hardware........................................................................................................16
6.1.1 Introduction ........................................................................................................16

6.1.2 Mount the modules.............................................................................................16
7 Software setup ...............................................................................................................21
7.1 System requirements..................................................................................................21

7.2 User administration functions......................................................................................21
7.3 Software structure ......................................................................................................22
7.4 Install the software......................................................................................................23
7.4.1 Introduction ........................................................................................................23
7.4.2 Install .................................................................................................................23
8 Disaster Recovery Plan..................................................................................................24
9 Software (configuration of system)...............................................................................25
9.1 Setup Boxes Node ID (setup Arc-network / rename boxes) .........................................25

9.1.1 Node ID .............................................................................................................25
9.1.2 Rename box name.............................................................................................27
9.2 Printer setup:..............................................................................................................28
9.3 System lock in run mode.............................................................................................28
10 Software setup..........................................................................................................28
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10.1 Starting the system.................................................................................................28

10.2 GUI Menu description in PyroMon start mode .........................................................29
10.2.1 Status bar ..........................................................................................................31
10.3 Configuration of chart setting (Edit settings)............................................................32
10.4 Logs rate: ...............................................................................................................35
10.5 General setup for Reports: .....................................................................................36
10.6 General setup for animals.......................................................................................37
10.7 General setup of resolution for measuring:..............................................................38
11 Users mode...............................................................................................................39
11.1 Software access Matrix...........................................................................................39

11.2 Master login (User mode / New user / Edit user / Erase user) .................................40
11.2.1 User mode: ........................................................................................................40
11.2.2 New User: ..........................................................................................................41
11.2.3 Edit Users ..........................................................................................................42
11.2.4 Erase User .........................................................................................................44
11.3 Standard user login: ...............................................................................................45
12 Audit Trail .................................................................................................................46
12.1 Audit trail Event / database trail: .............................................................................48

12.1.1 Procedure To Audit Trail:....................................................................................48
12.2 Event trail: ..............................................................................................................49
12.2.1 Event trail procedure: .........................................................................................49
13 Calibrate....................................................................................................................50
13.1 User calibration test procedure: ..............................................................................51

13.2 User calibration report: ...........................................................................................53
14 Data record / Logging...............................................................................................54
14.1 Data logging procedure ..........................................................................................54

14.2 Load record graph according to data logging. .........................................................54
14.3 Define Log Settings ................................................................................................56
15 Methods ....................................................................................................................57
15.1 New Method ...........................................................................................................57

15.2 Background to setup methods ................................................................................57
15.2.1 Create New Method ...........................................................................................59
15.2.2 Copy Method......................................................................................................64
15.2.3 Erase method:....................................................................................................67
16 Animal Database.......................................................................................................68
16.1 Rabbit information: .................................................................................................68

16.2 Create animals .......................................................................................................69
16.3 Erase Animals. .......................................................................................................71
16.4 New Animals Report...............................................................................................72
16.5 Deactivate Animals.................................................................................................73
16.5.1 Introduction ........................................................................................................73
16.5.2 Deactivate..........................................................................................................73
16.6 Inactivate Animals Report.......................................................................................74
17 Preparations .............................................................................................................75
17.1 Preparation Database.............................................................................................75

17.2 Edit Run(s) .............................................................................................................76
17.3 Prepare the test......................................................................................................76
17.4 Animal Weight ........................................................................................................79
17.5 Setup demand to weight:........................................................................................81
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18 Runsheet...................................................................................................................82
18.1 Abbreviation below a RUN in GUI:..........................................................................82

18.2 Abbreviation in Network GUI:..................................................................................82
18.3 Abbreviation in report: ............................................................................................82
18.4 Starting a Run ........................................................................................................82
18.5 Inject Group(s) .......................................................................................................84
18.5.1 Introduction ........................................................................................................84
18.5.2 Display setup on UI128 ......................................................................................85
18.6 Slipping Probe Alarm..............................................................................................87
18.6.1 Run Error ...........................................................................................................87
18.7 View Temperature Graph On Line ..........................................................................88
18.7.1 Graph.................................................................................................................88
18.7.2 Multi User...........................................................................................................90
18.8 Delete a rabbit in a test...........................................................................................91
18.8.1 Delete (Animals in Pre-test & main test) .............................................................91
18.9 Select a Replacement Rabbit (if any free)...............................................................94
18.9.1 The Procedure to replace a animals. ..................................................................94
18.10 Delete a Preparation/Test .......................................................................................95
18.10.1 Introduction....................................................................................................95
18.10.2 Delete ............................................................................................................95
18.11 View main test temperature Graph On-Line ............................................................96
18.11.1 Graph ............................................................................................................96
18.12 Run Completed ......................................................................................................98
18.12.1 End of test, result / graph printout...................................................................98
18.13 Test List ...............................................................................................................101
18.13.1 Test List Procedure ......................................................................................101
18.14 Sham Animals List................................................................................................101
18.14.1 Sham Animals List Procedure ......................................................................102
18.15 Results Handling ..................................................................................................102
18.15.1 Search in Preparation Procedure .................................................................102
18.15.2 Daily Results Procedure...............................................................................103
19 Repeat Preparations / failed result (high temperature).........................................104
19.1.1 Repeat Test .....................................................................................................104

19.1.2 Result form ......................................................................................................105
20 Simulation...............................................................................................................106
20.1.1 Introduction ......................................................................................................106

20.1.2 Simulated test ..................................................................................................106
20.1.3 Simulated test procedure..................................................................................106
20.2 Graphical view......................................................................................................109
20.2.1 Graphical view procedure.................................................................................109
20.3 Print Log Graph....................................................................................................109
20.3.1 Hard Copy procedure .......................................................................................109
21 Export functions .....................................................................................................110
21.1 Export Excel .........................................................................................................110

21.1.1 Export Excel procedure ....................................................................................110
21.2 Read procedure ...................................................................................................111
21.3 Export Prep Word.................................................................................................111
21.3.1 Export Prep Word procedure ............................................................................111
21.4 Special report / data setup....................................................................................112
22 Technical specifications ........................................................................................113
22.1.1 Network ...........................................................................................................113

22.1.2 TM9616 ...........................................................................................................113
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22.1.3 UI128 ...............................................................................................................113

22.1.4 PA9600 ............................................................................................................113
22.1.5 PS24V .............................................................................................................114
22.1.6 Coax cables .....................................................................................................114
22.1.7 Probes .............................................................................................................114
22.1.8 AL9600 (switch need connection to a bell or light) ............................................114
23 Alarm connection. ..................................................................................................115
23.1 Alarm connection example:...................................................................................115

24 Maintenance............................................................................................................116
25 Pyromon software Error Codes .............................................................................117
26 Troubleshooting .....................................................................................................119
27 Spare Parts: ............................................................................................................120
28 Enclosure no. 1:......................................................................................................121
29 Changelog...............................................................................................................122
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1 Safety Information
Use this equipment only as specified in this manual. Otherwise, the protection provided
by the equipment may be impaired.
The following definitions apply to the terms “Warning” and “Caution”.
“Warning” identifies conditions and actions that may pose hazards to the user.
“Caution” identifies conditions and actions that may damage the equipment being used.
1.1 Warnings
Disclaimer: Ellab manufactures equipment intended for use in thermal validation of
rabbit according to pharmacopia demand. Equipment used for applications other than
above is used at the discretion and sole responsibility of the customer. Ellab cannot
accept any responsibility for the use of equipment for any application other than thermal
validation thermal validation of rabbit according to pharmacopia demand.
1.2 General
DO NOT use the equipment for any application other than thermal measurement of
rabbit according to the pharmacopia demand. Any other use of the equipment may cause
unknown hazards to the user.
DO NOT use the equipment in environments other than those listed in the user’s guide.
Follow all safety guidelines listed in the user’s manual.
Only trained Personnel should use measurement equipment.
Inspect the equipment for damage before each use.
DO NOT use the equipment if it appears damaged or operates abnormally.
The equipment is intended for indoor use only.
1.3 Electrical Hazards

These guidelines must be followed to ensure that the safety mechanisms in the
equipment will operate properly. Equipment, when applicable, must be plugged into a
115 VAC (± 10%) or 230 VAC (± 10%) 50/60 Hz electric. The power cord of the
instrument is equipped with a three-pronged grounding plug for your protection against
electrical shock hazards. It must be plugged directly into a properly grounded three-
prong receptacle. The receptacle must be installed in accordance with local codes and
ordinances or adapter plug.
DO NOT use an extension cord. Consult a qualified electrician. Always inspect the
power cord before use for any damage to the insulation due to contact with hot surfaces,
cuts or abrasions.
Always replace the power cord with an approved cord of the correct rating and type. If
you have questions, contact an Ellab Authorized Service Center (see below for details).
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Cautions
Always operate hardware modules: IF9600, TM9616 and UI128 at room temperature
between 5°C to 50°C (41°F and 122°F).
DO NOT operates this equipment in an excessively wet, oily, dusty, or dirty

environment.
The equipment is a precision instrument. Although it has been designed for optimum
durability and trouble free operation, it must be handled with care.
The equipment and used sensors with it are sensitive instruments that can be easily
damaged. Always handle these devices with care. Do not allow them to be dropped,
struck, stressed, or overheated.
1.4 Directives
IP 54 (International Protection Rating)
Ellab hardware has been tested to meet the demand to IP54 according to standard no.
60529.
EMC Directive
Ellab's equipment has been tested to meet the European Electromagnetic Compatibility
Directive (EMC Directive, 89/336/EEC). The Declaration of Conformity for your
instrument lists the specific standards to which the unit was tested.
Low Voltage Directive (Safety)
In order to comply with the European Low Voltage Directive (73/23/EEC), Ellab
equipment has been designed to meet the EN 50081-1, 50082-2 and the EN 50082-1
standards.
Authorized Service Centers

Please contact one of the following authorized Service Centers to coordinate service on
your Ellab equipment:
Ellab A/S Phone: +45 4452 0500

Trollesmindealle 25 Fax: +45 4453 0505
DK-3400 Hilleroed, DENMARK
Ellab Inc. Phone: +1 303 425 3370

6551 South Revere Parkway Suite 145 Fax: +1 303 425 3384
Centennial, CO 80111, USA
Ellab GmbH Phone: +49 4286 926 620

An der Autobahn 5 Fax: +49 4286 925 818
D-27404 Bockel, GERMANY
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When contacting these Service Centers for support, please have the following
information available:
• Model Number
• Serial Number
• Voltage
• Complete description of the problem
2 Definitions
Definitions used in this manual, see description in table below.
Symbol or Description Unit
abbreviation
EMC European Electromagnetic -
Compatibility
GAMP Good Automated Manufacturing -
Practice.
CSV Character Separated Values -
CPU Central Processing Unit -
RS232 Radio Standard 232 -
USP United State Pharmacopoeia -
BNC T-Connector. -
BNC Special terminator -
BNC Terminator -
BNC Bayonet Neill Concelman -

UPS Utility Power Supply -
IR Fail Level
PE Fail Level Permanent Exclusion Fail Level. -
Overshoot Overshoot level (Individual) -
Level
SR Pass Summed response Pass Level -
OC Pass Overshoot Count Pass Number -
OC Fail Overshoot Count Fail Number -
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3 Introduction
The PyroMon software, in conjunction with Ellab equipment, offers you a complete
system for Pyrogens test according to pharmacopias (USP, ph.EUR etc.) demand.
Importen information
We recommend only running the PyroMon™ program during test as impact of another
computer program can cause computer to shutdown. Since all the information are
stored in the computer during the run then we recommend to secure the power supply to
the ARC-network and computer by means of either a local UPS (Utility Power Supply)
or a secure computer power supply.
3.1 The Program

This Pyrogen testing program has been developed in order to comply with every
Pharmacopoeia that exists in the world now. It has been developed in a way that allows
maximum flexibility for the users without violating any form of security or limits the
Pharmacopoeia states. The main purpose for this system is to deliver tamper free
documented evidence of the Products, Rabbits and Results. We have build many new
features into this system that makes manual record taking obsolete and makes life so
much easier for the operators and management i.e. Audit trail, Audit event trail,
Electronic Signature, List's of new and sham animals, Daily Results. Further on it is
possible to run different Pharmacopoeia (also Sham Test) at the same time without
fearing for injecting the wrong rabbits. The local monitors (UI 128) are equipped with
background lights that help reading the information for each test (Rabbit No / Channel
No. - Volume to inject for ea. Rabbit etc.) PyroMon™ running on Windows XP,
windows 98 or NT platform enables the user to use the computer efficiently to plan new
tests. There are a lot of printing facilities, possibilities to program new Pharmacopoeia
with limits that fits your products, simulate a previously performed test into other
Pharmacopoeia, without violating trace ability and security, all at the same time as the
program is capturing data from the animals. The system controls that rabbits under
quarantine cannot be used in analysis. The encrypted database has a phenomenal
strength and keeps you safe and clear with every step you take.
Note:
The Content of this manual and associated software are the property of Ellab A/S and
are copyrighted. Any reproduction in whole or in part is strictly prohibited. For
additional copies of the software or manual, please contact Ellab A/S or your local
distributor.
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3.2 Setup / Training demand:

3.2.1 Hardware setup
The person(s) involved with installation of the different hardware modules should have
the minimum knowledge of installing technical electronic equipment i.e. computers,
network etc.
3.2.2 Network
The PyroMon™ network is of the Arc Net (Attached Resource Computer NETwork)
type.
This type of network is the ideal solution for factory automated solutions because it
provides “Token Ring Protocol”, a highly reliable and proven network scheme.
By using Coaxial cables in our network gives us an excellent “four in one” solution
• Rugged and environmental safe cable type.
• Power supply for the network (100-240V AC 50/60Hz).
• Data carrier. Very good noise protection.
• Very long cable lengths is possible
Specifications: Data rate 1.25Mbps.
Overview by coaxial cable:

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4 Hardware Description
Below is a description of the individual hardware modules a PyroMon™ system
consists of.
4.1 Content
This section contains the following topics.
Module Label
IF 9600 Network Interface between computer and Network
PA 9600 Network Power Adapter
PS24V Network Power supply
TM 9616 Network 16 channel Temperature Module
UI 128 Network User Interface
4.1.1 IF9600
To this module you need connection to power supply and terminator in the end, to a
closed the Token ring.
This module has tree purposes.

• To convert the signals from the computer to "Network understandable
commands".
• To ensure that no matter the length of the coax cable then the signals always gets
to the right destination.
• To provide an external alarm if a probe slips out or gets damaged.
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4.1.2 PA9600
The network power adapter makes the link between the power supply and the network.
Further on it works as a filter, see setup on above figure.
4.1.3 PS24V
The power supply is a switch mode model enabling to give an output of 24V if it is
supplied with a voltage within the range of 100 to 240VAC 50/60Hz.
4.1.4 TM9616
The temperature module has a capacity of simultaneously monitor 16 temperatures. It is
manufactured of stainless steel to withstand a rugged industrial environment. The
PyroMon™ system has a capacity of handling up to 5 TM 9616 temperature modules at
the same time giving a total of 80 temperature channels. Do not hose down any TM
9616 modules since water can penetrate the small space between probe and socket and
coarse damage to the modules. We recommend mounting the TM 9616 modules in a
protective cabinet to prevent "Any accident".
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4.1.5 UI128
The monitor module can handle all the information of temperatures, dose, channel, test
no., pin code, etc. in the network. It operates as an interactive interface to the system
and serves the purpose of securing the system from illegal entry, starts and stops tests,
deleting rabbits & tests, temperature monitor and alarm monitor. The PyroMon™
system has a capacity of handling several UI128 modules at the same time. It is
manufactured of stainless steel to withstand a rugged industrial environment.
This interactive module has several functions that will be defined below.
Part Function
UI128 display Provides information to you about the run, in different
mode; see more information in chapters about setup UI128.
Setup mode:
Injection mode:
Pincode mode:
Normally Run mode:
Erase mode:
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Part Function
For the use of enter values like PIN codes into the system.
Scroll function between tests.
Selecting Rabbit Number/Channel Number and Test

Number/Preparation Number. It also functions as a "Clear" button
to be used during injection of multiple tests on the same monitor.
Serves as an accept function on issues like entry of PIN code, Tests

and Alarms.
F1 + password gives a command to start injection period, will

only be available if method is in injection mode Pre-test have
+ Password ended.
F2 + password gives a command to stop injection period, will

only be available when injection is started.
+ Password
Below run is you press F3 you will get a menu, see menu below:
+ Password F4 + password finish calibration of the system; will only be

available if you have started the calibration in PyroMon software.
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5 Component Check List

Introduction
This procedure has been developed for enabling you to perform a Component Check in
order to identify each unit in the PyroMon™ system. Follow the procedure below step
by step.
Note
Below you will find the list of all the parts existing in a Minimum PyroMon™ system.
Note that the number of IF 9616 & UI 128 modules, "T" Plugs, and Probes will vary
according to the system configuration.
Parts
Module Label Order Code
Software + Manual PyroMon™ software (CD-Rom) 22060000
IF 9600 Network Interface Module * 21209601
PS24V Power Supply to the network * NA
TM 9616 Temperature Network Module 22061610
UI 128 User Interface Module 22069600
Coaxial cable connector. One is
"T" Plugs NA
supplied together with each module
Network termination plugs. Two pcs. per
TRC system. * NA
Probes Rectal Probe, Rabbits (2,75 Meters) 26110004

Mounting Device For the use together with the modules NA
PA 9600 Power Adapter * NA
Alarm Switch, need connection to
AL 9600 bell or light, Ellab due not supplies 26320005
this connection.
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6 Install the hardware

6.1.1 Introduction
This Procedure has been developed to assist you in installing the PyroMon system,
setting up the interface, temperature and monitor modules. We recommend that the
person(s) who install the hardware must have a good technical knowledge of the
functions in a network system.
6.1.2 Mount the modules
First of all it is important to have a fixed plan to where the modules must be mounted.
Hint 1:IF9600 need connection so the COM cable is able to get PC COM port.
Hint 2: The TM9616 module should be mounted somewhere behind the rabbits in order
to get easy access to the probes. This also ensures the minimum cable length
required for the probes.
Hint 3:The UI128 modules must be mounted close to the front of the rabbits in order to
have easy access and visibility during operation.
Step Action
1
Remove the holding device for the modules and position them in the right place.
Screw them on to the wall / plate etc.
Mount the modules in the holding device according to planning, see example
below. All length of the cable can be different.
2
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Step Action
Mount the Coax cables between the modules, and connect whit a BNC T-
Connector.
Note: the short coax cable you need to use in the ending see figure above.
Mount the BNC T-Connector Plug's onto top on all the modules, see more
information in picture below.
Mount a short Coax cable between the IF9600 to a BNC T-connector in to BNC
connectors; see more information in figure below.
5
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Step Action
Mount a "BNC T-Connector" on the PA9600 unit, connect the coax cable from
IF9600 to PA9600 unit, and mount a short coax cable in the second end to BNC
connecters.
Mount the special Termination Plug (TRC) plug and terminator to the short coax
cable in BNC connecter; connect coax cable to the T-connects at PA9600 unit, the
connect to IF9600 to be as below.
7
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Step Action
Mount a short coax cable to the last module BNC T-Connector.
Mount the special Termination Plug (TRC) onto the BNC end of the coax
cable at end the line whit a terminator.
Connect one end of the serial RS232 cable to the IF9600 module in the slot
marked “Com 1”. The other end must be connected to the computer serial
COM 1 port (DE-9 connects).
IF9600 COM PC COM 1
Mount the plug from the power supply (PS24V) into the PA9600 unit.
9 Secure the power supply at PA9600 module, to avoid anyone by accident
should disconnect the unit.
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Step Action
Connect the entire temperature sensors to the TM9616 module.
10
The setup of the system is now complete and ready to run.

Switch ON
Switch On the power to the network. Wait until it has stabilized itself approx. 5-
10 seconds. On the front of the IF9600 & TM 9616 modules there are two LED.
The Power LED , flashing green with a rate of 50% On and 50% Off and the Arc
Net lighting red when the arc net is active. On the front of the UI128 module the
display shows the following text: Welcome to the Ellab A/S PyroMon system.
11
Imported: Remember to connect one termination plug (TRC) in each end of the coax
cable.
Note: If you need more information about connection a alarm switch see Alarm
connection no. 23.
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7 Software setup
The person(s) involved with installation of the software should have the minimum
knowledge of installing software on a Window 98, Window NT 4.0, Windows 2000,
Windows XP Professional and windows Vista operative system.
7.1 System requirements
Recommended System Requirements
• Pentium 4 CPU 2.6 GHz processor or higher
• Windows 2000, Windows XP, or Windows Vista operating system
• 512 MB RAM (Vista 1024 MB RAM)
• SVGA color monitor
• Screen Resolution 1024 x 768
• CD ROM (All speeds are acceptable)
• Hard drive with 25 MB of free space
Minimum System Requirements

• Pentium CPU 400 MHz processor
• Windows 2000, Windows XP, or Windows Vista operating system
• 128 MB RAM (Vista 1024 MB RAM)
• SVGA color monitor
• CD ROM (All speeds are acceptable)
• Hard drive with 25 MB of free space
The PyroMon software is validated using Windows XP SP2 operating system. Those
installing and using this software should have a basic knowledge of software installation
on Windows operating systems.
7.2 User administration functions

The PyroMon system support user administrator function you have different user level
in the PyroMon software. The first time the system is configured we assume that the
head of the Pyrogen test will be present, as there are some decisions to make during the
configuration.
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7.3 Software structure

This flow describes PyroMon software structure see diagram below.
Software flow sheet
General software system

(Windows 2000, 2000 Pro, XP, XP Pro, Vista) Hardware device
Connect IF9600 (alarm / convert module)
Pyromon (RS-232)
UI128 (user inface)
(ARC-net)
TM9616 (temperature module)
File Database Run Monitor View Window Help
Database Monitor Windows

* Edit * Buffers * Cascade
* Report * Network * Tile Horizontal
* Daily Results * Tests * Tile Vertical
* Sham Animals * Graph * Arrange Icons
* New Animals * Plot * 1 Message
* Inactive Animals * Settings * 2 Network
* Outputs * 3 Run
File Run View Help

* Start * Start * Toolbar * Contens
* Copy * Record * Status Bar * About PyroMon
* Print * Stop * Large Icons * PyroMon Logo
*Print Setup * Refresh * Small Icons * Node Manager
* Exit * List
* Details
* One Level Up
Edit Report Start Plot

* Runs
* Weight * All * Measurement
* Log
* Users * Selection * Calibration
* Test
* Animals * Query * Test
* Preparations
* Methods
* Markers
* Boxes
* Settings
Graphical User Interface in pyromon software

* User interface * Graph
* Event trail window. (Right click)

* Network window
* Settings
* Run window (below run). * Output
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7.4 Install the software

7.4.1 Introduction
This Procedure has been developed to assist installing the PyroMon software on the
computer. We recommend that the person(s) who install this software package must
have a good knowledge of the functions in Windows 98 / Window NT operative system.
7.4.2 Install
Follow below install step action table step by step.
Step Action
1 Start the computer.
Insert the CD of Pyromon and launch the file PyroMon2.91.exe (if it

2
hasn’t been launched automatically)
3 Select Run
4 Select language on arrow , and click OK.

5 Click Next
6 Input rabbit as password.
Click Next
Location window will appear, input location.
8
Click Next
Mark Create a desktop icon
9
Click Next
10
Click Install
Unmark Launch PyroMon 2.92
11
Select Finish
12 The PyroMon will be install
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8 Disaster Recovery Plan
There are 3 fatale events, where a recovery plan must be executed to recover the
PyroMon program and/ or any data collected in the database.
1. PyroMon has experienced a crash and cannot recover after a new program
restart.
2. The database has crashed i.e. due to power failure.
3. The hard disk is broken and cannot be rescued.
Event 1: Copy mdb files in PyroMon folder (PyroMon.mdb, AuditTrail.mdb and

EventTrail.mdb). Go to add/remove programs in the control panel and remove
PyroMon. Then do a reinstall of PyroMon software, and paste the mdb you have copy
in to the new PyroMon folder, erase files in the folder whit the files you paste in the
folder, you are now able to start the program, whit a restore mdb files.
Event 2-3: Ellab recommend you to copy the mdb PyroMon.mdb, AuditTrail.mdb and
EventTrail.mdb) files every month on network drive.
Go to add/remove programs in the control panel and remove PyroMon. Then do a
reinstall of PyroMon software, and paste the last copy mdb files in to the new
PyroMon folder, erase files with the new one, you are now able to start the program,
whit data from restore database.
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9 Software (configuration of system)

9.1 Setup Boxes Node ID (setup Arc-network / rename boxes)
You will only need this setup if you not see all modules in Network window the system
have the same address, and you will need procedure below.
9.1.1 Node ID
This feature is to setup the Arc-net module for enabling changes of physical address on
the PyroMon modules.
Step Action
1 Turn on the Computer.
Make sure that all the Units (IF9600, TM9616 & UI128) are connected and operate
properly.
You will see a red flash light in Access and green flash light in power, on the boxes
2 IF9600, TM9616 and you will also have power in UI128 and normal display will
show: Welcome To Ellab A/S PyroMon or you will temperature channel with
temperature.
3 Double click the PyroMon Logo with the left mouse button
Type in master as Login Name and as password type master, or what you have
changed the password to.
Mark Database Mode
Below Database Mode all the run function will be disable.
5 Select the OK button. The PyroMon programs will opens.

Select Help\ Node Manager.
7
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Step Action
Node manager window will open.
8
Select Read and wait until the system has found all the units on the
network.
Right click on the box that needs to change node address.
Click on the arrow in the field Node ID, and select the new
10 address. Do not make two units with the same number as it will cause your system
to fail / Error.
11 Click on the button, and wait until the system has updated the
numbers in the system.
12 Repeat step 10 to 12 until everything is OK.
13 Click to close the Node Manager window.

Select File\ Exit, the PyroMon program will close.
14
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9.1.2 Rename box name

Rename the Individual Box to fit your Lab. Number. Follow below procedure step by
step.
Step Action
Type in master as Login Name and as password type master, or what you have
changed the password to, unmark database mode. Select OK
Click Database\Edit\Boxes… the Boxes window will appears
.
Click on the field Description and edit the text.
4 Type in the Lab. No. Or other description.
5 Repeat step 5 & 6 until finished

Click OK. Changes will appear in the Content of the network.
6
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9.2 Printer setup:

The system used windows printer setup.
Step Action
1 Select start, and pick Printer unit (Windows XP)
Select the printer you need to used as a printer in PyroMon, and right click menu will
2
appear. (Windows XP)
Select printer to be the default printer. (Windows XP), the PyroMon system will always
3
select the default printer as output destination.
9.3 System lock in run mode

The system needs the program to be open if you due a run, and the system are not able
to lock the program in windows, if you lock windows the system will be unstable and
you can get some error, therefore Ellab will advice you to not run whit screen break.
10 Software setup
10.1 Starting the system
Step Action
1 Turn on your Computer.
2
Make sure that all the Units (IF9600, TM9616 & UI128) are connected and operate
according to Part 1.
3
Doubles click on the PyroMon Icon with the left mouse button.
Type master as password (See Figure 1) and click on the OK button.
Figure 1
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Step Action
5
The system checks the network and presents the content in Network [COM1]
explorer window (See in Figure 2). Note that all the modules are present.
Figure 2
10.2 GUI Menu description in PyroMon start mode

GUI menu is the name for a graphical symbol that is located in the toolbar. Pointing
with the mouse pointer on the icon creates a message window with information of its
function and clicking it activates the function. The toolbar (Figure 3) represents an easy
(shortcut) access to a group of selected menu items.
Figure 3
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Table description of figure no. 4

Signature on figure no. 4 Description
Run Record Used to record a measurement running whit out test sheet, this
log is able to view by Monitor\ Plot \ Log…
I
This record is also able to play in tools program Pyrosim only
used by Ellab A/S.
Run Stop Used to stop test, before ending.
Run Start Test Used to start test sheet (need to calibrate the sensor).
Run Start Calibration Used to user calibrate the TM9616 module.
Run Start Measurement Used to start online measurement every 5-minute whiteout test
sheet.
View Details Setup of GUI in window RUN and Network.
View List Setup GUI whiteout any information, in window RUN and
Network.
View small icon Setup GUI whiteout any information and whit small icon, in
window RUN and Network.
View Large Icon Setup GUI whit large icon, whiteout any information, in window
RUN and Network.
One Level up One Level up one the chart, in window RUN and Network.
File print Print function on graph.

File Copy Graph copy
File Export The program is able to export file to runs.
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10.2.1 Status bar

The status bar displays information on the current status of the program. Figure 4
displays the different items of PyroMon toolbar.
Figure 4
Log File Size Only facilities if you used record function, if not you will
see nothing in this field.
This will tell you have large the runs file is if you record
online measurement.
Log Time Only facility if you used record function, if not you will
see 0:00:00 in this field.
This will tell how long time you record the online
measurement.
Log status Only facility if you used record function, if not you will
logging off in this field.
This will tell you how long time you have record.
Refresh Signal Will always show when you run, calibrate and measurement:
R= Refresh signal
A= Available
Run mode This will tell you about the sampling mode.
Test mode (runsheet)
Measurement (online sampling)
Calibration (online calibration)
Line mode This will tell you Line mode:
Runsheet = Data from COMX.
Off-Line
Speed In factory facility used by Ellab you are able to speed up the
time, in normal user mode this will always setup to 1.
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Run Time Will tell user how long time the test have run, this time will
be reset is user selected Stop.
Current Time Online Time will reflect windows time.
Current Date Date today, will reflect windows date.
10.3 Configuration of chart setting (Edit settings)

This section gives possibility to change the settings in Chart using by a record and runs.
Follow the procedure below step by step if you need to change chart setup, below you
have definition on the chart type:
• Graphs (On-line) is present for file you see online below a run / measurement.
• Plots off-line is setting for a loaded record / runs graph.
Step Action
Click Database\Edit\Settings …the Edit settings dialog box appears.
Click on the tab Charts (See Figure 5).
Figure 5
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Step Action
Graphs (On-Line): Changing …
Multiple Graph windows: Click on the check box to activate this function.
Graph Rate: Double click the field and change the settings (Min. 60 – Max. 3600
seconds between each data points), normally you will see the rate every 300 second.
3
Graph Setting: Click on the Graph setting button and change the setting on scaling,
color, style and grid.
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Plots (off-line): Changing …

Multiple Plot windows: Click on the check box to activate this function.
Plot Rate: Double click the field and change settings. (Min. 60 seconds – Max.
3600 seconds between each data points), normally you will see the rate every 300
second.
Plot Setting: Click on the Plot Setting button and chart settings will appear mark
the change on scaling, color, style and grid and Select OK, the window will
closed.
Use method defined report times: Click on the check box to activate this
function. Note the Plot Rate setting is greyed out (no change possible), this will
show you the runs measurement, and normally you will used this to show the
result.
When all setting is setup, select OK
5 The chart window will close.
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10.4 Logs rate:

Logs rate is the most essential parameter in the system, due not change this if you due
not have a proper overview above all the method you have created, you need to have
measurement value on all time points to evaluate on product.
Step Action
Click Database\Edit\Settings …the Edit settings dialog box appears.
Click on the tab Logs

2
Figure 6
Data Logging: Changing …
This setting is present for record file and runs file.
Log Rate: Double click the field and change the settings. (Minimum 60 seconds
– Maximum 3600 seconds between each data points, the database will normally
show point every 5 minutes, so the file is not to large).
Maximal Log file size: Double click the field and change the settings.
(Maximum log file size 10000 kb).
3 Maximal Log period: Double click the field and change the settings. (Maximum
10000 minutes (166 times).
4 When all setting is setup, select OK
5 The Log window will close, and you have change the logs time.
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10.5 General setup for Reports:
Step Action
1 Click Database\Edit\Settings …the Edit settings dialog box appears.
Click on the tab Reports.
2
Figure 7
Test Report: Changing …
This fag is setup the printout function on the report, if you have error in the report, all data
is not able to be one page, you can adjust the parameter in this fag.
Ellab Recommendation for setup:

Report Temperature
Precision: Resolution
2 0.01
2 0.05
1 0.10
Report Rate: Double click the field and change the settings. (Min. 5 – Max. 30
minutes).
Use method defined report times: Click on the check box to activate the function.
Note that the Report Rate setting is greyed out (no change possible).
Maximum number of columns: Double click the field and change the settings.
The input number defines how many result columns maximum are printed on each
page.
Report spacing: Double click the field and change the settings. The input number
defines the space between the report sections.
A4 and Letter: Left clicking on these buttons opens the Reports dialog box telling the
number of columns installed in the report templates.
Animal Weighing: Changing …
4 Maximal number of days before run: This function gives access to decide how many
days before run the rabbits should have their weight updated.
5 When everything is as wanted click the Ok button to save the changes.

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10.6 General setup for animals
Step Action
Click on the tab Animals.
2
Animal Weighing: Changing …

4 Maximal number of days before run: This function gives access to decide how many
days before run the rabbits should have their weight updated.
Maximal weight change: This function tell how large change between to weight of the
5 rabbit.
6 Minimal weight: The minimum weight for rabbit to be attach to test.
7 Enforce Maximal weight change on/off button for Maximal weight function.
8 Enforce minimal weight requirement on/off button for minimal weight requirement.

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10.7 General setup of resolution for measuring:

Normally Ellab recommend 0.01 for calibration and Measurement.
Step Action
Click on the tab Resolution.
2
Ellab Recommendation for

setup:
Report Temperature
Precision: Resolution
2 0.01
3 2 0.05
1 0.10
Calibration Resolution is able to be 0,01, 0,05 or 0,10 this informer how the setup will
4 sample the measurement in the database, Normally Ellab recommend 0,01.
Measurement Resolution is able to be 0,01, 0,05 or 0,10 this informer how the setup will
5 sample the measurement in the database.
Test Resolution is able to be 0,01, 0,05 or 0,10 this informer how the setup will sample the
6 measurement in the database, Normally Ellab recommend 0,01

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11 Users mode
When using the PyroMon software you always need user login this is part of the
security system and the Audit trail, we have setup a user access matrix see below.
11.1 Software access Matrix.
To understand PyroMon software security system, have Ellab created a Security matrix
of the software system, see sheet below:
Pyromon
New User Master New User

Acces No Acces
Delted User Delted User
* All function, see
access on/off below * Non
Master User
New User
Delted User
Acces on / off No Acces

* Function, See access profile: * Run * One level up
* File * Start * All user profile.
* Window
* Save * Measurement * All user password
* Cascade
* Copy * Calibration * All PINCODE
* Tile Horizontal
* Print * Test * Tile vertical
* Print & setup * Record * Arrange & Icons
* Exit * Stop * Help
* Database * Refresh * Contents
* Edit * Monitor * About PyroMon
* Runs * Test * PyroMon logo
* Users password. * Graph * Node Manager
* Animals * Log
* Preprations * Test
* Markers * Plot
* Boxses * Log
* Setting * Settings
* Report *Outputs
* All * View
* Selection * Toolbar
* Query * Status bar
* Advance * Large Icons
* Importet * Small icons
* Daily result. * List
* Sham animals * Details
* New animals
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11.2 Master login (User mode / New user / Edit user / Erase user)
The PyroMon system have two login type master / normal user, to used master login
you need to be login as a master profile. This section gives possibility to change
settings for each operator of the system. We recommend that the master define and
write down exactly the limitations wanted for each operator before starting this
function. Follow the procedure below step by step. It is highly recommended that only
the person in charge of the PyroMon system must operate this function.
11.2.1 User mode:
Step Action
To open Users mode Select Database / Edit and Users.
User mode will appear.
The master will now be able to erase, change PINCODE, change password, change
user name and user login.
Note: The PINCode: can be any number from 1 to 9999 and is used to operate the
3
UI128 module. The PIN Code is linked to the “Operator” and the same PIN Code
must be used to operate the F1, F2 and F3 functions.
Note: As master you only able to see your own password, all other has stars.
User mode buttons:

The Database navigation buttons offers possibilities of finding and printing wanted
records.
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11.2.2 New User:
Step Action
4 In User mode, select icon .

New User mode will appear.
Filled out the information below General User Name, Login Name, Password,
6 PINCode and Access Level.
Note: The PINCode: can be any number from 1 to 9999 and is used to operate the UI128 module. The PIN Code is linked to
the “Operator” and the same PIN Code must be used to operate the F1, F2 and F3 functions.
If you select master select OK, User mode will close.
7
If you select Normal user, select Menus.
Menus window will open, select Edit.
The Denied menu access window will open, in Available select the function you
need denied for the user select icon.
9
Note: Normal user will never have access to master access mode.
10 The function will be removed to selected, select OK.
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Step Action
The Denied Menu access window will close and the menus window will appear, and
you will see the function you have denied the user.
11
Note: If you need to clear the input select button, the user will have access
to all information again.
12 Select OK, window will closed.
11.2.3 Edit Users
Step Action
Click Database\Edit\User … the Users [x] dialog box appears
Select user you need to edit the user access, select Menus.
2
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Menus window will open, select Edit.
The Denied menu access window will open, in Available select the function you
need denied for the user select icon.
4
Note: Normal user will never have access to master acess mode.
5 The function will be removed to selected, select OK.

The Denied Menu access window will close and the menus window will appear,
and you will see the function you have denied the user.
Note: If you need to clear the input select button, the user will have access to all information again.
7 Select OK, window will closed.

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11.2.4 Erase User
Step Action
Select user you need to erase.
Select , warning window will appear.
Select OK, the user will be erased.

4
Note. If you have used the user you are not able to erase the user.
5
Select OK, window will closed.
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11.3 Standard user login:

The PyroMon support normal user password administration, this function support change of
user’s password and PINcode, see procedure below.
Step Action
Change password or PINCode
The Normal user password administration, only give access to the user’s password
and PINCode.
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12 Audit Trail
Ellab defines an audit trail as "a record showing who has accessed a computer system and what
operations he or she has performed of critical change during a given period of time."
In the PyroMon system we have two Audit trail. One Event audit trail will tell you about the
communication between boxes: Login user, Slipping probe, Record, and Injection start / stop
etc. We also have audit trail there mark information we due in database, users handling, animals
handling, methods handling, runs sheet handling etc.
The PyroMon software meets the some of the guidelines for electronic signature as specified in
FDA Regulation 21 CFR part 11, Electronic Records; Electronic Signature.
• Two levels of audit trail (event trail / database trail)
• Two user levels Master (all function) / standard (profile manager)
• Unique identification – User name
• Audit trail Signature identifies the user (master / standard see event trail if you need
user id), this trail includes: Date, time and category of action (old / new value in
change).
• Event trail Signature identifies the user will always be user there has been login, and
includes: Date, time and mode = action.
Below we have try to list what functions are recorded in the in which audit trail and the software
structure (see diagram below for more information)
No. Software Function Audit trail Audit trail

Point mark: type:
1 Login Login in to system + Event
2 System detected Detected the system + Event
3 File Save txt No function is possibility to -
change.
2 File Copy No function is possibility to -
change.
3 File Print preview No data is possibility to - -
change.
4 File Print No function is possibility to - -
change.
5 File Exit Closed system - -
6 Database Edit \RUNS All function have audit trail + Audit
7 Database Edit \ Weight All function have audit trail + Audit
8 Database Edit\Users All Function have audit trail + Audit
9 Database Edit\Animals All function have audit trail + Audit
10 Database Edit\Preparations All Function have audit trail + Audit
11 Database Edit\Methods All Function have audit trail + Audit
12 Database Edit\Markers All function have audit trail + Audit

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13 Database Edit\Boxes No function is possibility to - -

change.
14 Database Edit\Setting All function have audit trail + Audit
15 Report No change for user. - -
16 Importet All function have audit trail + Audit
17 Sham animals No function is possibility to - -

Report change.
18 New animals No function is possibility to - -
Report change.
19 Inactive animals No function is possibility to - -
Report change.
20 RUN Start RUN All function have audit trail + Event
21 RUN Start record All function have audit trail + Event
22 RUN Start calibration All function have audit trail + Event
23 Monitor Buffers No function is possibility to - -

(screen) change.
24 Monitor Network No function is possibility to - -
(screen) change.
25 Monitor Test No function is possibility to - -
(Screen) change.
26 Graph All function have audit trail + Audit
27 Plot All function have audit trail + Audit
28 Settings All function have audit trail + Audit
29 Outputs All function have audit trail + Audit
30 View Include all No function is possibility to - -

change.
31 Window Include all No function is possibility to - -
change.
32 Help Contents No function is possibility to - -
change.
33 Help About PyroMon No function is possibility to - -
change.
34 Help PyroMon logo No function is possibility to - -
change.
35 Help Node All function have audit trail + Audit
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12.1 Audit trail Event / database trail:

PyroMon supports complete audit trails; to help understand this trail, we included the two
reports Audit trail report and event trail see below for example.
12.1.1 Procedure To Audit Trail:
A: Select Database \Report \All
B: Open window will appear.
C: Select audits.rpt and select open, Report will appear.
Audit trail reports:

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12.2 Event trail:

PyroMon support event trail there supported communication between hardware and software.
12.2.1 Event trail procedure:

A: Select Database \Report \All
B: Open window will appear.
C: Select Events.rpt and select Open. Report will appear.

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13 Calibrate
The Pyrogen tests system must be calibrated before it can be used for analyses. The
PyroMon user calibration adjusts only in one point (normally 38.50 this is normally
rabbit temperature, see figure below if more information need). The Calibration need to
be perform in the A high precision and stable calibrating bath with a good circulation
(The PyroMon sensor from Ellab have a Maximum error at 0.1°C (this deviation is from
the probes accuracy in the range 15 - 45 degree) this deviation is like pharmacopoeias
demand.
You are able to set criteria for how stable the temperature need to be before the sensor is
accept (setup in PyroMon 0,01 and 10 degree, default value is 0,5 degree) the sensor
will be adjust to the temperature reference (Like Ellab model ETS with display or
similar with calibration reference to National Metrology Institutes RISØ in Denmark,
NPL in the UK, NIST in the United States, PTB in Germany and many others) is
needed for the calibration.
Before calibration After calibration

e
ob
Pr
e
ob
Pr
Temperatur
Temperatur
Adjust
Temperatur
Temperatur
standard
standard
Time Scala Time Scala

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13.1 User calibration test procedure:

Follow below procedure step by step to obtain the best possible accuracy of the System.
Step Action
1 Turn on the calibration bath / block and set the thermostat to 38.50°C
Start the PyroMon Program, unmark database mode, at typing Login name and
2 password.
Note: Make sure that the login name used is allowed to perform the Calibration.
3 The PyroMon program will start.
Take all the sensors and make sure that the tip of the probe is at the same level. Use a
rubber band to bend them together.
3 Insert the temperature reference probe in the middle of the Pyrogen probes. Place the
probes in the calibration bath. Make sure that the probes are immersed in minimum
75mm liquid.
Wait until the water bath has stable readings. Check all the TM9616 modules
4 temperature readings. All the readings must be within 38.50°C ± 0.5°C. If any of the
readings are outside this range adjust the water bath temperature until they are.
Go to the PyroMon program and select the blue arrow (Run Calibration)
5 located on the Toolbar.
The calibration dialog box appears (the time will start to run).
Typing the standard temperature in the Reference Temperature.

6 Select start button.
7 Wait 5 minutes, the temperature need to be stable.
Go to the monitor (UI128) and press the F4 button followed by user Pin code.
If the message on the monitor is “Invalid ID", see troubleshooting in appendix.
8 Click Stop on the Message Box on the Computer Monitor. The dialog box closes.
Verify that offset values appear on the Network [COM1] “Content of TM9616
xxx.” screen.
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Step Action
Printout calibration Select clicking Database\Edit\ Boxes …
Note: This function only works if you have connection to the unit.
10 Boxes window open, select printer icon.
11 Calibration report open in print preview window.

12 Select print icon
Print window will appear, select OK.
12
13 Calibrations report will be printed.

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13.2 User calibration report:

The calibration report shows deviation to the temperature standard (ref.
Figure 8
Value) before calibration. All values will be adjusted to the standard
value after calibration, the Ref. You will see in end of report.
All deviation will reflect to the standard temperature, if the temperature is
below the standard value the measurement will get a “-“ on the
temperature, see figure no. 8.
If the temperature is above the standard temperature the deviation will be
positive, see figure no. 9.
If you get the N.C the sensor have failed, the deviation is more in 0.5
degree and unstable in 5 minutes, try again.
Factory calibration:
Normally you need to send the temperature (TM9616) module to Ellab,
for adjustment. This adjustment will only verify the electronic input to
from sensor to boxes according to calibration standard: ITS-90, only
user calibration will if you have problem whit the sensors, see more
information about the factory calibration below:
Figur 9
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14 Data record / Logging

This feature gives possibility to log temperature data over time whiteout any runs sheet
and preparations, if you need to see temperature data in the system online.
14.1 Data logging procedure
Step Action
Start the PyroMon Program, unmark database mode.
1 Typing login name and password.
Note: Make sure that the login name used is allowed to perform a measurement.
2 Activate the logging program by clicking the icon located on Toolbar.

3 Stop the logging program by clicking the icon located on Toolbar.
The file will be save as date and time and will store in folder Logs below PyroMon
4
folder.
14.2 Load record graph according to data logging.
Step Action
Select Monitor\Plot\Log … the Open file window will appear.
2 Mark file and select Open.

Plots Items will open.
3
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Step Action
Select and pick the channels you need to view.
Select OK, and graph will appear.
5
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14.3 Define Log Settings

This chapter explains setup of data logging see procedure below.
Step Action
Click Database\Edit\Settings … at the Main Bar. The Edit Settings dialog box
1 appears.
Click on the tab Logs. (See Figure 10).
Figure 10
Log Rate: Fill in data (Minimum 60 seconds – Maximum 3600 seconds between
3
each data points).
4 Maximal Log file size: Fill in data (Maximum log file size 10000 kb).
5 Maximal Log period: (Maximum 10000 minutes).
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15 Methods
This PyroMon™ system is designed to handle every possible pharmacopoeia existing
today. Further on the system gives the possibility to program user defined
Pharmacopoeia to suit special requirements. Since there are many possible
combinations in the Method Definitions we recommend the users to start "learning"
from the Pharmacopoeia already in the system, and from they’re on own programming.
We have also tried to give more information to due a setup in the chapter below.
15.1 New Method

This section gives possibility to user-define a new method (Pharmacopoeia). We
recommend that the user define and write down exactly the limitations wanted to make
for each method before starting programming. Follow the procedure below step by step.
15.2 Background to setup methods

Since there are many possible combinations in the Method definition, we recommend
the user to start "Learning" from the Pharmacopoeia already in the system (EP-IV, JP-
XIV, KP-VII, MRBP and USP-29NF24), and read the pharmacopoeia. The system is
capable of operating on any given Pharmacopoeia platform. This flexibility in the
system requires special skills from the operator deciding to program own
Pharmacopoeia. We use abbreviations that the user might not be familiar with. Please
read "Abbreviations".
It is highly recommended that only the person in charge of the PyroMon system must
operate this function. Under the tab General the users basically decide if it is a training
method (sham) or a real method. Then decide when or if a retraining is necessary and
the different quarantine periods. Under the tab Phases the user defines exactly which
data points the system must record and the pre-test, injection and main-test duration
time. Under the tab Btemp (Base temperature) the user defines individual criteria for
sample rate and definition, range and deviation of TB followed by group criteria for
temperatures and weights deviation and definition of the TR (response calculation).
Under the tab Criteria the user defines the repeat test conditions. Normally either total
temperature increases or overshoots level count. (See section 15.2.3). Under the tab
Remarks the user can add relevant comments.
General the PyroMon system record a data point every 5 minutes. Depending of the
Pharmacopoeia it will chose and defines a correct, “Control temperature” (TB) (base
temperature). Example: In the USB Pharmacopoeia the TB can either be an average of
the two data points “-30” and “0” or equal to the data point “0” (T2=TB). The system
will always have a data point lying in the interval 25-30 minutes before the data point
“0” -Entering F2 - fulfilling the USP Pharmacopoeia demand “to use the control
temperature taken not more than 30 minutes prior to injection”.
On image below we have try to show how the functions real works, according to Real
time and Test time, when injection start the system will setup “0” on time axis, and data
point before this step will be (-), when user selected stop the next point will be “5” on
time axis, below user can see example on how the system works, if more detail
information needed also look in too Enclosure no. 1.
In Injection time the system will not store any data points.
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System will always calculate the Respons time when the test is ended, and system will
automatic “remove” unused animals from the test.
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15.2.1 Create New Method
Step Action
Click Database\Edit\Methods … the Methods [x] dialog box appears.
Select new methods will appear .

A: Input data in Method Name this field have a max at 10 digits.
B: If the test is sham test you need to mark the test . The Sham is
training method for the rabbit; normally you need to trainings the rabbit before real
used.
If you unmark the sham you are able to fill out Normal-only / Sham + Normal.
If you mark the sham you are able to fill out Sham-only / Sham + Normal.
C: If no Re-Shamming is needed type in 999 in this field
Select the Phases when all information is filled out.

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Step Action
Phases window appear.
A: Input data in field you need methods to evaluate. Input

number and a comma, the methods will evaluate only on the time points number
and is able to calculate on this input, this field has a max at 251 digits,. Pre Test
points are defined as negative numbers. You can use any interval down to 5
minutes interval, but note at the standard report only shows up to 200 data points.
B: Input data in Pre test duration field, this field is time before injection the
rabbits and this field have min at 30 and a max at 180 minutes.
C: Input data in Injection duration field, this field is the time you have to inject
the animals; the input is the time pr. Animals. This field have minimum at 1 minute
and a maximum at 60 minutes.
D: Input data in Main Test duration, this field is the time rabbit main time. This
field have minimum at 90 and a maximum at 355 minutes (the standard report
shows data up to 200 points).
4 E: Input data in Injection field, this field will setup a max for injection volume.
In preparations mode you are able to setup the injection volume, but if you have
max volume on the method, you will not be able to perform this setup, max input
in this field is 9999 mL/kg.
Select BTemp when all information is filled out.

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Step Action
The B Temp window will appear.
A: Input data in Individual Criteria this evaluate on the base temperature.
The base temperature is a calculation on the Pre-test temperature.
T1 = measured past temperature, exsample if you have pre-test on 30 minutes T1
temperature is the temperature at -30 minutes.
T2 = measured current temperature, example if you pre-test on 30 minutes T2
temperature is the temperature at 0 minutes or the start temperature.
Abs(T1-T2) = Absolute temperature, this values will always be positive, this
demand is not USP or ph.EUR demand.
Base temperature = (T1 + T2)/2
B. Input data in Group Criteria

This will evaluate if you have more in two temperatures on TBmax – TBmin, if not
this two value will be TBmax and TBmin.
TBmax = Highest calculated TB in a group
TBmin = Lowest calculated TB in a group
C: Response Calculation
What response calculation you wise to used, if you not have select Pre-test this will
5 have influence on this calculation.
Example on influence on the calculation, if you have select TR = Tmax – TB and
TB = T2 and the calculation is whiteout pre-test you are able to TB there is large
end Tmax and the Response calculation will therefore be 0,00.
D: Equations
This field is used if you need more help to understand this field.
Select Criteria in the flag.

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Step Action
Criteria window will appear.
IR Fail Level
Individual Response Fail Level. An animal with response higher than the "IR Fail
Level" obtains a Fail verdict. This verdict does not affect the verdict for the whole
group.
PE Fail Level
Permanent Exclusion Fail Level. An animal with response higher than the "PE Fail
Level" is permanently excluded by means of deactivation.
Overshoot Level
Response Overshoot level (Individual). An animal with response higher than the
"Over shoot Level" contributes to the so-called "Overshoot Count".
Animals Per Test
To added group criteria, start to defined group in Animals Per Test 1 to 128 (max
system) animals.
6 SR Pass
Summed response Pass Level. A group of animals in a test with their responses
summed up and found below Pass Level.
SR Fail
Summed response Fail Level. A group of animals in a test with their responses
summed up and found higher than Fail Level.
OC Pass
Overshoot Count Pass Number. A group of animals not exceeding the predefined
count level in the method.
OC Fail
Overshoot Count Fail Number. A group of animals exceeding the predefined count
level in the method.
Criteria Are Per Test
Each test will be handled as it's own and no data from previous test will be transmitted to a
"Repeat Test".
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Step Action
Use Pre Test = Pre-test values used in the calculation
Uses the data collected in Pre & Main test to calculate Temperature Response, the
max and min value will also calculate on this parameter, if you not have select
Pretest the calculation will not take value according to this values.
Delete button will erase a Test index line.
Select Remarks in the flag.

Click on the Remarks and fill in data max 150 digit.
Select OK
8 Methods window will close, the new methods will be created.

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15.2.2 Copy Method

The system is able to copy defined methods, and used it in new way.
Step Action
Click Database\Edit\Methods ….
The Methods [x] dialog box appears, select the correct methods with
Select the icon and fill in data See figure below. Sham is training method. If
no Re-Shamming is needed type in 999 in the Sham required if animal not tested
for box, if you need more information to fill in data, see new methods procedure.
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Step Action
Click on the tab Phases and fill in data. Fill in field under Formal Evaluation &
Report Times exactly the time points you want the system to calculate responses.
Pre Test points are defined as negative numbers. You can use any interval down
to 5 minutes interval, if you need more information to fill in data, see new
methods procedure.
Note: You are not able to have shorter time phase in the original methods.
Click on the tab B Temp and fill in data. Select the Equations button opens the
About PyroMon dialog box, if you need more information to fill in data, see
new methods procedure.
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Step Action
Click on the tab Criteria fill in data. Wanting Criteria are per test check the
dialog box, wanting to use the pre test measurements in the analyses report
checkmark the Use Pre Test dialog box, if you need more information to fill in
data, see new methods procedure.
Click on the Remarks and fill in data.

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15.2.3 Erase method:

This procedure will describe how you erase the animals.
Step Action
Click Database\Edit\Methods … the Methods [x] dialog box appears.
Select the correct methods you want to erase with
3 When you have select the methods select button

Warning boxes will appear, select OK.
The method will be erase, at the next method will appear, you are not able to erase
5 the pre-defined method the software have from start is not possible to erase, the
method you are not able to erase is yellow.
6 When erase the method select OK, the methods window will closed.
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16 Animal Database
Before starting to run test with the system needs basic information to the PyroMon
Database. Among these information's are Tag Number (Animal ID), Room Number
(Cage), Sex and Weight. If a animal is used for other tests this might be indicated by
adding a number to there “Room Number”. The room number field is not locked and
can be edited after each run. An unused animal’s room number might be called 55U-
A5B3 indicating that it is unused for pyrogen test but has been used five times to
analyses A and three times for analyses B. When used first time remove the “U”. The
Exclude Markers can be used to secure that the rabbit only is used one time as
“unused”. Any special information about the rabbit might be placed under the tab
“Remark” in the “Animal” dialog box. General calling a rabbit for a preparation
(analyses) do NOT mean that a specific rabbit is linked to a specific preparation but to
the method (Pharmacopoeia). It is wisely to call one or two rabbits more than needed
for each different pharmacopoeia meaning that it is possibly to replace a bad animal in
the test. The database remember weight date, weight (last and current), weight change,
arrival date, sham expire date, quarantine expire date, marker(s) (exclude), start date,
stop date, last test date and last verdict. When used a rabbit card in the database might
look like below picture
The database information about the rabbit can be extracted by using the query. When a
rabbit dies or for any reason is wanted out it is possible to inactivate the animal. All
inactivated animals can be printed out in a special list. When animals are created or
shamed it is possibly to print an animal sham and new animal lists.
16.1 Rabbit information:

According to the pharmacopeias you will use rabbit. It is important to have a rectal
thermometer and to know how to use it. The normal rabbit temperature should be 39,45
degree (103 Fahrenheit) to 38,34 degree (101 Fahrenheit).
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16.2 Create animals

To create animals in the database follow the procedure below step by step. You need
test animals to test the injection product.
Step Action
In main menu select Database\Edit\Animals …
The Animals [x] dialog box appears.
Select a new animal will be created .

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Step Action
Fill in data.
TAG Number definition max 8 digit.
Room Number definition max 10 digit.
Active mark / unmark (the room number will disappear).
Weight definition max 4 digit.
Arrival = field definition, this field is automatic.
Sex: on / off male / female
Weight = field definition, this is automatic.
Sham Expiration = field definition, this is automatic.
Quarantine Expiration = field definition, this is automatic.
Select the tab Remarks in data. If more rabbits are needed repeat step 2-3,
Markers and Last Test are fill out automatically later and we information below
test what the field is used to.

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16.3 Erase Animals.
Step Action
In main menu select Database\Edit\Animals …
The Animals [x] dialog box appears.
Used to select the animals you what to erase.
3 Select warning window will appear.

Select OK, the animals will be erase.
5 Select OK, the animals window will close.

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16.4 New Animals Report

It is possible with a special report generator to have a printout of all new and Unused
Animals.
Follow the guide below to obtain this New Animals Report.
Step Action
In menu select Database\Edit\Animals.
The animals’ window will open.
Select Icon. The PyroMon New Animal List appears.

3 Report include Animals Tag, Weight, Arrival date, Sham Exp., Quar Exp., markers
etc.
4 To get a printout, click on the Icon.
5
Select OK, Select
6 Select OK, Animals window will close.
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16.5 Deactivate Animals

16.5.1 Introduction
This procedure has been developed so you can "Remove" not active rabbits in the
database. Please follow the procedure below step by step to deactivate rabbits.
16.5.2 Deactivate
Procedures to perform at deactivate animals.
Step Action
In menu select Database\Edit\Animals .
The Animals dialog box appears.
3 Select on dialog box to deactivate the animals

If you remove the mark the animals will be deactivate, the number will now
4 change to No.-001.
The animal has now been removed from the active list. The number can be
5 reused if wanted. The next time the rabbit with this number is deleted, it will be
with an appendix No: -002 etc.
6 When you are finish, select OK
7 The Animals window will close.

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16.6 Inactivate Animals Report
Step Action
In menu select Database\Inactive Animals.
2 The PyroMon Inactive Animal List appears.
3 To get a printout, click on the Icon.
Select OK
3 Click on the button, the report will close.

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17 Preparations
17.1 Preparation Database
Before the system is able to run a test it needs a Preparation (product) with information
from the PyroMon Database. To create preparations follow the procedure below step by
step.
Step Action
Click Database\Edit\Preparations .
The Preps [x] dialog box appears.
Click the icon and fill in data. (See Figure 11). If one animal needs to be
excluded from being tested with same type of material again, then click on small
arrow in the field Exclude Marker and select the exclude mark wanted. The tabs
Analyses, Tests and Results are automatically filled
out later. If the rabbits are to be injected with fixed volumes ad dose “0”
indicating special injection procedure. Calling the rabbit injection volumes from
the IU128 module will indicate injection volume 0 ml at all the preparation
channels.
Figure 11

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17.2 Edit Run(s)

17.3 Prepare the test
This Chapter will describe how to set-up a Pyrogen tests. From now on we assume the
Network & the PyroMon™ software is running.
Step Action
Click Database\Edit\Runs the Runs [x] dialog box appears. (See Figure 12).
1
Figure 12
Click on the icon.
Figure 13
Go to Schedule section and click on the arrow.

Typing number
Run Status =Automatic filled out
3 Run defined on = Automatic filled out.
Full date = Automatic filled out.
Run defined by = Automatic filled out.
Select the wanted date to perform the Run, and click on this date. Fill in
Remarks.
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Step Action
Click the tab Tests.
Figure 14
Click the button.

The Test dialog box appears
Fill in data. If the Animals are one only one rabbit is added, if the number is 6, a
group of six animals are added. The called “Operator” is responsible for the
analyses and only the operators PIN code can activate the F1, F2 and F3
5
functions on the IU128 module. If a test must be repeated to have verdict pass the
checkmark in the List unused preps only box must be deleted. Doing this the
Test Index automatically changes to current number plus 1.
Figure 15
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Step Action
When everything is as wanted click the Ok button to save the changes. The
6 system now gives automatically the required and free number of animals for this
test.
7 If more than one test then repeat from step 5 to 7.
Click the tab Animals (See Figure 16). This window shows overview of the
analyses sequence. Count the number of needed animals for each pharmacopoeia
chosen under the tab Tests and ad one or two more giving possibility for
exchanging bad rabbits.
Figure 16
When finished click the Ok button. The Runs dialog box closes.
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17.4 Animal Weight

Before running a test with the system it needs a valid rabbit weight to the PyroMon™
Database. If the operator has printed a Weight scheme, then use it to insert the rabbit's
valid weight in the following scenario, the system will default automatics evaluate
weight according to minimums weight at 1500 gram and weight change according to
25%, you need change see settings. To edit the rabbit weights follow the procedure
below step by step.
Step Action
Before starting a Run the rabbit weights must be updated. For this use the system can
generate a list for a person who is responsible for this area. The list serves the
purpose of two things.
1. Producing a list of animal ID`s to be used for this test and making it easy for
personnel to handle weight data.
2. Producing a list of animal ID`s matched with channel numbers and making it
very easy and safe to place rabbits at right location.
1 A: Select Database\Edit\Runs
B: Runs window will appear, select correct runs with .
C: In menu select animals

D: Select icon.
E: Select icon.
2 F: Select OK.
G: Animals is printout.
Go in to animals’ room, and get the rabbits you need to run according to the setup,
3
and weight the animals, according to the Animals form.
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Click Database\Edit\Weights …
4
The Animal Weights dialog box appears.

Note: Available Runs tell how many run you have weight sheet on.
Click on the small arrow in the Run Data field and select the wanted Date for the Run,
the system will always calculate the weight change, according to the start weight.
Click on the field New Weight and type in updated weight data. Use the down arrow
on the keyboard to select next animal.
Automatic control:
7 The systems automatic tell you if the animals are below 1500 gram, you are not able
to use this rabbit.
The start weight and the run weight will be match if you have more change in 25%
you will not be able to run the animals.
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17.5 Setup demand to weight:

If you need to change setup demand on weight demand (25% and a minimum 1500
gram), follow the procedure below:
Step Action
In PyroMon select Database \ Edit \ settings
Edit setting window will appear, select Animals, and change setup, minimal need to large
in 1000 gram before setup will take effect.
A: If you unmark Enforce maximal weight change you will not have any change on that.
B: If you unmark Enforce minimal weight requirement, you will have control at the weight
not is small in 1000 gram.
When you perform all change select OK.

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18 Runsheet
18.1 Abbreviation below a RUN in GUI:
Abbreviation Explanation
T(C) Measured temperature online.
Tb ( C ) Base temperature
Stat Stated for animals or preparation.
A Available rabbit or preparation.
I Rabbit wait for injection.
M Measurement temperature (main test is
started).
S Selected rabbit or preparation.
E Reconnected sensor
D Deleted test / rabbit
S.P Slipping probe
F Test is ended (finish).
D (ml) Dose in mille liter
S Sham
N No
Y Yes
18.2 Abbreviation in Network GUI:

N.A Not Available
O.K Pass criteria
N.C Not calibrated.
18.3 Abbreviation in report:

N.A Not Available
O.K Pass criteria
Failed Criteria are out specification.
18.4 Starting a Run

Now it’s time for starting the test. Remember that this system is working very strict
according to the different pharmacopoeia. So there might come some error messages the
first times the pharmacopoeia is used. To start the system follows the procedure below
step by step.
Step Action
Setup the animals according to the printout (Weight scheme) for this day's test and
1
insert the probes as the list shows.
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Start the Network. Make sure that all the boxes are connected and operate in good
2
order.
Start the PyroMon program.
3
Remember to complete edit weight procedure before next step. (See section 0).
4 Click on the Tool bar Icon with the red arrow .
Run window will appear, select the run you wish to start.
The run will start the network window will be minimized. A new run window will
5
appear.
6
Select animals , animals window will appear:
Figure 17
Note: Wanting to see all the information, click on the [+] in Animals, tests &
available.
7 If you need graph mode see View Temperature Graph On Line.
8 If you have slipping probe see more information in chapter.

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18.5 Inject Group(s)

18.5.1 Introduction
This procedure has been developed for making selection, start and stop functions on
UI128 Monitor as easy as possible. Follow the procedure below step by step.
Step Action
When Pre-test time has Ended an “i” appears in run windows stat field below
animals.
Go to animal room, and get ready to Inject.

2 Prepare syringes for the preparation.
3 On the UI128 Monitor Press Enter.
Select the test you want to perform (Use up and down arrow to scroll test list).
4
Note: Is you sham you normally will only have one preparation.
5 When arrow points on right test Press Enter on the UI128.
6
Press
Type in PinCode with number on the UI128 module and press to start
the injection period.
Read the channel number & dose. Inject according to the information on the UI128
7 display.
Note: (Volume “0” ml indicating a special dry sham test).
When finished with injection, Press F2 followed by your Pin Code and Enter to
8
end the injection period.
9 Repeat from step 4 to 8 until all tests are started.
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18.5.2 Display setup on UI128

The UI128 display give to possibility to setup rabbit number or channel number and test
number or preparation name, this setup will not have any effect on Run, only the
showing, below we have give a procedure to change display to your demand.
Step Action
If user display not show you the information below, select menu.
This is standard setup.

Rabbit No = Rabbit number will be showing in to UI128 display, see display
below.
Test No. = Test number will be showing in to display in run mode, see UI128
display below.
2
Used arrow on UI128.
3
Select on UI128 to mark or unmark the Rabbit no. or test no.
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Unmark rabbit no. see UI128 display.
4
The UI128, display will show runs as:
Unmark Test No. you will see UI128 display as:
5 The UI128, display will show rabbit as:

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18.6 Slipping Probe Alarm

18.6.1 Run Error
A: If during test a probe slips out of an animal then the system will detect the error and
respond by sending an error message to all UI128 Monitors, Alarm (Optional) and
Computer. The UI128 Monitor display will flash with slipping probe alarm information
of channel and animal number.
B: If an alarm is installed a relay contact will either break or connect a signal. The
operator must correct the error immediately. If action is not taken the rabbit will be will
be aborted from the test after 30 minutes.
C: Always remember to press on the UI128 monitor when the error is

corrected. If you forget then you might loose the test.
The slipping probe alarm will be activate if the temperature is drop, default value on this
criteria is –0,4 degree pr. Minute (setup range –10 to 10 degree pr. Minute) and if the
temperature level is below 36 degree (setup range is 0 to 50 degree).
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18.7 View Temperature Graph On Line

18.7.1 Graph
It is possible to display temperature graphs. Follow the procedure below step by step.
Step Action
Double click on the temperature module from wish graphical readings are wanted. See
Figure 18.
Figure 18
Select the wanted channels using the arrows. The screens can maximum display
128 channels simultaneously (max setup).
Select OK, when all sensor is pick.

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The group of animals will now be presented graphically.
If you need to change setup right click on graph setup will show
Select Settings, chart setting will appear, make change and Select OK.
Chart Settings can also be changed by double clicking the graphical area.
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Step Action
Re-Size the graphical area by placing the mouse pointer to one of the edges.
Hold down the mouse left button while dragging the boarder to fit the wanted
5
size.
6 Click Apply to see the changes. Close the window by clicking Ok.
Close the graph by clicking the Cross (×) in the right upper corner of the graphical
7 area.
Note
If the user make an error in the typing then press once on the Menu button on the
UI128 module. This action will bring you back to test selection.
18.7.2 Multi User

It is possible for more than one user to use each UI 128 Monitor. Example: First test is
selected and started by operator no.1. Operator no.2 would like to inject next
preparation group. Operator no.2 presses Menu button on UI128 Monitor. The content
of the display changes to test selection. Operator no.2 can now select the wanted test on
normal terms. Operator no.1 can anytime go back to the first test by follow the same
procedure as operator no.2 and finish the injection.
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18.8 Delete a rabbit in a test

The PyroMon™ system gives possibility to delete a rabbit in both Pre Test & Main Test
modes, you need to use UI128 module, you are not able to due this perform on the PC,
normally you need this in the animals room, below we have setup the setup periods you
always will perform, you also need to have the animals sham before real test is able to
perform.
Pre Test Injection Period Main Test
Follow the procedure below step by step.
18.8.1 Delete (Animals in Pre-test & main test)
Step Action
Below main / pre-test go to a UI128 Monitor.
Press the button on the UI module. A menu with four options pops up, on the
number lock pad select a number.
1) Delete a rabbit in pre-test period "DELETE RABBIT"

2) Delete a rabbit in main test period "DELETE RABBIT/ID"
3) Delete a preparation (group of rabbit)
4) Quit delete screen.
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Delete of rabbit in Pre-test:

The PyroMon software is started and you have rabbit you need to delete from the
test.
A: If the rabbit is in Pre Test. Press 1 on the UI128 Monitor, number lock.
B. A text Delete will pop on the screen.
C: Press the button repeatedly until the text Delete is positioned under the rabbit
wanted to be deleted. If more than tree rabbits are on test then use buttons in
combination with button.
D: Press followed by the PIN code on number lock on UI boxes and
confirm by entering .
E: The rabbit is now deleted in the test.

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Delete a rabbit in Main-test:

The PyroMon software has select rabbits in to the group, and you need to delete a rabbit,
in a group.
A: If the rabbit is in Main Test. Press 2 on the UI128 Monitor number lock, to
delete a rabbit.
B: Select the preparation including the rabbit to be deleted from using the buttons and
press .
C: Press the button repeatedly until the text Delete is positioned under the rabbit
wanted to be deleted. If more than tree rabbits are on test then use buttons in
combination with button.
E: Press followed by the PIN code on number lock on the UI128, and
confirm by pres .
The rabbit is now deleted in the test.

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18.9 Select a Replacement Rabbit (if any free)

The PyroMon™ system can continue a test if a rabbit has been if the rabbit is not able to
perform this test; but the following criteria's must be fulfilled.
• There must be free extra rabbits running together with the normal test(s)
• The rabbit(s) must be selected to the same Pharmacopoeia
• The rabbit(s) must have a valid base temperature (i)
18.9.1 The Procedure to replace a animals.
Step Action
Go to a UI128 Monitor
2 The display will contain all test(s) available.
3
Select using the buttons, the test wanted to be continued using another
rabbit.
4
Press on the UI128 module.
There will now be allocated a new rabbit to the test (See theUI128 Monitor
5
display). The group size is now increased to 4 rabbits. Use buttons to view
all rabbits. The other rabbits in the group will be zeroed in inject value for the
users convenience.
Prepare the syringe with solution to inject, if you needed dry test due not need
6
injection, only rabbit setup.
7
Press the button to start injection period, on UI128 module.
Adjust the amount of solution to be injected according to the information in the
8
UI128 Monitor display.
9
Press the button to end the injection period, on UI128 module.
Note: The test for this rabbit is prolonged to comply with the pharmacopoeia.
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18.10 Delete a Preparation/Test

18.10.1 Introduction
If a Preparation/Test must be deleted during the test for any reason, it is possible to
remove Preparation from system while other test(s) is running. Follow the procedure
below step by step.
18.10.2 Delete
Step Action
Go to a UI128 Monitor.
2
Press the button on the UI128 module.
Press 3 to delete a Preparation/Test, on the number lock on UI128 module.
4
Select the Preparation/Test and pick test you wanted to be deleted using the
buttons.
5
Press
Enter your PIN code on number on UI128 module, and press
7 The Preparation/Test is now deleted.

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18.11 View main test temperature Graph On-Line

18.11.1 Graph
It is possible to display temperature graphs on some or all the test while they are
running. Follow the procedure below step by step.
Step Action
Double click In the RUN window on preparation ID wanted to be displayed in
graphical form (Figure 19).
Figure 19
Select the group of animals using the double arrow (>>). This will move all
animals from left bank to right (Figure 20), you are able to have graph to max
system.
Figure 20
3 Click the Ok button.
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Step Action
The group of animals appears graphically (Figure 21).
Figure 21
Re-Size the graphical area by placing the mouse pointer to one of the edges. Hold
5
down the mouse left button while dragging the boarder to fit the wanted size.
Double clicking in the graphical area can change chart Settings. There is a
selection of Auto Scale or Fixed scale. Changes can be done in Range. Clicking
Apply visualize the changes. After the changes have been made click OK
button.
7 Close the graph by clicking Cross (x) in the right upper corner of graphical area.
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18.12 Run Completed

18.12.1 End of test, result / graph printout
When test cycle has ended, the system will inform the user in two ways that the entire
test's has been successfully completed. Follow the procedure below step by step.
Step Action
When all tests are finished the message “Run Completed” will flash on all UI128
Monitor displays.
On the computer the Message window will flash and pop up informing that the
2
Run has been saved.
To get the to days analyses report, select database in menu and pick Daily Results
Runs window will appear, Mark the runsheet you need to printout or view, and
select OK, Pyromon test result report will appear.
5 Select icon if you need to printout.

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To printout the Analysis report and graph, select Monitor\Plot\ Test
Preps window will appear.
In menu select Analyses

8
9 Select icon, PyroMon Analysis results report will appear.
10 Select icon and select OK to print the report.
11
In menu select
12 Select OK, plot Items will appear.
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Select with the temperature sensor (animals) you will see.
13
Select OK, when you select all sensor (animals), graph will appear.
14 Select and ok if you need printout.

Shut Down the program by clicking File\Exit in menu.
15
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18.13 Test List

PyroMon system support Test list for this use the system can generate a list for
personnel who are responsible for this area.
18.13.1 Test List Procedure
Step Action
Click on Database\Edit\Runs at the Main Bar. The Run [x] dialog
1 box appears.
2 Select the right Run Date.
3 Click your left mouse button on Tab Test.
4 Click on Print Icon . A PyroMon Run Tests Overview list

appears.
When graphical image is on screen then click on Print Icon again to

5
get a hard copy from your printer.
18.14 Sham Animals List

Working with the European pharmacopoeia it is needed to Re-Sham the rabbits that
have been more than 14 days without performing tests. For this use the PyroMon system
can generate a list of these specific animals so they can be trained without loss of time if
they were forgotten.
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18.14.1 Sham Animals List Procedure
Step Action
Click on Database\Sham Animals at the Main Bar. A PyroMon Sham Animals
1 List list appears.
When graphical image is on screen then click on Print Icon again to get a hard
2
copy from your printer.
18.15 Results Handling

One of the very powerful features in the PyroMon™ system is the report generator.
There are two ways to obtain a report from a Preparation.
1. Looking for one specific Preparation.
2. Daily Results Printout from all the tests done in one day.
18.15.1 Search in Preparation Procedure
Step Action
Click on Database\Edit\Preparations at the Main Bar. The Preps [x] dialog
1 box appears.
2 Click on search icon . The Find PrepNUM dialog box appears.
3 Type name / number of Preparation and click on Ok button.
4 Click on the tab Analyses.
5 Select the wanted analyse be clicking on it.
6 Click on tab Tests.
7 Click on Print Icon . A PyroMon Analysis Results list appears.

8
9 The Print dialog box appears. Choose and options and click Ok.
10 Click Close.
11 Click on tab Results.
12 Click on Print Icon . A PyroMon Test Results list appears.

13
15 Click Close and Click Ok.
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18.15.2 Daily Results Procedure
Step Action
Click on Database\Daily Results at the Main Bar. The Daily Result
1 Report dialog box appears.
Double click on date of the run wanted to be printed out. A PyroMon
2 Test Results list appears. The list reports all test results performed
this day.
When graphical image is on screen then click on Print Icon again to

3
get a hard copy from your printer.
5 Click Close.
6 Repeat step 1- 5 until all wanted reports are printed out.
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19 Repeat Preparations / failed result (high temperature)

This procedure has been developed for enabling the user to perform a repeat test
according to the defined demand in the test Follow the procedure below step by step.
19.1.1 Repeat Test
Step Action
Select Database\Edit\Runs
Runs window will appear, define a new Run or select an already existing Run in the
PyroMon™ software.
2 Select tab Tests and click with your left mouse button on it.
Select Add button (below in screen) and click with the left
mouse button on it, Test window will appear.
3
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Click with the left button mouse on the “List unused preps only”. (The check
4
mark will disappear) .
5 Click with the left mouse button on the arrow in the field “Preparation Number”.
Select the Preparation number you wanted to be performed repeat test on, in
6
Preparation number field.
7 Click with the left mouse button on arrow in “Method” field.
Select the Method. The "Test Index" field automatically has been filled out with
8
the number 2, and Animals fields are updated with 5 Rabbits.
Select the same Test Number as original test and add –1 to the number. The user
9 can add any number, but by doing it this way it is easier to track later in the
database.
10 Select Operator.
11 Press Ok button with the left mouse button.
12 The Run form will now be updated with the information.
13 Proceed with other test(s) as normal.

19.1.2 Result form
The repeat results will be shown on the standard result formula. However the previous
test will be included as well. This gives the operator a very easy and safe
documentation. The validation and interpretation of the result will be given
automatically.
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20 Simulation
20.1.1 Introduction
This chapter familiarises the user with the special function in performing simulation
from e.g. ph.EUR IV ⇒ USP 29 NF24. This function can save the user a lot of time as
it gives him a valid result based on an already performed test. Keep in mind that the
user can only perform this function if correct amount of data is present in the original
test. It will not be possible to simulate an USP 29NF24 ⇒ ph.EUR IV as pre-test is too
short (30 minutes).
20.1.2 Simulated test
This chapter is a procedure for simulate a previous test done with an other
Pharmacopoeia
20.1.3 Simulated test procedure
Step Action
Click Database\Edit\Preparations at the Main Bar. The Preps [x] dialog box appears.
(See Figure 22).
Figure 22
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Step Action
Click the tab Analyses and point mouse pointer on test wanted to be performed
simulated test on. Click once with the left mouse button to mark it. (See Figure
23).
Figure 23
Click Simulate Analyses. The LookUp dialog box appears. (See Figure 24).
Figure 24
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Step Action
Double click on method wanted for simulation test. A new line appears with Yes in the
Sim field
5 Click on the tab Tests.

6 Click on the Print Icon . A PyroMon Analysis Results list appears.
7
copy from the printer.
9 Click Close.
10 Click on the tab Results.
11 Click on the Print Icon . A PyroMon Test Results list appears.
12
14 Click Close.
16 Mark the simulated test line by clicking the left column.
17 Click Delete Simulation.
18 Click Ok.
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20.2 Graphical view

Wanting to see the results in a graph layout follow the below procedure step by step.
20.2.1 Graphical view procedure
Step Action
Click Monitor\Network at the Main Bar. The Network [com1] dialog box appears.
1 Double click on temperature module where the probes for this application are mounted.
Select the channels by double clicking each channel or clicking on the double
2 arrow (>>). This will move all channels (max 10) from the left bank box to the
right box.
3 Click Ok button. The Graph dialog box appears.
Re-Size graphical area by placing the mouse pointer to one of the edges. Hold
5
down the left mouse button, while dragging the boarder to fit the wanted size.
Double clicking in graphical area can change chart Settings. There is a selection
6 of Auto Scale or Fixed scale. Changes can be done in Range. Clicking Apply
will show the changes. After changes have been made click Ok button.
7 Close graph by clicking Cross (x) in right upper corner of graphical area.
20.3 Print Log Graph
Wanting to have a graphical hard copy of the log file, then follow the below procedure
step by step.
20.3.1 Hard Copy procedure
Step Action
Click on Monitor\Plot\Log … at the Main Bar. The Open File dialog box
1
appears.
2 Double click on the wanted Log file. The Plot Items dialog box appears.
3 Select the wanted channels by using the arrows.
4 Click Ok. The Plot dialog box appears.

5 Click File\Print.. at the Main Bar. The Print dialog box appears.
6 Accept the printer and print the graph.
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21 Export functions
This chapter familiarises the user with possibility to Export anything from one
Preparation / Test to all data in the PyroMon™ database i.e. Preparation data, animal
data etc. to any format the user might wish. Use the data for documentation,
Presentation etc. in Excel, Lotus or just send them by e-mail etc. This guide has been
developed for helping you to export one specific Preparation / test.
21.1 Export Excel
This procedure has been split-up into tree sections in order to make it as easy as
possible to perform this operation.
1. Export procedure
2. Read procedure
21.1.1 Export Excel procedure
Step Action
Click on Database\Edit\Preparations … at the Main Bar. The Preps dialog box
1
appears.
2 Click the icon.
3 Type name / number of Preparation and click on the Ok button.
5 Select the wanted analyses by clicking on the left column of the identification line.
Click on the tab Results. The Tests tab means a short form report the tab Results a
6
full detailed report.
7 Click the print icon.
8 When graphical picture is on screen then click on the "Suitcase" icon.
Select etc. the as CSV (Comma separated values) in Format: Select "Disk file" in
9
Destination.
10 Click Ok.
Click on “Same number format as in report” Must be a üin the þ
11
Click on “Same date format as in report” Must be a üin the þ
12 Click Ok. The Choose Export File dialog box appears.
13 Double Click on the folder Exports.
14 Type a name / number in "Filename" field.
15 Click Ok to execute Export.
16 Click Close.
17 Open the exported file with Excel, Lotus etc.
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21.2 Read procedure
Step Action
1 Open Excel and find the file in its location. PyroMon\Exports
Import file and start working on it. Finalize the modification. Graphs
2
bars etc.
21.3 Export Prep Word

21.3.1 Export Prep Word procedure
This procedure has been developed for enabling the user to export the results to
Microsoft Word. Follow the below procedure step by step.
Step Action
Click Database\Edit\Preparations … at the Main Bar. The Preps
1
dialog box appears.
2 Click the icon. The FindPREP dialog box appears.
3 Type name / number of Preparation and click on Ok button.

Select the wanted analyses by clicking on the left column of the
5
identification line.
Click on the tab Results. The Tests tab means a short form report
6
the tab Results a full detailed report.
7 Click on the print icon.
When graphical picture is on screen then click on "Suitcase" icon.
8
The Export dialog box appears.
9 Select Format: “Rich Text Format” and Destination: “Disk file”.
10 Click Ok. The Choose Export File dialog box appears.
11 Double Click on the folder Exports.
12 Type a name / number in "Filename" field.
13 Click Ok to execute Export.
14 Click Close.
15 Open the exported file with Word etc.
16 Change the page format to Landscape and A4
17 The document is now ready to E-mail, printing etc.

Edition 3.00
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21.4 Special report / data setup

The query function is a strong tool to create special reports, if you print you will only
get what you can have on one page, so we will adavice you to open in excel
Query procedure
Step Action
Click Database\Report\ Query\Standard. The Query Definition dialog box
appears.
Using the arrows select etc.: AnimalTag, BoxName, CalDate, ProductID,

2
RefTemp and OffsetTemp. The boxes reflect the input.
3 Click Ok. The Query [Export] dialog box appears.
Save the file with a proper name using the File\save.. option. The file is saved in
4
txt.
Close the Query [Export] dialog window. The Query [Export] dialog box
5
closes.
Close the PyroMon software by clicking File\Exit. The PyroMon program
6
closes.
Open the saved file with MS Excel and create the wanted report.
View in from Excel version 2000
Note: If you have setup the data view to see every 5 minuts, you will see one values
afther main test (Example if ended at = 90 you will see one values in 95), this values
will not be used in calculation but the system need this value to closed the run.
Edition 3.00
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22 Technical specifications
22.1.1 Network
The PyroMon™ network is of ArcNet type (Token Ring).
IF9600
Network Interface between computer and Network.
Power consumption: 90mA (24VDC)
Network port: 1
Com Ports: 2
Protection: IP 54
Dimensions (WxHxD): 230 x 190 x 60 mm
Weight: 2.5 Kg
Order Code:
22.1.2 TM9616
Network 16 channels Temperature Module
Network port: 1
Com Ports: 1
Protection: IP 54
Measurement Range: -100°C to +400°C
Measurement Accuracy: ±0.025°C / ±0.05°F
Resolution: 0.01°C / 0.02°F
Weight: 2.7 Kg
Order Code:
22.1.3 UI128
Network User Interface
Network port: 1
Com Ports: 0
Protection: IP 54
Weight: 2.5 Kg
Order Code:
22.1.4 PA9600
Network Power Adapter
Max Load: 3.0A (9-36VDC)
Protection: IP 54
Order Code:
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22.1.5 PS24V
Network Power supply
Input: 100-240VAC
Output: 24VDC
Max Load: 1.5A / 45Watt
Note 1: Indoors use only
Note 2: Only for use with the PyroMon
system
Order Code:
22.1.6 Coax cables
Cable type RG62 fitted with two screws on stainless steel adapters
Order Codes: 1 Meter: 26330034
2 Meter: 26330031
5 Meter: 26330037
10 Meter: 26330030
22.1.7 Probes
Pyrogen probe: Standard 2.75 meter long fitted
with Ellab type “A” Plug
Order Code: 26110004
22.1.8 AL9600 (switch need connection to a bell or light)
Alarm Module to be used together with the IF 9600 (Com 2)
Order Code: 26320005
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23 Alarm connection.
AL9600 switch
Connection possibilities
23.1 Alarm connection example:

Edition 3.00
Page 116 of 122
PC
IF9600 TM9616 UI128
AL9600
Connection setup DC Bell
Battery (9 volt)
The bell will make some sound if you have a slipping probe.
24 Maintenance
Part Action
The PyroMon™ Network modules can be cleaned with a damp cloth
Cleaning containing a mixture of water and soap.
Do not attempt to service this product yourself, as opening or

Service removing covers will destroy the product and you will loose the
warranty as well.
Ellab A/S recommends sending this equipment to Ellab A/S or local
Calibration
dealer for annual calibration.
Edition 3.00
Page 117 of 122
25 Pyromon software Error Codes
No. Error message in PyroMon software Action
Error below run.
1 Need to calibrate sensor.
Weight errors.
The rabbit has not the correct weight
to according to any pharmacopeia’s,
2
control the weight of the rabbit, or
the input in the weight sheet.
Weight errors.
The weights increase to large to be

3 normally, control the input in
database.
4 You have input more in 5 digits in

this field below methods.
You have input a negative number in

5
a field there need positive number.
6 You have failed in Overshoot field

below methods, change values to
new one 0.05 to 10.
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You have failed in PE field below

7 methods, change values to new one
0.05 to 10.
8
You have input more in 102 in test
index, below methods.
You have more in 128 in field

Animals per test, below methods.
The software has no response from

hardware.
9 • Control power
• Control RS232 cable
You have failed in IR failed below

10 methods, change value to a new
between 0.05 to 10.
User has performed runs, and you

11
are not able to erase user.
12 If test setup have used more rabbit

(animals) in attach, be sure at the
“Not enough animal for test”
animals is correct sham according
too test methods pharmacopoeia.
Edition 3.00
Page 119 of 122
26 Troubleshooting
No. Problem Action
1 Error below calibration.
User interface IU128 information
If the PIN code is wrong, Press F4 again types
below a calibration run: Invalid ID
the new PINCOD.
The system has unstable readings
or the user has entered a wrong PIN
code. If the system is unstable wait another 5 minutes
and try pressing F4 again.
2 Control at you windows time due not update

Measurement / run problem. below a run. Disconnected the online update
and run again.
3 If you are not able to injection the
animals on the UI128, even the
system have the stat i = injection
signal, you have disconnect
terminator. Control all the terminators, and stop the
session. Restart the session.
4 If you not see all module in the Arc

You need to change node ID.
Net (Token Ring).
5 If you have change the node ID,
Contact Ellab service department.
and you not able to see all module.
Edition 3.00
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27 Spare Parts:
Type designation Description Ordering code
PRG6200A275NL Rectal temperature, rabbits 26110004

PRA22350A275TS Rectal temperature, mice 26110002
and rats.
PRR04004A275SN Rectal temperature rats 26110006
PRF03080A275TS Rectal temperature, mice. 26110009
Edition 3.00
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28 Enclosure no. 1:
Edition 3.00
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29 Changelog
Edition Section Change Author
01 All New version 2.9.3 DE
02 10.5 Added: General reports setup. DE
10.6 Added: Animals general setup.
10.7 Added: Ellab recommendation for setup of
report precision and temperature resolution.
15.2.1 Added: Max main 355 minutes
15.2.1 Added: Max data points in standard report 200.
18.1 Added: Abbreviation below a RUN in GUI:
18.2 Added: Abbreviation in Network GUI:
18.3 Added: Abbreviation in report:
25 Added: “Not enough animal for test”
03 15.2 More information about how system is work. DE
28 Enclosure no. 1 (Pre-Test, Injection period,
Main-Test).

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PyroMon™ Manual

IF9600 (comminication module)

Version 3.00 Juni 2009

Trollesmindealle 25, DK-3400 Hilleroed, Denmark.

3.1 The Program ................................................................................................................9

4.1 Content ......................................................................................................................11

6 Install the hardware........................................................................................................16

6.1.1 Introduction ........................................................................................................16

7.1 System requirements..................................................................................................21

9 Software (configuration of system)...............................................................................25

9.1 Setup Boxes Node ID (setup Arc-network / rename boxes) .........................................25

10.1 Starting the system.................................................................................................28

11.1 Software access Matrix...........................................................................................39

12.1 Audit trail Event / database trail: .............................................................................48

13.1 User calibration test procedure: ..............................................................................51

14.1 Data logging procedure ..........................................................................................54

15.1 New Method ...........................................................................................................57

16.1 Rabbit information: .................................................................................................68

17.1 Preparation Database.............................................................................................75

18.1 Abbreviation below a RUN in GUI:..........................................................................82

19.1.1 Repeat Test .....................................................................................................104

20.1.1 Introduction ......................................................................................................106

21.1 Export Excel .........................................................................................................110

22.1.1 Network ...........................................................................................................113

22.1.3 UI128 ...............................................................................................................113

23.1 Alarm connection example:...................................................................................115

25 Pyromon software Error Codes .............................................................................117

27 Spare Parts: ............................................................................................................120

28 Enclosure no. 1:......................................................................................................121

DO NOT use the equipment if it appears damaged or operates abnormally.

The equipment is intended for indoor use only.

1.3 Electrical Hazards

DO NOT operates this equipment in an excessively wet, oily, dusty, or dirty

Authorized Service Centers

Ellab A/S Phone: +45 4452 0500

Ellab Inc. Phone: +1 303 425 3370

Ellab GmbH Phone: +49 4286 926 620

BNC Special terminator -

BNC Bayonet Neill Concelman -

3.1 The Program

3.2 Setup / Training demand:

Overview by coaxial cable:

This module has tree purposes.

Normally Run mode:

Scroll function between tests.

Selecting Rabbit Number/Channel Number and Test

Serves as an accept function on issues like entry of PIN code, Tests

F1 + password gives a command to start injection period, will

F2 + password gives a command to stop injection period, will

+ Password F4 + password finish calibration of the system; will only be

5 Component Check List

Probes Rectal Probe, Rabbits (2,75 Meters) 26110004

6 Install the hardware

The setup of the system is now complete and ready to run.

Minimum System Requirements

7.2 User administration functions

7.3 Software structure

Software flow sheet

General software system

File Database Run Monitor View Window Help

Database Monitor Windows

File Run View Help

Edit Report Start Plot