Lorrca MaxSis User manual

LORRCA MAXSIS
USER MANUAL
Version 5.04 MRN-231-EN
Master Registration Number: MRN-231-EN


Manufacturer: RR Mechatronics Manufacturing B.V.
Phone: +31 229 291 129
Fax: +31 229 241 534
E-mail: [email protected]
Internet: http://www.rrmechatronics.com
Postal address:
P.O. Box 225
1620 AE Hoorn
The Netherlands
Office address:
De Corantijn 13
1689 AN Zwaag
The Netherlands
© Copyright RR Mechatronics Manufacturing B.V.
All rights reserved.
Subject to changes without prior notice.
Issued by the Support Department of RR Mechatronics


Lorrca Maxsis User Manual Page 3
Version 5.04 MRN-231-EN
Document history overview
MRN-231-EN
Published date Friday, 15 March 2019
Issue No Date Revised
Section(s)
Changes Authorised
5.04 March 2019 Safety
Installation
Operational
instructions
Maintenance
Mains specification
changed
Oxygenscan
procedure changed
Cleaning
instructions
changed
Document History
added as appendix,
only latest changes
in introduction
H. Schavemaker
5.03 January 2019 Installation
Program
Operational
instructions
Introduction of
Oxygenscan option H. Schavemaker
5.02 October 2017 Installation
Program
Introduction
Software version
5.xx
Lorrca 1.01
H. Schavemaker


Contents
Lorrca Maxsis User Manual Page 5
Version 5.04 MRN-231-EN
CONTENTS
1.ABOUT RR MECHATRONICS .................................................................................... 11
2.INTRODUCTION .......................................................................................................... 12
2.1.About this manual .................................................................................................... 12
2.2.Typographical conventions ...................................................................................... 13
2.3.Used symbols .......................................................................................................... 14
3.INSTRUMENT DESCRIPTION ..................................................................................... 15
3.1.Instrument label Lorrca® MaxSis ............................................................................ 16
3.2.Technical specifications ........................................................................................... 17
3.3.Introduction Lorrca® MaxSis ................................................................................... 20
3.3.1.Intended use ................................................................................................. 20
3.3.2.Features of the Lorrca® MaxSis ................................................................... 21
3.3.3.Symbols ........................................................................................................ 22
3.3.4.General measurements description .............................................................. 24
3.3.4.1.Principle of operation Lorrca® MaxSis ..................................................... 24
3.3.4.2.Introduction Osmoscan ............................................................................. 26
3.3.4.3.Introduction RBC-elongation .................................................................... 26
3.3.4.4.Introduction RBC-aggregation .................................................................. 26
3.3.4.5.Introduction Oxygenscan .......................................................................... 27
4.SAFETY ........................................................................................................................ 28
4.1.General safety rules ................................................................................................ 28
4.2.Electrical safety ....................................................................................................... 30
4.3.Laser and mechanical safety ................................................................................... 31
4.4.Bio Safety bob assembly ......................................................................................... 32
4.5.Safety for working with compressed Nitrogen ......................................................... 33
4.6.Bio safety Standard Operating Procedures (S.O.P.) ............................................... 34
4.6.1.Basics of bio safety ....................................................................................... 34
4.6.2.S.O.P. for working with bio hazardous materials .......................................... 35
4.6.2.1.Facts and definitions: ................................................................................ 35
4.6.2.2.Medical requirements: .............................................................................. 35
4.6.2.3.General laboratory practices: ................................................................... 35
4.6.2.4.Specific laboratory practices and requirements: ....................................... 36
5.INSTALLATION ........................................................................................................... 37
5.1.Pre-installation requirements ................................................................................... 37
5.2.Transport ................................................................................................................. 39
5.3.Environmental conditions and setting up the instrument ......................................... 40
5.3.1.Conditions ..................................................................................................... 40
5.3.2.Main power connection ................................................................................. 41
5.3.3.Unpacking / Setting Up ................................................................................. 41
5.4.First Start-up ............................................................................................................ 45

Contents
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5.5.Checking Lorrca® MaxSis functionality ................................................................... 47
5.5.1.Instrument status .......................................................................................... 48
5.5.2.Lorrca IO ....................................................................................................... 49
5.5.3.Camera ......................................................................................................... 50
6.LORRCA MAXSIS PROGRAM .................................................................................... 51
6.1.Main screen ............................................................................................................. 52
6.2.Main screen settings ................................................................................................ 52
6.2.1.Screen communication settings .................................................................... 53
6.2.2.End of the day wash screen ......................................................................... 54
6.3.Hardware check status ............................................................................................ 54
6.3.1.Hardware check IO screen ........................................................................... 55
6.3.2.Hardware check Camera screen .................................................................. 56
6.3.2.1.Hardware check Camera Led on screen .................................................. 57
6.3.3.Hardware pO2 .............................................................................................. 57
6.4.Settings screen ........................................................................................................ 58
6.4.1.Files .............................................................................................................. 59
6.4.2.General options ............................................................................................ 60
6.4.3.Elongation ..................................................................................................... 60
6.4.3.1.Deformability curve Parameters ............................................................... 60
6.4.3.2.Stress curve determination Parameters ................................................... 61
6.4.3.3.Stability test parameters ........................................................................... 62
6.4.4.Aggregation .................................................................................................. 62
6.4.4.1.Disaggregation options ............................................................................. 62
6.4.4.2.Syllectogram options ................................................................................ 63
6.4.4.3.Iteration parameters setting ...................................................................... 64
6.4.4.4.FSAR options ........................................................................................... 66
6.4.5.Osmoscan options ........................................................................................ 66
6.4.6.Oxygenscan options ..................................................................................... 67
6.4.6.1.pO2 Steps................................................................................................. 68
6.4.7.Screen communication settings .................................................................... 71
6.5.Osmoscan screen .................................................................................................... 73
6.5.1.Osmoscan result screen ............................................................................... 74
6.5.1.1.Osmoscan parameters explanation .......................................................... 75
6.5.1.2.Rinse gradiënt Osmoscan screen ............................................................ 76
6.5.2.Osmoscan curve ........................................................................................... 77
6.6.Deformability curve determination screen ............................................................... 78
6.6.1.Deformability curve result screen ................................................................. 79
6.6.1.1.Deformability curve determination parameters explanation ..................... 80
6.6.1.2.Explain Rinse cup deformability screen .................................................... 80
6.7.Oxygenscan screen ................................................................................................. 81
6.7.1.Oxygenscan result screen ............................................................................ 82
6.7.1.1.Oxygenscan parameters explanation ....................................................... 83
6.7.1.2.Explain Rinse gradient Oxygen screen .................................................... 83
6.8.Stability Curve determination screen ....................................................................... 85
6.8.1.Stability curve determination results screen ................................................. 86
6.8.1.1.Stability curve determination parameters explanation .............................. 87
6.8.1.2.Open Stability curve files .......................................................................... 87

Contents
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6.9.Cell Membrane stability screen ............................................................................... 88
6.9.1.Deformability results 1 screen ...................................................................... 89
6.9.2.Rinse cup cell membrane screen ................................................................. 89
6.9.3.Empty cup cell membrane screen ................................................................ 90
6.9.4.Cell membrane stability results screen ......................................................... 91
6.9.5.Deformability results 2 screen ...................................................................... 92
6.9.6.At measurement completion ......................................................................... 93
6.9.6.1.Deformability results 1 parameters explanation ....................................... 93
6.9.6.2.Stability results parameters explanation ................................................... 94
6.9.6.3.Deformability results 2 parameters explanation ....................................... 95
6.10.RBC aggregation screen ...................................................................................... 96
6.10.1.RBC aggregation result screen ..................................................................... 97
6.10.1.1.Aggregation parameters explanation ...................................................... 98
6.10.1.2.Open Aggregation files ......................................................................... 100
6.10.1.3.Rinse cup RBC Aggregation................................................................. 100
7.GENERAL OPERATION PROCEDURE .................................................................... 101
7.1.Powering up ........................................................................................................... 101
7.2.Preparations .......................................................................................................... 102
7.2.1.Lorrca reagents ........................................................................................... 102
7.2.2.RBC necessary per test/scan ..................................................................... 103
7.2.3.Estimated RBC in laser ............................................................................... 104
7.2.4.Oxygenscan whole blood volume calculation ............................................. 104
7.3.Performing Osmoscan ........................................................................................... 104
7.3.1.Preparing a blood sample ........................................................................... 105
7.3.2.Place sample tube Osmoscan screen ........................................................ 106
7.3.3.Adjust video camera Osmoscan screen ..................................................... 108
7.3.4.Osmoscan result screen ............................................................................. 109
7.3.5.Start new measurement .............................................................................. 109
7.4.Performing Deformability curve test ...................................................................... 111
7.4.1.Preparing a blood sample ........................................................................... 111
7.4.2.Insert blood sample deformability screen ................................................... 112
7.4.3.Adjust video camera deformability screen .................................................. 114
7.4.4.Deformability curve result screen ............................................................... 115
7.4.5.Start new measurement .............................................................................. 116
7.5.Performing Cell stability test .................................................................................. 117
7.5.1.Preparing a blood sample ........................................................................... 117
7.5.2.Insert blood sample stability screen ............................................................ 118
7.5.3.Adjust video camera stability screen .......................................................... 120
7.5.4.Stability curve determination results screen ............................................... 121
7.5.5.Start new measurement .............................................................................. 122
7.6.Performing Cell membrane stability test ................................................................ 123
7.6.1.Preparing a blood sample ........................................................................... 123
7.6.2.Insert blood sample membrane screen ...................................................... 124
7.6.3.Adjust video camera membrane screen ..................................................... 126
7.6.4.Cell membrane stability results screen ....................................................... 127
7.6.5.Deformability results 2 screen .................................................................... 128
7.6.6.Start new measurement .............................................................................. 128

Contents
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7.7.Performing RBC Aggregation test ......................................................................... 130
7.7.1.Preparing blood sample for RBC aggregation test ..................................... 131
7.7.2.Insert blood sample RBC aggregation screen ............................................ 132
7.7.3.Adjust temperature RBC aggregation screen ............................................. 133
7.7.4.RBC aggregation result screen ................................................................... 134
7.7.5.Start new measurement .............................................................................. 135
7.8.Performing Oxygenscan ........................................................................................ 137
7.8.1.Pre-test preparations .................................................................................. 137
7.8.2.Preparing a blood sample Oxygenscan ...................................................... 138
7.8.3.Place sample Oxygenscan test .................................................................. 138
7.8.4.Oxygenscan ................................................................................................ 141
7.8.5.Discard of sample ....................................................................................... 142
7.9.End of day wash .................................................................................................... 142
7.10.Powering down .................................................................................................. 144
7.11.Decontamination procedures Routine ................................................................ 145
7.12.Waste container disposal ................................................................................... 145
8.REPORTING .............................................................................................................. 146
8.1.Deformability Report .............................................................................................. 146
8.2.Cell Membrane Stability report page 1 of 3 ........................................................... 147
8.3.Cell Membrane Stability report page 2 of 3 ........................................................... 148
8.4.Cell Membrane Stability report page 3 of 3 ........................................................... 149
8.5.Osmoscan Report .................................................................................................. 150
9.TROUBLE SHOOTING .............................................................................................. 151
9.1.Error messages ..................................................................................................... 152
9.2.Error Messages (Oxygenscan) .............................................................................. 154
9.3.Trouble shooting table ........................................................................................... 156
10.MAINTENANCE ......................................................................................................... 157
10.1.Maintenance schedule ....................................................................................... 158
10.2.Cleaning ............................................................................................................. 159
10.3.Oxygen sensor spot protocol ............................................................................. 160
10.4.Replacement sensor-spot .................................................................................. 161
10.5.Visual checks ..................................................................................................... 163
10.6.Lorrca reagents routine ...................................................................................... 163
10.7.Adjusting geometry parameters ......................................................................... 164
10.8.Back up the results file ....................................................................................... 164
10.9.Update the software ........................................................................................... 164
10.10.Adjustments and replacements ...................................................................... 165
10.10.1.Adjusting projection screen ..................................................................... 165
10.10.2.Adjusting camera for slides ..................................................................... 167
10.10.3.Replace the main fuses ........................................................................... 170
10.10.4.Waste and rinse pump tube replacements .............................................. 171

Contents
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10.10.4.1.Waste and rinse pump tube replacement ........................................... 171
10.10.4.2.Pump connection tubing ..................................................................... 172
10.10.5.Tubing replacements ............................................................................... 174
10.10.5.1.Gradient pump tube replacement ....................................................... 175
10.10.5.2.Install LORC070901 tubing ................................................................ 176
10.10.5.3.Install LORC070902 tubing set 1 ........................................................ 179
10.10.5.4.Install LORC070903 tubing set 2 ........................................................ 181
10.10.5.5.Install LORC070904 tubing set 3 ........................................................ 183
10.10.5.6.After replacement of all tubing ............................................................ 183
10.10.6.Preparation for long time inactivity .......................................................... 184
11.APPENDIX FOR LORRCA® MAXSIS ....................................................................... 185
11.1.Preparation for transport. ................................................................................... 186
11.2.Instructions for packing: ..................................................................................... 187
11.3.Part 1: ................................................................................................................ 187
11.4.Part 2a: .............................................................................................................. 188
11.5.Part 2b: .............................................................................................................. 189
11.6.Appendix - Document History Extended overview ............................................. 194
11.6.1.Preface ....................................................................................................... 197
11.6.2.Principle of operation .................................................................................. 198
11.6.2.1.RBC-deformability measurements ........................................................ 199
11.6.2.2.RBC-aggregation and –relaxation measurements ............................... 205
11.6.2.3.Flow to Stasis Aggregation Ratio (FSAR) ............................................ 212
11.6.3.References ................................................................................................. 215
12.DRAWINGS AND PARTS LORRCA® MAXSIS ........................................................ 219
12.1.LORC070020 Tubing diagram ........................................................................... 219
12.2.LORC080020 Connection diagram .................................................................... 220
13.LOG BOOK (EXAMPLE) ........................................................................................... 221
14.GLOSSARY OF TERMS ............................................................................................ 223
15.INDEX ......................................................................................................................... 225


About RR Mechatronics
Lorrca Maxsis User Manual Page 11
Version 5.04 MRN-231-EN
1. ABOUT RR MECHATRONICS
Since being founded in The Netherlands in1986, we have adhered to the belief in the exponential
strength of technological advancement. RR Mechatronics develops, manufactures and markets
worldwide instruments for scientific research- and medical centres. Microprocessor technology
plays a vital role in every aspect. We have a track record of thinking in terms of solutions, not
problems and do not have all the answers, but persistently strive to find them in close collaboration
with research scientists and our other partners. These partnerships significantly contribute to our
high quality work.
RR Mechatronics is ISO 13485:2016 certified by Dekra certification.
The unique collaboration between the scientific world and our research & development department
enabled us to develop the Lorrca® MaxSis. This also makes it our responsibility to link and
disseminate the knowledge gained in the worldwide community of researchers and clinicians.
Our people are passionate about the invention and development of highly precise analytic
instruments. RR Mechatronics focuses on medical analytics laboratory instruments. We serve
laboratory customers and other partners all over the world. About 90% of our total production is
exported through a worldwide network of exclusive and qualified distributors.
RR Mechatronics is the world leader in automated true Westergren ESR instruments.
In addition to the haematology related instruments, RR Mechatronics develops very specific
environment related high technology instruments. To complement our line of instruments, we also
offer diluents, cleaning-agents, controls, and specific reagents.
Mechatronics USA is the specialized sales and service organization for RR Mechatronics’
instruments sold in the United States. We understand that service of daily used instruments must
be performed on-site and we are organized to do so. Mechatronics operates one service number
for any service request and is available 24/7.

Introduction
Page 12 Lorrca Maxsis User Manual
Version 5.04 MRN-231-EN
2. INTRODUCTION
2.1. About this manual
This manual describes all necessary procedures and information required for the correct and
successful use of the Lorrca® MaxSis, covering:
Installation
Normal operation
User maintenance
Troubleshooting
This manual does include details about possible errors, listed in the chapter troubleshooting. Here
a description can be found about known errors of the instrument. If other errors occur, which are
not mentioned in this section, please contact our service department.
RR Mechatronics retains the right to make any changes to the contents without any previous
warning. Check our website for the latest version of this manual http://www.rrmechatronics.com.
For information concerning settings, repair and maintenance which is not mentioned in this
manual, please contact RR Mechatronics.
Any remarks or suggestions will be gratefully received. RR Mechatronics accepts no liability for any
mistakes in this User Manual, nor for the consequences of any faulty interpretation of text or
drawings.
Read the whole Manual through carefully, especially chapter Safety
(on page 28), before using the instrument.
The section LoRRca MaxSis Program (on page 51) is interactive
and most of the software functions are the same as in the program
itself.

Introduction
Lorrca Maxsis User Manual Page 13
Version 5.04 MRN-231-EN
2.2. Typographical conventions
Menu selection Items you must select, such as menu options, command
buttons, or items in a list.
Emphasis Use to emphasise the importance of a point or for variable
expressions such as parameters.
In Software descriptions:
Tabs like SCAN SETTING
Text buttons like "Stop", "Save"
Toggle-buttons like [p-type], [<=X]
Input parameters like Current Density, Scan Speed
Names of the keys on
the keyboard like [ALT]+[PRINT SCREEN]
Specific warning text is shown as:
Warning: Do not open during operation

Introduction
Page 14 Lorrca Maxsis User Manual
Version 5.04 MRN-231-EN
2.3. Used symbols
In this manual, the following graphical symbols are used to draw attention to important information:
This symbol indicates warnings and other danger related information. Ignoring this
information could result in personal injury, damage to the instrument or property or
malfunction of the instrument.
Warning sign to prevent personal injury due to electrical shocks
Warning sign to prevent personal injury due to rotating parts
Warning sign to prevent personal injury due to biohazard.
Dangerous laser radiation. Avoid direct exposure to laser beam. Laser safety class
3R
Information sign on the supplied materials intended to inform about the “USE BY”
date.
This symbol indicates useful tips and other important information, that are not
related to any specific danger.
This symbol indicates a reference to this or other product documentation.

Instrument description
Lorrca Maxsis User Manual Page 15
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3. INSTRUMENT DESCRIPTION
The Lorrca® MaxSis consists of the instrument and a control PC with printer. You can find detailed
drawings of the main components in LORC109000 Desk arrangement.
Main components:
1. Computer and display
2. BOB
3. CUP
4. Projection screen
5. De-ionized water bottle, Waste bottle
6. Pumps
7. Valves
8. Laser
9. Osmo High, Osmo Low, Elon ISO bottles
10. Sample unit

Instrument description
Page 16 Lorrca Maxsis User Manual
Version 5.04 MRN-231-EN
3.1. Instrument label Lorrca® MaxSis
The CE marking and other important information can be found on the Mechatronics instrument
identification plate, an illustration of this is shown below with explanation.
The instrument identification plate is located on the right-hand side of the rear panel of the
instrument under the main switch panel.
Explanation:
1. Name
2. Type
3. Instrument serial number
4. Electrical information
5. Protection class
6. Date of manufacturing
7. Warning(s)
8. Marking(s) and info

Instrument description
Lorrca Maxsis User Manual Page 17
Version 5.04 MRN-231-EN
3.2. Technical specifications
Technical specifications for the Lorrca® MaxSis:
Lorrca® instrument models:
Model Model name Catalogue number
Lorrca® MaxSis LORC109003
Mains voltage 100/240V 50-60Hz
Fuse (20 x 5 mm) Slow blow 220V 1.6 Amp
Slow blow 110V 3.15 Amp
Power consumption Standby 100 VA
Maximum 150 VA
Heat output Standby 100 Watt
Full operation 150 Watt
Dimensions Width 470 mm
Height with closed lid 400 mm
Height with open lid 630 mm
Depth 300 mm
Total weight 70 Kg
Min. table size Width 1000 mm
Lorrca+Laptop Depth 700 mm
Sound level < 55 ± 2 dB
Working temperature 15 - 35 °C
Relative humidity 10 - 90%
Specifications of other equipment
Camera Objective mount C-mount
Connection USB 3.0
Minimal resolution 780x582
black/white

Instrument description
Page 18 Lorrca Maxsis User Manual
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Dimensions 40x40x40 mm
Laser Wave length 655 nm
Focus distance 170 mm
output power Max 3 mW
Blood sample Tube solution EDTA-Blood
Deformability test +/- 25 l
Osmoscan +/- 200 l
Oxygenscan +/- 50 l
Tech specs Couette assembly
CUP Inner Radius 16.01 ± 0.005 mm
Surface roughness Ra<0.026 µm
Material PMMA
BOB Outer Radius 15.65 ± 0.005 mm
Surface roughness Ra<0.026 µm
Material PMMA
Ambient temperature + 4°C
Drive Minimal cup speed 0.03 rps
Maximum cup speed 20 rps
Break time from sudden stop from
106 rpm to 0 rpm
<30 ms
Shear rate 0 - 800 s-1
Warming-up time Bob Maximum 2 minutes
Heater Heating accuracy ± 0.2 °C
Range 25 - 45 °C
Tech specs Gradient assembly
Gradient mixer range 0 - 25 mS/cm
mixer accuracy ±-0.5 mS/cm
Reagents 50 - 500 mosm/kg
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