Diestro 103APV4R Operating manual

ELECTROLYTE ANALYZER
OPERATOR AND SERVICE MANUAL
DIESTRO 103APV4R
V 1.0 MARCH 2022
RE 0851
CONTENT

DIESTRO 103APV4R ELECTROLYTE ANALYZER
2JS Medicina Electrónica
CONTENT........................................................................................................................... 1
1 - INTRODUCTION ........................................................................................................... 5
2 - SECURITY MEASURES................................................................................................ 6
1. IMPORTANT SAFETY INSTRUCTIONS ........................................................................ 6
2. SYMBOLOGY................................................................................................................ 7
3 –INSTALLATION .......................................................................................................... 10
1. UNPACKING....................................................................................................................10
2. INSTALLATION REQUIREMENTS...................................................................................10
3. CONNECTION .................................................................................................................12
4. RETRACTABLE FILL PORT..........................................................................................16
4 –CALIBRATION SOLUTIONS (PACK) ......................................................................... 19
1. PACK REF IN 0100 (WITHOUT PH) AND IN 0102 (WITH PH)...............................................19
2. MICROCHIP (UCHIP).....................................................................................................20
3. VALIDITY OF THE PACK..............................................................................................20
4. CONSUMPTION OF CALIBRATOR SOLUTIONS.........................................................20
5. PACK PERFORMANCE................................................................................................21
6. PACK REPLACEMENT.................................................................................................21
5 - SERUM/PLASMA/WHOLE BLOOD MEASUREMENT................................................ 24
1. OVERVIEW ...............................................................................................................24
2. SAMPLE LOADING.......................................................................................................24
3. MEASUREMENT ..........................................................................................................25
4. PRINTING RESULTS....................................................................................................28
5. PHCORRECTED CALCIUM MEASUREMENT........................................................................29
6 - URINE MEASUREMENT............................................................................................. 30
1. OVERVIEW...................................................................................................................30
2. SAMPLE LOADING.......................................................................................................31
3. MEASUREMENT ..........................................................................................................31
7 - CALIBRATION............................................................................................................. 32
1. OVERVIEW...................................................................................................................32
2. 1POINT CALIBRATION OF IONS AND PH...................................................................32
3. TWO POINT CALIBRATION OF IONS AND PH.............................................................33
4. TCO2 CALIBRATION....................................................................................................33
5. CALIBRATION RESULT................................................................................................34
6. PRINTING THE CALIBRATION RESULT......................................................................36
7. SAVED RESULTS.........................................................................................................37
8. CALIBRATION OPTIONS .............................................................................................37
9. ELECTRODE HISTORY................................................................................................40
10. PACK HISTORY........................................................................................................40
11. STANDBY FUNCTION...............................................................................................41
8 –RINSE......................................................................................................................... 42
1. OVERVIEW...................................................................................................................42
2. AUTOMATIC RINSE .....................................................................................................42
3. ON DEMAND RINSE.....................................................................................................42
9 –PURGES..................................................................................................................... 44
1. PURGE STDS...............................................................................................................44

DIESTRO 103APV4R ELECTROLYTE ANALYZER
3 JS Medicina Electrónica
2. PURGE LACTIC............................................................................................................44
3. AUTOMATIC PURGE....................................................................................................44
10 –QUALITY CONTROL................................................................................................ 45
1. OVERVIEW...................................................................................................................45
2. QUALITY CONTROL MEASUREMENT [LEVEL 1, 2AND 3].........................................46
3. STATISTICS .................................................................................................................47
4. RANGES.......................................................................................................................48
5. MEMORY......................................................................................................................49
6. BRAND AND LOT..........................................................................................................50
11 - CLOCK ...................................................................................................................... 51
1. DEFINITION..................................................................................................................51
2. CLOCK ADJUSTMENT.................................................................................................51
12 –MEMORY.................................................................................................................. 52
1. OVERVIEW...................................................................................................................52
2. RESULTS HISTORY.....................................................................................................53
3. SAMPLER RESULTS HISTORY ...................................................................................53
4. CALIBRATION HISTORY..............................................................................................55
13 - NON-DETECTABLE SAMPLES ................................................................................ 56
1. OVERVIEW...................................................................................................................56
2. MANUAL POSITIONING...............................................................................................56
14 –CONFIGURATION.................................................................................................... 58
1. OVERVIEW...................................................................................................................58
2. ENABLING/DISABLING ELECTRODES AND UNIT SELECTION .................................59
3. AUTOMATIC SAMPLE LOAD........................................................................................59
4. RESULT VISUALIZATION TIME ...................................................................................59
5. NORMAL VALUES........................................................................................................60
6. CONNECTIONS............................................................................................................60
7. INTERNAL PRINTER....................................................................................................61
8. DETECTION THRESHOLDS.........................................................................................61
9. INSTITUTION NAME.....................................................................................................61
10. LANGUAGE...............................................................................................................62
15 –SERIAL PORT OUTPUT CONFIGURATION FOR LIS INTERFACE........................ 63
16 –INSTALLATION OF BARCODE READER AND/OR EXTERNAL KEYBOARD (OPTIONAL)
.................................................................................................................................. 67
17- ERROR MESSAGES.................................................................................................. 68
1. ANALYZER STATUS.....................................................................................................68
2. ERROR MESSAGES.....................................................................................................69
18 –MAINTENANCE........................................................................................................ 71
1. DAILY MAINTENANCE.................................................................................................71
2. WEEKLY MAINTENANCE.............................................................................................72
3. OTHER MAINTENANCE AND REPLACEMENT OF SPARE PARTS OR COMPONENTS72
4. OPEN THE FRONT.......................................................................................................74
5. MOUNT THE FRONT....................................................................................................74
6. INSTALLATION/REPLACEMENT OF THE DIESTRO SAMPLING CLEANER...............75
7. TRANSPORTATION OFEQUIPMENT..........................................................................77
8. WASTE DISPOSAL.......................................................................................................78
9. FINAL DISPOSITION OFTHE EQUIPMENT.................................................................78

DIESTRO 103APV4R ELECTROLYTE ANALYZER
4JS Medicina Electrónica
19 - SERVICE................................................................................................................... 79
1. OVERVIEW...................................................................................................................79
2. ACCESS TO THE SERVICE MENU ..............................................................................81
3. REVIEW AND EVALUATION OF THE STATUS OF THE ELECTRODES......................83
4. SAMPLE MVMEASUREMENT......................................................................................84
20 –REPLACING ELECTRODES.................................................................................... 85
1. REPLACING ELECTRODES.........................................................................................85
21 - REPLACING PRINTING PAPER............................................................................... 87
22 - PERISTALTIC HEAD RELACEMENT ....................................................................... 88
23–FILL PORT NEEDLE REPLACEMENT....................................................................... 90
1. CHANGE OF THE TIP ........................................................................................................90
2. CHANGING THE FILL PORT NEEDLE (STAINLESS STEEL CAPILLARY)......................................90
25–AUTOSAMPLER (OPTIONAL) .................................................................................. 92
1. OVERVIEW...................................................................................................................92
2. INSTALLATION.............................................................................................................92
3. MEASUREMENT USING THE AUTOSAMPLER...........................................................95
4. WAYS TO LOAD THE SAMPLE INTO THE AUTOSAMPLER........................................97
5. CONFIGURATION........................................................................................................99
6. BAR CODE SPECIFICATIONS ...................................................................................100
7. SPECIFICATIONS OF PRIMARY TUBES AND CUPS.................................................101
8. MAINTENANCE..........................................................................................................104
9. HOW TO REMOVE THE TUBE HOLDER DISC FROM THE SAMPLER......................104
10. CHANGE SAMPLER DISC SEPARATORS..............................................................107
26- DIAGRAMS............................................................................................................... 108
27- TECHNICAL SPECIFICATIONS............................................................................... 115
ANNEX I - CLINICAL SIGNIFICANCE OF SERUM/PLASMA/BLOOD ELECTROLYTES119
ANNEX II - CLINICAL SIGNIFICANCE OF ELECTROLYTES IN URINE....................... 125
ANNEX III - PRINCIPLE OF OPERATION...................................................................... 127
ANNEX IV - REFERENCE VALUES............................................................................... 130
ANNEX V - PARTS, REFERENCE CODE AND GUARANTEES.................................... 131

DIESTRO 103APV4R ELECTROLYTE ANALYZER
5 JS Medicina Electrónica
1 - INTRODUCTION
The Diestro analyzer is an in vitro diagnostic equipment manufactured with state-of-the-art technology,
precise, accurate and designed to be easy to use and maintain.
Intended Use
The DIESTRO 103APV4R Ion Analyzer allows the simultaneous measurement of ions (Na+, K+,
Ca2+,Cl-,Li+), pH, TCO2, in whole blood, serum, plasma or urine, depending on the configuration.
The data obtained is used by medical or biochemical professionals for diagnostic purposes. The
latter are responsible for the use and interpretation of the data obtained with the DIESTRO
103APV4R Ion Analyzer.
All configured electrolytes can be measured simultaneously in the same sample.
Each model of the DIESTRO 103APV4R is expandable in the amount of ions to be measured, until reaching the
maximum quantity.
Manufactured by:
JS Medicina Electrónica S.R.L.
Bolivia 462 (B1603CFJ) - Villa Martelli
Provincia de Buenos Aires
República Argentina
Phone/Fax:: [phone]
Email: [email protected].ar
Web: www.jsweb.com.ar
Technical Direction: Farm. Marcelo Miranda
National Registration No. 13104
Provincial Registration No. 15964
ANMAT-AUTHORIZATION IN PROCESS
"Exclusive sale to PROFESSIONALS"
Apple tree s.a
53 Boulevard Général Wahis
1030 Brussels, BELGIUM
Phone: +(32) 2. 732.59.54
Fax: +(32) 2.732.60.03
E-Mail: [email protected]
JS Medicina Electrónica, Diestro, Diestro 103APV4R and its images are a registered trademark of JS Medicina
Electrónica S.R.L
The contents of this manual, hardware and firmware are protected by intellectual property and international
treaties, file in process.
The total or partial reproduction of this manual, hardware, software or firmware of the Diestro 103APV4R analyzer
without written permission from JS Medicina Electrónica S.R.L. is prohibited.
All rights reserved.
Patent Pending.
Model and Industrial Design Registration in process.
JS Medicina Electrónica SRL reserves the right to modify the content of the manual or equipment specifications
without prior notice.
JS Medicina Electrónica SRL is not responsible for loss or damage caused directly or indirectly to the user or
third parties due to the use of the analyzer or the interpretation of the results.
JS Medicina Electrónica SRL Manufactures under ISO 9001/ ISO 13485 Standards
JS Medicina Electrónica SRL Manufactures under Standard GMP according to the regulations of the ANMAT
(National Administration of Food Drugs and Medical Technology of the Argentine Republic -MERCOSUR)

DIESTRO 103APV4R ELECTROLYTE ANALYZER
6JS Medicina Electrónica
2 - SECURITY MEASURES
1. IMPORTANT SAFETY INSTRUCTIONS
DANGER –Misuse of electrical equipment can cause electrocution, burns, fire and other
HAZARDS.
Basic safety precautions, including those listed below, should always be taken into account.
READ THESE WARNINGS BEFORE YOU USE YOUR ANALYZER
•Check that the supply voltage coincides with the available mains voltage.
•Connection to the power network: Connect the equipment to a power base (outlet) that has
ground connection.
•Do not place the equipment in a place where liquid may fall. If the the analyzer gets wet,
disconnect the power supply without touching it.
•Use the analyzer only for the purposes described in the instructions for use.
•Do not use accessories that are not supplied or recommended by the manufacturer.
•Do not use the analyzer if it does not work properly, or if it have suffered any damage.
Examples:
oDamage to flexible power cords or their socket.
oDamage caused by the fall of the equipment.
oDamage caused by falling equipment in water or splashing water on it.
oAny type of error message or alarm on the equipment, loss of liquids or damaged
pipes.
oAny other type of anomaly.
•Do not allow the equipment or its flexible power cord to be exposed to surfaces that are too
hot to the touch.
•Do not place anything on top of the equipment.
•Do not drop or place anything in any of the openings of the equipment, or on any hose or
coupling.
•Do not use the equipment outside.
•The outlet where the power supply of the equipment is connected must be accessible at all
times to allow it to be unplugged in any situation.
•Always wear gloves.
ALL PERSONNEL USING THE ANALYZER MUST READ THE MANUAL CAREFULLY AND
BE AUTHORIZED BY THE LABORATORY MANAGER
The operator's manual includes instructions and guidelines to observe during the
commissioning, operation and maintenance of the analyzer. Therefore, the operator or anyone
handling the DIESTRO 103APV4R analyzer should carefully read the manual before starting to
use the equipment.
The buyer of the equipment is responsible for training and reading the manual to each new
operator of the equipment. A health professional duly qualified for this purpose must interpret

DIESTRO 103APV4R ELECTROLYTE ANALYZER
7 JS Medicina Electrónica
the results issued by the Analyzer. Do not process samples without having carried out a quality
control and verified the correct functioning of the Analyzer.
If the equipment is not used in the manner specified by the manufacturer, the protection
provided by the equipment may be affected.
2. SYMBOLOGY
Different safety instructions are given in each chapter of the manual and on the analyzer, to
highlight aspects related to safe operation.
Note: Identify references to information in other sections of the manual
Press on the touch screen.
DANGER. There may be damage if the equipment or its parts are handled without
due care. Consult the manual and documentation before use.
Biohazard. There are parts of equipment, accessories or supplies that can cause
damage and biological infections if not handled with due care. WEAR GLOVES
WHENEVER WORKING WITH THE EQUIPMENT, ITS PARTS AND SAMPLES,
AS THEY ARE POTENTIALLY INFECTIOUS.
Batch information
Serial Number
Reference/Catalog Number
In Vitro Diagnostic Equipment
Authorized
Representative in the
European Union
Read the manual before use.
For indoor use only

DIESTRO 103APV4R ELECTROLYTE ANALYZER
8JS Medicina Electrónica
Do not dispose of the product as if it were household waste. Failure to comply with
these instructions may have detrimental effects. The user must dispose of the
product as special waste, complying with the regulations applicable in their
jurisdiction.
Manufacturer's details
Date of Manufacture
Connector
Polarity
Ground Connection
Temperature limits
Expiration date
Install before this
date. If the component
is not installed, from
this date the warranty
time begins to elapse.
GUARANTEE
Number of months warranty of the
component or input
Fragile
Box orientation
European Compliance
Maximum number of boxes that can be
stacked
Standard A calibrating solution
Standard B calibrating solution
Lactic Acid
Lactic Acid Return
Waste
USB Port
Pack’s uChip

DIESTRO 103APV4R ELECTROLYTE ANALYZER
9 JS Medicina Electrónica
−For more information about the analyzer, press the +INFO button.
+INFO Menu Contents
To exit, press the back arrow.

DIESTRO 103APV4R ELECTROLYTE ANALYZER
10 JS Medicina Electrónica
3 –INSTALLATION
1. UNPACKING
Carefully unpack the two boxes and check for the following items:
•DIESTRO Analyzer 103APV4R.
•Autosampler for DIESTRO Analyzer 103APV4R (Optional).
•ISE Calibration Pack.
•Urine diluent ISE.
•ISE Cleaning Solution.
•Sodium Conditioner.
•DIESTRO Cleaner.
•DIESTRO Trilevel.
•DIESTRO Control Ampoules (Models with pH electrode)
•Pipe Kit for Pack connection.
•CD with user manual.
•Quick start guide.
•Power supply 15V 4A. (Only models with External Source)
•Peristaltic pump head.
•Tip for the capillary.
•Capillary Adapters.
•Ground cable.
•Pack Tray.
For more detailed information see sections:
TECHNICAL SPECIFICATIONS and DIAGRAMS
2. INSTALLATION REQUIREMENTS
2.1. Supply Voltage
100 - 240 V 50 / 60 Hz 1A
The supply voltage and outlet must comply with local electrical regulations.
There must be a grounding available to ground the equipment.
For more detailed information see section:
POWER SUPPLY SPECIFICATIONS

DIESTRO 103APV4R ELECTROLYTE ANALYZER
11 JS Medicina Electrónica
The mains voltage must be free of noise and variations. If necessary, use a stabilizer.
2.2. Environmental conditions of installation
Verify the environmental operating conditions detailed in the "Technical Specifications" section
For more detailed information see section:
TECHNICAL SPECIFICATIONS
2.3. Place of installation
It must be installed in a level, clean, vibration-free place that support the weight of the
equipment and allows the operator to stand in front of it without any obstacle, with sufficient
place in front of the analyzer so that when opening the front cover, it is fully supported, and
without any objects touching the sides of the analyzer.
Dimensions
Height: 280 mm
Width: 470 mm
Depth: 210 mm / 470 mm with pack included (Auto Basic and Auto Plus models)
Weight (Analyzer): 4.3 kg.
Weight (with AutoSampler): 6,5 Kg.
The outlet where the Power Supply of the Equipment is connected must have easy
access for connection and disconnection at any time.
See the section:
POWER SUPPLY SPECIFICATIONS

DIESTRO 103APV4R ELECTROLYTE ANALYZER
12 JS Medicina Electrónica
3. CONNECTION
Before performing the installation, see the "DIAGRAMS" section to identify the
parts and accessories of your analyzer.
Use the cables and accessories provided with the equipment.
If any need to be replaced, use spare parts provided or recommended by the
manufacturer.
Connect the ground wire to the grounding terminal of the analyzer to a ground connection
duly verified by qualified personnel
Connect the external power supply to the analyzer connector.
Don’t connect the power supply to the outlet yet.
uChip connector
Power supply connector
(External Power Supply)
Grounding terminal
Power supply connector
(Optional Internal Power Supply)
Grounding and power supply connection

DIESTRO 103APV4R ELECTROLYTE ANALYZER
13 JS Medicina Electrónica
−Unscrew the caps, break the aluminum security seals and insert the special connection
caps. Connect them to their corresponding couplings in the analyzer.
Keep the caps that you removed to cover the bottles of the Pack at the time of discarding it.
Observe color coding and text on your analyzer and Pack
Pipe Kit for Pack Connection
- Open the front of the analyzer by turning the clamp screw a quarter turn and tilt the front
forward.
Cleaning Solution
uChip Pack
Caps
Analyzer
couplings

DIESTRO 103APV4R ELECTROLYTE ANALYZER
14 JS Medicina Electrónica
Clamp screw
Clamp screw
-
- Take the Cleaning Module, open the transparent packaging and remove the safety seal from
the Sample Taking Cleaner as indicated in the figure.
1) Opening front
Clamp screw
2) Opening front
3) Opening front
4) Opening front

DIESTRO 103APV4R ELECTROLYTE ANALYZER
15 JS Medicina Electrónica
Opening the cleaner, step 1 Opening the cleaner, step 2
- Carefully lift the fill port until it takes a horizontal position, present the DIESTRO cleaning
module on the front of the position guides, and slide gently until it stops against the bottom.
Make sure the Cleaning Module is in the correct position,
labeled "Front/Front" towards the operator.
Placing the cleaner, step 1 Placing the cleaner, step 2
For more details see the section:
"INSTALLATION /REPLACEMENT OF THE DIESTRO SAMPLING CLEANER"
−Return the fill port to the original position, raise the front and turn the clamp screw to lock
position.
−Connect the power supply to the outlet. Turn on the analyzer, it will automatically perform
a purge and a calibration.

DIESTRO 103APV4R ELECTROLYTE ANALYZER
16 JS Medicina Electrónica
See the section
"CALIBRATION" AND "PURGE"
When the calibration is complete, the analyzer displays the following screen:
-Check that the date and time of the analyzer are correct.
4. RETRACTABLE FILL PORT
The analyzer with the fill port in the resting position

DIESTRO 103APV4R ELECTROLYTE ANALYZER
17 JS Medicina Electrónica
Fill port position for Capillary Fill port position for Tube or Syringe.
See "RETRACTABLE FILL PORT"
4.1 Capillary Adapter
BIOHAZARD. Samples, capillaries and adapters are potentially infectious.
Handle with gloves.
After removing the sample, clean the sampling capillary well with ISE Cleaning
Solution Solution ISE REF IN 0400
The Capillary Adapter is specially made to adapt the sample needle of the analyzer to a
Capillary:
●Place the sample in the capillary position
●Connect the adapter to the end of the capillary that has the sample loaded.
●Hold the end of the fill port and connect the adapter with the capillary and press “Load”.
●Once the sample is loaded, remove the capillary and the adapter and press ready.
Discard the adapter and capillary at the end of each measurement.

DIESTRO 103APV4R ELECTROLYTE ANALYZER
18 JS Medicina Electrónica
1) 2)
Capillary Adapter 1 Capillary Adapter 2
BIOHAZARD. Capillary samples and adapters are potentially infectious. Handle
with gloves.
Before starting to measure capillaries, clean the fill port with ISE Cleaning
Solution REF IN 0400

DIESTRO 103APV4R ELECTROLYTE ANALYZER
19 JS Medicina Electrónica
4 –CALIBRATION SOLUTIONS (PACK)
1. Pack REF IN 0100 (without pH) and IN 0102 (with pH)
Pack and Connection pipes
It provides:
A set of pipes for connection of the Pack. It consists of 3 special connection caps of green,
orange and red color with their corresponding couplings and tubes to connect these to the
analyzer.
These tubes are reusable and always connected to the analyzer.
There are different types of Pack according to the country, region and distributor where the
analyzer was purchased. The type of Pack is independent of the model.
The type of Pack your analyzer needs can be identified by pressing the +INFO button at the top
left of the screen.
If the pack type is not appropriate, the analyzer will display an error message: "Pack Invalid"
JS Medicina Electrónica recommends the simultaneous
replacement of the Fill Port Cleaner with the DIESTRO®Pack.
See the section:
"ERROR MESSAGES"

DIESTRO 103APV4R ELECTROLYTE ANALYZER
20 JS Medicina Electrónica
2. MICROCHIP (uChip)
Pack’s uChip
The uChip integrated in the Pack/Kit provides the analyzer with information about the volumes
of solutions, calibration values, content, type, batch and expiration date of the Pack.
3. VALIDITY OF THE PACK
Check the expiration date of the pack to be connected.
In the event that the pack is expired, the analyzer will display and print the message Pack
Expired and the
status light flashes green to alert the user. Even so, you can use the equipment, under the sole
responsibility of the operator.
4. CONSUMPTION OF CALIBRATOR SOLUTIONS
The analyzer electronically discounts "doses" from the uChip.
When the pack is empty, the analyzer will display the message "Pack Empty", and will stop
working with that pack.
When the pack is empty, you will need to discard it and install a new one.
The red cap and associated tubing of the Analyzer may contain potentially
infectious residues, use caution, wear gloves, do not splash.
The depleted pack contains potentially infectious residues. Discard the pack
following the clarifications in "WASTE DISPOSAL"
Take care not to contaminate the green and orange lids and their respective tubing,
as they are used for the next pack.
To avoid spills, place the green, orange and red caps into their respective
containers before discarding.