Анализатор электролитов avl 9180 инструкция - Инструкции, руководства, мануалы

MEDICAL INSTRUMENTS

AVL 9120, 9130, 9140, 9180, 9181 Electrolyte Analyzers

Service Manual

Tenth Edition

November 1997

Copyright, 1997, AVL Scientific Corporation. All rights reserved. Unless otherwise noted, no part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language in any form without the written permission of AVL Scientific Corporation.

For information contact:
AVL Scientific Corporation	AVL MEDICAL INSTRUMENTS AG	AVL LIST GmbH
50 Mansell Court	Stettemerstrasse 28	Kleiststrasse 48
P.O. Box 337	CH-8207 Schaffhausen	A-8020 Graz
Roswell, Georgia USA 30077	Switzerland	Austria
1-800-526-2272	41-848-800-885	43-316-787-0
Printed in USA
US0285 REV K

Important Information!

This Operator´s Manual contains important warnings and safety information to be observed by the user.

This instrument is only intended for one area of application which is described in the instructions. The most important prerequisites for application, operation and safety, are explained to ensure smooth operation. No warranty or liability claims will be covered if the instrument is applied in areas other than those described or if the necessary prerequisites and safety measures are not observed.

The instrument is only to be operated by qualified personnel capable of observing these prerequisites.

Only accessories and supplies either delivered by or approved by AVL are to be used with the instrument.

Due to the operating principle of the instrument, analytical accuracy not only depends on correct operation and function, but also upon a variety of external influences beyond the manufacturers control. Therefore, the test results from this instrument must be carefully examined by an expert, before further measures are taken based on the analytical results.

Instrument adjustment and maintenance with removed covers and connected power mains are only to be performed by a qualified technician who is aware of the dangers involved.

Instrument repairs are only to be performed by the manufacturer or qualified service personnel.

Symbol	Explanation
	Attention symbol — Refer to the Operator’s Manual or Service
	Manual for further instructions. This symbol is located on the
	inside of the instrument.
	Type B instrument symbol — An instrument of the B type falls under
	safety categories I, II, or III, or has an internal power supply providing
	the required insulation against discharge current and reliable ground
	connections.

Important Information!

iii

Operating Safety Information

•This instrument falls under Safety Category I.

•This instrument is a Class B instrument.

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference’s, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Warning: Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communication. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does not cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

•Reorient or relocate the receiving antenna

•Increase the separation between the equipment and receiver

•Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

•Consult the dealer or an experienced radio TV technician for help

Caution:

•The instrument is designed as a conventional device (closed, not waterproof type).

•Do not operate the instrument in an explosive environment or in the vicinity of explosive anesthetic mixtures containing oxygen or nitrous oxide.

•This instrument is suitable for continuous operation.

•The power plug is to be plugged into a ground socket only. When using an extension cord, make sure that it is of the proper size and is properly grounded.

•Any breakage of the ground lead inside or outside the instrument or a loose ground connection can cause a hazardous condition when operating the instrument. Intentional disconnection of the grounding is not permitted.

•When replacing the fuses, make sure that they are of the same type and rating as the original fuses. Never use repaired fuses or short-circuit the fuse holders.

Operating Safety Information

Contents

1	Introduction ………………………………………………………………………………..	1
2	General Description ……………………………………………………………………	2
	2.1 Reported Parameters …………………………………………………………	2
	2.2 Operating Parameters ………………………………………………………..	2
3	Software	…………………………………………………………………………………….	5
	3.1	System Software Flow Charts 9120, 30, 40 ………………………….	7
	3.2	System Software Flow Charts 9180 …………………………………..	17
	3.3	System Software Flow Charts 9181 …………………………………..	29
	3.4	Service Functions …………………………………………………………..	42
4	Description of Modules ……………………………………………………………..	48
	4.1	Mechanical Assemblies ……………………………………………………	48
	4.2	Fluidic Module ………………………………………………………………	52
	4.3	Electronics …………………………………………………………………….	56
5	Maintenance and Troubleshooting ……………………………………………..	59
	5.1	Maintenance Procedures …………………………………………………	59
	5.2	Error Messages and Troubleshooting ………………………………..	60
6	Adjustments ……………………………………………………………………………..	71
	6.1	Sample Sensor Adjustment ………………………………………………	71
	6.2	Temperature Adjustment ………………………………………………….	71
7	Electronic Diagrams ………………………………………………………………….	72
	System Block Diagram 9120, 30, 40, 80 ………………………………….	74
	System Block Diagram 9181 ………………………………………………….	75
	System Interconnect 9120, 30, 40 …………………………………………..	76
	SBC PCB — Power Supply 9120, 30, 40 ………………………………….	77
	SBC PCB — Valve Drivers 9120, 30, 40 …………………………………..	78
	SBC PCB — Pump Motor Driver/Door Detect 9120, 30, 40 …………	79
	SBC PCB — Input Amplifiers 9120, 30, 40 ………………………………..	80
	SBC PCB — Temperature Circuit 9120, 30, 40 ………………………….	81
	SBC PCB — Analog Selector and A/D Converter 9120, 30, 40 …….	82

SBC PCB — Microprocessor 9120, 30, 40 ……………………………….	83
SBC PCB — Printer/Display Drivers 9120, 30, 40 ………………………	84
Printer Daughter PCB 9120, 30, 40, 80, 81 ………………………………	85
Lamp PCB 9120, 30, 40 ……………………………………………………….	86
Display Daughter PCB 9120, 30, 40 ………………………………………..	87
System Interconnect 9180/9181 ……………………………………………..	88
SBC PCB — Power Supply 9180/9181 …………………………………….	89
SBC PCB — Valve Drivers 9180/9181 ……………………………………..	90
SBC PCB — Pump Motor Driver/Door Detect 9180/9181 ……………	91
SBC PCB — Input Amplifiers 9180/9181 …………………………………..	92
SBC PCB — Temperature Circuit 9180/9181 …………………………….	93
SBC PCB — Analog Selector and A/D Converter 9180/9181 ……….	94
SBC PCB — Microprocessor 9180/9181 ………………………………….	95
SBC PCB — Printer/Display Drivers 9180/9181 …………………………	96
SBC PCB — Fluid Pack Detector 9180/9181 …………………………….	97
Lamp PCB 9180/9181 ………………………………………………………….	98
Display Daughter PCB 9180 …………………………………………………..	99
8 Parts List …………………………………………………………………………….	100
Main Assembly Front ………………………………………………………….	101
Main Assembly Rear …………………………………………………………..	102
Electrode Holder Assembly ………………………………………………….	103
Needle Unit Assembly …………………………………………………………	104
Rear Panel Assembly …………………………………………………………..	105
Front Door Assembly ………………………………………………………….	106
9 Interface Specifications ……………………………………………………………	107
9.1 Interface Information……………………………………………………..	107
9.2 Example Data String Information ……………………………………..	108
9.3 Data Link Information ……………………………………………………	108

1 Introduction

The Service Manual for the 9120, 30, 40, 80, and 81 Electrolyte Analyzers contains the technical information needed to ensure easy fault identification. This manual is intended to be complementary to the Operator’s Manual where detailed instructions for operation, maintenance and troubleshooting are provided.

As for all clinical instrumentation, a thorough understanding of the principles of operation is prerequisite to attempting service of this product. Training along with experience will enhance the use of this manual.

Service and repair of 9120, 30, 40, 80, and 81 analyzers should be performed only by qualified repair technicians. Care should be taken when removing the covers as hazardous voltages are exposed. Use only accepted electronic test procedures and static protection when replacing and handling all electronic parts.

This manual is divided into 9 chapters to facilitate location of technical information. Chapter 2 provides specifications and operating parameter information. Chapter 3 includes flow charts for all system functions and detailed operation of system test procedures. In Chapter 4, all mechanical, fluidic and electronic assemblies are described. Chapter 5 outlines routine maintenance and troubleshooting procedures. Chapter 6 includes electronic adjustments and Chapter 7 provides the system block diagram and all circuit schematic diagrams and wiring interconnection information. In Chapter 8, part identification, location and description is provided by the illustrated parts list.

Finally, in Chapter 9 interface specifications are provided for the RS232 output.

2 General Description

Specifications

2.1 Reported Parameters	Measuring Range	Resolution
Whole Blood
Serum
Plasma
Sodium	Na+	40 — 205 mmol/L	0.1	mmol/L
Potassium K+	1.5 — 15	mmol/L	0.01 mmol/L
		(0.8 — 15	mmol/L dialysate)
Chloride	Cl—	50 — 200 mmol/L	0.1	mmol/L
Calcium	Ca++	0.2 — 5.0 mmol/L	0.01 mmol/L
Lithium	Li+	0.1 — 6.0 mmol/L	0.001 mmol/L
Urine
Sodium	Na+	1 — 300 mmol/L	1.0	mmol/L
Potassium K+	4.5 — 120 mmol/L	0.1	mmol/L
		(60 — 120 mmol/L	w. addit. dilution)
Chloride	Cl—	1 — 300 mmol/L	1.0	mmol/L

Calcium and Lithium are not measured in urine samples. Lithium is not measured in dialysate samples.

2.2 Operating Parameters
Sample type	Whole blood, serum, plasma, urine,
	dialysate (acetate or bicarbonate)
Sample device	Syringe, sample cup, collection tube, capillary
Sample size	95 µL
Analysis time	50 seconds
Sample rate	45	per hour with printout
	60	per hour without printout

Measurement
Sodium (Na+) sensor	Ion-selective, flow-through, glass capillary
	electrode
Potassium (K+) sensor	Ion-selective, flow-through, liquid membrane
	electrode
Chloride (Cl—) sensor	Ion-selective, flow-through, liquid membrane
	electrode
Calcium (Ca++) sensor	Ion-selective, flow-through, liquid membrane
	electrode
Lithium (Li+) sensor	Ion-selective, flow-through, liquid membrane
	electrode
Reference System	Open liquid junction, flow-through electrode
Calibration	Fully automatic
	1 point with each sample
	2 point every 3 hours (9180/9181 every 4 hrs.)
Standby Mode	suspends calibrations
Warm-up time	1 minute
Temperature	Room temperature, 15 — 32° C, 60 — 90° F
Humidity	maximum 85% relative humidity,
	non-condensing
Data management	Quality Control memory storage, 3 levels,
	35 values; calculation of mean, standard
	deviation, and coefficient of variation (CV)
Diagnostic Programs	user-controlled diagnostics,
	YES/NO operation via the display
Electronics	Microprocessor-controlled
Display	LCD dot-matrix, 2 line, 16 characters per line
Printer	Integral thermal printer, 16 character width
Autosampler (9181 only)	Integral turntable — 18 positions,
	2 mL or 0.25 mL sample cups

Interface		RS232C Serial Port
Data Link		Data link to Compact 2/3 (9180/9181)
Electrical	requirements	100 — 240 V~, 50/60 Hz,
		1.4 A max.
Nominal power	Self-adjusting

consumption	30 W
Dimensions
height	12.2″;	335mm
width	12.4″;	315m
depth	12.0″;	295mm
weight	approx. 13 lbs; 6kg
Classifications
Safety category	I
Device type	B (according to ÖVE-MG/EN 60601-1,
		IEC 601-1)
Mode of operation	continuous operation
Protection	classification	IP 20
Explosion	protection	the device is not designed for operation in
		explosive environments.
Approvals		CSA, CE, FCC Class B
		CLIA Complexity Category: Moderate
		Test System Code: 04739
		FDA 510(k) number: K972673
		Analyte Codes:	Na+ :	5805
				K+ :	4910
				Cl— :	1018
				iCa++ :	1004
				Li+ :	3712

Data subject to change without notice. Technical information is supplied for general informational purposes only.

3 Software Operation

3.1 Software Operation — 9120, 9130, 9140

Software operation of the 9120, 9130, 9140 analyzers can be accessed by YES/ NO selection on the analyzer front panel. The following flow chart diagrams are provided to identify operating sequences of the 9120, 9130, 9140 Analyzers:

1.Overall Program Operating Flow

2.Main Menu

3.Measurement Sequence

4.Print Functions Menu

5.QC/Standard/Urine Sample Menu

6.Daily Maintenance Menu

7.Operator Functions Menu

8.Program Instrument Menu

9.Service Functions Menu

10.Calibration Sequence

3.2Software Operation — 9180

1.Overall Program Operating Flow

2.Main Menu

3.Measurement Sequence

4.Print Functions Menu

5.QC/Std/Dialysate/Urine Sample Menu

6.Daily Maintenance Menu

7.Operator Functions Menu

8.Program Instrument Menu

9.Service Functions Menu

10.Calibration Sequence

11.Power-up Sequence

3.3Software Operation — 9181

1.Overall Program Operating Flow

2.MainMenu

3.MeasurementSequence

4.PrintFunctionsMenu

5.QC/Std/Dialysate/UrineSampleMenu

6.DailyMaintenanceMenu

7.Operator Functions Menu

8.ProgramInstrumentMenu

9.ServiceFunctionsMenu

10.CalibrationSequence

11.Power-up Sequence

The Service Functions Menu is also provided with a more detailed description of each test parameter for use in testing instrument subassemblies.

R E AD Y

1 2 :4 5

P R IN T

Q C/S T AN D AR D /

D A IL Y

O P E R AT O R

P R O G R A M

S E R V I CE

C AL I B R A T I O N ?

40 30, 9120, — Operation Software13.

F U N CT I O N S ?

U R IN E S AM P L E ?

M A IN T E N AN CE ?

F U N C T I O N S ?

IN S T R U M E N T ?

F U N CT I O N S ?

9120, — Flow Operating Program Overall1

Yes

P r int las t

Q C L evel 1

D aily

C heck/C hange

E nter C ode:

T es t

C AL I B R A T E ..

S am ple R epor t?

S am ple?

C leaning?

S napP ak ?

AAA

E lectr odes ?

P r int

Q C L evel 2

D aily

G o to

P r ogr am Q C

T es t

Cal. R epor t?

S am ple?

Conditioning?

S tandby M ode?

L evel 1 R anges ?

S am pl e S ens or ?

P ri nt Q C V alues

Q C L evel 3

R em ain in D aily

S et

P r ogr am Q C

T es t

and S tatis tics ?

S am ple?

Yes

M aintenance?

T im e/D ate?

L evel 2 R anges ?

S am ple D oor ?

R em ain in P r int

S tandard

C AL I B R A T E

R es et

P r ogr am Q C

T es t

Yes

F unctions ?

S am ple?

S am ple N um ber ?

L evel 3 R anges ?

P um p?

U r ine

T ake O ut of

P r ogr am

T es t

S am ple?

O per ation?

N orm al R anges ?

V alves ?

R em ain i n Q C /

R em ain in

P r ogr am

T es t Inter face?

30,

Yes

S td/U ri ne S am ple?

Yes

O perator F unc.?

C orr . F actor s ?

J um p P ins 2 & 3

P r ogr am

T es t

P r inter S etup?

Am plifier ?

	R em ain in		E nter
	P r ogr am F unc.?		S er vice Code?
Yes


		No			No

					R em ain in
			Yes	S er vice F unc.?

2 Main Menu — 9120, 30, 40

MAIN MENU

Display prompt

FUNCTIONS?

Action performed by analyzer

QC/STANDARD/

URINE SAMPLE?

2-second display prompt

DAILY

MAINTENANCE?

Decision-making by analyzer

OPERATOR

FUNCTIONS?

PROGRAM

INSTRUMENT?

SERVICE

FUNCTIONS?

CALIBRATION?

3 Measurement Sequence — 9120, 30, 40

READY	12:45	NO		PRINT
					FUNCTIONS?
OPEN			YES

FLAP
					Open Sample Door
					Introduce Sample
				NO	DOOR OPENED

					WITHIN 2s?
						YES
Please
Introduce Sample
				< air
CHECK SS	voltage
VOLTAGE
			> air
			voltage
Remove Sample		Remove Sample
and Wipe Probe		and Wipe Probe
		2s				2s
Please Close		Please Close
Sample Door		Sample Door
			FLAP				FLAP
		CLOSED			CLOSED
Serum Sample		Blood Sample
in Process	49		in Process 49
Na	K		Cl		Na	K	Cl
151	5.1	114		151	5.1	114
							YES/NO
							1 min.
YES/NO
1 min.

4 Print Functions Menu — 9120, 30, 40

PRINT	NO	QC/STANDARD/

FUNCTIONS?		URINE SAMPLE?
YES
Print Last	YES	PRINTING

Sample Report?			…
NO
Print	YES	PRINTING	READY	12:45

Cal. Report?			…
NO
Print QC Values	YES	PRINTING

and Statistics?			…
NO
YES	NO	READY	12:45
Remain in Print
Functions?

5 QC/Standard/Urine Sample Menu — 9120, 30, 40

QC/STANDARD/

DAILY

URINE SAMPLE?

MAINTENANCE?

YES

SAMPLE

OPEN

CLOSED

QC Level 1

Open Sample Door

Introduce

Wipe Probe/Close

QC Level 1

Sample?

Introduce Sample

Sample

Sample Door

in Process

2 min.

VALUES

Store

REJECTED!

Values?

99.65.34 88.2

YES

2 min

VALUES

READY

12:45

YES

OPEN

ACCEPTED!

SAMPLE

QC Level 2

Open Sample Door

Introduce

Wipe Probe/Close

CLOSED

QC Level 2

Sample

Sample?

Introduce Sample

Sample Door

in Process

2 min.

VALUES

Store

REJECTED!

Values?

99.6 5.34 88.2

YES

2 min

VALUES

READY

12:45

YES

ACCEPTED!

SAMPLE

OPEN

CLOSED

QC Level 3

Open Sample Door

Introduce

Wipe Probe/Close

QC Level 3

Sample

Sample?

Introduce Sample

Sample Door

in Process

2 min.

VALUES

Store

REJECTED!

Values?

99.6 5.34 88.2

2 min

YES

VALUES

READY

12:45

ACCEPTED!

Standard

YES

Open Sample Door

OPEN

Introduce

SAMPLE Wipe Probe/Close CLOSED Standard Sample

Sample?

Introduce Sample

Sample

Sample Door

in Process 49

158.8

5.82 113.2

1 min.

2 min.

NO/

YES

OPEN

SAMPLE Wipe Probe/Close CLOSED

Urine

Open Sample Door

Introduce

Urine Sample

Sample?

Introduce Sample

Sample

Sample Door

in Process 49

238

18.8

198

1 min.

2 min.

NO/

YES

Remain in QC/

NO/

READY 12:45

YES Std/Urine Sample? 2 min.

6 Daily Maintenance Menu — 9120, 30, 40

DAILY

OPERATOR

MAINTENANCE?

FUNCTIONS?

YES

Daily

YES Open Sample Door OPEN

Wipe Probe/CloseCLOSE

Cleaning Solution

YES

CLEAN

Cleaning?

OPEN

Introduce Sample

Sample Door

detected?

NO	NO
	Cleaning Solution
	not detected!

Daily	YES Open Sample Door OPEN	Wipe Probe/Close CLOSE	Condition. Solution	YES
					CONDITION
Conditioning?	OPEN	Introduce Sample	Sample Door	detected?

Condition. Solution

not detected!

Remain in Daily

YES Maintenance?

NO/1min.
CLEANING AND/OR	YES	30 SECOND	CALIBRATE	READY	12:45
COND. PERFORMED?		STABILIZATION

NO
Calibration	YES

due?
NO

7 Operator Functions Menu — 9120, 30, 40

OPERATOR

PROGRAM

FUNCTIONS?

INSTRUMENT?

YES

Check/Change

YES

37%

Change

YES

New SnapPak

YES

Fluid Counter

SnapPak?

remaining

SnapPak?

installed?

reset to 100%

YES

Go to

***STANDBY!***

Standby Mode

YES -> READY

Maint. due?

YES/NO

New Pack

Prime …

Leave

CALIBRATE

Standby Mode?

YES

PRESS YES

YES

READY

12:45

CALIBRATION

WITHIN 2s

DUE?

YES

Daily

Remain in Daily

Cleaning?

Conditioning?

Maintenance?

YES

1min/NO

Set

YES

Date: 01-FEB-94

YES

CLEAN

CONDITION

Time/Date?

Time: 12:00 ok ?

CALIBRATION

DUE?

YES

Date: 01-FEB-94

30 SECOND

Time: 12:00 ok

STABILIZATION

YES

READY

12:45

CALIBRATE

Reset

YES

Are you sure?

YES/

SET SAMPLE

Sample Number?

NUMBER TO 0

YES

Take out of

Shutdown Plug /

YES

Transp Housing

YES

Remove Water

YES

All Electrodes

Operation?

YES

Water installed?

Ref installed?

and Press YES

& Plug Removed?

YES

Remain in

ShutdownComplete

YES

Do You Wish to

YES

Pump Windings

4 Relief Clamps

Operator Func?

Turn Power Off

DELETE all Data?

Relieved?

Inserted?

YES

8 Program Instrument Menu — 9120, 30, 40

PROGRAM

SERVICE

INSTRUMENT?

FUNCTIONS?

YES

IN-

YES

Enter Code:

CORRECT CODE ERROR!

AAA

RETRY?

CORRECT

Program QC

YES

Current Lot: 0000

YES

Print old Values

New Lot!

YES

Enter last 4 Dig

Level 1 Ranges?

Change Lot?

and Statistics?

Delete old Data?

of Lot#: 0000

YES

Cl low

050

YES

K low

1.5

YES

Na low

040

YES

Lot Number

Cl high

200

K high

15.0

Na high

205

ok?

Program QC

YES

«see Level

Level 2 Ranges?

1″

Program QC

YES

«see Level

Level 3 Ranges?

1″

Program

YES

Na low

= 135.0

YES

K low

3.50

YES

Cl low

95.0 YES

Normal Ranges?

Na high

= 150.0

K high

5.50

Cl high

108.0

Program

YES

Reset Corr

Input/Verify

Remain in

Corr Factors

Factor (default)?

Corr Factors?

YES

Corr Factors?

YES

Cl (b)

+00.0

YES

K (b)

+00.0

YES

Na (b)

+00.0

Cl (m)

1.000

K (m)

1.000

Na (m)

1.000

YES

YES/

Program Printer

Patient Report

Print two

Automatic

Setup?

off?

Patient Reports?

Cal Report?

YES

Remain in

YES

Program Func?

READY

12:45

Service Functions Menu — 9120, 30, 40

SERVICE

CALIBRATION?

FUNCTIONS?

YES

Test

YES

Test

YES

Std. A:

Na =0000

Electrodes?

Standard A?

K =0000 Cl =0000

Test

YES

Std. B:

Na =0000

Standard B?

K =0000 Cl =0000

Test

YES

Open Door and

OPEN

Introduce Sample

External Sample?

Introduce Sample

YES

Ext.:

Na =0000

CLOSED

Wipe Probe and

Remain in

Test Electrodes?

K =0000 Cl =0000

Close Sample Door

Test

YES

DRY: 80-120: 102

YES

External:

102

wash…

Sample Sensor?

YES=Pump/NO=Exit

Pump:

NO=OFF

Test

YES

Sample Door:

Sample Door?

C:Closed O:Open

Test Pump?

YES

Test Pump!

Very slow speed

Slow speed

Medium speed

Fast speed

Test Valves?

YES

Test Valve A:

Test Valve B:

Test Valve V:

Test Valve R:

YES/NO=ON/OFF

YES

Test Interface?

YES

— Test —

Interface

Remain in

Jump Pins 2&3

— Interface —

ok!

Test Interface?

Test

YES

Na=-1030 K=-1200

Ground

Amplifier?

Cl = -1093

-2500mV = -2496

YES

Enter

YES

Enter Code:

YES

Is Code

YES

Code

Enter Other

Service Code?

AAA

ok?

valid?

Accepted!

Service Code?

Code

Error!

Remain in

Calibration?

Calibrate…

READY

12:45

YES

Service Func?

10 Calibration Sequence — 9120, 30, 40

CALIBRATION?

YES

Calibration in

Process 124

Clear Sample

Path

Calibrate

Sample Sensor

Voltage ok?

YES

Prime

Standard B

detected?

YES

Prime

Standard A

detected?

YES Pressurize Ref. Asp. Std. A into Meas. Chamber

Reference

Housing ok?

YES

***CHECK***

SAMPLE SENSOR

**STANDARD B** NOT DETECTED

**STANDARD A** NOT DETECTED

***CHECK***

REF HOUSING

A
Asp. Std. A into
Meas. Chamber
Standard A	NO	STANDARD A

detected?		NOT DETECTED
YES
Obtain Electrode
Voltages Std. A
3 Std. A Values	NO

obtained?
YES		NO

Are Values	NO	6 Aspir. of

reproducible?		Std.A performed?
YES		YES

Aspir. Std. B into

Meas. Chamber

Standard B	NO

detected?
	YES

Obtain Electrode

Voltages Std. B

Perform

Wash Cycle

Aspir. Std. A

into Meas.

Chamber

YES

Calculation of

Std.A-Std.B

(slope)

	Slope of all	NO
	Electrodes in


	Range?
		YES


	READY 12:45

**STANDARD B** NOT DETECTED

**STANDARD A** NOT DETECTED

At least 1 slope NO in Range?

YES

READY 12:45

XX NOT CAL’D

***CHECK***

ELECTRODES

***CHECK***

ELECTRODES

Na K Cl READY

QC/STD/DIALYSATE No

DAILY

OPERATOR

PROGRAM

SERVICE

CALIBRATION?

9180 — Operation Software23.

FUNCTIONS?

/URINE SAMPLE?

MAINTENANCE?

FUNCTIONS?

INSTRUMENT?

FUNCTIONS?

Flow Operating ProgramOverall1

Yes

Print last

QC Level 1

Perform Daily

Check/Change

Enter Code:

Test

CALIBRATE…

Sample Report?

Sample?

Cleaning?

SnapPak?

AAA

Electrodes?

QC Level 2

Perform Daily

Go to

Program QC

Test

Cal. Report?

Sample?

Conditioning?

Standby Mode?

Level 1 Ranges?

Sample Sensor?

Print QC Values

QC Level 3

Remain in Daily

Set

Program QC

Test

and Statistics?

Sample?

Yes

Maintenance?

Time/Date?

Level 2 Ranges?

SnapPak Sensor?

Remain in Print

Standard

CALIBRATE…

Select Parameter

Program QC

Test

Yes

Functions?

Sample?

Configuration?

Level 3 Ranges?

Language Switch?

Bicarbonate

Reset

Program

Test

—

9180

Sample?

Sample Number?

Normal Ranges?

Sample Door?

Acetate

Take Out of

Program

Test

Sample?

Operation?

Corr. Factors?

Pump?

Urine

Remain in

Program Bicarb.

Test

Sample?

Yes

Operator Func.?

Corr Factors?

Valves?

Remain in QC/

Program Acetate

Test Interface?

Std/Urine Sample?

Corr Factors?

Jump Pins 2 & 3

Yes

Program Urine

Test

Corr Factors?

Amplifier?

Program

Enter

Printer Setup?

Service Code?

Program

Remain in

Interface?

Service Func.?

Yes

Remain in

Yes

Program Func.?

2 Main Menu — 9180

MAIN MENU
NA K CL	LEGEND
READY
NO
PRINT
FUNCTIONS?
NO
QC/STD/DIALYSATE
/URINE SAMPLE?
NO
DAILY
MAINTENANCE?
NO
OPERATOR
FUNCTIONS?
NO
PROGRAM
INSTRUMENT?
NO
SERVICE
FUNCTIONS?
NO
NO
CALIBRATION?
18

Display prompt

Action performed by analyzer

2-second display prompt

Decision-making by analyzer

3 Measurement Sequence — 9180

NA K CL READY	NO		PRINT
				FUNCTIONS?
OPEN		YES

FLAP
				Open Sample Door
				Introduce Sample
			NO	DOOR OPENED
				WITHIN 2s?
					YES
	Please
Introduce Sample
CHECK SS	< air voltage

	VOLTAGE
		> air voltage
Remove Sample and		Remove Sample and
Wipe Probe		Wipe Probe
	2s			2s
Please Close		Please Close
Sample Door		Sample Door
		FLAP				FLAP
	CLOSED				CLOSED
Serum Sample		Blood Sample
in Process	49		in Process	49
Na	K	Cl		Na	K	Cl
151	5.1	114		151	5.1	114
						YES/NO
						1 min.
YES/NO
1 min.

4 Print Functions Menu — 9180

PRINT	NO	QC/STD/DIALYSATE

FUNCTIONS?		/URINE SAMPLE?
YES
Print Last	YES
	PRINTING…
Sample Report?

NO
Print	YES	PRINTING…	NA K CL	READY

Cal. Report?

NO
Print QC Values	YES	PRINTING…

and Statistics?

NO
YES	NO	NA K CL	READY
Remain in Print
Functions?

5 QC/Standard/Dialysate/Urine Sample Menu — 9180

QC/STD/DIALYSATE

DAILY

/URINE SAMPLE?

MAINTENANCE?

YES

OPEN

SAMPLE

CLOSED

QC Level 1

Open Sample Door

Introduce Sample

Wipe Probe/Close

QC Level 1

Sample?

OPEN

Introduce Sample

Sample Door

in Process

2 min.

2 s

VALUES

Store

REJECTED!

Values?

99.6 5.34 1.250

YES

2 min

2 s

VALUES

NA K CA READY

YES

OPEN

ACCEPTED!

SAMPLE

CLOSED

QC Level 2

Open Sample Door

Introduce Sample

Wipe Probe/Close

QC Level 2

Sample?

OPEN

Introduce Sample

Sample Door

in Process

2 min.

2 s

VALUES

Store

REJECTED!

Values?

99.6 5.34 1.250

YES

2 min

2 s

VALUES

NA K CA READY

ACCEPTED!

YES

OPEN

SAMPLE

CLOSED

QC Level 3

Open Sample Door

Introduce Sample

Wipe Probe/Close

QC Level 3

Sample?

OPEN

Introduce Sample

Sample Door

in Process

2 min.

2 s

VALUES

Store

REJECTED!

Values?

99.6 5.34 1.250

2 min

2 s

YES

VALUES

NA K CA READY

ACCEPTED!

5 s

Standard

YES

Open Sample Door

OPEN

Introduce Sample

SAMPLE

Wipe Probe/Close

CLOSED

Standard Sample

Sample?

OPEN

Introduce Sample

Sample Door

in Process

158.8

5.82

1.250

1 min.

NO/YES

2 min.

5 s

YES

OPEN

SAMPLE

CLOSED

Bicarbonate

Open Sample Door

Introduce Sample

Wipe Probe/Close

Bicarb. Sample

Sample?

OPEN

Introduce Sample

Sample Door

in Process

158.8

5.82

1.250

1 min.

NO/YES

2 min.

5 s

YES

OPEN

SAMPLE

CLOSED

Acetate

Open Sample Door

Introduce Sample

Wipe Probe/Close

Acetate Sample

Sample?

Introduce Sample

Sample Door

in Process

158.8

5.82

1.250

OPEN

1 min.

2 min.

NO/YES

5 s

YES

OPEN

SAMPLE

CLOSED

Urine

Open Sample Door

Introduce Sample

Wipe Probe/Close

Urine Sample

Sample?

Introduce Sample

Sample Door

in Process

238

18.8

198

OPEN

1 min.

NO/YES

2 min.

Remain in QC/

NA K CA READY

Std/Urine Sample?

NO/2 min.

YES

6 Daily Maintenance Menu — 9180

	DAILY	NO	OPERATOR
	MAINTENANCE?		FUNCTIONS?
	YES
	Perform Daily	YES	Open Sample Door	OPEN	Wipe Probe/Close	CLOSE	Cleaning Solution	YES
	Cleaning?		Introduce Sample		Sample Door		detected?	CLEAN

		OPEN
	NO						NO
					Cleaning Solution
					not detected!
	Perform Daily	YES	Open Sample Door	OPEN	Wipe Probe/Close	CLOSE	Condition. Solution	YES
	Conditioning?		Introduce Sample		Sample Door		detected?	CONDITION

		OPEN
							NO
					Condition. Solution
					not detected!
	Remain in Daily
YES	Maintenance?
	NO/1min.

CLEANING AND/OR	YES				NA K CA READY
		30 SECOND		CALIBRATE
COND. PERFORMED?			STABILIZATION

YES

Calibration due?

7 Operator Functions Menu — 9180

*****STATUS*****

**NO SnapPak**

Pack

OPERATOR

PROGRAM

detected?

*Background check in all menus

FUNCTIONS?

INSTRUMENT?

GLOBAL*

YES

except «Take out of Operation?»

YES

Check/Change

YES

37%

Change

New SnapPak

YES

Fluid Counter

SnapPak?

remaining

SnapPak?

installed?

reset to 100%

YES

Go to

***STANDBY!***

Standby Mode

YES -> READY

Maint. due?

YES/NO

New Pack

Prime …

Leave

CALIBRATE

Standby Mode?

YES

PRESS YES

YES

READY

WITHIN 2s

CALIBRATION

DUE?

YES

Daily

Remain in Daily

Cleaning?

Conditioning?

Maintenance?

YES

1min/NO

Set

YES

Date: 01-FEB-94

YES

CLEAN

CONDITION

Time/Date?

Time: 12:00 ok ?

CALIBRATION

YES

DUE?

New

Date: 01-FEB-94

30 SECOND

Parameter

Time: 12:00 ok

STABILIZATION

added?

YES

NA K

READY

CALIBRATE

Electrodes

in place?

YES

Select Parameter

Sel. Parameter:

Configuration?

[Na] [K] [ ] ok?

[Na] [K] [Cl] ok?

[Na] [K] [Ca] ok?

[Na] [K] [Li]

ok?

YES

YES/

Reset

Are you sure?

SET SAMPLE

Sel. Parameter:

Sample Number?

NUMBER TO 0

([Na]) [ ] [Li] ok?

[Na] [

] [Li]

ok?

YES

Take out of

Shutdown Plug and

YES

Transp Housing

YES

Remove Water

YES

All Electrodes

Operation?

YES

Water installed?

Ref installed?

and Press YES

& Plug Removed?

YES

Shutdown

YES

Remain in

Do You Wish to

Pump Windings

5 Relief Clamps

Complete

Operator Func?

DELETE all Data?

Relieved?

Inserted?

Turn Power Off

YES

8 Program Instrument Menu — 9180

PROGRAM

SERVICE

INSTRUMENT?

FUNCTIONS?

YES

IN-

YES

Enter Code:

CODE ERROR!

CORRECT

AAA

RETRY?

CORRECT

Program QC

YES

Current Lot: 0000

YES

Print old Values

New Lot!

YES

Enter last 4 Dig

Level 1 Ranges?

Change Lot?

and Statistics?

Delete old Data?

of Lot#: 0000

YES

Additional

YES

K low

1.5

YES

Na low

040

YES

Enter last 4 Dig

Parameters?

K high

15.0 ok?

Na high

205 ok?

of Lot#: 0000 ok?

YES

Cl low

050

YES

Ca low

0.2

YES

Li low

0.1

YES

Cl high

200 ok?

Ca high

5.0 ok?

Li high

6.0 ok?

Program QC

YES

«see Level 1»

Level 2 Ranges?

Program QC

YES

«see Level 1»

Level 3 Ranges?

Program

YES

Na low

136

YES

K low

03.5

YES

Normal Ranges?

Na high

145 ok?

K high

05.1 ok?

YES

Program

YES

Reset Corr

Input/Verify

Remain in

Na (b)

+00.0

YES

K (b)

+00.0

Corr Factors

Factor (default)?

Corr Factors?

Na (m)

1.000

K (m)

1.000

YES

Program Bicarb.

YES

Reset Bicarb.

Input/Verify

Remain in

Na (b)

+00.0

YES

K (b)

+00.0

Corr Factors

Factor (default)?

Bicarb. Factors?

Bicarb Factors?

Na (m)

1.000

K (m)

1.000

YES

Program Acetate

YES

Reset Acetate

Input/Verify

Remain in

Na (b)

+00.0

YES

K (b)

+00.0

Corr Factors

Factor (default)?

Acetate Factors?

Na (m)

1.000

K (m)

1.000

YES

Program Urine

YES

Reset Urine

Input/Verify

Remain in

Na (b)

+00.0

YES

K (b)

+00.0

Corr Factors

Factor (default)?

Urine Factors?

Na (m)

1.000

K (m)

1.000

YES

YES/

YES

Program Printer

Patient Report

Print two

Automatic

Enter Comment

Enter Comment:

Setup?

off?

Patient Reports?

Cal Report?

Line?

YES

Program

YES

Activate

Interface?

Data Link?

YES/NO

Remain in

NA K

READY

YES

Program Func?

9 Service Functions Menu — 9180

SERVICE

CALIBRATION?

FUNCTIONS?

YES

Test

YES

Test

YES

Std. A: Na = 0000

Test

YES

Std. B: Na = 0000

Electrodes?

Standard A?

K = 0000

Ca = 0000

Standard B?

K = 0000 Ca = 0000

Test

YES

Std. C: Na = 0000

Standard C?

K = 0000

Ca = 0000

Test

YES

Open Door and

OPEN

Introduce Sample

External Sample?

Introduce Sample

YES

Remain in

Ext.:

Na = 0000

CLOSED

Wipe Probe and

Test Electrodes?

K = 0000

Ca = 0000

Close Sample Door

Test

YES

DRY: 80-120: 102

YES

External:

102

wash…

Sample Sensor?

YES=Pump/NO=Exit

Pump:

NO=OFF

Test

YES

SnapPak:

YES/NO

SnapPak Sensor?

I=In

O=Out

Test

YES

Language Switch

YES/NO

Language Switch?

English

Test

YES

Sample Door:

Sample Door?

C:Closed O:Open

Test Pump?

YES

Test Pump!

2 s

Test Pump!

Very slow speed

Slow speed

Medium speed

Fast speed

Test Valves?

YES

Test Valve A:

Test Valve B:

Test Valve C:

Test Valve V:

YES/NO=ON/OFF

YES

Test Interface?

YES

— Test —

Interface

Remain in

Test Valve R:

Jump Pins 2&3

— Interface —

ok!

Test Interface?

YES/NO=ON/OFF

Test

YES

Na = -1030 K = -1200

Ground

Temp (mV)

-2670

Amplifier?

Cl = -1093

-2500mV

-2496

Temp (°C)

26.2

YES

Enter

YES

Enter Code:

YES

Is Code

YES

Code

Enter Other

Service Code?

AAA

ok?

valid?

Accepted!

Service Code?

Code Error!

YES

Retry?

Remain in

Calibration?

Calibrate…

NA K CA

READY

YES

Service Func?

10 Calibration Sequence — 9180 (1)

(Example Na/K/Li Calibration)

CALIBRATION?

YES

Calibration in

Process 124

Clear Sample

Path

Calibrate

Sample Sensor

Voltage ok?

YES

Prime

Standard B

Prime

Standard C

Prime

Standard A

All 3 Standards

not detected?

Two Standards

not detected?

Standard A,B,C

not detected?

NO Pressurize Ref. Asp. Std. A into Meas. Chamber

Reference

Housing ok?

YES

2nd try

***CHECK***

SAMPLE SENSOR

*********CLOG********

CHECK FLUID PATH

**STANDARD X/Y** NOT DETECTED

**STANDARD X** NOT DETECTED

***CHECK***

REF HOUSING

A
Asp. Std. A into
Meas. Chamber
Standard A	NO	STANDARD A

detected?		NOT DETECTED
YES
Obtain Electrode
Voltages Std. A
3 Std. A Values	NO

obtained?
YES		NO

Are Values	NO	6 Aspir. of
reproducible?		Std.A performed?
YES		YES

Aspir. Std. B into				YES	At least 1

Meas. Chamber						Channel reprod. ?
		NO				NO




Standard B	STANDARD B			*CHECK*

detected?			NOT DETECTED			ELECTRODES

YES

Obtain Electrode

Voltages Std. B

Calc. of Std.A-

Std.B (slope)

At least 1 slope	NO	*CHECK*
in Range?			ELECTRODES

Perform

Wash Cycle

10 Calibration Sequence — 9180 (2)

Aspir. Std. A into Meas. Chamber

Standard A

detected?

YES

Aspir. Std. C into Meas. Chamber

Standard C

detected?

YES

Obtain Electrode

Voltages Std. C

Perform

Wash Cycle

Aspir. Std. A into Meas. Chamber

Standard A

detected?

YES

Obtain Electrode

Voltages Std. A

Calculation of

Std.A-Std.C (Use last Std. A)

NO	STANDARD A

		NOT DETECTED

NO	STANDARD C

		NOT DETECTED

NO	STANDARD A

		NOT DETECTED

C
			NO


At least 1 slope		*CHECK*

in Range?				ELECTRODES
	YES		NO




Slope A-B and A-C		NA K LI READY

ok for all Electrodes?				XX, XX NOT CAL’D
	YES		NO




All Std.A	NA K LI READY

volt. reprod.?				XX, XX NOT CAL’D
	YES



NA K LI READY

11 Power-up — 9180

Power-up

AVL9180 A80X1.AA

WARM UP

All dots lit

for 1/2 sec.

YES

Cold start?

Set

Date:

1-JAN-95

Time/Date

Time:

12:00

YES

Power Fail

1-Nov-95 1:12

(Print)

*Background check in all menus

Pack in place?

except «Take out of Operation»

Global*

and «Service Functions»

YES

*****PLEASE*****

Perform Daily

Remain in Daily

Is Calibration

*******WAIT*******

Cleaning?

Conditioning?

Maintenance?

1min

due?

(Wash)

YES

Clean/Cond.

Clean…

Condition…

Stabilizing

needed?

30 sec.

NO
AVL9180 A80X1.AA		YES	Clean/Cond.

WARM UP	59		NO	needed?

					NO
		NO	Pack inserted?	YES	New SnapPak	YES	Reset
Calibration…				counter to
	Global*		installed?
					100%

*Background check in all menus except «Take out of Operation»

****STATUS**** NO and «Service Functions» **NO SnapPak**

Pack in place?	NO			PRINT	NO	QC/STD/DIALYSATE/	NO	DAILY

Global*	YES			FUNCTIONS?		URINE SAMPLE?		MAINTENANCE?

	NA K CA	READY	NO					NO

	CALIBRATION?	NO	SERVICE	NO	PROGRAM	NO	OPERATOR

		FUNCTIONS?		INSTRUMENT?		FUNCTIONS?
	NO

			*1	No
Na K Cl	READY	No	AUTOMATED	PRINT
			MEASUREMENT?		FUNCTIONS?
	Yes		Yes		Yes

MANUAL

AUTOM.

Print last

MEAS.

Sample Report?

Print Last

Automated Run?

Cal. Report?

Print QC Values

and Statistics?

Remain in Print

Functions?

Yes

QC/STD/DIALYSATE

DAILY

/URINE SAMPLE?

MAINTENANCE?

Yes

QC Level 1

Perform Daily

Sample?

Cleaning?

QC Level 2

Perform Daily

Sample?

Conditioning?

QC Level 3

Remain in Daily

Sample?

Yes

Maintenance?

Standard

CALIBRATE

Sample?

…

Bicarbonate

Sample?

Acetate

Sample?

Urine

Sample?

Remain in QC/

Yes

Std/Urine Sample?

No	OPERATOR	No
		FUNCTIONS?
			Yes

		Check/Change
		SnapPak?

			No

		Go to
		Standby Mode?

			No

		Set
		Time/Date?

			No

		Select Parameter
		Configuration?

			No

		Reset
		Sample Number?

			No

		Take Out of
		Operation?

			No


		Remain in
Yes	Operator Func.?


			No

Yes

*1 only with Autosampler plugged in *2 with Li+ off

PROGRAM No

INSTRUMENT?

Yes

Enter Code:

AAA

Program QC

Level 1 Ranges?

Program QC

Level 2 Ranges?

Program QC

Level 3 Ranges?

Program

Normal Ranges?

Program

Corr. Factors?

Program Bicarb.

Corr Factors?

Program Acetate

Corr Factors?

Program Urine

Corr Factors?

Program

Printer Setup?

Program

Interface?

Remain in

Program Func.? Yes

		No		No
SERVICE	CALIBRATION?
FUNCTIONS?
	Yes				Yes

Test			CALIBRATE
Electrodes?			…

	No


Test
Sample Sensor?

	No

Test
SnapPak Sensor?

	No

Test
Language Switch?

	No
	*1
Test Probe?

	No
	*1
Test Sampler?

	No

Test
Pump?

	No

Test
Valves?

	No

Test Interface?
Jump Pins 2 & 3

	No

Test
Amplifier?

	No

Enter
Service Code?

	No

Remain in
Service Func.?

	No

Flow Operating Program Overall 1	9181 — Operation Software 3.3
9181 —

Loading…

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9180 Electrolyte Analyzer Instructions for Use

Cis©

RDGw

OBAS a trademark of Roche.2007 Roche Diagnostics

oche Diagnostics GmbH-68298 Mannheimermany

ww.roche-diagnostics.com

US-1Roche 9180 Analyzer Instructions for Use

The contents of this manual, including all graphics and photographs are the property of Roche Diagnostics.No part of this document may be reproduced or transmitted in any form or by any means, electronic, ormechanical, for any purpose, without the express written permission of Roche Diagnostics.

Roche Diagnostics has made every reasonable effort to ensure that all the information contained in thismanual is correct at the time of printing. However, Roche Diagnostics reserves the right to make anychanges necessary without notice as part of ongoing product development.

COBAS, ROCHE OMNI, and MYLABONLINE are trademarks of Roche.

This instructions for use manual is published by the Roche Diagnostics Technical Publication department.Questions or comments regarding the contents of this instructions for use can be directed to:

Roche DiagnosticsTechnical Publications Department9115 Hague RoadP.O. Box 50457Indianapolis, IN 46250-50457USA

Additional copies of this document can be obtained by sending a message [email protected] or leaving a message at the Technical Publication Hotline at1-800-845-7355, mailbox 26699.

U.S. order number 0575-02-0507

US-10834-01-0607

Roche 9180 Analyzer Instructions for UseUS-2

Revisions

Revisions to this document are provided by Roche Diagnostics when necessary. No part of thisdocument may be reproduced in any form or by any means without prior written consent.

Publication Date Revision purposeReference Number

575-01-0803 July 2005 Title-2-4 new standards references,Revision 2.0 removed IVD symbol, and updated

trademark statement.1-5, 1-25, 3-4, 4-1, 4-4, 5-11: Updated QC

procedure.1-2: New “Install by” and “Use by”

symbols.2-1: New K+ range for urine.3-7: New urine measurement range and

dilution multiplication factors.3-10: m=d/c corrected in fig. 3-83-11 and 3-12: new sections 3.6

“Additional Settings” 3.6.1, “PrinterSettings,” 3.6.2, Interface Settings”3.6.3, and “Enter Codes” from 4-2.

5-7. 5-8, 5-10, 5-13: New “perform QCafter maintenance” statement insections 5.4.1, 5.5.1, 5.6.1,and 5.7.2.

5-9: Additional steps in valve procedure.6-1, 6-5, 6-6: New text for

“Na/D/Cl/Ca/Li not calibrated,” and“Check electrode holder lock,” and“Interface Error.”

6-8: new section 6.2.2.1 “not calibratedpotassium electrode.”

6-9: new fig. 6-1 Language switchsettings.

6-12: modified Service code QCCaction.

8-15: m=d/c corrected in correlationfactor worksheet.

Corrections for U.S. English throughout.

US-3Roche 9180 Analyzer Instructions for Use

US Supplement

575-02-0507 May 2007Revision 4.0

spelling & US language mistakes correctedsymbols modified: symbols “Biohazard”triangle (all chapters), “Biohazard”(Consumables), “Toxic”, “Dangerous toEnvironment”, “Irritant”Title (5) modified: Safety Information:standards referencesTitle (Safety Information), 1.4.1, 3.1.1, 5, 5.6.1,5.7.2, 5.7.3modified: general maintenance safety (protectiveclothing), from cobas b cobas b cobas b cobas b cobas b 221 system1.5.1 / 1-11 new: Serial Interface1.6.1 / 1-12 modified: Fig. 1-13 (arrows)1.7 6) / 1-29 new: link to chapter 6, “Delete allData”2.11.1 / 2-11 ff. modified: SnapPak storagetemperature: 15 – 30 °C2.12.1 / 2-14 new: 2 main fuse specifications3.1.1 / 3-2 new: note on silicone / samplecontainers3.5.1 removed: determination of correlationfactors4-2 ff. modified: QC material setup: updated5.1.1 / 5-1 new: 3

rd item “… each area

contaminated with biological …” in list of partsto be decontaminated5.1.1 / 5-1 removed: “Roche recommends …”5.2.1 / 5-3 new: note: “wipe sample probe ..:”5.3.2 / 5-4 new: “dispose of useddecontamination materials …”6.2.10 new: Status LEDs6.4 new: Deleting Data7.1 new: clinical significane (Li new, others fromcobas b cobas b cobas b cobas b cobas b 221 system)8 removed: correlation worksheet

Revisions Continued…

Publication Date Revision purposeReference Number

Roche 9180 Analyzer Instructions for UseUS-4

Warranty

Roche Diagnostics warrants the instrument (except for consumable items and lamps) against defectsin materials and workmanship for a period of one year. Roche Diagnostics, at its option, will eitherreplace or repair free of charge on an f.o.b Indianapolis, Indiana basis, all parts proven to be defectiveand subject to such warranty.

Field-installed options and used equipment carry a ninety (90) day parts and labor warranty. Anycomponent part(s) and labor necessary to complete a repair are guaranteed for thirty (30) days. Thiswarranty does not apply to an instrument not installed by a Roche Diagnostics representative (or anauthorized agent of Roche Diagnostics) and/or not used according to instructions or damaged byaccident, alteration, misuse, tampering and/or abuse.

We warrant that the services provided under a Roche Diagnostics warranty will be free from defects ofworkmanship for a period of thirty (30) days from the date of service.

WE HEREBY DISCLAIM ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED,INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULARPURPOSE, WITH RESPECT TO THE INSTRUMENT, PARTS AND SERVICES PROVIDED,EXCEPT THE LIMITED WARRANTY SET FORTH ABOVE. WE ARE NOT LIABLE FOR ANYINCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES, INCLUDING BUTNOT LIMITED TO, LOST PROFITS OR REVENUES, LOSS OF THE USE OF THE CAPITAL,COST OF SUBSTITUTE EQUIPMENT, FACILITIES OR SERVICES AND DOWN-TIME COSTS,RESULTING FROM OR ARISING IN CONNECTION WITH THE PERFORMANCE, DELAY INPERFORMANCE OR NONPERFORMANCE OF ANY TERMS OR CONDITIONS OF A ROCHEDIAGNOSTICS WARRANTY OR SERVICE AGREEMENT OR FROM THE USE OR MISUSE OFTHE INSTRUMENT (OR ANY SUBSTITUTE THEREFORE) OR ANY MATERIAL ORWORKMANSHIP DELIVERED HEREUNDER, EVEN IF WE HAVE BEEN ADVISED, KNEWOR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES. YOUR EXCLUSIVEREMEDY UNDER THIS LIMITED WARRANTY WILL BE RE-PERFORMANCE OF ANYSERVICE WHICH PROVES TO BE DEFECTIVE.

Service and the Roche Technical Support Center

Roche Diagnostics provides 24-hour, 7-day-a-week emergency telephone assistance. In addition, on-site service is provided in a timely manner. Call the following number to reach the Roche TechnicalSupport Center:

1-800-526-2272

During normal working hours the Roche Technical Support Center answers all calls pertaining toRoche Diagnostics products. If Technical Support cannot resolve a problem by phone, a RocheDiagnostics representative is dispatched in accordance with the service contract.

During other than normal working hours and on holidays, the Roche Technical Support Center isresponsible for handling customer emergency problems. This is accomplished with the use of ananswering service and paging system. As during normal hours, if Technical Support cannot resolve aparticular problem, a Roche Diagnostics representative is dispatched.

Refer questions relating to service policy to your local Roche Diagnostics representative at1-800-845-7355.

US.1 General Information

US-5Roche 9180 Analyzer Instructions for Use

If it becomes necessary to consult the Roche Technical Support Center in order to troubleshoot achemistry or instrument problem, please be prepared with the following information:

for a chemistry problem:

• account number• software version (found on the INSTRUMENT INFO screen)• assay(s) affected• description of the problem• catalog and lot numbers of reagents, calibrators and controls in use• calibration results from the last few calibrations performed• control material results• patient results (with correlation results, if relevant).

for an instrument problem:

• account number• software version (found on the INSTRUMENT INFO screen)• instrument serial number (found on the INSTRUMENT INFO screen)• description of the problem including relevant alarm(s)• other instrument or maintenance related information.

Having this information available assists in rapid resolution. It is helpful if the caller is conversantwith the problem, preferably the primary trained operator or the designated key operator.

In some cases, the Technical Support Center may ask that you return product to us so that we can testit in our laboratory. For these times, we will ask that you not discard the reagent or part in questionand save it until you have contacted the Roche Technical Support Center. Roche may also ask you toretain the reagent or part for an extended period of time during the investigation of a complaint. Inaddition, to also assist us in troubleshooting with you, we ask that you keep some of our assayedcontrols on hand. If you do not have these and are using other manufacturer’s materials, we willexperience a delay in resolving your concern as we wait for your control material order to arrive.

Contacting Service Representatives

In order for us to comply with federal record keeping requirements, if you need to contact your RocheDiagnostics service representative, call the Roche Technical Support Center at 1-800-526-2272. They,in turn, will notify your representative to contact you.

Customer Training

Training for the Roche 9180 analyzer is provided by Roche Diagnostics. Contact your local Rocherepresentative for any questions or information on Roche 9180 analyzer training.

Test Specific Information

Information specific to a particular assay can be found in the package insert.

Ordering Information

Replacement parts, consumable materials, reagents, calibrators and controls should be ordered asnecessary from Roche Diagnostics. When ordering, please use the Roche Diagnostics catalog numberand reference name for each item. To place an order, contact Roche Diagnostics Customer Service atthe following number:

1-800-428-5076

US.1 General Information

Roche 9180 Analyzer Instructions for UseUS-6

Customer Communications

As the need arises, you will receive various customer communications concerning information aboutyour Roche 9180 System. These updates are usually in one of the following forms:

• Customer Bulletins – Customer Bulletins are printed on special Roche Diagnostics letterheadwith a denoting Analyzer, Software or Reagent banner. They contain information that is vitalbecause it directly affects the performance of your system and/or reagents. Communicate bulletininformation internally to all analyzer operators. File bulletins for reference until you are notifiedby Roche Diagnostics to discard them.

• Urgent Product Recall – Urgent Product Recalls are printed on Roche Diagnostics letterheadwith the words Urgent Product Recall printed at the top. These require immediate attention bythe operator and are to be filed for reference until further notice.

• Customer Bulletin Index – This is an index of current bulletins that you should have on file. Ifyou find that you are missing any bulletin, call the Roche Technical Support Center at1-800-526-2272.

• Customer Letter – Customer Letters are printed on special Roche Diagnostics letterhead andcontain general information or attachments that you may remove and place in your files. Youmay discard Customer Letters after reading them and following any applicable instructionscontained in them.

• Product Announcement – Product Announcements (PA) are printed on special RocheDiagnostics letterhead titled PA and usually announce product launches. They contain specificdetails about a new product such as features and benefits, kit configuration and pricing. PAs mayor may not be discarded depending on your laboratory’s preference.

Customer communications can also be viewed on the internet.Go to http://www.MYLABONLINE.com and select Documentation.

CLIA/CLSI Guidelines

Roche Diagnostics documentation, which includes: this operator’s manual, reagent package insertsand active customer bulletins, conforms with the guidelines in effect at the time of publication listed inthe Code of Federal Regulations (CFR) and the Clinical and Laboratory Standards Institute (formerlyNCCLS) General Laboratory Practices and Safety Guidelines. Roche Diagnostics documentation alsomeets the Centers for Medicare and Medicaid Services (formerly HCFA) interpretation of therequirements for the Clinical Laboratories Improvement Act (CLIA ’88). Customizable test proceduresin a NCCLS-approved format are available on the internet. Go to http://www.MYLABONLINE.comand select Documentation > Point of Care > Blood Gas > Test Information.

Technical Publications Hotline

The Technical Publications departments are responsible for most of the written documentation youreceive from Roche Diagnostics. This includes: manuals, training material and customercommunications. To reach the Technical Publications group, call the following number and leave amessage with your request. We will get back to you, or fill your request, as soon as possible.

[email protected]

1-800-845-7355, mailbox 26699

US.1 General Information

US-7Roche 9180 Analyzer Instructions for Use

To Change Addresses or Contact Names

To change your mailing address or the contact name for your account leave a voice message or sendthe information electronically either through electronic mail or through the MyLabOnline website.Please provide your name and account number in your message. Your account number is provided toyou by a Roche Diagnostics representative when your analyzer is installed.

• Computer access: http://www.mylabonline.com, access Customer Support, then click onContact Change

• To email, use: [email protected]• To leave a message, call: 1-800-845-7355, mailbox 26699

US.2 Technical Publications and RD Documentation

Roche 9180 Analyzer Instructions for UseUS-8

End US Supplement

Roche Diagnostics GmbHD-68298 Mannheim / Germany

www.roche.com

The contents of this document may not be reproduced in any form or communicated to any third party without the prior writ-ten consent of Roche Diagnostics. While every effort is made to ensure its correctness, Roche Diagnostics assumes no respon-sibility for errors or omissions which may appear in this document. Subject to change without notice.

ROCHE MICROSAMPLER, SNAPPAK, ISETROL are trademarks of Roche.

REF/No. 0 4381092001Rev. 4.0, April 2007

First edition: April 1996

– Important information! – Always follow! –

These Instructions for Use contain vital warning and safety information.

This instrument is intended to be used only for the specialized purpose described in the instructions. Themost important prerequisites for use, operation, and safety are explained to ensure smooth operation. Nowarranty or liability claims will be covered if the instrument is used in ways other than those described or ifthe necessary prerequisites and safety measures are not observed.

The instrument may be operated only by persons whose qualifications enable them to comply with the safetymeasures that are necessary during operation of the instrument.

Suitable protective equipment, like laboratory clothing, protective gloves, protective goggles and if necessarymouth protectors, must be worn to prevent direct contact with biological working materials. In addition, aface mask is required if there is a risk of splashes. Suitable disinfection and sterilization procedures must beapplied.

Adjustments and maintenance performed with removed covers and connected power may be attempted onlyby a qualified technician who is aware of the associated dangers.

Instrument repairs are to be performed only by the manufacturer or qualified service personnel.

Only accessories and supplies either delivered by or approved by Roche are to be used with the instrument.These items are manufactured especially for use with this instrument and meet the highest quality require-ments.

Operation of the instrument with solutions whose composition is not consistent with that of the originalsolutions can negatively affect, above all, the long term measurement accuracy. Deviations in the compositionof the solutions can also decrease the service life of the electrodes.

The quality control requirements must be completed at least once daily for safety reasons. Since the measure-ments of the instrument depend not only on the correct characteristic function, but also on a series of mar-ginal conditions (e.g. pre-analysis), results obtained from the instrument should be submitted for an expertopinion before taking additional measures based on the supplied measurements.

Explanation:

Meaning: «Caution (refer to accompanying documents). Please refer to safety-relatednotes in the manual accompanying this instrument».

– Important information! – Always follow! –

– Operating safety information –

The instrument has been constructed and tested according to the following European Stan-dards:

• IEC/EN 61010-1:2001• IEC/EN 61010-2-101:2002• IEC/EN 61010-2-081:2002 + A1:2003

It was delivered from the factory in flawless condition with regards to safety features. In orderto preserve this condition and ensure safe operation, the user must observe the notices andwarnings that are contained in these Instructions for Use.

• This instrument is classified under the protection class I according to IEC 1010-1 / EN 61010-1.

• The instrument meets the conditions for overvoltage category II.

• The instrument meets the conditions for contamination level 2.

• Do not operate the instrument in an explosive environment or in the vicinity of explosiveanesthetic mixtures containing oxygen or nitrous oxide.

• If objects or liquids enter the internal areas of the instrument, remove the instrument fromits power supply and allow an expert to check it thoroughly before using it again.

• The instrument is suitable for long-term operation indoors.

CAUTION:

• The power cord must be plugged into a grounded power receptacle. When using an exten-sion cord, make sure it is properly grounded.

• Any rupture of the ground lead inside or outside the instrument or a loose ground connec-tion may result in hazardous operating conditions for the operating personnel. Intentionaldisconnection of the grounding is not permitted.

• The instrument is not suitable for operation with a direct current power supply.Use only the original mains plug delivered with the instrument.

– Operating safety information –

Contents — Instructions for Use

1 Introduction1.1 General notes ……………………………………………………………………………………………………. 1-2

1.2 Measurement and calibration procedures ………………………………………………………. 1-5

1.3 Measurement evaluation …………………………………………………………………………………. 1-5

1.4 Important safety instructions …………………………………………………………………………… 1-6

1.5 System description …………………………………………………………………………………………… 1-7

1.6 Installation ………………………………………………………………………………………………………. 1-12

1.7 Shutdown ………………………………………………………………………………………………………… 1-26

1.8 Standby mode …………………………………………………………………………………………………. 1-30

2 Specifications2.1 Performance parameters …………………………………………………………………………………. 2-1

2.2 Linearity ……………………………………………………………………………………………………………. 2-5

2.3 Interferences …………………………………………………………………………………………………….. 2-6

2.4 Limitations ………………………………………………………………………………………………………… 2-7

2.5 Relationship of ionized calcium to total calcium …………………………………………….. 2-7

2.6 Bibliography ……………………………………………………………………………………………………… 2-8

2.7 Sample throughput …………………………………………………………………………………………… 2-9

2.8 Sample volumes ……………………………………………………………………………………………….. 2-9

2.9 Sample types …………………………………………………………………………………………………….. 2-9

2.10Calibrations ………………………………………………………………………………………………………. 2-9

2.11Environmental parameters ……………………………………………………………………………… 2-10

2.12Product data ……………………………………………………………………………………………………. 2-14

2.13Printer ……………………………………………………………………………………………………………… 2-14

2.14Display …………………………………………………………………………………………………………….. 2-14

3 Measurement3.1 Preanalytics ………………………………………………………………………………………………………. 3-1

3.2 Limitations of clinical analysis …………………………………………………………………………. 3-3

3.3 Measuring procedure ………………………………………………………………………………………. 3-4

3.4 Normal ranges ………………………………………………………………………………………………….. 3-8

3.5 Correlation factors ……………………………………………………………………………………………. 3-8

3.6 Additional settings ………………………………………………………………………………………….. 3-10

Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007 1

Contents — Instructions for Use

4 Quality control4.1 General QC concept …………………………………………………………………………………………..4-1

4.2 Material setup ……………………………………………………………………………………………………4-2

4.3 Performing a QC measurement …………………………………………………………………………4-4

4.4 Printing a QC report …………………………………………………………………………………………..4-5

5 Maintenance5.1 Decontamination ……………………………………………………………………………………………….5-1

5.2 Daily maintenance ……………………………………………………………………………………………..5-2

5.3 Weekly maintenance ………………………………………………………………………………………….5-4

5.4 Monthly maintenance ………………………………………………………………………………………..5-5

5.5 Semi annual maintenance …………………………………………………………………………………5-8

5.6 Annual maintenance ………………………………………………………………………………………….5-9

5.7 Unscheduled maintenance …………………………………………………………………………….. 5-10

6 Troubleshooting6.1 Error messages …………………………………………………………………………………………………..6-1

6.2 Service functions ……………………………………………………………………………………………….6-7

6.3 Service codes …………………………………………………………………………………………………. 6-11

6.4 Deleting data ………………………………………………………………………………………………….. 6-13

7 Theoretical foundations7.1 Clinical significance …………………………………………………………………………………………..7-1

7.2 Principles of Operation ………………………………………………………………………………………7-7

7.3 Electrode specifications …………………………………………………………………………………. 7-10

7.4 Calibration procedure …………………………………………………………………………………….. 7-16

8 Appendix8.1 Description of reports ………………………………………………………………………………………..8-1

8.2 Specifications of the solutions ………………………………………………………………………….8-3

8.3 Specification of the QC solutions ………………………………………………………………………8-7

8.4 Declaration of conformity ………………………………………………………………………………. 8-10

8.5 Program flow chart …………………………………………………………………………………………. 8-13

8.6 Maintenance schedule …………………………………………………………………………………… 8-14

9 Index

2 Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007

1 Introduction

1.1 General notes ……………………………………………………………………………………………………. 1-2

1.1.1 Symbols………………………………………………………………………………………………………………………………………….1-2

Used in the Instructions for Use ……………………………………………………………………………………………………………….1-4

1.2 Measurement and calibration procedures ………………………………………………………. 1-5

1.2.1 Measurement procedure…………………………………………………………………………………………………………….1-5

1.2.2 Calibration procedure………………………………………………………………………………………………………………….1-5

1.3 Measurement evaluation …………………………………………………………………………………. 1-5

1.4 Important safety instructions …………………………………………………………………………… 1-6

1.4.1 Sample collection and handling ………………………………………………………………………………………………..1-6

1.4.2 Disposal of SnapPak, electrodes, and instrument ………………………………………………………………….1-6

Disposal of the reference electrode …………………………………………………………………………………………………………1-6

1.4.3 Handling electrodes …………………………………………………………………………………………………………………….1-6

1.5 System description …………………………………………………………………………………………… 1-7

1.5.1 Analyzer components ………………………………………………………………………………………………………………….1-7

Display …………………………………………………………………………………………………………………………………………………………..1-8Keypad ………………………………………………………………………………………………………………………………………………………….1-8Printer ……………………………………………………………………………………………………………………………………………………………1-8Measuring chamber ……………………………………………………………………………………………………………………………………1-9Peristaltic pump …………………………………………………………………………………………………………………………………………..1-9Sample probe mechanism …………………………………………………………………………………………………………………………1-9Valves ………………………………………………………………………………………………………………………………………………………… 1-10SnapPak …………………………………………………………………………………………………………………………………………………….. 1-10Rear panel …………………………………………………………………………………………………………………………………………………. 1-11Serial port ………………………………………………………………………………………………………………………………………………….. 1-11

1.6 Installation ………………………………………………………………………………………………………. 1-12

1.6.1 Location ……………………………………………………………………………………………………………………………………… 1-12

Accessories ………………………………………………………………………………………………………………………………………………. 1-13

1.6.2 Setting up …………………………………………………………………………………………………………………………………… 1-13

1.6.3 Electrodes and measurement chamber ………………………………………………………………………………… 1-14

1.6.4 Preparing the Analyzer for Operation……………………………………………………………………………………. 1-18

1. Selecting language ……………………………………………………………………………………………………………………………… 1-182. Start-up …………………………………………………………………………………………………………………………………………………. 1-183. Setting date and time …………………………………………………………………………………………………………………………. 1-194. Installing the SnapPak ………………………………………………………………………………………………………………………… 1-205. Installing the printer paper ………………………………………………………………………………………………………………… 1-206. Daily Maintenance (manual) …………………………………………………………………………………………………………….. 1-22

Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007 1-I

1 Introduction

7. Selecting parameter configuration …………………………………………………………………………………………………… 1-24

1.7 Shutdown ………………………………………………………………………………………………………… 1-261. Installing shutdown plug ……………………………………………………………………………………………………………………. 1-262. Installing the transport housing ………………………………………………………………………………………………………… 1-273. Washing the lines ………………………………………………………………………………………………………………………………… 1-274. Removing the electrodes and the shutdown plug …………………………………………………………………………. 1-285. Installing the relief clamps and removing the pump windings ……………………………………………………. 1-286. Turning the analyzer «off» ………………………………………………………………………………………………………………….. 1-29

1.8 Standby mode …………………………………………………………………………………………………. 1-30

1-II Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007

1 Introduction

The 9180 Electrolyte Analyzer is a powerful tool designed to quickly, accurately and effi-ciently conduct basic electrolyte testing in the convenience of the laboratory.

This manual will help guide through setting up the analyzer and analyzing samples. As the user become familiar with the operation of the unit, the manual may be used as a reference for day-to-day routines and as a guide for maintenance and troubleshooting.

Fig. 1-1

Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007 1-1

1 Introduction

1.1 General notes

1.1.1 Symbols

This product fulfills the requirements of the directive 98/79/EC on in vitro diagnostic medical devices.

Lot number

Electrodes: This date indicates the limit of the maximum storage time of an electrode. The electrode must be used in the instrument no later than the imprinted date.If the installation takes place on the imprinted date, it still falls within the specifications. The calculation of the “Install before” date is based on the production date of the electrode.

Consumables: use by… (expiry date)The consumables must be completely consumed by the indicated date.If a day is not indicated, apply the last day of the respective month.

Storage noteThe conditions necessary to preserve the product’s shelf life before opening.

For in vitro diagnostic use

„Grüner Punkt“ (Germany)

Manufacturer—according to In Vitro Diagnostic guidelines 98/79/EC

1-2 Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007

1 Introduction

Danger symbol: T: Toxic (on the packaging of the reference electrode)

Rating: Inhalation, swallowing or skin contact with even small quantities can lead to serious health risks, including fatal risks. Characteristics of this type of item are severe, possibly irreversible damage to health through repeated or prolonged contact, particularly with carcinogenic, genetic or reproductive (danger to reproductive capabilities) effects.

Caution: Avoid any contact with the human body. If you feel unwell, con-tact a doctor immediately. Any substances with carcinogenic, genetic or reproductive dangers are indicated appropriately. Always observe the reg-ulations when handling such substances.

Danger symbol: N: Dangerous to the environment (on the packaging of the reference electrode)

Rating: If released into aquatic and non aquatic environments, can cause immediate or delayed damage to ecosystems through a change in environ-mental conditions.These substances or their by-products can cause substantial damage to sen-sitive environmental areas.

Caution: Depending on the potential for damage, do not allow the sub-stance to enter sewers, soils or the environment. Observe the specific dis-posal regulations.

Danger symbol: Xi: Irritant

Rating: Although not corrosive, momentary, longer-lasting, or repeated contact with skin or mucous membrane may result in inflammation. Dan-ger of sensitization during contact with skin (when classified with R 43).

Caution: Avoid contact with eyes and skin, do not inhale vapors.

Store upright

Risk of infection! (according to the standard DIN EN 61010-2-101:2002)(Instrument)

Risk of infection! (according to the standard DIN ISO 15223-1:2005)(Consumables)

Reference and/or ordering number

T:R23/33/50-53

N:S45/60/61/7

XI: R36/37/38, S 26-37

Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007 1-3

1 Introduction

IMPORTANT: read and follow Instructions for Use!

Please read and follow the information on the packaging insert / instructions for use.

Serial number (model plate)

Do not use content if the packaging is damaged

Protective gloves, protective goggles and suitable protective clothing must be worn

Used in the Instructions for Use

Sections marked with this symbol (see Instructions for Use) contain information that must be observed to avoid potential injuries (to patients, users and third par-ties).

Risk of infection!

All sections / passages that are marked with this symbol describe procedures and/or indicate conditions or dangers that could damage or lead to a malfunction in the 9180 Electrolyte Analyzer, and therefore should never be attempted.

TIP: All sections / text locations marked with «TIP» describe safe procedures that are intend-ed to provide the user with additional help.

1-4 Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007

1 Introduction

1.2 Measurement and calibration procedures

1.2.1 Measurement procedureThe 9180 Electrolyte Analyzer methodology is based on the ion selective electrode (ISE) measurement to determine the measurement values (see chapter 7, section «The measure-ment principle»).

There are six different electrodes used in the 9180 Electrolyte Analyzer: sodium, potassium, chloride, ionized calcium, lithium and a reference electrode. Each electrode has an ion-selective membrane that undergoes a specific reaction with the corresponding ions con-tained in the sample being analyzed. The membrane is an ion exchanger, reacting to the elec-trical charge of the ion causing a change in the membrane potential, or measuring voltage, which is built up in the film between the sample and the membrane.

A galvanic measuring chain within the electrode determines the difference between the two potential values on either side of the membrane. The galvanic chain is closed through the sample on one side by the reference electrode, reference electrolyte and the «open terminal». The membrane, inner electrolyte and inner electrode close the other side.

A difference in ion concentrations between the inner electrolyte and the sample causes an electro-chemical potential to form across the membrane of the active electrode. The poten-tial is conducted by a highly conductive, inner electrode to an amplifier. The reference elec-trode is connected to ground as well as to the amplifier.

The ion concentration in the sample is then determined by using a calibration curve deter-mined by measured points of standard solutions with precisely known ion concentrations.

1.2.2 Calibration procedureA 2-point or a 3-point calibration is performed automatically every 4 hours in [READY] mode and a 1-point calibration is automatically performed with every measurement.

An automatic calibration procedure is also performed shortly after power-on or reset. A cal-ibration cycle can also be initiated manually at times when no sample measurements are per-formed.

1.3 Measurement evaluationThe validity of the test results from the 9180 Electrolyte Analyzer must be carefully exam-ined by a clinical-medical specialist who will take the patient’s clinical condition into con-sideration before any clinical decisions are reached based on the test results.

In order to ensure the quality of the measurement results, complete a quality control test on 3 levels (low, normal, high) after each electrode exchange, after each replacement of the SnapPak, after startup of the instrument as well as after monthly, semi annual and annual maintenance steps.

Additionally, at least once daily one QC measurement has to be performed in alternating levels (low, normal, high) (e.g., day 1 — level 1, day 2 — level 2, day 3 — level 3, day 4 — level 1, etc.). When required by local regulations, QC measurements must be performed more often.

A quality control program for electrolytes includes the analysis of sample materials with known ranges of expected values and the comparison of these values with analyzer results. For further information, see chapter 4: «Quality control».

Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007 1-5

1 Introduction

1.4 Important safety instructionsFor your own safety and the proper operation of your equipment, always follow these pre-cautions when working with the 9180 Electrolyte Analyzer:

• Keep the analyzer away from all sources of liquids such as sinks and wash basins.

Don’t use ammonia-based or alcohol-based cleaners, which can chemically react with plastic, on or around the analyzer.

• Always handle blood samples and collection devices with appropriate care.• Use approved protective gloves to avoid direct contact with sample.• Aseptic procedures are required when cleaning the sampling probe to avoid contamina-

tion.• Dispose of SnapPak according to local regulations.

1.4.1 Sample collection and handlingUniversal precautions must be observed when collecting blood specimens. It is recommend-ed that all blood specimens be handled as potentially infectious specimens capable of trans-mitting human immunodeficiency virus (HIV), hepatitis B virus (HBV), or other blood-borne pathogens. Proper blood collection technique must be followed in order to minimize risk to the laboratory staff.

Suitable protective equipment, like laboratory clothing, protective gloves, protective gog-gles and if necessary mouth protectors, must be worn to prevent direct contact with biolog-ical working materials. In addition, a face mask is required if there is a risk of splashes. Suit-able disinfection and sterilization procedures must be applied.

Please refer to NCCLS document M29-A2, «Protection of Laboratory Workers from Occupa-tionally Acquired Infections», Approved Guidelines — Second Edition 2001, for further infor-mation on safe handling of these specimens. For further information, see chapter 3: «Mea-surement».

1.4.2 Disposal of SnapPak, electrodes, and instrument

Dispose of used SnapPak, electrodes and the instrument according to applicable lab-oratory regulations (biologically contaminated–hazardous waste!)

Disposal of the reference electrode

This electrode contains mercury. Therefore dispose of it in accordance with applicable regulations (hazardous waste!).

1.4.3 Handling electrodes• Store electrodes according to packaging instructions.• The shelf life of the electrodes is limited. • Please see electrode label and packaging for correct storage temperature and maximum

shelf life.

T:R23/33/50-53 N:S45/60/61/7

1-6 Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007

1 Introduction

1.5 System description

1.5.1 Analyzer components

Fig. 1-2

Fig. 1-3

front cover

sample door

keypaddisplay

ISE SnapPakTM

measuring chamber

sample door

thermal printer

peristaltic pump

valves

Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007 1-7

1 Introduction

Display

The analyzer communicates to the user through a dot matrix display. This two line, alpha-numeric read-out allows up to 16 characters per line, displaying the activities of the analyz-er, sample results and other programmed information.

Fig. 1-4

Keypad

The communication with the analyzer is performed through a keypad with YES and NO keys. With these keys, all analyzer functions, including: sample measurement, data input, pro-gramming and quality control testing can be performed.

Fig. 1-5

Printer

The thermal printer uses heat-sensitive paper to output information in 16 columns. The analyzer will print measured values, calibration values, electrode voltages, and amount of liquid remaining in the SnapPak as well as cleaning and maintenance information. The unit is configured to allow convenient storage of a second roll of paper in the paper tray.

Fig. 1-6

Na K Cl READY

1-8 Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007

1 Introduction

Measuring chamber

The measuring chamber consists of the movable left locking device that holds the electrodes in place, the electrodes, the right electrode holder with sample sensor connector, and the measuring chamber base.

Fig. 1-7

Peristaltic pump

A peristaltic pump transports all sample and operating fluids inside the instrument.

Fig. 1-8

Sample probe mechanism

The sample probe mechanism is located behind the sample door at the front of the unit.

Fig. 1-9

Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007 1-9

1 Introduction

Valves

Valves control the movement of the liquid within the analyzer.

Fig. 1-10

SnapPak

The self-contained ISE SnapPak is constructed to ensure that waste cannot spill out of the package.

Fig. 1-11

1-10 Instructions for Use, 9180 Electrolyte Analyzer, Rev. 4.0, April 2007

1 Introduction

Rear panel

The rear panel of the unit contains a serial number plate, as well as the power switch/power receptacle module and an RS232 interface port.

Fig. 1-12

Serial port

The analyzer is equipped with a serial RS232 interface and allows data to be exchanged with commercially available computer systems. The analyzer can be connected to COMPACT 2/3 systems via the 9-pin DB-9 connector to output a common measurement report.

Measurement data is transferred after each measurement and calibration data is transferred after each calibration. The interface is always active, and data is sent independently of the printer setup.

Refer to COMPACT 2/3 Instructions for Use for details.

A higher leakage current can be expected when using the serial interface. This must be checked by suitably qualified personnel, depending on the local regulations.

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1 Introduction

1.6 Installation

1.6.1 LocationLocation is important for optimal operation of your analyzer. Before you begin setup, choose a site that is convenient for your sampling needs and meets the following physical requirements of the unit:

• Ambient temperature + 15°C to + 32°C• Avoid exposure to direct sunlight, vibration and strong electromagnetic fields (electric

motors, transformers, X-ray equipment, cellular phones, etc.).• Use a stable and level work surface.• Maximum relative humidity of 85 % (15 % — 85 %)• Ample room to allow air to circulate freely around the unit, see Fig. 1-13.• Avoid exposure to explosive gases or vapors.• Check for correct voltage: 100 to 240 VAC, 50/60 Hz.

Fig. 1-13

After setting up the 9180 Electrolyte Analyzer in a location that meets the above require-ments, perform the following steps to ensure the instrument is ready for operation:

• Refer to the packing slip to check for the completeness of the shipment.• If the shipment is incomplete, please inform your Roche representative immediately.

If the instrument was damaged during shipment, immediately inform the company that made the delivery. Retain all packaging materials and products as this may be needed as evi-dence in the event of a damage claim.

Do not remove the analyzer from the shipping carton by pulling upward on the poly-styrene (styrofoam) packing materials. These packaging materials do not provide strength to support the analyzer.

340 mm

350 mm

330 mm

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Accessories

The following parts are delivered as standard equipment with the 9180 Electrolyte Analyzer:

• Printer paper• Electrode Dummy• Quad Ring, 1.78×1.02 mm• Fuse set• Sample probe stylet• Syringe, 12 mL, with tapered tip• Quick Reference Guide

You also need a supply of lint-free tissues and disposable sample cups, which should be kept in a location convenient to the analyzer.

1.6.2 Setting upPrior to beginning the actual installation, it is recommended to completely read through this chapter to develop an understanding of the procedures that are required.

Begin by placing the analyzer on a secure table top that allows plenty of working space and is convenient to a power connection.

Open the analyzer main door. Locate and carefully remove the five red relief clamps. Save the clamps for reuse to prevent damaging the tubes, if the analyzer is later shut down for any reason.

TIP: Save the relief clamps for reuse to prevent damaging the tubes, if the analyzer is later shut down (see section «Shutdown»).

• Slip the two pump windings around the analyzer pump rollers, making sure not to over-stretch the tubing.

Fig. 1-14 Fig. 1-15

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1 Introduction

1.6.3 Electrodes and measurement chamberThe next procedure involves preparing and installing the electrodes in the measurement chamber.

• Remove the reference housing and electrodes from their protective boxes and place them on a soft, clean surface. Check to make sure each electrode has an o-ring on the left side.

Fig. 1-16

• Unscrew the red transport housing from the reference electrode and check that the o-ring on the electrode is properly seated. Rinse, dry and save the transport housing for storage of the reference electrode in the event the analyzer is turned off or taken out of service for any reason.

Fig. 1-17

• Carefully screw the reference electrode into the reference electrode housing and place it with the other electrodes.

Fig. 1-18

red transport housing

reference electrodereference electrodehousing

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1 Introduction

• Slide the measurement chamber forward until it locks in the front position. • Unclamp the left electrode holder by moving the clamp forward.

• Locate the sample sensor cable and ensure that it is securely inserted in the receptacle above the measurement chamber. Check that an o-ring is present in the right electrode holder

Fig. 1-21

Now install the electrodes in the measurement chamber, beginning on the right and working to the left (the reference electrode will be installed last).

TIP: The electrode on the right may be one of the following: chloride, ionized calcium, lith-ium or a dummy electrode, if no third test is needed. If sodium and lithium are selected, the potassium electrode is replaced by a dummy electrode.

Fig. 1-19 Fig. 1-20

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1 Introduction

• Check to make sure that the lettering on the electrode corresponds with the proper elec-trode station number on the tray. Also, note that all electrodes have a lip on the bottom that rests on the flat edge of the measurement chamber to aid in proper positioning.

Fig. 1-22

• After all electrodes have been installed, close the clamp on the left electrode holder by lifting it upward until it locks in the back position, and ensure that the electrodes are properly seated.

Fig. 1-23

• Slide the measurement chamber back until it snaps into position.

Fig. 1-24

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1 Introduction

• Plug the tubing connector of the reference housing assembly in the receptacle below the left side of the measurement chamber.

Fig. 1-25

Possible parameter configurations are the following:

Fig. 1-26 Parameter configurations

Use of calibration solutions, electrodes or QC-material that were not produced by Roche leads to an invalidation of the instrument’s guarantee.

For details, see section «7. Selecting parameter configuration».

Electrode pos. Parameter configuration

Na+ Na+ Na+ Na+ Na+ Na+

K+ K+ K+ Dummy K+ Dummy

Cl- / Ca++ / Li+ Dummy Cl- Cl- Ca2+ Ca2+

Electrode pos. Parameter configuration

Na+ Na+ Na+ (Na+) Na+

K+ K+ Dummy Dummy Ca2+

Cl- / Ca++ / Li+ Li+ Li+ Li+ Li+

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1 Introduction

1.6.4 Preparing the Analyzer for Operation

1. Selecting language

Before the analyzer is powered on, the language setting must be selected. The factory-set language is English.

• Remove the paper tray and use a pen to set the switch to the desired language position as indicated on the label.

TIP: If you decide to change the language after the unit is powered on, you must cycle the power to activate the new language.

2. Start-up

• Locate the power switch on the back of the unit and make sure that it is in the OFF (O) position.

• Plug the power cord into the power receptacle module on the back of the unit, then plug the cord into a grounded electrical outlet (100 — 240 V, 50/60 Hz).

Fig. 1-27

• Push the power switch to the ON (I) position. The unit will automatically begin to operate.

Fig. 1-28

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Now that the 9180 Electrolyte Analyzer is functioning, begin using the keypad interface to communicate with the instrument. Use the NO key to make changes, the YES key to accept the displayed values or information.

TIP: After start-up, date and time should be set and the printer paper inserted.

3. Setting date and time

The analyzer will display a default date and time and will allow the operator to input the correct date and time:

Date: 01-JAN-02 Time: 00:00

To enter the correct date and time:

• Press NO, until the actual day is displayed. To accept this value, press YES and the cursor will move to the month.

• By keeping the NO key depressed, the analyzer will automatically scroll through the numbers, first slowly, then faster.

• Press NO, until the actual month is displayed. To accept this value, press YES.• Press NO, until the actual year is displayed. To accept this value, press YES. Now, the

actual date will be displayed.• Follow the same procedure to enter the current time.• After entering the time, the analyzer will prompt [ok?]. Press YES if the date and time

entered are correct, or press NO to make a change.• After pressing YES at the last prompt, the analyzer will prompt: [STATUS:

NO SnapPak].

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4. Installing the SnapPak

Use of calibration solutions, electrodes or QC-material that were not produced by Roche leads to an invalidation of the instrument’s guarantee.

• Record the installation date of the SnapPak on the label on the SnapPak.• Remove the protective strip and slide the SnapPak into position on the left side of the

analyzer. Save the protective strip for the case of a shutdown or disposal.

Once the protective strip is removed, be sure to keep the SnapPak upright to avoid spillage. Save the protective strip to use to close the nipples on the SnapPak prior to disposing.

• At the prompt [New SnapPak Installed?], press YES.• Again, at the prompt [Are you sure?], press YES.

5. Installing the printer paper

TIP: The printer paper is heat sensitive on one side only. Please make sure that you insert the paper roll correctly.

The thermal printer paper supplied by Roche Diagnostics contains an indicator strip to alert you when the paper roll should be changed. To change the roll:

• Place a new paper roll in the paper tray and thread it into the feeder slot.

Fig. 1-29 Fig. 1-30

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Fig. 1-31

• Press the paper feed button to completely feed the paper through the printer.

Fig. 1-32

TIP: By pressing the paper advance button once, the paper will automatically advance 10 lines.

Do not pull the paper out of the printer to avoid damage to the printer.

Now perform the initial Daily Maintenance.

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6. Daily Maintenance (manual)

Prior to performing the first calibration or running the first sample, the 9180 Electrolyte Analyzer needs to undergo a simple cleaning and conditioning procedure that helps ensure that the analyzer will perform properly. This procedure is called daily maintenance, because it must be performed each day the analyzer is used to conduct sampling.

The process involves cleaning and conditioning the sample path and electrodes, which pre-pares the 9180 analyzer for calibration. The bottles containing Cleaning Solution A and Electrolyte Conditioning Solution should be ready, along with a package of lint-free tissues that will be used to dry the probe.

Check expiration date on the bottles of the Cleaning Solution A and the Electrolyte Conditioning Solution.

In some cases, when the analyzer prompts you for an action and you do not respond within a set period of time, an alarm will sound and the unit will discontinue its cur-rent operation.

To start the daily maintenance:

• Press the NO key, until [DAILY MAINTENANCE?] is displayed, and YES to select. Select [Perform Daily Cleaning?] by pressing YES.

• Pour a small amount of Cleaning Solution A into a clean container.• At the prompt [Open Sample Door Introduce Sample], lift the sample door and

the pump will begin to aspirate.

Fig. 1-33

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• Hold the Cleaning Solution A under the probe, until [Wipe Probe/Close Sample Door] is displayed, and use a lint-free tissue to remove the cleaning solution from the probe. Close the sample door.

Fig. 1-34

• While the analyzer displays [Thank You!] and a brief countdown, pour a small amount of conditioning solution into a clean container.

• Answer the prompt [Perform Daily Conditioning?] by pressing YES.• At the prompt [Open Sample Door Introduce Sample], lift the sample door and

the pump will begin to aspirate.

Fig. 1-35

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• Hold the Electrolyte Conditioning Solution under the probe, until [Wipe Probe/Close Sample Door], use a lint-free tissue to remove the conditioning solution from the probe. Close the sample door.

Fig. 1-36

• After the analyzer has displayed [Thank You!] and a brief countdown, the prompt [Remain in Daily Maintenance?] can be answered with NO, and an automatic cal-ibration will be started.

It is very important that the main door is closed during calibration, since it provides shielding from sources of electromagnetic interference.

Calibration is an automatic process. During this time, the analyzer is conducting measurement operations to ensure the accuracy of the instrument. Occasionally, additional time is required, and the analyzer displays an asterisk.

After finishing the calibration, the analyzer returns to [READY] and is now ready for QC.

7. Selecting parameter configuration

After completion of the daily maintenance procedure, the analyzer starts an automatic cal-ibration for sodium and potassium.

To select a different parameter configuration, interrupt the calibration by pressing NO.

• Continue pressing NO, until [OPERATOR FUNCTIONS?] is displayed. Press YES.• Press NO until the prompt [Select Parameter Configuration?] is displayed, see

Fig. 1-26. Press YES and the current configuration will be displayed. The default config-uration is the following:

Sel. Parameter:[Na][K][ ] ok?

• Press NO until the desired configuration is displayed. Press YES to accept this selection.

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TIP: If [(Na)][ ][Li] is selected, only lithium is reported. Install the sodium electrode and calibrate for lithium.

In order to ensure the quality of the measurement results, complete a quality control test on 3 levels (low, normal, high) after each electrode exchange, after each replace-ment of the SnapPak, after startup of the instrument as well as after monthly, semi annual and annual maintenance steps.

Additionally, at least once daily one QC measurement has to be performed in alter-nating levels (low, normal, high) (e.g., day 1 — level 1, day 2 — level 2, day 3 — level 3, day 4 — level 1, etc.). When required by local regulations, QC measurements must be performed more often.

A quality control program for electrolytes includes the analysis of sample materials with known ranges of expected values and the comparison of these values with ana-lyzer results. For further information, see chapter 4: «Quality control».

The 9180 Electrolyte Analyzer is now ready to operate.

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1 Introduction

1.7 ShutdownA complete shutdown of the analyzer may be indicated to prepare the analyzer for shipping or in case the analyzer is not being used for an extended period of time. For this procedure, you will need a special shutdown kit (not supplied with the analyzer).

Never attempt to turn the power off for an extended period of time without perform-ing a complete shutdown of the analyzer.In case the analyzer is not being used for several days only, it is not recommended to perform a complete shutdown, but to put the analyzer in Standby Mode.

To perform the shutdown, you will need the following items:

• One shutdown plug (supplied with shutdown kit).• Five solenoid relief clamps (supplied with analyzer and shutdown kit).• Two reference electrode transport housings (supplied with shutdown kit).• Two containers, one filled with at least 100 mL of water, the other one empty.• Protective strip for SnapPak (supplied with shutdown kit).

Starting at the [READY] display, do the following:

• Press NO until [OPERATOR FUNCTIONS?] is displayed. Press YES.• Select [Take out of Operation?] and press YES.• Confirm [Are you sure?] by pressing YES.

1. Installing shutdown plug

The analyzer prompts [Shut Down Plug & Water Installed?].

• Remove the SnapPak and push the protective strip firmly onto the SnapPak connector.• Fill one container of the shutdown kit about halfway with distilled water.• Insert the shutdown plug carefully into the SnapPak receptacle.• Place the blue marked line into the disposable container filled with distilled water.• Place the red marked line into the empty container.• Begin the tubing wash procedure by pressing YES.

Fig. 1-37

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2. Installing the transport housing

The analyzer will prompt [Transport Ref Housing Installed?].

• Pull the electrode holder forward and remove the reference electrode assembly.• Carefully unscrew the reference electrode from the reference electrode housing.• Temporarily place the reference electrode on a clean, soft cloth. • Pour the remaining reference solution in the reference housing into a transport hous-

ing.• Carefully screw the reference electrode into the filled transport housing.• The second transport housing is screwed into the reference housing.• Place the reference housing back into the electrode holder and move the lever back-

wards, making sure all electrodes are seated properly. The electrode holder remains in the forward position.

• Press YES.

3. Washing the lines

The analyzer will take approximately one minute to flush all lines with water. Upon com-pletion, you will receive the prompt [Remove Water and Press YES].

• Remove the line with the blue mark from the distilled water and place it on a cloth.• Press YES. During this cycle, all lines are purged of distilled water.• Upon completion, [All Electrodes & Plug Removed?] will be displayed.

Fig. 1-40

Fig. 1-38 Fig. 1-39

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4. Removing the electrodes and the shutdown plug

• Remove the shutdown plug from the SnapPak receptacle.• Unplug the reference connector below the left side of the electrode holder.• Move the lever on the left side forward and remove all electrodes, placing them on a soft

cloth.• Move the lever back and push the empty electrode holder into its back position.• Unscrew the transport housing from the reference housing.• Empty the reference housing and place all electrodes into their protective boxes.• Press YES.

Fig. 1-41

5. Installing the relief clamps and removing the pump windings

The display will prompt [All 5 Relief Clamps Inserted?].

• Install the red relief clamps making sure that they are snapped securely into position.

• Press YES.

Fig. 1-42

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Never insert the solenoid relief clamps with the SnapPak in place.

• The prompt [Pump Windings Relieved?] appears. • Grasp the front winding close to the pump roller and gently pull it off the roller.• Repeat the same procedure for the rear pump winding.

• Press YES. The prompt [Do You Wish to DELETE All Data?] will appear.• By pressing YES, all QC values and statistics will be deleted and the sample number is

reset to 0. QC and normal ranges as well as correlation factors, printer settings, date/time and SnapPak volume are reset to default. Also, all service codes are deactivated. A deletion of all data is recommended in case the analyzer is used by different labora-tory later on.

• Press NO to retain all data.See chapter 6.4.2: «Clearing all data».

6. Turning the analyzer «off»

• The prompt [Shutdown Complete Turn Power Off] will appear.• Turn the analyzer off.• Unplug the power cord from the receptacle.• Close the front door.• Clean all external surfaces of the analyzer as well as the areas accessible through the

main door and sample door (see chapter 5: «Maintenance», section «Clean sample probe and fill port»).

• Shutdown is complete.• Use the original packaging when transporting the analyzer.

Fig. 1-43

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1.8 Standby modeThe 9180 Electrolyte Analyzer is designed to calibrate automatically every four hours during normal operation. If sampling will be delayed for an extended period of time, such as eve-nings and weekends, you may place the analyzer into Standby mode to suspend automatic calibration.

TIP: The analyzer can be programmed to automatically enter Standby mode. For instruc-tions see chapter 6, section «Service codes».

To enter standby mode:

• Press NO until [OPERATOR FUNCTIONS?] appears. • Press YES, then NO, until [Go to Standby Mode?] appears.• Press YES.

The analyzer shows a Standby mode status on the display.

To exit from Standby mode:

• Press YES, [Leave Standby Mode?] will be displayed.• Press YES again.

Depending on the duration of the standby mode, an automatic calibration can be per-formed. After that, the analyzer returns to [READY].

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2 Specifications

2.1 Performance parameters …………………………………………………………………………………. 2-1

2.1.1 Measurement parameters…………………………………………………………………………………………………………..2-1

2.1.2 Reproducibility………………………………………………………………………………………………………………………………2-1

Material: ISETROL Protein Based Aqueous Control Material (Level 1), n=80 ………………………………….2-2Material: ISETROL Protein Based Aqueous Control Material (Level 2), n=80 ………………………………….2-2Material: ISETROL Protein Based Aqueous Control Material (Level 3), n=80 ………………………………….2-2Material: RNA EQUIL Reduced Bovine Hemoglobin Solution (Level 2), n=80 …………………………………2-2Material: Aqueous Standard Solution (Level 1), n=80 …………………………………………………………………………2-3Material: Aqueous Standard Solution (Level 2), n=80 …………………………………………………………………………2-3Material: Pooled Human Serum, n=80 ……………………………………………………………………………………………………2-3Material: Acetate Dialysate Solution, n=80 …………………………………………………………………………………………….2-3Material: Bicarbonate Dialysate Solution, n=80 …………………………………………………………………………………….2-4Material: Urine, n=80 ………………………………………………………………………………………………………………………………….2-4

2.2 Linearity ……………………………………………………………………………………………………………. 2-5

2.2.1 Linearity in aqueous standard solutions…………………………………………………………………………………..2-5

2.2.2 Linearity in serum…………………………………………………………………………………………………………………………2-5

Correlation to flame …………………………………………………………………………………………………………………………………….2-5Correlation to direct ISE — not flame-correlated …………………………………………………………………………………….2-6Correlation direct ISE — flame-correlated ………………………………………………………………………………………………..2-6Correlation to chloridometry ……………………………………………………………………………………………………………………..2-6