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 ................................................................................................. 1 2
3.1 System description .............................................................................................12
3.1.1 Function Elements ............................................................................................ 13
3.1.2 Measuring Principle .......................................................................................... 15
3.1.3 Concentration Table (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 ...................................................................................................2 8
6. Operation ..................................................................................................... 3 1
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 .................................................................... 3 4
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 ........................................................................... 4 0
9. Mechanics .................................................................................................... 41
9.1 Mechanical moduls..............................................................................................41
9.1.1 T ransport arm .................................................................................................... 41
9.1.2 Tray..................................................................................................................... 41
9.1.3 T op 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.................................................................. 5 0
9.1.12 LB Home P osition.............................................................................................. 51
9.1.13 Motor Belt Drive Cross T ransport...................................................................... 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 Cross Transport ................................................................................................. 58
10. Electronics................................................................................................. 5 9
10.1 Overview Electronics ..........................................................................................59
10.2 Power supply ....................................................................................................... 60
10.3 Electronic modules .............................................................................................62
10.3.1 PCB Main ........................................................................................................... 6 2
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 Cross Transport...................................................................... 70
10.3.12 Motor Measuring Head Drive............................................................................. 71
10.4 Circuit diagram .................................................................................................... 72
10.4.1 PCB Main ........................................................................................................... 7 2
10.4.2 PCB Interface ..................................................................................................... 77
10.4.3 PCB Measuring Head......................................................................................... 81
11. Software..................................................................................................... 8 2
11.1 Overview ..............................................................................................................82
11.2 Flow Diagram of Menu Selection ....................................................................... 83
11.2.1 Flow Diagram of the W orklist Men u.................................................................. 84
11.2.2 Flow Diagram of the Working Mode Menu ....................................................... 85
11.2.3 Flow Diagram of the Reprint Menu ................................................................... 8 6
11.2.4 Flow Diagram of the Setup Menu ..................................................................... 8 7
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 ................................................................................................... 1 01
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 .......................................................11 0
12.6.5 Protocol "/SPE-D/ + Data": Data protocol color + turbidity...........................11 1
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 .........................................11 1
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:........11 5
12.8.3 Automatic adaption to the test procedure used by the host ..........................11 6
13. T roubleshooting....................................................................................... 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 .............................................................................................. 12 7
14.1 Complete spare part list.................................................................................... 127
14.2 Part i dentification ..............................................................................................128
14.3 Exploded view Miditron® Junior II...................................................................131
15. Instrument, Strips, Accessories ............................................................. 133
15.1 Complete list ...................................................................................................... 133
16. Interface Assignment .............................................................................. 1 3 4
16.1 Host/PC interface ..............................................................................................134
16.2 External Printer interface.................................................................................. 135
16.3 Barcode reader interface .................................................................................. 135
17. Routine Care and Cleaning ..................................................................... 1 3 6
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
Please empty the waste tray.
Once the waste tray is empty and the self-check has finished, the analyz er is
ready . Y ou see displa yed.
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 a way fr om 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 W ait" will be display ed. When the display shows "Dip Strip 2", repeat
the procedure for the second and any subsequent test strips.
®
Junior II. You see displayed:
Empty Waste Tray
"Please empty the waste tray"
READY - <START>
"The analyzer is ready to
measure"
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
("READ Y - <START>" is display ed).
IMPORTANT:
Before operating Miditron® Junior II for the first time, y ou have the option of entering various
settings in the SETUP menu.
For your own safety, and to avoid operator err ors, please read the f ollowing operating
instructions carefully .
Please refer to the relevant sections of the Operator’s Manual for information on selection of SET-
UP 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
1.1 Limitations
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.
1.2 Mailing / 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
1.3 Security advice
Please carefully read the paragraphs marked by a
warning triangle!
This instrument was constructed in accordance with DIN
VDE 0750, P art 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 (V erein Deutscher Elektronik-Hersteller = Society of
German Electronics Manufacturers) and meets the
requirements of the MedGV (Medizinische Geräteverordnung
= Medical Instrument Regulation).
T o maintain these conditions and guarantee saf e 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 e xpose 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 oper ated by trained personnel only.
®
T o prevent injury , keep hands a way 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 m ust 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 V erlagsgesellschaft 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
1.4 Confirmation dec laration
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
2.1 Update service for this manual
New information and modifications will be sent via T echnical
News. Please send us your name and address to ensure
you receive updates automatically.
Update Service:
Fax this page to Technical Service-Roche Mannheim
+49 (0)621 759 3985
Name:......................................................
Address:..................................................
..................................................................
..................................................................
F AX 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 / P age 5
Instrument: Miditron® Junior II
Order- number: 1702602
Instrument code: MJ
Version: 1.0
Date of edition: June 1998
Page: 5
2.2 Instrument 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
3.1 System description
Urine test strips simplify laboratory diagnosis through their
ease of use, sensitivity and specificity. These benefits allo w
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 unfavourab le 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/ Displa y
Contains 6 function keys , 10
num. k eys and liquid crystal
display
T ransport 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
3 different colours indicates
the status of the instrument
Serial interface
Used to connect to a
barcode reader
Program chip card
Contains program f or SW
update
Printer paper
Thermal paper
Serial interface
Used to connect to external
printer
DC- socket
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.
Reprint
Reprints the patient report(s)
as defined in the Reprint
menu.
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.
<0-9> and <.>
Used to enter (alpha)
numeric values.
External power supply ,
provides the instrument with
+5V DC and +12V DC
ç
Backspace ke y f or correcting
input, scrolling backwards or
jumping back one
Start
Used to start test strip
measurement, also to
escape from menus back to
"READ Y - <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
3.1.2 Measuring 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 wav elengths. 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.
LED
1
Reading is done electro-optically , as f ollows:
Detector Analog-to-Digital Converter Microprocessor
3
2
4
Test Area
Concentration Result
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.
5
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 wav elengths 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 wa velengths . 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 ev aluating 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 T able (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
666
6.5 6.5 6.5
777
888
999
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
3.1.4 Changing 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 ER Y .
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
3.2 System 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)
Po wer Supply: External Universal Pow er Supply Model No. 78-095-0300
with integral ON/OFF s witch
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 (F ast 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. T emperature: +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
3.3 Service Concept
3.3.1 Service 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 la yout and economic production.
SMD-technology increases reliability on better economical
basis in production. Repair costs often do not relate to
production costs for ne w parts with the latest improvement.
This cuts the number of repairable parts.
On repairable modules the quality and function is alwa ys
provided by the manufacturer according to the latest
technology . This keeps Miditron
highest quality level.
®
Junior II alwa ys on the
The exchange price for modules will be kept on a lo w le v el
to guarantee repairs, on economical basis.
3.3.2 Handling of warranty and repairs
Warranty period f or 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 w orks 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 manuf acturer .
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 f or “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 inv estigation 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. N ew and repaired
parts could be recognized by different material numbers
(language version).
(e.g. ne w part: 1234567-001, repaired part: 1234567- 984)
Repaired parts should be ordered together with new parts
via the order processing department in Mannheim (OUVDG). P arallel to the ordering process of a repaired part,
the defectiv e 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-L V).
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 Rprice 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 T elefon : +49 (621) 759 81 84
D-68167 Mannheim Fax : +49 (621) 759 80 93
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
4.1 Chec king f or Dama ge in Transit
Miditron® Junior II is shipped in one package. Please
contact the supplier or carrier immediately regarding any
damage that may hav e occurred in transit.
4.2 Unpacking
Unpack the Miditron® Junior II accessories and check that
all are present:
- Operator’s Manual
- T r ansport Arm
- Universal Pow er Adapter with Connecting Cable
- Printer Paper (5 Rolls)
- Power Cord
Fig. 31
4.3 Proper Setting
Set up Miditron® Junior II on a firm and straight surf ace. Do
not expose the analyzer to direct sunlight or to an y other
direct light source.
4.4 Setting 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).
Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 25
Fig. 32
4. Installation
3. Plug one end of the power connector cable into the
power sock et 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 po wer 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 T ray" is then displa y ed. This
message is displayed whene ver the analyz er has been
left switched off or in Standby Mode ov ernight. Press
<Start> to cancel the "Empty Waste Tray" message. The
analyzer will display "READY - <ST AR T>" or "Please
Calibrate".
5. If "Please Calibrate" is displayed, press <Start>. This will
allow you to b ypass calibration at this point if y ou wish to
change the user interface language. (The def ault
language setting is English.)
Fig. 33
6. Press <Paging> until "Setup" is display ed. 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 <ST AR T>" or "Please Calibrate".
7. Insert the roll of printer paper as shown in Figs 34 to 37.
(refer to Section 4.5).
8. Y ou ma y then calibrate the analyz er (ref er to Section 6).
Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 26
4. Installation
Fig. 34
Fig. 35
4.5 Inserting Printer Paper
The printer paper (thermal paper) is heat-sensitive and
must be kept aw a y from direct sunlight and high
temperatures. Chec k that there is sufficient printer paper in
the printer paper compartment. To insert a new roll of printer
paper, follo w one of the tw o 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 towar ds the printer) (Fig. 34).
4. Lift the lever on the printer (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 le ver
(Fig. 35).
Fig. 36
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 towar ds 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).
Fig. 37
Service Manual Miditron® Junior II / ID 1997491 / MJ / 1.2 - February 2000 / Page 27
5. Calibration
Miditron® Junior II is factory-calibrated bef ore shipment.
The analyzer must be calibrated again before being used f or
the first time, and then every 14 da ys. The message "Please
Calibrate" will appear in the display whene v er the 14-da y
period has expired.
Calibration is a procedure in which allowance is made f or
changes in the optical system by reference to an internal
compensation pad. If there hav e been marked changes ,
caused for instance b y soiling of the ref erence pad or
because of low-level light output from a def ectiv e LED, an
error message is printed out.
Control-Test M calibration strips (Catalogue Number 1 379
194) are standardized grey plastic strips that hav e 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 calibr ating, ensure that the tr ansport arm
and strip receiving tray / waste tra y are clean and dry.
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"
To calibrate, proceed as follo ws:
Press <Calibrate> when you see displa yed:
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 follo wing display ed:
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
wav elengths. Position 0 is the internal reference pad.
If, after sev eral repeat calibrations , y ou 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
Difference of < 1 % R
Yes
Stored
calibration is still
valid.
Calibration is valid.
New calibration values
will be stored.
Yes
No
Cal. Error 10 - 45
Calibration not valid.
Measurement of a second
calibration strip necessary
Difference of < 1 % R between 1st and 2nd
calibrat i o n st r ip
No Yes
Calibration not valid.
Recalibration necessary.
No
Cal. Error 50 - 85
Calibration not valid.
Recalibration necessary.
Display message:
"Recalibrate !"
Cal. Error 10 - 45
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, y ou 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
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