You are on page 1of 56

High Technology, Inc.

BioChem SA
ANALIZADOR DE QUIMICA SEMI - AUTOMATICO

MANUAL DE OPERADOR - ESPAÑOL

Document Number : OM-E-BC-30


Revision Level : Rev. 3
Effective Date : 2018-08-24
Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

Product Information
Product model: BioChem SA
Product name: HTI BioChem SA BioChemistry Analyzer
Manufacturer: High Technology, Inc. Massachusetts, USA

Symbols
Symbols used in the Manual

Notes contain additional information or tips when using the instrument. All
recommendations must be followed carefully to ensure your instrument work
correctly and to avoid unnecessary personal injury.

Symbols on the Box

The symbol means the instrument packaged should not be upended at any time

This means that instrument should handle with care during transportation, so as not
to damage it.

The symbol means that the environment of instruments must be damp-proof during
transport, and instrument must be kept in a dry environment.

This symbol indicate that the analyzer should be protected from overexposure to
sunlight

Symbols on the Analyzer

This symbol indicated the location of the external ground connection

This symbol indicates the Power Switch. “O” is Power Off and “I” is Power On

This symbol indicates the power connection on the analyzer.

RS232 This symbol indicates the data connection for the analyzer

This symbol denotes the Catalog number

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

The symbols for “SERIAL NUMBER”, The serial number shall be after or
below the symbol, adjacent to it

The symbol indicates the manufacturer and its address, after which are shown its
name and address

This symbol denotes to Consult instructions for use

This symbol denotes that this product conforms to the directive 98/79/EC (IVD-
directive)

The symbol indicates EU representatives of the manufacturer and their addresses,


after which are shown their names and addresses

The symbol means the product is in vitro diagnostic medical device.

Declaration
High Technology, Inc. reserves the right to change the product described in this Operating Manual. All
information contained in this Operating Manual is subject to change without prior notice.

Manufacturer’s Responsibility
High Technology, Inc. (HTI) is responsible for the safety, reliability and performance of the device, and will
provide warranty under the following conditions:

• Operation of this device conforms to the instructions in this Manual.


• Assembling, upgrading, installation, and repair will be performed by HTI authorized personnel.
• Product storage environment, operating environment, and electrical environment are as described in
this manual.
• Product serial number and labels are intact to verify the products identity as manufactured by HTI.
• Damages not due to by miss-use, physical impacts, or acts of God.

Free services apply to those products with applicable items within warranty period. For those beyond the
description of warranty conditions, HTI will charge for service. For all returned goods to HTI for service,
customers should pay for the transportation and any applicable customs fees.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

Warranty
The Analyzer is covered by a one-year limited warranty from date of the purchase. They carry a one-year limited
warranty. Consumables are excluded from this warranty.

The following situations are not included in the warranty:

• The serial number of the analyzer is missing or unreadable


• The analyzer is damaged due to improper connection with other equipment
• The analyzer is accidentally damaged
• The analyzer has been modified without written authorization from the manufacturer.

Return Procedures
If a return is necessary, take the following steps:

• Obtain a return merchandise authorization from HTI’s Customer Service Department.


• Obtain the serial number and mark this serial number on the shipping box. If the serial number cannot be
recognized, the return cannot be accepted.
• Briefly describe the reasons for the return.
• Freight Charge: Customer is responsible for freight charges (including customs) for any returns.

• Software design may vary depending on modification of device

• NOTE: This instrument adopts a high-grade quartz flow colorimetric pool. Every
day before shutdown, press the “Other Services” button to enter into “Other
Services”, then press “Wash” to absorb distilled water to clean the colorimetric
pool, and to keep the liquid circuit system clean. For storing or operating in
environment prone to freeze, press the “Wash” to absorb air to evacuate the
colorimetric pool, to avoid the liquid in the pool freezing, which may lead to
breakdown of the colorimetric pool.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

Copyright and Statement


Copyright© High Technology Inc. All Rights Reserved. You have selected a product from High Technology
Inc. Thank you for your trust. The BioChem SA semi-automatic biochemical analyzer will bring you a brand-
new experience and convenience.

The specifications of the BioChem SA semi-automatic chemistry analyzer manufactured by High


Technology Inc.
High Technology Inc. owns all the copyrights of the BioChem SA Semi-automatic Biochemical Analyzer
Operating Manual. Without the written permission of High Technology Inc., any use of the BioChem SA
Semi-automatic Biochemical Analyzer Operating Manual, including reproduction, copy, translating to
other languages or transmitting in any form by any person or entity is prohibited.

This manual contains the latest information as of printing. High Technology Inc. reserves the right to change
the relevant content without further notice.

Pictures in the manual may include some schematic drawings which are for reference only. If the picture
does not match the object, the object shall prevail.

Statement
• BioChem SA Semi-automatic Biochemical Analyzer Operating Manual involves the agreements on the
rights and obligations of the product quality assurance responsibility and the after-sale service between High
Technology Inc. and the users.
• The user must read the manual carefully and operate in strict accordance with the guidance of this
manual.
• If the user who is responsible for operating the instrument can’t conduct a satisfying maintenance plan, it
may result in instrument failure.
• High Technology Inc. makes no implied warranty of merchantability and fitness of the instrument for a
purpose.
• High Technology Inc. will be paid to provide the circuit diagrams and relevant information upon user
request, so that the user can find an appropriate and qualified technician to repair those parts of the
instrument classified by High Technology Inc. that can be repaired and maintained by the user.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

Quality assurance and after-sale service commitment:


High Technology Inc. provides a one-year quality warranty and after-sale service for failures due to manufacturing
process or material problem during normal operation from the day of the acceptance of the instrument. The
company promises to make arrangement within 24 hours after receiving the maintenance request of the user.
High Technology Inc. only undertakes the obligation of free maintenance, including the man-hours and material
expenses of the quality assurance maintenance but excluding the losses and additional costs caused by the
instrument downtime.

For example:
• Freight (including the customs fees and insurance premiums).
• Losses caused by out of commission of using the instrument.

High Technology Inc. assumes no responsibility for the direct, indirect or final damage and delay caused by the
following conditions.

• Improper operation.
• Instrument maintenance is not achieved as required.
• Use of accessories which are not supplied or approved by High Technology Inc.
• Accessories are replaced without approval of High Technology Inc., or personnel not authorized by High
Technology Inc. have repaired or altered the instrument.

We have an experienced after-sale service department with rich working ability. If you have any questions,
comments or suggestions, please contact us through the information on the back cover.

How to use this Manual


Welcome to the BioChem SA Semi-automatic Biochemical Analyzer Operating Manual. This manual contains
the contents about instrument installation, routine test, quality control, maintenance, precautions, etc. To maintain
the best performance of the instrument, the operation and maintenance must be carried out in accordance with
the contents of this manual.

The data given in the manual are verified, effective and credible data for the BioChem SA semi-automatic
biochemical analyzer. If the instrument is used for a purpose or operating step and method goes beyond the
provision of the manual, please consult High Technology Inc. for validity and applicability, otherwise High
Technology Inc. cannot guarantee the accuracy and effectiveness of the test results and assumes no
responsibility and obligation for the direct or indirect results caused by this.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

Avoidance of Potential Hazards


All users should carefully read the ‘Safety Notes’ and ‘Operating Notes’ in this manual.
This manual gives the following safety warning signs, guiding the instrument operator to avoid injury to
oneself or damaging the instrument and getting wrong test results. To remind the operator to avoid potential
dangers and hazardous conditions, we give different warning signs depending on the hazard extent of the
operation.

• WARNING: If the instrument is not operated in accordance with the


operating steps, great harm to the operator, environment or both may be
caused.

• ATTENTION: Emphasis on the operation method that must be complied with,


avoiding potential danger or damage to the instrument or generating incorrect
test results.

• NOTE: Emphasis on important information.

All personnel who may operate, maintain, or move the instrument should read the manual carefully.
BioChem SA semi-automatic biochemical analyzer is hereafter referred to as the instrument. High
Technology Inc. is hereafter referred to as HIGH TECHNOLOGY INC.

Safety Notes
For the safe and effective operating of this instrument, be sure to firstly read the following notes carefully. If
the instrument is not operated in the way specified by the manufacturer, the protection function of the
system may be damaged, resulting in personal injury or damage to the instrument.

• Prevention from Electric Shock


Unauthorized maintenance personnel shall not open the instrument when the power is on.
If liquid enters inside the instrument or leakage occurs in the instrument, please turn off the instrument
immediately and contact the after-sale service department of HIGH TECHNOLOGY INC. or the local
agency. Improper use of liquid may cause a risk of electric shock and damage to the instrument.

• Protection from Biochemistry Hazard


Improper use of the sample will lead to the risk of infection.
Do not touch the sample, reagent or waste liquid with bare hands. Be sure to wear gloves during the
operation to protect against infection.
If the skin is exposed to the sample, remedial actions should be taken immediately in accordance with the
user's standard or by consulting the doctor.
Be careful when using the reagent, preventing bare hands or cloth contacting the reagent directly.
If hands or cloth is exposed to the reagent, rinse with soap and water immediately.
If the reagent gets into eyes, immediately rinse with plenty of water and consult a doctor to take further
treatment.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

• Waste Liquid Disposal


Some of the substances in the reagent, quality control serum and sample are subjected to the control of the
pollution regulations and emission standards. Please abide by local emission regulations and consult the
reagent manufacturer.

• Fire and Explosion Prevention


Do not use flammable dangerous materials around the instrument.

Safety Notes
To operate the instrument safely and reliably, it is important to abide by the following notes.

• Application Range
Pay attention to the declared application range of this instrument, and do not use it out of the application
range.

• Operating Environment Restrictions


The instrument must be installed in the installation environment and conditions specified in this manual.
Installing or operating the instrument exceeding the specified conditions may lead to unreliable results and
may cause damage to the instrument.
If you need to change the instrument state, please contact the after-sale service department of HIGH
TECHNOLOGY INC. or the local agency.

• Requirements on Operator
This instrument is to be operated by persons who have been trained and authorized by the manufacturer only.

• Operating and Maintenance


The components or parts shall only be supplied by the manufacturer and replaced by or under the guidance
of the manufacturers engineers.
Operating and maintenance procedure shall be in strict accordance with the requirements of the manual.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc. Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

MANUAL DE OPERADOR: BioChem SA

CONTENT
1.0 SOBRE VISTA ................................................................................................................ 1
1.1 Propiedades del producto, Estructura Principal y Rango de Aplicacion ............................... 1
1.2 Principio de Medida .............................................................................................................. 1
1.3 Sistepa Optico Colorimetrico del Instrumento ...................................................................... 2
1.4 Medio ambiente de Operacion y condiciones de trabajo ...................................................... 2
1.5 Transporte y condiciones de almacenaje ............................................................................. 3
1.6 Pricipales Indicadores Tecnicos del Instrumento ........................................................................ 3
1.7 Tamañ o y Peso................................................................................................................... 3
2.0 INTRODUCCIÓ N AL INSTRUMENTO ............................................................................ 4
2.1 Vista Frontal
............................................................................................................................ 4
2.2 Vista Trasera ....................................................................................................................... 5
3.0 INSTALACIÓ N DEL INSTRUMENTO ............................................................................. 6
3.1 Preparacón antes de la instalación |........................................................................................... 6
3.2 Instalación del Instrumento ................................................................................................... 7
4.0 OPERACION ................................................................................................................. 14
4.1 Menu Principal ................................................................................................................... 14
4.2 Pruebas ............................................
..................................................................................... 15
4.3 Reporte de Muestras ......................................................................................................... 19
4.3.1 Reporte de mustras de hoy ............................ ............................................................................. 19
4.3.2 Reporte de Pruebas de hoy ......................................................................................................... 20
4.3.3 Informa de entrada Manual ........................................................................................................ 21
4.3.4 Busqueda de Reporte de Historial ................................................................................................. 22
4.3.5 Nombre del Hospital .................................................................................................................... 23
4.3.6 Ingreso de Información de Paciente ............................................................................................. 23
4.3.7 Nombre del Instrumento ............................................................................................................. 23
4.3.8 Eliminar Resultado ......................................................................................................................... 24
4.4 Prueba de Celda de Flujo ................................................................................................... 25
4.5 Prueba de Cubeta .............................................................................................................. 27
4.6 QC...................................................................................................................................... 27
4.6.1 QC Ajustes de Parametros............................................................................................................. 28
4.6.2 Busqueda de Reporte de QC .................. ......................................................................................... 29
4.6.3 Eliminar Reporte de QC................................................................................................................. 30
4.7 Austes de Sistema ............................................................................................................. 31
4.7.1 Ajustes de Tiempo ....................................................................................................................... 31
4.7.2 Ajustes de Impresora ................................................................................................................... 32
4.7.3 Ajustes de Temperatura ............................ .................................................................................. 32
4.7.4 Ajustes de Stand By ..................................................................................................................... 33
4.7.5 Modo Depurar .............................................................................................................................. 34
4.7.6 Volumen de la Bomba .................................................................................................................. 35
4.7.7 Reestaurar Valores ........................... ........................................................................................... 35
4.7.8 Escaneo de Tarjeta ...................................................................................................................... 36

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24
Manual de Operador BioChem SA Plus

4.8 Otros Servicios....................................................................................................................37


4.8.1 Seteo de Blanko ............................................................................................................................ 37
4.8.2 Lavado ......................................................................................................................................... 38
4.8.3 Prueba de Absorvancia ................................................................................................................ 39
4.8.4 Corriente Oscura .......................................................................................................................... 40
4.8.5 Envío de Información ................................................................................................................... 40
4.9 Apagado ............................................................................................................................41
4.10 Contador de Pruebas ..........................................................................................................41
5.0 USO DIARIO................................................................................................................... 42
6.0 MANTENIMEINTO Y SOLUCIÓ N DE PROBLEMAS .................................................... 43
6.1 Pantalla Táctil ...................................................................................................................43
6.2 Diario....................................................................................................................................43
6.3 Semanal .............................................................................................................................43
6.4 10,000 Pruebas ..................................................................................................................43
6.5 Como necesite ....................................................................................................................43
6.6 Otros| ...................................................................................................................................43
6.7 Solución de Problema ........................................................................................................44

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

1.0 Overview
1.1 Product Properties, Main Structure and Application Range
Para satisfacer las demandas de compra, actualizar los instrumentos de examen clínico de muchas
instituciones mé dicas y luego de añ os de investigació n, desarrollo y pruebas clínicas, el analizador
bioquímico semiautomá tico BioChem SA ha sido fabricado con un rendimiento estable y funciones
versá tiles. Posee las siguientes propiedades:

• Los mé todos analíticos del analizador incluyen el mé todo diná mico, el mé todo de punto final, el
mé todo de dos puntos, etc.

• Los mé todos de calibración incluyen la calibración de un punto y la calibració n de mú ltiples puntos, etc .;

• Rango de longitud de onda de 340 nm ~ 630 nm;

• Almacenamiento de datos y funciones de salida.

Estructura principal del instrumento.


Consta de un sistema de control de circuito de microprocesador, sistema colorimé trico ó ptico,
impresora, pantalla táctil LCD, etc.

Rango de aplicació n del producto.


El analizador adopta el principio de medició n de Ley de Lambert - Beer para realizar aná lisis
cuantitativos de elementos bioquímicos que incluyen suero humano, plasma sanguí neo, lí quido
cefalorraquí deo, etc.

1.2 Principio de Medició n


El analizador bioquímico semiautomático se utiliza principalmente para el análisis cuantitativo
de productos de bioquímica clínica. El principio de medición es la Ley de Lambert-Beer:

𝑨 = 𝑲𝒃𝒄 = 𝐥 𝐠(𝑰𝑶/𝑰)
En dónde:
A: absorbancia
K: absortividad
b: espesor de la capa líquida
c: concentracion de solucion
I0: intensidad de luz incidente
I: intensidad de luz transmitida

De acuerdo con la fó rmula anterior, bajo cierto espesor de capa lí quida e intensidad de luz
incidente, si se mide la intensidad de luz transmitida, se puede calcular la concentració n
C de la solució n.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 1 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

1.3 Sistema colorimé trico ó ptico del instrumento.


Basado en el principio de medición anterior, el analizador bioquímico bioquímico de BioChem SA
adopta un filtro óptico desarrollado y producido con tecnología especial, que posee características
de alta resistencia a la humedad, resistencia a altas temperaturas, larga vida útil, pequeña derivación
de longitud de onda central y alta señal translúcida. relación ruido-ruido. Como las longitudes de onda
son idénticas en toda el área del filtro, la selección de la longitud de onda de la luz monocromática es
más precisa. Un pequeño error mecánico no conducirá a un error de selección de longitud de onda, lo
que garantiza un funcionamiento confiable. El dibujo esquemático del sistema colorimétrico óptico del
analizador bioquímico semiautomático BioChem SA es el siguiente:

Como un instrumento de DIV, la precisió n y la precisió n de HTI BiochemSA son fundamentales


para informar resultados confiables. Es importante verificar la precisión y la precisió n perió dicamente
para verificar que el instrumento funciona correctamente. Las pruebas de precisió n y precisió n deben
realizarse mensualmente o despué s de cualquier mantenimiento en el fotó metro, lá mpara o ví a de
reactivos. El analizador le requerirá que realice una verificació n de absorbancia y precisió n cada
10,000 pruebas. Esto debe hacerse con el kit de precisió n HTI BioChem-Check® , siguiendo las instrucciones
en la sección 6 en la pá gina 43. Puede pedir el kit de precisión BioChem-Check® de HTI usando el número
de pieza BC-3000-035.

Recomendamos encarecidamente tener al menos un Kit de precisió n HIT Accu-Chek®


disponible en su laboratorio en todo momento.

1.4 Entorno operativo y condiciones de trabajo

Temperatura ambiente: 10 ° C ~ 30 ° C
Humedad relativa: = 70%
Presión atmosférica: 86 ~ 106Kpa
Fuente de alimentación: 100 ~ 240VAC; 50 / 60Hz
Manténgalo alejado de fuentes de interferencias electromagnéticas fuertes.
Evite la exposición directa a la luz brillante.
Circuito electrico a tierra

Page 2 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

1.5 Condiciones de transporte y almacenamiento:


El analizador debe transportarse en el embalaje de acuerdo con los requisitos del contrato de pedido.

El instrumento empaquetado debe almacenarse en el interior donde esté libre de gas corrosivo, bien
ventilado y donde la temperatura ambiente esté entre -20 ° C y 55 ° C con una humedad relativa de = 70%.

1.6 Principales Indicadores Té cnicos del Instrumento:


Métodos de prueba: método dinámico, método de punto final, método de dos puntos
Rango de longitud de onda: 340nm ~ 630nm
Precisión de longitud de onda: ± 2 nm
Piscina colorimétrica: piscina colorimétrica de flujo 32µL, trayectoria de luz: 10 mm
Muestra de volumen de succión: 0 ~ 3000µL, ajustable
Fuente de luz: lámpara halógena de larga vida útil
Rango de absorbancia: 0.0 ~ 3.500 Abs; Precisión de absorbancia: 0,001Abs externos, 0,0001Abs internos
Control de temperatura: 37 ° C
Contaminación cruzada: = 1%
Impresión: impresora térmica
Pantalla: pantalla LCD gráfica
Modo de funcionamiento: pantalla táctil
Interfaz: interfaz estándar RS-232
Fuente de alimentación: 100 ~ 240VAC; 50 / 60Hz
Potencia: 120VA
Tiempo medio entre fallas: 13,000 horas.

1.7 Tamañ o y Peso


Dimensión del contorno: 495 mm (L) * 330 mm (W) * 150 mm (H)
Peso: alrededor de 5 Kg.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 3 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

2.0 Introducciín al Instrumento


2.1 Vista Frontal

3
1

1 : Bloque Termico
2 : Cronometro
3 : Impresora
4 : Pantalla Tactil
5 : Tubo de aspiracion
6 : Boton de aspiacion
7 : Escaneo de Tarjeta

Page 4 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

2.2 Vista Trasera

1 2 3 4 5

1 : Boton encendido
2 : RS-232 Conector
3 : AC Conector
4 : Coneccion a tierra
5 : Coneccion Desperdicios

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 5 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

3.0 Instalació n del Instrumento


3.1 Preparació n Previa a la Instalació n
Cable a tierra
El analizador bioquímico semiautomático BioChem SA es un instrumento electrónico de precisión.
Inspeccione el laboratorio para verificar si hay cables de tierra dedicados para instrumentos médicos.
La resistencia de tierra requerida es menor que 0.1 O; o designe a un electricista profesional para
que instale el cable de conexión a tierra.

Estabilizador de voltaje
El voltaje de la fuente de alimentación inestable tiene un efecto negativo en el instrumento. Se recomienda
comprar un estabilizador de alta calidad cuya potencia sea superior a 500 W antes de la instalación y
conecte su terminal de tierra de voltaje a tierra.

• ADVERTENCIA: este instrumento no se puede colocar en la misma habitació n ni usar


la misma toma de corriente elé ctrica con otros equipos de alta potencia o de gran
perturbación, como centrifugadoras, refrigeradores y / o incubadoras, etc.

• ATENCIÓ N: Mantenga el instrumento alejado de ventiladores, aire acondicionado, etc.,


para no afectar la precisió n del control de temperatura. Evite las vibraciones durante
el proceso de prueba. Evite la luz solar directa y las condiciones de trabajo polvorientas.

Page 6 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

3.2 Instalación del Instrumento


Abra la caja de empaque y verifique cuidadosamente que el instrumento y los accesorios
en la caja de empaque cumplan con la "Lista de empaque del analizador bioquímico
semiautomático de BioChem SA" y si la apariencia está intacta. Si falta algún componente
o está dañado, póngase en contacto con el proveedor. Si el inventario es correcto, saque
el instrumento con cuidado y colóquelo en una mesa de trabajo estable y suave, evitando
sacudidas fuertes. Conecte el cable de tierra del instrumento médico a la columna de tierra
dedicada en el panel posterior de BioChem SA.

Conecte el tubo de desechos al conector de desechos en el panel posterior de BioChem SA.


Coloque el otro extremo del tubo en una botella de líquido de desecho.Prepare el agua destilada
en un vaso de precipitados u otro tipo de recipiente. Saque el dispositivo de suministro de energía
del instrumento, conecte el extremo redondo pequeño al concentrador de alimentación en el lado
inferior derecho del panel posterior de BioChem SA y conecte el otro extremo a una toma de tierra.
Coloque el tubo de la bomba peristáltica en la posición de trabajo de la bomba, como se muestra
en la siguiente imagen:

Asegú rese de que la dirección del tubo sea correcta: la bomba debe empujar el lí quido en los
tubos desde la unidad de medició n hasta el desecho.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 7 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

Encienda el interruptor de alimentación en el lado derecho del panel trasero. El sistema mostrará
la pantalla de bienvenida de la siguiente manera:

Luego entrará en la pantalla de precalentamiento automá ticamente.

Para la primera operació n del instrumento, es necesario esperar 10 minutos hasta que se haya
completado el precalentamiento antes de que se realicen má s operaciones.

El usuario puede presionar el botó n " Cancelar " para ingresar a la pantalla principal o esperar hasta
que se complete el precalentamiento y el instrumento ingrese automá ticamente a la pantalla principal.
Entonces el usuario puede iniciar la operació n diaria.

El Sistema Está Precalentando

Page 8 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

Luego de que aparezca la pantalla del Menú principal, presione "Otros servicios" para ingresar al menú Otros servicios.

En primer lugar, presione el botó n " Corriente oscura", el sistema apagará automá ticamente la lá mpara
y empesará a probar la corriente oscura. La corriente oscura normal de todas las longitudes de onda
debe estar entre 10 a 50; Como se muestra abajo:

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 9 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

Si los valores están dentro del rango, presione " Guardar " para guardar los valores, luego presione
" Volver " para volver al menú Otras configuraciones.

En el caso de que algunos de los valores de AD estén fuera del rango (10-50), comuníquese
con su proveedor.

En segundo lugar, presione el botón " Configuració n en blanco". El sistema le pedirá que aspire
agua destilada. Por favor, aspirar el agua destilada.

Please aspirate distilled water

Page 10 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

Una vez completado, el sistema comenzará a probar y mostrará los valores de AD para cada una de
las longitudes de onda. Los valores normales de AD para cada una de las longitudes de onda deben
estar dentro de los rangos de 18000 a 29000.

Si los valores de AD están dentro del rango, presione " Guardar " para guardar los valores, luego
presione "Volver" para volver al menú Otras configuraciones.

En el caso de que algunos de los valores de AD estén fuera del rango (18000-29000); se necesita
un ajuste del potenció metro, consulte la secció n 4.7.5 (" Modo de depuració n ") para localizar el
procedimiento.

En tercer lugar, presione el botó n " Prueba de absorbancia" ; El sistema le pedirá que aspire una muestra.
Por favor, aspirar una muestra (por ejemplo, agua destilada). Despué s de eso, el sistema comenzará a
probar y mostrará la absorbancia, los valores de AD y la curva de absorbancia de una longitud de onda.
Observe durante 5 minutos para ver si la curva se vuelve plana. Si la curva sigue sin ser plana despué s
de cinco minutos, presione el cuadro de entrada " Seleccionar WL ". Seleccione la longitud de onda deseada
y presione la tecla " Confirmar ", el sistema probará la estabilidad de absorbancia durante cinco minutos
nuevamente.

Please aspirate sample.

Observe la curva de prueba de absorbancia que debe ser plana y cerca de la línea horizontal media.
HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 11 of 44
Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

Cuando el cambio de absorbancia es pequeñ o (menos de la altura de una celda), presione " Regresar "
y continú e con la siguiente operació n.

340

Presione el botón "Configuración del sistema" en el Menú principal para ingresar al menú Configuración
del sistema. Luego presione el botón "Temperatura" para ingresar al menú de Configuración de temperatura.
Los cambios de temperatura dentro de 37 ± 0.5 ° C, esto significa que el sistema de control de temperatura
del instrumento está funcionando correctamente.

Page 12 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

Despué s de completar los pasos de aceptació n enumerados anteriormente, y todos los datos cumplen
con los requisitos, se puede determinar que el instrumento y su mé todo de instalació n está n calificados.

Antes de ejecutar las pruebas, es necesario activar una tarjeta de prueba. Consulte la secció n 4.7.8
para localizar este procedimiento.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 13 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

4.0 Operació n
Antes de probar cualquier muestra, el programa de prueba debe configurarse de acuerdo con cada
parámetro de reactivo. Después de completar la configuración, ingrese el programa de prueba para
probar el programa correspondiente.
4.1 Menu Principal
La estructura del menú de BioChem SA es que los submenús están integrados en el menú principal.
Los contenidos del menú principal son los siguientes:

1. Prueba de programa
Test counter: 100
2. Informe de muestra

3. Prueba de celda de flujo

4. Prueba de cubeta

5. Control de calidad

6. Configuración del sistema

7. Otros servicios

8. Apagar

9. Prueba de contador

El operador puede usar el lá piz para presionar el botón en la pantalla del menú principal para completar
las operaciones correspondientes.

Los detalles son los siguientes:


1. Toque el botó n de funció n correspondiente con el lá piz para ingresar a diferentes pantallas de funciones.

2. De acuerdo con las sugerencias de funciones, toque los diferentes botones de funció n con el lá piz
para completar la operació n de la funció n correspondiente.

3. Los espacios en blanco se pueden seleccionar durante las operaciones. Pueden ser
modificados o utilizados para la entrada. Estos tipos de cuadros se pueden dividir en dos categorí as:
uno es el cuadro de elecció n y el otro es el cuadro de entrada. Para el cuadro de selecció n, toque
con el lá piz ó ptico una vez, y cambiará la opció n por una vez. Para ingresar nú meros o caracteres,
presione el cuadro de entrada y el cursor comenzará a parpadear, y luego presione el botó n
correspondiente en el teclado para ingresar.

Page 14 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

4.2 Pruebas
Se han preestablecido 32 pruebas en el instrumento con 48 pruebas adicionales definidas por el usuario
que se pueden agregar; Para un total de 80 pruebas disponibles. Las 32 pruebas preestablecidas está n
diseñ adas para usarse con reactivos fabricados por HTI. Los usuarios pueden especificar abreviaturas
en Español para las pruebas definidas por el usuario. Seleccione " Prueba de programa" en la pantalla del
menú principal para ingresar a la pantalla de selección de prueba. Como se muestra abajo:

E n la p antalla d e selecció n d e p rueb a, cad a b otó n muestra la ab rev iatura en E sp añ ol d e la p rueb a


seleccionad a. Cuand o selecciona una p rueb a, la p arte sup erior d e la p antalla mostrará el nomb re
en E sp añ ol corresp ond iente. Presione " Conf irmar " el sistema ing resará al mod o d e p rog ramació n
p ara la p rueb a seleccionad a, como se muestra a continuació n:

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 15 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

Test Name
When entering this screen, the “Test Name” input box will display the initial English abbreviation
of the test. If the user wants to modify the initial English abbreviation, press the ‘Test Name’ input
box, and the keyboard screen will pop up. In the keyboard screen, the user can input all the
numbers and characters in the keyboard and can shift case of the input letters by pressing the
‘Caps Lock’ button. In case of input error, press the ‘←’ button to delete it. As shown below:

Test Method
Optional methods include “End-Point”, “Two-points”, “Kinetic” and “Absorbance”. Repeatedly
touch the white box behind the “Test Method” to select the corresponding analytical method.
Each touch will change the analytical method once.

Prime WL
There are 7 optional wavelengths including 340nm, 405nm, 492nm, 510nm, 546nm, 578nm and
630nm. Repeatedly touch the white box next to “Prime WL” to select the corresponding
wavelength. Each touch will change it once.

Second WL
There are 8 optional wavelengths including 340nm, 405nm, 492nm, 510nm, 546nm, 578nm,
630nm and Without. The ‘Without’ option means that no wavelength is selected. If the analytical
method is “Kinetic” or “Two-points”, the second wavelength automatically becomes ‘Without’,
meaning that these two test methods cannot conduct dual wavelength test on the instrument.

Dilute Ratio
It’s equal 1 as default, there is no need to change this for routine testing.

Temperature
Set the test temperature by inputting the corresponding temperature through the soft keyboard on
the right of the screen. The temperature is generally 37 °C.

Page 16 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

Sample Volume
Sets the sample absorption volume of the test. The unit is ‘μL’. The pump volume has been calibrated
when leaving the factory, and the users only need to input the corresponding sample absorption volume.
Independent pump volume can be set for each project. The system will absorb samples according to the
corresponding pump volumes during the test.

Unit
Sets the units for the test results. According to different units, the system will convert to the set units
before display. Each touch will change it once. After these settings are completed, press the “Page
Down” to set other the parameters. As shown below:

Decimal Point
Set the decimal places of the test results by inputting the corresponding decimal places by using the soft
keyboard on the right of the screen.

Blank
There are three options including “Reagent Blank”, “Sample Blank” and “Without”. Specify and set the type
of blank used in the test. The default type is “Reagent Blank”. Each touch will change it once.

Factor
The test factors are generally known refer to reagent insert sheet. Input the factor by using the soft
keyboard on the right of the screen.

For tests with unknown factors, the instrument can automatically calculate the factor by test blank and
standard, with no need to input manually.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 17 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

Delay Time
Sets the delay time. Different tests require different delay times. The delay times of each method
have been given in the reagent insert sheet, and the delay time of the end-point method is
generally not less than 5 seconds.

Test Time
Sets the test time. Different tests require different test times. The test time of each method have
been given in the reagent insert sheet, and the test time of the end-point method is generally not
less than 5 seconds.

Reference Range
Sets the reference range of the test results. The latter value must be greater than the former
value.

Linearity Range
Sets the linearity range of the reagent. This information can be found in documentation for
reagent set. The latter value must be greater than the former value.
After these settings are completed, press “Page Down” to set other test parameters.

If the test requires calibration, specify the quantity of standard concentration and input the values
of the standard concentration on this screen. Touch the white box behind the ‘Standard Quantity’
to change the standard quantity. Once the standard quantity is specified, the corresponding
quantity of standard concentration can be input in the following standard concentration box.

For example: The standard quantity is specified to ‘1’, the operator can input the standard
concentration value in the ‘Standard 1 Conc.:’, and the ‘Standard 2 Conc.:’ ~ ‘Standard 6 Conc.:’
will become gray to disable input.

• NOTE: During Test Programming, use the “Page Up” and “Page Down” buttons to
switch between pages, and use the “Cancel” button to exit setting. But these
operations will not save any previous setting operations. The previous settings can
only be saved by press the “Save” button on the third page.

Page 18 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

4.3 Sample Report


From the Main Menu screen, press the “Sample Report” button to switch to the Sample Report
screen. In this screen the following functions can be achieved:

1. Sample Report for


Today
2. Project Report for
Today

3. Manual Input Report

4. History Report

5. Hospital Name

6. Sample Info Input

7. Instrument Name

8. Delete Results

4.3.1 Sample Report for Today


In the Sample Report menu, select “Sample Report for Today”. Input the first and last
sample number, press the “Show” to show all the sample test results of today.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 19 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

This function can achieve the search of a sample number of today. Press “Print All” to
print all results, press “Select” next to each result and press the “Print Select” button to
print selected results.

4.3.2 Test Report for Today


In the Sample Report menu, select “Test Report for Today”. Then select a project in the
project selection screen and press “Confirm” to enter the “Test Report of Today” screen,
as shown below:

Page 20 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

Input the first and last sample number, press the ‘Show’ button to show all the sample
test results for today. This function can achieve the search of a sample of a particular test
for today. If needing to print, press the ‘Print’ button after outputting the search results to
print all the test results of the project of today. As shown below:

4.3.3 Manual Input Report


In the Sample Report screen, select the “Manual Input Report” to manually input the test
report.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 21 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

4.3.4 History Report Search


In Sample Report screen, select the “History Report Search” to search the test results
of a specific day. Input the date, the first and last sample number, and then press ‘Show’.

Press “Print All” if it’s needed to print all found results, press “Select” to select specific
results and press the “Print Select” button to print selected results. As shown below:

Due to the limited storage space of the instrument, it can only store 10000 history
records. Only when the number of records from the searched history date till the
searching day is less than 10000, can the report be searched.

Page 22 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

4.3.5 Hospital Name


For printing the report with the hospital name at the header, please input the
corresponding hospital name in this function screen. The hospital name should be no
longer than 18 characters.

4.3.6 Patient Information Input


In the Sample Report screen, select the “Patient Information Input” to input the patient
information. The information will be printed on the report after the test is completed.

4.3.7 Instrument Name


For printing the report with the instrument name at the header, please input the
corresponding instrument name in this function screen. For example, you can input
“BioChem SA”.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 23 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

4.3.8 Delete Result


In the Sample Report screen, select “Delete Result” to delete a test result.

Page 24 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

4.4 Flow-cell Test


This is the basic menu which is used for running samples, QC, standards etc., with the flow-cell
cuvette.

Under the Main Menu screen, press the “Flow-cell Test” button, the system enters the test
selection screen. Select the test and then press “Confirm” to enter the specific test submenu.

The test parameter information is displayed on the top-left of the test screen, where the Sample
No. is there will be a white input box, the user can modify the Sample No. in the input box. If not
modified, the Sample No. will automatically increase by one in order, as shown below:

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 25 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

Screen for modifying the Sample No. is as follows:

For the first test sample, blank setting is required. Touch the “Blank” button, the system will
prompt “Aspirate distilled water” for the zero setting. After the blank setting is completed, if the
test needs to test the blank value, the system will prompt “Aspirate blank solution” for the test.

To conduct QC test, please press the “QC” button. The system will prompt “Aspirate QC solution”
for the QC test.

To conduct standard solution test, press the “Standard” button. The system will prompt “Aspirate
standard solution” for the calibration test.

1. To conduct sample test, please press the “Test” button. The system will prompt “Aspirate
sample” for the sample test.
2. To clean the system before or after the test, please press the “Wash” button. The system will
prompt “Aspirate cleaning solution” to clean the liquid circuit.
3. To exit the test, please press the “Return” button.

Result Report
The instrument uses three modes to print the result report, as described below:

1. Automatic Print
If “Real-time Print: On” is set in the System Settings, the test result will be printed automatically
after each sample test.
2. Manual Print in the Test Menu
If “Real-time Print: Off” and it’s needed to print the result, or the “Real-time Print: On” and you
want to print the result one more time, press “Print” button at the lower right corner, and the last
result will be printed.
3. Manual Print from “Sample Report”
Enter the Sample Report in the main screen to print the patient report according to point 4.3 of
present Manual.

Page 26 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

• NOTE: Due to the limited storage space of the instrument system, the
instrument can only store 10,000 test records. The length of the retroactive date
depends on the frequency of use. To review greater storage capacity,
considering connecting to the computer. The instrument will automatically
transmit the test results to the computer software. The storage, calling and
searching of the database are done by the computer.

4.5 Cuvette Test


This menu is used in case of you use disposable consumables – special plastic cuvettes which
should be installed into measuring unit instead of the flow-cell cuvette.

Testing with plastic cuvette procedure:


1. Add reaction solution into the cuvettes (not vials) according specific procedure for a reagent.
2. Insert needed cuvette into measuring unit before measuring.
3. Push aspiration button to start testing.

All the rest operations for running tests proceed at the same way as for flow-cell test (section 4.4).

4.6 QC
Press the “QC” button in the Main Menu screen to enter the QC menu. The QC menu contains
the following 3 functions:

As shown below:

1. QC
Parameter
Settings

2. Search QC
Report

3. Delete QC
Report

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 27 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

4.6.1 QC Parameter Settings


To carry out the QC measurement correctly, you must set the QC parameters first.
Press the “QC Parameter Settings” button. The system will enter the Item Selection'
screen. Select the items that you want to modify in this screen, and then press the
“Confirm” button. The system will switch to the QC Parameter Setting screen.

In this screen, Batch Number represents the batch number of the QC solution. Target
Value is the nominal value on the QC solution instructions. SD is the reference range of
the QC solution measurement.

After the completion of setting the parameters, the results of these settings will be used in
association with the QC test introduced in Section 4.4.

Page 28 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

4.6.2 Search QC Report


As shown below, input the time and QC batch number you want to search in the screen,
and then you can get the QC report results.

If you need to print the QC report, press the 'Print' button.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 29 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

4.6.3 Delete QC Report


Input time and QC batch number, you want to search in the screen, and then press the
“Delete” button to delete it.

Page 30 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

4.7 System Settings


Press the “System Settings” button on the Main Menu screen to access the System settings
menu. The System settings menu contains the following 8 functions:

As shown below:

1. Time settings

2. Printer Settings

3. Temperature Settings

4. Standby Settgins

5. Debug Mode

6. Pump Volume

7. Restore Defaults

8. Scan Card

4.7.1 Time Settings


This function is used to set the system date and time. Refer to the system prompt for the
specific operations.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 31 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

4.7.2 Printer Settings


After entering the printer setting screen, enable/disable the Real-time Print function by
selecting whether the printer is turned on. After pressing on the “Paper” button, you can
conduct the printer test.

4.7.3 Temperature Settings


This function is used to observe the current system temperature and reset the target
temperature.

Page 32 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

4.7.4 Standby Settings


Enabling this function can extend the working life of the light source lamp inside the
instrument. After entering the setting screen, the user can select from five options,
“Without”, “30 minutes”, “60 minutes”, “90 minutes” and “120 minutes”. When you choose
“Without”, this function is disabled. When you choose “30 minutes”, the instrument will
turn off the inside light source automatically and turn into sleep state after no operation
for 30 minutes. Other options are similar. When the system is in sleep state, the user can
touch any part of the screen to wake it up.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 33 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

4.7.5 Debug Mode


This function is necessary for adjusting potentiometer. To enter the adjusting interface,
please input the password “232323”.

The system will prompt to aspirate distilled water. Please aspirate distilled water. The
system will switch to the Potentiometer Setting screen.

There will be numbers from 0 to 6 in the left column “Select Value”. Press on the number
for wavelength that you need to adjust and input the value (from 0 to 6), then press
“Confirm”. The AD value in according box in right column AD Value will appear.

The all AD Values should be within the range of 18000-29000. If the AD Value is below
the range, you need to increase value in left column and press “Confirm”, the AD value
will be updated. If the AD Value is above the range, you need to decrease value in left
column and press “Confirm”, the AD value will be updated. After all the AD Values are
within the range, press “Confirm” and then “Return”.

It’s necessary to do perform the operation Blank Setting (please refer section 4.8.1) after
finishing this procedure and before running samples.
Page 34 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL
Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

4.7.6 Pump Volume


Instruments have all been strictly calibrated before leaving the factory, but during long-
term use, the aging of some of the parts in the instrument liquid circuit can result in
inaccurate liquid volumes. The user can perform this function to calibrate the liquid
volume. After entering the pump volume calibration screen, you can input different
calibration factors from 0.5 to 1.5. When you want a comparatively smaller pump volume,
the input value is less than 1; otherwise, the input value is greater than 1.

4.7.7 Restore Defaults


This function is used to restore any parameter of the system to the factory defaults. When
executing this function, the system will prompt the user to wait. After completing
restoration, the system prompts 'Restart'. Then you must restart the instrument to
complete the restoration successfully.

The function is only available to the factory or the maintenance personnel. You can enter
this function only after inputting the correct password.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 35 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

4.7.8 Scan Card


This function is used to activate test cards and update “Test counter” number.

Place the card near special area and press “Scan Reagent Card”. If the card is correct,
the number will be updated (increased by the number of tests on the card). In other
cases, there will be system messages.

Please take it into account that a test card can be activated only once. After the card is
activated on any analyzer, it can’t be used anymore.

If the system can’t pass a correct test card, please contact your supplier.

Page 36 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

4.8 Other Services


Press the “Other Services” button on the Main Menu screen to enter the Other Services menu.
The Other Services menu contains the following five functions:

1. Blank Setting

2. Wash

3. Absorbance Test

4. Dark Current

5. Send Data

4.8.1 Blank Setting


This function is mainly used for blank setting operation for all 7 options of wavelength,
and it should be used daily before running tests.

Before blank setting, aspirate distilled water in accordance with the system prompts.

Please aspirate distilled water

After that, the system will start testing and show the AD values for each of the
wavelength. The normal AD values for each of the wavelengths should be within the
range from 18000 to 29000.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 37 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

If the AD values are within the range, press “Save” to save the values, then press
“Return” to go back to the Other Settings menu.

In the case that some of AD values are out of range (18000-29000) an adjustment of the
potentiometer is needed, please refer to section 4.7.5 (“Debug Mode”) to find the
procedure.

4.8.2 Wash
Press the “Wash” button, and the system will complete the cleaning of liquid circuit.

Please Aspirate Cleaning Solution

Page 38 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

4.8.3 Absorbance Test


This function is used to check the stability of absorbance measuring.

Press the button “Absorbance Test”. The system will prompt to aspirate sample.
Aspirate a sample (for example, distilled water, sample or reagent). After that, the system
will start testing and display the measured values of absorbance, absorbance difference
and AD value at the bottom in real-time. It will show the curve of measured absorbance
change in this screen in real-time to observe the absorbance stability. Observe for 5
minutes to see if the curve becomes flat.

When entering the Absorbance Test the initial wavelength is 340nm. The user can press
the wavelength the “Select WL” input box to modify it. When the required wavelength is
shown in the box, press the “Confirm” button to select the wavelength, and the system
will test the absorbance stability for five minutes again.

Please aspirate sample.

Observe the absorbance test curve which should be flat and near the middle horizontal
line. When the absorbance change is small (less than the height of one cell), press
“Return” and proceed to the next operation. If you want to replace the test liquid, press
the “Aspirate” button and follow the prompts of the system.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 39 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

4.8.4 Dark Current


Press the “Dark Current” button in Other Services menu, the system will automatically
turn off the light and start testing the dark current. The normal dark currents of all the
wavelengths should be between 10 to 50.

If the values are within the range, press “Save” to save the values, then press “Return” to
get back to the Other Settings menu.

In the case that some of the AD values are out of range (10-50), please contact your
supplier.

4.8.5 Send Data


When pressing the “Send Data” button, the system sends a packet of data via COM-port
to check the connection with host PC software. The connection is good, if the PC
software will receive the data.

Page 40 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

4.9 Power Off


The user should use this function daily before turning off the instrument. It’s necessary to wash
liquid circle to leave it clean while instrument is not used.

Press “Power off” on the Main Menu, system will prompt you to aspirate the water.

Please aspirate water to wash first

Aspirate the water and follow the system messages. After washing the system will prompt to turn
the instrument off.

4.10 Test Counter


Test counter is displayed on the Main Menu. The counter’s value is the number of tests available
on the instrument. It’s equal 0 as default. The user needs to activate a test card to be able to run
tests. Please refer to section 4.7.8 to find the procedure.

When the number of the counter is less than 10, the system warns about that the quantity of test
are low in the Test Menu before testing. When the number of the counter is 0, the system does
not allow to run tests and asks to activate new test card.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 41 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

5.0 Daily Use


Brief Operation Instructions of Daily Use

Preparation and Inspection Before Use

Before starting up the instrument, you should inspect whether the power plug and outlet is
connected firmly, whether the instrument is placed levelly, whether surface of the instrument is
clean and undamaged. After the inspection, turn on the power switch at the back of the
instrument.

Daily Use

1. After the system is just turned on, the user will see System Preheating screen.
User can wait for 10 minutes, after which, it automatically goes to the Main Menu screen.
If user wants to do some operations not related with measuring (program parameters, search
reports etc.), they can skip the preheating by pressing “Cancel” and follow to the Main Menu
(Even in this case, system needs to be preheated for 10 minutes minimum before any
measuring actions, including “Blank setting”).

Note: The preheating time should be extended when the room temperature is very low.

2. After startup, wash the system liquid circuit (section 4.8.2).

3. Follow to Other Services and perform the Blank Setting operation (section 4.8.1).

After performing these steps, the system is ready for running tests.

Measurement of the Sample

Measure the sample according to the method in this Manual.


Please refer to section 4.4 if you use flow-cell cuvette.
Please refer to section 4.5 if you use disposable plastic cuvette
Print the Patient Results

• NOTE: Do not turn off the power switch suddenly in the measurement process.

Shutdown
After the completion of these operations, press the “Power Off” button in Main Menu and follow
the prompts (section 4.9). Turn off the power switch after washing.

Page 42 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA

6.0 Maintenance and Troubleshooting


For precautions and maintenance, to make sure the instrument has reliable operation and accurate
results, please conform to the following precautions.

6.1 Touch Screen


When you are operating this instrument's touch screen, you need to use the stylus. When
touching the touch screen, use moderate force. Do not use excessive force. During the touching
process, sometimes due to improper operation, it may appear fail of single touch. Please try to
repeat the operation.

6.2 Daily
Every day, after starting up the system, wash liquid tubes by doing the operation “Wash” in the
“Other Services” menu.

Clean the probe tube with lint-free cloth after aspirating samples to avoid cross-contamination.
Wash the system before turning it off with by doing the operation “Turn Off” in Main Menu, or
perform the operation “Wash” in “Other Services” menu before turning the system off manually.

6.3 Weekly
Once a week clean the cuvette and tubing by performing the following procedure:

1. Enter “Wash” from “Other Services” menu.


2. Aspirate wash solution.
3. Keep the wash solution in the cuvette and tubing for 15 minutes.
4. Rinse the cuvette and tubing with distilled water at least 3 times.

This procedure can minimize the number of residual reagents or serum proteins inside the
cuvette and tubing, and particularly, on the inner wall of flow-cell cuvette.

6.4 10,000 Tests


Verification of absorbance and precision using HTI BioChem-Check® Precision Kit.
Follow instruction provided in the Kit.

6.5 As Needed
Wipe with a damp cloth when cleaning the instrument case. Detergent can also be used, except
organic solvents such as alcohol.

6.6 Other
If you find imprecision or other failures when using the instrument, you can directly contact our
service department for support. High Technology Inc. provides free repair service for instruments
within warranty period. As to instruments beyond the warranty period, both parties can negotiate
on the maintenance issues.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 43 of 44


Document Number OM-E-BC-30
Revision Level Rev.3
High Technology, Inc.
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 2018-08-24

Operator’s Manual: BioChem SA Plus

6.7 Troubleshooting
Common failures and troubleshooting are shown in the following table:

Failure
Cause Analysis Troubleshooting
Phenomenon
1. Fastening screws of pump head
is loose. Tighten the fastening
1. Sample suction pump doesn't screws.
work. 2. Cut off a small portion of the
Sample suction 2. Pump pipe is loose. pump pipe joints.
failure 3. Sample suction time is 0. 3. Reset the correct sample suction
4. Pump pipe is damaged time.
5. Pump pipe adhesion 4. Replace the pump pipe.
5. Remove the pump tube and open
the adhesion positions.
1. The power switch is not turned
1. Turn on the power switch
No screen on.
2. Reinsert the power plug
display 2. Power failure
3. Reinsert the display cable
3. Display signal line is loose
1. Either the printer power line or
1. Reconnect the power line or
communication line is loose.
communication line.
The printer 2. Out of paper
2. Replace the paper.
doesn't work 3. Paper is jammed.
3. Clean up the paper jam site.
4. Thermosensitive paper is
4. Reinstall the print paper.
reversed.
1. Certain wavelength is over the
Absorbance range, while the rest are normal:
test 1. Redetect with distilled water.
distilled water is not used.
long-time 2. Exhaust bubbles in the
2. All wavelengths are detected
instability colorimetric pool.
over the range.
3. Clean the colorimetric pool with
A. There're bubbles in the flow-
cleaning solution.
cell cuvette.
B. Flow-cell cuvette is dirty.
1. Retest absorbance during
1. No absorbance test at startup;
system maintenance;
2. Reagent failure;
2. Replace with effective reagent;
Unstable 3. Sample suction amount
3. Adjust sample suction amount ≥
measurement insufficient;
600 μL;
results 4. Without standard solution;
4. Retest with blank standard
5. The wavelength indicated on the
solution;
reagent manual is not applicable.
5. Test with another wavelength.

Page 44 of 44 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL

You might also like