SYSMEX SP-50 User manual

Sysmex House, Garamonde Drive, Wymbush, Milton Keynes, MK8 8DF, United Kingdom · Phone [phone] · Fax [phone]
[e-mail]· www.sysmex.co.uk
Routine Use Training Workbook
SP-50
Date:
26/10/2020
Document Ref:
SUKBMS-24-334
Version:
4.0
Classification:
Unrestricted
IFU version:
1801

Disclaimer –SP-50
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Contents
Contents 2
Disclaimer 4
Revision History 4
Reference Documents 4
SP-50 Overview 5
Analyser components 6
Outside the analyser 6
Front Components 8
Smear Unit 9
Stain Unit 10
Reagents On-board the SP-50 11
Smear Production 12
Staining Principles 13
SP-50 –IPU Layout 14
Main Screen 14
Status Area 15
Instrument Status 15
Indicator 16
Slide Preparation Mode 16
Sample Number 16
Sampler/Manual 17
Mode 17
Quick Guide: Maintenance 18
Daily Maintenance 19
Performing Shutdown 1 19
Wipe Stain Baths 21
Performing Start-up 22
Weekly Maintenance 24
Cleaning the Spreader Glass 24
Cleaning the Smear/Stain Unit 27
Cleaning the Stain Pool 30
Monthly Maintenance 31
Performing Shutdown 2 31
As Required Maintenance 34
Loading Glass Slides 34
Replace Spreader Glass 35

Disclaimer –SP-50
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Replacing Ink Ribbon 39
Replacing Reagents –CellPack DCL, Stains & Buffer Solution 42
Replacing Methanol 46
Quick Guide: Running Samples 47
Sample Preparation 47
Sampler Preparation 47
Manual Preparation 47
Sample Volumes 48
Sampler Mode 49
Smearing Mode 50
Staining & Smearing Mode 50
Operation of the SP-50 on the XN Track 51
Placing into ‘Offline’ or Isolation 51
Running Samples in ‘Offline’ or Sampler Mode 51
Manual Mode 52
Manual –Smearing & Staining 52
Manual –Stain Only 56
Manual –Smear Only 59
Manual –Print Only 62
Responding to Alarms 65
Audit Logs 66
Contact Us 69

Disclaimer –SP-50
Sysmex House, Garamonde Drive, Wymbush, Milton Keynes, MK8 8DF, United Kingdom · Phone [phone] · Fax [phone]
[e-mail]· www.sysmex.co.uk
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Disclaimer
Please note the information in this presentation, workbook or training session provided by Sysmex
should not be used as an alternative to your sites Standard Operating Procedure (SOP)/Contract. If you
have any particular questions regarding any site specific use of reagents, consumables and/or
equipment please contact your Management Team.
Revision History
Revised section
Alteration
Name
Date
Daily maintenance
Added wipe stain bath
K. Elgerton
January 2019
Weekly maintenance
Amended weekly schedule
K. Elgerton
January 2019
Reagents
Amended changing stain
K. Elgerton
January 2019
Audit logs
Added exporting CSV
K. Elgerton
January 2019
Reagents
Amended changing Buffer
K. Elgerton
January 2020
Front cover
New logo added
K. Elgerton
January 2020
Contacts
Reagent hotline updated
K. Elgerton
January 2020
Maintenance
Shutdown times updated
K. Elgerton
January 2020
Title page
Workbook name changed to
include routine use.
N. Bowen
October 2020
Reference Documents
Document title
Version
Date
SP-50_BO (IFU)
1801
January 2018
SP-50_GI (IFU)
1801
January 2018
SP-50_TS (IFU)
1801
January 2018

Reference Documents –SP-50 Overview
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SP-50 Overview
Facts and Figures
SP-Series analysers
SP-1000i
SP-10
SP-50
Throughput
SP-50 S –30 samples/hr
SP-50 H –75 samples/hr
Capacity
Standalone analyser –50 samples
Tracked analysers –racks are automatically sent to the SP if a
smear is requested.
Sample Type
Whole blood
Sampler Mode
Regular tube
Raised bottom tube (RBT) –requires RBT rack
Manual Mode
Manual (Closed)
Manual (Open)
Manual (RBT)
Manual (Micro)
Aspiration Volumes
Sampler mode - 70µl
Manual (Closed) mode - 70 µl
Manual (Micro) mode - 38 µl
Staining Protocols
May-Grunwald-Giemsa stain
Wright single stain
Wright-Giemsa stain

Analyser components –SP-50 Overview
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Analyser components
Outside the analyser
1. Main Power Switch Cover –Open this cover to turn the main power switch ON/OFF, and to
regulate the pressures if required.
2. Stain Unit Cover –Open thiscover to inspect the interior of the stain unit. Accesscan be gained
for cleaning or maintenance tasks. Locked during operation.
3. Start-up (Power) Switch –Press to start up the instrument.
4. Eject Switch –Press to eject magazines from the stain unit.
5. IPU Touchscreen –Use to operate the instrument and configure settings.
6. Sample Tube Holder –Used to set samples for manual analysis.
7. Mode Switch –Press to switch between manual analysis and sampler analysis. Pressing it
opens and closes the sample holder.
•When the sample holder is open: Manual preparation
•When the sample holder is closed: Sampler preparation

Analyser components –SP-50 Overview
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8. Start Switch –Press to start manual analysis.
9. Status Indicator LED - Shows the current status of the analyser.
LED Indicator Light
Description
Green
Ready (Analysis or maintenance is possible)
Flashing Green
Starting up / Analysis in progress / Maintenance in progress
Orange
Sample analysis stopped / not possible. An error has occurred, but the
instrument is still operational.
Flashing Orange
Starting up/Preparing a slide/Switching the slide preparation mode/ Shutting
down/Sleeping
Red
Stopped - Error (without alarm) / initialising system / Analyser ready to be
turned off at the end of shutdown
Flashing Red
Stopped - Error(with alarm)
Not Lit
Powered OFF
10. Manual Magazine Holders - This is used for loading manual slides into the analyser for manual
staining.
11. Lower Front Cover - Open this cover to inspect the interior of the main unit to perform cleaning
or maintenance tasks. Analyser must be turned off.
12. Manual Magazine Holder Status LED –Shows the current status of the manual magazine
holder. A magazine cannot be loaded or removed while the LED is flashing.
LED Indicator Light
Description
Green
Containing magazine
Red
Error
Not Lit
Powered OFF

Analyser components –SP-50 Overview
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13. Slide Unit Cover - Open to load glass slides. Locked during operation.
14. Smear Unit Cover - Open this cover to inspect the interior of the smear unit to perform cleaning
or maintenance tasks. The smear unit cover and the slide set cover are one piece. To open the
smear unit cover, remove the slide supply cassette first. Locked during operation
Front Components
1. 0.07 MPa Regulator –Regulates the source pressure to 0.07 MPa
2. Main Power Switch –Press to turn the main power of the main unit on/off
3. Slide Supply Cassette Status LED –Shows the current status of the supply cassettes. A
cassette cannot be loaded or removed while the LED is flashing.
4. Printer –Prints sample information and patient demographics onto glass slide.
5. Slide Supply Cassettes –Loads/stores glass slides for use on the SP-50.
LED Indicator Light
Description
Green
Slides loaded
Red
No slides/error
Not Lit
Powered OFF

Analyser components –SP-50 Overview
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Smear Unit
1. Smear Unit –Spreads the dispensed sample onto glass slide. Contains spreader glass unit.
2. Print Unit –Prints sample information and patient demographics onto glass slide. Contains the
ink ribbon.
3. Smear Dryer Unit –Dries the smeared sample.
4. Slide Supply Unit –Takes out glass slides from the supply cassettes.

Analyser components –SP-50 Overview
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Stain Unit
A. Stain Unit Cover –Open thiscover to inspect the interior of the stain unit. Accesscan be gained
for cleaning or maintenance tasks. Locked during operation.
B. Stain Unit –Depending upon protocol; fixes, stains, rinses and dries the prepared slides.
There are 7 staining pools which are filled up with the following reagents. The types of reagent varies
depending on the staining method. Samples move through the staining pool in the direction of the arrow
as illustrated above.
Stain Pool
Role
Reagent
1*
Fixing
Methanol
2
Fixing
Stain 1
3
Staining
Stain 1/buffer
4
Rinsing
Rinse
5
Staining
Stain 2/buffer
6
Rinsing
Rinse & dry
*Use depends upon protocol
A
B
A

Analyser components –Reagents On-board the SP-50
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Reagents On-board the SP-50
The number of on-board reagents on the SP-50 depends on the staining protocol used. The table below
summarises the reagents recommended for use on the SP-series.
*See product insert and/or container for specific data.
Reagent Name
Function
On-board Stability
Cell Pack DCL
Rinse solution used for rinsing the whole blood
aspiration line.
60 days
May-Grunwald stain
Used for staining blood smears.
N/A*
Giemsa stain
Used for staining blood smears.
N/A*
Buffer solution pH 7.0
Used in the preparation of blood smears.
N/A*
Methanol
Used in staining process depending on protocol
and during maintenance procedures.
N/A*
CellClean
Alkaline detergent used for internal cleaning of the
SP-50
60 days

Analyser components –Smear Production
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Smear Production
1. Once the barcode has been read the first step in smear production is for a slide to be removed
from either slide supply cassette (1).
2. The slide is transported to the slide print position where the print unit (2) prints sample information
on the frosted end of the slide.
3. Next, slides are transported to the dispensing and smear position (3). The dispensing pipette
dispense blood evenly over a wide area. The flexible suspension plate prepares the smear by
adjusting the angle and speed of the spreader glass according to the HCT value.
4. Once prepared, the smear is transported via the conveyance block (4) to the staining block.
During this process the smear passes a drier unit where it is dried.
5. Once at the staining block the (depending upon protocol) smear is placed in stain block 1 (5),
followed by stain block 2 (6). Then finally on to the rinse block (7).
6. Once dry, the slides are transported to the magazine feeder unit (8).
7. The prepared slides are placed into an empty magazine and fed out to the magazine storage
unit (9).

Analyser components –Staining Principles
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Staining Principles
Romanowsky stains, such as Giemsa, Leishman and May-Grunwald, are used widely for the routine
staining of peripheral blood films. Whichever combination of stains is used the distinction in staining is
achieved due to the balance of basic and acidic components within the stains.
The colour and particular cellular component stains, is dependent on the binding that occurs between
the staining compounds and chemical structures within the cell, as well as interaction between dye
molecules, pH and time.
Whichever combination of stains are used the process must be carried out at the correct pH. If the pH
is too acidic the basophilic components appear too pink. If the pH is too alkaline conversely there is over
staining as too much basic stain is taken up.
These reaction are also dependent on time as DNA binds to staining compounds more rapidly than RNA
and Haemoglobin is even slower. As a results incorrect concentration of stains and/or timings will result
in poor stains.
Cellular Component
Staining Principle
Proteins and Nucleic Acids
Both bind to the basic component of the stain. This results in a blue-
violet
or blue colour.
Haemoglobin
Has a high affinity for the more acidic components of the stain
resulting in a
red
or orange colour.
Eosinophil Granules
Eosinophil granules have a basic components which have a strong
affinity for acidic components of the stain resulting in a
red
or orange
colour.
Basophil Granules
Basophil granules contain heparin which are strongly acidic and
therefore have a strong affinity for the basic component resulting in
dark purple
colour.

Main Screen –SP-50 –IPU Layout
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SP-50 – IPU Layout
Main Screen
Area
Function
Toolbar (fixed)
Most frequently used functions are displayed here.
Toolbar (Changeable)
Displays options that can be used in the currently displayed
screen.
Main area
The various options and areas for use within the SP-50 are
displayed here.
Status area
Displays the current status of the instrument. In addition, you
can perform operations such as slide preparation and
maintenance.

Status Area –SP-50 –IPU Layout
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Status Area
Instrument Status
LED Indicator Light
Description
Green
Ready (Analysis or maintenance is possible)
Flashing
Green
Starting up / Analysis in progress / Maintenance in progress
Orange
Sample analysis stopped / not possible. An error has occurred, but the
instrument is still operational.
Flashing Orange
Starting up/Preparing a slide/Switching the slide preparation mode/
Shutting down/Sleeping
Red
Stopped - Error (without alarm) / initialising system / Analyser ready to
be turned off at the end of shutdown
Flashing
Red
Stopped - Error(with alarm)
Not Lit
Powered OFF

Status Area –SP-50 –IPU Layout
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Host
Comput
er
Indicator
The statuses of the instrument, connected reagents and peripheral devices are displayed by icons.
If a reagent or device is not connected, an icon does not appear.
Slide Preparation Mode
Displays the selected slide preparation mode.
Sample Number
Displays a sample number. [>] at the beginning of the sample number indicates that the instrument
is ready to aspirate the next sample. If the sample number is not read, or if it has not been entered
manually, a message is displayed to prompt the input of the number.
Icon
Indication
Touch to display the [Reagent Replacement] dialog box.
Changes to orange when reagent volume is low.
Changes to red when reagent has run out.
Changes to red if there is a connection error.
Present on analysers connected to the DI-60.
Changes to red if there is a connection error.
Changes to red if there is a sampler error.
Present on analysers connected to a CF-70.
Changes to red if there is an error occurs.
Reagent
Status
Sample
r Status
DI-60
Status
Host
CF-70
Status

Status Area –SP-50 –IPU Layout
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Sampler/Manual
Touch to register sample information and slide preparation conditions.
Select to display the [Manual Preparation] dialog box or [Sampler Preparation] dialog box.
The icon displayed varies depending on the selected slide preparation method and settings.
Error Message
Displays the highest priority error among all current errors. DI-60 & CF-70 (if connected) errors are
also displayed here.
Mode
Touch to select the slide preparation mode.
Display
Slide Preparation
Setting
Sampler Preparation
N/A
Manual Preparation
[Cap Open] is OFF
[Cap Open] ON
[RBT] is ON
Colour
Status
Orange background/black text
Caution
Red background/white text
Warning

Status Area –Quick Guide: Maintenance
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Quick Guide: Maintenance
Maintenance Key:
Instructions for Use (IFU) recommended maintenance in BLACK
Sysmex recommended maintenance (optional) in BLUE
As part of routine operation, maintenance must be performed on the SP-50 in order to maintain
optimum instrument performance.
IMPORTANT: Failure to follow recommended maintenance protocols can lead to unnecessary
downtime.
Execute maintenance according to the schedule below:
Maintenance task
Daily Maintenance
Perform shutdown 1
Wipe stain baths
Weekly Maintenance
Clean spreader glass
Cleaning the smear/stain unit
Cleaning the stain pool
Monthly Maintenance
Perform shutdown 2
As Required Maintenance
Loading glass slides
Replacing spreader glass
Replacing ink ribbon
Replacing rinse
Replacing reagents

Daily Maintenance –Quick Guide: Maintenance
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Daily Maintenance
Performing Shutdown 1
Before commencing Shutdown 1 confirm the following:
•Make sure that slide glass has been loaded. Replenish slide glass if not sufficiently loaded.
•Confirm an empty magazine is loaded in the manual magazine holder. Load an empty magazine
if it is not loaded.
•Make sure that there are sufficient reagents available.
•If SP-50 is on the XN track, place the analyser into ‘offline’ mode.
To perform Shutdown 1:
1. From the [Menu] select [Shutdown].

Daily Maintenance –Quick Guide: Maintenance
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2. The Shutdown dialog box appears and the manual tube holder extends. Select [Shutdown 1].
3. Follow the instructions on the IPU - Place 4mL CELLCLEN AUTO into the tube holder (cap
removed).
4. Press the Manual Analysis Start Switch. The sample tube holder retracts into the analyser and
aspiration begins.