9.ifam AU 400 Mechanical

7/28/2019 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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AU400 ISE Mechanical and Function Manual Manual History TableP1/1

Ver. Page Replace Reason of Change

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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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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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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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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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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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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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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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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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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.

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9.ifam AU 400 Mechanical