RX Modena Operator Manual
RX Modena Operator Manual
RX Modena Operator Manual
Amendment Record
Update to
3.10 xiii - xliv Cross Contamination table (pg xx) RANDOX March 2018
and Carryover table (pg. xxi)
FOREWORD
INFORMATION FOR OPERATORS
5 Calibration.......................................................................................................................5—3
5.1 Overview ......................................................................................................................5—3
5.1.1 Flow of Calibration Measurement .............................................................................................. 5—4
5.2 Preparation ..................................................................................................................5—5
5.2.1 Register Orders with Manual Entry ............................................................................................ 5—5
5.2.1.1 Normal Calibration ................................................................................................................ 5—5
5.2.1.2 Worklist Screen (Calibration) ................................................................................................ 5—7
5.2.1.3 Multi-Calibration ..................................................................................................................... 5—8
5.2.1.4 Worklist Screen > Multi-Calibration ................................................................................... 5—10
5.2.1.5 Diluted Calibration ............................................................................................................... 5—11
5.2.1.6 C1 Blank ................................................................................................................................ 5—13
5.2.1.7 Worklist Screen > Diluted Calibration/C1 Blank Measurement ...................................... 5—14
5.2.2 Register Orders with Sample Barcodes.................................................................................... 5—15
5.2.3 Copying and Deleting Orders ................................................................................................... 5—15
5.3 Execute Calibration ..................................................................................................5—16
5.4 Check Results ............................................................................................................5—16
5.5 Multi-Calibration Settings ........................................................................................ 5—17
5.5.1 Multi-Calibration Screen............................................................................................................ 5—17
5.5.2 Register the Multi-Calibrator .................................................................................................... 5—18
5.5.3 Edit the Multi-Calibrator............................................................................................................ 5—19
5.5.4 Delete the Multi-Calibrator....................................................................................................... 5—20
5.5.5 Print the Multi-Calibrator .......................................................................................................... 5—21
5.6 Diluted Calibration Settings..................................................................................... 5—22
5.6.1 Register the Diluted Calibration Settings.................................................................................. 5—23
5.6.2 Edit the Diluted Calibration Settings ......................................................................................... 5—24
5.6.3 Delete the Diluted Calibration Settings .................................................................................... 5—25
Section 6 QC Measurement .................................................................................................6—1
6 Preparation for Measurement ...................................................................................... 6—3
6.1 Overview ......................................................................................................................6—3
6.1.1 Flow of QC Measurement .......................................................................................................... 6—3
6.2 Preparation ..................................................................................................................6—4
6.2.1 Registering Orders with Manual Entry ........................................................................................ 6—4
6.2.1.1 Worklist Screen (QC Measurement) .................................................................................... 6—5
6.2.2 Register Orders with Samples Barcodes .................................................................................... 6—6
6.2.3 Copying and Deleting Orders ..................................................................................................... 6—6
6.3 Execute QC Measurement ......................................................................................... 6—7
6.4 Check Results in the QC Chart.................................................................................. 6—7
6.4.1 Check the QC Results for 1 Day ................................................................................................ 6—7
6.4.2 Check the Cumulative Results for 30 Days in the Past.............................................................. 6—9
6.4.3 QC Chart Screen ....................................................................................................................... 6—11
6.5 Check Results in the QC Results List ...................................................................... 6—13
6.5.1 Search and Filter QC Measurement Results ............................................................................ 6—13
6.5.1.1 Check the QC Results for 1 Day ......................................................................................... 6—13
6.5.1.2 Check the QC Results for a Specified Period ..................................................................... 6—15
6.5.1.3 Check the QC Results for an Item ...................................................................................... 6—17
6.5.2 Delete or Output the QC Table Screen .................................................................................. 6—19
6.5.2.1 Delete Unnecessary QC Measurement Results ................................................................. 6—19
6.5.2.2 Print QC Measurement Results ........................................................................................... 6—20
6.5.2.3 Output QC Measurement Results to a File ........................................................................ 6—21
6.5.3 QC Table Screen ....................................................................................................................... 6—22
6.5.3.1 Search Function Area ........................................................................................................... 6—22
6.5.3.2 QC Table Screen (Daily) ...................................................................................................... 6—24
6.5.3.3 QC Table Screen (Cumulative) ........................................................................................... 6—26
6.5.3.4 QC Table Screen (Detail) .................................................................................................... 6—28
9 Maintenance ....................................................................................................................9—3
9.1 Overview ......................................................................................................................9—3
9.2 Unit Maintenance Screen ...........................................................................................9—4
9.3 Work Hour Counter Screen ......................................................................................9—6
9.4 Daily Inspection and Cleaning ....................................................................................9—7
9.4.1 Management of Reagent Bottles ................................................................................................. 9—7
9.4.2 Sample Disposal ........................................................................................................................... 9—7
9.4.3 Replenish Detergents .................................................................................................................. 9—7
9.4.3.1 Check and Replace Detergent Bottles .................................................................................. 9—7
9.4.3.2 Check of Detergents .............................................................................................................. 9—9
9.4.4 Lamp Operation Time - Check ................................................................................................. 9—10
9.4.4.1 Water Blank Absorbance Check ......................................................................................... 9—10
9.4.4.2 Maintenance > System Monitor > Water Blank Absorbance............................................ 9—10
9.4.5 Sample Pipette Unit - Inspection and Cleaning ........................................................................ 9—12
9.4.5.1 Internal Pipette Cleaning ...................................................................................................... 9—14
9.4.6 Reagent Pipette Units - Inspection and Cleaning ..................................................................... 9—15
9.4.6.1 Inspection .............................................................................................................................. 9—15
9.4.6.2 Exterior Cleaning .................................................................................................................. 9—15
9.4.6.3 Internal Pipette Cleaning ...................................................................................................... 9—17
9.4.7 Washing Unit - Inspection and Cleaning................................................................................... 9—17
9.4.8 Mix Units - Inspection and Cleaning ......................................................................................... 9—19
9.5 Weekly Inspection and Cleaning .............................................................................9—21
9.5.1 Troughs - Inspection and Cleaning ........................................................................................... 9—21
9.5.2 Sample Carousel - Inspection and Cleaning ............................................................................. 9—21
9.5.3 Reagent Carousel - Inspection and Cleaning ............................................................................ 9—24
9.5.4 Work Table - Inspection and Cleaning ..................................................................................... 9—27
9.5.5 Water Blank Absorbance Check 1 ........................................................................................... 9—27
9.5.6 Water Blank Absorbance Check 2 ........................................................................................... 9—28
9.5.7 Wash Cuvettes .......................................................................................................................... 9—29
9.5.8 Perform a Cuvette C1 Solution Soak ....................................................................................... 9—31
9.6 Maintenance Work Performed by the Administrator ..........................................9—32
9.6.1 Replace the Halogen Lamp ....................................................................................................... 9—32
9.6.1.1 Lamp Post-replacement Check ............................................................................................ 9—35
9.6.2 Fluidic Wash ............................................................................................................................... 9—36
9.6.2.1 Wash Procedure ................................................................................................................... 9—37
9.6.3 Remove Pipette Blockages ........................................................................................................ 9—40
9.7 Maintenance by Service Engineers ..........................................................................9—42
Section 10 Miscellaneous Settings......................................................................................10—1
10 Miscellaneous Settings .................................................................................................10—3
10.1 Change Device Settings ............................................................................................10—4
10.1.1 Host Communication Settings .................................................................................................. 10—5
10.1.2 Sample ID Settings ..................................................................................................................... 10—6
10.1.3 Automatic Print Settings ............................................................................................................ 10—7
10.1.4 Notification Sound Settings ....................................................................................................... 10—8
10.1.5 Other Device Settings ............................................................................................................... 10—9
10.2 Operation Settings ..................................................................................................10—10
10.2.1 Operation Settings Screen....................................................................................................... 10—10
10.2.1.1 Change Operation Settings ................................................................................................ 10—11
10.3 User Accounts .........................................................................................................10—12
10.3.1 Administer User Accounts ...................................................................................................... 10—12
10.3.1.1 User Accounts Screen ........................................................................................................ 10—12
10.3.1.2 Add a User Account ........................................................................................................... 10—13
10.3.1.3 Change the Password/User Level ..................................................................................... 10—14
10.3.1.4 Delete a User ...................................................................................................................... 10—16
10.3.2 List of Available Screens by User Level .................................................................................. 10—17
RX modena — Operator Manual Document No. RX9003
Page x Rev 3.01 — March 2018
Foreword
Information for Operators
NOTE: Screen images shown in this manual are representative of those displayed by the analyser system.
Due to continuous improvements in the analyser software and differences in equipment implementation,
images may not be exactly the same as those displayed by the analyser.
FOREWORD
Intended Use
The analyser is designed to analyse human samples such as serum, plasma, urine and whole blood.
• Never use the analyser for any purpose other than sample analysis.
Target User
This manual is written for clinical laboratory technologists.
• Before using this product, please read the instructions described in this manual carefully, and make
sure to keep this manual for future reference.
Disclaimer
Randox Laboratories Ltd. shall not be responsible for any failure or damage of the analyser or any damage
caused by direct or indirect use of the analyser under the following conditions.
• Failures or damages caused by not following the instructions, precautions and intended use described
in this manual.
• Failures or damages caused by repair or alteration performed by any company other than those
designated by our company.
• Failures or damages caused by the use of the analyser in conjunction with any instrument other than
those designated by our company.
• Failures or damages caused by not using the analyser under the operating environment specified in
this manual such as power supply conditions and installation environment.
• Failures or damages caused by earthquake, flood or other natural disasters.
• Failures or damages caused by relocation or transportation of the analyser after the installation, which
our company is not informed of.
For the warranty period, repairs and after sales service, contact the local Randox Representative or
distributor or contact the relevant Randox business unit listed at the end of this section.
• The warranty may become void if the analyser is not used in accordance with the instructions
described in this manual.
Trademarks
• Randox is a trademark of Randox Laboratories Ltd.
• Windows® 8.1 Pro is either a registered trademark or trademark of Microsoft Corporation in the
United States and/or other countries.
• Intel is either a registered trademark or trademark of Intel Corporation in the United States and/or
other countries.
• All brand and product names are registered trademarks, trademarks or service marks of their
respective holders.
Randox Laboratories Ltd are registered in Randox Teoranta are registered in the
the United Kingdom at: Republic of Ireland at:
55 Diamond Road Meenmore
Crumlin County Donegal
County Antrim F94 TV06
BT29 4QY Republic of Ireland.
United Kingdom.
NOTE: Exact design and details may vary. Always refer to the label attached the analyser.
About Manuals
Composition of Separate Volumes
The manuals for the analyser include the following separate volumes.
Warning Symbols
The following symbols are used in this manual to indicate hazards and associated warnings.
ELECTRICAL
Precautions required for the prevention of electric shock.
HAZARD
HOT
SURFACE Precautions required for the prevention of burns to the skin.
HAZARD
BIOLOGICAL
Precautions required for the prevention of infection.
HAZARD
DO NOT Prohibited actions regarding the contact with the analyser that may lead to
TOUCH injury, damage or skin burn.
Performance Assurance
• Do not install the analyser close to any device that may generate abnormal noise.
• Do not install the analyser close to any device that may generate electromagnetic waves.
• Install the analyser in a location where the temperature range is between 15 and 30 °C
and where the variation is less than ± 2 °C per hour.
• Install the analyser in a location where the humidity range is between 45 and 85 %.
• Purified water must meet the NCCLS C3-A3 Type ll Guideline or higher (such as
NCCLS C3-A3 Type l or LSI C3-A4).
• Make sure purified water is free from air bubbles and foreign substances.
• Keep the temperature of purified water between 5 and 25 °C. Water outside this range
may affect the measurement results.
• Make sure that fluid tubes connected to the supply and waste ports have no severe
bends, deflections or deformity. Conditions such as these may lead to restricted fluid
flow that may affect measurement results, disconnection or leakage during operation.
• Make sure that external storage devices such as USB memory sticks are virus checked
(and not infected with a computer virus) before use. An infected PC or storage device
may lead to abnormal operation of the analyser.
• Do not install any software that is not specified on the analyser PC. Unspecified software
may lead to abnormal operation of the analyser.
• Make sure that the software versions are correct. Contact your Randox representative
for the latest (or most appropriate) software for your specific equipment. Incorrect
software versions may lead to abnormal operation of the analyser.
Prevention of Infection
• Make sure protective gloves, masks and goggles (PPE) are worn to prevent infection when
handling samples and other materials/equipment.
• Do not directly touch potentially infectious samples, reagents or waste water.
• Do not touch the analyser or associated equipment with wet hands. It may transmit infection.
• If samples or reagents contact your skin, eyes or mouth, immediately flush with clean water
then, if required, seek medical attention.
• If sample or reagent fluids are found on the analyser, immediately wipe them off.
Clean/sterilise the affected area as required.
Handling of Samples
The analyser is designed to analyse human samples such as serum, plasma, urine and whole blood.
There may be some assay items (reagents) that are not measureable on the analyser. For details,
contact your Randox Representative.
• Use samples that are free from foreign substances. Such substances may block the sample
pipette and may affect the measurement results.
• Some chemical substances found in samples such as medical agents, anticoagulants, or
preservatives may have clinically significant effect on the result.
• Some assay items (reagents) may require special handling. Refer to the documentation that
accompanies the item(s) or contact your Randox Representative.
• Medical agent or metabolic products of haemolysed, turbid, or high-bilirubin serum may
affect the measurement results. For details, contact your Randox Representative.
• Store samples in appropriate environment. Improper storage of samples may lead to
deterioration of their components.
• To prevent evaporation or contamination of samples, do not leave them unsealed for an
extended period of time. It may lead to incorrect measurement results.
Column 1 Column 2
Albumin Iron
Glucose GODPAP Phosphate
Uric acid Phosphate
ALT Phosphate
AST Phosphate
LD Phosphate
CK Phosphate
ALP (AMP) Magnesium
ALP (DEA) Magnesium
Glucose Hexokinase Magnesium
CKMB Magnesium
Triglycerides Magnesium
Cholesterol Magnesium
Uric Acid Magnesium
Potassium Sodium
Direct Bilirubin Sodium
Transferrin Sodium
Total Protein Sodium
Total Protein Potassium
Total Protein Copper
Transferrin Chloride
Direct Bilirubin Chloride
Cholesterol Lipase
Triglycerides Lipase
Potassium LDH
Potassium GLDH
Urea GLDH
Creatinine* CRP
Fructosamine Bile acids
Amylase Magnesium
Pancreatic amylase Magnesium
Liquid CO2 Magnesium
Direct LDL Lipase
Cholesterol Calcium
TIBC Iron
Myoglobin HFABP
Cystatin C HFABP
Adiponectin HFABP
Micro-albumin Calcium
*When testing Creatinine and CRP in the same run on the Rx Imola, Randox recommend using the Full
Range CRP kit, Catalogue numbers CP3847 or CP3849.
The use of CRP kit CP3826 is not recommended.
*Randox HFABP should be run in isolation or separated from other IT assays in the measurement order.
* Bile acids and Lipase should not be tested in the same run.
* NEFA and Triglycerides should not be tested in the same run.
*Lipase and Triglycerides should be the last two chemistries in the testing running order.
(All other Chemistries) / (Lipase) / (Triglycerides).
Catalogue number:
• C1 wash – RX8143
• Acid Wash – WS8397
If you require any further information about this, please contact your local Randox Representative or
Technical Support.
Performance Assurance
• Only use the analyser in a location where the temperature range is between 15°C and
30°C and where the temperature variation is less than ±2°C per hour.
• Only use the analyser in a location where the humidity is between 45% and 85%.
• Make sure that the temperature of purified water is between 5°C and 25°C. Out of
range temperatures may affect the measurement of results.
• To minimise interference from external light or other environmental factors, do NOT
open the front cover, the rear cover, the side covers or the top cover during operation.
NOTE: Operation will stop and the analyser will not generate correct measurement results
when the lid of the reagent carousel or the sample carousel is opened during operation.
• Perform QC measurements to verify that the analyser performance is as expected.
• Make sure that there is sufficient volume of reagent(s) and wash solution(s) before
measurement.
• Make sure that there are valid calibration curves before measurement.
• Perform fresh calibration when the lot number of reagent has been changed.
• Make sure that there is sufficient volumes of sample before measurement.
• Make sure that there are no fluid leaks from the sample pipette and/or the reagent
pipettes.
• Make sure that the purified water is free from air bubbles and foreign substances.
• Do NOT use portable radios or cellular phones in the area where the analyser is
installed. These equipment types may generate electromagnetic waves or other
interference which may lead to abnormal operation of the analyser.
Data Management
• Make sure that external storage devices such as USB memory sticks are virus checked
(and virus free) before use. An infected PC or storage device may lead to abnormal
operation of the analyser.
• Be careful not to enter erroneous patient information. In order to avoid such errors, it is
recommended to prepare patient information on the host computer before starting
analysis.
• Do NOT shutdown the analyser and the analyser PC during operation. Sudden
shutdown may lead to database corruption.
• When shutting down the analyser and the analyser PC, make sure to follow the correct
shutdown procedures as written in this manual.
• Create regular backup copies of the database stored in the analyser PC. If backup copies
are not created, the database cannot not be recovered in the event of a problem such as
a malfunction of the analyser.
Prevention of Infection
• Any part removed from the analyser for replacement may be contaminated and MUST
be cleaned/sterilised before repair or disposal. For disposal of waste, contact your
Randox Representative.
• Where appropriate Personal Protective Equipment (PPE) such as gloves, masks and
goggles to prevent direct skin contact with sample and reagent fluids.
If samples or reagents contact your skin, eyes or mouth, immediately provide first
aid such as flushing with water and seek medical attention if necessary.
If samples or reagents are found on the analyser or associated equipment,
immediately wipe them off. Clean/sterilize the affected area as required.
• Work surfaces, work equipment or other similar material must be cleaned and sterilised
using laboratory grade cleaning products. Cleaning solution residues should be removed
with laboratory grade water to prevent accidental contamination of samples.
• Do not directly touch potentially infectious equipment, samples, reagents or wastewater.
Make sure to wear appropriate PPE to prevent transfer of infection.
Performance Assurance
• Use only genuine consumables and Randox parts.
For the purchase of parts, contact your Randox Representative or your distributor.
Any use of non-genuine parts may affect the performance and safety of the analyser.
• Only perform user maintenance as described in this manual to maintain the performance
of the analyser.
Randox Laboratories Ltd shall not be responsible for any damage caused by
maintenance work performed by any service engineer not trained by Randox.
• After any replacement of parts, make sure that the measurement results are correct.
Data Management
• Periodically create backup copies of the database to secure against unexpected loss of
data.
• Create regular backup copies of the database stored in the analyser PC. If backup copies
are not created, the database cannot not be recovered in the event of a problem such as
a malfunction of the analyser.
Type I Type II
Minimum resistivity 10 1
(MΩ • cm @ 25 °C)
Microbial content (CFU/ml) 10 1,000
Silicate (mg/l) 0.05 0.1
pH Not specified Not specified
Particulate matter 0.22 µm filter Not specified
Organic contaminants Activated carbon, distillation or Not specified
reverse osmosis
Warning Labels
Types of Labels
The following types of labels are attached on the areas that are considered dangerous.
Location of Labels
External View
* This label is attached to the lamp case inside of the lamp cover.
Installation/Operation Environment
This section describes the installation/operation environment required for correct operation of the
analyser and standard accessories. Installation (unpacking, installation and operation check) must only be
performed by service engineers designated by Randox or a Randox distributor with Randox trained service
personnel.
Never relocated the analyser by yourself. To relocate the analyser, contact the Randox
Technical Services or your Randox distributor.
Installation/Operation Conditions
Install and operate the analyser in a place…
• that is indoors.
• that is not subject to direct sunlight.
• that is not subject to direct wind, rain or any form of water. (Keep the analyser indoors.)
• where amounts of dust are small.
• that is not subject to vibration or noise.
• where the floor is flat and has virtually no inclination.
• where the floor is capable of supporting the weight of the analyser (approximately 300 kg) and any
associated equipment.
• where the voltage variation Less than ± 10 %.
• where there is no strong noise sources (facility or instrument) around the analyser.
• where there is no fluorescent light directly above the analyser.
• at an altitude of 2000 meters or less above the sea level.
• where the analyser will not be adversely affected by environmental factors such as atmospheric
pressure, temperature, humidity, ventilation, sunlight, dust, salt, sulphur.
• that is not near to where chemicals are stored, and where no gas is generated.
• where the power cord of the analyser can be safely connected to the power source so that the failure
of the analyser may not adversely affect the facility or important medical devices in the facility such as
power supply systems for operation.
Temperature/Humidity Conditions
• Room temperature of 15 to 30°C and temperature variation of less than 2°C per hour.
• Room humidity of 45 to 85% (no condensation).
• Install the analyser in a place that is well ventilated or equipped with a ventilation system.
• Install the analyser in a place where the analyser is not subject to direct drafts from the ventilation
system.
Installation Space
Make sure sufficient space is maintained around the analyser to allow access for maintenance and allow
ventilation of heat from the analyser.
• Keep a space of at least 500 mm behind the analyser for ventilation, maintenance and
emergency shutdown. Do not leave things around the power supply unit.
• Keep a space of at least 1000 mm on the right side of the analyser for ventilation,
maintenance and operation of the PC.
• Keep a space of at least 1000 mm in front of the analyser for operation and maintenance.
Water Supply
Space for
Power Outlet ventilation
Drainage 500 mm or
more
Supply Port
Drainage
Ports
PC
850 mm
Analyser
1000 mm or more
FRONT
Power Supply
Connect the power cord from the power inlet of the analyser (approx. 5 m) to a 3-core power outlet with
a ground terminal (A-Type, S-Type or O-Type).
Make sure that the ground resistance is less than 100 Ω.
• Grounding of the power outlet must only be performed by suitably qualified person.
• Use the power breaker on the back of the analyser (as shown below) to turn the power
OFF in cases where there has been a system or electrical malfunction.
Remove the power cable from the building power outlet to guarantee that power to
the analyser cannot be restored (switched back on).
Pressure-resistant hose
Purified water (accessory) Water supply to
6 Water supply supply analyser
• Internal diameter: 12 mm
• External diameter: 18 mm
Drainage System
Drainage capacity 20 litres per hour
Height Higher than 300 mm between the drainage system and drain ports
Tubing condition Arrange tubing so that the wastewater is discharged by gravity.
The tips of drain tubes are kept in the air and not in contact with the surface of
wastewater in the drainage system.
Components
No. Name Qty. Remarks
1 RX modena 1 Analyser
2 Accessory set 1 Refer to the accessory list for details.
3 User manual 1 ―
4 Accessory list 1 ―
5 Package insert 1 ―
Operating Software
To operate the analyser, the software must be installed on a specified PC (sold separately).
System Requirements
When using an external storage devices, such as USB memory sticks, always run a virus check
before use.
If the PC or the external storage device is infected with computer viruses, it may lead to
abnormal operation of the analyser.
Do not install any software on the PC that is not specified by Randox. Unspecified software
may lead to abnormal operation of the analyser.
Software List
The software for the analyser PC (sold separately) is as follows:
NOTE: Contact your Randox Representative for the latest software version.
Specifications
Analyser Specifications
Model Name RX modena - Clinical Chemistry Analyser
Usage • General chemistry as photometric assay
• Immunology as photometric assay (Latex reagent available)
Assay type • 1 point end • 1 point rate
• 2 point end • 2 point rate
Type of • Factor • Exponential
Calibration • Linear • Spline
• Point to point • Spline 2
• Log-logit
Throughput • Max. 800 tests per hour (general chemistry assay only)
• Max. 1200 tests per hour (general chemistry assay and ISE assay)
Incubation Time • 1 Reagent Assay: 10 minutes (R1)
• 2 Reagents Assay: 5 minutes (R1) + 5 minutes (R2)
• Able to test 1 reagent and 2 reagents assays simultaneously.
Sample Type • Serum • Haemocyte (after centrifugation)
• Plasma • Whole Blood
• Urine
Simultaneous Up to 100 assays + 3 ISE assays (Na, K, Cl)
Assays
Unit Components • Chassis Unit (CHS) • Supply Water Unit (SWU)
• Incubation Reaction Unit (IRU) • Trough Unit (TR)
• Sample Carousel Unit (ASP) • Washing Unit (WU)
• Sample Pipette Unit (SPT) • Subtank Unit (Subtank)
• Reagent Carousel Unit (RCU) • Power Supply Unit (PSU)
• Reagent Pipette Unit 1/2 (RPT1, • Control Unit (CNU)
RPT2) • Sample Barcode Reader (ASP-
• Sample Pump Unit (SPP) BCR)
• Reagent Pump Unit1/2 (RPP1, • Reagent Barcode Reader (RCU-
RPP2) BCR)
• Wash Pump Unit (WPP) • Degassing Unit (DGU)
• Detector Unit (DTR) • Clot Detection Sensor Unit
• Mixing Unit 1/2 (MIX1, MIX2) • ISE Unit
Incubator (IRU) Heating method Direct heating by silicon-rubber heater
Heating range • 37 ± 0.1 °C (Stand-by)
• 37 ± 0.2 °C (During run)
Cuvette Material • Resin
• Glass (optional)
Dimensions W3 × D5 × H30 (mm)
Light path 5 mm
Quantity 153
Minimum reaction 50 µl to 250 µl
volume
Analysis Specifications
Number of Assays • General chemistry: 240 assays.
• ISE: 3 assays (Na, K, Cl)*1.
Normal range 50 ranges (6 prefixed ranges included).
Multi-calibrator 30 calibrators.
QC sample 40 samples.
Panel test 50 sets.
Calculated test 40 sets.
Template 10 sets.
Worklist 1000 samples.
Reagent registration 200 reagents.
Number of reagent bottles 100 bottles.
Measurement results • Results for samples: • Calibration results:
1,000,000 tests. 25,000 tests.
• Time course for sample: • Time course for calibration:
60,000 tests. 6.000 tests.
Calibration curve 240 assays × 2 curves (Old/New).
QC results 50,000 tests.
Number of patients 30,000 patients.
Number of rounds per day*2 99 rounds.
During operation, the Reagent Barcode Reader and the Sample Barcode Reader each emit a laser beam in
the direction shown below.
Sample barcode
Bar module 0.25 mm to 1.00 mm
width
Barcode height 12 mm or higher.
Barcode length 673 mm or shorter, including the quiet zone.
Quiet zone 4 mm or 10 times the length of the minimum module width, whichever is greater.
Print Black on a white background.
Quality standard shall comply with the ANSI MH10.8M standard.
Location
Sample
Sample ID Digit General ID Details
Category
Routine xxxxxxxxxxxxxxx 3 to 15 xxxxxxxxxxxxxxx-nn1 x: Sample ID
Routine (Emergency) xxxxxxxxxxxxxxx 3 to 15 xxxxxxxxxxxxxxx-nn1 y: Reagent code
z: Concentration
Routine (Paediatric) xxxxxxxxxxxxxxx 3 to 15 xxxxxxxxxxxxxxx-nn1
n: Number of tests*1
Online xxxxxxxxxxxxxxx 3 to 15 xxxxxxxxxxxxxxx-nn1 m: Replication*2
Online (Paediatric) xxxxxxxxxxxxxxx 3 to 15 xxxxxxxxxxxxxxx-nn1
STAT 99000xxx 8 99000xxx-nn1
STAT (Paediatric) 990009xx 8 990009xx-nn1
Orderless 920000xx 8 920000xx-nn1
QC Sample 970000xx 8 970000xx-nnm
Calibrator 98yyyyyz 8 98yyyyyz-nnm
Multi-Calibrator 950000xz 8 950000xz-nnm
Calibrator (Dilution) 93yyyyyz 8 93yyyyyz-nnm
C1 Blank 9510000x 8 9510000x-nnm
Reagent Blank 91yyyyy1 8 91yyyyy1-nnm
EMC Compliance
This is a group 1, class ‘A’ product in accordance with EN 55011/CISPR 11.
This product does not generate and/or intentionally use radio-frequency energy, in the form of
electromagnetic radiation, inductive and/or capacitive coupling, for the treatment of material or inspection
/ analysis purpose, is suitable for use in all establishments other than those directly connected to a low
voltage power supply network which supply buildings used for domestic purposes.
This is a class ‘A’ product.
There may be potential difficulties in ensuring electromagnetic compatibility in non-industrial environments,
due to conducted as well as radiated disturbances.
Cables used for this product are as follows:
• Power cord (5 m or shorter, non-shielded)
• LAN cable (3 m or shorter, non-shielded)
This equipment complies with the emission and immunity requirements described in this
part of the IEC 61326 series:
• This equipment has been designed and tested to CISPR11 Class A. In a domestic environment it may
cause radio interference, in which case, you may need to take measures to mitigate the interference.
The electromagnetic environment should be evaluated prior to operation of the device.
Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g.
unshielded intentional RF sources), as these may interfere with the proper operation.
WEEE Directives
Information for Users on Collection and Disposal of Old Equipment and Used
Batteries:
• The symbols on the products, packaging, and/or accompanying documents mean that used electrical
and electronic products and batteries should not be mixed with general household waste.
• For proper treatment, recovery and recycling of old products and used batteries, please take them to
applicable collection points, in accordance with your national legislation and the Directives
2002/96/EC and 2006/66/EC.
• By disposing of this product correctly, you will help to save valuable resources and prevent potential
negative effects on human health and the environment, which could otherwise arise from
inappropriate waste handling.
• For more information about collection and recycling of old products, contact your local municipality,
your waste disposal service or the point of sale where you purchased the items.
• In accordance with national legislation, penalties may be applicable for incorrect disposal of this waste,
Contact Randox
Randox welcomes customer contact and will be happy to discuss your training, service and warranty
requirements. We also welcome feedback on our products and documentation that may be used to bring
future improvements.
If making contact to report an equipment malfunction or similar issues, please supply the equipment type
and specific equipment serial number. Also, where possible, please supply as much detail as possible about
the issue and the circumstances in which it occurred.
• Should the equipment no longer be under warranty or not subject to a Service Contract, before any
work is done, you will be advised of any costs that may be incurred to return your equipment to
operational use.
To help us meet your needs quickly and efficiently, please contact the Randox Representative that is most
relevant to your area of business:
NOTE: Local representatives may be available in some regions.
Refer to the purchase documentation for further details.
Technical Services
+44 (0) 28 9445 1070
technical.services@randox.com
SECTION 1
OVERVIEW
Section 1 − Contents
Section 1 Overview................................................................................................................1—1
1.1 Features and Major Functions................................................................................ 1—3
1.2 Part Names and Function ....................................................................................... 1—4
1.2.1 External View .............................................................................................................................. 1—4
1.2.2 Inside of Top Cover ................................................................................................................... 1—5
1.2.3 Inside the Front Door ................................................................................................................ 1—6
1.3 Operation Flow ........................................................................................................1—7
1.4 Assay Settings ..........................................................................................................1—8
1.4.1 Measurement Principles and Assay Methods ............................................................................ 1—8
1.4.1.1 Principles ............................................................................................................................. 1—8
1.4.1.2 Operation Sequence .......................................................................................................... 1—9
1.4.1.3 Special Assay Procedure .................................................................................................. 1—10
1.4.1.4 Dilution Measurement of a Routine Sample ................................................................... 1—10
1.4.1.5 Reagent Blank Measurement ........................................................................................... 1—11
1.4.1.6 Reagent Blank Measurement using Purified Water ........................................................ 1—12
1.4.2 Assay Specifications of this Analyser ....................................................................................... 1—13
1.4.2.1 Wavelength....................................................................................................................... 1—13
1.4.2.2 Incubation Time................................................................................................................ 1—13
1.4.2.3 Volumes of Sample and Reagent Used............................................................................ 1—13
1.4.2.4 Minimum and Maximum Volume of Reaction Solution .................................................. 1—13
1.4.2.5 Dummy Volumes.............................................................................................................. 1—14
1.4.2.6 Dead Volume ................................................................................................................... 1—14
1.4.3 Assay Types Classification........................................................................................................ 1—14
1.4.3.1 1 Point End Method ......................................................................................................... 1—14
1.4.3.2 2 Point End Method ......................................................................................................... 1—15
1.4.3.3 Liquid Volume Offset ....................................................................................................... 1—15
1.4.3.4 1 Point Rate Method (Single Kinetic Method) ................................................................ 1—16
1.4.3.5 2 Point Rate Method (Double Kinetic Method) ............................................................. 1—16
1.4.3.6 Liquid Volume Offset ....................................................................................................... 1—17
1.4.4 Blank Measurement .................................................................................................................. 1—17
1.4.4.1 Water Blank Measurement .............................................................................................. 1—17
1.4.4.2 Reagent Blank Measurement ........................................................................................... 1—17
1 Overview
① Sample pipette Aspirates a sample from the sample carousel and discharges it into a
cuvette on the incubator.
② Mixing units Used to stir reagent and sample in a cuvette.
③ Incubator Holds cuvettes. The interior is always kept at the specified
temperature.
④ Troughs Used to wash the sample pipette, reagent pipettes and mixing unit.
⑤ Washing unit Washes cuvettes before and after measurement.
⑥ Reagent pipettes Aspirates a reagent from the reagent carousel and discharges it to a
cuvette on the incubator.
⑦ Reagent carousel Used to place reagent bottles. The interior is kept at a low
temperature.
⑧ Lamp cover Open this cover when replacing a halogen lamp.
⑨ Sample carousel Used to hold sample tubes or sample cups.
⑩ Start switch Used to confirm the added samples and restart.
⑪ STAT switch Used to transition to the mode for adding samples.
⑫ STAT LED Indicates whether it is possible to add samples to each tray.
⑬ STAT lids Used to add samples on the outer and middle trays of the sample
carousel respectively.
⑭ ISE cover Open this cover when conducting maintenance on the ISE unit.
Calibration
Execute each of the steps below and review the result:
• Partial calibration.
• Full calibration.
QC measurement
Execute the QC measurement and review the result.
Review of results
The results of the completed measurement can be searched on the Results
Screen, results can be displayed and reviewed here.
• Results can also be printed or saved in CSV format.
• If required, results can be sent to a host computer.
1.4.2.1 Wavelength
After the reagent and sample are stirred in a cuvette on the incubator, the detector unit measures the
absorbance of the reaction solution.
The detector unit gathers rays of light from a halogen lamp to pass them through the cuvette, and
measures the light simultaneously using 13 types of wavelengths predetermined by the grating method, i.e.
340, 380, 415, 450, 478, 510, 546, 570, 600, 660, 700, 750, and 800 nm (up to 2 wavelengths can be
selected for each assay).
The reagent is aspirated from the reagent bottle placed in 1-1 to 10-10 in the reagent carousel. To start
the measurement procedure, the total volume of the reagent and sample must be within the correct
volume range of the reaction solution (between the minimum and maximum of the reaction solution
volume).
The volume of the reaction solution is calculated using the following formula:
Volume of reaction solution =
Volume of sample + R1 (reagent) + R1 (purified water) + R2 (reagent) + R2 (purified water).
NOTE: Whether or not the reagent blank is present can be specified for each assay item. Refer to
Section 1.4.4.
NOTE: Whether or not the reagent blank is present can be specified for each assay item. Refer to
Section 1.4.4.
However, if the liquid volumes of photometric ranges 1 and 2 are on the same level (both photometric
ranges 1 and 2 of 1 reagent assay item occur after dispensing of the R2 reagent), the liquid volume offset
is not required (d = 1).
Variation in absorbance ΔABS at this time is calculated using the formula:
ΔABS = (A2 - B2 - C) - (A1 - C - B1).
NOTE: Whether or not the reagent blank is present can be specified for each assay item. If the reagent
blank is not corrected, variation in absorbance ΔABS is the same value as the absorbance variation of
the sample, i.e., ΔABSA.
NOTE: Whether or not the reagent blank is present can be specified for each assay item; If the reagent
blank is not corrected, variation in absorbance ΔABS can be calculated by using the following formula:
ΔABS = ΔABSA2 – d x ΔABSA1
Refer to Section 1.4.4.
Intentionally Blank
SECTION 2
BASIC OPERATIONS
Section 2 – Contents
Section 2 Basic Operations ...................................................................................................2—1
2.1 Handling of Samples................................................................................................2—3
2.1.1 Available Sample Tubes and Cups ............................................................................................. 2—3
2.1.1.1 Location of Barcode Labels on Sample Tubes .................................................................. 2—4
2.1.2 Sample Preparation .................................................................................................................... 2—4
2.1.2.1 Arrangement of Samples.................................................................................................... 2—4
2.1.2.2 Placing Sample Cups........................................................................................................... 2—5
2.1.2.3 Placing Sample Tubes ......................................................................................................... 2—7
2.1.2.4 Adding Samples during the Measurement Procedure ...................................................... 2—9
2.2 Handling of Reagents ............................................................................................ 2—12
2.2.1 Reagent Carousel ..................................................................................................................... 2—12
2.2.2 Reagent Preparation ................................................................................................................. 2—12
2.2.2.1 Placing Reagents ............................................................................................................... 2—13
2.3 Operation Software............................................................................................... 2—15
2.3.1 Screen Configuration................................................................................................................ 2—15
2.3.1.1 Status Display Area .......................................................................................................... 2—16
2.3.1.2 Status Display ................................................................................................................... 2—16
2.3.1.3 Operation Area ................................................................................................................ 2—17
2.3.2 Operations ................................................................................................................................ 2—18
2.3.2.1 Switching Screens ............................................................................................................. 2—18
2.3.2.2 Menu Icons - Main Hierarchies and Sub-Hierarchies ..................................................... 2—18
2.3.2.3 Menu Icons - Sub-Hierarchy View by Category ............................................................. 2—18
2.3.2.4 Menu Icons List ................................................................................................................. 2—19
2.3.2.5 Function Key Operations ................................................................................................. 2—20
2.3.2.6 Keyboard Shortcuts ......................................................................................................... 2—20
2.3.2.7 On-Screen Keyboard ....................................................................................................... 2—21
2.3.2.8 Touch Screen Operation ................................................................................................. 2—21
2.3.3 Rounds ...................................................................................................................................... 2—22
2.4 Online and Offline Operations ............................................................................. 2—23
2.4.1 Online Operations ................................................................................................................... 2—23
2.4.1.1 Online Real Time.............................................................................................................. 2—23
2.4.1.2 Online Batch ..................................................................................................................... 2—23
2.4.2 Offline Operations.................................................................................................................... 2—23
2.5 Startup and Shutdown .......................................................................................... 2—24
2.5.1 Startup Procedure .................................................................................................................... 2—24
2.5.1.1 Login Rights....................................................................................................................... 2—24
2.5.2 Shutdown Procedure ............................................................................................................... 2—25
2.6 Sleep Feature .........................................................................................................2—26
2.6.1 Sleep and Wakeup Settings...................................................................................................... 2—26
2.6.1.1 Sleep and Wakeup Screen ............................................................................................... 2—26
2.6.1.2 Edit the Sleep and Wakeup Time .................................................................................... 2—27
2.6.2 Switch into Sleep Mode............................................................................................................ 2—27
2.6.3 Return from Sleep Mode ......................................................................................................... 2—27
2.7 Operation Emergency........................................................................................... 2—28
2.7.1 What to Do in Case of an Alarm ............................................................................................ 2—28
2.7.2 Emergency Stop ........................................................................................................................ 2—28
2 Basic Operations
The sample carousel consists of three types of tray. Each tray has its own sample tube holders.
Type Description
Prepare and register the samples to be added and their measurement orders.
• The procedures for adding an order depend on the operating mode of the analyser.
The reagent carousel has outer and inner trays, each with its own holders.
It is capable of reading barcode labels attached to reagent bottles.
Outer tray 1 to 5 Contains five holders, each capable of storing ten 70 ml reagent
bottles.
Inner tray 6 to 10 Contains five holders, each capable of storing ten 20 ml square
reagent bottles. R1 reagents cannot be placed in the inner tray.
②
④
① Status display area This area displays status messages, start time of test, estimated end
time of measurement, and other information of the analyser.
③ Operation area This area has blue operation buttons that are used across multiple
screens.
④ Menu icons These menu icons are used to select features to be displayed or
configured.
③ Emergency Stop Icon Click this icon to bring the analyser to an emergency stop.
④ Current Date and Time Displays the current date and time.
⑥ Estimated Displays the estimated end time of the measurement procedure that
Measurement End Time is currently running.
⑦ Next Round Start Time Displays the estimated time when the next round can be started.
Display Meaning
Waiting for Start-up Communications are not established between the analyser and the
controls, or the analyser is not powered up.
Preparing The analyser is preparing for analysis, including filling cuvettes and
priming.
Ending Measurement The dispensing procedure is stopped to add samples or the dispensing
Processing (ASP Cover Can be procedure is completed.
Open)
Error Dispensing Stopping The dispensing procedure is stopped because an error has occurred.
Emergency Stop Executing The analyser was brought to an emergency stop with an error or by a
user operation.
Display Meaning
Ending Measurement An error has occurred that prevented dispensing from being
Processing (ASP Cover Can be continued.
Open)
Dispensing Ending Process Measurement was terminated after an error caused dispensing to be
Executing interrupted.
Some buttons in the operation area may not be displayed or may not be enabled at that time.
For example, if no settings are changed on the Settings screen, the Save icon ( ) will be inhibited and
cannot be clicked.
2.3.2 Operations
The analyser software (hosted on a standalone PC) is operated using a touch screen monitor or with a
standard keyboard or mouse. This manual explains the operations of the analyser using a mouse and
keyboard, unless otherwise indicated.
8 Shut down Shuts down the software and turns OFF the power to the analyser PC.
For the icons in the sub hierarchy and screen transitions, refer to the Appendices.
NOTE: Depending on the login rights of the user, some menu icons may not be displayed.
F12 Tab menu move down Moves one tab menu down.
Shift + Esc Warning sound Stops a warning sound that is emitted when an alarm has
stop occurred.
Key Description
Changes the on-screen keyboard transparency to aid in viewing the whole screen.
The keyboard returns to its normal appearance when used.
Docks the on-screen keyboard from a pop-up window into the software.
Recommended if keyboard input is frequently required.
Operation Description
Pull-down menu When tapped, a list of menu items are displayed from which items can be selected.
List menu For an item for which you can enter characters and select pre-written content from
a pull-down menu, if you tap an entry field and tap Space on the on-screen
keyboard, the available items will be listed.
Check box This is a square box allowing users to tap to select or deselect an option.
A check mark / tick ( ) in the box indicates that the option is enabled.
2.3.3 Rounds
This analyser manages cycles of measurements in units of a ‘round’. A round represents a cycle from the
start to the end of a measurement.
• Rounds are numbered sequentially each day.
• Rounds can be used to identify the number of tests per day or as search conditions for
measurement results.
When the Windows desktop screen is displayed, double-click the [Analyser] icon.
The Login screen will be displayed.
CAUTION: Do NOT turn the PC power off with the analyser in sleep mode. The automatic wake
from standby will not take place.
② ③
SECTION 3
ACCESSORY FUNCTIONS
Section 3 − Contents
Section 3 Accessory Functions ............................................................................................. 3—1
3.1 Parameter Settings .................................................................................................3—3
3.1.1 Setup Screen ............................................................................................................................... 3—3
3.1.1.1 Parameter 1 Screen ............................................................................................................ 3—3
3.1.1.2 Parameter 2 Screen ............................................................................................................ 3—7
3.1.2 Register a Parameter .................................................................................................................. 3—8
3.1.3 Editing a Parameter .................................................................................................................... 3—9
3.1.4 Copying a Parameter................................................................................................................ 3—10
3.1.5 Importing Parameters............................................................................................................... 3—11
3.1.6 Export a Parameter .................................................................................................................. 3—12
3.1.7 Delete a Parameter .................................................................................................................. 3—13
3.1.8 Print a Parameter...................................................................................................................... 3—13
3.1.9 Various Range Settings ............................................................................................................. 3—14
3.1.9.1 Normal Range .................................................................................................................. 3—14
3.1.9.2 Technical Range ................................................................................................................ 3—15
3.1.9.3 Comparison Check (%) ................................................................................................... 3—15
3.1.9.4 Abnormal Range ............................................................................................................... 3—15
3.1.9.5 Panic Range ....................................................................................................................... 3—15
3.2 Limit Check Settings ............................................................................................. 3—16
3.2.1 Linearity Limit ........................................................................................................................... 3—16
3.2.2 Prozone Limit ........................................................................................................................... 3—17
3.2.2.1 Absorbance Limit ............................................................................................................. 3—18
3.2.3 Range Shift Function ................................................................................................................. 3—19
3.3 Reagent Blank and C1 Blank ................................................................................ 3—20
3.3.1 Measuring Conditions .............................................................................................................. 3—20
3.3.2 Reagent Blank Timing ............................................................................................................... 3—20
3.3.3 Reagent Blank Method ............................................................................................................. 3—21
3.3.4 Replication ................................................................................................................................ 3—21
3.3.5 Reagent Blank Deviation Limit ................................................................................................. 3—21
3.4 Normal Range Name Settings ............................................................................. 3—22
3.4.1 Normal Range Screen .............................................................................................................. 3—22
3.4.2 Registered a Normal Range Name.......................................................................................... 3—23
3.4.2.1 Editing a Normal Name Range ........................................................................................ 3—24
3.4.2.2 Deleting a Normal Range Name ..................................................................................... 3—25
3.5 Setting Measurements of Serum Indices ............................................................ 3—26
3.5.1 Serum Indices Screen ............................................................................................................... 3—26
3.5.2 Serum Indices............................................................................................................................ 3—27
3.5.3 Settings Related to Measurements of Serum Indices .............................................................. 3—28
3.5.4 Settings Related to Measurements of Serum Indices .............................................................. 3—29
3.5.4.1 Edit Defined Settings for Serum Indices Measurements ................................................. 3—30
3.5.4.2 Print Defined Settings for Serum Indices Measurement ................................................. 3—30
3.5.5 Running Order .......................................................................................................................... 3—31
3.5.5.1 Running Order Screen ..................................................................................................... 3—31
3.5.5.2 Run Order Settings........................................................................................................... 3—32
3.6 Contamination Prevention Settings .................................................................... 3—33
3.6.1 Contamination Prevention Screen........................................................................................... 3—33
3.6.2 Registering a Contamination Prevention Setting..................................................................... 3—34
3.6.3 Edit a Contamination Prevention Setting ................................................................................ 3—35
3.6.4 Delete a Contamination Prevention Setting ........................................................................... 3—36
3.6.5 Printing a Contamination Prevention Setting .......................................................................... 3—36
3 Accessory Functions
① ②
⑮
⑯
③
⑰
⑤ ④
⑱
⑥ ⑲
⑦ ⑳
⑫ ⑩ ⑪
⑬
21
22
23 24 25
⑭
⑤ Unit Enter a unit for the assay item (using up to six alphabet characters and
symbols).
NOTE: Depending on the analyser settings, the editing of items in user level L3 may also be unavailable.
For details, contact your Randox Representative.
③
①
②
④
NOTE: Depending on the analyser settings, the editing of items in user level L3 may also be unavailable.
For further details, contact your Randox Representative.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
Click ( …).
• The folder select dialog box is
displayed.
Click Import.
• Parameters are imported.
• All the parameter setting files
contained in the folder are imported.
• The imported parameters can be
selected from assay numbers.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
Click ( …).
• The folder selection screen is
displayed.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
To specify the threshold for the variation in absorbance from 1 to 99,999 (mAbs/10)/per min.) and the
threshold in percentage form from 0.1 to 99.9 (%).
• Linearity is checked based on the slope ratio between the first and second halves of the
photometric range. The gradient ratio of photometric range 2 is used for the 2 point rate
method.
• If the linearity ratio is greater than the set value, a linearity error occurs and an error flag [LIN] is
shown on the measurement results.
• If ΔABS1 is less than the sensitivity limit, a Prozone check is not performed.
• If a measurement value exceeds the allowable limit of the Prozone check value, an error flag
PRO is added to the measurement results and automatic rerun (high) will be applied.
Set the Reaction Trend (increase or reduce) and the Limit value (1 to 999,999).
Set the Limit absorbance as the upper limit for increased reaction, or set it as the lower limit for
reduced reaction, and perform the allowable limit check of absorbance.
• The absorbance is calculated in the range of the formula: (Absorbance of primary wavelength -
Water blank of primary wavelength) < Limit value.
• The inside of the photometric range is checked for 1 point rate reaction, while the reaction on
the part of photometric range 2 is checked for 2 point rate reaction.
• When 2 or more starting measuring points are within the absorbance limit, ΔABS is calculated
using the absorbance of measuring points within the range. If the value exceeds the absorbance
limit set on the Parameter 2 screen, an error flag (AB2) is displayed on the measurement results.
• When 8 or more continuous measuring points are within the absorbance limit or when all
measuring points are within the limit, error flag (AB2) is not displayed.
• When there is 1 or less measuring point within the limit, error flag (AB1) is displayed. The
measurement results are not displayed in this case.
①
②
③
3.3.4 Replication
Select the frequency of reagent blank measurement from the drop-down menu.
①
②
③
NOTE: The initial values are registered in No. 01 to 06 as shown in the following.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
CAUTION: The numeric values may not match the actual concentrations of lipids,
Haemolytic haemoglobin and bilirubin under the influence of medical agents or other factors.
Do not use serum indices as the basis for diagnosis.
⑥ ⑦
①
② ⑧
③
④
⑤
⑨
⑦ Instrument Factor The discrepancies in measurement results due to using different devices
can be corrected for each assay item.
Assay items that can be corrected are Haemolytic, Lipid, and Icteric.
Enter a and b values for correction expression Y = aX + b. (a (slope):
-99.9 to 99.9, b (intercept): -999.99 to 999.99).
⑧ Haemolytic Specify a display format for qualitative determination.
NOTE: Depending on the analyser settings, the editing of items in user level L3 may also be unavailable.
For details, contact your Randox Representative.
Although we recommend that you use the following factors, relevant factors can be set as necessary.
A: 1271, B: 42189, C: 320, D: 4350, E: 889020, F: 223968.
NOTE: Set the qualitative determination character for each index and threshold values as indicated
below.
If the measurement results are H=20, L=200, I=30, results of qualitative determination of serum
indices are displayed as H1 L++ I---.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
① ②
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
SECTION 4
PREPARATION FOR MEASUREMENT
Section 4 − Contents
Section 4 Preparation for Measurement............................................................................. 4—1
4.1 Check Consumables ................................................................................................4—3
4.1.1 Check Detergent ........................................................................................................................ 4—3
4.1.2 Check the Halogen Lamp Operating Time ............................................................................... 4—3
4.2 Check Reagents .......................................................................................................4—4
4.2.1 Check Reagent Bottles ............................................................................................................... 4—4
4.2.1.1 Register a Reagent Bottle with a Barcode......................................................................... 4—5
4.2.1.2 Enter Information on the Inventory Screen to Register a Reagent Bottle....................... 4—6
4.2.1.3 Delete Registration Information of an Unnecessary Reagent Bottle ............................... 4—7
4.2.1.4 Print Registration Information of a Reagent Bottle........................................................... 4—8
4.2.2 Inventory Screen......................................................................................................................... 4—9
4.3 Register Patient Information ............................................................................... 4—11
4.3.1 Register and Edit Patient Information ...................................................................................... 4—11
4.3.1.1 Register Patient Information ............................................................................................ 4—11
4.3.1.2 Edit Patient Information ................................................................................................... 4—12
4.3.1.3 Import Patient Information .............................................................................................. 4—13
4.3.1.4 Export Patient Information .............................................................................................. 4—14
4.3.1.5 Delete Unnecessary Patient Information ........................................................................ 4—15
4.3.2 Patient Registration Screen ...................................................................................................... 4—16
4.4 Check the Analyser Status ................................................................................... 4—18
NOTE: If it is not within the available range, replace the halogen lamp. See Section 9.7.1.
If the remaining volume of reagent is insufficient, place a new reagent bottle in the reagent
carousel. Refer to Section 2.2.2.
If the remaining amount of reagent is insufficient, place a new reagent bottle into the reagent
carousel.
• Write down the position at which a new reagent bottle has been placed.
Click OK.
• This deletes the registration
information of the reagent bottle.
②
③
④
⑦ ⑤ ⑥
⑧
⑨
⑩
⑪
⑫
⑬
⑭ ⑮
⑯
① Reagent Bottle List Displays a list of reagent bottles placed in the reagent carousel. To
register a reagent bottle, select the desired position from this list.
② Position Select a position to place a reagent bottle in the reagent carousel.
③ Reagent Name*1 Displays the name of the reagent that is contained in the bottle at the
selected position.
• If registered, click Reagent Selection to select the
registered reagent name.
④ Reagent Type Select the type (R1/R2 reagent, detergent, or diluent) of the reagent
that is contained in the bottle at the selected position.
⑤ Lot No. Enter the lot number of the reagent that is contained in the bottle at
the selected position (001 to 999).
• If reagent lot number is skipped, this item will be blank.
⑥ Bottle Size Select the capacity of the bottle at the selected position.
• All the capacities can be selected at positions 1-1 to 5-10.
• The capacity is limited to 20 ml at positions 6-1 to 10-10.
⑦ Volume (ml) Enter the remaining amount of the reagent that is contained in the
bottle at the selected position.
• When a reagent is first registered, its remaining amount is
set to the maximum volume of the bottle.
• The default volume is indicated by the value that is obtained
by subtracting the dead volume from the maximum volume.
⑧ Number of Tests Displays the number of tests that are able to be measured with the
bottle at the selected position.
⑨ Assay Name Displays the assay item name that is set to the reagent of the bottle at
the selected position.
⑩ Total Number of Tests*2 Displays the number of tests that can be measured with all the bottles
placed in the reagent carousel for each assay item.
⑪ Expiry Date Double-click the item field, then select the expiry date of the reagent
of the bottle at the selected position.
• If the expiry date is skipped, this item will be blank.
⑫ Onboard Stability Displays the remaining number of days to ensure the stability of the
reagent that is contained in the bottle at the selected position.
• Used to check reagent bottles for which the stability period
check is enabled.
⑬ Barcode Displays the information received from scanning the barcode that is
placed on the bottle at the selected position.
• The information of a barcode can be entered directly from
this item.
⑭ Reagent Scan Starts scanning the barcode of each reagent bottle in the reagent
carousel.
• If item 13 contains the information of the specified barcode,
it is overwritten by the information of the new barcode that
is scanned from the reagent bottle at the same position.
The setting of item 13 is maintained when:
• Reagent scanning is carried out when there are no reagent
bottles set at the same position; and reading of the barcode
at the target position has failed during scanning of the
reagent.
• If necessary, reagent scanning can be performed
automatically when the reagent carousel cover is opened or
closed.
Click Import.
• The folder selection dialog box is
displayed.
Click Open.
• Patient information is imported.
• The imported patient information is
added to the patient information list
in the right hand pane of the screen.
Click Export.
• The folder selection dialog box is
displayed.
Click Open.
• The patient information file is saved
in the specified folder.
• If a patient information file with the
same name already exists in the
folder, it is overwritten.
Click OK.
• Patient information is deleted.
⑯
① ②
③ ④
⑤
⑥
⑦
⑧
⑨
⑩ ⑪
⑫
⑬
⑭
⑮ ⑰ ⑱ ⑲
⑯ Patient Displays a list of patient information (patient ID, patient name, and social
information list security number).
• The number of registered patient information items is displayed
at the bottom of the list.
SECTION 5
CALIBRATION
Section 5 − Contents
Section 5 Calibration .............................................................................................................5—1
5.1 Overview ..................................................................................................................5—3
5.1.1 Flow of Calibration Measurement ............................................................................................. 5—4
5.2 Preparation ..............................................................................................................5—5
5.2.1 Register Orders with Manual Entry ........................................................................................... 5—5
5.2.1.1 Normal Calibration ............................................................................................................ 5—5
5.2.1.2 Worklist Screen (Calibration) ........................................................................................... 5—7
5.2.1.3 Multi-Calibration................................................................................................................. 5—8
5.2.1.4 Worklist Screen > Multi-Calibration ............................................................................... 5—10
5.2.1.5 Diluted Calibration ........................................................................................................... 5—11
5.2.1.6 C1 Blank............................................................................................................................ 5—13
5.2.1.7 Worklist Screen > Diluted Calibration/C1 Blank Measurement .................................. 5—14
5.2.2 Register Orders with Sample Barcodes .................................................................................. 5—15
5.2.3 Copying and Deleting Orders .................................................................................................. 5—15
5.3 Execute Calibration............................................................................................... 5—16
5.4 Check Results.........................................................................................................5—16
5.5 Multi-Calibration Settings .................................................................................... 5—17
5.5.1 Multi-Calibration Screen .......................................................................................................... 5—17
5.5.2 Register the Multi-Calibrator ................................................................................................... 5—18
5.5.3 Edit the Multi-Calibrator .......................................................................................................... 5—19
5.5.4 Delete the Multi-Calibrator ..................................................................................................... 5—20
5.5.5 Print the Multi-Calibrator ......................................................................................................... 5—21
5.6 Diluted Calibration Settings ................................................................................. 5—22
5.6.1 Register the Diluted Calibration Settings ................................................................................ 5—23
5.6.2 Edit the Diluted Calibration Settings ....................................................................................... 5—24
5.6.3 Delete the Diluted Calibration Settings................................................................................... 5—25
5 Calibration
5.1 Overview
Calibrations are required to calculate the calibration curve to use as the measurement standard on the
analyser and for correcting the calibration curve. This involves executing the measurement of calibrators
that reproduce the concentration of a specific component.
Calibration is broadly divided by usage as follows:
Required Execute at the frequency specified for each Frequency specified for each assay
Frequency*1 assay item, or in the following cases: item.
NOTE: *1 - For details on the calibration frequency, contact the manufacturer or distributor of the
reagents to be used and the corresponding calibrators.
Normal This is the normal calibration executed for each assay item.
calibration
Multi-calibration This calibration uses a multi-calibrator that can be applied to multiple assay items.
Diluted This calibration is used instead of using a separate calibrator for each
calibration concentration, by diluting a calibrator with the maximum concentration.
C1 blank This is partial calibration using a C1 blank sample that can be applied to multiple
assay items.
This manual describes the actual work performed for calibration; namely, registering orders for
measurement, the measurement execution and checking methods.
For details about the calibration curve, calibration settings and the execution schedule, check with the
administrator in advance.
Calibrator Preparation
Order Registration
Measurement Start
Results Check
5.2 Preparation
5.2.1 Register Orders with Manual Entry
The following explains the method for directly entering the order for calibration measurement from the
Worklist screen.
NOTES:
• When placing calibrators in the middle tray or outer tray, check the number label on the tray
and place the calibrators in a position with a smaller number than any routine sample.
• When executing full calibration, check the number label on the tray and be sure to place the
calibrators in the sample carousel in sequence, starting with the calibrator with the lowest
concentration.
• When executing partial calibration, register a separate order for each measuring point of the
calibrators with the required concentration.
NOTE: In calibration and QC measurement, a template function can be used to register a combination
of sample placement positions and orders in advance, which can be called later. When templates are
registered, the required settings can be called and used from Template on the Worklist screen.
To set up a template, refer to Section 7.7.2.
For details on the Worklist screen and the corresponding operations, refer to Section 7.9.1.
When Calibrator is selected in Sample Category on the Worklist screen, the screen switches to the
following display.
① ②
③ ④
② Template*1 Calls a template in which a combination of the status of each sample in the
sample carousel and the individual orders has been registered in advance.
③ Pos. (From) Select the position of the samples to use for measurement. To execute full
calibration, specify the position of the lowest concentration calibrator (C1).
④ No. Select the concentration to execute calibration.
• To execute full calibration, select Full.
• To execute partial calibration, select from C1 to C7.
⑤ Assay Items*2 • Select the check box to the left side of an assay item name to order
measurement for the corresponding assay.
• The background colour of the assay item indicates warnings. If both
red and yellow are activated, the red warning display is prioritised.
o Red: Calibration has not been executed or the effective period
has expired.
o Yellow: QC measurement has not been executed, or the
measurement interval for QC has elapsed.
o Grey: The reagent bottles have not been registered.
*1
The administrator can configure the setting of this item on the Template screen.
• *2
The administrator must set the registration contents of this item in advance on the Parameter
1 screen and Parameter 2 screen. Also, the calibration settings must be registered for each assay
item on the Calibration screen.
5.2.1.3 Multi-Calibration
NOTES:
• When placing calibrators in the middle tray or outer tray, check the number label on the tray
and place the calibrators in a position with a smaller number than any routine sample.
• When executing full calibration, check the number label on the tray and be sure to place the
calibrators in the sample carousel in sequence, starting with the calibrator with the lowest
concentration.
• When executing partial calibration, register a separate order for each measuring point of the
calibrators with the required concentration.
NOTE: In calibration and QC measurement, a template function can be used to register a combination
of sample placement positions and orders in advance, which can be recalled later. When templates are
registered, the required settings can be used from Template on the Worklist screen.
When Multi-Calibrator is selected in Sample Category on the Worklist screen, the screen switches to
the following screen.
① ②
③ ④
① Sample List Lists the samples registered in the sample carousel and their positions.
② Template*1 Calls a template in which a combination of the status of each sample in the
sample carousel and the individual orders has been registered in advance.
③ Pos. (From) Select the position of the samples to use for measurement.
⑥ Assay items*3 When the multi-calibrator name is selected, the check boxes to the left side
of the assay item names that are set for calibration are selected automatically.
Deselect check boxes as necessary.
Place a calibrator (to use for diluted calibration) in the sample carousel. Refer to Section 2.1.2.
NOTE: When placing calibrators in the middle tray or outer tray, check the number label on the tray
and place the calibrators in a position with a smaller number than any routine sample.
NOTE: In calibration and QC measurement, a template function can be used to register a combination
of sample placement positions and orders in advance, which can be selected later. When templates are
registered, the required settings can be selected from Template on the Worklist screen.
The administrator can configure the settings of the template from the Template screen.
5.2.1.6 C1 Blank
Place a calibrator (to use for diluted calibration) in the sample carousel. Refer to Section 2.1.2.
NOTE: When placing calibrators in the middle tray or outer tray, check the number label on the tray
and place the calibrators in a position with a smaller number than any routine sample.
NOTE: In calibration and QC measurement, a template function can be used to register a combination
of sample placement positions and orders in advance, which can be selected later. When templates are
registered, the required settings can be selected from Template on the Worklist screen. The
administrator can configure the settings of the template from the Template screen.
① ②
③
④
⑤
① Sample list Lists the samples registered in the sample carousel and their positions.
② Template*1 A template containing each sample and assay requiring calibration that is
registered in advance.
④ Pos. (From) Select the position of the samples to use for measurement.
• Select the check box to the left side of an assay item name to order
measurement for the corresponding assay.
When C1 Blank is selected in Sample Category.
• The check boxes to the left side of the assay names set for
calibration are selected automatically. Deselect check boxes as
necessary.
The background colour of the assay item indicates a warning.
• *1 The administrator can configure the setting of this item on the Template screen.
• *2 The administrator must set the registration contents of this item in advance on the Parameter
1 screen and Parameter 2 screen. Also, the calibration settings must be registered for each assay
on the Calibration screen and Diluted Calibration screen.
• Place the same way for multi-calibration, diluted calibration and C1 blank.
NOTE: For details on registering orders with sample barcodes, refer to Section 7.2.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
① ③ ④ ⑤
⑤ Offset Enter this value to correct the effects of any minute amounts of fluid
remaining in the cuvette.
SECTION 6
QC MEASUREMENT
Section 6 − Contents
Section 6 QC Measurement .................................................................................................6—1
6.1 Overview ..................................................................................................................6—3
6.1.1 Flow of QC Measurement ......................................................................................................... 6—3
6.2 Preparation ..............................................................................................................6—4
6.2.1 Registering Orders with Manual Entry ...................................................................................... 6—4
6.2.1.1 Worklist Screen (QC Measurement)................................................................................ 6—5
6.2.2 Register Orders with Samples Barcodes ................................................................................... 6—6
6.2.3 Copying and Deleting Orders .................................................................................................... 6—6
6.3 Execute QC Measurement ..................................................................................... 6—7
6.4 Check Results in the QC Chart .............................................................................. 6—7
6.4.1 Check the QC Results for 1 Day............................................................................................... 6—7
6.4.2 Check the Cumulative Results for 30 Days in the Past ............................................................ 6—9
6.4.3 QC Chart Screen ..................................................................................................................... 6—11
6.5 Check Results in the QC Results List .................................................................. 6—13
6.5.1 Search and Filter QC Measurement Results ........................................................................... 6—13
6.5.1.1 Check the QC Results for 1 Day..................................................................................... 6—13
6.5.1.2 Check the QC Results for a Specified Period ................................................................. 6—15
6.5.1.3 Check the QC Results for an Item .................................................................................. 6—17
6.5.2 Delete or Output the QC Table Screen ................................................................................. 6—19
6.5.2.1 Delete Unnecessary QC Measurement Results ............................................................. 6—19
6.5.2.2 Print QC Measurement Results....................................................................................... 6—20
6.5.2.3 Output QC Measurement Results to a File .................................................................... 6—21
6.5.3 QC Table Screen ...................................................................................................................... 6—22
6.5.3.1 Search Function Area ....................................................................................................... 6—22
6.5.3.2 QC Table Screen (Daily) ................................................................................................. 6—24
6.5.3.3 QC Table Screen (Cumulative) ....................................................................................... 6—26
6.5.3.4 QC Table Screen (Detail) ................................................................................................ 6—28
6.6 Register QC Samples ............................................................................................ 6—29
6.6.1 QC Sample Registration Screen .............................................................................................. 6—29
6.6.2 Register Samples ....................................................................................................................... 6—30
6.6.3 Edit QC Samples ...................................................................................................................... 6—31
6.6.4 Delete QC Samples.................................................................................................................. 6—32
6.7 Set the Conditions for QC .................................................................................... 6—33
6.7.1 QC Range Screen ..................................................................................................................... 6—33
6.7.1.1 Replication ........................................................................................................................ 6—35
6.7.1.2 Judgement Conditions...................................................................................................... 6—35
6.7.1.3 Set the QC Range ............................................................................................................ 6—36
6.7.1.4 Edit the QC Range ........................................................................................................... 6—37
6.7.1.5 Delete the QC Range ...................................................................................................... 6—38
6.7.1.6 Print the QC Range .......................................................................................................... 6—38
6.1 Overview
To guarantee the accuracy of measurement within the analyser, it must clearly show the accuracy level
when routine samples are measured. QC measurement is a function for maintaining and managing
accuracy based on the results of measuring QC samples for which a certain concentration has been
defined.
NOTE: Calibration must be performed before measuring routine samples.
2. Order Registration
Register the order for QC measurement.
3. Measurement Execution
Execute QC measurement.
4. Results Check
Check the results of QC measurement.
6.2 Preparation
6.2.1 Registering Orders with Manual Entry
Entering the order for QC measurement from the Worklist screen:
In calibration and QC measurement, a template function can be used to register in advance, a combination
of sample placement positions and orders for later selection.
When templates are registered, the required settings can be used from Template on the Worklist
screen.
The administrator can configure the settings of the template from the Template screen.
① ②
③
④
⑤
⑤ Assay Items When the QC sample name is selected, the check boxes to the left
side of the assay item names that are set for QC measurement are
selected automatically. Deselect check boxes are necessary.
The background colour of the assay item indicates warnings. If both
red and yellow are activated, the red warning display is prioritised.
Red: Calibration has not been executed or the effective period has
expired.
Yellow: QC measurement has not been executed, or the
measurement interval for QC has elapsed.
Grey: The reagent bottles have not been registered.
*1 The administrator can configure the setting of this item on the Template screen.
*2 The administrator must set the registration contents of this item in advance on the QC Sample
Registration screen.
*3 The administrator must set the registration contents of this item in advance on the Parameter 1
screen and Parameter 2 screen. Also, the accuracy values to be managed must be registered on the QC
Range screen.
NOTE: For details on registering orders with sample barcodes, refer to Section 7.2.
Click Execute.
• The QC results of the specified date
are displayed in a chart.
Click Execute.
• The QC results of 30 days in the
past including the specified date are
displayed in a chart.
• If multiple QC measurements was
performed on the same day, the results
are displayed together on the vertical
axis.
⑤ ⑨
② Assay Name Displays the assay item name. Entered automatically when Assay
No. is selected.
③ Date Specify the date for starting the graph search.
• Enter the search start date directly on the keyboard, or
specify the date from the calendar screen displayed in
the drop-down menu.
④ Display Format Select the display format of the chart from the drop-down menu.
• Daily: Displays the QC data for 1 day on the date
specified in Date.
• Cumulative: Displays the cumulative QC data going back
30 days in the past from the specified date.
⑤ Execute Executes the search for QC data.
Click Execute.
• The data calculated from the QC
results of the specified date are listed in
QC Table Screen (Daily).
Check the QC results to see whether the accuracy has been maintained.
• When QC results deviate greatly from the average value, the cause must be identified and
corrected.
Click Execute.
• The data calculated from the QC
results of the specified period are listed
in QC Table Screen
(Cumulative).
Check from the QC results that the
accuracy has been maintained.
• When QC results deviate greatly
from the average value, the cause
must be identified and remedied.
Click Execute.
Check from the QC results that accuracy
has been maintained.
• When QC results deviate greatly from
the average value, the cause must be
identified and corrected.
Click OK.
• The displayed QC measurement
results are deleted.
• When there are 1000 or more
deletion targets, a confirmation
screen is displayed to inform you that
deletion is not possible. Click OK
and change the search conditions.
Click Execute.
• The print dialog box appears.
Click Execute.
• The save file dialog box is displayed.
①
⑦
②
③
④
① ② ③ ④ ⑤ ⑥ ⑦ ⑧ ⑨ ⑩
⑩ WARNING/ERROR When QC data in the search results exceeds the standard set for
WARNING or ERROR, the corresponding concentration is
displayed.
• When the judgment results contain multiple errors, the
error with the highest priority is displayed.
*
1 The administrator must register the judgement standard for WARNING and ERROR in advance on
the QC Sample Registration screen.
① ② ③ ④ ⑤ ⑥ ⑦ ⑧ ⑨ ⑩
① ② ③ ④ ⑤ ⑥ ⑦ ⑧ ⑨
6.6.1
① QC Sample Registration Screen
⑤
③
①
②
③ QC Sample Lot No. Enter the QC sample lot number (using up to 6 alphanumeric
characters).
④ Linked Assay Names Displays the assay items linked to the QC sample.
①
②
③ ⑤
④
⑥ ⑧ ⑨
⑥ Point (*2) Set the range for past measurement results (1 to 99).
• Set how many past measurement results to use, starting from the
latest measurement results.
⑦ QC Sample Name Select the QC samples.
⑧ Mean Value If the Mode is Mean-R, enter the average concentration of the QC
samples.
• If the Mode is X-R, the average concentration calculated from
the measurement results is displayed.
⑨ SD Enter the standard deviation value for the QC samples
(0.001 to 999.999).
⑩ Rules The value is determined based on the SD value of the measurement
results for the QC samples, and the result trend.
• There are 10 types of judgement conditions and a flag can be
added to the judgement results.
For the judgment results, the plot for each measurement result is
displayed on the QC Chart screen in colour.
• Black: Not judgement.
• Yellow: Warning.
• Red: Error.
If multiple judgement results have been added to a single measurement
result, the highest judgement conditions will be displayed.
• For details on the judgement conditions, refer to Section 6.7.1.2.
*1 If Mode is X-R, it is necessary to specify the range for the QC table that will be used.
*2 If Mode is X-R.
6.7.1.1 Replication
Specify the number of QC measurements.
①
②
③
② Duplicate Sets the QC range to the average obtained from the results of 2
measurements.
③ Triplicate Sets the QC range to the median obtained from the results of 3
measurements.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
SECTION 7
SAMPLE MEASUREMENT
Section 7 − Contents
Section 7 Sample Measurement .......................................................................................... 7—1
7.1 Overview ..................................................................................................................7—5
7.1.1 Flow of Sample Measurement ................................................................................................... 7—5
7.2 Register Orders .......................................................................................................7—6
7.2.1 Register Orders Online .............................................................................................................. 7—6
7.2.1.1 When Barcodes are Used Online in Real Time Mode ..................................................... 7—6
7.2.1.2 When Barcodes are NOT Used Online in Real Time Mode........................................... 7—6
7.2.1.3 When Barcodes are used in Online Batch Mode ............................................................. 7—7
7.2.1.4 When Barcodes are NOT used in Online Batch Mode ................................................... 7—8
7.2.2 Register Orders Offline .............................................................................................................. 7—9
7.2.2.1 Register Orders Using Manual Entry ................................................................................. 7—9
7.2.2.2 Register Orders through Barcodes ................................................................................. 7—11
7.2.3 Copying Order ......................................................................................................................... 7—12
7.2.4 Delete Unnecessary Orders .................................................................................................... 7—13
7.2.4.1 Delete an Individual Order .............................................................................................. 7—13
7.2.4.2 Delete Multiple Orders .................................................................................................... 7—13
7.2.4.3 To Batch-Delete Orders.................................................................................................. 7—14
7.2.5 Worklist Screen ........................................................................................................................ 7—15
7.3 Execute Measurement .......................................................................................... 7—18
7.4 Orderless Test .......................................................................................................7—18
7.4.1 Set the Orderless Items ........................................................................................................... 7—19
7.4.2 Change Orderless Settings ...................................................................................................... 7—20
7.5 Monitor Measurement Progress .......................................................................... 7—21
7.5.1 Monitor the Sample and Reagent Status ................................................................................. 7—21
7.5.1.1 Carousel Monitor Screen................................................................................................. 7—22
7.5.1.2 Display of Sample Categories .......................................................................................... 7—22
7.5.1.3 Display of Measurement Status ....................................................................................... 7—23
7.5.1.4 Display of Reagent Placement Status .............................................................................. 7—23
7.5.2 Monitor Detailed Measurement Progress ............................................................................... 7—24
7.5.2.1 Round Monitor Screen..................................................................................................... 7—24
7.6 Set the Panel Test .................................................................................................7—26
7.6.1 Panel Test Screen ..................................................................................................................... 7—26
7.6.2 Register the Panel Test............................................................................................................. 7—27
7.6.3 Edit the Panel Test.................................................................................................................... 7—28
7.6.4 Delete the Panel Test ............................................................................................................... 7—29
7.6.5 Print the Panel Test .................................................................................................................. 7—30
7.7 Set Templates........................................................................................................7—31
7.7.1 Template Screen....................................................................................................................... 7—31
7.7.2 Register a Template ................................................................................................................. 7—32
7.7.3 Edit a Template......................................................................................................................... 7—33
7.7.4 Delete a Template.................................................................................................................... 7—34
7.7.5 Print a Template ....................................................................................................................... 7—35
7.7.6 Import a Template ................................................................................................................... 7—35
7.7.7 Execute an Auto Template ...................................................................................................... 7—35
7.8 Set the Calculated Testing ................................................................................... 7—36
7.8.1 Calculated Test Screen ............................................................................................................ 7—36
7.8.2 Register a Calculated Test ....................................................................................................... 7—38
7.8.3 Edit a Calculated Test............................................................................................................... 7—39
7.8.4 Delete a Calculated Test.......................................................................................................... 7—40
7.8.5 Print a Calculated Test ............................................................................................................. 7—41
Intentionally Blank
7 Sample Measurement
7.1 Overview
For measurements of routine samples, the workflow of sample measurements involving the placement of
samples and registration of orders is similar to that of calibration measurement and QC measurement.
This section explains how to measure routine samples, how to review measurement progress, and how to
add samples during measuring.
1. Preparing Samples
Place routine samples in the sample carousel.
2. Registering Orders
Register the order of measurement.
3. Executing Measurement
Execute measurement.
5. Adding Samples
Add samples as needed.
6. Finishing Measurement
Once measuring is finished, the ending procedure starts.
7.2.1.2 When Barcodes are NOT Used Online in Real Time Mode
When barcodes are not used (for example, when barcode reading fails), manually enter sample IDs using
the following steps.
NOTE: If the Emergency check box is selected, the measurement of that routine samples takes
precedence.
NOTE: If the Emergency check box is selected, the measurement of that routine samples takes
precedence.
Click Save ( ).
• The order is registered.
NOTE: It is possible to consecutively copy the registered order of SID (From) to SID (To) by selecting
SID (From) and SID (To).
Click OK.
• The order of the selected sample
ID is deleted.
Click OK.
• The order of the selected Sample
ID is deleted.
Click OK.
• All orders that have been registered
are deleted.
② ③
④
⑤ ⑥
⑦ ⑧ ⑨ ⑩
⑪
⑬ ⑭
⑪ Each time the button is clicked, the view of item 13 toggles between
the list of assay items and diagnostic information entry area. Refer to
Section 7.2.5.
⑫ Assay Select the check box to the side of an assay item name to order
measurement for the corresponding assay item.
The background colour of the assay item indicates warnings. If both
red and yellow are activated, the red warning display is prioritised.
• Red: Calibration has not been executed or the effective
period has expired.
• Yellow: QC measurement has not been executed, or the
measurement interval for QC has elapsed.
• Grey: The reagent bottles have not been registered.
⑬ Host Query The order is obtained from the host.
⑭ Rotate Carousel Used to rotate the sample carousel until available holders come under
the STAT lid when adding samples to multiple holders during
measurement.
• *1 Selecting the Manual Scan check box allows entry of a sample ID using a barcode scanner
(sold separately) instead of entering it through the keyboard.
• *2 Depending on the combination of Sample Category and Vessel settings, the high-order digits of
sample ID may result in a fixed value. In this case, you can arbitrarily set the numbers in the range
shown below within the sample ID.
• *3 The sample aspiration volume for each of Decrease, Normal, and Increase options has been
preset by the administrator. The administrator can set the sample aspiration volume for each of
the Decrease, Normal, and Increase options for each parameter on the Parameter 1 screen.
NOTE: Click on the Print icon ( ) to print the registered content of the order.
Press the F1 key while holding down the Shift key on the keyboard.
• The Orderless Test confirmation dialog box is displayed.
The function that measures all the measurable assay items for all the samples placed in the sample
carousel is called the ‘orderless test’.
• Before performing an orderless test, set the assay items for which measurement is
permitted.
① Assay items Displays the assay item list. Here, select the assay items for permitting
orderless measurement by ticking the check boxes.
NOTES:
• Samples can be added during the measurement procedure.
• If anything is wrong in the information displayed on the Carousel Monitor screen, contact the
administrator.
① ②
NOTES:
• Samples can be added during the measurement procedure. For details, refer to Section 7.11
during the Measurement Procedure.
• If you find anything wrong in the information displayed on the Round Monitor screen, contact
your administrator.
① ② ③
④ ⑤ ⑥ ⑦ ⑧ ⑨ ⑩ ⑪ ⑫
⑧ Status Shows the measurement progress with bar graphs. If an error occurs,
‘E‘ is displayed to enable identification of which stage the error
occurred.
R1 The progress bar indicates that the dispensing of R1 reagent is
completed when it has reached 100%.
S The progress bar indicates that the dispensing of samples is completed
when it has reached 100%.
M1 The progress bar indicates that the first stirring is completed when it
has reached 100%.
O1 The progress bar indicates that the first reaction is completed when it
has reached 100%.
R2 The progress bar indicates that the dispensing of R2 reagent is
completed when it has reached 100%.
M2 The progress bar indicates that the second stirring is completed when
it has reached 100%.
O2 The progress bar indicates that the second reaction is completed
when it has reached 100%.
⑨ Results Displays measurement results in terms of numbers.
⑩ Cuvette No. Displays the number assigned to the cuvette used for measurement.
③
①
②
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
① ②
③
④
② Template Name Select or enter the template name (Using up to six alphanumeric
characters and symbols).
③ Schedule (*) Set the schedule for automatically displaying the templates.
• Enable/Disable: Specify whether the Auto Template function
is ON/OFF for each template.
• Date/Day: Specify the day or date when to activate the Auto
Template function. Either dates or days of the week can be set.
• Time/Round No. Specify the timing when to activate the
Auto Template function. Either times or round numbers can be
set.
• Pos. Set the positions in the sample carousel of the calibrators
or QC samples to be set in the template.
④ Worklist registration Specifies the position at which to place the samples, and the assay items
area. for each sample.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
Click Save ( ).
• The changes are saved.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
Click Delete ( ).
• The confirmation dialog box is
displayed.
Click OK.
• The template is deleted.
⑧
① ②
④ ⑤
③
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
NOTE: Click the Print icon ( ) to print the registered content of the order.
Do not open the STAT window before the STAT LED lights up.
NOTE: There is a pin on the bottom of each holder that fits into the holes on the bottom of the
sample carousel. When removing a holder, pull it straight up.
NOTES:
• Be sure to insert a sample tube straight into a holder as far as it goes to prevent them from
moving during the measurement procedure.
• Ensure that any barcode label, if affixed, is positioned correctly. Refer to the illustration above.
• For measurement involving less than 5 ml of sample, place paediatric sample cups into sample
tubes on the tray.
NOTE: Insert holder straight into the sample carousel until the pin in its bottom engages the hole in the
carousel.
NOTE: After sample tubes have been placed, make sure that the STAT lid and sample carousel cover
are securely closed.
Do not open the STAT window before the STAT LED lights up.
NOTE: There is a pin on the bottom of each holder that fits into the holes on the bottom of the
sample carousel. When removing a holder, pull it straight up.
NOTES:
• Be sure to insert a sample tube straight into a holder as far as it goes to prevent them from
floating during the measurement procedure.
• Ensure that any barcode label, if affixed, is oriented correctly. Refer to the illustration above.
• For measurement involving less than 5 ml of sample, place paediatric micro sample cups inserted
into their own sample tubes on the tray.
NOTE: Insert holder straight into the sample carousel until the pin in its bottom engages the hole in the
carousel.
NOTE: After sample tubes have been placed, make sure that the STAT lid and sample carousel cover is
securely closed.
NOTE:
• Pins on the bottom of the holder locate in the holes on the bottom of the sample carousel.
When removing a holder, pull it straight up.
• Make sure a sample tube is straight when placed into the holder and that it is fully seated to
prevent it from floating during the measurement process.
• Make sure that any barcode label, if affixed, is oriented correctly. Refer to step 6.
• When measuring 0.5 ml or less samples, put paediatric micro sample cups inserted into their
own sample tubes on the tray.
Put the holder back into the sample carousel and close the STAT lid.
NOTE:
• Insert the holder straight into the sample carousel until the pin in its bottom engages the hole in
the carousel.
• After inserting sample tubes, make sure that the STAT lid and sample carousel cover are
securely closed.
Do not open the STAT window before the STAT LED lights up.
NOTE: Pins on the bottom of the holder locate in the holes on the bottom of the sample carousel.
When removing a holder, pull it straight up.
NOTES:
• Be sure to insert a sample tube straight into a holder as far as it goes to prevent them from
floating during the measurement procedure.
• For measurement involving less than 5 ml of sample, place paediatric sample cups inserted into
their own sample tubes on the tray.
NOTE: Insert holder straight into the sample carousel until the pin in its bottom engages the hole in the
carousel.
NOTE: After sample tubes have been placed, make sure that the STAT lid and sample carousel cover
are securely closed.
Do not open the STAT window before the STAT LED lights up.
NOTE: Pins on the bottom of the holder locate in the holes on the bottom of the sample carousel.
When removing a holder, pull it straight up.
NOTES:
• Be sure to insert the sample tube into the holder as far as it will go to prevent them from
becoming loose during the measurement procedure.
• For measurement involving less than 5 ml of sample, place paediatric sample cups into sample
tubes on the tray.
NOTE: Insert holder straight into the sample carousel until the pin in its bottom engages the hole in the
carousel.
NOTE: After sample tubes have been placed, make sure that the STAT lid and sample carousel cover
are securely closed.
Check the STAT LEDs and open the STAT lid of the sample carousel where the LED is lit.
Remove the holders and place sample tubes on them.
NOTE:
• Pins on the bottom of the holder locate in the holes on the bottom of the sample carousel.
When removing a holder, pull it straight up.
• Make sure a sample tube is straight when placed into the holder and that it is fully seated to
prevent it from floating during the measurement process.
• When measuring 0.5 ml or less samples, put paediatric micro sample cups inserted into their
own sample tubes on the tray.
Put the holders back into the sample carousel and close the STAT lid.
NOTE:
• Insert the holder straight into the sample carousel until the pin in its bottom engages the hole in
the carousel.
• After inserting sample tubes, make sure that the STAT lid and sample carousel cover are
securely closed.
SECTION 8
MEASUREMENT RESULTS
Section 8 − Contents
Section 8 Measurement Results ........................................................................................... 8—1
8.1 Review Measurement Results ................................................................................ 8—3
8.1.1 Review Measurement Results .................................................................................................... 8—3
8.1.1.1 Execute a Search ................................................................................................................ 8—3
8.1.1.2 Delete Search Results ........................................................................................................ 8—4
8.1.1.3 Delete Individual Measurement Results ............................................................................ 8—5
8.1.2 Review Time Course.................................................................................................................. 8—6
8.1.3 Results Screen............................................................................................................................. 8—8
8.1.3.1 If ‘All’, ‘Routine Sample’ or ‘STAT’ is Selected in Sample Category................................ 8—9
8.1.3.2 Measurement Results Display Area................................................................................. 8—11
8.1.3.3 If Calibrator is Selected in Sample Category ................................................................... 8—12
8.1.3.4 If QC Sample is Selected in Sample Category ................................................................ 8—15
8.1.3.5 If Reagent Blank is Selected from Sample Category ....................................................... 8—18
8.1.3.6 If Number of Tests is Selected in Sample Category ....................................................... 8—21
8.1.3.7 Time Course Output Settings Area ................................................................................ 8—23
8.1.3.8 Pop-up Window Showing Time Course ......................................................................... 8—23
8.2 Print Measurement Results .................................................................................. 8—24
8.2.1 Set the Report Format ............................................................................................................. 8—24
8.2.1.1 Report Format Screen ..................................................................................................... 8—24
8.2.2 Register a Report Format ........................................................................................................ 8—26
8.2.3 Edit a Report Format................................................................................................................ 8—27
8.2.4 Delete a Report Format........................................................................................................... 8—27
8.2.5 Print a Report Format .............................................................................................................. 8—28
8.2.6 Print Measurement Results with Normal Print Format .......................................................... 8—29
8.2.7 Print Measurement Results with Report Print Format ........................................................... 8—30
8.2.8 Printing Measurement Results with History Print Format ...................................................... 8—31
8.2.9 Print Time Course .................................................................................................................... 8—32
8.3 Output Measurement Results as a File ............................................................... 8—34
8.3.1 Output Measurement Results as a CSV File ........................................................................... 8—34
8.3.2 Output Time Course as a CSV File ......................................................................................... 8—35
Click Execute.
• The search for measurement results is
executed with the specified search
condition and a list of search results is
displayed to the right of the screen.
• If the number of search results exceeds
2000, the search is cancelled. Modify
the search condition and search again.
Click Execute.
• The search for measurement results is
executed with the specified search
condition and search results are
displayed to the right of the screen.
Click OK.
• All measurement results selected in the
search are deleted.
Click Execute.
• The search for measurement results is
executed with the specified search
condition and search results are
displayed to the right of the screen.
Click OK.
• The measurement results are deleted.
Click Execute.
• The search for measurement results is
executed with the specified search
condition and search results are
displayed to the right of the screen.
③ ④
①
④ Search Results Display Area Displays the search results. The view depends on the Sample
Category for the samples to be searched.
⑤ Measurement Results Display Displays the measurement results selected from the search
Area results. The view depends on the Sample Category for the
samples to be searched.
⑥ Time Course Output Settings Used for setting time course output.
Area
⑦ ⑧
④ Round No. Enter the round number to be searched within the range of 1 to
99.
• Enter an asterisk (*) if the round number is not
specified.
• Immediately after measuring, the number assigned to
the round that was performed immediately up to that
point will be automatically set.
⑤ Host Transfer Status Specify the state of transfer to the host computer in online
mode.
All: The host transfer status is not used as the search condition.
Transferred: The measurement results for which transfer to
the host was successful are to be searched.
Non-Transferred: The measurement results for which
transfer to the host failed are to be searched.
⑥ Output to Select a search result output destination. Refer to Sections 8.2
and 8.3.
⑦ Selected Assay Click to show the selection list of assays.
• From the list, select the assay item to be searched.
• The selected assays are shown in light blue.
⑧ Select Output ---
⑨ Execute A search of measurement results is executed based on the
specified condition.
1 Not displayed if Sample Category is set to All.
*
① ② ③ ④
2 The ISE unit is an optional component that can be purchased alongside the equipment.
*
⑥ ⑦
④ Round No. Enter the round number to be searched within the range of 1
to 99.
• Enter an asterisk (*) if the round no. is not specified.
• Immediately after measuring, the number assigned to
the round that was performed will be automatically set.
⑤ Output to Select the output method for the search results.
Refer to Sections 8.2 and 8.3.
⑥ Select Assay Click to show the selection list of assays.
• From the list, select the assay item to be searched.
• The selected assays are shown in light blue.
⑦ Select Output ---
① ② ③ ④
⑤
⑥
⑦ ⑧
④ Round No. Enter the round number to be searched within the range of
1 to 99.
• Enter an asterisk (*) if the round number is not
specified.
• After measuring, the number assigned to the round
that was performed immediately up to that point will
be automatically set.
⑤ Host Transfer Status Fixed to All.
① ② ③ ④
⑥ ⑦
④ Round No. Enter the round number to be retrieved within the range of 1
to 99.
• Enter an asterisk (*) when not specifying the round
number.
• Immediately after the completion of measurement, the
number assigned to the round performed immediately
up to that point will be automatically set.
⑤ Output No. Select the output method for the search results.
Refer to Sections 8.2 and 8.3.
⑥ Select Assay Click to show the selection list of assays.
• Select the assay item to be retrieved from the list.
• The selected assays are shown in light blue.
⑦ Select Output ---
① ② ③
The list of the results of search performed based on the specified condition is displayed.
The measurement results details area shows details of results you selected in this area. You can view the
results of measurements just completed on this screen. If there are many searches or display items, you
can view hidden information by moving the scroll bar.
①
② ③
①
②
① ② ③ ④ ⑤
⑥ ⑦
⑬
⑨
⑩ ⑪
② Lines per page Enter the maximum number of lines per page.
④ Print start position Specify the print staff position with the following parameters:
• OffsetX: Specify the X coordinate of the print start position (20
to 200).
• OffsetY: Specify the Y coordinate of the print start position (20
to 200).
⑤ Scale Specify the magnification ratio for printing (25 to 200).
⑥ Header Specify the contents and display position of the header (Maximum five
lines).
• Line 1: Maximum 20 characters, font size 20 points.
• Lines 2 to 5: Maximum 50 characters, font size 10 points.
The display position can be moved by dragging and dropping.
⑦ Print date and time The positions for printing the date and time can be moved by dragging
and dropping.
⑧ Patient information The positions for printing the following patient information can be moved
by dragging and dropping.
Double-click the item names to be edited:
• Patient: Patient name (up to eight alphanumeric characters and
symbols).
• ID: Patient ID (up to six alphanumeric characters).
• SID: Sample ID (up to six alphanumeric characters).
• Comment: Comments on each sample (up to 12 alphanumeric
characters and symbols).
• Physician: Name of physician in charge (up to 12 alphanumeric
characters and symbols).
• Classification: (up to 16 alphanumeric characters and symbols).
• Bed No.: Bed number (up to 12 alphanumeric characters and
symbols).
• CollectionDate: Date when the samples were taken (up to 20
alphanumeric characters and symbols).
• Date: Date of measurement (up to eight alphanumeric
characters and symbols).
• Time: Time of measurement (up to eight alphanumeric
characters and symbols).
• Gender: (up to 10 alphanumeric characters and symbols).
• Age: (up to six numeric characters).
• SSNo.: Social security number (up to 10 alphanumeric
characters and symbols).
• Race: (up to eight alphanumeric characters and symbols).
• Ward: (up to eight alphanumeric characters and symbols).
• BloodType: (up to 12 alphanumeric characters and symbols).
• Reference1: [1] as defined on Operation Settings screen (up to
10 alphanumeric characters and symbols).
• Reference2: [2] as defined on Operation Settings screen (up to
10 alphanumeric characters and symbols).
⑨ Result display The positions for printing the following measurement results can be
moved by dragging and dropping.
• Method.
• Results.
• Units.
• Flag.
• Normal Range.
• R1 Lot: R1 reagent lot number.
• R2 Lot: R2 reagent lot number.
⑩ Import background Imports a background image for printing.
image
• Only PNG format images can be selected.
⑪ Reset Deletes the edited contents and resets the report format to the default.
⑫ Background image Configure the settings of the image imported by 10 with the following
setting parameters:
• Image OffsetX: Specify the X coordinate of the print start
position for the background image (0 to 200).
• Image OffsetY: Specify the Y coordinate of the print start
position for the background image (0 to 200).
• Image Scale: Specify the magnification ratio for the background
image (25 to 400).
⑬ Recycle Unnecessary items can be deleted by dragging and dropping.
NOTE: If the report format has not been registered, the report format will be printed with the initial
values.
Click Execute.
• The search for measurement results
is executed with the specified search
condition and the Windows Print
dialog box is displayed.
Check the print settings and start
printing.
• For information on print settings,
refer to the manual that accompanied
the printer.
Click Execute.
• The search for measurement results
is executed with the specified search
condition and the Windows Print
dialog box is displayed.
Check the print settings and start
printing.
• For information on print settings,
refer to your printer manuals. Search
results are printed.
Click Execute.
• The search for measurement results
is executed with the specified search
condition and the Windows Print
dialog box is displayed.
Check the print settings and start printing.
• For information on print settings,
refer to your printer manuals. Search
results are printed.
Click Execute.
• A search of measurement results is
executed based on the specified search
condition.
Parameter Description
M Measuring range. M1 is measuring range 1, and M2 is measuring range 2.
S Absorbance of samples. S2 is the absorbance at the primary wavelength,
and S1 is the absorbance at the secondary wavelength.
W Water blank absorbance. W2 is the water blank absorbance at the primary
wavelength, and W1 is the absorbance at the secondary wavelength.
R Reagent blank absorbance. R2 is the reagent blank absorbance at the
primary wavelength, and R1 is the reagent blank absorbance at the secondary
wavelength.
Click ( …).
• The folder selection dialog box is
displayed.
Click Execute.
• The search for measurement results
is executed with the specified search
condition and search results are
saved.
• The name of a CSV file is automatically
determined based on the date and time
of search.
Click Execute.
• A search of measurement results is
executed based on the specified search
condition.
Parameter Description
M Measuring range. M1 is measuring range 1, and M2 is measuring range 2.
S Absorbance of samples.
• S2 is the absorbance at the primary wavelength.
• S1 is the absorbance at the secondary wavelength.
W Water blank absorbance.
• W2 is the water blank absorbance at the primary wavelength.
• W1 is the absorbance at the secondary wavelength.
R Reagent blank absorbance.
• R2 is the reagent blank absorbance at the primary wavelength.
• R1 is the reagent blank absorbance at the secondary wavelength.
SECTION 9
MAINTENANCE
This chapter explains the procedures for maintaining the safety and
performance of the instrument.
Section 9 − Contents
Section 9 Maintenance ..........................................................................................................9—1
9.1 Overview.....................................................................................................................9—3
9.2 Unit Maintenance Screen ......................................................................................... 9—4
9.3 Work Hour Counter Screen .................................................................................... 9—6
9.4 Daily Inspection and Cleaning .................................................................................. 9—7
9.4.1 Management of Reagent Bottles ................................................................................................ 9—7
9.4.2 Sample Disposal.......................................................................................................................... 9—7
9.4.3 Replenish Detergents ................................................................................................................. 9—7
9.4.3.1 Check and Replace Detergent Bottles .............................................................................. 9—7
9.4.3.2 Check of Detergents .......................................................................................................... 9—9
9.4.4 Lamp Operation Time - Check ............................................................................................... 9—10
9.4.4.1 Water Blank Absorbance Check ..................................................................................... 9—10
9.4.4.2 Maintenance > System Monitor > Water Blank Absorbance ....................................... 9—10
9.4.5 Sample Pipette Unit - Inspection and Cleaning ....................................................................... 9—12
9.4.5.1 Internal Pipette Cleaning .................................................................................................. 9—14
9.4.6 Reagent Pipette Units - Inspection and Cleaning .................................................................... 9—15
9.4.6.1 Inspection ......................................................................................................................... 9—15
9.4.6.2 Exterior Cleaning .............................................................................................................. 9—15
9.4.6.3 Internal Pipette Cleaning .................................................................................................. 9—17
9.4.7 Washing Unit - Inspection and Cleaning ................................................................................. 9—17
9.4.8 Mix Units - Inspection and Cleaning ........................................................................................ 9—19
9.5 Weekly Inspection and Cleaning............................................................................ 9—21
9.5.1 Troughs - Inspection and Cleaning .......................................................................................... 9—21
9.5.2 Sample Carousel - Inspection and Cleaning ............................................................................ 9—21
9.5.3 Reagent Carousel - Inspection and Cleaning .......................................................................... 9—24
9.5.4 Work Table - Inspection and Cleaning ................................................................................... 9—27
9.5.5 Water Blank Absorbance Check 1 .......................................................................................... 9—27
9.5.6 Water Blank Absorbance Check 2 .......................................................................................... 9—28
9.5.7 Wash Cuvettes ......................................................................................................................... 9—29
9.5.8 Perform a Cuvette C1 Solution Soak ...................................................................................... 9—31
9.6 Maintenance Work Performed by the Administrator ......................................... 9—32
9.6.1 Replace the Halogen Lamp ...................................................................................................... 9—32
9.6.1.1 Lamp Post-replacement Check ....................................................................................... 9—35
9.6.2 Fluidic Wash ............................................................................................................................. 9—36
9.6.2.1 Wash Procedure .............................................................................................................. 9—37
9.6.3 Remove Pipette Blockages ....................................................................................................... 9—40
9.7 Maintenance by Service Engineers ........................................................................ 9—42
9 Maintenance
9.1 Overview
The items for the inspection after the completion of work are as follows.
Item Frequency
Management of reagent bottles
Sample disposal
Check of detergents
Check of lamp operation time
Daily
Inspection and cleaning of sample pipette
Inspection and cleaning of reagent pipettes
Inspection and cleaning of washing units
Inspection and cleaning of mixing units
Inspection and cleaning of troughs
Inspection and cleaning of sample carousel
Inspection and cleaning of reagent carousel At least once a week
Inspection and cleaning of work table
Check of water blank absorbance
⑪
①
②
③
④
⑤
⑥
⑦
⑧
⑨
⑩
③ Check Water Blank Measures water blank to judge the quality of the cuvettes.
Measurement is performed for all cuvettes in all
wavelengths. Check the measurement results in the
Water Blank Absorbance screen.
⑪ Pump Test Configure the amount of time and type of pump to test.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
①
②
③ ⑤
④ ⑥
③ Halogen Lamp Displays the remaining operation time until halogen lamp
replacement.
(Replacement cycle: 1,000 hours)
④ Periodic Maintenance Displays the remaining number of days until periodic maintenance.
• 6 Months - Displays the remaining number of days until
the 6-month periodic maintenance.
• 1 Year - Displays the remaining number of days until the
1-year periodic maintenance.
⑤ Plunger Seal Displays the remaining operation time until plunger seal
replacement.
⑥ Detergent Bottle Displays the remaining operation time until detergent bottle
replacement.
NOTES:
• After replacing consumables, click the Reset button to reset the remaining time.
• The alarm sounds when the remaining hours or number of tests reaches 0 or less.
• Click the Print icon ( ) on the lower part of the screen to print the displayed content.
NOTE: The remaining time (count) in the [Halogen Lamp] field is displayed in yellow when the value is
low and in red when the value reaches zero. If the value is displayed in red, the halogen lamp should be
replaced.
③
①
④ ⑦ ⑧
⑨ ⑩
⑥
⑤ Period Specify up to how many past measurements to display the water blank
absorbance.
⑥ Threshold Set the threshold for water blank measurement (unit: mAbs/10). (Initial
setting: 5,000)
⑦ Auto Adjust Set the function for automatically adjusting the display range of the water blank
absorbance chart.
⑧ Max./Min. Change the display range of the chart manually.
⑨ Export Saves the saved water blank absorbance in a file. The water blank absorbance
for the past 3 months can be saved. The daily average values are calculated
and saved.
⑩ Replace This function is used by service engineers.
Cuvettes
While the water blank absorbance is being exported, do not remove the storage medium
containing the save location of the data or turn off the power source of the operational PC.
NOTE: Click the Print icon ( ) on the lower part of the screen to print the displayed content.
Check the status display and confirm that all functions have stopped.
Fill a sample cup or sample tube with C-1 solution diluted 100 times and place it on the sample
carousel.
• Refer to Section 2.1.2.
• When using sample barcodes, proceed to step 6.
• In order registration for sample pipette detergents, a template function can be used to register
a combination of sample placement positions and orders in advance, which can be called later.
When templates are registered, the required settings can be called and used from Template
on the Worklist screen.
• The administrator can configure the settings of the template from the Template screen.
• Protect the top of the incubator during work to prevent the adherence of foreign matter such
as dirt, fluid or dust in the cuvettes.
• The alcohol used for cleaning is flammable. Make sure that there are no flames in the
surrounding area before use.
• Be careful not to cut yourself accidentally on the end of the pipette while cleaning.
• Do not use excessive force when wiping the pipette. For the analyser to function correctly, it is
important that the pipette is vertical. If it is not vertical, it may cause pipette damage or
inaccurate measurement results.
• Wipe after cleaning to ensure that no drops of fluid remain.
Check the status display and confirm that all functions have stopped.
Check that reagent bottles containing C-1 solution are placed on the reagent carousel.
Navigate to Routine > User Maintenance.
Check the status display and confirm that all functions have stopped.
Make sure that the reagent pipettes are not on the sample carousel.
• If reagent pipettes are not on reagent carousel, move them slowly by holding the shaft.
NOTE: Values exceeding the threshold in the selected wavelength are displayed in red, and values
exceeding the threshold in other wavelengths are displayed in yellow.
• If 51 or more cuvettes exceed the threshold, measurement cannot start.
• When a cuvette is displayed in red or yellow, perform Cuvette Wash.
NOTES:
• If a cuvette is displayed in red or yellow even after washing the cuvette, the halogen lamp must
be replaced. For the replacement procedure, refer to Section 9.7.1. After replacing the halogen
lamp, check the water blank absorbance again.
• If the water blank absorbance exceeds the threshold even after replacing the halogen lamp,
cuvette replacement may be required. Contact your Randox Representative.
Settings>Advanced
Settings>Operator Settings.
Maintenance>System
Maintenance>Unit Maintenance
Do not touch the glass surface of the halogen lamp with bare hands. Grease from your
hands may adhere to the glass and cause a malfunction.
• The alarm sounds when automatic gain fails. Contact your Randox Representative.
• If the gain value of each wavelength is less than 10, contact your Randox Representative.
NOTE: If an item in the Voltage field of each wavelength is displayed in red, contact your Randox
Representative.
NOTE: Perform the following Tube Wash procedure every 2 weeks to prevent tubes and sub-tank
from bacteria.
Preparation
Fill a 1 litre container with purified water and 5 litre tank with C-1 diluent.
Remove the tubes from the detergent bottles and insert them into the 1 litre container.
After the designated time, insert the maintenance supply tube and detergent tubes into the 5 litre
tank (filled with C-1 diluent).
Turn off the power source of the analyser and the PC.
NOTE: In the subsequent steps, the clot will fall down from the tip of the pipette. Put a cloth under the
tip of the pipette in advance to receive the clot that will fall down.
Install the pipette cover and tighten the 4 screws (M3 x 8).
After turning on the power source of the analyser, clean the inside of the pipettes.
SECTION 10
MISCELLANEOUS SETTINGS
Section 10 − Contents
Section 10 Miscellaneous Settings ..................................................................................... 10—1
10.1 Change Device Settings ........................................................................................ 10—4
10.1.1 Host Communication Settings ................................................................................................. 10—5
10.1.2 Sample ID Settings .................................................................................................................... 10—6
10.1.3 Automatic Print Settings........................................................................................................... 10—7
10.1.4 Notification Sound Settings ...................................................................................................... 10—8
10.1.5 Other Device Settings .............................................................................................................. 10—9
10.2 Operation Settings ..............................................................................................10—10
10.2.1 Operation Settings Screen ..................................................................................................... 10—10
10.2.1.1 Change Operation Settings ............................................................................................ 10—11
10.3 User Accounts .....................................................................................................10—12
10.3.1 Administer User Accounts ..................................................................................................... 10—12
10.3.1.1 User Accounts Screen.................................................................................................... 10—12
10.3.1.2 Add a User Account ...................................................................................................... 10—13
10.3.1.3 Change the Password/User Level................................................................................. 10—14
10.3.1.4 Delete a User ................................................................................................................. 10—16
10.3.2 List of Available Screens by User Level ................................................................................. 10—17
10.4 Backup ..................................................................................................................10—18
10.4.1 Backup Screen ........................................................................................................................ 10—18
10.4.2 Data Backup............................................................................................................................ 10—19
10.4.2.1 Save the Database .......................................................................................................... 10—19
10.4.2.2 Load a Backup the Database ......................................................................................... 10—20
10.4.2.3 System Parameters Backup ............................................................................................ 10—21
10.4.2.4 Load System Parameters ............................................................................................... 10—22
10.4.3 Automatic Backup .................................................................................................................. 10—23
10.4.3.1 Set the Automatic Backup Function .............................................................................. 10—23
10.4.3.2 Load Automatic Backup Data........................................................................................ 10—24
10 Miscellaneous Settings
Settings > Advanced Settings > Device Settings
① ② ③ ④
⑥
⑤
③ Remote Maintenance Set each item for the transfer of maintenance data.
④ Data Bit Select the data bit from 7 bit and 8 bit.
(initial setting: 8 bit).
⑤ Stop Bit Select the stop bit from 1 bit and 2 bit.
(initial setting: 1 bit).
⑥ Parity Bit Select the parity bit from None, Even and Odd.
(initial setting: Even).
⑦ Protocol (E1318) Select the protocol from Normal and No Handshake.
(initial setting: Normal).
② ③
④
⑤
⑤ Barcode Type Up to 4 barcode types can be specified for use as the sample barcodes.
This can only be set when Sample Barcode is Enable.
• UPC (JAN): with check digit
• NW7: with/without check digit
• Code39: with/without check digit
• ITF: with/without check digit
• Code128: with check digit
NOTES:
• When the Automatic Print check box is selected, the print format can be selected.
• For details on report registration, refer to Section 8.2.2.
①
②
NOTES:
• When the sound volume is set to Mute, the notification sound does not sound regardless of
the level setting.
• When the round complete sound is set to OFF, the notification sound does not sound.
①
②
③
④
NOTES:
• The lamp power save mode is a function for reducing the power consumption of the halogen
lamp during standby.
• When the lamp power save mode is used, it takes approximately 2 minutes to switch the
voltage.
• If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
① ④
⑤
② ⑥
③ ⑧
⑦ Detergent for Specify the detergent to use for washing reagent pipettes.
Reagent Pipettes
Select 1 of the detergents registered on the Reagent Code screen.
⑧ Detergent for Specify the detergent to use for filling cuvettes. Select 1 of the detergents
Cuvettes registered on the Reagent Code screen.
⑨ Popup Control Set the pop-up screen to display automatically during operation.
Set Enable to display the pop-up, and Disable to NOT display the pop-
up.
For L3 users, the ‘Do not do this show again’ check box is displayed
when the pop-up is displayed. When the check box is selected, the
corresponding pop-up is not displayed again.
NOTE: The following 2 types of pop-ups can be set in the initial state.
• Do you want to log out?
• Check remaining volume of detergents.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions then
continue operation.
①
②
③
④
⑤
③ Current Password Enter the old password before changing the password.
NOTE: The number of users that can be registered is limited according to the user level. The upper
limit for each level is as follows.
• L1: 20 users
• L2: 10 users
• L3: 5 users
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions then
continue operation.
10.4 Backup
The state of the analyser can be saved as data.
The backup data can be saved on the HDD or other storage medium (such as a USB memory stick). This
data can be loaded from the operation software to return the analyser to a past state.
①
②
⑤ Database Recovery Recovers the full backup that was last created by the automatic backup
function.
CAUTION:
Do not remove the storage medium containing the backup data or turn off the power
source of the operational PC while the backup data is being saved or loaded.
NOTE: When the database is loaded, all the current data is overwritten. As a precaution, be sure to
create a backup of the current database before loading.
NOTE: When the database is loaded, all the current data is overwritten. As a precaution, be sure to
create a backup of the current database before loading.
NOTES:
• The save location of automatic backup files is different from the folder specified with ( …).
• The save location cannot be changed.
NOTE: When the database is loaded, all the current data is overwritten. As a precaution, be sure to
create a backup of the current database before loading.
SECTION 11
TROUBLESHOOTING
Section 11 − Contents
Section 11 Troubleshooting................................................................................................11—1
11.1 About Troubleshooting......................................................................................... 11—3
11.1.1 Check the Operating Environment ......................................................................................... 11—3
11.1.2 Items to Communicate to your Randox Representative ....................................................... 11—3
11.1.2.1 When Contacting About Assay Problems ...................................................................... 11—3
11.1.2.2 When Contacting About Analyser Problems ................................................................. 11—3
11.2 Measurement Result Problems ............................................................................ 11—4
11.2.1 Check of Reagent, Calibrator and QC Sample Preparation .................................................. 11—4
11.2.1.1 About Reagent Preparation ............................................................................................. 11—4
11.2.1.2 About QC Sample Preparation ....................................................................................... 11—4
11.2.1.3 About Calibrator Preparation ......................................................................................... 11—4
11.2.2 Case-by-Case Check Descriptions .......................................................................................... 11—5
11.2.2.1 Measurement Results for a Specific Assay Item in all Samples (High or Low) .............. 11—5
11.2.2.2 Abnormal Measurement Results Occur at Random ...................................................... 11—6
11.2.2.3 Measurement Results for Multiple Assay Items in an Abnormal Specific Sample ......... 11—6
11.3 Analyser Problems ................................................................................................11—7
11.3.1 Analyser Power Source Does Not Turn On .......................................................................... 11—7
11.3.2 Alarms and Recovery Actions.................................................................................................. 11—7
11.3.2.1 What to Do in Case of an Alarm .................................................................................... 11—7
11.3.2.2 Save Alarms ...................................................................................................................... 11—8
11.3.3 Alarm History Screen ............................................................................................................... 11—9
11.4 Flag Information ..................................................................................................11—10
11.4.1 Evaluation Flag ........................................................................................................................ 11—10
11.4.2 Error Flag ................................................................................................................................ 11—10
11 Troubleshooting
Cause Action
The calibrators have not been prepared Check the calibrator preparation.
appropriately.
The validity period of the calibrator’s is Refer to the package insert of the calibrators for details on the
expired. stability of the prepared calibrators.
The calibrators have not been stored Refer to the package insert of the calibrators for details on the
appropriately. appropriate storage method.
The reagents have not been prepared Check the reagent preparation.
appropriately.
The reagents are contaminated.
The reagents have deteriorated.
The reagents have not been prepared Refer to the package insert of the reagents for details on the
appropriately. stability of the prepared reagents.
The reagents have not been stored Refer to the package insert of the reagents for details on the
appropriately. appropriate storage method.
Cause Action
The sample pipette or reagent pipettes Clean the sample pipette or reagent pipettes.
are dirty.
There is variation in the dispensing Check whether leakage or dripping is occurring around the
volume of samples or reagents. sample pipette or reagent pipettes. If this is occurring, contact
your Randox Representative.
The usage period of the halogen lamp Replace the halogen lamp.
has expired.
11.2.2.3 Measurement Results for Multiple Assay Items in an Abnormal Specific Sample
Cause Action
The sample has not been prepared Check the sample preparation and handling methods.
appropriately.
NOTE:
• Saving the alarm history may not be available, depending on the login rights.
• The administrator should assign rights for user level L3 on the User Account screen to save the
alarm history. For details on the User Account screen, refer to the Service Manual.
① Alarm History Displays the history of the alarms that have occurred in the analyser in a
list.
Alarm No. Provide the alarm number when contacting your Randox Representative.
Date and Time Displays the date and time of alarm occurrence.
Message Displays the status of the analyser when the alarm occurred in an
abbreviated form.
② Message (Full) Displays detailed information about the alarm, including the action to
take.
③ Software Version Displays version information for the operation software and the software
used for analyser control in a list. Refer to Software List and Software
Version Check in the Foreword.
④ Search Parameters Select the alarm date, time and level for specify results.
⑤ Export Log Saves a log of operations between the analyser and operational PC. The
log is saved in the save location specified with (...). This is not used
under normal circumstances, but we may request a record of operations
for troubleshooting.
Evaluation flag • Added when measurement results are above or below the normal range.
• Added when measurement results are above or below the technical range.
Each flag is displayed on the Results screen, and when the measurement results are printed, the flags are
printed together with the measurement results.
The technical range and normal range used as the basis for the evaluation flags are set as parameters for
each assay item by the administrator.
AB1 Absorbance limit error 1 The absorbance limit has been exceeded in
measurement using the rate method.
The absorbance limit has been exceeded in all
measurement points, or the 1st point in the
measurable range is within the absorbance limit but
the 2nd and subsequent points exceed the
absorbance limit.
AB2 Absorbance limit error 2 The absorbance limit has been exceeded in
measurement using the rate method.
The first 2 points in the measurable range are within
the absorbance limit, but the 3rd and subsequent
points exceed the absorbance limit.
DB There are no diluent bottles. Register the corresponding diluent bottles on the
Inventory screen.
EST An abnormality occurred Check the Alarm History screen and take action for
during measurement. the problem.
EXP The validity period of the Use reagents within the validity period.
reagents has expired.
LIN Linearity limit error The limit has been exceeded in measurement using
the rate method, and variation has been found in
the linearity of the time course.
PRO Prozone limit error The limit is exceeded, and the prozone
phenomenon has been found in the measured time
course.
R1S There is no remaining volume Register the corresponding reagent bottle on the
for the R1 reagent. Inventory screen.
Check whether the corresponding bottle is filled
with sufficient reagent.
R1W Washing the reagent pipettes Check the Alarm History screen and take action for
before R1 reagent dispensing the problem.
failed.
R2B There is no R2 reagent bottle. Register the corresponding reagent bottle on the
Inventory screen.
Check whether the corresponding bottle is filled
with sufficient reagent.
R2S There is no remaining volume Register the corresponding reagent bottle on the
for the R2 reagent. Inventory screen.
Check whether the corresponding bottle is filled
with sufficient reagent.
R2W Washing the reagent pipettes Check the Alarm History screen and take action for
before R2 reagent dispensing the problem.
failed.
SEN Sensitivity limit error The measurement results exceed the sensitivity
limit.
SFT The range shift function is Indicates the measurement values for which the
being applied. AB1 and AB2 error flags were avoided by shifting
the photometric range of the measurement values.
SPS The sample pipette has been Check the following points:
clotted.
Is the sample pipette blocked?
Are there samples with sufficient volume?
Is the sample pipette damaged, bent or dirty?
Are there obstructions on the movement lines of
the sample pipette?
SPW Washing the sample pipette Check the Alarm History screen and take action for
failed. the problem.
STB The onboard stability of Use reagents within the onboard stability period.
reagents has expired.
Intentionally Blank
SECTION 12
RX MODENA - ISE MODULE
Section 12 − Contents
Section 12 RX modena - ISE Module ................................................................................. 12—1
12.1 Precautions for Operation and Measurement ........................................................ 12—3
12.1.1 Precautions for the use of Samples ......................................................................................... 12—3
12.1.2 Precautions for the use of Solution ......................................................................................... 12—3
12.1.3 Precautions before Measurement ........................................................................................... 12—3
12.1.4 Precautions for the Test Parameter ........................................................................................ 12—4
12.2 Precautions for Preventive Maintenance ................................................................ 12—5
12.2.1 Precautions for Samples ........................................................................................................... 12—5
12.2.2 Precautions for the Seal Replacement ..................................................................................... 12—5
12.2.3 Precautions for the Storage of the Cl Electrode ..................................................................... 12—5
12.2.4 Precautions for the Storage of the Ref Electrode ................................................................... 12—5
12.2.5 Precautions for Washing the Wash Bottle.............................................................................. 12—5
12.2.6 Precautions for the Aging of the Electrode ............................................................................. 12—5
12.3 Overview .....................................................................................................................12—6
12.3.1 Features and Major Functions .................................................................................................. 12—6
12.3.1.1 System Diagram of the ISE Unit ....................................................................................... 12—6
12.3.1.2 Measurement Flow........................................................................................................... 12—6
12.4 Specifications ..............................................................................................................12—7
12.5 Consumables and Periodical Replacement Parts ................................................... 12—8
12.5.1 Consumables ............................................................................................................................ 12—8
12.6 Operation Procedures ............................................................................................... 12—9
12.6.1 Works required at installation ................................................................................................. 12—9
12.6.1.1 Removing the protection tape ......................................................................................... 12—9
12.6.1.2 Aging of the ISE Electrode................................................................................................ 12—9
12.6.1.3 Placement of ISE Electrodes .......................................................................................... 12—10
12.6.1.4 Placement of the Buffer Bottle and the Internal Standard Solution Bottle .................. 12—10
12.6.2 Checks Prior to Use ............................................................................................................... 12—11
12.6.2.1 Check the Buffer Bottle and Internal Standard Solution Bottle ................................... 12—11
12.6.3 Calibration .............................................................................................................................. 12—11
12.6.4 Procedures .............................................................................................................................. 12—12
12.6.4.1 Calibration Ranges ......................................................................................................... 12—12
12.6.5 Patient Sample Measurement ................................................................................................ 12—12
12.6.6 Check and Output of Measurement Results......................................................................... 12—12
12.7 ISE Parameter Screen .............................................................................................12—13
12.7.1 Normal Range Setting ............................................................................................................ 12—14
12.7.2 Instrument Factor Setting ....................................................................................................... 12—14
12.7.3 ISE Rerun Setting .................................................................................................................... 12—15
12.8 Maintenance .............................................................................................................12—16
12.8.1 Daily ........................................................................................................................................ 12—16
12.8.1.1 Replacement of the standard solution ~ ISE Calibration .............................................. 12—16
12.8.1.2 Checks Prior to Use ....................................................................................................... 12—16
12.8.1.3 Maintenances after the Daily Routine Tests ................................................................. 12—16
12.8.2 Weekly .................................................................................................................................... 12—16
12.8.2.1 Electrode Line Wash ...................................................................................................... 12—16
12 ISE Module
12.3 Overview
12.3.1 Features and Major Functions
The ISE unit is an electrolyte measurement module that is installed on the analyser. The ISE unit can
measure Na (Sodium), K (Potassium) and Cl (Chlorine) in serum or urine at the same time, using the
automatic dilution function.
The sample to be tested is dispensed into the ISE unit by the sample pipette of the analyser.
Sample Pipette
EV1
NC
COM NO
REF Na K CI D.P.
EV3
NC NC NO DG DG
COM
NO COM
EV2
12.4 Specifications
Principle Na/K/Cl: Ion Selective Exchange method.
Sample Volume 22 μl
Calibration The automatic 2-point calibration by the standard solution (Low and High).
Measurement Serum: Na: 100~200 mmol/l, K: 2.5~10 mmol/l, Cl: 50~200 mmol/l
Range Urine: Na: 10~400 mmol/l, K: 2~300 mmol/l, Cl: 15~400 mmol/l
Required Power
DC24V 1.5A, DC5V 1A, Supplied from the analyser.
Supply
Internal Standard Solution Placed in the designated rack inside the analyser. The 1-point
L (200 ml bag) calibration is automatically performed in each measurement.
Buffer Solution (3L bottle) Placed in the lower part of the analyser.
Standard Solution for Placed in the sample carousel and dispensed into the ISE unit by
Serum (Low/High) the sample pipette.
The standard solution is used by the combination of Low and
High for the 2-point calibration of the ISE unit, and its result is
used for the concentration conversion of the serum test.
Standard Solution for Placed in the sample carousel and dispensed into the ISE unit by
Urine (Low/High) the sample pipette of the analyser.
The standard solution is used by the combination of Low and
High for the 2-point calibration of the ISE unit, and its result is
used for the concentration conversion of the urine test.
Electrode Cleaning Placed in the sample carousel and dispensed into the ISE unit by
Solution the sample pipette of the analyser.
It is also used for the line cleaning.
ISE Electrode Four types of electrodes (Na, K, Cl and Ref) are used.
Hold the knurled screw tightly. If the knurled screw is held loose, the electrodes may be
pressed back from the cell during the measurement and cause leakage.
12.6.1.4 Placement of the Buffer Bottle and the Internal Standard Solution Bottle
1. Uncap the buffer solution bottle, and attach the bottle connector.
2. Uncap the internal standard solution bottle, and attach the bottle connector.
3. Perform a prime of the buffer solution and the internal standard solution. During the prime
sequence, remove air bubbles inside the flow path as much as possible. In case air bubbles enter
the flow path, continuously check that there is no leakage or slack especially on the connection
parts.
• Check that liquid flows out smoothly from the dilution cell. If liquid does not flow
out smoothly, there may be a misconnection or blockage in the waste line. In such
cases, stop the sequence on the ISE unit immediately.
• In case the line is blocked, remove Na and K electrode and check if there is
blockage in the flow path. It is impossible to visually check for a blockage in the Cl
electrode, because of its structure.
• In case that liquid does not flow out smoothly despite there is no doubtful point on
the above checks, replace the ISE electrodes.
12.6.3 Calibration
The calibration is necessary before measuring patient samples. After each calibration, previous calibration
result will be deleted.
The calibration must be performed separately for serum and urine. It may affect the
precision or accuracy of the result if an undesignated sample is used for the calibration
(e.g. using urine sample for serum calibration etc.).
12.6.4 Procedures
1. Place the standard solution of the same sample type with one that requires the calibration (serum
or urine, Low and High for each) on the sample rack of the analyser.
29 µl (sample volume: 22 µl, dummy volume: 7 µl) is required for each sampling.
SERUM Na K Cl
URINE Na K Cl
Potential (High) 50 ≦×≦ 110 725 ≦×≦ 825 −90 ≦×≦ −35
Potential (Low) −280 ≦×≦ −220 170 ≦×≦ 270 40 ≦×≦ 100
The calibration result may be out of the acceptable range if the analyser is left unused for a long time or the
electrodes are dirty.
• If the calibration result is out of the range, perform electrode cleaning.
• If the result is out of range after electrode cleaning, replace the ISE electrode.
① ISE Type In case that the sample category is Other, select the ISE test type from
ISE and ISE(U).
• If the sample category is Serum or Plasma, only ISE can be
selected.
• If the sample category is Urine, only ISE(U) can be selected.
② Instrument Factor Enter the slope and the intercept to correct the measurement result.
The slope (a) and the intercept (b) is entered to perform the first order
correction using the formula y=ax+b.
③ Normal Range Enter the range of the normal value for the ISE test for each normal
range those are configured at Normal Range screen.
Editable Range
Na: 0~999.9.
K: 0~99.99.
Cl: 0~999.9.
Minimum: If the result is lower than this, such results will have ‘L’ flag.
Maximum: If the result is higher than this, such results will have ‘H’ flag.
4. Press the Save icon ( ). The settings for the ISE parameter is saved.
Editable Range
A: -99.99 ~ 99.99
B: -999.99 ~ 999.99
3. Press the Save icon ( ). The setting for the ISE parameter is saved.
① Auto Rerun It performs the ISE automatic rerun when the check-box is ticked.
12.8 Maintenance
This chapter describes the procedures of the preventive maintenance of the ISE unit.
12.8.1 Daily
12.8.1.1 Replacement of the standard solution ~ ISE Calibration
ISE calibration must be performed once each day (of operation).
• For each ISE calibration, pour fresh standard solution H and L (that is within the expiry date), into the
sample cup.
Make sure that the buffer solution and the internal standard solution are within the expiry
date.
12.8.2 Weekly
12.8.2.1 Electrode Line Wash
Perform the electrode line wash once a week:
1. Remove Na, K, Cl and Ref electrode and replace with the dummy electrode for the line wash.
2. Remove the cap on the dummy electrode.
3. Pour approximately 5 ml of the electrode wash solution using tools such as a pipette.
The electrode cleaning solution contains sodium hypochlorite. In case of skin or eye contact,
wash off with plenty of clean water and consult a doctor immediately.
4. Press ISE line wash button on the ISE Calibration screen to start the electrode line wash.
5. The electrode wash solution may flow over the supply port of the cell pot at the end of the line
wash. In case of the over flow, wipe out the liquid by swab.
6. After the line wash, remove the dummy electrode and replace the Na, K, CI and Ref electrode.
7. Perform ISE prime 10 times using the ISE Calibration screen.
8. Perform ISE calibration.
APPENDICES
Appendices − Contents
Appendices ............................................................................................................................ A—1
Menu List .......................................................................................................................... A—3
Glossary ............................................................................................................................ A—5
Operator Maintenance Schedule ................................................................................... A—9
A Appendices
Menu List
Routine Menu Calibration Menu
Carousel Monitor Calibration
Worklist ISE Calibration
Inventory
Round Monitor QC Menu
Results QC Chart
User Maintenance QC Table
Patient Registration QC Range
Sleep and Wakeup
Settings Menu
Assay Settings 1 Assay Settings 2
Parameter 1 Calibration
Parameter 2 Multi Calibration
ISE Parameter Diluted Calibration
Maintenance Menu
System Maintenance System Monitor
Unit Maintenance Water Blank
Absorbance
DTR Adjustment Work Hour Counter
Backup Sleep
Backup
Shutdown
Alarm Menu
Alarm History
Glossary
Terms that should be understood when using the analyser are listed below. Also refer to the Service
Manual.
Terms Description
Terms Description
Terms Description
Terms Description
Sleep A function that puts the analyser into stand-by mode without shutting
down completely, allowing it to be awoken ready for measurement at a
specified time.
Soak Wash * A maintenance sequence that washes the outside of the pipettes and
stirrers by soaking them in detergent filled cuvettes.
Stability Check A function to check the onboard stability of each reagent.
Technical Range A range of measurable values for each assay item.
Template A function to pre-configure regularly used samples such as calibrators
and QC samples.
Test Mode A function to select a sampling volume from 3 pre-sets.
Test Sequence Number * Supplementary information attached to the end of sample IDs to show
the number of replication tests.
Time Course A set of data that shows changes in absorbance during reaction.
Trough Wash * A maintenance sequence that washes the pipettes and stirrers at the
troughs.
Water Blank * A sequence that dispenses system water into the cuvettes used for
measurement and measures the absorbance of each cuvette.
WORK A calibration curve obtained by partial calibration.
Worklist A term that shows which assays are to be tested.
Intentionally Blank