Siemens Hematek 3000 System User manual

Hematek®3000 System
Instruction Manual
– Instructions for Use –
11209634
Manual Version: 1.3
Date of Issue: 2015-01
We reserve the right to make changes in the course of technical development without previous notice.
© 2015 Siemens Healthcare Diagnostics Products GmbH. All rights reserved.
Emil-von-Behring-Str. 76
35041 Marburg
Germany
Neither this manual nor any parts of it may be duplicated or transmitted in any way without the written approval
of Siemens Healthcare Diagnostics Products GmbH.

Updating
Trademarks Hematek is a trademark of Siemens Healthcare Diagnostics.
Disclaimer Siemens Healthcare Diagnostics has validated the provided instructions,
reagents, instrument, software and customizable features for this system to
optimize product performance and meet product specifications. User
defined modifications are not supported by Siemens as they may affect
performance of the system and test results.
Version Date Changes
1.0 2013-08 First version
1.1 2013-09 Update
1.2 2013-11 Update
1.3 2015-01 Update
Siemens Healthcare Diagnostics Products GmbH
Emil-von-Behring-Str. 76
35041 Marburg
Germany
www.siemens.com/diagnostics

Chapter overview
Hematek®3000 System – Instruction Manual – Version 1.3
Chapter overview
1 Introduction
2 Safe handling
3 Life cycle
4 Description
5 Operating
6 Cleaning
7 Performing maintenance
8 Troubleshooting
9 Appendix
Addendum to the instruction manual

Hematek®3000 System – Instruction Manual – Version 1.3
Chapter overview

Table of contents
Hematek®3000 System – Instruction Manual – Version 1.3 1TOC
Table of contents
1 Introduction 1-1
1.1 About this manual 1-1
1.2 Orientation tips 1-1
1.3 Service 1-2
1.4 Warranty 1-2
1.5 Ordering information 1-2
2 Safe handling 2-1
2.1 Intended use 2-1
2.2 General safety information 2-1
2.2.1 Operator qualification 2-1
2.2.2 Electrical safety 2-2
2.2.3 Mechanical safety 2-2
2.2.4 Operational safety 2-3
2.2.5 Safe handling of glass slides and consumables 2-3
2.3 Safety messages 2-5
2.3.1 Signal words in safety messages 2-5
2.3.2 Structure of safety messages 2-5
2.4 Symbols on the slide stainer and consumables 2-6
2.5 Statutory requirements 2-7
2.6 Obligations of the system owner 2-8
3 Life cycle 3-1
3.1 Delivery 3-1
3.1.1 Unpacking and checking the delivery 3-1
3.1.2 Scope of delivery 3-2
3.2 Installation 3-2

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Table of contents
3.3 Non-operation 3-6
3.4 De-installation 3-8
3.5 Transport 3-8
3.6 Disposal 3-10
4 Description 4-1
4.1 Slide stainer 4-1
4.1.1 Fluid delivery components 4-3
4.1.2 Slide transport components 4-7
4.1.3 Electrical components 4-9
4.1.4 Leveling components 4-12
4.1.5 Lid 4-12
4.2 Consumables and spare parts 4-12
4.2.1 Hematek Stain Pak - Modified Wright’s Stain 4-12
4.2.2 Hematek Stain Pak - Wright-Giemsa Stain 4-13
4.2.3 Hematek Cannula Set 4-13
4.2.4 Hematek Pump Tube Set 4-14
4.2.5 Hematek Underplaten Tubing Set 4-14
4.2.6 Glass slides 4-15
4.2.7 Line fuses 4-15
4.2.8 Knurled thumb screw 4-15
5 Operating 5-1
5.1 Starting the system 5-1
5.2 Priming the pump tubing 5-1
5.3 Preparing priming slides 5-2
5.4 Loading smeared glass slides 5-2
5.5 Switching off the system 5-4
6 Cleaning 6-1
6.1 Periodic cleaning 6-2

Table of contents
Hematek®3000 System – Instruction Manual – Version 1.3 3TOC
6.2 Cleaning the exterior surfaces 6-2
6.3 Cleaning the stain tube and cannula 6-2
6.4 Cleaning the platen 6-4
6.5 Cleaning the waste tank 6-5
6.6 Cleaning the drain troughs and the rear guide rail 6-6
7 Performing maintenance 7-1
7.1 Periodic maintenance 7-1
7.2 Installing the Hematek Stain Pak 7-1
7.3 Replacing the pump tubing 7-3
7.3.1 Removing the pump tubing 7-3
7.3.2 Installing the pump tubing 7-6
7.4 Replacing the underplaten tubing 7-8
7.4.1 Removing the underplaten tubing 7-8
7.4.2 Installing the underplaten tubing 7-13
8 Troubleshooting 8-1
8.1 Troubleshooting chart 8-1
8.2 Leveling the system 8-4
8.3 Checking the adjustment of the sensing switch fingers 8-5
8.4 Adjusting the sensing switch fingers 8-6
8.5 Adjusting the pump volumes 8-8
8.5.1 Checking the staining process 8-8
8.5.2 Correcting the pump volumes 8-9
8.5.3 Verifying the pump volumes 8-11
8.5.3.1 Recorded volumes fall within specified ranges 8-14
8.5.3.2 Recorded volumes do not fall within specified ranges 8-15
8.6 Replacing the line fuses 8-15

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Table of contents
9 Appendix 9-1
9.1 Principle of operation 9-1
9.2 Staining process 9-2
9.2.1 Example for the calculation of the stain-to-buffer ratio 9-2
9.3 Technical specifications 9-3
Index IX-1
Addendum to the instruction manual 1

1 Introduction
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1
1Introduction
This chapter gives orientation tips for using this manual and information
about service and warranty.
1.1 About this manual
This manual describes the use of the Hematek 3000 System in clinical
laboratories.
1.2 Orientation tips
Bullets Bullets indicate a list.
Example:
The box contains:
•Monitor
•Keyboard
•Manual
Numbers Numbers indicate a procedure.
Example:
1. Open the box.
2. Check the content.
3. Read the manual.
The numbering is also used if the procedure includes only one step.
Arrow An arrow indicates one or more results of an action.
Example:
1. Select Print.
 The dialog Print opens.
Bold type Bold type is used to put a special emphasis on something.
Example:
This process must never be canceled.

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Gray note Gray notes indicate important background information.
Example:
1.3 Service
Siemens and its representatives are available to repair the system during
customary local office hours. Should you require service at any other time,
contact the Siemens service or your local Siemens representative. In the
following, Siemens service refers to both, the Siemens service or any local
representative authorized by Siemens. You will receive information about
how to reach the Siemens service when the system is installed, or visit
www.siemens.com/diagnostics to find contact information.
The scope of agreed service is included in your service contract.
1.4 Warranty
Siemens and its representatives guarantee that the system shows no
defects during operation if installed and operated according to this manual.
For more information about warranty, contact the Siemens service.
The warranty is not valid for damage that occurs as a consequence of non-
observance of this manual.
Repairs and servicing must only be carried out by persons authorized by
Siemens.
Only perform maintenance as described in this manual. Improper
interventions on the system void the warranty and can result in service
charges.
Only use the system as intended. If the system is not used as intended,
Siemens disclaims all liability for damage to the system.
1.5 Ordering information
Use only original Siemens consumables, accessories and spare parts.
Order these only from Siemens. For ordering information, see the Siemens
product catalog or contact the Siemens service.
Note: Once the shift change has been activated, it cannot be
interrupted.

2 Safe handling
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2 Safe handling
This chapter describes the intended use of the system and gives general
safety instructions regarding the operation of the system.
2.1 Intended use
The Hematek slide stainer is a fully automated, bench-top hematology
system for in vitro diagnostic use in the clinical laboratory. It automatically
stains manually (or other method) prepared blood or bone marrow smears
on standard glass microscope slides.
System functions The system accepts, conveys, fixes, stains, and delivers dry blood or bone
marrow smear preparations that are spread on standard thickness
25mm x 75mm or 1in x 3in glass slides. The glass slides are stained at the
rate of one glass slide per minute.
Two conveyor spirals move the glass slides along the platen. Three sensing
switches are triggered sequentially as the glass slides move along the
platen. Each sensing switch activates its respective pump, which delivers
the stain, buffer, or rinse into the capillary space between the glass slide and
the platen. After the staining and rinsing processes have been completed,
the glass slide is dried by a flow of air from a low velocity blower and it is
then deposited in a slide drawer.
2.2 General safety information
The slide stainer has been inspected for technical safety before shipment.
To maintain this status and to ensure hazard-free operation:
•Always follow the instructions in this manual.
•Only use the system as intended. If the system is not used as intended,
Siemens disclaims all liability for any personal injury and property
damage.
•Always follow good laboratory practice.
•Make sure the electrical and environmental conditions described in
Chapter 9.3 are met.
The system must be operated as described in this manual. The quantity of
freely accessible flammable liquid is limited to a maximum of 5mL of
methanol which can not cause the spread of fire.
2.2.1 Operator qualification
Risk of death and serious injury due to lack of knowledge. To avoid this
hazard:
•The system must be operated only by persons whose skills, knowledge
and practical experience qualify them to do so, and who have read and
understood this manual.

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2.2.2 Electrical safety
Risk of electric shock when contacting live parts. Even when the system is
switched off, some components, for example, capacitors, can be live as
they can still be electrically charged. Death or serious injury can result. To
avoid this hazard:
•Connect the system only to a socket with a ground contact (earth).
•Use only correctly rated extension cables with sufficient power capacity
and a protective conductor and ground contact.
•Never disconnect the ground contacts from the line.
•Never interrupt the protective conductor inside or outside the system.
•Never remove protective guards or fused components.
•Ensure that all surfaces, including the floor, are dry when using the
system.
•Make sure that the power switch of the system is easily accessible.
•If the slide stainer needs to be opened before maintenance, repair or
replacement work, switch off the slide stainer and disconnect it from all
voltage sources as described in the relevant procedure.
Risk of short-circuit by spilled liquids that can come into contact with live
parts. Damage to the system can result. To avoid this hazard:
•Never pour liquids or place containers with liquid on top of the system.
•Disconnect the main plug immediately if liquid is spilled in the system.
Risk of malfunctions in nearby electrical devices due to radio interference.
The slide stainer complies with the emission and immunity requirements
described in IEC 61326-2-6. The slide stainer has been designed and
tested to CISPR 11 Class A. In a domestic environment, it can cause radio
interference. To avoid this hazard:
•Assess the electromagnetic environment prior to operating the slide
stainer.
•Use the cables supplied.
Risk of malfunctions of the slide stainer due to radio interference by other
electrical devices. To avoid this hazard:
•Do not operate strong electromagnetic transmitters, for example, mobile
phones, walkie-talkies, door openers, or elevators, in the vicinity of the
slide stainer.
2.2.3 Mechanical safety
Risk of serious injury by moving parts. To avoid this hazard:
•Never open or remove the covers of the system during operation.
•Never bypass or remove safety devices, for example, cover switches.
•Keep clear of moving parts when the system is in operation. Long hair,
necklaces, bracelets and similar objects can get caught in moving parts.

2 Safe handling
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2.2.4 Operational safety
Risk of burns by combustion of flammable liquids. Death or serious injury
can result. To avoid this hazard:
•Keep flammable liquids away from heat or open flame.
•Place the system in a well-ventilated area.
If a flammable liquid has been spilled, immediately take the following
measures to prevent combustion:
•Eliminate all sources of ignition.
•Remove flammable liquid with a non-combustible absorbent material.
•Flush the stained area with water.
•Vent the room.
Explosion risk due to ignition caused by sparks generated by the system’s
switch contacts. Death or serious injury can result. To avoid this hazard:
•Never operate the system in an environment containing explosive
mixtures of oxygen, hydrogen or other flammable gases.
Risk of property damage due to inaccurate handling of the system. Rough
handling or dropping can disturb or damage internal components. Improper
interventions on the system void the warranty and can result in service work
having to be charged for. To avoid this hazard:
•Always handle the system with care.
•Switch off the system and secure it against accidental operation if there
is visible damage to the system.
•Only carry out maintenance and repair work or replace parts as
described in this manual.
•Only use Siemens spare parts.
2.2.5 Safe handling of glass slides and consumables
Risk of infection by potentially infectious material. Blood and bone marrow
smears and parts of the system which have come into contact with this
material are potentially infectious. Death or serious injury can result. To
avoid this hazard:
•Wear appropriate personal protective equipment; that is, gloves,
protective clothing, safety glasses and mask.
•Pay attention to the manufacturer's information regarding the gloves'
compatibility with the materials and liquids used.
•Handle potentially infectious material in accordance with good
laboratory practice, for example, as described in CLSI documents
available at www.clsi.org.
•Avoid contact of the skin and mucosa with potentially infectious material.
•Check with local waste disposal authorities for specific requirements
regarding potentially infectious material.

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•Discard potentially infectious material according to laboratory standards
and national and local standards and regulations.
Risk of very serious irreversible health effects by inhalation of or contact
with methanol contained in the Hematek Stain Pak. Death or serious injury
can result. To avoid this hazard:
•Keep the bottles in the Hematek Stain Pak closed.
•Refer to the Hematek Stain Pak labeling and to Material Safety Data
Sheets for details concerning any special precautions related to the
handling of Hematek Stain Paks. Material Safety Data Sheets are
available from Siemens.
Risk of irritation of the skin and mucous membranes by cleaning agents.
Minor or moderate injury can result. To avoid this hazard:
•Wear appropriate personal protective equipment; that is, gloves,
protective clothing, safety glasses and mask.
•Pay attention to the manufacturer's information regarding the gloves'
compatibility with the materials and liquids used.
•Follow all product manufacturer’s warnings.
Risk of property damage and inaccurate processing of smeared glass slides
due to inaccurate handling of consumables. To avoid this hazard:
•Use high quality glass slides.
•Do not use chipped or broken glass slides.
•Do not use glass slides of variable thicknesses.
•Do not use bevel-edged glass slides.
•Only use approved Siemens consumables.
•Do not use consumables after their expiry date.
•Be sure to read and observe any instructions for use that are supplied
with the consumables.
Risk of pollution by improper waste disposal. Damage to the environment
can result. To avoid this hazard:
•Discard glass slides, consumables, spare parts and liquid waste
according to laboratory standards and national and local standards and
regulations.
•Refer to the Hematek Stain Pak labeling and to Material Safety Data
Sheets for details concerning any special precautions related to the
disposal of Hematek Stain Paks. Material Safety Data Sheets are
available from Siemens.

2 Safe handling
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2.3 Safety messages
All safety messages must be observed to avoid hazardous situations which
can result in death, injury or damage to the equipment.
2.3.1 Signal words in safety messages
The following explains the signal words and their meaning.
2.3.2 Structure of safety messages
The following explains the structure of safety messages.
Signal word Meaning
Indicates a hazardous situation which, if not avoided, will result in death
or serious injury
Indicates a hazardous situation which, if not avoided, could result in
death or serious injury
Indicates a hazardous situation which, if not avoided, may result in minor
or moderate injury
Indicates a property damage message
Table 2-1 Signal words
DANGER
WARNING
CAUTION
NOTICE
WARNING
This section states nature and source of the hazard.
This section states potential consequences of not avoiding the hazard. This
section may be combined with the previous section.
•This section lists preventive actions to avoid the hazard.

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2.4 Symbols on the slide stainer and consumables
This chapter describes the symbols used on the slide stainer and on the
consumables used with the slide stainer.
Symbol Meaning
Consult instructions for use
Caution, consult accompanying documents
In vitro diagnostic medical device
CE mark
Manufacturer
Authorized representative in the European Community
,
Catalog number
Serial number
Waste electrical and electronic equipment
For more information, see Chapter 3.6.
Power on
Power off
Stain is low
Waste tank is full; Waste tank is removed
Prime tubing
Lock position of the pump tubing release knob
Unlock position of the pump tubing release knob
Stain
Buffer
Rinse
Table 2-2 Symbols on the slide stainer and consumables

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2.5 Statutory requirements
CE conformity The slide stainer bears a CE mark which certifies that the slide stainer
meets the essential requirements of the following European directives:
•In Vitro Diagnostic Medical Devices Directive 98/79/EC
•Directive on Waste Electrical and Electronic Equipment 2012/19/EU
•Directive on Restriction of Hazardous Substances 2011/65/EU
International standards The slide stainer has been developed, tested, and manufactured in
accordance with IEC 61010-2-101, ISO 14971, IEC 61326-2-6, and
IEC 62366.
Electromagnetic compatibility
(EMC), radio interference
suppression and immunity to
interference
The slide stainer has been tested in accordance with IEC 61326-2-6. The
slide stainer corresponds to CISPR 11 Class A.
Biological hazard
The labeled area can come into contact with potentially infectious
material. The safety instructions regarding infectious material must be
observed, see Chapter 2.2.5.
,
Content is toxic if swallowed, inhaled, or in contact with skin
, ,
Content is flammable
Content is harmful if swallowed, inhaled, or in contact with skin
Batch code
Use by
Recycle the packaging
Do not use if packaging has been damaged
Temperature limitation
This side up
Symbol Meaning
Table 2-2 Symbols on the slide stainer and consumables (continued)

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2.6 Obligations of the system owner
The system owner takes on the obligations arising from the national
legislation about the operation of in vitro diagnostic medical devices.

3 Life cycle
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3
3 Life cycle
This chapter describes the stages the system goes through, from delivery
to disposal, and the requirements involved for the operator with each stage.
3.1 Delivery
3.1.1 Unpacking and checking the delivery
To unpack and check the delivery, proceed as follows:
1. Before opening, check the transport container for signs of external
damage.
2. If the transport container shows any visible signs of damage,
immediately file a complaint with the carrier.
3. Open the transport container.
4. Carefully cut the straps securing the foam packing.
5. Remove all small single packages.
6. Remove the upper part of the foam packing.
7. Grasp the slide stainer from both sides under its frame where the foam
packing is cut out.
8. Carefully remove the slide stainer by lifting it by its frame.
9. Remove the plastic bag from the slide stainer.
10. Retain the transport container, plastic bag, and foam packing. If the
system needs to be transported, these will afford the best protection.
11. Check the content for completeness, see Chapter 3.1.2, and intact
condition.
12. If anything is missing or damaged, inform the Siemens service
immediately.
CAUTION
The straps securing the foam packing are highly tensioned and can
snap back when being cut
Minor or moderate injury can result.
•Use a suitable tool to cut the straps.
•Take special care while cutting the straps.

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3.1.2 Scope of delivery
The delivery includes three separate packages with the following content:
•1 Hematek 3000 slide stainer
•1 Hematek Pump Tube Set
•1 Hematek Cannula Set
•1 Hematek 3000 System Instruction Manual (language-specific)
•1 Power cord (country-specific)
3.2 Installation
To install the system, proceed as follows:
Note: A Hematek Stain Pak is required for operation, but is not included
in the delivery and must be ordered separately.
1 Lid
2 Knurled thumb screw with cardboard strip
3 Middle cover
4 Red waste tank light
5 Conveyor spirals
Figure 3-1 Installing the system
7
7
1
5
6
8
4
2
3
9
10