Roche Midtron Junior II Service manual

Miditron® Junior II

Service Manual

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 1

Table of contents

Short operating instructions ........................................................................			6
1. General Note		..................................................................................................	7
1.1	Limitations .............................................................................................................		7
1.2	Mailing / telephone address .................................................................................		7
1.3	Security advice ......................................................................................................		8
1.4	Confirmation declaration ....................................................................................		10
2. Documentation ............................................................................................			11
2.1	Update service for this manual ..........................................................................		11
2.2	Instrument code for service ...............................................................................		11
3. Introduction .................................................................................................			12
3.1	System description .............................................................................................		12
	3.1.1	Function Elements ............................................................................................	13
	3.1.2	Measuring Principle ..........................................................................................	15
	3.1.3	ConcentrationTable (Program I) .......................................................................	17
	3.1.4 Changing Range Remisson Bordes ..................................................................		18
3.2	System Specification ..........................................................................................		19
3.3	Service Concept ..................................................................................................		20
	3.3.1	Service level .......................................................................................................	20
	3.3.2 Handling of warranty and repairs .....................................................................		20
4. Installation ...................................................................................................			25
4.1	Checking for Damage in Transit .........................................................................		25
4.2	Unpacking ............................................................................................................		25
4.3	Proper Setting .....................................................................................................		25
4.4	Setting Up ............................................................................................................		25
4.5	Inserting Printer Paper .......................................................................................		27
5. Calibration ...................................................................................................			28
6. Operation .....................................................................................................			31
6.1	Overview ..............................................................................................................		31
6.2	Normal Mode ........................................................................................................		32
6.3	Accelerated Mode ................................................................................................		32
6.4	Fast Mode .............................................................................................................		32
6.5	Principle movement of the Miditron® Junior II .................................................		33
7. Service mode and adjustment ....................................................................			34
7.1	How to make adjustments ..................................................................................		34

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 2

Table of contents

7.2	General .................................................................................................................		35
7.3	Procedure .............................................................................................................		35
8. Adjustment / Dismantling ...........................................................................			40
9. Mechanics ....................................................................................................			41
9.1	Mechanical moduls ..............................................................................................		41
	9.1.1	Transport arm ....................................................................................................	41
	9.1.2	Tray .....................................................................................................................	41
	9.1.3	Top of housing ...................................................................................................	42
	9.1.4	PCB Main ...........................................................................................................	43
	9.1.5	PCB Interface .....................................................................................................	44
	9.1.6	Display ...............................................................................................................	45
	9.1.7	Printer ................................................................................................................	46
	9.1.8	Status LED .........................................................................................................	47
	9.1.9	Keyboard ............................................................................................................	48
	9.1.10	PCB Measuring Head .........................................................................................	49
	9.1.11	LB Measuring Head Home Position ..................................................................	50
	9.1.12	LB Home Position ..............................................................................................	51
	9.1.13	Motor Belt Drive CrossTransport ......................................................................	52
	9.1.14	Motor Measuring Head Unit ..............................................................................	53
	9.1.15	Tooth Bar Measuring Head Unit ........................................................................	54
	9.1.16	Carrier for tray ....................................................................................................	55
	9.1.17	Reference Field Carrier ......................................................................................	56
	9.1.18	Crossbar complete ............................................................................................	57
	9.1.19	CrossTransport .................................................................................................	58
10. Electronics .................................................................................................			59
10.1	Overview Electronics ..........................................................................................		59
10.2	Power supply .......................................................................................................		60
10.3	Electronic modules .............................................................................................		62
	10.3.1	PCB Main ...........................................................................................................	62
	10.3.2	PCB Interface .....................................................................................................	65
	10.3.3	Display ...............................................................................................................	67
	10.3.4	Printer ................................................................................................................	67
	10.3.5	Status LED .........................................................................................................	67
	10.3.6	Keyboard ............................................................................................................	68
	10.3.7	PCB Measuring Head .........................................................................................	68
	10.3.8	LB Measuring Head Home Position ..................................................................	69
	10.3.9	LB Home Position ..............................................................................................	69

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 3

Table of contents

	10.3.10	LB reference position ........................................................................................	70
	10.3.11	Motor Belt Drive CrossTransport ......................................................................	70
	10.3.12	Motor Measuring Head Drive .............................................................................	71
10.4	Circuit diagram ....................................................................................................		72
	10.4.1	PCB Main ...........................................................................................................	72
	10.4.2	PCB Interface .....................................................................................................	77
	10.4.3	PCB Measuring Head .........................................................................................	81
11. Software .....................................................................................................			82
11.1	Overview ..............................................................................................................		82
11.2	Flow Diagram of Menu Selection .......................................................................		83
	11.2.1	Flow Diagram of the Worklist Menu ..................................................................	84
	11.2.2	Flow Diagram of the Working Mode Menu .......................................................	85
	11.2.3	Flow Diagram of the Reprint Menu ...................................................................	86
	11.2.4	Flow Diagram of the Setup Menu .....................................................................	87
	11.2.4.1	Flow Diagram of Color Setup ...........................................................................	89
	11.2.4.2	Flow Diagram of Clarity Setup ..........................................................................	90
	11.2.4.3 Flow Diagram of Parameter Setup ....................................................................		91
11.3	Service/Status Software .....................................................................................		92
11.4	Software update ..................................................................................................		92
	11.4.1	Software update via chip cards .........................................................................	92
	11.4.2	Software update via printer interface ................................................................	93
11.5	Loading instrument settings via Download ......................................................		97
	11.5.1	Specification of the INI-file ................................................................................	98
11.6	Saving instrument settings via Upload ...........................................................		100
12. Interface ...................................................................................................			101
12.1	Host Interface ....................................................................................................		101
12.2	Character definitions, representation conventions ........................................		102
12.3	Protocols ............................................................................................................		103
12.4	Upload timing and handshake .........................................................................		106
12.5	Download timing and handshake ....................................................................		108
12.6	Protocol structure .............................................................................................		110
	12.6.1 Protocol "/REP/": Repeat request ....................................................................		110
	12.6.2	Protocol "/SPM/": Start Communication .........................................................	110
	12.6.3	Protocol "/MOR/": Receipt confirmed/Request for next set ............................	110
	12.6.4	Protocol "/END/": End of communication .......................................................	110
	12.6.5	Protocol "/SPE-D/ + Data": Data protocol color + turbidity ...........................	111

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 4

Table of contents

	12.6.6	Protocol "/SPE-E/ + Data": Data protocol results .........................................	111
	12.6.7	Protocol "/SPE-A/ + Pat-Id.": Data protocol Pat-Id. .......................................	112
12.7	Format of results-data : ....................................................................................		112
	12.7.1 Structure of results-data Programm-1 (International) : ...................................		112
12.8	Procedures for checking test bytes .................................................................		114
	12.8.1 European language variations of Miditron® software: LRC test bytes ..........		114
	12.8.2 American/Canadian language version of Miditron® Junior II software: ........		115
	12.8.3 Automatic adaption to the test procedure used by the host ..........................		116
13. Troubleshooting .......................................................................................			117
13.1	Error at self-test .................................................................................................		117
13.2	Repairable errors during normal mode ...........................................................		118
13.3	Non-repairable errors during normal mode (Major Error) ............................		119
13.4	Errors during INI-file Download .......................................................................		120
13.5	List of all error codes ........................................................................................		121
14. Spare Parts		..............................................................................................	127
14.1	Complete spare part list ....................................................................................		127
14.2	Part identification ..............................................................................................		128
14.3	Exploded view Miditron® Junior II ...................................................................		131
15. Instrument, Strips, Accessories .............................................................			133
15.1	Complete list ......................................................................................................		133
16. Interface Assignment ..............................................................................			134
16.1	Host/PC interface ..............................................................................................		134
16.2	External Printer interface ..................................................................................		135
16.3	Barcode reader interface ..................................................................................		135
17. Routine Care and Cleaning .....................................................................			136
17.1	General ...............................................................................................................		136
17.2	Cleaning .............................................................................................................		136

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 5

Short operating instructions

Directions in Brief

Please read carefully the sections marked with this symbol in the margin!

Miditron® Junior II is designed for ease of use. To carry out routine strip measurements in Normal Mode (sequential reading with automatic consecutive numbering), proceed as follows:

Switch on Miditron® Junior II.You see displayed:

Please empty the waste tray.

Once the waste tray is empty and the self-check has finished, the analyzer is ready.You see displayed.

Empty Waste Tray

"Please empty the waste tray"

READY - <START>

"The analyzer is ready to measure"

1.Press <Start> and follow the display messages:

2.When the status LED flashes green and the beep tone sounds ("Dip Strip 1" is displayed), briefly dip the test strip in the urine sample (for about 1 second) and then remove it again, drawing the edge of the strip over the rim of the specimen container to wipe off excess urine.

3.While the status LED is green, you may insert the test strip, reagent zones upwards, into the insertion area between the two guides on the leading edge of the strip receiving tray.

The end of the test strip must be supported by the rear inside edge of the strip receiving tray (Fig. 10).

WARNING: To prevent injury, keep hands away from the analyzer when it is transporting test strips!

4.After about 20 seconds the first test strip will be transported from the waiting position to the measuring position and "Please Wait" will be displayed. When the display shows "Dip Strip 2", repeat the procedure for the second and any subsequent test strips.

5.The first test strip will be measured 60 seconds after it was dipped and the result will be automatically printed as long as the internal printer was not disabled in the SETUP menu. When a strip is no longer detected at the measuring position, Miditron® Junior II automatically returns to the initial state ("READY - <START>" is displayed).

IMPORTANT:

Before operating Miditron® Junior II for the first time, you have the option of entering various settings in the SETUP menu.

For your own safety, and to avoid operator errors, please read the following operating instructions carefully.

Please refer to the relevant sections of the Operator’s Manual for information on selection of SETUP menu options, calibration, working with Patient ID’s, cleaning and maintenance.

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 6

1. General Note

1.1Limitations

The data and information provided in this manual correspond to the state of knowledge existing at the time of introducing the Miditron® Junior II on the market. Any important changes will be taken into account in the next edition of this manual.

The packaging leaflet should be regarded as authoritative.

This service manual was created for the telephone service and technical service staff.

The operation manual contains special information for the telephone service.

1.2Mailing / telephone address

Service department, DA-ST

Telephone:	+49 (0) 621 / 759 / 3227
Fax:	+49 (0) 621 / 759 / 3985
Hot-line logistic (RA)
Telephone:	+49 (0) 621 / 759 / 8094
Fax:	+49 (0) 621 / 759 / 8093

When calling from outside Germany, add the international dialing code at the beginning and omit the first ‘0’.

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 7

1. General Note

1.3Security advice

Please carefully read the paragraphs marked by a warning triangle!

This instrument was constructed in accordance with DIN VDE 0750, Part 1/DIN IEC 601, Part 1, “Medical Electrical Equipment; Part 1: General Requirements for Safety” and checked to meet all technical demands on safety before leaving the factory.

The instrument received the „GS“ (Geprüfte Sicherheit = safety-tested) label for meeting the safety requirements of the VDE (Verein Deutscher Elektronik-Hersteller = Society of German Electronics Manufacturers) and meets the requirements of the MedGV (Medizinische Geräteverordnung = Medical Instrument Regulation).

To maintain these conditions and guarantee safe operation, the operator should read this information and observe the warnings given in these operating instructions.

The instrument should be used only with the external power supply included in the delivery.

This instrument belongs to Protection Class I (protective conductor).

Do not insert the plug into any type of AC outlet other than a shock-proof outlet. Do not use an extension cord without a protective conductor to prevent that the protective effect is circumvented.

Interrupting the earth conductor inside or outside of the instrument or disconnecting the earth conductor lug may create a hazardous situation for the operator.

Do not open the covers or remove parts that cannot be opened or removed by hand, as this can expose live parts. Connectors may also be live. Any adjustment, maintenance or repair on an opened instrument with the power on should be carried out only by trained personnel authorized by Roche Mannheim who are aware of the danger involved.

If you suspect that the instrument can no longer be operated safely, turn it off and take steps to ensure that it cannot be turned on accidentally. Make certain that the Miditron® Junior II is operated by trained personnel only.

To prevent injury, keep hands away from the analyzer when it is transporting a strip.

A personal computer or printer connected to the analyzer

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 8

1. General Note

must meet the regulations of EN 60950, UL 1950 or CSA C22.2 No. 950.

General Information:

The data and information contained in this manual are current as of issue. Any basic changes will be included in subsequent editions. In case of uncertainty, the package insert included with the product in question shall prevail.

The instrument meets the requirements of Overvoltage Class 2 and Pollution Class 2.

Medical Instrument Regulation („MedGV“)

MedGV is a safety regulation for technical medical instruments (effective only in Germany).

According to the MedGV of 01/14/85, the Miditron® Junior II is classified in Group 3. The user must follow the proper guidelines for Group 3.

Reference:

Regulation on Safety of Technical Medical Instruments.

Author: Adolf Krebs, ISBN 3-921958-41-S, 1985 Bibliomed. Published by: Medizinische Verlagsgesellschaft mbH, Melsungen.

Miditron® Junior II should be used by qualified persons only.

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 9

1. General Note

1.4Confirmation declaration

Confirmation declaration for electromagnetic compatibility according to the laws of the European Union.

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 10

2. Documentation

2.1Update service for this manual

New information and modifications will be sent via Technical News. Please send us your name and address to ensure you receive updates automatically.

Update Service:

Fax this page to Technical Service-Roche Mannheim [phone]

Name:......................................................

Address:..................................................

..................................................................

..................................................................

FAX No. + ____ _____________________

You will find the version identification in the bottom line of every page.

Explanation of the index:

Service Manual Miditron® Junior II / ID 1702602 / MJ / Vers. 1.0 - June 1998 / Page 5

Instrument:	Miditron® Junior II
Ordernumber:	1702602
Instrument code:	MJ
Version:	1.0
Date of edition:	June 1998
Page:	5

2.2Instrument code for service

The service code of Miditron® Junior II is: MJ

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 11

3. Introduction

3.1System description

Urine test strips simplify laboratory diagnosis through their ease of use, sensitivity and specificity. These benefits allow you to identify pathological changes in the urine quickly and reliably.

Automated urinalysis with Miditron® Junior II assures that the reading of results is standardized by eliminating potential sources of error associated with visual reading of test strips (such as unfavourable lighting conditions at the workplace, differences in operators’ ability to discriminate between colours and keep to prescribed times, etc.). The test strips used are multi-parameter strips for measuring specific gravity, pH, leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin and erythrocytes in urine.

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 12

3. Introduction

						3.1.1				Function Elements
										Built in printer with lid
										for documentation of the
										results
										Keyboard/ Display
										Contains 6 function keys, 10
										num. keys and liquid crystal
										display
										Transport arm
										Transports test strip from
										wait position into measuring
										position
										Waste tray
										Three functional areas, test
										strip insertion, incubation/
										measurement area and
										waste container
Status LED							Program chip card
3 different colours indicates							Contains program for SW
the status of the instrument							update

Printer paper

Serial interface

Used to connect to a barcode reader

Thermal paper

Serial interface

Used to connect to external printer

DCsocket

To connect the external power supply

Serial interface

Used to connect to a host,

PC

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 13

3. Introduction

Color

For manually selecting colour and clarity for inclusion with results.

Set

Used to select a menu option.

Enter

Used to terminate keyboard input, e.g. <0-9> and to confirm an option or a procedure.

<0-9> and <.>

Used to enter (alpha) numeric values.

External power supply, provides the instrument with +5V DC and +12V DC

Reprint

Reprints the patient report(s) as defined in the Reprint menu.

ç

Backspace key for correcting input, scrolling backwards or jumping back one

Display

The display consists of 1 line of 16 characters.

Line Feed

advances paper one line at a time or advances continously while key is depressed

Calibrate

Starts the calibration procedure.

Paging

Used to scroll forwards vertically through menus without branching to menu options and without saving settings.

Start

Used to start test strip measurement, also to escape from menus back to "READY - <Start>", "ACC MODE Start" or "FAST MODE <START>", to stop printing during Reprint, and to acknowledge warning messages and prompts.

Power cord

(Country specific)

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 14

3. Introduction

3.1.2Measuring Principle

Miditron® Junior II is a semi-automated reflectance photometer for in-vitro semi-quantitative reading of urine test strips from Roche Mannheim.The light sources (lightemitting diodes, LED’s for short) and reading times are optimized for the reaction chemistry and colour development occurring on the test pads.

The measuring head of Miditron® Junior II contains 3 LED’s of differing wavelengths. The test strip is held stationary at the measuring position and the measuring head moves over each test pad in turn, starting from a "Reference position" used to test the optical system.

During measurement, Miditron® Junior II checks that the test strip is properly positioned under the measuring head by carrying out a plausibility check on the light that is reflected. If the strip is not properly positioned under the measuring head, Miditron® Junior II prints an error message.

Reading is done electro-optically, as follows:

Detector	Analog-to-Digital Converter				Microprocessor
3		4			5

LED

1

			Test Area
					Concentration Result
	2

An LED (1) flashes light of a defined wavelength at an optimum angle onto the surface of the test pad (2). The light hitting the surface is reflected with an intensity that is dependent on the colour of the test pad, and is received by a photodiode detector (3) positioned directly above the test pad. The detector sends an analogue electrical signal to the analogue-to-digital converter (4), which converts it to a digital figure.The microprocessor (5) corrects the digital figure based on a value from an internal reference pad and converts it to a relative value by scaling to a calibration standard, and then computes the absolute reflectance value.

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 15

3. Introduction

The semi-quantitative concentration result is determined by comparing the absolute reflectance value with the so-called range boundaries ( = constant, parameter-specific reflectance values stored in the analyzer).

Results can be printed out, saved in memory, and sent to a computer.

The wavelengths of the LED’s used to measure each of the urine test strip parameters are listed in the table below. The results of certain parameters are improved through the use of two different wavelengths. The third LED is for future options

Parameter	Measuring Wave length [nm]
Specific Gravity	620
pH	557 and 620
Leukocytes	557
Nitrite	557
Protein	557
Glucose	557
Ketone	557
Urobilinogen	557
Bilirubin	557
Erythrocytes	557 and 620
Color	557 and 620

The photometric reflectance measurement for all of the parameters is carried out after an incubation time of 60 seconds. As with earlier urine analyzers from Roche Mannheim, allowance for intrinsic urinary colour, which is a recognized interfering factor, is made through measurement of a blank reagent pad, the so-called "compensation pad". Upon immersion into the urine sample, the compensation pad absorbs the sample liquid and assumes the intrinsic colour of the urine. Measuring the compensation pad helps prevent false positives when the urine sample is strongly coloured.

In strongly alkaline urine samples, Miditron® Junior II automatically corrects the result obtained when the test pad for specific gravity is read.

Miditron® Junior II reads the strip and determines urine colour by evaluating the compensation pad. The settings necessary for this are selected in the Setup menu. Whether the colour is to be printed together with the results is also defined in the Setup menu.

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 16

3. Introduction

		3.1.3	Concentration Table (Program I)
		Miditron®	Junior II prints the test results in the following
		concentration ranges:
Parameter	Conventional			SI	Arbitrary (Standard)
Specific Gravity	1.000			1.000	1.000
(SG)	1.005			1.005	1.005
	1.010			1.010	1.010
	1.015			1.015	1.015
	1.020			1.020	1.020
	1.025			1.025	1.025
	1.030			1.030	1.030
pH	5			5	5
	6			6	6
	6.5			6.5	6.5
	7			7	7
	8			8	8
	9			9	9
Leukocytes	neg.			neg.	neg.
(LEU)	25	/µl		25 /µl	+
	100	/µl		100 /µl	++
	500	/µl		500 /µl	+++
Nitrite	neg.			neg.	neg.
(NIT)	pos.			pos.	pos.
Protein	neg.			neg.	neg.
(PRO)	25	mg/dl		0.25 g/l	+
	75	mg/dl		0.75 g/l	++
	150	mg/dl		1.5 g/l	+++
	500	mg/dl		5 g/l	++++
Glucose	norm.			norm.	neg.
(GLU)	50 mg/dl			3 mmol/l	+
	100 mg/dl			6 mmol/l	++
	300 mg/dl			18 mmol/l	+++
	1000 mg/dl			56 mmol/l	++++
Ketone	neg.			neg.	neg.
(KET)	5	mg/dl		0.5 mmol/l	+
	15	mg/dl		1.5 mmol/l	++
	50	mg/dl		5 mmol/l	+++
	150	mg/dl		15 mmol/l	++++
Urobilinogen	norm.			norm.	neg.
(UBG)		1 mg/dl		17 µmol/l	+
		4 mg/dl		68 µmol/l	++
		8 mg/dl		135 µmol/l	+++
	12 mg/dl			203 µmol/l	++++
Bilirubin	neg.			neg.	neg.
(BIL)	1	mg/dl		17 µmol/l	+
	3	mg/dl		50 µmol/l	++
	6	mg/dl		100 µmol/l	+++
Erythrocytes	neg.			neg.	neg.
(ERY)	10	/µl		10 /µl	+
	25	/µl		25 /µl	++
	50	/µl		50 /µl	+++
	150	/µl		150 /µl	++++
	250	/µl		250 /µl	+++++

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 17

3. Introduction

3.1.4Changing Range Remisson Bordes

The boundaries of the reflectance ranges used by Miditron® Junior II to compute and output the test results were derived from rigorous comparative tests carried out by Roche Mannheim with native urine. If required, the factory-set default ranges for Miditron® Junior II may be changed to suit individual laboratories’ requirements. Results obtained based on individually modified ranges are flagged with an asterisk * under the "Urinalysis" headline on the patient report.

The ranges for the parameters pH and SG cannot be modified; nor can the thresholds for wavelength changes for pH and ERY.

Operator´s Manual outlines how ranges can be selected.

Roche Mannheim can give no guarantee as to the accuracy of results when range boundaries have been changed.

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 18

3. Introduction

3.2System Specification

Dimensions:	Height:	195 mm
	Width:	349 mm
	Depth:	470 mm
Weight:	7.45 kg
Interfaces:	3 serial RS 232 C interfaces
	(host/PC, barcode reader, external printer)
Power Supply:	External Universal Power Supply Model No. 78-095-0300
	with integral ON/OFF switch
	Input:	110 V - 240 V; 50-60 Hz; 0.4-0.2 A
	Output:	5 V	2.0 A
		12 V	2.0 A
Power Consumption:	Operation:	30 W
	Standby:	15 W
System Description:	Type:	reflectance photometer
	Light source:	LED’s (light emitting diodes)
	Wavelengths:	557 nm, 620 nm
		(the 656 nm LED is for future options)
	Measuring head:	1 measuring head with 3 LED’s
	Work flow:	approx. 36 seconds (Normal Mode)
		approx. 20 seconds (Accelerated Mode)
		approx. 12 seconds (Fast Mode)
	Incubation time:	60 seconds
	Printer:	Seiko thermal line printer
	Display:	liquid crystal display, 1 line, 16 characters
Environmental conditions:
	Operating	Non-Operating
Temperature:	+15°C - +34°C	-20°C - +60°C
Relative humidity:	20 % 80 %	20 %	95 %
Optimum	Opt.Temperature:	+22°C - +26°C
operating conditions:	Opt. Rel. Humidity:	30 %	60 %

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 19

3. Introduction

3.3Service Concept

3.3.1Service level

From the early stage of development, Miditron® Junior II was designed for simple error detection and easy exchangeability of modules. This gives the service workshops the possibility of a fast and easy repair of the instrument on service level A (module level). No big stock or expensive equipment is necessary and service technicians are easier to train. Also, a permanent technical improvement in layout and economic production.

SMD-technology increases reliability on better economical basis in production. Repair costs often do not relate to production costs for new parts with the latest improvement. This cuts the number of repairable parts.

On repairable modules the quality and function is always provided by the manufacturer according to the latest technology. This keeps Miditron® Junior II always on the highest quality level.

The exchange price for modules will be kept on a low level to guarantee repairs, on economical basis.

3.3.2Handling of warranty and repairs

Warranty period for instruments and spare parts

The warranty period for instruments is 16 months starting with the date of shipment ex works Mannheim/ Federal Republic of Germany or 12 months starting with the date of the first installation, whichever period is shorter.

The warranty period for spare parts is 6 months from installation date of the part, however not longer than 24 months after having delivered ex works Mannheim/ Federal Republic of Germany.

Hint:

In case the instrument has a remaining warranty period of more than 6 months, the parts remain under warranty until the warranty period of the instrument expires.

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 20

3. Introduction

Handling of warranty claims

The warranty claim has to be handled via Return Authorization procedure or accepted equivalent. Please answer all the questions on the RA form with the greatest care.

Especially a detailed fault description is needed or the warranty claim will not be accepted by the manufacturer. Complete instruments are not accepted unless this has been agreed with the service department of the relevant product group responsible at RD GmbH.

Important information:

-Only parts marked with „A“in the price list are generally accepted under warranty.

-Only return those parts marked with „R“in the spare parts price list.

-Warranty claim for “R” parts will be accepted, if the part was returned to Mannheim.

-All defective parts ( non-“R“ and „A“ parts ) should be kept on stock for a period of 7 months. In case the manufacturer needs the part for investigation it will be requested from Mannheim.

-All parts returned to Mannheim and not requested by Mannheim will be send back at the expense ofthe countries.

-The RA claim for warranty has to be in Mannheim no later than 8 weeks after the problem date.

Exclusion of warranty

The aforementioned warranties do not apply in case of improper use, handling, transportation or storage, faulty installation, repair or maintenance, chemical influence or contamination as well as damages resulting from that, failure to follow operating instructions, alterations or modifications of instruments or parts thereof not authorized or recommended by RD GmbH and resulting damages, normal wear and tear and in case of other circumstances beyond the control of RD GmbH.

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 21

3. Introduction

Handling of repairs

As a general rule, all instrument repairs should be carried out by authorized and trained personnel only.

Repair of parts marked with „R“

Parts which are economically worth repairing are marked with „R“in the spare parts price list. New and repaired parts could be recognized by different material numbers (language version).

(e.g. new part: 1234567-001, repaired part: 1234567-984)

Repaired parts should be ordered together with new parts via the order processing department in Mannheim (OUVDG). Parallel to the ordering process of a repaired part, the defective part should be returned together with the filled RA form (giving full details of the defect and marked choice box with repair) to Logistic Instruments (Goods Receipt) in MA-Wohlgelegen (LI-LV).

Repair of instruments

Complete instruments are not accepted for replacement or repair unless this has been agreed with the product group responsible at RD GmbH.

Before replacement or repair can take place, the validity of the request must be examined and the question of costs must be settled in a written agreement with RD GmbH.

Terms of delivery

Shipments to the countries with the routine truck are c.i.f./ shipments outside this procedure are ex works Mannheim .

Emergency shipments require additional costs to be charged.

Handling of costs

“Repaired”-parts (Material-No. 1234567-984) are shipped at a repair price. In case the defective parts are not returned within 3 or 8 weeks for european or oversea countries after ordering the repaired part, the countries will be charged later on with the difference to the new price.

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 22

3. Introduction

After the receipt of a warranty request for “A”-parts, RD-G will credit 100 % of the currently effective ex MA price.

In case the manufacturer does not accept the warranty request, the countries will be charged lateron with the R- price for R-parts and the new price for non R-parts.

RA form

Return Authorization

Please answer all the questions on the RA form with the greatest care and sign the form.

-Country code

-Problem date

-Type of instrument

-Serial no. of the instrument

-Installation date of instrument

-Defective instrument or spare part

-Part number and material number of the spare part

-Old / new serial no.

-Fault description

-Alarm code

-Service / workshop report no.

In case of instrument out of warranty

- Installation date of spare part

All returned parts should be individually labeled with the corresponding RA no. and shipped together with the completed RA form to:

Roche Diagnostic Mannheim GmbH

Logistic Instruments

RA Management

Friedrich Ebert Str. 100

D - 68167 Mannheim

Germany

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 23

3. Introduction

RA form

In the following please find important hints on how to fill in

the RA-Form correctly.

ROCHE DIAGNOSTICS MANNHEIM GmbH

Friedrich-Ebert-Strasse 100

Telefon : [phone]

D-68167 Mannheim

Fax :

[phone]

Germany

Return Authorization

No.:

Country code:

Date:

Instrument:

Serial No.:

Installation date:

Spare Part:

Customer:

Address:

(will be filled in by RD)

Part No.:

Qty.:

Part Name:

Repair

Comments

Mat.-No.:

Warranty

Installation date of Spare Part:

Warranty Repair

OLD serial No.:

Modification

NEW serial No.:

Replacement

Fault Description:

Alarm Code:

Service Report No.:

Workshop Report No.:

Place:

Date:

Signature:

Remarks (will be filled in by RD)

NOS

Credit

FC

RD

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 24

4. Installation

4.1Checking for Damage in Transit

Miditron® Junior II is shipped in one package. Please contact the supplier or carrier immediately regarding any damage that may have occurred in transit.

4.2Unpacking

Unpack the Miditron® Junior II accessories and check that all are present:

-Operator’s Manual

-Transport Arm

-Universal Power Adapter with Connecting Cable

-Printer Paper (5 Rolls)

-Power Cord

4.3Proper Setting

Set up Miditron® Junior II on a firm and straight surface. Do not expose the analyzer to direct sunlight or to any other direct light source.

4.4Setting Up

Do not start the analyzer immediately if it has been subject to an abrupt change in temperature or humidity.

1.Check that the strip receiving tray / waste tray is correctly positioned in its holder.

2.Attach the transport arm. Grasp the handle end and, while holding it at an angle of 45° from the vertical, insert it as far as it will go along the visible guide, then push down so it snaps into position (Fig. 31).

Fig. 31

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 25

Fig. 32

Fig. 33

4.Installation

3.Plug one end of the power connector cable into the power socket at the rear of the instrument and the other end into the AC power adapter (Fig. 32). Plug the AC power cord first into the AC power adapter and then into an appropriate AC wall socket.

4.When the AC power adapter is switched on (Fig. 33), Miditron® Junior II automatically runs a self-check. The message "Empty Waste Tray" is then displayed. This message is displayed whenever the analyzer has been left switched off or in Standby Mode overnight. Press <Start> to cancel the "Empty Waste Tray" message. The analyzer will display "READY - <START>" or "Please Calibrate".

5.If "Please Calibrate" is displayed, press <Start>. This will allow you to bypass calibration at this point if you wish to change the user interface language. (The default language setting is English.)

6.Press <Paging> until "Setup" is displayed. Press <Set> until the desired language appears in the display, then <Enter> to confirm your selection. Pressing <Start> closes the setup routine and returns you to "READY - <START>" or "Please Calibrate".

7.Insert the roll of printer paper as shown in Figs 34 to 37. (refer to Section 4.5).

8.You may then calibrate the analyzer (refer to Section 6).

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 26

4. Installation

•

‚

Fig. 34

„

ƒ

Fig. 35

…

Fig. 36

†

Fig. 37

4.5Inserting Printer Paper

The printer paper (thermal paper) is heat-sensitive and must be kept away from direct sunlight and high temperatures. Check that there is sufficient printer paper in the printer paper compartment. To insert a new roll of printer paper, follow one of the two methods below:

Method 1:

1.Open the printer cover •(Fig. 34).

2.Remove the old core and any remaining paper ‚(Fig. 34).

3.Place a new roll of paper in the printer paper

compartment (with the end of the paper pointing downwards and towards the printer) ‚(Fig. 34).

4.Lift the lever on the printer ƒ(Fig. 35).

5.Cut off the end of the paper at an angle and insert it into the paper slot on the printer „(Fig. 35).

6.Pull the paper through the printer and lower the lever ƒ (Fig. 35).

7.Feed the paper through the slot in the printer cover and then close the printer cover …(Fig. 36).

8.Press <Line Feed> to advance the paper.

Method 2:

1.Open the printer cover •(Fig. 34).

2.Remove the old core and any remaining paper ‚(Fig. 34).

3.Place a new roll of paper in the printer paper compartment (with the end of the paper pointing downwards and towards the printer)‚(Fig. 34).

4.Cut off the end of the paper square and insert it into the paper slot on the printer †(Fig. 37).

5.Press <Line Feed> to advance the paper.

6.Feed the paper through the slot in the printer cover and then close the printer cover …(Fig. 36).

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 27

5. Calibration

READY - <START>

"The analyzer is ready to measure in Normal mode"

ACC MODE <START>

"The analyzer is ready to measure in Accelerated mode"

FAST MODE<START>

"The analyzer is ready to measure in Fast mode"

Please Calibrate

"The analyzer needs calibrating"

Insert Cal Strip

"Insert calibration strip"

Press <Calibr.>

"Press the Calibrate key"

Calibrating

"Calibration being carried out"

Miditron® Junior II is factory-calibrated before shipment. The analyzer must be calibrated again before being used for the first time, and then every 14 days. The message "Please Calibrate" will appear in the display whenever the 14-day period has expired.

Calibration is a procedure in which allowance is made for changes in the optical system by reference to an internal compensation pad. If there have been marked changes, caused for instance by soiling of the reference pad or because of low-level light output from a defective LED, an error message is printed out.

Control-Test M calibration strips (Catalogue Number 1 379 194) are standardized grey plastic strips that have constant, defined reflectance characteristics. Calibration strips should not be removed from their container until shortly before use, and should be used once only. Do not touch the elevated grey areas on the strip (see the package insert for more details). Before calibrating, ensure that the transport arm and strip receiving tray / waste tray are clean and dry.

To calibrate, proceed as follows:

Press <Calibrate> when you see displayed:

Note:

The "Please Calibrate" message can be bypassed by pressing <Start>. In this case, a message will be printed on the patient report.

Two messages will appear alternately in the display:

Place the Control-Test M calibration strip in the centre of the strip receiving tray.

Press <Calibrate> again. The calibration strip is transported into the analyzer and you see the following displayed:

After about 60 seconds, a printout will occur as long as the printer has not been disabled in the Setup menu.

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 28

5. Calibration

SW.Vers.		1 1.00
22.01.1998		9:21
Calibration o.k.
	557	620	657
0	64.50	63.60	63.20
1	64.49	63.76	63.11
2	64.40	63.73	64.56
3	64.44	63.82	63.48
4	64.44	63.70	63.39
5	64.32	63.76	63.37
6	64.05	63.50	63.34
7	64.40	63.67	63.26
8	64.55	63.64	63.22
9	64.17	63.70	63.04
10	64.55	63.67	63.28
11	64.35	63.71	63.43

SW.Vers. 1 1.00 22.01.1998 9:21 Cal. Err. ##

Calibration successful: Printout of reflectance values in % R.

Calibration unsuccessful:

Recalibration necessary.

The printout quotes the current software version number, the date and time of calibration, and the positions of the individual test pads on the calibration strip, together with the measured reflectances in % R at the respective wavelengths. Position 0 is the internal reference pad.

If, after several repeat calibrations, you still receive the message "Recalibrate !", please refer to Section 8 "Troubleshooting". During the calibration procedure, the values read from the calibration strip are compared with the stored calibration values. The calibration procedure is as follows:

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 29

5. Calibration

Difference of < 10 % between measured value and reference value

No

Yes

Difference of < 1 % R

Cal. Error 50 - 85

Calibration not valid.

Recalibration necessary.

No

Yes

Cal. Error 10 - 45

Stored

Calibration not valid.

Display message:

calibration is still

Measurement of a second

"Recalibrate !"

valid.

calibration strip necessary

Difference of < 1 % R between 1st and 2nd calibration strip

	Yes				No
Calibration is valid.					Cal. Error 10 - 45
New calibration values				Calibration not valid.
will be stored.				Recalibration necessary.

Miditron® Junior II is ready to read as long as there are valid calibration values stored in the analyzer. Calibration every 2 weeks is recommended. If calibration cannot be carried out for any reason, e.g. because there are no Control-Test M calibration strips available, you can bypass the calibration procedure and continue reading by pressing <Start> at the "Please Calibrate !" prompt. Miditron® Junior II then uses the stored calibration values to carry out further readings.

Note: In this case, "Calibration is necessary" will be printed on the results report.

Roche Mannheim can give no guarantee as to the accuracy of results if the analyzer has not been calibrated.

Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 30