Norma NICA-AL50 User manual

Operator’s Manual
for assembly, setup and operation
Norma Autoloader
Norma Instruments Zrt.
Papírgyár u. 58-59, 1038 Budapest, HUNGARY
Arany János u. 11-13, 3530 Miskolc, HUNGARY
PRODUCT CODE: NICA-AL50
ICON-5 SW VERSION: 1.5.1318.0 or higher
ISSUE DATE: 2021.03.22.
MANUAL REVISION: v04

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Table of Contents
1. INTRODUCTION................................................................................................3
WHO SHOULD READ THIS MANUAL?...................................................................................3
INTENDED USE ...............................................................................................................3
DISCLAIMER...................................................................................................................3
FEATURES .....................................................................................................................4
LIMITATIONS..................................................................................................................4
SAFETY MEASURES,NOTES................................................................................................5
SYMBOLS ON THE OUTSIDE OF THE AUTOLOADER ..................................................................6
TECHNICAL CONTACT.......................................................................................................7
WARRANTY ...................................................................................................................8
2. PACKAGE CONTENTS........................................................................................9
3. INSTALLATION REQUIREMENTS .....................................................................10
4. IDENTIFICATION OF PARTS.............................................................................11
FRONT VIEW................................................................................................................11
REAR VIEW..................................................................................................................11
SIDE VIEW ...................................................................................................................12
TRAY..........................................................................................................................12
ASSEMBLED VIEW .........................................................................................................13
5. INSTALLATION................................................................................................14
ADJUSTMENTS .............................................................................................................14
6. OPERATION....................................................................................................15
7. AUTOLOADER FUNCTIONS IN ICON-5 SOFTWARE ..........................................17
RUNNING SAMPLES USING AUTOLOADER...........................................................................19
Selected samples mode .......................................................................................20
Full Scan Mode ....................................................................................................21
DEFINE INDIVIDUAL SAMPLE INFORMATION (OPTIONAL) .......................................................22
AUTOMATIC SCANNING..................................................................................................23
PAUSE –RESUME OPERATION.........................................................................................24
8. DISASSEMBLY FOR STORAGE OR TRANSPORTATION......................................25
9. MAINTENANCE...............................................................................................25
10. SPECIFICATIONS.........................................................................................26
11. TROUBLESHOOTING...................................................................................27
12. REVISION HISTORY.....................................................................................29

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1. Introduction
Norma Autoloader is an accessory for Norma Icon-5 automated hematology
analyzer series with closed sample vial opening. Installing the Autoloader
allows the Icon-5 processing up to 50 samples without operator interaction.
The Autoloader features built-in sample mixing and sample barcode scanning.
Who should read this manual?
This manual is written for operators of the Autoloader describing the structure,
daily routine and basic maintenance required to keep the Autoloader in good
working condition to ensure reliable and dependable operation.
Intended use
Norma Autoloader can only be used with a Norma Icon-5 automated
hematology analyzer with closed sample vial opening. The Autoloader is
designed to further automate the operation of the analyzer by allowing the
processing of up to 50 sample vials without operator interaction.
Disclaimer
The manufacturer reserves the right to:
-modify the contents of this manual without prior notice,
-change technology applied within the Autoloader without prior notice,
-change technical specifications without prior notice.
The manufacturer does not warrant this manual to be 100% free of
unintentional errors.
Please note that this manual may be revised without prior notification. The
manufacturer reserves the right to change the specifications of the product
and/or the contents of this manual as deemed necessary, without prior notice.
Pictures included in this manual may differ from the actual delivered product.
Performance and reliability are never influenced by minor visual differences
between this manual and the actual product.

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Features
-Operation when connected to Icon-5 analyzer: selected or continuous
loading of vials into Icon-5’s closed sample vial opening.
-Vial detection logic (empty vial spaces are skipped).
-Mixing of samples in a separate mixing position prior to sampling.
-Sample vial barcode reading.
-Barcode data (if available) transmitted to Icon-5 for processing.
-Force limited movement of sampling arm.
-Trays recognized and identified as #1 and #2 or #3.
Limitations
The Autoloader is inoperable on its own and can only be used with Norma Icon-
5 automated hematology analyzers with support for closed sample vials.
The Autoloader supports the following primary blood collection vials: BD
Vacutainer and Greiner Vacuette.
NormaCont and NormaCal vials (control vials in general) should not be
loaded in the Autoloader.
The device is equipped with a vial detection logic –empty spaces are skipped.
Vials (even with cap) shorter than 75mm are not going to be processed and
may report an error.

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It is not recommended to remove vials from the tray while the Autoloader is
running. Also avoid touching the tray, the moving arm or moving (pushing) the
entire system (analyzer + autoloader).
Safety measures, notes
-Always use the power supply provided with the Autoloader.
-Do not pour liquid into or over the Autoloader.
-Moving parts are equipped with force limitation to avoid injury to the
operator.
-Do not block movement, do not touch moving parts.
-Use only vial types supported by the manufacturer.
-Do not use control blood in the Autoloader.
-Use vials with caps.
-Make sure to align the vials properly, avoid caps sticking higher than
others –this could block the movement of the pickup arm.
-Do not move the Autoloader during operation.
-When relocating Icon-5 equipped with Autoloader, never lift the
assembly by the base plate. The plate is not designed to bear the
weight of the two devices.
-When the system (analyzer + autoloader) has been relocated, or any
of the devices has been temporarily removed, a sample opening
calibration needs to be performed on the analyzer to avoid feeding
errors.
-Always use good laboratory practice, use protective gear (e.g. lab coat,
gloves, goggles) when handling blood sample vials.
-Only allowed to connect certified external devices against electrical
hazard.
-If the equipment is used in a manner not specified by the
manufacturer, then the protection provided by the equipment may be
impaired!

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For final disposal, the device should be considered as potential
biohazard and electronic waste; always follow your local
regulations for waste management.
Leftover samples, processed samples should be considered as
potential biohazard waste; always follow your local regulations
for waste management.
Symbols on the outside of the Autoloader
Symbol
Meaning
WARNING - Risk of personal injury
AUTOMATIC START-UP - Unexpectedly moving parts
BIOHAZARD
Risk of biological infection, contamination
CE mark
Address of manufacturer
Serial number
for In Vitro Diagnostic use
USB
Standard USB connector
USB-B
USB-B connector for connection to Icon-5

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Technical contact
There are no user serviceable parts inside this Autoloader. Adjustments of
internal structures and repairs of these structures should only be performed
by qualified service personnel.
Your local dealer is always ready to help you in case of malfunction.
The contact of your local dealer is available on the insert of this Manual.
Please use the [e-mail] email address to contact the
manufacturer directly.
Norma will be doing its best to resolve your problems either directly or
indirectly with the help of its local representative.

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Warranty
The Autoloader comes with a one-year manufacturer’s warranty against
workmanship defects. Warranty claims must be made through your local
representative. Your supplier will only be able to repair and warrant operation
of the analyzer as per its specifications if all service actions are performed by
qualified service personnel, and the Warranty Label is intact.
Warranty is void if any of the below can be identified, or inoperability,
malfunction can be traced back to any of the events listed below:
-intentional damage and/or modification to the analyzer;
-improper use, use against instructions in this manual, against intended
use, use of non-approved sampling vials;
-damage from intentional activities overriding built-in safety logic;
-natural disaster;
-uncertified power supply, or unapproved peripheral has been
connected to the analyzer;
-disassembly, repair attempt performed by unauthorized staff;
-damage rooted back to unreported shipping and/or installation
induced activities.
Exclusions: The below listed items are not covered by warranty unless they
were found damaged upon arrival to the End User. In such cases, proper
complaint must be filed along with a complaint registered with the
forwarder/Distributor company:
-External power cable, USB cable
-Plastic cover elements, sample vial trays
-Labels, printed material

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2. Package contents
electrical power cord
Autoloader
USB 2.0 cable
4 x
2 trays for
50 vials each
4 instrument feet
for Icon-5
power supply
Model: Sunny SYS1548-6524-T2
normaboard baseplate
Grounding +
spare o-rings for the gripper

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3. Installation requirements
Position of disconnection. The power source must be easily
reachable to plug out the device in case of emergency.
Space: a 50x50x50 cm space is required for safe and convenient installation
and operation of the Icon-5 and the Autoloader. It is recommended to place
the reagent pack behind the Icon-5 device.
For safe and unobstructed operation, leave room around the assembled
devices as indicated on the image above.
H = 500, D = 500, W = 500 (mm, minimum)
Electrical: an additional power outlet is required for operation; the Autoloader
and the Icon-5 must be powered from the same power network.
Environment: see specifications / operating conditions
The installation procedure requires alteration to the main device (Icon-5).
Installation must be carried out by trained professionals only
Icon-5 analyzer must run the newest software version that supports
Autoloader operation.

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4. Identification of parts
Front view
Picking arm
(retracted position)
Mixer cover
Tray inserted
USB ports (2 slots)
Power button
Rear view
Mixer cover
Picking arm
(retracted position)
Power connector
Exit opening for
fallen vial
USB B (to Icon-5)
socket

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Side view
Picking arm
(retracted
position)
Mixing position
Tray (inserted)
Mixer cover
(The barcode
scanner is
inside)
Power button
Tray
ID pins
Vial1
Vial5
Vial 6
Vial 46
Vial50
Make sure that the tray is inserted properly.

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Assembled view
Icon-5’s
closed vial
opening
Mixing position
and barcode
scanner
Picking arm
(retracted)
Tray
normaboard
(baseplate)
Icon-5 side
Autoloader side

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5. Installation
For Installation details of the Norma Autoloader please refer to the Quick
Installation Guide or follow the procedure through our installation video.
Please contact your local distributor for further information.
Installation must be carried out by a trained service engineer.
The procedure consists of the following:
-install modified instrument feet on Icon-5.
-install Icon-5 and Autoloader on the normaboard baseplate.
-connect protective grounding between devices.
-connect Autoloader power supply (before connecting USB cable).
-connect the two devices with a USB cable.
-install operating software to support Autoloader operation.
-verify and calibrate vial positions.
Adjustments
There are no user serviceable parts inside this equipment. Adjustment of the
Autoloader should only be performed by qualified service personnel.

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6. Operation
WARNING!
Device must be operated by trained operator only
Power on: Briefly press the button in the front.
Power off: Press and hold the button in the front.
The power button has an illuminated frame. The color of this frame is providing
status information.
Description
Status light
Power off
dark
Power off, low input voltage
red with flashing blue
Power off, high input voltage
flashing red
ON all OK
green
In Standby, no USB link to Icon-5
orange with flashing green
Tray is pulled off
green with flashing blue
Self-test active
flashing orange
Self-test error
Orange with flashing red
Operation controlled by Icon-5
yellow
Operation paused by User
flashing yellow
Operation stopped due to error
yellow with flashing red
Fatal hardware error
red

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Load vials starting in the top row in the left side. Do not load vials without caps,
do not load unsupported vials. Load vials continuously, do not leave positions
empty. Always finish a row before staring the next one.
Loading trays: slide the tray into its guides firmly until it clicks in place.
Unloading: when the device finished processing the tray, you can pull the tray
off and load the next tray. The Autoloader can identify its three trays: using
the ID pins on the rear of the trays.
Barcodes: the built-in barcode reader supports the following codes:
-EAN13
-UPC-A
-EAN8
-UPC-E
-Codabar
-Code 93
-Code 39 (Regular)
-Code 39 (FullASCII)
-Code 128
Pause –resume operation: Autoloader can be paused by:
-pulling out the tray
-a quick press on the Autoloader power button
-stopping operation using Icon-5’s user interface

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7. Autoloader functions in Icon-5 software
When the Icon-5 operating software detects the presence of the Autoloader,
an Autoloader symbol will be displayed in the upper left of the screen of Icon-
5.
The Autoloader symbol will display status information.

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Autoloader status symbols:
Diagnostic /
Service mode
Running.
No tray found
Tray I loaded
Tray II loaded
Tray III loaded
Running paused
by user or due
to an error.
Autoloader
operation
aborted. Going
to standby
(sleep) mode
Autoloader
startup in
progress.

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Running samples using Autoloader
Main menu / Daily Routine (Sampling) / Autoloader
Tap on the Auto Loader row to access the Tray view and startup functions.
Tapping on Press to Init will automatically start Icon-5’s regular startup
procedure (internal tests and blank measurement) to reach ready to operate
status. Autoloader will also perform its startup and test sequence and will
report the result to Icon-5.
After completing the startup sequence, and if both devices are in ready state,
detection and analysis of the samples can start. Vials will be processed in
rows of 5, starting at the top left corner.
The pickup arm will test the vial for presence of a cap:
the arm will attempt to “tap” the cap of the vial. If a
vial cap is detected, then the sample will be picked up
and placed to the mixing position.
When mixing and barcode scanning is done, the vial
will be placed into Icon-5’s closed vial sample opening,
and Icon-5 processes the sample.

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Operation is overlapped; upon feeding a vial to Icon-5, the next vial will be
detected and moved to the mixing position. After the vial has been processed,
the Autoloader will put it back to its original location in the tray.
You can run samples using the Autoloader in two modes: Full Scan Mode and
Selected Samples Mode.
Selected samples mode
The tray positions are displayed on the screen (1-50). Tapping on a vial position
will display the sample information screen with:
-Tray position
-Sample ID (optional)
-Measurement profile to use (optional)
Add: sample information provided will be used for the given vial position, and
the sample is selected for processing.
Remove: the sample is removed from the list of samples to be processed.
Repeat “Add” for as many vials as many you wish to process.