9.ifam AU 400 Mechanical
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A0 Cover ifam_cover.doc A0-1
M015
AU400 ISE
Mechanical and Function Manual
Rev.0
Technical Support Group
Global Business Technical Support Department
Beckman Coulter K.K
Version Date Version Date
First
Issued
2011/01/07
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Table of Contents
Part 1: OutlineInstrument Outline 1 1 to 1 3
Specifications1 - 4
Limited Conditions1 - 5
Product Unit1 6 to 1 9
Part 2: SpecificationSpecification 2 1 to 2 3
Part 3: Overall ConstructionOverall Construction3 1
Piping Diagram
Part 4: Operation ExplanationsOperation Explanations 4 1 to 4 2
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AU400 ISE Function and Mechanism Manual
Part 1 Outline1 - 1
Product Outline
Product Aim
1. Lineup completion under the AU800 and the AU600 in regard to the processing speed.2. Share expansion by system business correspondence of reagents and equipment.
3. Offering of user merits by standardization of reagents and operationally with the AU600.
Target Market1. Target Area
Japan / US / Europe / Asia/Oceania
2. Target Facilities
Japan, Europe : Small, Medium size hospitals (Maximum 50 samples/day)
US, Asia/Oceania : Small, Medium and Large size hospitals (Maximum 100 samples/ day)
3. Purpose
Electrolyte analyze for serum and urine
Positioning at the market and competitors1. Positioning
A biochemical analyzer aiming for processing of medium and small sample quantities for
the market for medium and small hospitals.
Biochemical analyzer for STAT inspections for the market for medium and large hospitals
2. Competitors
Manufacture Product Feature
Beckman Coulter AU400 Na, K, Cl : 3 items 200 samples/hour
Hitachi 7070 Na, K, Cl : 3 items 180 samples/hour
Shimazu CL-8000 Na, K, Cl : 3 items 133 samples/hour
Toshiba 40FR Na, K, Cl : 3 items 200 samples/hour
Du Pont Dimension AR Na, K, Cl, TCO2 : 4 items 67 samples/hour
J&J Ektachem 550 Na, K, Cl, TCO2 : 4 items
Bayer Opera Na, K, TCO2 : 4 items
Our main competitor is HITACHI 7070.
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AU400 ISE Function and Mechanism Manual
Part 1 Outline1 - 2
Correspondence to Law and Regulations1. Acquired External Standards
Japan : Pharmaceutical Affairs Law
USA : FDA510K
FCC Part 15 Class A
CSA C 22. 2 No. 1010-1
Europe : CE Marketing EMC Emission EN55011 (Conform to CISPR11)
Immunity EN50082-2
Low Voltage Equipment (Safety) Regulations EN61010-1
H Mark
Australia/New Zealand : AS/NZS CISPR11
All destinations : Radiation Field (Testing is represented by Europe Destination)
2. Observed External Standards
Japan : Package Recycle Law
Waste Process Law
Water Pollution Control Law
Sewage Law
Security Export Management regulations
USA : FDC regulation, Part 1040. 10
(Safety of lasers and other light-emitting product)
FDC regulation, 21 CFR Part 820 (GMP)
Regulation in regard to packaging materials containing
Harmful Substance HIPPA
Regulations for Used Batteries CE4212
Europe : Instructions in regard to the batteriesGovernment degrees in regard to packaging waste materials (DE)
Equipment safety standards for hospital laboratories (UK)
Universal : Law for protections of the ozone layer
PL Law
Regulations in regards to asbestos
Note: The ISE is a factory option.
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AU400 ISE Function and Mechanism Manual
Part 1 Outline1 - 3
Quality Aim1. Feature
As an option of the AU400, when there is indication for analysis of Na, K and Cl items,take 20 l of sample (serum) or 25 l (Urine) from the device and measure the ion
concentration of Na, K, Cl for 18 second cycle per sample.
2. Electrode Life
Storage life
Na electrode : Max. 12 months
K electrode : Max. 12 months
Cl electrode : Max. 12 months
Reference electrode : Max. 12 months
Expiration date
Na electrode : Max. 2 months or 20,000 samples*
K electrode : Max. 2 months or 20,000 samples*
Cl electrode : Max. 2 months or 20,000 samples*
Reference electrode : Max. 24 months or 150,000 samples*
*It is expired in that period or number of samples whichever comes first.
Service Life5 years or 150,000 tests (100 samples/day 25 days/month 12 months 5 years)
Except for the consumption parts and periodical exchanged parts
Product Life5 years
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AU400 ISE Function and Mechanism Manual
Part 1 Outline1 4
Feature
Selling Points
1) Crown ether membrane is used to measure Na and K electrodes, and Molecular
oriented membrane (MO membrane) is used to measure Cl electrodes, and that
possesses good response and improves durability.
The crown ether membranes of Na, K electrodes have high-speed response, goodselectivity, and are insusceptible to chemical inhibitors (Protein and etc.).
Cl electrode uses Molecular Oriented membrane (MO membrane) to build up tens ofthousands of the molecular firms and change the molecular firms to solid, by this
solidificationtechnology the new CL electrode obtains more high-speed response and
high selectivity (counter Br, counter HCO3.
By the high-speed response, one each electrode can process the measurements ofthe Na, K, and Cl electrolytes for 200 samples per hour.
2) Different from the flame photometry method, the ISE does not used Propane gas and
the amount of the heat generation is smaller.
3) The ISE can analyze the primitive urine and does not have to dilute samples.
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Part 1 Outline1 - 5
Limiting Condition(Use Environment, Cautions and Prohibitions and etc.)
Installation and Use Environment A place not exposed to direct sunlight
A place with little dust
A flat place with little inclination (max. slope: 1/200)
A place where the floor can withstand the instrument weight
A place without serve voltage fluctuations (Voltage fluctuations within 10 %)
A place with no machines producing abnormal noise in the vicinity The temperature should be 18 to 32 during the instrument is working, and the
fluctuation should be within 2 .
The humidity should be 40 to 80 % RH and there should be no condensation.
(Temperature at the storage condition should be between 5 to 40.)
Cautions and Prohibitions For general caution items, refer to the contents of the notification by the Pharmaceutical
Affairs Bureau of the Japan
Ministry of Health and Welfare, dated June 1, 1972, listed in the operation manual.
In addition, the caution items listed in the operation manual and the caution labels on the
equipment must be observed.
Instrument UsersOperators and users of this instrument shall be those who are trained by Beckman Coulter or
trainers certified by Beckman Coulter.
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AU400 ISE Function and Mechanism ManualPart 1 Outline of the System
1 6
Product Unit
Type List
Parts No. Name Destination
MU4970 M514-OPA01 JAPAN
MU4971 M514-OPA02 USA
MU4972 M514-OPA03 Europe
MU4986 M514-OPA04 Asia/Oceania
Unit composition
Pcs.
MU4970 MU4971 MU4972 MU4986CompositionUnit
PartsNo.
ProductName M514-
OPA01M514-OPA02
M514-OPA03
M514-OPA04
Remarks
MU4977 M015-AA01 1 1 1 1
MU4978 M015-DA01 1 1 1 1
MU5010 M015-JA01 1 1 1 1
MU3223 M014-EF01 1 1 1 1
MU3545 M014-BA02 2 2 2 2
MU2465 M510-SA01 1 1 1 1
M504-EJ01 1 1 1 1 R syringe
M902-EM03 1 1 1 1 SyringeCase
MB9807 Model Label 1 1 1 1
MB9132 EC Label 1 1 1 1MD7476 Tube 2 2 2 2
Main body
MD7477 Connector 4 4 4 4MU3213 M014-ACC11 1Standard
accessories
MU3214 M014-ACC12 1 1 1Starter kit MU3216 M014-TRN11 1
PackingMaterials
MU4991 M015-DPC11 1 1 1 1MU4993 Name label J 1 1MU4994 Name label A 1
Namelabel set
MU4995 Name label E 1Consumables MU3218 M014-CSS11 (1) (1) (1) (1)Repair parts MU4992 M015-REP11 (1) (1) (1) (1)
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AU400 ISE Function and Mechanism ManualPart 1 Outline of the System
1 7
Standard Accessories Composition
Pcs. RemarksMU3213 MU3214
CompositionUnit
PartsNo.
ProductName
M014-ACC11 M014- ACC12
MU9623 P tube 1 1
ZM2970 Pinch valvetube
1 11 1
MA1198 Warranty 1 1 WarrantyCheck list 1 1 Package check
list
Packing List 1 1
StandardAccessories
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AU400 ISE Function and Mechanism Manual
Part 2 Specification2 - 1
Specification
MethodDilution-type ion electrode method
*Dilution Tube Fixed Method
Measurement ItemNa, K, Cl ion
Measurement sampleSerum, Urine
ThroughputMaximum 200 samples/ hour
*18 seconds cycle
Sample volumeSerum : 20 L (Extrusion water: 8 L)
Urine : 25 L (Extrusion water: 10 L)
Buffer solution volumeSerum : 618 L
Urine : 750 L
Reagents to be used Buffer solution
MID-STD solution
REF solution
Serum H standard solution
Serum L standard solution
Urine H standard solution
Urine L standard solution
Selectivity check solution
Wash water Electrode solution
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Part 2 Specification2 - 2
Calibration External two-point calibration (electrode sensitivity calibration)
*Independent calibration for serum and urine
External one-point calibration (ACAL)
Measuring RangeSerum mode (mmol/l) Urine mode (mmol/l)
Na 50 to 200 10 to 400
K 1. 0 to 10.0 2.0 to 200
CL 50 to 200 15 to 400
ElectrodeNa Electrode : Crown ether membrane
K Electrode : Crown ether membrane
Cl Electrode : Solid membrane (Class 4 ammonium salt)
REF Electrode : Liquid junction method
Electrode Shelf LifeNa Electrode : 12 months from production
K Electrode : 12 months from production
Cl Electrode : 12 months from production
REF Electrode : 12 months from production
Electrode Shelf ConditionTemperature : 0 to 40
Humidity : 20 to 90 %
Atmospheric pressure : 0.7 to 1.1
Electrode LifeNa Electrode : 2 months or 20,000 samples
K Electrode : 2 months or 20,000 samples
Cl Electrode : 2 months or 20,000 samples
REF Electrode : 24 months or 150, 000 samples
Whichever sooner
*When the electrode is started using within the electrode shelf life.
The electrode that is after the shelf life regards as that the electrode is started using on
the last day of the shelf life, use the electrode life.
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Part 2 Specification2 - 3
Perister Tube Life3 month or 20,000 samples
Syringe Life150, 000 samples
Use EnvironmentTemperature : 18 to 32
Temperature fluctuation : 2 (After the calibration)
Humidity : 40 to 80 % R. H.
PowerDC + 5 V
DC + 24 V
Max Rated Power SupplyMaximum 100 VA
WeightAbout 10 kg
* Only for the case part of the Main body
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AU400 ISE Function and Mechanism Manual
Part 4 Operation Explanations4 - 1
Operation Explanations
Analysis1) The sample probe of the main body dispenses the sample by the extrusion dispensing
to the dilution tube (Sample pod).
Sample type Serum (Sample Volume: 20 uL, Extrusion dispensing water: 8 L)
Urine (Sample volume: 25 L, Extrusion dispensing water: 10 L)
2) The sample probe discharges the dilution
Dilution volume Serum (618 L)
Urine (750 uL)3) The mix bar mixed the sample.
4) The perister pump aspirates the mixed mixture to the flow cell.5) The bypass tube drains the residual liquid in the dilution tube (sample pod) to prepare
the next mixture.
6) Measure the voltage of each Na, K, and Cl electrode referring to REF electrode.
REF solution Serum (120 L)
Urine (150 L)
7) The thermistor measures the temperature of the mixture.
8) The probe dispenses the STD solution to the dilution tube.
STD solution Serum (750 L)Urine (991 L)
9) Same as the sample, measure the temperature of the potential measurements of Na,
K, Cl, and mixture
10) Calculate the concentration from the mixture and the STD solution potential after the
temperature correction.
Correction1) The sample probe of the main body dispenses the STD solution by the extrusion
dispensing to the dilution tube (sample pod).
STD solution For serum: H, L
For urine: H, L
2) Perform the same operation as the analysis operation.
3) Perform calculation.
Selectivity Check1) The sample probe of the main body dispenses the selectivity check solution by the
extrusion dispensing to the dilution tube (sample pod).
Selectivity check solutions: for Na, for K
2) Perform the same operation as the analysis operation.
Wash before Analyze1) The sample probe dispenses the STD solution to the dilution tube (sample pod).
2) The perister pump aspirates the mixed STD solution to the flow cell.
3) The bypass tube drains the residual liquid in the dilution tube (sample pod) to prepare
the next mixture.
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AU400 ISE Function and Mechanism Manual
Part 4 Operation Explanations4 - 2
Wash after the analysis1) The probe dispenses the STD to the dilution tube (sample pod).
2) The perister pump aspirates the mixed STD solution to the flow cell.3) The bypass tube drains the residual liquid in the dilution tube (sample pod) to prepare
the next mixture.
Cleaning1) The sample probe of the main body dispenses the cleaning solution by the extrusion
dispensing to the sample tube (sample pod).
2) The probe dispenses the dilution to the dilution tube (Sample pod).
3) The mix bar mixes the dilution to wash the dilution tube (sample pod).
4) The perister pump aspirates the cleaning solution to the flow cell to wash the flow cell.
5) The probe dispenses the STD solution to the dilution tube (sample pod).6) The mixing bar mixes the STD solution to wash the dilution tube (sample pod).
7) The perister pump aspirates the mixed STD solution to the flow cell to wash the flow
cell.