Crst001 forte technical_service_manual_chapter_1_eng_rev1

Hospitex Diagnostics Technical Service Manual - Forte
Forte Rev. 1.0 - June 2013
Document Code N. SM0066.02.1
Technical Service Manual
Chapter 1
Introduction

Document Code N. SM0066.02.1
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Document Code N. SM0066.02.1 Chapter 1 - page [3 of 24 ]
Contents
1. Introduction............................................................................5
1.1 General Description ............................................................................5
1.2 Main Characteristics ...........................................................................6
1.3 Warranty .............................................................................................8
1.4 Installation.........................................................................................10
1.4.1 Unpacking ...........................................................................................................10
1.4.2 Installation...........................................................................................................11
1.4.3 Environmental Requirements..............................................................................11
1.4.4 Setting the Analyzer on a Level Plane ................................................................11
1.4.5 Operating Temperature Limits...........................................................................11
1.4.6 Power Requirements...........................................................................................11
1.5 Installation Procedure .......................................................................12
1.5.1 Connecting Peripheral Devices...........................................................................12
1.5.2 Hydraulic Connections ........................................................................................12
1.6 Analyzer Structure ............................................................................15
1.6.1 Prepper, Reaction and Measurement System ....................................................16
1.6.1.1 Sampling Arm..................................................................................................................16
1.6.1.2 Probe Washing Station....................................................................................................17
1.6.1.3 Reaction and Reading System........................................................................................18
1.6.1.3.1 Analytical Plate and Chamber .........................................................................................18
1.6.1.3.2 Cuvettes Washing System ..............................................................................................19
1.6.1.3.3 Cuvettes Washing Arm....................................................................................................19
1.6.1.3.4 Photometer......................................................................................................................19
1.6.2 Reagents, Samples, Standards and Controls Integrated System .......................20
1.6.2.1 Reagents.........................................................................................................................20
1.6.2.2 Samples, Standards and Controls Configuration ............................................................20
1.6.3 Pumps, Valves and Diluter Module .....................................................................22
1.7 Software............................................................................................23
1.7.1 Software Configuration........................................................................................23

Document Code N. SM0066.02.1 Chapter 1 - page [ 4 of 24 ]
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1. INTRODUCTION
1.1 GENERAL DESCRIPTION
Forte is a fully automatic random access clinical chemistry analyzer designed to run with
the same speed and efficiency your daily work, a profile or a STAT.
Thanks to its most sophisticated technologies and software, Forte provides maximum
flexibility and operational reliance. Due to its characteristics, it is the ideal instrument for
every laboratory regardless of size. Forte has a productivity of 180 (typical 150) chemistry
tests per hour plus 90 electrolytes.

1.2 MAIN CHARACTERISTICS
FORTE is a true random access analyzer as it processes all sample tests in succession.
Each sample is handled as a STAT.
FULLY AUTOMATED once programmed, all operations are carried out automatically
with no need for user intervention.
THROUGHPUT 180 (typical 150) single-reagent chemistry tests per hour regardless of
method, plus 90 electrolytes via a built-in ISE module (Optional) for Na, K and Cl.
SAMPLE CAPACITY there are 24 places for sample primary tubes (75x12.5mm) or
small cups with an adaptor. There are predilution cups for all samples, standards and
controls. Up to 240 samples can be programmed in one set, with the possibility of loading
and programming them while the analyzer is in operation. As an option, it is possible to
identify primary tubes via a Bar Code Reader.
REAGENT CAPACITY there are 36 refrigerated places on-line for reagents. There are 4
types of bottles (50, 30,10 and 5 ml). Only the 24 bottles placed in the outer rim of the
plate can be identified via the Bar Code Reader.
REAGENT reagents volume is measured and monitored all along in each bottle and
converted to the number of tests that can be performed with the given volume. The
absence of reagent is flagged.
REAGENT VOLUME the minimum volume required for tests reading is 300µl. R1 can
be programmed between 3 and 600 µl and R2 between 3 and 597µl with 1µl increments.
OPEN SYSTEM - an unlimited number of one or two reagent methods, profiles, standards,
calibrators and controls can be programmed. Up to 36 single-reagent or 18 two-reagent
methods can be executed.
AUTOMATIC SAMPLE PRE-DILUTION can be programmed in the Method or
implemented via the Prep function prior to starting the tests.

SAMPLING PROBE - PROBE transfers both reagent and sample (min 3µl and max
70µl) into the reaction cuvettes and mixes them. It performs as liquid level sensor as well.
DIRECT READING - measurement takes place through the reaction cuvette via a
photometer equipped with interferential filters. Reagent blank is read for each sample, so
as to compensate for any reagent drift, prior to delivering and mixing the sample and then
carrying out the readings required by the method.
AUTOMATIC REPETITION OF RESULTS - tests results outside linearity or affected by
substrate depletion can be automatically repeated using half sample size and by
multiplying the Optical Density by 2.
USER FRIENDLY SOFTWARE with graphic presentation makes operations easy
and simple.
HELP ON-LINE the help program walks the user through programming.
ON-LINE QUALITY CONTROL standardization and processing accuracy is
automatically checked daily. Results, including graphs, mean values, S.D. as well as
theoretical and percent CV, are memorized for 90 days.
STATS AN INTELLIGENT STOPS - allows introducing samples (STATs) whenever
necessary without interfering with ongoing tests.
PATIENT REPORTS are user tailored and automatically saved on the hard disk.

1.3 WARRANTY
HOSPITEX DIAGNOSTICS warrants the instruments, certified accessories and software
(provided on CD-Rom or other media), sold directly or by any of its authorized dealers, to
be free from faults in materials and workmanship for normal consumer usage over the
periods indicated below.
PRODUCTS COVERED LENGTH OF COVERAGE
Products as defined above One (1) year from the date of delivery to
the customer
Accessories as defined
above
One (1) year from the date of delivery to
the customer
Software as defined above*
Ninety (90) days from the date of delivery
to the customer
* Applies only to physical defects of the media on which the software is recorded (e.g.
CD-ROM, Pen drive)
HOSPITEX DIAGNOSTICS retains full and exclusive entitlement to determine, at its
unquestionable judgment, the causes of malfunctioning and therefore whether repairs and
or substitution are covered under its warranty.
EXCLUSIONS FROM WARRANTY
Failure to submit to HOSPITEX DIAGNOSTICS the complete installation/warranty
registration form within 15 days from receiving the product.
Failure to return to HOSPITEX DIAGNOSTICS faulty products within the warranty
periods indicated above.
Normal Wear and Tear - Periodic maintenance, repair and replacement of parts due to
normal wear and tear.
Parts with limited lifetime under normal usage, e.g.: bulbs, valves, syringes, fuses,
memory media and hoses.
Abuse & Misuse. Malfunction or damages due to: (a) improper installation, operation,
storage, misuse or abuse, accident or neglect; (b) abnormal use or storage of products
and accessories; and (c) other situations which cannot be attributed to faulty HOSPITEX
DIAGNOSTICS instruments.
Use of other than HOSPITEX DIAGNOSTICS-approved Products and Accessories.
Malfunction or damages caused by the use of other than HOSPITEX DIAGNOSTICS-
approved or certified Products, Accessories, Software and other peripheral equipment.

Unauthorized Service or Modifications. Malfunction or damages caused by service,
testing, adjustment, installation, maintenance, alteration, including without limitations
software changes or modifications, not carried out by HOSPITEX DIAGNOSTICS or its
authorized service centers.
Altered Products. Products or Accessories with a) serial numbers or date tags removed,
altered or obliterated; b) broken seals or seals showing evidence of tampering; c)
mismatched board serial numbers; or d) non-conforming or non-HOSPITEX
DIAGNOSTICS parts.
Software on Physical Media. There is no warranty that software products will operate
without interruption or be error free, or that all software faults will be corrected.
Transportation Damages. The carrier, not HOSPITEX DIAGNOSTICS, shall be liable for
transportation damages to equipment, accessories and parts from collection to delivery
point. All claims for transportation damages must be filed without delay by the customer
directly with the carrier.
Inadequate Packaging Damages The customer, not HOSPITEX DIAGNOSTICS, shall
be liable for transportation damages due to inappropriate packaging of items sent back to
HOSPITEX DIAGNOSTICS for repairs or service.
TO GET SERVICE the buyer shall:
a) request HOSPITEX DIAGNOSTICS for instructions on how best to
package and ship products, accessories and software;
b) meet HOSPITEX DIAGNOSTICS packaging and shipping instructions;
c) return to HOSPITEX DIAGNOSTICS, freight fully pre-paid, the faulty items
within the above indicated warranty period;
d) provide a copy of the purchase receipt, bill of sale or any other proof of
purchase;
e) provide a written description of the problems;
f) indicate the location where the equipment is installed; and
g) provide full name and address of the laboratory.
WHAT WILL HOSPITEX DIAGNOSTICS DO?
HOSPITEX DIAGNOSTICS shall replace or repair, at its indisputable judgment, free of
charge any defective item, except those not covered by warranty.

1.4 INSTALLATION
1.4.1 Unpacking
Shipping and packing materials have been selected so as to provide maximum protection
during transportation under normal handling conditions. There are markings on the sides
of the crate indicating how to handle it.
Figure 1.4-1 - Shipping crate
Upon receipt examine the shipping crate for traces of damage, e.g. crushed or indented
parts, holes and scratches, water marks, etc. Ensure that the carrier records any such
damage on the delivery receipt so as to facilitate entering a claim in the event that the
instrument has been damaged.
Removing of the instrument from the crate should be carried out by at least two
people.
Remove stoppers A at the bottom of the crate, cut fasteners, lift the cover of the crate
and then carefully lift the instrument (see Fig. 1.4-1 above).
It is advisable to save all packing materials till the expiry of the warranty period.

1.4.2 Installation
The Analyzer must be installed by authorized technicians. At the time of installation the
system must be checked to ensure that it is functioning properly.
The Forte is a robust high precision instrument. Proper installation will ensure optimum
performance.
1.4.3 Environmental Requirements
Install the system on a table or workbench free from vibration, dust, direct sunlight, heat
sources and strong magnetic fields.
1.4.4 Setting the Analyzer on a Level Plane
Ensure the proper leveling of the analyzer via its four adjustable feet (PK on Fig. 1.4-2).
Figure 1.4-2 Front View
1.4.5 Operating Temperature Limits
Ambient room temperature from 15° C to 32° C
Max. humidity 65% (non-condensing)
1.4.6 Power Requirements
The instrument can be operated on a 230/115 Volt - 50/60 Hertz - 400 Watts power
supply, as indicated at the back of the instrument. It is important to ensure proper
electrical grounding.
A stabilizer (UPS), with a minimum rating of 600VA, should be used if power fluctuates by
more than 10%.

1.5 INSTALLATION PROCEDURE
The Analyzer is supplied fully assembled and ready to use.
1.5.1 Connecting Peripheral Devices
Locate at the back of the analyzer the appropriate connectors for all peripheral devices
such as monitor, printer, mouse, keyboard, etc. (See Fig. 1.5-1).
Figure 1.5-1 - Connecting Peripheral Devices
1.5.2 Hydraulic Connections
To identify the various containers see Figure 1.5-2.
1) WASH SYSTEM The WASH solution container holds 5 liters of distilled water
mixed with 4 drops of Systemic Solution. In preparing the solution mix slowly to
avoid foaming. Close the container with its cap.
a. The system will send a warning when the volume of Wash Solution is low
though sufficient to carry out the programmed work.
b. Add, when required, freshly prepared wash solution.
c. Change the wash solution once a week. Clean carefully the container with
distilled water prior to introducing the newly prepared solution.

ANALYTICAL CHAMBER - Use only bidistilled water to prevent calcium deposits from
forming on the walls of the cuvettes and on the read windows.
The Analytical Chamber is automatically filled up at START up. Water level is monitored
by a sensor which activates the temperature control system as well. Level and
temperature are constantly monitored. No-water or low-water level are automatically
flagged.
To prevent mould or bacteria, replace the bidistilled water at least every two weeks.
Replacement can be done automatically via the Maintenance Program. Activate Drain
Bath to empty the chamber and Fill Inc. Bath to fill it up.
Warning Use only bidistilled water for the Analytical Chamber.
ISE CALIBRATOR A: place the Calibrator A container in its place inside the Analyzer
and close it with its cap. The calibrator is in use also when the Analyzer is Off.
WASTE empty daily the WASTE container and wash it with a suitable detergent to
prevent bacteria formation.
Figure 1.5-2 - Electro - Hydraulic Connections Rear View
Connections at the back of the Analyzer
1) ON/OFF Power Switch
2) Main POWER-IN plug
3) Voltage selector 230V - 115V
4) Auxiliary power supply sockets (Printer & Monitor) (230V or 115V as the Main
input voltage)
5) Power supply socket for the AIR PUMP
6) AIR PUMP
7) AIR PUMP Inlet connector
8) INCUBATOR Inlet connector
9) WASH Inlet connector
10) WASTE Outlet to the Waste container
11) WASTE container
12) WASH container
13) INCUBATION container

14) Inlet for the ISE module power supply cable
Containers:
WASTE: the 5 liters container collects all waste liquids irrespective of source.
WASHING: the container holds 5 liters of distilled water mixed with 4 drops of
Systemic Solution.
INCUBATION: the container holds 1 liter of bidistilled water for the analytical
chamber.
ISE Calibrator A: If the instrument is provided with the ISE Module installed, place
the 250 ml container inside the analyzer through the front opening.

1.6 ANALYZER STRUCTURE
The analyzer is composed of two main units assembled on the base of the instrument (Fig.
1.6-1/2). The units are described in detail hereafter.
Figure 1.6-1 Analyzer - Internal View
Figure 1.6-2 Analyzer View from Top
Prepper & Measurement System
Integrated Reagents & Samples System

1.6.1 Prepper, Reaction and Measurement System
1.6.1.1 Sampling Arm
The Arm (Fig. 1.6-3) holds a sampling Probe connected to a precision diluter. The
function of the Arm is to deliver sample and reagents into the reaction cuvette and to mix
them.
Figure 1.6-3 Sampling Arm

1.6.1.2 Probe Washing Station
To prevent contamination it is essential to ensure the proper cleaning of the Probe after
each sampling operation. The washing station (fig. 1.6-4) has been designed to wash the
probe both inside and out (Pump P1 inside) e (Pump P2 outside). On the way out of the
cuvette the Probe is dried by an air jet.
Figure 1.6-4 - Washing Station

1.6.1.3 Reaction and Reading System
1.6.1.3.1 Analytical Plate and Chamber
See Fig. 1.6-5 and 6. Reaction takes place in an analytical plate immersed in a
thermostatically controlled bath at 37°C (± 0.2°C) heated by round resistance placed at the
bottom of the chamber. Temperature is controlled by a thermostat and spread by the
rotation of the plate. The chamber is filled and drained by linear pump P4. Reading is
carried out by a photometer directly through the quartz cuvettes.
Figure 1.6-6 - Analytical Chamber
Figure 1.6-5 - Analytical Plate and Cuvette

1.6.1.3.2 Cuvettes Washing System
To ensure reliable results it is essential to ensure that every cuvette is washed and dried
very accurately for immediate re-use. For this purpose, cylindrical cuvettes with a spherical
bottom are being used so as to avoid corners which are difficult to cleanse.
1.6.1.3.3 Cuvettes Washing Arm
The cuvettes washing station comprises two probes.
The first one empties the cuvette and rinses it with the
WASH solution. Several rinsing cycles are carried
out. The second probe injects pressurized air to dry
the cuvette and eliminate all WASH solution residue.
1.6.1.3.4 Photometer
The photometer, equipped with 8 narrow-band
interferential filters, has been designed to ensure
maximum response and accuracy in O.D. reading
through the reaction cuvettes.
The filters wavelengths are: 340. 380, 405, 510, 546,
578, 620, and 700 nm.
Figure 1.6-8 - Photometer
Figure 1.6-7 Cuvette Washing
Double Arm

1.6.2 Reagents, Samples, Standards and Controls Integrated System
1.6.2.1 Reagents
The analyzer is equipped with a Multifunction
Plate holding 24 through 36 reagent bottles.
There are 4 different bottle types: 50, 30, 10
and 5 ml. All reagents are cooled. (Fig. 1.6-10)
In the outer side of the housing there is an
opening for the identification of reagents and
samples via the Bar Code Reader.
Only the 24 reagent bottles placed in the outer
rim of the plate can be positively identified via
the Bar Code Reader. The plate can be
removed and placed in a fridge to preserve
reagents stability while the analyzer is turned
OFF:
1.6.2.2 Samples, Standards and Controls Configuration
The outer rim of the plate can hold either 25 primary sample tubes (75x12.5) for positive
identification via the Bar Code Reader or a similar number of sample cups with adaptor.
There is a predilution cup for each sample. In addition there is one position for a STAT and
its predilution cup.
The inner ring of the plate holds just small cups. There are 10 positions for standards and
2 positions for controls, all with their respective predilution cups. In addition there is one
cup for Calibrator B and 1 for Clean S., both for the ISE module.
Figure 1.6-9 - Integrated System

Figure 1.6-10 - Multifunction Plate
WARNING When placing back the Plate in its housing, ensure that the plate driving pin
in the housing fits correctly in the corresponding hole at the bottom of the plate.

1.6.3 Pumps, Valves and Diluter Module
The pumps, valves and diluter module is installed inside at the back of the instrument. It is
necessary to remove the back panel to get access to the module.
Here below is a brief description of the various functions.
P1 Washes the inner side of the Probe
P2 Washes the outer side of the Probe
P3 - Washes the Reaction Cuvettes
P6 Drains the Probe washing station
Diluter the high precision diluter, connected to the Probe, delivers reagents and samples
to the cuvettes. Reagent volumes can be set from 3 µl to 600 µl with 1 µl increments.
Figure 1.6-11 - Pumps, Valves and Diluter Module

1.7 SOFTWARE
The Forte Software comprises 8 Sections and is presented in a friendly Register for ease
of use.
Figure 1.7-1 - Home Page
1.7.1 Software Configuration
From the Home Page click on ? in the Menu Bar and then on About in the scroll down
menu to see the Software Configuration installed in the Analyzer (Fig. 1.7-2).
For additional information click on More.
To enable Hospitex Diagnostics to provide quick and efficient service, customers are
invited to provide always in writing a detailed description of the problem encountered with
a copy of the error messages, if any, accompanied by the Software configuration shown in
Fig. 1.7-2.

Figure 1.7-2 - Software Configuration

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