HLC-723G8 Service Manual

1. Introduction

1. Introduction

1.1 Outline

This service manual is intended for use as a reference for repair and maintenance
by personnel who have received maintenance training from TOSOH. TOSOH is not
responsible for equipment damage, personal injury or other loss incurred during or
as a result of attempted maintenance by unqualified personnel.

The operator’s manual and specialized columns, elution buffers, and Hemolysis
and Wash solution described on below are required to use the instrument. Other
columns and reagents cannot be used. TOSOH is not responsible for losses
incurred if other columns or reagents are used.

The HLC-723G8, hereinafter “G8”, is intended to assay A1c (%) out of the total
hemoglobin in blood for in vitro diagnostic use based on High Performance Liquid
Chromatography principle with the cationic non-porous ion exchanger using the
ionic deference. To use the analyzer, simply place the cap-pierced primary tube on
the rack of the sample loader, and the analyzer will assay for A 1c every 1.0 minutes
with sampling and dilution. In addition to A1c (HbA1c ), both HbA1 and hemoglobin F
(HbF) can be measured.

Dedicated column for the TOSOH Automated Glycohemoglobin Analyzer

HLC-723G8:
TSKgel G8 HSi
Dedicated reagents for the TOSOH Automated Glycohemoglobin Analyzer
HLC-723G8:
G8 Elution Buffer HSi No.1 (S)
G8 Elution Buffer HSi No.2 (S)
G8 Elution Buffer HSi No.3 (S)
HSi Hemolysis and Wash Solution (L) and (LL)

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1. Introduction

1.2 Analyzer Configuration

Fig. 1-1 External Appearance (with 90SL connected)

Fig. 1-2 External Appearance (with 290SL connected)

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1.3 Units and Functions

Fig. 1-3 Front View (unit location)

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1. Operation panel
The operation panel is a monochrome LCD with touch keys. The operation is
controlled through the touch keys on the screen. Various settings can be made
on the screen.
Individual basic function keys such as POWER, START, STOP, HOME and
ERROR RESET are provided on the right side of the display. Routine
operations are executed with these keys.

2. LED panel
Three kinds of light emitting diodes (LEDs) indicate the analyzer status: Power,
Run, and ERROR.

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3. Printer
The printer paper roll is thermal-sensitive. It prints out assay results, error
messages and parameter status. The assay results can be printed out in two
different formats. A roll can handle about 350 sample results depending upon
the format.

4. Storage device
The analyzer is equipped with an internal Smart Media socket. It is used to
store assay results, update and backup program versions. A maximum of
12,000 sets of assay results (approximately 500 days’ worth) can be stored on
one card (32 MB) formatted by the analyzer. The last 800 sets of assay results
are also automatically saved to the analyzer's internal memory.

1. Only insert a smart media card.

2. Use a card with 128 MB or less of memory.
3. The number of assay results that can be saved differs depending on the
formatting method and the type of files saved together. The format of data
used by other applications or the format of brand new card may differ, thus
reducing the number of assay results that can be saved. Prior to use, we
recommend formatting the card with the analyzer or a PC running Windows
2000 or Windows XP. Cards formatted by the analyzer can also be used on
a PC.

5. Line filter
The line filter prevents impurities (such as samples or dust from a broken
valve seal) from entering the assay line. The filter element can easily be
replaced by hand.

6. Column oven
The column oven contains the column, a critical component in assaying.
The column must be kept at a constant temperature at all times to prevent
temperature fluctuations that affect the test results. The column oven
maintains a constant temperature so that no wait time is required prior to
starting an assay, unless the main power switch (side breaker) is turned off.
The column can be manually connected. This allows the column to be easily
replaced without using any special tools.

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7. STAT port
Place priority samples here. The port can handle dedicated sample vials and
primary tubes (75 mm).

100 mm primary tubes cannot be used.

8. Drain valve
If an air bubble enters the pump, open this valve to expel the bubble with a
drain flush. Do not open this valve during an assay.

9. Injection valve
This valve is used to inject a sample into the assay line after sample dilution.
The sample loop volume is 4 µL.

10. Rotary valve

The rotary valve is used to switch flow paths during sampling and elution
buffer priming.

11. Sampling mechanism

The analyzer automatically senses the sample containers and takes in a
sample. The whole blood sample is automatically diluted and introduced into
the assay line. When the assay begins, the sample rack is transferred and
continuous sampling starts and continues until the metal end marker, which
indicates the last rack, or an empty rack on the loader is detected.
When a query is requested of the host computer, (hereinafter, "host"), you can
select and assay only the sample for which a query has been requested,
skipping the others.

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Fig. 1- 4 Right Side View (unit location)

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12. Detector
The detector is used to detect changes in the absorption level of hemoglobin
in the sample separated with the column. The light source is a blue LED. The
detector and column temperatures are both controlled by the column oven.

13. Pump
The pump uses the plunger method to deliver the Elution Buffer required for
the assay. The pump operates continuously to deliver the Elution Buffer during
the assay and feeds three different concentration Elution Buffers in 1.0-minute
cycles by switching the solenoid valves. It also forms a gradient (concentration
control), and the hemoglobin elements are separated by the column.

14. Degassing unit

The degassing unit removes air bubbles in the pumped Elution Buffer. The
vacuum pump runs intermittently to keep a constant vacuum pressure in the
chamber.

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15. Bar code reader

The bar code reader reads the bar code label on the primary tube and the
analyzer prints it on the report. Assay information can be requested from the
host using the bar code. If you are using a sample vial, attach a bar code label
on a vial adapter, set the adapter on the rack, and place the sample vial on top
of the adapter.

16. Main power switch

The main power switch is located on the AC inlet, on the left rear side of the
main unit. Usually, turn the main unit power on and off using the POWER key
on the right side of the display. Always keep the main power switch in the ON
position.

Fig. 1-5 Left Rear Side

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1. Introduction

1.4 Assay Principle

Based on the principles of ion-exchange, high-performance liquid chromatography,

the HLC-723G8 separates hemoglobin components according to the charge
difference using a column packed with a non-porous packing material (approx. 2.5
µm grain diameter) containing cationic exchange bases. Hemoglobin A1c (%) is
measured from the component ratios.

Samples are placed in primary tubes or special sample cups (vials) and set in a
rack. The sample loader sensor recognizes the type of container and sets the
needle lowering position automatically. In addition, although by default primary
tubes are set for whole blood and sample cups (vials) are set for diluted samples,
these settings can be changed. (LOADER SMP MODE)

For whole-blood assays, approximately 3 µL of sample is taken, diluted

approximately 200 times in the dilution port, and drawn into the sample loop. When
assaying diluted samples, approximately 80 µL of sample is taken, needle washing
operations are executed, and the sample is drawn into the sample loop.

There are 3 Elution Buffers: Buffer No. 1 is used to elute A 1a, A1b, and F; Buffer No.
2 is used to elute LA1c + and SA1c ; and Buffer No. 3 is used to elute A 0.
Sample injections are repeated every 1 minute (Standard Analysis Mode) or 1.5
minute (Variant Analysis Mode). The above Elution Buffers are introduced and
switched in sequence, and the sample components are separated and eluted from
the column. The separated hemoglobin components are monitored based on the
absorbance at 415 nm / 500 nm. The chromatogram, peak information, and
HbA1c % information are printed as output.

Refer to the operator ’s manual for details regarding the sequence of operations
to follow after the power has been turned on.

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