Milestone HistoDream EW User manual

HistoDream EW
Embedding Workstation
Operator Manual - MM164
MILESTONE
HELPING
PATIENTS

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Thank you for choosing one of our systems and welcome to the increasingly crowded club of Milestone
laboratory instrumentation users.
We feel confident that you will be fully satisfied adding this new device to your laboratory.
We recommend you read this operator manual carefully and always keep it within reach for convenient and
quick referencing.
For any clarification or request for assistance, please contact our representative in your country:
You can also contact us directly at:
Milestone s.r.l.
Via Fatebenefratelli, 1/5
24010 Sorisole (BG) Italy
Tel. +39.035.412 8264
Fax [phone]
Website www.milestonemed.com
e-mail [e-mail]
Read this manual carefully before using the instrument.
MM164-001-HistoDream EW - Operator Manual
2019-04

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INDEX
INDEX................................................................................................................................................................ 4
1. INTRODUCTION........................................................................................................................................ 6
1.1. Symbols used .................................................................................................................................... 6
1.2. Designated use.................................................................................................................................. 8
1.3. Technical Specifications.................................................................................................................... 9
1.3.1. HistoDream DM, Dispensing Module........................................................................................... 9
1.3.2. HistoDream CM, Cold Embedding Module................................................................................ 10
1.3.3. HistoDream TM, Thermal Module.............................................................................................. 11
1.4. Transport and storage conditions.................................................................................................... 11
1.5. Warning information......................................................................................................................... 12
1.6. Instrument label ............................................................................................................................... 14
1.7. Compatible reagents........................................................................................................................ 14
1.8. Waste disposal ................................................................................................................................ 15
1.9. Waste disposal of the reagents ....................................................................................................... 16
2. INSTALLATION........................................................................................................................................ 17
2.1. Space requirements......................................................................................................................... 17
2.2. Unpacking and check list................................................................................................................. 18
2.3. Electrical installation ........................................................................................................................ 21
2.4. Module connection........................................................................................................................... 22
2.5. Final placement ............................................................................................................................... 25
2.6. Installation of unassembled parts.................................................................................................... 25
2.7. General description.......................................................................................................................... 27
2.8. Keyboard description....................................................................................................................... 28
2.8.1. Key operation............................................................................................................................. 28
2.9. Reagents.......................................................................................................................................... 29
2.10. Operating settings............................................................................................................................ 29
2.11. Load wax.......................................................................................................................................... 30
2.12. HistoDream EW settings.................................................................................................................. 30
2.12.1. Set date and time................................................................................................................. 30
2.12.2. Temperature setting............................................................................................................. 31
2.12.3. Temperatures with a standalone cold module..................................................................... 31
2.12.4. Using the unit in manual mode............................................................................................ 32
2.12.5. Automatic start-up and shutdown programming.................................................................. 32
2.12.6. Programming holidays......................................................................................................... 33
3. USING HistoDream EW ........................................................................................................................... 34
3.1. Preparation ...................................................................................................................................... 34
3.2. Operating screens ........................................................................................................................... 34
3.3. Embedding a specimen with wax .................................................................................................... 35
3.3.1. Filling a mould............................................................................................................................ 35
3.3.2. Wax flow..................................................................................................................................... 35
3.3.3. Work area................................................................................................................................... 36
3.3.4. Wax collection drawers.............................................................................................................. 36
3.3.5. Cooling point.............................................................................................................................. 37
3.3.6. -Work area lighting..................................................................................................................... 37
3.3.7. Tweezer containers.................................................................................................................... 38
3.3.8. Wax scraper............................................................................................................................... 38
4. MAINTENANCE ....................................................................................................................................... 39
4.1. Introduction...................................................................................................................................... 39
4.2. Before/after every embedding ......................................................................................................... 39
4.3. Daily................................................................................................................................................. 39
4.4. Yearly............................................................................................................................................... 39
5. CLEANING UP......................................................................................................................................... 40
5.1. Safety precautions........................................................................................................................... 40
5.2. HistoDream EW cleaning up............................................................................................................ 40
6. OPTIONAL PARTS .................................................................................................................................. 42
6.1. HistoDream DM, Dispensing Module .............................................................................................. 42
6.2. HistoDream CM, Cold Module......................................................................................................... 42

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6.3. HistoDream TM, Thermal Module ................................................................................................... 42
6.4. HistoDream TS tracking system...................................................................................................... 43
6.4.1. Label .......................................................................................................................................... 48
6.4.2. PC settings for MacroPATH Viewer........................................................................................... 49
6.4.3. Using MacroPATH Viewer......................................................................................................... 50
6.4.4. How to change the language of the Operating System and Keypad......................................... 51
6.5. USB bar code readers ..................................................................................................................... 53
6.6. Removable drawers for wax collection............................................................................................ 53
6.7. Removable tray for cassettes.......................................................................................................... 53
6.8. Tweezers ......................................................................................................................................... 53
6.9. Heated tweezers.............................................................................................................................. 54
6.10. Magnification lens............................................................................................................................ 56
7. RESOLUTION OF ANOMALIES.............................................................................................................. 60
7.1. The power supply light does not switch on...................................................................................... 60
7.2. Wax is not dispensed....................................................................................................................... 60
7.3. Alarm messages.............................................................................................................................. 60
The manufacturer reserves the right to change and/or improve specifications without
notice and without incurring in any obligation.

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1. INTRODUCTION
1.1. Symbols used
The instructions marked with this symbol are important and must be read carefully.
An instruction marked by this WARNING symbol means caution is required. Failure to
follow the instruction may endanger the user or cause damage to the instrument.
An instruction marked with this symbol means caution is required as there is an
electric shock hazard. Carefully follow the instruction in order to prevent this kind of
accident.
Biohazard: pay attention when performing a procedure marked with this symbol, as
there is a biological contamination hazard.
Surfaces identified with this symbol have a hazardous temperature.
CE Logo: this instrument complies with European Community directives.
IVD medical device according to directive 98/79/EC.
Symbol of the European WEEE directive (2002/96/EC):
electric/electronic material –do not dispose of in the environment.
Authorised and qualified customer support personnel only.
Manufacturer.
Fragile.
Specifies the manufacturer’s serial number.
Specifies the manufacturer’s reference code.
Indicates the manufacturer's batch number.
Indicates the correct position of the packaging during transport

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Surfaces identified by this symbol have a high temperature hazard.
The mark guarantees the unit is tested according the UL61010-1 and certified by
INTERTEK.
Keep dry

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1.2. Designated use
HistoDream EW (Embedding Workstation) is a highly efficient instrument to embed wax-infiltrated tissue
specimens for use in pathology laboratories.
Only for the following operations:
- Dissolve solid wax for specimen embedding and to keep it melted at the required temperature.
- Fill the moulds where the tissue specimens have been placed with wax.
- Heat and keep the temperatures of the moulds and tweezers.
The instrument is intended for laboratory use (indoor use) only.
Use of the equipment in manners other than specified may void the warranty provided by
the manufacturer.

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1.3. Technical Specifications
1.3.1. HistoDream DM, Dispensing Module
MODEL
REF 500002-TB
REF 500002
•Electrical connections
100-120V50-60Hz
220-240V50-60Hz
•Power consumption
(without HistoDream TM, Thermal Module)
5.2A
2.65A
•Power consumption
(with HistoDream TM, Thermal Module)
8.6A
4.40A
For both HistoDream DM, Dispensing Module models:
•Dimensions
Width
Depth
Height
345mm (13.6’’)
641mm (25.2’’)
405mm (15.9’’)
•Weight
20.5 kg (45.2lb)
•Adjustable temperature
ranges:
- Wax cavity
from 40°C (104°F) to 70°C (158°F)
- Work area
from 40°C (104°F) to 70°C (158°F)
- Thermal chambers
for moulds and cassettes
from 40°C (104°F) to 70°C (158°F)
- Optional heated tweezers
from 60°C (140°F) to 75°C (167°F)
•Wax cavity capacity
5L
•Cooling point
5°C (41°F)
•Fuses:
100 –120 V, 2 x T10A
220 –240 V, 2 x T6.3A
•Sound Pressure
< 45 dB(A) measured at a distance of 1m from the unit
•Pollution degree
2
•Overvoltage category
II
•Floor loading requirements
150kg/m2

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1.3.2. HistoDream CM, Cold Embedding Module
MODEL
REF 500001-TB
REF 500001
REF 500001-TJ
•Electrical connections
110-120V50-60Hz
220-240V50-60Hz
100V50-60Hz
•Power consumption
3.3A
2.3A
2.4A
For all HistoDream CM, Cold Embedding Module models
•Dimensions
Width
Depth
Height
335mm (13.2’’)
623mm (24.5’’)
395mm (15.6’’)
•Weight
24.5 kg (54lb)
•Adjustable temperature range
From 0°C (32°F) to -12°C (10.4°F)
•Capacity
60 moulds
•Cold plate size
Width
Depth
375mm (14.8’’)
307mm (12.1’’)
•Fuses
110 –120 V, 2 x T10A
220 –240 V, 2 x T6.3A
100V~,2XT10A
•Sound Pressure
< 45 dB(A) at a distance of 1m from the unit
•Pollution degree
2
•Overvoltage category
II
•Floor loading requirements
150 kg/m2
•Recommended environmental operating conditions:
- Maximum humidity 60% (non-condensing)
- Temperature range 15°C (59°F) to 26°C (78°F)

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1.3.3. HistoDream TM, Thermal Module
MODEL
REF 500003-TB
REF 500003
•Electrical
connections
To connect only with: HistoDream DM,
Dispensing Module REF 500002-TB
100-120V50-60Hz
To connect only with: HistoDream DM,
Dispensing Module REF 500002
220-240V50-60Hz
For both HistoDream TM, Thermal Module models:
•Dimensions
Width
Depth
Height
340mm (13.4’’)
623mm (24.5’’)
395mm (15.6’’)
•Weight
16kg (35.3lb)
•Thermal chamber for moulds
Width
Depth
Height
- Dimensions
269mm (10.6’’)
510mm (20.1’’)
88mm (3.5’’)
- Capacity
2 removable trays with capacity for 2 racks (200 cassettes)
Without removable trays capacity for 3 racks (300 cassettes)
•Thermal chambers for
cassettes
Width
Depth
Height
- Dimensions
275mm (10.9’’)
170mm (6.7’’)
180mm (7.1’’)
- Capacity
400 moulds
1.4. Transport and storage conditions
- Transport and storage conditions: from -20°C (-4°F) to +50°C (122°F)
- Operating conditions: from 15°C (59°F) to 26°C (78.8°F) (at a 60% maximum relative humidity)
Altitude up to 2000m above sea level
Indoor use only
Before switching on the unit (when coming from a storage chamber), allow the instrument
to reach operating environment conditions (at least half an hour).
Repair or maintenance work is usually performed at the site of installation. If this is not possible for some
particular reasons, the instrument may be returned to Milestone. The contact address can be found at the
end of this instruction manual.

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1.5. Warning information
PERSONAL DATA SAFETY
The Device described herein is not intended for managing personal data of natural persons. Personal data of
natural persons shall not be inserted into the Device during the use of the Device. The organization that uses
the Device shall implement appropriate measures to ensure that no personal data of natural persons are
inserted into the Device. All the data referred to a person and inserted into the device shall use, at least, the
“pseudonymization”, in such a manner that the personal data can no longer be attributed to a specific data
subject without the use of additional information, provided that such additional information is kept separately
and is subject to technical and organizational measures to ensure that the personal data are not attributed to
an identified or identifiable natural person.
DO NOT OPEN THE UNIT'S BODY. Failure to comply with the instructions in the
documentation might lead to a reduction in the device's safety. Should the
equipment not work correctly you are kindly requested to contact the supplier or
manufacturer.
Do not remove the instrument, optional parts, panels or cover. Only authorised and
qualified personnel may repair and access the instrument's internal components.
It is important that normal standards for safety and good laboratory practices are
applied. Always use common sense and the best-known laboratory practice when
operating the instrument.
The Competent Authority who owns the instrument has the primary responsibility for
incidents due to operations on the instrument performed without attending
personnel in charge of use or repairs.
Only use the reagents listed in chapter 1.7 Compatible reagents to avoid damaging
the instrument. Failure to comply with the instructions might lead to decreased
instrument safety.
The instrument must not be used in the presence of flammable gases. Moreover, the
instrument must not be exposed to conditions where hazardous gas concentrations
may occur.
All instrument containers are only suitable for wax and not for other flammable
materials.
The frozen parts of the cold module may cause hand injuries. The equipment must
only be used by properly trained laboratory personnel. We recommend using
protective gloves.
The surfaces marked with this symbol or referred to in this instruction manual as hot
can be very hot. Be careful not to burn yourself.
The specimens used during the intended operation of the instrument might be
potentially infectious. For this reason, it is recommended to comply with general
laboratory rules for biological hazard protection.
When working with infectious specimens, comply with all applicable safety
procedures. When working with infected material, adequate safety and disinfection
measures must be taken. Safety clothing must be worn according to the rules and
regulations for handling infected material in each laboratory (e.g. particle mask,
gloves, protective shoe covers). Infected waste must be disposed of according to
relevant regulations.

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To avoid the risk of instrument malfunction, it must only be used in a controlled
electromagnetic environment. This means that transmitters such as mobile phones
must not be used in close proximity of the instruments.
In the event of malfunctions and/or servicing, please turn off the instrument and
contact your local dealer.

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1.6. Instrument label
For the explanations of the symbols, refer to chapter 1.1.
1.7. Compatible reagents
Histology wax.
DO NOT USE REAGENTS OTHER THAN THOSE LISTED ABOVE.
In case of doubts please contact: [e-mail].
Do not use any solvents, acids, chlorine-based reagents, aggressive reagents.
HistoDream TM: for use only connected to HistoDream DM, Dispensing Module

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1.8. Waste disposal
This instrument is an in-vitro medical device and it is installed in a laboratory where there are specimens and
other biological tissue. For your safety, it is therefore required to clean and disinfect the instrument prior to
coming into contact with it. It is also required to wear gloves when operating the system.
Should this instrument be returned to Milestone S.r.l., the unit must be cleaned and disinfected before
shipping it. Non-disinfected devices shall not be accepted and you will be contacted to pay the relevant
disinfection costs.
International health standards require that biohazard material be shipped in standard containers (risk of
sanctions).
After the final shutdown of the instrument, it is recommended to contact a local recycling company for
disposal, in accordance with applicable national regulations.
Removal of equipment in use for disposal:
1. Switch off the instrument and disconnect the unit.
2. If the thermal or cold module is connected, unplug the connection cable.
3. Empty the wax cavity or wait for solidification.
4. Clean and disinfect all parts of the equipment according to the manufacturer’s specifications.
5. Dispose of all electric and electronic parts of the equipment
Complying with directive 2012/19/EC of the European Parliament and of the Council of 4 July 2012 on waste
electrical and electronic equipment (WEEE), the separate collection environmental managed of equipment is
mandatory.
It is necessary to return the used equipment to the distributor or to inquire about the presence of a local
empowered system for collection and disposal of WEEE.
The in-observance of Directive 2012/19/EC or of the local law which acknowledge it can have potential
effects on the environment and human health.
This symbol indicates separate collection
for electrical and electronic materials
If additional requirements on accident prevention and environmental protection exist in the country of
operation, this instruction manual must be supplemented by appropriate instructions to ensure compliance
with such requirements.
Do not remove the frame panels of the instrument during cleaning up operations.
Disconnect the power supply before any operation.
Do not use water directly on the instrument or at high-pressure to clean the unit.
For safety reasons, any operation without the personal protective equipment must be
avoided.

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1.9. Waste disposal of the reagents
For further information please refer to the safety data sheets (MSDS) provided by the manufacturer.
Handle with care and store in a cool dry space using a tightly closed container.
Vapours may collect in empty containers. Therefore, empty containers should be treated
as hazardous waste.
Waste material should be disposed of in an approved incinerator or in a designated landfill
site, in compliance with all provincial and local government regulation.
Certain reagents may have effects on health and cause environmental pollution.

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2. INSTALLATION
2.1. Space requirements
Place HistoDream EW onto a flat, stable surface with ventilation clearance both behind and above the unit to
ensure adequate air circulation. The clearance between the unit and the wall must be at least 10 cm.
HistoDream EW is shipped in an 81kg (178.57lb) cardboard box sized as follows:
Width: 1200mm (47.24’’)
Height: 500mm (19.68’’)
Depth: 800mm (31.49’’)
Unit dimensions:
Width: 1020mm (40.15’’)
Min. height: 405mm (15.94’’)
Max height: 680mm (26.77’’) with
open wax cavity
Depth 641mm (25.23’’)
Dimensions of the space required to position the unit: add 10cm for each side to the unit’s dimensions
Width: 1040mm (40.94’’)
Height: 690mm (27.16’’)
Depth 651mm (25.62’’)
HistoDream EW is a heavy instrument. Check the bench for proper load bearing capacity by referring to
chapter 1.3 Technical Specifications.

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2.2. Unpacking and check list
This section illustrates the installation and preliminary operations. Please read the following chapters
carefully before operating HistoDream EW.
When unpacking check that all the parts are there.
HistoDream EW consists of three modules that are used to easily and comfortably perform the tissue
embedding procedure:
1. Cold module: HistoDream CM, Cold Embedding Module
2. Dispensing module: HistoDream DM, Dispensing Module
3. Thermal module: HistoDream TM, Thermal Module
Available versions are as follows:
HistoDream EW, Embedding Workstation 220-240V
REF 500000
1.HistoDream CM, Cold Embedding Module 220-240V50/60Hz
2.HistoDream DM, Dispensing Module 220-240V50/60Hz
3.HistoDream TM, Thermal Module 220-240V50/60Hz
HistoDream EW, Embedding Workstation 110-120V
REF 500000-TB
1.HistoDream CM, Cold Embedding Module 110-120V50/60Hz
2.HistoDream DM, Dispensing Module 100-120V50/60Hz
3.HistoDream TM, Thermal Module 100-120V50/60Hz
HistoDream EW, Embedding Workstation 100V
REF 500000-TJ
1.HistoDream CM, Cold Embedding Module 100V
2.HistoDream DM, Dispensing Module 100-120V50/60Hz
3.HistoDream TM, Thermal Module 100-120V50/60Hz
All modules can be purchased separately (refer to chapter 6).
The cold embedding module and the dispensing module are the only ones that can operate as standalone
units while the thermal module must be connected to the dispensing module.
When unpacking check that all the parts are there. Pay the utmost attention when unpacking HistoDream
EW to prevent scratches or damage to its body.
Before removing the modules from their packaging, carefully inspect them for any damage that may have
occurred during transport.
If any signs of damage are found, do not open the package and immediately notify Milestone.
Remove the cardboard, any shipping materials and the packaging.
Please keep the original packaging and foam core parts for any return shipments. Put recyclable materials in
suitable containers.
1
3
2

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DESCRIPTION
Q.TY
IMAGE
HistoDream DM, Dispensing Module
Dispensing module
1
HistoDream DM, Dispensing Module Power supply cable
1
HistoDream DM, Dispensing Module excess wax collection
drawers
2
HistoDream CM, Cold Embedding Module
Cold module
1
HistoDream CM, Cold Embedding Module Power supply
cable
1
HistoDream CM, Cold Embedding Module Control cable
1
HistoDream TM, Thermal Module
Thermal module
1
HistoDream TM, Thermal Module Cover
1

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DESCRIPTION
Q.TY
IMAGE
Removable trays for cassette positioning in the HistoDream
TM, Thermal Module
2
HistoDream TM, Thermal Module F-F power supply cable
1
HistoDream TM, Thermal Module R-R power supply cable
1
HistoDream TM, Thermal Module Sensor connection cable
1
Wax dispensing pedal with cable
1
Wax scraper
1
USB key containing:
- Operator manual in electronic format
- Recovery software for PC of HistoDream TS (see chapter
6.4)
For the optional parts, see Chapter 6.
The pictures are only an example.