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DS5 Analyser User Manual

Drew Part Number 274-020


Preliminary Pages Page i
DS5 Analyser User Manual January 03

DS5 Analyser
User Manual

Issue 4 2003

The DS5 Analyser conforms to directives 89/336/EEC & 73/23/EEC


and is manufactured by Drew Scientific Limited, an ISO9001 accredited company.

Copyright Drew Scientific Limited © 2003


Page ii Preliminary Pages
January 03 DS5 Analyser User Manual

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Preliminary Pages Page iii
DS5 Analyser User Manual January 03

Preface
The Drew DS5 Analyser User Manual, Part Number 274-020 is published in the United Kingdom by
Drew Scientific Limited. Neither the whole or any part of the information contained herein may be adapted
or reproduced in any material form except with the prior written approval of Drew Scientific Limited.

All information of a technical nature and particulars of the DS5 Analyser and its use are given by Drew
Scientific Limited in good faith but may contain errors. This manual is intended only to assist the user in the
use of the DS5 Analyser and therefore, Drew Scientific Limited shall not be liable for any loss or damage
whatsoever arising from the use of any infomation or particulars in, or any errors or omission in this manual.

The following convention is used throughout this manual to alert the user to health and safety information.

WARNING A warning notice denotes a hazard to health.

The notice will state the nature of the hazard, the means by which it can be avoided, and
the consequences of ignoring the notice.

CAUTION A caution notice denotes a risk to the integrity of the instrument and its software.

The notice will state the nature of the hazard, the means by which it can be avoided, and
the consequences of ignoring the notice.

For further health and safety information, refer to Appendix B of this manual.

Unless stated to the contrary the words up, down, left, right, top, bottom, back, front, clockwise and counter
clockwise refer to these directions when viewed from the touchscreen of the DS5 Analyser.

The DS5 Analyser described in this manual and products for use with it are subject to continuous
development and improvement. Drew Scientific Limited reserves the right to change component types,
manufacturers, sources of supply or technical specification at any time.

All correspondence relating to the DS5 Analyser or this manual should be addressed to:

Product Support Department


Drew Scientific Limited
Sowerby Woods Industrial Estate
Park Road
Barrow-in-Furness
Cumbria
LA14 4QR
United Kingdom
Tel: ++44 (0)1229 432089
Fax: ++44 (0)1229 432096

e-mail: products@drew-scientific.com
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Table of Contents Page v
DS5 Analyser User Manual January 03

Contents
Preliminary Pages i to vi
Preface ............................................................................................................................................. iii
Section 1 Understanding the DS5
General Description ...................................................................................................................... 1-1
Intended Use .................................................................................................................................1-1
Summary & Explanation ................................................................................................................ 1-1
Scientific Principle .......................................................................................................................... 1-1
Component Description ................................................................................................................. 1-2
Front Panel .................................................................................................................................. 1-2
Rear Panel ................................................................................................................................... 1-3
Top View ...................................................................................................................................... 1-4
Reagent Kits ................................................................................................................................. 1-5
Calibrators and Controls ............................................................................................................. 1.5
Section 2 Installation
Unpacking the DS5 ....................................................................................................................... 2-1
Positioning the DS5 ....................................................................................................................... 2-1
Connecting the Tubing and Installing the Reagents ........................................................................... 2-2
Installing the Pump Tube Cassette .................................................................................................. 2-3
Installing the Column ...................................................................................................................... 2-5
Installing the Software .................................................................................................................... 2-6
Connecting to the Power Supply .................................................................................................... 2-6
Installing the Printer Paper .............................................................................................................. 2-7
Calibration System ......................................................................................................................... 2.7
Connection of Data Cable and Optional Bar Code Reader ............................................................. 2.8
Section 3 Getting Started
Quick Reference ............................................................................................................................ 3-3
Main Menu - Run Samples ............................................................................................................ 3-4
Main Menu - Change Date & Time ................................................................................................3-7
Main Menu - Change Kit and Calibration ....................................................................................... 3-8
Main Menu - Reprint ................................................................................................................... 3-11
Maintenance Menu - Wash .......................................................................................................... 3-12
Maintenance Menu - Decontamination ......................................................................................... 3-13
Section 4 DS5 Operating System
System Components ...................................................................................................................... 4-1
Typical Use ................................................................................................................................... 4-2
Explanation of Terms ..................................................................................................................... 4-2
Using the DS5 ............................................................................................................................... 4-4
Main Menu Options ....................................................................................................................... 4-5
Second level (Maintenance Menu) Options .................................................................................... 4-6
Using the Main Menu ..................................................................................................................... 4-7
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January 03 DS5 Analyser User Manual

Enter Sample ID .......................................................................................................................... 4-7


Run Samples ................................................................................................................................. 4-9
Interrupting a Run ................................................................................................................... 4-12
Change Date and Time ........................................................................................................... 4-13
Change Kit ................................................................................................................................ 4-14
System Calibration .................................................................................................................... 4-16
Reprint ....................................................................................................................................... 4-20
Using the Maintenance Menu ....................................................................................................... 4-22
Wash .......................................................................................................................................... 4-22
Decontamination ....................................................................................................................... 4-23
Diagnostics Menu ....................................................................................................................... 4-25
Return to Main Menu ................................................................................................................... 4-25
Section 5 Precautions and Sample Requirements
Operating Precautions ....................................................................................................................5-1
Hazards .........................................................................................................................................5-1
Sample Requirements ....................................................................................................................5-2
Sample Collection and Preparation ......................................................................................... 5-2
Section 6 Maintenance and Troubleshooting
Visual Inspection ..........................................................................................................................6-1
Cleaning Instructions .....................................................................................................................6-1
Fuse Replacement ........................................................................................................................6-1
Troubleshooting .............................................................................................................................6-2
The Chemistry .............................................................................................................................6-2
The Software ...............................................................................................................................6-2
The Hardware .............................................................................................................................6-2
Diagnostics Menu ..........................................................................................................................6-3
Autosampler Diagnostics ...............................................................................................................6-4
Main Instrument .............................................................................................................................6-6
Touch Screen ...............................................................................................................................6-7
Sofware Loading ...........................................................................................................................6-7
Error Messages .............................................................................................................................6-8
International Set-up .................................................................................................................... 6-11
Factor & Offset Editing and Selecting the Calibration System ........................................................ 6-12
Section 7 Specifications
Samples ........................................................................................................................................7-1
Environmental Conditions ...............................................................................................................7-1
Assay Time ...................................................................................................................................7-1
Size ...............................................................................................................................................7-1
Autosampler ..................................................................................................................................7-1
Thermal Printer ..............................................................................................................................7-1
Section 8 Spares and Accessories
Ordering Information .....................................................................................................................8-1
Spares and Accessories .................................................................................................................8-1
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DS5 Analyser User Manual January 03

Section 9 References
References .................................................................................................................................... 9-1

Appendix A User Manual Supplement


Introduction .................................................................................................................................. A-1
Getting the DS5 Analyser Warmed Up .......................................................................................... A-2
Removal or air bubbles trapped in the flow cell .............................................................................. A-4
Troubleshooting ............................................................................................................................ A-6

Appendix B Health and Safety Information


DS5 Analyser Pink Reagent Kit .................................................................................................... B-1
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Understanding the DS5 Page 1 - 1
DS5 Analyser User Manual January 03

1 Understanding the DS5

1.1 General Description


The DS5 Analyser is an automated instrument for the assay of haemoglobin fractions.
Reagent Kits are available for the routine measurement of HbA1c for monitoring diabetics. The
DS5 Analyser is designed to carry out the tests on whole blood with a minimum of sample
preparation and is provided with a 15 position autosampler for unattended automatic operation.

1.2 Intended Use


The DS5 Analyser and Reagent Kit are intended for in vitro estimation of human glycated
haemoglobin in samples from normal and diabetic patients. The ratio of glycated haemoglobin
to total haemoglobin A can be estimated in the presence of HbS and HbC.

1.3 Summary & Explanation


Human haemoglobin inside erythrocytes undergoes a non-enzymic chemical reaction with
glucose and other saccharides derived from it (1). The rate and extent of this reaction are
thought to be dependant on the average blood glucose concentration during the lifetime of the
erythrocyte (2,3). There are several reaction products-glycated haemoglobins-which collectively
are known as HbA1 (4). The most abundant of these is HbA1c. The ratio of HbA1c to the
total HbA concentration has been suggested as a reliable measure of the degree of metabolic
control in diabetic patients.

1.4 Scientific Principle


The DS5 Analyser uses low pressure cation exchange chromatography in conjunction with
gradient elution to separate human haemoglobin subtypes and variants from haemolysed whole
blood (5-7). The separated haemoglobin fractions are monitored by means of absorption of
light at 415nm. The chromatogram obtained is recorded and stored by the internal computer.
A software program performs the analysis of the chromatogram and generates a results report
on the thermal printer.
Page 1 - 2 Understanding the DS5
January 03 DS5 Analyser User Manual

1.5 Component Description

1.5.1 Front Panel

touch screen

door handle

disk drive
instrument door

peristaltic pump
detector cover

column holder

Figure 1-1 Front Panel

Touch Screen
A resistive touch screen with an LCD display. The screen is divided into graphic icons or
buttons which change depending upon which menu has been accessed. The operation of the
analyser is controlled entirely via the touch screen.

The following components are housed behind the instrument door:

Peristaltic Pump
A multi-channel peristaltic pump for drawing in and dispensing reagents for column elution and
washing the probe. The pump also controls the flow of waste to the waste bottle.

Disk drive
A 3.5 inch disk drive for the DS5 operating software. The disk remains installed at all times.
Understanding the DS5 Page 1 - 3
DS5 Analyser User Manual January 03

Column Holder
A column holder which has a threaded clamp to hold the column in place. The clamp also forms
the sample tubing connection.

Detector Cover
Provides a cover for the lamp shield and sample inject valve. The cover is removed together
with the lampshield when replacing the lamp.

1.5.2 Rear Panel


RS232

loudspeaker

fan

power connector
and switch

reagent B

reagent A

waste

Figure 1-2 Rear Panel

Reagent Inlet Tubes


Feed tubes supplying Reagents A and B to the DS5 Analyser.

Waste Outlet Tube


A tube from the DS5 Analyser for waste. The tube should be directed to a suitable container
for disposal.
Page 1 - 4 Understanding the DS5
January 03 DS5 Analyser User Manual

Fan
A cooling fan for the equipment. This should not be obstructed, a minimum of 100mm clearance
is required at the rear of the analyser for air flow.

Mains Input & Switch


The ON / OFF switch is located in the power connector block. The unit is ON when the top
of the switch is pressed in. A button to the right of the Mains Inlet Switch will light up when the
power is ON. The unit is OFF when the bottom of the switch is pressed in. The fuses are located
in the power connector block; they can only be accessed when the power cord has been
removed for safety purposes.

RS 232
The instrument is supplied with a cover fitted to this port. This cover provides protection against
Electrostatic Damage (ESD). In order to comply with European EMC regulations the cover
should be fitted wherever a data output cable is not fitted to this port.

CAUTION To prevent damage to computer equipment connected to the RS232 port,


only use the data cable kit supplied with the DS5, Part Number 270-149S.
Make sure the power is turned off before connecting the cable.

1.5.3 Top View

Figure 1-3 Top View

Thermal Printer
Integral thermal printer for printing out results and summaries

Autosampler
Sample tray with 15 positions.
Understanding the DS5 Page 1 - 5
DS5 Analyser User Manual January 03

1.5.4 Reagent Kits


Reagent kits are colour coded PINK.
When a kit is due to be changed a warning message appears on the screen to advise that it is
time to change the reagents and column. See section 4.7.5 for details.

Pink 75 Test Reagent Kit (Drew Part Number 014-200)


The contents of the reagent pack are:

1 x 270 mL Reagent A
1 x 500 mL Reagent B
1 x 80mL Haemolyser Reagent
1 column, suitable for 75 tests
Sample vials

Pink 300 Test Reagent Kit (Drew Part Number 014-350)


The contents of the reagent pack are:

4 x 270 mL Reagent A
4 x 500 mL Reagent B
1 x 440 mL Haemolyser Reagent
4 columns, suitable for 300 tests
Sample vials
Pump Tube Cassette

1.5.5 Calibrators and Controls


The following products are available.

Glycated Haemoglobin Two Level Control Kit (Drew Part Number 014-175)

This pack contains 3 vials of each level.


Each vial contains the equivalent of 0.3 mL of whole blood.

Glycated Haemoglobin Two Level Calibrator Kit (Drew Part Number 014-380)

This pack contains 4 vials of each level and 2 vials of reconstitution fluid.
Calibrator values are provided for both NGSP and IFCC calibration systems.
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Installation Page 2 - 1
DS5 Analyser User Manual January 03

2. Installation
CAUTION Prior to handling or operating the analyser, read the following instructions
carefully. If the analyser is not handled or operated in the manner specified,
the integrity of the analyser and its software may be impaired.

2.1 Unpacking the Analyser


WARNING The DS5 Analyser is heavy, therefore handle with care. To prevent personal
injury or accident, two people should lift the analyser, one person positioned
at the back and one at the front.

Visually inspect that all the following items have been supplied. Contact your local distributor
if any items are missing or have been damaged in transit.

DS5 Analyser including waste and reagent tubes


Power Cord
Fuses
Thermal Printer paper (2)
Program Disks (2)
Blank column (Red) for decontamination (10)
Data Cable Kit

Unpack the Reagent kit.

2.2 Positioning the DS5


The DS5 Analyser requires the following :-

A clean, level surface away from direct sunlight and air vents from heating or air conditioning
systems.

An operating temperature of 15°C to 30°C. During operation the temperature must not vary
by more than +/- 2°C.

270mm (11 inch) wide x 415mm (16 inch) deep of bench space with a suitable power supply.

Approximately 100 mm (4 inches) of clearance behind the analyser for cool air circulation,
the waste and reagent tubing and connection of the power cable.

The equipment must be positioned so that it is not difficult to reach and operate the power
switch (disconnect device) on the rear panel.
Page 2 - 2 Installation
January 03 DS5 Analyser User Manual

2.3 Connecting the Tubing and Installing the Reagents


Direct the waste pipe to an appropriate waste point or a suitable collection vessel positioned
at the same height as the analyser.

WARNING Dispose of the waste in accordance with local regulations.

Place the reagent bottles to the side of the DS5 Analyser. Each tube is fitted with a threaded
cap (supplied). The position of the cap is designed so that the tubing reaches the bottom of
the container.

Remove the caps from the reagent bottles and place the reagent tubing into the bottles. The
two reagent bottles have different coloured caps, Reagent A is colour coded white and reagent
B is colour coded black. Ensure that they are fitted correctly.

CAUTION The bottle of haemolyser supplied with the kit has a white cap, take care to
check the bottle labels carefully so that the correct bottle is connected to the
analyser.
Installation Page 2 - 3
DS5 Analyser User Manual January 03

2.4 Installing the Pump Tube Cassette


The instrument can be left switched on when replacing a cassette but the pump must be idle.

1. Lower the instrument door.

2. Undo the thumb screw at the centre of the back plate, behind the column; this frees the
base tray which has the column and peristaltic pump attached.

3. Slide the tray forward until the pump can be accessed easily.

The red tabs on the body of the pump are not required for operating the pump or
installing the cassette.

4. Undo the 5 white plastic clips which hold the pump tube cassette in place. There is a lever
at the top right of each clip, which when lowered frees the clip.

5. Take each clip out.

6. When replacing an old pump tube cassette, pull the black strips (which fit into holes either
side of the base tray) upwards out of the tray. Use absorbent paper to wipe up any reagent
which may have siphoned up through the holes.

red

[space]

yellow

yellow

black

Black strip Pump tubing Coloured tag

Figure 2-1 Pump tube cassette

7. Place the new tube cassette over the rollers of the pump. The black tagged tubing
should be at the front with the red at the back. Ensure that the coloured tabs are on the
right hand side as you look at the instrument (see fig. 2-1).

8. Insert the black strips into the base tray either side of the pump.

9. Working from the back forwards, place the plastic clips one at a time over the tubing.
Ensure that the levers are down and are installed at the right hand side of the pump.
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January 03 DS5 Analyser User Manual

10. Pull the tubing through the sides of the clip from right to left to secure it. Ensure that the
coloured tag engages the lug. (see fig. 2-2)

11. When the tubing is in place, so that it fits neatly under the arch of the clip, move the lever
upwards and push fully across (to 45 degrees), then pull back two clicks to lock the tubing
in place. The correct position for the lever is shown in Fig. 2.2.

lever

tubing fits under


arch

PUMP
coloured tag

lug
pump tubing

Fig 2-2 Pump tube clip with tubing secured in place.

12. The first tube to be installed should be the red tagged tubing at the back. The next position
on the pump is a blank. The clip should be secured in place but there should be no tubing
underneath it.

13. The remaining 3 tubes are colour-coded yellow, yellow, and black respectively; the latter
being at the front of the pump.

14. The tube casette installation is complete when all levers have been raised and the tubing
is held in place by the clips. The slack in the tube cassette will be taken up when the pump
is started.

15. Slide the tray carefully back into the instrument and tighten the thumb screw on the centre
of the back plate.

16. If replacing an existing cassette, close the door and start to run the instrument. Program
a wash to remove any air that may have been introduced into the system.(See section
4.8.1).
Installation Page 2 - 5
DS5 Analyser User Manual January 03

2.5 Installing the Column


The instrument can be left switched on when replacing the column.

The column holder is located on the base of the instrument in the centre of the base tray.

knurled nut

plastic column holder

Figure 2-3 Column Holder

1. Remove the column supplied with the reagent kit from its storage container.
The column consists of a short length chromatography column mounted in a plastic
housing. The housing is colour coded pink.

2. The instrument is shipped with a red column blank in place. Unscrew the knurled nut
upwards. When the nut has been raised sufficiently, remove the blank column and install
the pink column.

3. Position the column so that the bottom of the column (narrower section) fits into an
indentation on the base plate of the instrument.

4. Finger tighten the nut until it fits securely into the top of the column.

knurled nut
plastic
column holder

base tray column

Figure 2-4 Column in place


Page 2 - 6 Installation
January 03 DS5 Analyser User Manual

2.6 Installing the Software


The disk drive is located at the top left of the instrument. Open the instrument door, insert the
program disk into the disk drive, label uppermost. Close the instrument door.

The second program disk is a duplicate; store it in a safe place.

2.7 Connecting to the Power Supply


WARNING The DS5 Analyser must be earthed/grounded. If you are in any doubt as to
the safety of your electrical supply system, consult a competent, qualified
electrician.

WARNING For continued protection against fire hazard, only use the same type and
rating of fuse originally fitted in the analyser.

1. Using a small screwdriver, prise open the fuseholder in the power connector block.

2. Insert the supplied fuses into the cartridges, and slide the cartridges into the fuseholder.
Close the fuseholder.

3. Connect the DS5 Analyser to a switched and fused power supply using the power cord
provided. The DS5 Analyser automatically adjusts for a wide range of different voltages
and mains frequency is not critical.

4. Turn the power supply ON.

5. Switch the DS5 Analyser ON.

The software is loaded from the disk.

One short beep sounds and a series of system checks starts.

The Touch Screen lights up and a copyright message is displayed until the checks are
complete.

The Main Menu appears on the Touch Screen indicating that the DS5 Analyser is ready.
Installation Page 2 - 7
DS5 Analyser User Manual January 03

2.8 Installing the Printer Paper


Take the printer tray (slotted) out of the instrument.

With the printer roll in the correct orientation feed the edge of the paper through the stainless
steel rollers at the back of the printer head.

Paper Out
Printer Roll Rollers

Printer Head

Fig 2-5 Paper roll installation.

Press the reprint icon on the main menu screen (see section 4.7.7) and use the paper feed
facility to feed the paper through the printer head.

2.9 Calibration System


The DS5 can be calibrated to either the NGSP or IFCC systems. Before using the system,
select the system you intend to use by following the procedure in section 6-11.

NB NGSP means “National Glycohemoglobin Standardization Program”


IFCC means “International Federation of Clinical Chemistry and Laboratory Medicine”

The DS5 stores calibration information for both systems. It is necessary to select the system
in use so that the correct error checking is performed after each calibration run.

The Drew Scientific Calibrator Kit contains a two level calibrator. Both NGSP and IFCC
values are given for each level and this information together with the lot number is available in
the kit as a bar code for ease of data entry.

CAUTION The DS5 should be calibrated and operated within the recommended temperature
range of 15 - 30°C. Do not allow the operating temperate to vary by more than
+/-2°C. Extreme changes in temperature during calibration and subsequent
operation may reduce accuracy and precision. Ensure that the reagents are
equilibrated at the operating temperature before use.
Page 2 - 8 Installation
January 03 DS5 Analyser User Manual

2.10 Connection of Data Cable and Optional Bar Code Reader


The DS5 has one RS232 data port on the back of the instrument.This port is used for both data
uploading to a laboratory data system and for communication with the optional bar code reader.
The bar code reader can be used for both sample identification entry and for entering the
calibration information supplied with Drew Scientific Calibrators, Part Number 014-380

To use just the data uploading option:-

Connect the DS5 to the remote computer using only the data cable kit supplied.

CAUTION To prevent damage to computer equipment connected to the RS232 port,


only use the data cable kit supplied with the DS5, Part Number 270-149S.
Make sure the power is turned off before connecting either the data cable or the
bar code reader.

To use just the Bar Code Reader option:-

Connect the DS5 to the Bar Code Reader using the gender adapter supplied with the
instrument.

To use both the data uploading and Bar Code Reader options:-

Connect the DS5 to the “INPUT-OUTPUT” port on the RS232 switch box (Part Number
002-935S).
Connect the remote computer to the switch box on port A using the data cable supplied.
Connect the Bar Code Reader to the switch box, port B.

INPUT-OUTPUT

Port A Port B

RS232 switch box rear panel

Place the switch in position B when using the Bar Code Reader and in position A when using
the data uploading feature at the end of a run.
The gender adaptors are not required when using the RS232 Switch Box.
Getting Started Page 3 - 1
DS5 Analyser User Manual January 03

3 Getting Started
This section contains diagrammatic summaries to help users run samples quickly and
easily.

Although these summaries will help a user who is unfamiliar with the DS5 Analyser to get
results quickly, they are not intended as a substitute for carefully reading and understanding
the other sections of this manual.
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Getting Started Page 3 - 3
DS5 Analyser User Manual January 03

3.1 Quick Reference

Main Menu Maintenance Menu

Run Samples Wash


(see section 4.7.2) (see section 4.8.1)

Change Date and Time Decontamination


(see section 4.7.4) (see section 4.8.2)

Change Kit Diagnostics Menu


(see section 4.7.5) (see section 6)

Reprint Return to Main Menu


(see section 4.7.7)

To Maintenance Menu
Page 3 - 4 Getting Started
January 03 DS5 Analyser User Manual

3.2 Main Menu - Run Samples


Run Samples

Enter Sample ID
(Manual or Bar Code)

Select Manual

Enter numbers/letters
(toggle)

Select Well number

Print List of ID

Accept

Run Samples screen

Run Samples
Getting Started Page 3 - 5
DS5 Analyser User Manual January 03

3.2 Main Menu - Run Samples - continued


Run Samples

Enter Sample ID
(Manual or Bar Code)

Select Bar Code

Select Well No.

Delete selected ID

Clear ALL ID’s

Print List of IDs

Confirm all ID’s

Run Samples
Page 3 - 6 Getting Started
January 03 DS5 Analyser User Manual

Assay in progress
1

[Abandon run]

Prints out results of assay

Main Menu

Prints out summary after a batch (1-15 samples)


....and displays the data download screen:-

Press ; to download or : to return to


the Main Menu without downloading.
Getting Started Page 3 - 7
DS5 Analyser User Manual January 03

3.3 Main Menu - Change Date & Time

Change Date & Time

Change time

Change date

Confirm changes

Cancel

Main Menu
Page 3 - 8 Getting Started
January 03 DS5 Analyser User Manual

3.4 Main Menu - Change Kit & Calibration

Change Kit

Cancel

Change column &


confirm

Change Reagent A

Change Reagent B

Check Waste

Confirm

System flushes

Calibration Prompt - see next page


Getting Started Page 3 - 9
DS5 Analyser User Manual January 03

3.4 Main Menu - Change Kit & Calibration - continued

Select Calibration Abandon Calibration


- see next page

Either use:- Manual Or use:- Bar Code


Data Entry Data Entry

Enter Low
Calibrator Value.......

.....then the
Lot number.

Repeat for the High Calibrator


Value and Lot Number.

Press to confirm
data entry. Press X to abandon.

Press to begin
Calibration Run.

Press to confirm Calibration run


Page 3 - 10 Getting Started
January 03 DS5 Analyser User Manual

3.4 Main Menu - Change Kit & Calibration - continued

Bar Code
Data Entry

Press to complete data entry

Press to confirm
Calibration Run.

Press

Abandon Calibration
Getting Started Page 3 - 11
DS5 Analyser User Manual January 03

3.5 Main Menu - Reprint


Reprint

Paperfeed

Select graph templates

Print all chromatograms

or

Select chromatograms to
print

No data for that well.

Well 12 selected.

Print selected wells

or

Cancel

Main Menu

Print Summary File Print Calibration Report


Page 3 - 12 Getting Started
January 03 DS5 Analyser User Manual

3.6 Maintenance Menu - Wash

Wash

Cancel

Start wash

[Abandon wash ]

Maintenance Menu
Getting Started Page 3 - 13
DS5 Analyser User Manual January 03

3.7 Maintenance Menu - Decontamination

Decontamination

Disinfection stage

Cancel

Swap Reagent A for disinfectant and confirm

Insert red column (blank) and confirm

Confirm Flush with Disinfectant

Cancel

Exchange disinfectant for water and confirm

Confirm Flush with Water

Maintenance Menu

Install Reagent A and Pink column and


perform a wash.
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DS5 Operating System Page 4 - 1
DS5 Analyser User Manual January 03

4 DS5 Analyser Operating System


This section provides background information about how the DS5 Analyser operates,
and describes how to use the software.

4.1 System Components


The DS5 Analyser comprises a multi-channel peristaltic pump, one multiport rotary
valve (sample inject valve), two solenoid valves and a fixed wavelength flow-through
spectrophotometer in conjunction with a computer control system to perform low
pressure cation exchange chromatography on haemoglobin samples.

The peristaltic pump delivers reagent to the column via the rotary valve, pumps waste
to the waste outlet tube and pumps wash reagent to and from the sample probe.

One of the solenoid valves controls the proportion of A and B reagents in order to produce
a gradient of increasing eluent strength.
The second solenoid valve controls the flow of wash reagent. This is either delivered to
the wash station via the peristaltic pump or recycled back through the valve.

Sampling is achieved using the multi-port rotary valve. The pump aspirates sample from
the vial into the loading loop on the valve. When the valve changes position the sample
loop contents are swept into the column by the reagent feed stream. During the elution
process reagent is pumped through the loading loop to prevent cross-contamination of
samples.
Page 4 - 2 DS5 Operating System
January 03 DS5 Analyser User Manual

4.2 Typical Use

After installing the reagent kit, the DS5 prompts the user to perform a Calibration run. Using
3 samples of patient blood and one sample of each of the low and high level calibrators, the
calibration run adjusts the DS5 results to either the NGSP or IFCC calibration systems.
A batch of samples is prepared (between 1 and 15) according to the assay requirements (see
section 5-3). The samples are then loaded into the Autosampler.
The DS5 Analyser is started and analysis proceeds automatically and unattended.
After each sample analysis the results are printed. When the batch is complete a summary
of the results is printed.

4.3 Explanation of Terms

4.3.1 Assay
A quantitative analysis of haemoglobin fractions.

The DS5 Analyser performs a 5 minute HbA1c assay.

4.3.2 Kit
A kit comprises sufficient Reagent A and B, Haemolyser, Columns, Vials to run a
defined number of samples.

The DS5 Analyser keeps track of the number of tests performed using the kit, and
displays the number remaining on the touch screen on the change kit icon. The assay
capacity is limited by the capability of the column to analyse samples reliably, and the
volume of reagents that the assay requires.

When a batch of samples is selected, the DS5 Analyser checks the number in the
requested batch against the number of samples remaining in the appropriate kit.

If a sample is requested when there is insufficient kit life left the DS5 Analyser will
prompt the user to change the kit.

Columns must not be used for more than the stated number of assays. The quality and
accuracy of results deteriorate if a column is over used.

4.3.3 Changing a Kit


If the installed kit has been used (or nearly used), then it should be disposed of in
accordance with local safety procedures.

When the reagent bottles and column have been changed the DS5 Analyser will flush the
old reagents from the system and wash the column twice in order to equilibrate it for use.
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DS5 Analyser User Manual January 03

4.3.4 Interrupting a Run

It is possible to interrupt a batch of samples during analysis (see section 4.7.3).

4.3.5 Decontamination Cycle

The decontamination cycle is used to disinfect the DS5 Analyser. Approved disinfectants,
and full details of the procedure are in section 4.8.2.

4.3.6 Wash

There is an automatic flushing through of reagents after each kit change and an Autowash
every 24 hours.

However it is sometimes necessary to flush air out of the system or to re-equilibrate the
column using the manual wash facility.

When a wash is in progress, a time bar will gradually fill as the wash progresses. This
takes approximately 5 minutes.

While the wash is running, it is possible to abandon it, and the DS5 Analyser returns
immediately to the Main Menu. However this is not normally advisable as the column
may not be sufficiently equilibrated for the next sample.

Refer to section 4.8.1 for how to use the wash program.

4.3.7 Calibration

Every new reagent kit and column should be calibrated to ensure that the results are aligned with
either the NGSP or IFCC calibration systems.

The DS5 prompts you to run a calibration sequence at the end of each kit change operation.

Three samples of patients blood are placed in wells 1 to 3 to ensure that all air bubbles are
eliminated. Samples of the low and high level calibrators are placed in wells 4 and 5 respectively.
The assigned values for the calibrators can be entered either using the touch screen or by means
of the oiptional bar code reader kit.(The bar code reader can also be used to input patient
identification information)

After the calibration run, the DS5 calculates the required factor and offset and prints a
calibration report.

Refer to section 4.7.6 for how to use the calibration program.


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January 03 DS5 Analyser User Manual

4.4 Using the DS5 Analyser


Ensure that the Installation Instructions in Section 2 have been followed.

If you have not already done so, switch the DS5 Analyser ON using the main power
switch at the rear of the analyser.

The software is loaded from the disk .The DS5 Analyser gives one short beep and a series
of system checks commences.

The touch screen lights up and a copyright message is displayed until the checks have
been completed successfully.

The Main Menu is displayed on the touch screen indicating that the DS5 Analyser is
ready.

4.4.1 The Touch Screen Display


The touch screen display uses graphic icons to provide ease of operation.

The display is divided into several sections, or icons, which are touch-sensitive. Pressing
an icon leads to another level of options.
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DS5 Analyser User Manual January 03

4.5 Main Menu Options


The main menu options are as follows:

4.5.1 Run Samples


Allows the user to enter sample IDs and starts the processing of samples in
the Autosampler. See section 4.7.2

4.5.2 Change Date and Time


Allows the user to alter date and time
See section 4.7.4

4.5.3 Change Kit


Prompts the user to load a new kit.
See section 4.7.5

4.5.4 Reprint
Allows the user to reprint the results from the last batch.
See section 4.7.7

4.5.5 Maintenance Menu


Accesses the Maintenance Menu
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4.6 Second level (Maintenance Menu) Options

Maintenance menu

4.6.1 Wash

Allows the user to perform a manual wash.


See section 4.8.1

4.6.2 Decontamination

Disinfects the DS5.


See section 4.8.2

4.6.3 Diagnostics Menu

Accesses the Diagnostics software.


See section 4.9 and 6.9

4.6.4 Return to Main Menu

Accesses the Main Menu screen


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DS5 Analyser User Manual January 03

4.7 Using the Main Menu

4.7.1 Enter Sample ID


When the run samples icon on the Main Menu screen is pressed, the
following screen is displayed:

This screen is used to select the method of entry for the sample identification information.

Manual Data Entry

Press this button to select manual text entry via the touch screen.
The following screen is then displayed:-

The screen shown above allows the operator to enter numeric characters as part of the ID for
each well. By pressing the button marked A-Z, the screen display changes to:

This screen allows the operator to enter alphabetic characters as part of the ID.

These buttons toggle between the two data entry screens allowing the
use of both numbers and letters.

This button selects the well number for sample identification.


Press to advance the well number.

This button deletes only the ID for the current well.

This button prints the current sample ID list.


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January 03 DS5 Analyser User Manual

Pressing the tick button accepts the data entry and causes the ‘Select ID
Method’ screen to be displayed once again.

Press “Run Samples” to start the run.

Bar Code Data Entry

Press this button to select bar code entry of sample identification information.
The following screen is displayed:-

Press to clear all existing sample identification information. Use the Bar Code
Reader to enter the information for well 1.

This button indicates the current well number. Press to advance to the next
well number.

This button deletes only the ID for the current well number.

Press to confirm that all the sample identification data has been
entered. The following screen will be displayed once more:-

Press “Run Samples” to start the run.


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DS5 Analyser User Manual January 03

4.7.2 Run Samples

Overview

During sample analysis, the following screen is displayed:-

The autosampler icon at the left dispays the current sample number inside.
The sample tube icon is empty after sample aspiration.
The current time is displayed at the bottom.
The middle of the screen shows a timer which counts down in seconds and shows the remaining
time for the current sample to complete.

The ‘hand icon’ allows the operator to abandon the run.

See section 4.7.3 for more details.

Installing the Sample Tray


Ensure that the sample tray is seated correctly. There is a stainless steel pin underneath
the tray which fits into a slot on the base of the autosampler unit.

Rotate the tray in a counter clockwise direction to locate the slot.

When the pin is engaged in the slot, push the tray home.

If the sample tray is not seated correctly, has been removed during a run, or is missing
the following screen will be displayed:

Clear the message by correcting the mistake or pressing the abandon icon.

When a sample tray is in place it will rotate to position 1.


If there is an error in rotating the sample tray, the following error message is displayed:

Clear the error message by pressing the abandon icon. The display returns to the Main Menu
and the error log is updated (see section 6.9).
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January 03 DS5 Analyser User Manual

Check Printer Paper


Before running any samples, check that there is sufficient thermal paper installed.
If there is a red line down the side of the paper install a new roll (see section 2.8); this will
prevent the paper running out during the next batch of samples.

If the paper does run out during a run either:


wait until the end of the batch, install the new paper roll and reprint the samples (see section
4.7.7) or interrupt the batch (see section 4.7.3) and then install the roll.

Loading samples
The peristaltic pump starts operating for approximately a minute before the first sample of a
batch is loaded; this creates sufficient pressure in the system prior to analysis. The first sample
is then loaded.

The probe moves across to the first sample well. When the sample is being taken up by
the probe, the well number is displayed in the middle of the autosampler icon, and the
level of sample in the vial icon decreases.

When the sample has been loaded, the probe returns to its home position in the wash station
and the sample tray moves forwards one well ready for loading the next sample.

Analysis
After loading, the sample analysis starts and the progress is displayed by the count down timer
in the middle of the screen.
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Print Results

The print-out displays the date and time of the


analysis,the well number, the patient identification
and results.
The results are tabulated to show retention times
(seconds) and % HbA1c.
During the printing the next sample is loaded and
analysis continues.

At the end of a batch of samples a summary


report is printed.

After the summary report starts to print, the data downloading screen will be displayed.

Press ; to download the summary file. Press : to return to the Main Menu.

Press the run samples icon again to assay another batch of 1-15 samples.
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January 03 DS5 Analyser User Manual

4.7.3 Interrupting a Run

It is possible to interrupt a run in one of two ways.

Stop after sample

Remove the sample tray during a run, after the probe has returned to the wash station.

When the probe returns to sample the next well a message appears on the screen notifying
the user that there is no sample tray present.

Clear the message by pressing the abandon icon (hand).


Abandon

Press the abandon icon on the Run Samples screen.

Depending upon which stage in the process the icon is pressed,


the following can occur:

1. Abandon pressed before probe entered vial Probe returns to wash station

2. Abandon pressed after probe enters vial Flush Probe


but before analysis

3. Abandon pressed during analysis Wash Column, Flush Probe

4. Abandon pressed after analysis Flush Probe

The following screen is displayed to indicate how long the abandon process will take:
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DS5 Analyser User Manual January 03

4.7.4 Change Date and Time

Press the change date and time icon on the Main Menu screen.

The following screen appears:-

Change the time (hours and minutes) and the date (day, month, year) by pressing the up
and down arrows. Due to the size of the arrows, it is advisable to use the flat end of a
pencil to activate the up and down arrows. The date and time format can be changed (see
section 6.10, International Set-up)

When the time and date is correct press the confirm (tick) icon to enter the
information.

The new date and time is entered and the display returns to the Main menu.
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4.7.5 Change Kit

This procedure is used when loading a new kit.

Check the change kit icon on the Main Menu from time to time. The number
of tests remaining will be displayed next to the column icon, and the liquid
75 levels displayed in the reagent bottles will indicate approximately the actual
levels of reagents.

For example:

75
When a run has been requested and there are no reagents remaining to analyse that sample,
the No reagents icon will appear.

Press the no reagents icon to display the Change Kit screen or press the abandon icon to
return to the Main menu screen.

When a run has been requested and there are insufficient reagents remaining to complete the
run, the following screen appears:-

The user may choose to change the kit (left button), continue with the run (middle button) or
return to the Main Menu (right button).

Notes:

If you choose to continue with the run, make sure you only run the number of samples as
indicated. If the reagents run out during a sample, no useable result will be obtained.

The Change Kit screen can also be accessed by pressing the change kit icon on the Main
Menu screen.

Changing the Pump Tube Cassette

The pump tube cassette must be changed every 300 tests or when the first kit of a
pack of reagents is installed. Refer to section 2.4 for the procedure detailing how
to replace the cassette.
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DS5 Analyser User Manual January 03

Change Kit Screen

The following display appears:-

Column A B Waste Cancel

Change the column (see section 2.5 for details) and then press the column icon.

A tick (9) appears on the icon. This means that the task has been completed.

Change the bottle of Reagent A (see section 2.3) and then press the Reagent A icon.

Change the bottle of Reagent B and then press the Reagent B icon.

Empty the Waste bottle and then press the Waste icon.

After all the icons have been pressed, the last icon changes to a tick and the change kit
process is complete.

If this is the first of a pack of reagents, replace the pump tube cassette now before
proceeding to the next stage (see section 2.4).

Press the confirm icon.(9)

The DS5 Analyser automatically flushes the system through with the new reagents and
a message screen appears to indicate how long this process will take.

Press the abandon icon to stop this process. The calibration screen will be displayed.
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4.7.6 System Calibration

After the installation of the reagent kit is complete, the DS5 prompts the user to perform a
calibration by means of the following screen:-

Press this button to select calibration set-up.


The following calibration menu screen will be displayed:-

This screen allows you to select the method of entry for the calibration
data (assigned value and lot number). Either you can enter the information using the touch screen
or if you have the optional bar code reader, the calibration data can be read into the DS5 from the
Calibrator Kit Data Sheet.

Manual Entry of Calibration Data.

Press this button to select manual data entry when the following screen will be
displayed:-

Use the number keys to enter the HbA1c assigned value and lot number for each calibrator.
Use the “LOW” and “HIGH” buttons to select between the calibrators.
Use the “LOT NO” button to select between the lot numbers for the low and high calibrators.

The CLR button will clear the whole entry.


The DEL button will delete the last character only.

Press to accept the calibration information you have entered. This will return the
display to the calibration menu screen.
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DS5 Analyser User Manual January 03

Bar Code Entry of Calibration Data.

Press this button to select bar code data entry when the following screen will be
displayed:-

The two bar codes on the Calibrator Kit Insert contains all of the necessary data for the two level
calibrator. After entering the bar codes both assigned values and lot numbers should be displayed.

Press to accept the calibration data entered with the bar code reader.
This will return the display to the calibration menu screen.

Start Calibration Sequence

After accepting the calibration data, the display will show the calibration menu screen:-

Press this button to start the calibration sequence.

A confirmation screen is displayed to let you check the data supplied and to prompt
you to place 3 patient samples in wells 1, 2 and 3. The low calibrator sample must be placed in
well 4 and the high calibrator sample in well 5.

Press to confirm the calibration data and start the sequence.


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January 03 DS5 Analyser User Manual

The Calibration Report

The calibration sequence runs 3 patient samples in wells 1 to 3 and the low and high calibrator
samples in wells 4 and 5 respectively. After each sample has completed, the chromatogram will print as
normal. The lot numbers and entered values for the calibrator samples will appear in the Sample ID field
on the chromatogram.
At the end of the sequence, a calibration report is printed:-

The calibration report shows:-

- which calibration system is selected


- the lot numbers and assigned values for the low and high calibrators
- the factor and offset determined by the DS5 software
- the factor and offset from the previous calibration run, for comparison
- the upper and lower alarm limits set in the DS5 software for the factor and offset
- Calibration Accepted or Calibration Rejected

Note that a common reason for the calibration to be rejected is that the low and high calibrators
have been placed in the wrong wells.
Ensure that the low calibrator is in well 4 and the high in well 5.

If the calibration is rejected, the following screen will be displayed:-

You may either repeat the calibration or return to the Main Menu.
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DS5 Analyser User Manual January 03

Abandon the Calibration Sequence

The calibration sequence can be abandoned (avoided) by pressing:-

on the Select Calibration screen.

The following screen will be displayed, prompting you to confirm abandon.

Press to confirm the abandon. This will return the display to the Main Menu:-

Press to reject the abandon.


This will return the display to the Select Calibration screen:-

If you abandon the calibration, the subsequent results will be calculated using the factor and offset
stored from the last calibration run. Alternatively, the factor and offset can be entered manually by
reference to the Reagent Kit Insert - see section 6.11.

Note:

During the calibration sequence, pressing the Abandon button will return the screen to the Main
Menu.
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4.7.7 Reprint

This option recalls stored sample data from disk to the printer.
It can be used to obtain print outs of sample results that were assayed after the printer
paper ran out.

Press the reprint icon.

The following display appears:

To print all of the chromatograms stored on the disk, press :-

To select individual chromatograms to reprint, press:-

The following screen is displayed:-

The status of all 15 sample wells is displayed in the centre of the screen.

This indicates that the data from the sample in well 13 is stored on the disk.

This indicates that there is no data stored for that particular well.

Select the data to be reprinted by pressing the relevant icon.


For example, if you want data from well 12 reprinted, press

The display changes from a cross to a tick when the button is pressed.
Pressing the icon again deselects the well.

You can select as many of the wells to be reprinted as you require.

Press the confirm icon (9) to reprint the results of the well numbers selected.
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DS5 Analyser User Manual January 03

This message displays the well number relating to the data being re-printed.

Pressing this icon will print the summary table.

Pressing this icon will print the Calibration Report comprising the
chromatograms for wells 4 and 5, together with the Calibration Report Table.

Paper Feed

This allows the user to manually feed the thermal paper. This facility is also used
when installing the printer paper (see section 2.8).

Graph

Pressing the graph icon, allows the operator to choose whether the
chromatogram is printed or not.

After pressing the graph button the following screen is displayed:

Pressing the up and down arrows allows the operator to choose between graph or no
graph. Pressing the tick button accepts the user's choice. Pressing the cancel icon
cancels the operation.
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4.8 Using the Maintenance Menu

Choose the Maintenance Menu by pressing the Maintenance Menu icon on


the Main Menu screen.

4.8.1 Wash
This allows the user to perform a manual wash.

When this icon is pressed the following display appears:

Press the confirm icon (9) to start the wash. The cancel icon (X) stops the wash process and
the Maintenance Menu screen is displayed.

When a wash starts the following screen is shown:-

The timer counts down as the wash progresses. This takes approximately 300 seconds.
Press the abandon icon to stop the wash and return to the Maintenance Menu. When the
wash is finished the Maintenance Menu screen is displayed.
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4.8.2 Decontamination

Prepare the disinfectant according to the manufacturer’s instructions. We recommend


Microbiocide D (Drew Part Number 014-299) . The decontamination procedure will
take approximately 50mL of disinfectant.

Selecting this icon activates the DS5 Analyser’s decontamination routine.


The purpose of decontamination is to inactivate any virus that may have been
introduced into the DS5 Analyser from patients' samples.

After selecting the decontamination icon from the Maintenance Menu, the
decontamination screen is displayed:

Place the Reagent A tubing in the disinfectant and confirm by pressing this
icon.

A tick appears on the icon. This means that the task is completed.

Replace the existing Pink column with a Red column (blank) and confirm by
pressing this icon.

A tick appears indicating that the task is completed.

When both icons have been pressed the cancel icon (X), changes to a
confirm icon (9).

Press the confirm icon to start the decontamination process. This will take
approximately 20 minutes.
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January 03 DS5 Analyser User Manual

During this time a timer screen will appear:

The timer counts down as the decontamination process progresses. To stop this process, press
the abandon icon.

NOTE At this stage the red column is still in place and the reagent A tubing is in the
disinfectant.

When the decontamination process is complete the following screen is displayed:

Take the reagent A tubing out of the disinfectant and place in a bottle of
distilled water. Confirm this action by pressing the change to water icon.

A tick appears on the icon, and the cancel icon changes to a confirm icon.

Press the confirm icon to activate the wash with distilled water. This will
flush the disinfectant out of the instrument and takes approximately 25
minutes.

During this stage a timer screen appears as before.

Press the abandon icon, to stop this process.

When the distilled water wash is complete the Maintenance Menu screen appears.
Install Reagent A and the Pink column. Perform a wash to flush the system with Reagent A
(see section 4.8.1).
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4.9 Diagnostics Menu


The DS5 Analyser has a Diagnostics Menu. This performs some diagnostic
checks on the instrument and prints out an error log.
See section 6 for details.

4.10 Return to Main Menu


Pressing this icon, accesses the Main Menu screen.
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Precautions & Sample Requirements Page 5 - 1
DS5 Analyser User Manual January 03

5 Precautions and Sample Requirements

5.1 Operating Precautions


The DS5 Analyser is designed to be left connected to an a.c. supply.

Turn off the power before connecting either the data cable or the bar code reader.

The software disk is designed to be left in the disk drive. Never remove the disk when the disk
drive indicator light is on as the disk is being accessed) and you may damage the disk.

The maximum non destructive voltage that can be applied to the RS232 output is 5V.

Prepare samples carefully as described in Sample Collection and Preparation.

Only use Drew Scientific Limited approved reagents supplied for use with the DS5 Analyser.

Do not use reagents and columns that are past the expiry date.

Do not mix different batches of reagent.

Do not use columns for more than the recommended number of assays.

When changing columns, reagents etc always confirm each step on the touch screen.

5.2 Hazards
With the exception of the pump tube cassette, there are no user maintainable parts in the
instrument. Do not remove the cover from the DS5 Analyser.

BIOHAZARD WARNING

Decontaminate the DS5 Analyser regularly.


See section 4.8.2 for details of the decontamination procedure.

When using disinfectant, follow the manufacturer’s directions.

Gloves should always be worn when handling samples and waste materials.

All samples should be treated with the caution accorded to those known to contain pathogenic
organisms.
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January 03 DS5 Analyser User Manual

The reagents provided in the DS5 Reagent Kits contain 0.02% sodium azide:

AVOID skin contact or ingestion.


In case of skin or eye contact, wash the area thoroughly with water and seek medical attention.
In case of ingestion, wash the mouth out thoroughly with water, give plenty of water to drink
and seek medical attention.

DISPOSE of liquid waste safely in accordance with local regulations.

DO NOT allow the azide-containing waste to come into contact with heavy metals as explosive
compounds may be formed.

DO NOT allow the azide-containing waste to come into contact with acids as a toxic gas may
be liberated.

Material Safety Data Sheets for each of the constituents of the DS5 Reagents are available from
your local distributor.

5.3 Sample Requirements

5.3.1 Sample Collection and Preparation


Blood sample procurement must be carried out under proper medical supervision, including site
selection, specific procedures utilised, and sample handling documentation. Sterile technique
is required at all times to avoid infection of the puncture site. The specific details of any collection
must be approved by the medical person responsible.

Blood samples should be collected into EDTA-coated tubes. Store samples at 4°C.

Prepare the haemolysate as soon as possible after sample collection using the Drew Dispenser
and 1 pipette tip per sample.

Haemolysed samples are stable for 2 days at 4°C.

NOTES

Values for HbA1c in patients with elevated levels of HbF will be raised because HbF is not
separated from HbA1c. Very rare variants that co-elute with HbA1 fractions will also give
abnormally high values for HbA1c.

The presence of labile (or pre-HbA1c) interferes with the measurement of HbA1c and will lead
to raised values. However if samples are prepared in accordance with the following procedure,
Precautions & Sample Requirements Page 5 - 3
DS5 Analyser User Manual January 03

using the haemolyser supplied, more than 90% of the labile HbA1c is destroyed.

The Dispenser unit supplied with the DS5 Analyser is designed to eliminate labile HbA1c from
samples before analysis. It achieves this by raising the haemolyser/diluent temperature in a
patented procedure (EP0663072 & US5739037).

No interference was detected from bilirubin at levels of up to 40mg / dL or from triglycerides


at up to 1g / dL.

All samples must be treated with the caution accorded to those known to contain pathogenic
organisms.
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Maintenance and Troubleshooting Page 6 - 1
DS5 Analyser User Manual January 03

6 Maintenance and Troubleshooting


WARNING With the exception of the pump tube cassette there are no user maintainable
parts in the instrument and on no account should the cover be removed.

6.1 Visual Inspection


At each kit change we recommend that the user visually inspects the DS5 Analyser, checking
for any leaks. If any of the tubing is showing signs of wear then contact your local distributor.

CAUTION The pump tube cassette must be changed after 300 tests (see section 2.4).
A replacement is supplied with each Pink 300 Test Reagent Kit.

6.2 Cleaning Instructions


Stainless steel areas may be cleaned. Wear gloves, and wipe with soft tissues, distilled water
and alcohol disinfectant where necessary.

The touch screen should be cleaned from time to time with isopropanol (isopropyl alcohol)
using lint-free wipes. Use fingertips when operating the screen. AVOID abrasives , sharp edges
and metals.

With the instrument switched off, wipe the exterior of the instrument from time to time with a
cloth lightly dampened with water and alcohol disinfectant. No other sterilising should be
carried out.

6.3 Fuse Replacement


The fuses for the DS5 are located in the power inlet connector.

WARNING For continued protection against fire hazard, only use the same type and
rating of fuse originally fitted in the analyser.

1. Remove the power cord to access the fuse holder.

2. Insert a small screwdriver into the lip of the fuse holder and gently prise it open.

3. Withdraw the cartridge containing the fuses and replace as necessary.


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January 03 DS5 Analyser User Manual

6.4 Troubleshooting
If the DS5 Analyser fails to produce correct results there are three areas of the system to
examine.

The chemistry (i.e. the column or the reagents).


The software (i.e. the program disk has become corrupted).
The hardware (i.e. a component inside the DS5 has failed).

6.4.1 The Chemistry


The system continuously produces repeatable traces no matter which column or which batch
of reagents are in use. Occasionally however it is noticeable that the shape or the retention time
of the peaks and hence the accuracy of the analysis can become degraded.

If this should happen first check the expiry date of the reagents. If they are out of date change
them for a new batch immediately.

If no improvement has been found check the column. It is possible that it has been overused
and is no longer separating the haemoglobin fractions correctly. It must only be used for the
specified number of tests; beyond that number the accuracy of the results can not be guaranteed.

If the column and reagents have been recently changed and no improvement in the trace or the
results is noted, it is likely to be a hardware fault that is causing the problem. However, changing
the column is very quick and easy to do and is a good way of confirming whether it is definitely
a hardware problem.

6.4.2 The Software


A software problem is usually indicated by a failure of the system to start up correctly.

Replace the disk in use with the backup disk. If this also fails then it could be due to faulty
software.

6.4.3 The Hardware


There is a diagnostics program on the DS5 Analyser which gives the user the option to perform
some diagnostic checks on the instrument. The user will also be able to print out the error log.

In the case of possible hardware failure contact your local distributor.


Maintenance and Troubleshooting Page 6 - 3
DS5 Analyser User Manual January 03

6.5 Diagnostics Menu


Select the Maintenance Menu icon from the Main Menu screen.

The Maintenance Menu screen appears:

Press the Diag icon to access the Diagnostics software.

The Diagnostics screen appears:

Facilitates diagnosis of Autosampler faults


(see section 6.6)

Facilitates diagnosis of main instrument faults


(see section 6.7)

Facilitates diagnosis of Touch Screen faults


(see section 6.8)

Press to access the software loading screen


(see section 6.9)

International Set-up
(see page 6-10)

Factor & Offset Editing and Selection of Calibration System (see section 6.11)

Return to Maintenance menu


Page 6 - 4 Maintenance and Troubleshooting
January 03 DS5 Analyser User Manual

6.6 Autosampler Diagnostics


The Autosampler Diagnostics are accessed by pressing the autosampler icon.

A display similar to the one shown below appears:

6.6.1 Control icons


There are 4 control icons.

Move probe

This icon moves the or the probe to


probe to the vial the wash station

The icon changes to reflect the current position of the probe.

Locate position 1.
The sample tray rotates to position 1.

Locate vials continuously


The sample tray rotates continuously. When this is selected a display similar to the
following appears:

The vial number updates every time the probe enters a vial.
Pressing the abandon icon (hand) stops the rotation.
Pressing the locate position 1 icon displays the same screen but the number of vials is not
updated.
If the abandon icon is pressed the sample tray stops rotating. When the autosampler has
located position 1 the abandon icon disappears.
Maintenance and Troubleshooting Page 6 - 5
DS5 Analyser User Manual January 03

Status Boxes
There are 6 Status boxes which track the position of the probe and presence of the sample tray
and vial.
The status is indicated by a cross (X) or tick.(9)
If for example there is a vial present a tick appears.
If there is no vial present the tick changes to a cross.

1. Probe in Vial ?

2. Probe between Wash station and Vial ?

3. Sample tray present ?

4. Probe in Wash Station ?

5. Vial Present?

6. Sample tray in position 1?

Return to main Diagnostics Menu


By pressing this icon the operator is returned to the main diagnostics menu.
Page 6 - 6 Maintenance and Troubleshooting
January 03 DS5 Analyser User Manual

6.7 Main Instrument


The following screen appears when the instrument icon is pressed:

This screen helps the service engineer diagnose an instrument fault.

Version of DS5 Multi-Functional (GMG) board installed.

Displays the current detector ADC reading.


The ADC reading should be nominally 20,000 - 23,000.
Make sure that the peri-pump is running when the ADC reading is taken.

Switches the sample inject valve between load (L) and elute (E) positions.

Switches valve 1 ON (solid line) or OFF (dotted line)


Valve 1 controls the flow of Reagent A into the wash station.

Switches the peristaltic pump ON or OFF

Switches the detector lamp ON or OFF

Count: Total number of samples run on instrument

Adjusts the ratio of Reagent A to Reagent B.

Pressing the up and down arrows adjusts the % of Reagent A. The arrows have
an auto-repeat function.

Returns to the Main Menu


Maintenance and Troubleshooting Page 6 - 7
DS5 Analyser User Manual January 03

6.8 Touch Screen


Pressing the touch screen button displays the following screen:

As each cell is pressed it toggles between a black spot, a cross and back to a blank
cell.

Pressing the arrow returns the user to the main diagnostic menu.

6.9 Software Loading


Pressing the software loading button displays the following screen:

This screen is used to load the software program and glyco.ini files from floppy
disk into the DS5 flash memory, to adjust the LCD settings, to print the saved error
log and to return to the previous menu.

Loads the software program from floppy to disk to the DS5 flash memory.
Ensure that the correct floppy disk with the required program version is inserted
into the disk drive before pressing the button.

Loads the glyco.ini file from floppy to disk to the DS5 flash memory.
Ensure that the correct floppy disk with the required program version is inserted
into the disk drive before pressing the button.

Toggles between two LCD display modes. If the display seems to be offset to one
side, try pressing this button to correct it.

Prints out the error log (next section 6.9.1).

Returns the display to the previous menu.


Page 6 - 8 Maintenance and Troubleshooting
January 03 DS5 Analyser User Manual

6.9.1 Error Messages

1000 Out of memory Not enough memory to continue.


Switch off and report problem to
supplier.

1001 Missing language file Cannot find a GMF file

1002 Missing glyco.ini file. Infile error %d No glyco.ini file The %d represents the
error number

1003 Missing screen driver - %s No screen driver named by the %s e.g.


ega, vga, bgi

1004 Cannot initialise display Problem initialising the display

1005 Missing settings .ini file. Infile error %d No settings.ini file. The %d represents
the error number.

1006 Cannot find printer driver %s The printer driver named by %s cannot
be found e.g. thermal.bgi

1007 Error %d Loading Resource file %s Error loading the data file with the icons
in the %d represents the error number.
The %s is the file e.g. g15.dat

1008 Control error: %s A control sequence has failed. The %s


is the failure e.g. timeout at line 5.

1012 File Not Initialised File error - contact supplier

1013 File Not Open File error - contact supplier

1014 File No record File error - The file is not of the correct
structure or has become corrupted.

1015 Invalid record pointer File error - The file is not of the correct
structure or has become corrupted.

1016 Couldn't Read File File error - The file is not of the correct
structure or has become corrupted.

1017 File no open mode File error - The file is not of the correct
structure or has become corrupted.

1018 Couldn't Write in file File error - The file is not of the correct
structure or has become corrupted.

1019 Could not make file File error - The file is not of the correct
structure or has become corrupted.

1020 Too many files already open File error - contact supplier

1021 File already open File error - contact supplier


Maintenance and Troubleshooting Page 6 - 9
DS5 Analyser User Manual January 03

1022 File doesn't exist File error - the file could not be found.

1023 Bad file File error - The file is not of the correct
structure or has become corrupted.

1024 Bad version File error - The file is not of the correct
structure or has become corrupted.

1025 Bad issue File error - The file is not of the correct
structure or has become corrupted.

1026 Bad type File error - The file is not of the correct
structure or has become corrupted.

1027 Bad class File error - The file is not of the correct
structure or has become corrupted.

1028 Invalid key type File error - The file is not of the correct
structure or has become corrupted.

1029 No index File error - The file is not of the correct


structure or has become corrupted.

1030 Too many indexes File error - The file is not of the correct
structure or has become corrupted.

1031 File already exists File error - the file already exists

1032 File not locked File error - contact supplier

1033 Error in loading chromatogram The chromatogram file could not be


loaded due to a file error.

1034 GETPOINT out of range %d Trying to get a data point out of range.
The %d is the actual point number.

1035 SETPOINT out of range %d Trying to set a data point out of range.
The %d is the actual point number.

1036 GETPEAK out of range %d Trying to get a peak that doesn't exist.
The %d is the peak number.

1037 SETPEAK out of range %d Trying to set a peak that doesn't exist.
The %d is the peak number.

1038 Could not save summary file Error in saving the summary file.

1039 Printer driver error %d Error in the printer driver. The %d is the
error number. Contact supplier.

1040 Cannot switch to VDU %d Error in switching from printer to screen


The %d is the error number.

1041 Cannot print - error %X Error in printing - %X is a IIex error code.


Contact supplier.
Page 6 - 10 Maintenance and Troubleshooting
January 03 DS5 Analyser User Manual

1042 Cannot create file %s Cannot create the file named by %s.

1043 Cannot open file %s Cannot open the file named by %s.

1044 Cannot write to file %s Cannot write to the file named by %s.

1045 Cannot read file %s Cannot read the file named by %s.

1051 Error %s loading font Could not load in a required font. The %s
is the actual error that occurred.

1108 Restart DS5 for changes to take effect Appears when change language in
diagnostics.

1125 No IFCC Calibration Data available Data not present in the bar code.
Maintenance and Troubleshooting Page 6 - 11
DS5 Analyser User Manual January 03

6.10 International Set-up

Pressing the International Set-up icon displays the following screen:

Select the date format you prefer.

Select the time format you prefer.

Press the confirm icon (9) to update the relevant files.

If the cancel icon (X) is pressed this will not alter the settings in the files.
Page 6 - 12 Maintenance and Troubleshooting
January 03 DS5 Analyser User Manual

6.11 Factor & Offset Editing and Selecting the Calibration System

This icon enables the user to edit the factor and offset and to select the
calibration system. The following screen is displayed:

Initially the current Factor is displayed. This value can be edited using the
number and delete buttons. Pressing the Offset button causes the Screen to
display the Offset Value :-

Offset: -0.1000

The Calibration system is selected by toggling between NGSP and IFCC.


Press the button until the desired calibration system is displayed. Enter
numbers as required.
If the cancel button is pressed (X) the original values for the factor, offset
and calibration system are used. If the OK button is pressed (9) the new
values are stored in the glyco.ini file and will be used for all subsequent results
calculations. You will then return to the diagnostics menu.

Press to return to Maintenance Menu

The Maintenance Menu screen appears:

Press this icon to return to the Main Menu (see section 4.5)
Specifications Page 7 - 1
DS5 Analyser User Manual January 03

7 Specifications

7.1 Samples
Whole blood, properly collected into EDTA-coated tubes, 20µL, prepared and stored as
described in Section 5.

7.2 Environmental Conditions

Operation
Temperature Range: 15°C to 30°C
During operation the temperature must not vary by
more than +/- 2°C.
Humidity Range: 10 to 80 % (non condensing)

Transportation and Storage


Temperature Range: -5°C to 40°C
Humidity Range: 5 to 80% (non condensing)

Power Requirements
Fuse Rating: 120V-20mm Semi-delay T6.3A
240V-20mm Antisurge T3.15A
Power Rating: 300VA
Voltage: 110/115V or 220/240V 50/60Hz

7.3 Assay Time


Standard HbA1c (Pink Kit) 5 minutes/sample

7.4 Size
Width: 270mm (11 inches)
Depth: 415mm (16 inches)
Height: 355mm (14 inches)
Weight: Approx. 20Kg (44 lbs)

7.5 Autosampler
15 sample positions

7.6 Thermal Printer


Thermal Graphics Printer, 42 chrs/line, 256 pixels width
Page 7 - 2 Specifications
January 03 DS5 Analyser User Manual

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Spares & Accessories Page 8 - 1
DS5 Analyser User Manual January 03

8 Spares and Accessories

8.1 Ordering Information


To ensure that your order is dealt with quickly and efficiently, please give the following
information when ordering spares or accessories.

• DS5 Analyser serial number


• Drew Part Number
• Description
• Quantity required

The number shown in the Quantity column is the number of items supplied against that part
number. If the quantity is more than 1, only multiples of that number can be supplied.

8.2 Spares and Accessories

Drew Description Quantity


Part No.

002-001S Fuses, 3.15A for 240V operation 4


002-063S Fuses, 6.3A for 120V operation 4
270-813 UK Power Supply Lead (UK operation) 1
270-813 ROW Power Supply Lead (European operation) 1
270-813 USA Line Cord (US operation) 1
014-110 Empty Red Column, pack of 10 1 pack
274-030S Model DS5 Program Disks (GMG) 2
274-031S Model DS5 Program Disks (GMF) 2
014-200 HbA1c Pink 75 Test Reagent Kit 1
014-350 HbA1c Pink 300 Test Reagent Kit 1
003-605S Thermal Printer Roll 2
250-106S Pump Tube Cassette 1
014-299 Microbiocide D for decontamination 500mL
002-161S Bar Code Reader 1
002-149S Data Cable 1
002-935S RS232 Switch Box 1
014-380 HbA1c Calibrator Kit 1
014-175 Glycated Haemoglobin Two Level Control Kit 1
Page 8 - 2 Spares & Accessories
January 03 DS5 Analyser User Manual

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References Page 9 - 1
DS5 Analyser User Manual January 03

9 References
1. Thorpe, S.R. & Baynes, J.W.(1982) in The Glycoconjugates,
(Horowitz,M.I.,ed) Vol.3, p113-132, Academic Press,
New York, USA.
2. Rahbar, S.(1968) Clin.Chim.Acta, 22, 296.
3. Koenig, R.J. et al (1976) N.Engl.J.Med. 295, 417.
4. Garlick, R.L. et al (1983) J.Clin.Invest. 71, 1062.
5. Ersser, R.S. et al (1986) Biomed. Chromatogr. 1, 183.
6. Ersser, R.S. et al (1987) J.Auto.Chem. 9, 92.
7. Ersser, R.S. et al (1991) Biomed. Chromatogr. 5, 226.
Page 9 - 2 References
January 03 DS5 Analyser User Manual

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Appendix A A-1 of 12
DS5 Analyser User Manual January 03

Appendix A User Manual Supplement

1. Introduction
This supplement has been produced to accompany the User Manual with a view to help new
Users produce good results once a new DS5 analyser has been installed. It is however on no
account meant as a replacement to reading the User Manual fully.

The Analyser should be installed as instructed in Section 2 of the DS5 User Manual. In
addition, the User should read through Section 3 in order to get a feel for the way in which
the Analyser works.

Once the instrument has been installed the User should follow the following instructions:
A-2 of 12 Appendix A
January 03 DS5 Analyser User Manual

2. Getting the DS5 Analyser warmed up


1. Press this icon to enter the Diagnostics Menu (User Manual, section 6-5)

2. Press this icon to enter the Main Instrument menu (User Manual, section
6-7).

The following screen is displayed:

3. Turn on the peristaltic pump by pressing this icon.

4. Turn on the lamp by pressing this icon.

5. Using the up/down arrows, adjust the ratio of reagent A to reagent B


until it reads 50%. Leave the Analyser running for approximately 20
minutes in order to purge any air bubbles that may be in the system.

6. In the meantime, check the following;

• the pump tube cassette is correctly in position

• the clip levers should all be pointing to about 11 'o' clock


(page 2-4)

• the pump is turning, that reagent from both reagent bottles


is moving along the tubing towards the back of the Analyser

• the column is seated properly, the Knurled nut is finger tight

• there is no liquid seeping from around the column.

By the end of the 20 minute period the majority of the air initially in the
Analyser should have been replaced by liquid and reagent should be
emerging from the waste outlet.
Appendix A A-3 of 12
DS5 Analyser User Manual January 03

7. If the reagents are not flowing through the analyser check that the reagent bottle
tubing is below the level in the bottle.

8. With the lamp on, check the ADC reading. It should be showing a value between
20,000-21,000. If the value is less than this or if the value fluctuates to values
below 20,000 then this is a sign that there is an air bubble trapped in the flow
cell.
A-4 of 12 Appendix A
January 03 DS5 Analyser User Manual

3. Removal of Air bubbles trapped in the flow cell.


The most common problem encountered by new Users is the removal of air bubbles trapped
within the flow cell particularly when it is first installed. There are a number of methods which
may be employed to remove trapped air bubbles, most of which utilise a sharp change in
pressure within the flow cell which tends to dislodge the bubbles.

1. While the Analyser is running, take hold of the waste outlet tubing and squeeze in order
to stop the flow of waste out of the instrument. Continue to squeeze for about three
minutes in order to cause a build up of pressure in the flow cell , then release, repeat 3-
4 times or until ADC reading reaches 20,000-21,000.

2. If the above method does not work then again while the Analyser is running, undo
the Knurled nut of the column holder slightly then tighten again.

3. Try switching the sample inject valve between load (L) and elute E, in the
Diagnostics, Main Instrument menu.

4. Alternatively, try running 5 test blood samples through the Analyser, the first few
traces may well be very poor indeed. The sloping baselines in Traces 1 and 2 are
typical of an air bubble trapped in the flow cell, however traces should get better.

Trace 1
Appendix A A-5 of 12
DS5 Analyser User Manual January 03

Trace 2

By the fifth sample, traces should have flat horizontal baselines.

5. The final method involves removal of the Stainless Steel detector cover as follows;

• Enter Diag, Main Instrument.

• Stop the peristaltic pump.

• Open the instrument door.

• Undo the thumb screw at the centre of the back plate, behind the column.

• Slide the tray forward until the detector cover can be accessed easily.

• Undo the 2 hex drive screws which secure the detector cover to the base tray.

• Slide the detector cover forwards to remove it.

• This will reveal 5 coloured plastic nuts.

• Restart the peristaltic pump, then quickly loosen then retighten the Yellow plastic
nut, this should cause the ADC reading to increase. Repeat until the ADC reading
is between 20,000-21,000.

If none of the above methods help then there may be another problem with the instrument for
instance, the detector may need realigning or there may be a leak (contact a Service Engineer).
A-6 of 12 Appendix A
January 03 DS5 Analyser User Manual

4. Troubleshooting

4.1 Analyser will not Boot-up

Turn on
instrument

Does Check mains


No
the analyser connection and
respond? fuses, then retry

Analyser starts Still no response,


Yes
to boot up call Service
Engineer

Does
Analyser Yes
Analyser is OK continue with
complete the
installation procedure
boot- up
stage?

No

Insert Back-up Original Disk faulty,


Disk and re-boot return to supplier for
checking

Does
Analyser Yes
complete the
boot- up
stage?
No Maybe a Hardware
problem, Call Service
Engineer
Appendix A A-7 of 12
DS5 Analyser User Manual January 03

4.2 No Peaks

Is Is
No Probe No Autosampler
Sample
moving to Problem, Call
taken up?
Vial? Service Engineer

Yes

Yes
Is Vial in No Place Vial
place and correctly
flat? and rerun

Yes

Is
Install Pump
Pump tube No
tube cassette
cassette installed
correctly and
correctly?
rerun

Yes

Was new Pump tube No Install new Pump


cassette installed within tube cassette and
last 300 Samples? rerun

Yes

Is Pump No Severe Blockage or


turning? Hardware Failure, Call
Service Engineer

Yes
Continued on
next page
A-8 of 12 Appendix A
January 03 DS5 Analyser User Manual

Check Kit is
installed correctly

Check Check Lamp/


Reagents Check Column Detector, ADC
reading in Diag

Sufficient No Install Install


new kit No Pink
Reagent in Is there a Pink
bottles? and rerun column in place? column
and
rerun
Yes
Yes
Re seat
Are column,
reagents No Swop Any Yes making sure
connected tubing, leaks around that the
to correct flush and column? Knurled nut
tubing? rerun is finger
tight and
No rerun

Yes Column may be


blocked, install a new
one and rerun, if still
no peaks, Call a
Service Engineer
Are
Reagent Push tubing
No
below liquid What
tubes below
level and > 20,000 and is the ADC
liquid level?
rerun steady ? reading in
Diag?

Yes Peak Dectection


Problem, Call < 20,000 and/or
Service Engineer fluctuating ?
Are
Reagent Yes Untighten
caps too and rerun Possible Air in
tight? flow cell or
lamp requires
replacing
Reagents OK
Appendix A A-9 of 12
DS5 Analyser User Manual January 03

4.3 Unusual Peak Shapes/Retention Times

Run Samples

Maybe a leak/
Early? Blockage
Are Peak No
Retention times
OK?
Maybe a Blockage.
Late?

Yes

Has Expiry Change Kit


Yes
date of Kit immediately
elapsed? and rerun

No

Change Kit
Yes
Has column been immediately
over used? and rerun

No

Maybe a Hardware
Problem, Call the
Service Engineer
A-10 of 12 Appendix A
January 03 DS5 Analyser User Manual

4.3.1 Early Peaks

Do Peaks elute No Yes Leak on B line,


Any liquid
within first 60 Call Service
under instrument?
seconds? Engineer

No
Yes Reseat
column,
making sure
Any leaks Yes
that the
around column?
Knurled nut is
Install finger tight
Are Reagents No Reagents and rerun
the correct way correctly No
around? and run
samples
again Are
Yes Reagent No Push tubing
tubes below below liquid
liquid level? level and
rerun
What is ADC
reading in Diag? Yes

Are
Reagent Yes Untighten
> 20,000 and caps too and rerun
steady tight?

< 20,000
and/or No
fluctuating
Peak Dectection
Problem, Call
Service Engineer
Possible Air in
flow cell or
lamp requires
replacing
Appendix A A-11 of 12
DS5 Analyser User Manual January 03

4.3.2 Late Peaks

Do Samples Yes Blockage, Change column, spin


contain cell samples and rerun. If problem
debris? not solved call Service Engineer

No

Yes Leak on A line,


Any liquid under
Call Service
instrument?
Engineer

No

Any leaks Yes Reseat column, making


around column? sure that the Knurled nut is
finger tight and rerun

No

Yes Are Yes


Are Reagent tubes Untighten
Reagent caps
below liquid level? and rerun
too tight?

No No

Push tubing
below liquid Was new Pump No Install new Pump
level and tube cassette installed tube cassette and
rerun within last 300 rerun
Samples?

Yes Peak Detection problem,


Call Service Engineer
A-12 of 12 Appendix A
January 03 DS5 Analyser User Manual

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Health and Safety Information Page B-1
DS5 Analyser User Manual January 03

Appendix B Health and Safety Information

DS5 Analyser Pink Reagent Kit


Product Silica, surface modified
Hazard Class NR UN No CAS No 7631-86-9

Physical data
Description Fine white powder
M Pt(deg C) n/a B Pt(deg C) n/a Specific gravity n/a
Solubility in water Immiscible in water or insoluble
Vapour pressure n/a mmHg at Deg. C
Vapour density n/a (air=1)
Fire and Explosion Hazard Not applicable
Flash point(deg C) n/a
Explosive limits(%): lower n/a,upper
Auto-ignition temperature Not applicable
Health Hazard Has drying effect on skin. Causes temporary discomfort to eyes, possibly with
physical damage. Chronic exposure to dust may cause silicosis.
Toxicity Data No data found
Carcinogenicity No evidence of carcinogenic properties
Mutagenicity/teratogencity No evidence of mutagenic or teratogenic effects
Exposure limits None established

First Aid
Eyes Irrigate thoroughly with water. If discomfort persists obtain medical attention.
Lungs Remove from exposure
Mouth Wash out mouth thoroughly with water. In severe cases obtain medical attention.

Reactive Hazards
Stability Stable
Reaction with water None
Other known hazards Can cause violent reaction in contact with oxygen difluoride, with vinyl acetate and
magnesium
Avoid contact with: Water(no) Bases(no) Oxidisers(no) Combustibles(no)

Spillage Disposals
Precautions Wear appropriate protective clothing
Carefully sweep up and dispose of in accordance with local regulations. For large
spillages liquids should be contained with sand or earth and both liquids and solids
transferred to salvage containers. Any residues should be treated as for small
spillages.
If materials has entered surface drains it may be necessary to inform local authorities,
including fire service if flammable.

Storage and Handling


Special requirements None
Page B-2 Health and Safety Information
January 03 DS5 Analyser User Manual

Product NN-Bis(2-hydroxyethyl) (iminotris) (hydroxymethyl)methane (Bis-Tris)


Hazard Class NR UN No CAS No 6976-37-0

Physical data
Description White crystalline powder
M Pt(deg C) n/a B Pt(deg C) n/a Specific gravity n/a
Solubility in water Soluble
Vapour pressure n/a mmHg at Deg. C
Vapour density n/a (air=1)
Fire and Explosion Hazard May evolve toxic fumes in fire
Flash point(deg C) n/a
Explosive limits(%): lower n/a,upper
Auto-ignition temperature Not applicable
Firefighting measures Not applicable
Health Hazard Human toxicity unknown, but expected to be slight. Exercise caution in handling
material.
Toxicity Data No data found
Carcinogenicity No evidence of carcinogenic properties
Mutagenicity/teratogencity No evidence of mutagenic or teratogenic effects
Exposure limits Not assigned (Long-term, 8 hour TWA)

First Aid
Eyes Irrigate thoroughly with water. If discomfort persists obtain medical attention.
Lungs Remove from exposure
Skin Wash off thoroughly with soap and water.
Mouth Wash out mouth thoroughly with water. In severe cases obtain medical attention.

Reactive Hazards
Stability Stable
Reaction with water None
Other known hazards No data
Avoid contact with: Water(no) Bases(no Oxidisers(no) Combustibles(no)

Spillage Disposals
Precautions Wear appropriate protective clothing
Mix with sand, transfer carefully to container and arrange removal by disposal
company. Wash site of spillage thoroughly with water and detergent.
For large spillages liquids should be contained with sand or earth and both liquids and
solids transferred to salvage containers. Any residues should be treated as for small
spillages.
If materials has entered surface drains it may be necessary to inform local authorities,
including fire service if flammable.

Protective measures as appropriate to quantities handled


Respirator Dust Mask
Ventilation Not applicable
Gloves Rubber or plastic
Eye protection Goggles or face shield
Other measures Plastic apron, sleeves, boots-if handling large quantities

Storage and Handling


Special requirements None
Health and Safety Information Page B-3
DS5 Analyser User Manual January 03

Product Sodium azide


Hazard Class 6.1 UN No 1687 CAS No 7631-86-9

Physical data
Description Colourless crystals
M Pt(deg C) n/a B Pt(deg C) n/a Specific gravity n/a
Solubility in water Very soluble
Vapour pressure n/a mmHg at Deg. C
Vapour density n/a (air=1)
Fire and Explosion Hazard May explode if heated.May evolve toxic fumes in fire.
Flash point(deg C) n/a
Explosive limits(%): lower n/a,upper
Auto-ignition temperature Not applicable
Health Hazard Very toxic by ingestion and inhalation, causing somnolence, headache, irritability
and gastric disturbances. Irritating to skin and eyes.
Toxicity Data LD50 27 mg/kg oral, rat
Carcinogenicity No evidence of carcinogenic properties
Mutagenicity/teratogencity Evidence of mutagenic effects
Exposure limits OES, mg/m3 0.3 (Long-term, 8 hour TWA)

First Aid
Eyes Irrigate thoroughly with water for at least 10 minutes. Obtain medical attention.
Lungs Remove from exposure, rest and keep warm. In severe cases obtain medical
attention.
Skin Wash off skin thoroughly with water. Remove contaminated clothing and wash
before re-use. Obtain medical attention.
Mouth Wash out mout thoroughly with water and give plenty of water to drink. Obtain
medical attention.
Reactive Hazards
Stability Stable unless heated.
Reaction with water Slow at ambient temperartures unless water contains dissolved carbon dioxide.
decomposes violently in hot water.
Other known hazards Contact with acids liberates highly toxic gas. forms readilily detonatable salts with
many metals particularly heavy metals. Can react violently with bromine or chromyl
chloride. forms explosive products with carbon disulphide.
Avoid contact with: Water(no) Bases(no) Oxidisers(no) Combustibles(no)

Spillage Disposals
Precautions Wear appropriate protective clothing. Inform others to keep at a safe distance.
Spread soda ash liberally over the spillage. If local regulations permit, mop up
cautiously with plenty of water and run to waste, diluting greatly with running water.
Otherwise transfer to container and arrange for removal by disposal company.
wash site of spillage thoroughly with water.
For large spillages liquids should be contained with sand or earth and both liquids and
solids transferred to salvage containers. Any residues should be treated as for small
spillages.
If materials has entered surface drains it may be necessary to inform local authorities,
including fire service if flammable.

Protective measures as appropriate to quantities handled


Respirator Dust Mask
Ventilation Not applicable
Gloves Rubber or plastic
Eye protection Goggles or face shield
Other measures Plastic apron, sleeves, boots-if handling large quantities.

Storage and handling


Special requirements Avoid contact with copper, lead, mercury and other heavy metals, particularly in
drainage systems.
Page B-4 Health and Safety Information
January 03 DS5 Analyser User Manual

Product Sodium chloride


Hazard Class NR UN No CAS No 7647-14-5

Physical data
Description Colourless crystals or white crystalline powder
M Pt(deg C) 804 B Pt(deg C) 1413 Specific gravity 2.17
Solubility in water Very soluble in water
Vapour pressure n/a mmHg at Deg. C
Vapour density n/a (air=1)
Fire and Explosion Hazard Not applicable
Flash point(deg C) n/a
Explosive limits(%): lower n/a,upper
Auto-ignition temperature Not applicable
Firefighting measures Not applicable
Health Hazard Ingestion of large amounts may cause diarrhoea, nausea, vomiting, hypernoea and
convulsions. may irritate eyes.
Toxicity Data LD50 3000mg/kg oral, rat
Carcinogenicity No evidence of carcinogenic properties
Mutagenicity/teratogencity Evidence of reproductive effects
Exposure limits Not assigned (Long-term, 8 hour TWA)

First Aid
Eyes Irrigate thoroughly with water. If discomfort persists obtain medical attention.
Lungs Remove from exposure
Skin Wash off thoroughly with soap and water.
Mouth Wash out mouth thoroughly with water. In severe cases obtain medical attention.

Reactive Hazards
Stability Stable
Reaction with water None
Other known hazards No data
Avoid contact with: Water(no) Acids(no) Bases(no) Oxidisers(no) Combustibles(no)

Spillage Disposals
Precautions Wear appropriate protective clothing.
If local regulations permit, mop up cautiously with plenty of water and run to waste,
diluting greatly with running water. Otherwise transfer to container and arrange for
removal by disposal company. Wash site of spillage thoroughly with detergent and
water.
For large spillages liquids should be contained with sand or earth and both liquids and
solids transferred to salvage containers. Any residues should be treated as for small
spillages.
If materials has entered surface drains it may be necessary to inform local authorities,
including fire service if flammable.

Protective measures as appropriate to quantities handled


Respirator Dust Mask
Ventilation Not applicable
Gloves Rubber or plastic
Eye protection Goggles or face shield
Other measures Plastic apron, sleeves, boots-if handling large quantities

Storage and Handling


Special requirements None

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