AU400 ISE Mechanical and Function Manual

Manual History Table

P1/1 Reason of Change

Ver. First

Page All

Replace Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No Yes, No

Newly released

Table of Contents
Part 1: Outline
Instrument Outline 1 1 to 1 3 Specifications1 - 4 Limited Conditions 1 - 5 Product Unit 1 6 to 1 9

Part 2: Specification
Specification 2 1 to 2 3

Part 3: Overall Construction

Overall Construction 3 1 Piping Diagram

Part 4: Operation Explanations

Operation Explanations 4 1 to 4 2

AU400 Part 1

ISE Function and Mechanism Manual

1-1

Outline

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 Market
1. 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 competitors

1. 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 Beckman Coulter Hitachi Shimazu Toshiba Du Pont J&J Bayer Product AU400 7070 CL-8000 40FR Dimension AR Ektachem 550 Opera Feature Na, K, Cl : 3 items 200 samples/hour Na, K, Cl : 3 items 180 samples/hour Na, K, Cl : 3 items 133 samples/hour Na, K, Cl : 3 items 200 samples/hour Na, K, Cl, TCO2 : 4 items 67 samples/hour Na, K, Cl, TCO2 : 4 items Na, K, TCO2 : 4 items

Our main competitor is HITACHI 7070.

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AU400 Part 1

ISE Function and Mechanism Manual

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Outline

Correspondence to Law and Regulations

1. Acquired External Standards
Japan USA : Pharmaceutical Affairs Law : FDA510K FCC Part 15 Class A CSA C 22. 2 No. 1010-1 : CE Marketing EMC Emission EN55011 (Conform to CISPR11) Immunity EN50082-2 Low Voltage Equipment (Safety) Regulations EN61010-1 H Mark : AS/NZS CISPR11 : Radiation Field (Testing is represented by Europe Destination)

Europe

Australia/New Zealand All destinations

2. Observed External Standards

Japan : Package Recycle Law Waste Process Law Water Pollution Control Law Sewage Law Security Export Management regulations : 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 : Instructions in regard to the batteries Government degrees in regard to packaging waste materials (DE) Equipment safety standards for hospital laboratories (UK) : Law for protections of the ozone layer PL Law Regulations in regards to asbestos

USA

Europe

Universal

Note: The ISE is a factory option.

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AU400 Part 1

ISE Function and Mechanism Manual

1-3

Outline

Quality Aim
1. 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 K electrode Cl electrode Reference electrode
Expiration date Na electrode K electrode Cl electrode Reference electrode

: Max. 12 months : Max. 12 months : Max. 12 months : Max. 12 months

: Max. 2 months or 20,000 samples* : Max. 2 months or 20,000 samples* : Max. 2 months or 20,000 samples* : Max. 24 months or 150,000 samples*

*It is expired in that period or number of samples whichever comes first.

Service Life
5 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 Life
5 years

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AU400 Part 1

ISE Function and Mechanism Manual

14

Outline

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, good selectivity, and are insusceptible to chemical inhibitors (Protein and etc.). Cl electrode uses Molecular Oriented membrane (MO membrane) to build up tens of thousands of the molecular firms and change the molecular firms to solid, by this solidification technology 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 of the 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. The ISE can analyze the primitive urine and does not have to dilute samples.

3)

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AU400 Part 1

ISE Function and Mechanism Manual

1-5

Outline

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 Users
Operators 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 Manual

16

Part 1 Outline of the System

Product Unit
Type List
Parts No. MU4970 MU4971 MU4972 MU4986 Name M514-OPA01 M514-OPA02 M514-OPA03 M514-OPA04 Destination JAPAN USA Europe Asia/Oceania

Unit composition
Parts No. MU4977 MU4978 MU5010 MU3223 MU3545 MU2465 Product Name M015-AA01 M015-DA01 M015-JA01 M014-EF01 M014-BA02 M510-SA01 M504-EJ01 M902-EM03 Model Label EC Label Tube Connector M014-ACC11 M014-ACC12 M014-TRN11 M015-DPC11 Name label J Name label A Name label E M014-CSS11 M015-REP11
MU4970 M514OPA01 1 1 1 1 2 1 1 1

Composition Unit

Main body

Pcs. MU4971 MU4972 M514M514OPA02 OPA03 1 1 1 1 1 1 1 1 2 2 1 1 1 1 1 1 1 1 2 4 1 1 1 2 4 1 1

MU4986 M514OPA04 1 1 1 1 2 1 1 1

Remarks

R syringe Syringe Case

Standard accessorie s Starter kit Packing Materials Name label set

Consumables

MB9807 MB9132 MD7476 MD7477 MU3213 MU3214 MU3216 MU4991 MU4993 MU4994 MU4995 MU3218 MU4992

1 1 2 4 1 1 1 1

1 1 2 4 1 1 1

1 (1) (1) (1) (1) 1 (1) (1) (1) (1)

Repair parts

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AU400

ISE Function and Mechanism Manual

17

Part 1 Outline of the System

Standard Accessories Composition

Composition Unit
Standard Accessories

Parts No. MU9623 ZM2970

Product Name P tube Pinch valve tube Warranty Check list Packing List

Pcs. MU3213 M014-ACC11 1 1 1 1 1 1 MU3214 M014- ACC12 1 1 1 1 1 1

Remarks

MA1198

Warranty Package check list

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AU400 Part 2

ISE Function and Mechanism Manual

2-1

Specification

Specification
Method
Dilution-type ion electrode method *Dilution Tube Fixed Method

Measurement Item
Na, K, Cl ion

Measurement sample
Serum, Urine

Throughput
Maximum 200 samples/ hour *18 seconds cycle

Sample volume
Serum : 20 L (Extrusion water: Urine : 25 L (Extrusion water: 8 L) 10 L)

Buffer solution volume

Serum : 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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AU400 Part 2

ISE Function and Mechanism Manual

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Specification

Calibration
External two-point calibration (electrode sensitivity calibration) *Independent calibration for serum and urine External one-point calibration (ACAL)

Measuring Range
Na K CL Serum mode (mmol/l) 50 to 200 1. 0 to 10.0 50 to 200 Urine mode (mmol/l) 10 to 400 2.0 to 200 15 to 400

Electrode
Na Electrode : Crown ether membrane K Electrode : Crown ether membrane Cl Electrode : Solid membrane (Class 4 ammonium salt) REF Electrode : Liquid junction method

Electrode Shelf Life

Na 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 Condition

Temperature : 0 to 40

Humidity : 20 to 90 % Atmospheric pressure : 0.7 to 1.1

Electrode Life
Na 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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AU400 Part 2

ISE Function and Mechanism Manual

2-3

Specification

Perister Tube Life

3 month or 20,000 samples

Syringe Life
150, 000 samples

Use Environment
Temperature
x

: 18 to 32

Temperature fluctuation : 2 (After the calibration) Humidity : 40 to 80 % R. H.

Power
DC + 5 V DC + 24 V

Max Rated Power Supply

Maximum 100 VA

Weight
About 10 kg * Only for the case part of the Main body

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AU400 Part 3

ISE Function and Mechanism Manual

3-1

Overall Construction

Overall Construction
Top View

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1 3 6
M 5 1 4 Sample probe

2 7 8

A
ME 8 2 2 9 ( T1 2 65)
a
MD 9 8 9 5

ME 9 7 1 8 ME 5 0 0 1

PM
M MB 0 2 0 5 ( P 3. 2 * Z M2 9 7 0
a

B 120)

( MF 7 3 2 9 ( T1 2 600) * MB 8 3 6 0 ( S1 3 170) MU 3 2 2 7
Mixture Change Valve
MA 3 7 4 6

MB 0 0 2 4 4 20)

B
2
c
MB 1 4 8 3

MB 0 9 7 5 1

MD 9 8 9 0

MB 5 9 0 0

Cl
MD 9 8 9 2 ( D M1 0 3 3 ) 5
Thermistor

MD 7 4 7 7

( T1 2 700)

Na K
*

MD 7 4 7 6 MB 9 8 9 3 MU 2 9 4 5
Dilution valve b
MA 3 7 5 6 ( D M0 6 9 6 ) ( U MG 1 - T 1 - M- D C 2 4 V )

MB 8 3 6 4

MF 7 3 3 0
c

C
a
MA 7 4 0 8
MB 0 9 2 8

( T1 NO

520)

Standard solution pump

M0 1 4 - B A 0 2 6 NC MU 3 2 2 6
REF Valve ( P 2 . 5

( T1 2 220)

Re f

* MB 8 3 5 4 ( P1. 6 3. 2

20)
b

C
(
MB 1 4 8 5

20)

M B MA 4 8 1 8
MB 7 9 8 4

Heat Exchange Unit

MF 7 3 2 2 8 COM ( L F VA2 4 2 0 1 1 0 H)
# # 7 MA 4 8 2 2

NC

NO

MB 8 3 5 4 ( P1. 6 3. 2 20) MA 3 5 0 2 4. 5 120)

MD 9 8 9 1

MA 4 7 5 7 MA 3 7 5 3 ( P2. 5 4. 5 200) MB 0 1 5 3 ( P2. 5 4. 5 20)

4 MD 7 4 7 7 MD 7 4 7 6

MD 9 8 9 0

MB 0 9 2 8

9 ME 6 3 3 9 ( T1
R sylinge Dilution dispenser

# e #

MB 7 9 8 5

D
PM
#

MA 7 4 0 8

2
Blue M D 9 8 9 3

140) ME 5 7 4 2

MF 7 3 3 1 ( T1 2 1100)
Yellow
MD 9 8 9 4 # # MD 8 6 4 6

* MB 8 3 5 9 ( S1 3 150) 650

Mixture aspiration pump

*1)
M0 1 4 - B A 0 2 MA 5 1 0 7 ( L12 MA 5 1 0 7 ( L12 18 180) 18 180)

a: b: c: d: e:

MA 3 6 2 7 MD 7 5 5 9 MD 9 8 9 7 MD 9 8 9 8

Red

MD 7 5 6 0 # MD 0 1 7 0
# MD 8 6 4 6 # MD 8 6 4 7
Yellow

600

MD 9 8 8 8 ( T1 2 1100) # MD 9 8 9 9

2)
To the M514 main body drain

T - - Teflon Tube P - - Poalon Tube

E
Blue
# MD 9 8 7 6

Red

# #

MD 9 8 7 8 MD 9 8 7 9 # MB 7 4 8 7

S - - Silicon Tube - - Lifelon Tube 3 ) Parts with # is organaized in the M015-DA01

MD 9 8 7 5

MD 9 8 8 0

F
REF

MD 5 3 9 9 ( S3 6 28) # MD 7 4 8 6

Remarks :
I NT . S T D BUF F E R

F
[16] 2009.09.25 [2] 1997.07.04

Issued

Service Manual House Code Item Sht. NO.

3 4 5 6

MU4977 M015-AA01 1/1

AU400 Part 4

ISE Function and Mechanism Manual

4-1

Operation Explanations

Operation Explanations
Analysis
1) 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) The sample probe discharges the dilution Dilution volume Serum (618 L) Urine (750 uL) The mix bar mixed the sample. The perister pump aspirates the mixed mixture to the flow cell. The bypass tube drains the residual liquid in the dilution tube (sample pod) to prepare the next mixture. Measure the voltage of each Na, K, and Cl electrode referring to REF electrode. REF solution Serum (120 L) Urine (150 L) The thermistor measures the temperature of the mixture. The probe dispenses the STD solution to the dilution tube. STD solution Serum (750 L) Urine (991 L) Same as the sample, measure the temperature of the potential measurements of Na, K, Cl, and mixture Calculate the concentration from the mixture and the STD solution potential after the temperature correction.

2)

3) 4) 5) 6)

7) 8)

9) 10)

Correction
1) 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 Perform the same operation as the analysis operation. Perform calculation.

2) 3)

Selectivity Check
1) 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 Perform the same operation as the analysis operation.

2)

Wash before Analyze

1) 2) 3) The sample probe dispenses the STD solution to the dilution tube (sample pod). The perister pump aspirates the mixed STD solution to the flow cell. The bypass tube drains the residual liquid in the dilution tube (sample pod) to prepare the next mixture.
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AU400 Part 4

ISE Function and Mechanism Manual

4-2

Operation Explanations

Wash after the analysis

1) 2) 3) The probe dispenses the STD to the dilution tube (sample pod). The perister pump aspirates the mixed STD solution to the flow cell. The bypass tube drains the residual liquid in the dilution tube (sample pod) to prepare the next mixture.

Cleaning
1) 2) 3) 4) 5) 6) 7) The sample probe of the main body dispenses the cleaning solution by the extrusion dispensing to the sample tube (sample pod). The probe dispenses the dilution to the dilution tube (Sample pod). The mix bar mixes the dilution to wash the dilution tube (sample pod). The perister pump aspirates the cleaning solution to the flow cell to wash the flow cell. The probe dispenses the STD solution to the dilution tube (sample pod). The mixing bar mixes the STD solution to wash the dilution tube (sample pod). The perister pump aspirates the mixed STD solution to the flow cell to wash the flow cell.

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