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Diestro 103APV4R User Manual

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

Table of Contents

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Diestro 103APV4R Specifications

General IconGeneral
BrandDiestro
Model103APV4R
CategoryMeasuring Instruments
LanguageEnglish

Summary

1 - INTRODUCTION

Intended Use

Defines the analyzer's purpose, sample types, and measurement capabilities.

2 - SECURITY MEASURES

IMPORTANT SAFETY INSTRUCTIONS

Critical warnings and precautions for safe operation, handling, and electrical safety.

SYMBOLOGY

Explains standard symbols used in the manual and on the analyzer for clear communication.

3 – INSTALLATION

UNPACKING

Details the process of unpacking the analyzer and checking all included items for completeness.

INSTALLATION REQUIREMENTS

Specifies essential requirements for setup, including power, grounding, and environmental conditions.

CONNECTION

Provides step-by-step instructions on connecting the analyzer's components and grounding.

RETRACTABLE FILL PORT

Explains the function, operation, and capillary adapter use of the analyzer's fill port.

4 – CALIBRATION SOLUTIONS (PACK)

Pack REF IN 0100 & IN 0102

Details calibration packs, their components, connection, and identification via +INFO.

MICROCHIP (uChip)

Explains the function of the uChip for pack information, calibration values, and expiration dates.

VALIDITY OF THE PACK

Covers checking the expiration date of the calibration pack and its implications for use.

CONSUMPTION OF CALIBRATOR SOLUTIONS

Details how the analyzer tracks solution consumption and alerts when a pack is empty.

PACK PERFORMANCE

Provides recommendations for optimal performance and explains pack design for sufficient solution.

PACK REPLACEMENT

Outlines the step-by-step procedure for safely replacing the calibration pack.

5 - SERUM/PLASMA/WHOLE BLOOD MEASUREMENT

OVERVIEW

Introduces serum/plasma/whole blood measurement, emphasizing correct functioning and sample prep.

SAMPLE LOADING

Details the procedure for loading serum, plasma, or whole blood samples, including safety.

MEASUREMENT

Explains how to perform measurements, including lever operation and selecting TCO2/Ions.

PRINTING RESULTS

Describes the format and content of printed measurement reports, including electrolyte values.

pH Corrected Calcium Measurement

Explains how to measure and calculate pH-corrected calcium values using a specific equation.

Quality Control

Details how to perform quality control for serum/plasma measurements, linking to QC section.

6 - URINE MEASUREMENT

OVERVIEW

Introduces urine measurement, emphasizing correct function, QC, and dilution requirements.

SAMPLE LOADING

Details the procedure for loading urine samples, including dilution and safety precautions.

MEASUREMENT

Explains how to perform urine measurements, including dilution and referencing serum measurement.

7 - CALIBRATION

OVERVIEW

Introduces the three types of calibration performed by the analyzer: Ions, pH, and TCO2.

1 POINT CALIBRATION OF IONS AND PH

Explains the automatic 1-point calibration process performed during sample measurement.

TWO POINT CALIBRATION OF IONS AND PH

Details automatic and on-demand procedures for 2-point calibration and frequency modification.

TCO2 CALIBRATION

Describes the process for calibrating the TCO2 module, noting factory calibration.

CALIBRATION RESULT

Explains how to view and interpret calibration results, including status, gain, and balance.

PRINTING THE CALIBRATION RESULT

Details the information included in a printed calibration report, such as Lot, Expires, and Reagents.

SAVED RESULTS

Explains how to access and view previously saved calibration results from memory.

CALIBRATION OPTIONS

Covers settings for calibration, including enabling/disabling electrodes and unit selection.

Configuring the measurement correction

Details how to fine-tune analyzer values using correction equations for accuracy.

ELECTRODE HISTORY

Provides access to historical data related to installed electrodes, such as serial number and usage.

PACK HISTORY

Details how to view historical data related to the calibration pack usage, including type and expiration.

STANDBY FUNCTION

Explains the analyzer's standby mode, its automatic operations, and recommended uptime.

8 – RINSE

OVERVIEW

Explains the purpose of rinsing electrodes during measurement or calibration for optimal performance.

AUTOMATIC RINSE

Details when automatic rinsing procedures are performed by the analyzer between samples and calibrations.

ON DEMAND RINSE

Describes how to initiate a rinse procedure manually when needed, including specific types.

9 – PURGES

PURGE STDS

Explains the process of filling pack and equipment pipes with calibration solutions for purging.

PURGE LACTIC

Details the purging procedure for the lactic acid pipe circuit, especially for TCO2 modules.

AUTOMATIC PURGE

Describes the automatic purge performed after installing a new pack, followed by calibration.

10 – QUALITY CONTROL

OVERVIEW

Introduces the analyzer's quality control capabilities, control levels, and statistical calculations.

QUALITY CONTROL MEASUREMENT [LEVEL 1, 2 AND 3]

Details the procedure for measuring quality control samples at different levels.

STATISTICS

Explains how to view measurement evolution graphs and select sample numbers for statistical analysis.

RANGES

Describes how to edit limits for each analyte in the evolution graph and apply Westgard rules.

MEMORY

Explains how to view quality control measurements and delete stored data from memory.

BRAND AND LOT

Details entering the brand and batch of controls used for quality control for traceability.

11 - CLOCK

DEFINITION

Explains that the analyzer maintains date and time when powered off using an internal battery.

CLOCK ADJUSTMENT

Guides on how to access and adjust the analyzer's date and time settings via the settings menu.

12 – MEMORY

OVERVIEW

Introduces access to measurement and calibration results, ordered chronologically for review.

RESULTS HISTORY

Details how to select and view measurement results, with printing and LIS transfer options.

SAMPLER RESULTS HISTORY

Explains how to view measurements made with the autosampler, grouped by session and tube.

CALIBRATION HISTORY

Guides on how to select, view, and print calibration results from the analyzer's memory.

13 - NON-DETECTABLE SAMPLES

OVERVIEW

Addresses samples not detected by the analyzer due to low conductivity or insufficient volume errors.

MANUAL POSITIONING

Explains how to manually position samples when the analyzer encounters a "Not Filled" error.

14 – CONFIGURATION

OVERVIEW

Introduces the analyzer's configuration menu for various settings and options.

ENABLING/DISABLING ELECTRODES AND UNIT SELECTION

Guides on enabling/disabling electrodes and selecting measurement units, including pH temperature.

AUTOMATIC SAMPLE LOAD

Covers enabling/disabling automatic sample loading and setting delays for easier operation.

RESULT VISUALIZATION TIME

Explains how to set the duration for displaying measurement results before returning to the main menu.

NORMAL VALUES

Details how to edit lower and upper bound values considered "normal" for measurement ranges.

CONNECTIONS

Covers enabling serial output, choosing ports, speed, and protocols for LIS interface.

INTERNAL PRINTER

Explains how to enable or disable the internal ticket printer functionality.

DETECTION THRESHOLDS

Covers editing detection values for various liquids used by the analyzer.

INSTITUTION NAME

Guides on configuring the institution name displayed on tickets and the main menu.

LANGUAGE

Explains how to change the analyzer's display language and the requirement to restart.

15 – SERIAL PORT OUTPUT CONFIGURATION FOR LIS INTERFACE

Connection cable

Provides pinout details for the serial port connection cable between the analyzer and PC/LIS.

16 – INSTALLATION OF BARCODE READER AND/OR EXTERNAL KEYBOARD (OPTIONAL)

Optional External Device Installation

Explains connecting external USB barcode readers or keyboards to the analyzer's USB ports.

17- ERROR MESSAGES

ANALYZER STATUS

Describes how to view the analyzer's status via semaphore, reagent level, and electrode status indicators.

ERROR MESSAGES

Lists common errors, their causes, effects, and recommended actions for troubleshooting.

18 – MAINTENANCE

DAILY MAINTENANCE

Details daily cleaning and decontamination procedures, including ISE cleaning.

WEEKLY MAINTENANCE

Outlines weekly tasks, including sodium conditioning and internal cleaning of the equipment.

OTHER MAINTENANCE AND REPLACEMENT OF SPARE PARTS OR COMPONENTS

Discusses general maintenance and the importance of using original spare parts for longevity.

OPEN THE FRONT

Provides step-by-step instructions for opening the analyzer's front cover using a clamp button.

MOUNT THE FRONT

Guides on closing the analyzer's front cover and adjusting the clamp button securely.

INSTALLATION/REPLACEMENT OF THE DIESTRO SAMPLING CLEANER

Details the installation and replacement of the sampling cleaner module, including safety.

TRANSPORTATION OF EQUIPMENT

Provides instructions for safely transporting the equipment within the lab or for longer transfers.

WASTE DISPOSAL

Gives guidelines for the proper disposal of supplies, components, and consumables according to regulations.

FINAL DISPOSITION OF THE EQUIPMENT

Provides guidance on the final disposal of the analyzer itself after its service life.

19 - SERVICE

OVERVIEW

Introduces the service menu for evaluating hydraulic circuits and the status of installed electrodes.

ACCESS TO THE SERVICE MENU

Guides on accessing manual/automatic maintenance menus and modifying detection thresholds.

REVIEW AND EVALUATION OF THE STATUS OF THE ELECTRODES

Explains measuring voltage to evaluate electrode stability and gain for performance.

SAMPLE mV MEASUREMENT

Details measuring voltages to verify electrode gain, referencing technical specifications.

20 – REPLACING ELECTRODES

REPLACING ELECTRODES

Provides a step-by-step guide for replacing analyzer electrodes using original spare parts.

21 - REPLACING PRINTING PAPER

REPLACING PRINTING PAPER

Details the procedure for replacing the thermal paper roll in the analyzer's printer.

22 - PERISTALTIC HEAD RELACEMENT

PERISTALTIC HEAD REPLACEMENT

Guides on how to safely remove and replace the peristaltic head, including performing a purge.

23–FILL PORT NEEDLE REPLACEMENT

Change of the tip

Explains how to replace the tip of the fill port needle assembly.

Changing the fill port needle (stainless steel capillary)

Details the process of replacing the stainless steel capillary needle, including alignment.

25– AUTOSAMPLER (Optional)

OVERVIEW

Introduces the autosampler, its capabilities, barcode reader option, and sample capacity.

INSTALLATION

Guides on how to install the autosampler and attach it to the analyzer, including cable connections.

MEASUREMENT USING THE AUTOSAMPLER

Explains how to access the autosampler menu and select measurement modes (Easy Serum/Urine).

WAYS TO LOAD THE SAMPLE INTO THE AUTOSAMPLER

Details different methods for loading samples into the autosampler, including tubes and cups.

CONFIGURATION

Covers the configuration options available for the autosampler, such as primer and error handling.

BAR CODE SPECIFICATIONS

Details the barcode formats accepted by the analyzer for patient data entry via the autosampler.

SPECIFICATIONS OF PRIMARY TUBES AND CUPS

Lists the specifications for primary tubes and sample cups used with the autosampler.

MAINTENANCE

Details the end-of-day ISE Cleaning Solution procedure for the autosampler and disc cleaning.

HOW TO REMOVE THE TUBE HOLDER DISC FROM THE SAMPLER

Guides on removing the tube holder disc for cleaning after a liquid spill inside the sampler.

CHANGE SAMPLER DISC SEPARATORS

Explains how to change sampler disc separators for using shorter tubes with the autosampler.

26- DIAGRAMS

Front View Diagrams

Illustrates the front view of the analyzer with key components labeled for identification.

Side View Diagrams

Illustrates the side view of the analyzer with key components labeled for identification.

Rear View Diagrams

Illustrates the rear view of the analyzer, showing ports and connections.

27- TECHNICAL SPECIFICATIONS

Equipment Size and Weight

Provides dimensions and weights for the analyzer, autosampler, and their respective boxes.

Operating Conditions

Specifies ambient temperature and humidity limits for analyzer operation.

Storage and Transport Conditions

Outlines conditions for storing and transporting the equipment to maintain integrity.

Mains Voltage

States the required mains voltage and frequency for the analyzer's operation.

Power Supply Specs

Lists input and output voltages for internal and external power supplies.

Sample Throughput

Provides sample measurement rates per hour for different analyzer configurations.

Max Sample Volume for Serum

Specifies the maximum sample volume the analyzer attempts to load for serum analysis.

Min Sample Volume for Serum

States the minimum sample volume required to fill the measuring chamber for serum.

Urine Diluent Volume

Specifies the volume for diluted urine samples used in the analysis.

Measurement Specs

Lists detection ranges, resolution, and repeatability for electrolytes in serum and urine.

Electrode Type

Notes that the analyzer uses maintenance-free selective ion electrodes.

Electrode Gain Range

Provides ranges for electrode gain and mV delta between calibration standards.

Internal Clock Battery

Mentions the 3V Lithium Battery CR1220 used for the internal clock.

Optional Backup Battery

Notes the optional NiMh backup battery pack provided by the manufacturer.

External Device Specs

Lists supported barcode standards for external barcode readers and keyboards.

ANNEX I - CLINICAL SIGNIFICANCE OF SERUM/PLASMA/BLOOD ELECTROLYTES

Potassium (cK+) Clinical Significance

Explains the clinical significance of potassium levels in serum/plasma, including low and high ranges.

Sodium (cNa+) Clinical Significance

Details the clinical significance of sodium levels in serum/plasma, including causes of variations.

Chloride (cCl-) Clinical Significance

Explains the clinical significance of chloride levels in serum/plasma and its relation to anion gap.

Calcium (cCa++) Clinical Significance

Details the clinical significance of ionized calcium levels in serum/plasma and factors affecting it.

Lithium (cLi+) Clinical Significance

Explains the clinical significance of lithium levels in serum/plasma and therapeutic range considerations.

pH Value and Clinical Interpretation

Covers pH definition, reference range, and clinical interpretation of acid/base balance disorders.

ANNEX II - CLINICAL SIGNIFICANCE OF ELECTROLYTES IN URINE

Chlorine and Sodium Concentration in Urine

Discusses variations in urine chloride and sodium concentrations and their clinical relevance.

Potassium in Urine (Potasuria)

Explains variations in urine potassium concentration and clinical relevance, relating to salt intake.

ANNEX III - PRINCIPLE OF OPERATION

Measurement Technology: ISE Direct

Explains the Direct ISE measurement technology, its principles, and application in analyzers.

Principle of Operation of TCO2 Determination

Details the chemical reaction and measurement principle for TCO2 determination using pressure changes.

ANNEX IV - REFERENCE VALUES

ELECTROLYTE RANGE

Provides a table of reference values for electrolytes in serum and urine, including critical limits.

ANNEX V - PARTS, REFERENCE CODE AND GUARANTEES

PARTS, REFERENCE CODE AND GUARANTEES

Lists analyzer parts, their reference codes, installation periods, and guarantees.