Rev 02-2010
TissueSAFE
High Vacuum
Biospecimens Transfer System
i
Operation Manual (MM074)
October 2010
TissueSAFE Operation Manual 1/60
Rev 02-2010
Thank you for having selected our system and welcome to the ever growing club of satisfied Milestone
users. We invite you to read this operator manual carefully and to keep it in reach for convenient and fast
consultation.
For any possible clarification or any request for assistance please contact either our Representative in your
country :
Or:
Milestone Srl
Via Fatebenefratelli, 1/5
24010 Sorisole (BG) Italy
Tel. +39-035-4128264
Fax +39-035-575498
Web site www.milestonemedsrl.com
E-mail medical@milestonesrl.com
Caution!
Please read the user manual before using the instrument!
TissueSAFE Operation Manual 2/60
Rev 02-2010
SUMMARY
1.
INTRODUCTION .............................................................................................................................. 4
1.1. IMPORTANT NOTES ................................................................................................................ 4
SYMBOLS USED IN THIS MANUAL ................................................................................................ 4
DESIGNATED USES ........................................................................................................................ 4
1.2. SAFETY ..................................................................................................................................... 5
2.
SETTING UP THE INSTRUMENT.................................................................................................... 6
2.1. SITE REQUIREMENTS ............................................................................................................. 7
2.2. ELECTRICAL REQUIREMENTS .............................................................................................. 7
2.3. UNIT OVERVIEW ...................................................................................................................... 8
2.4. SWITCH ON AND OFF .............................................................................................................. 9
2.5. FUMES EXTRACTION SYSTEM............................................................................................. 10
3.
MILESTONE VACUUM BAGS ........................................................................................................ 11
4.
OPERATING TISSUE SAFE........................................................................................................... 13
4.1. CONTROL PANEL .................................................................................................................. 13
4.2. USER LOG IN .......................................................................................................................... 14
4.3. SELECT A PROGRAM ............................................................................................................ 15
4.4. RUN A PROGRAM .................................................................................................................. 15
4.5. MODIFY A PROGRAM ............................................................................................................ 21
4.6. STOP A PROGRAM ................................................................................................................ 23
4.7. SEAL A PLASTIC BAG ........................................................................................................... 23
4.8. SERVICE MENU ...................................................................................................................... 24
4.8.1
Watch ............................................................................................................................... 24
4.8.2
Language .......................................................................................................................... 24
5.
ACCESSORIES .............................................................................................................................. 25
5.1. NON MOBILE REFRIGERATOR ............................................................................................ 25
5.2. THERMAL BAG....................................................................................................................... 26
5.3. PORTABLE REFRIGERATOR 26 LITRES ............................................................................. 28
5.4. KIT PORTABLE REFRIGERATOR 65 LITRES ...................................................................... 30
5.5. KIT PRINTER........................................................................................................................... 32
5.6. BAG OPENER ......................................................................................................................... 32
5.7. TEMPERATURE MONITORING SYSTEM .............................................................................. 33
5.8. HOW TO OPERATE THE TEMPERATURE MONITORING SYSTEM ................................... 41
6.
CONSUMABLES ............................................................................................................................. 49
6.1. POLYSTYRENE CONTAINERS WITH PERFORATED LIDS ................................................. 50
6.2. POLYSTYRENE CONTAINING TRAYS ................................................................................. 50
7.
MAINTENANCE .............................................................................................................................. 51
7.1. CARBON/HEPA FILTER REPLACEMENT............................................................................. 52
8.
WASTE DISPOSAL ........................................................................................................................ 53
8.1. WASTE DISPOSAL OF VACUUM BAGS ............................................................................... 53
8.2. WASTE DISPOSAL OF PROTECTION BAGS FOR PDA ...................................................... 53
8.3. WASTE DISPOSAL OF ELECTRICAL AND ELECTRONIC EQUIPMENT ............................ 53
APPENDIX A .......................................................................................................................................... 54
DECONTAMINATION PROCEDURE .................................................................................................... 54
SAFETY PRECAUTIONS ................................................................................................................... 54
DECONTAMINATION PROCEDURE ................................................................................................ 55
APPENDIX B .......................................................................................................................................... 59
APPENDIX C .......................................................................................................................................... 60
TissueSAFE Operation Manual 3/60
Rev 02-2010
1. INTRODUCTION
1.1. IMPORTANT NOTES
SYMBOLS USED IN THIS MANUAL
An instruction accompanied by this symbol provides a cautionary
statement: WARNING. Failure to follow the instruction may endanger
the user or cause damage to the instrument.
An instruction accompanied by this symbol provides a caution against
electric shock. Be sure to follow the instruction to prevent accidents
resulting from electric shock.
Biohazard
Warning, danger of crushing hand
CE logo: This instrument complies with European community
directives
IVD medical device according to 98/79/EC directive
Please read carefully this instruction.
Please read Service Manual (operation for service only).
WEEE European directive symbol (2002/96/EC):
Electric/electronic device do not throw out in the environment
(3)
Figures in brackets refer to item nos. in drawings
DESIGNATED USES
The Milestone TissueSAFE system is intended for the following laboratory
applications:
 Histological specimen preservation
 Histological specimen transportation
 Long term specimen preservation (with an appropriate fixative into the plastic bag)
The Milestone TissueSAFE must be operated exclusively as reported in this manual.
Any other use of the instrument is considered improper!
TissueSAFE Operation Manual 4/60
Rev 02-2010
1.2. SAFETY
This paragraph details important safety information. Please read this section carefully:
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 any instrument and/or accessory panel or cover.
Only authorized and qualified service personnel may repair the
instrument and access the instrument’s internal components.
It is important that normal standards of safety and good laboratory
practices are employed. Always use common sense and the best
known practice when operating the instrument.
The institution owning the instrument has primary responsibility for
accident-free operation together with designated personnel who
operate, service or repair it.
To avoid damage to the instrument, use only the plastic bags
described in this manual, supplied by Milestone s.r.l.
Waste disposal of plastic bags
Plastic bags supplied by Milestone s.r.l. are preventively irradiated
with B rays before the use. After their use, treat empty plastic bags as
hazardous.
Waste material should be disposed in an approved incinerator in
compliance with all federal, provincial and local government
regulations.
TissueSAFE Operation Manual 5/60
Rev 02-2010
2. SETTING UP THE INSTRUMENT
The Milestone TissueSAFE is a precision instrument that must be unpacked and
installed with care. Move the TissueSAFE to its final location.
Make sure that the floor is level and is made of non-flammable material.
The instrument physical dimensions are:
W 45cm (18”) x D 60cm (24”) x H 135cm (54”)
Extra Space required : Back 15cm (6”), sides 5cm (2”) each
TissueSAFE weight is approximately 74Kg (164lb) when empty.
The Milestone TissueSAFE system, if dealing with Formalin fixed specimens,
must be connected to the fumes extraction system of the Laboratory to
guarantee a healthy environment.
TissueSAFE Operation Manual 6/60
Rev 02-2010
2.1. SITE REQUIREMENTS

Practically vibration-free floor

Room temperature constantly between +10°C (50°F) and +40°C (104°F)

Relative humidity maximum 80% (non condensing)

Avoid vibrations, direct sunlight and heavy variation in temperature

Floor must be able to support the weight (74Kg, 164lb)
2.2. ELECTRICAL REQUIREMENTS
Check the voltage label on the back of the instrument to ensure that the instrument is set
to the correct voltage range.
The TissueSAFE requires 115Vac/230Vac 3kWp.
The power supply voltage for the instrument is factory-preset and CANNOT be
altered by the user.
The Milestone TissueSAFE system must be connected to the power supply
and grounded to guarantee the optimal performance of all the high voltage
components.
All Milestone units are assembled to be connected to the ground of the laboratory and
operating room electrical system. Please contact our distributor to confirm that the power
ground cable is securely grounded.
TissueSAFE Operation Manual 7/60
Rev 02-2010
2.3. UNIT OVERVIEW
1
6
7
2
3
8
9
89
8
4
5
Cabinet front
1.
Working area cover
2.
Control panel
3.
Plastic bags drawer
4.
Metallic shelf
5.
Cover (removable shelves
holding vacuum bags inside)
Holder PDA
Cabinet back
for
Holder RFID
(Temperature reader)
6.
HEPA (high efficiency particulate air)
filter, that satisfies the EN 1822
normative (filter class H12).
7.
Charcoal/Formalin filter.
8.
Connector for fume extraction system
9.
Pump Oil level indicator
Space for the plastic bags
TissueSAFE Operation Manual 8/60
Rev 02-2010
2.4. SWITCH ON AND OFF
The electrical plug is located on the back of the unit (see red square in the picture
below).
Connect the cable provided by Milestone S.r.l, as described in the following pictures:
It is now possible to switch the unit on by pressing the main switch (A) on top of the
control panel (see picture below). The same main switch (A) must be used to switch the
unit off.
A
Make sure that the switch (A) is in OFF position before plugging the power
supply cable.
TissueSAFE Operation Manual 9/60
Rev 02-2010
2.5. FUMES EXTRACTION SYSTEM
The unit can be connected to an external fume extraction system through the built-in
connector (see red circle).
TissueSAFE Operation Manual 10/60
Rev 02-2010
3. MILESTONE VACUUM BAGS
Milestone provides the TissueSAFE system with plastic vacuum bags of four different
sizes (not included, to be ordered apart), that are preventively irradiated with B rays.
The use of the TissueSAFE system is allowed with Milestone proprietary
plastic vacuum bags ONLY.
P/N 68047SS
P/N 68055SS
P/N 68054SS
P/N 68046SS
Milestone S.r.l. provides these types of Milestone vacuum bags:
P/N
VACUUM BAGS
Double welding for enhanced vacuum seal
68047SS Special vacuum bag 140μ - Size SMALL (Q.ty 200)
Dimensions: external 250 x 300 mm – internal: 230 x 125 mm
68055SS Special vacuum bag 140μ -Size MEDIUM (Q.ty 200)
Dimensions: external 340 x 385 mm – internal 320 x 150 mm
68054SS Special vacuum bag 140μ -Size LARGE- (Q.ty 200)
Dimensions: external 340 x 550 mm – internal 320 x 320 mm
68046SS Special vacuum bag 140μ - Size EXTRA-LARGE (Q.ty 200)
Dimensions: external 340 x 550 mm – internal 320 x 500 mm
TissueSAFE Operation Manual 11/60
Rev 02-2010
An annotation label is placed on the outside of each bag. Normally such notes are taken
by the nurses in the OR while the surgical operation is going on.
At the end of the surgical operation, the MD can fill the request form and place it inside
the appropriate pocket.
Requisition form can be sealed inside the dedicated pocket. In this way requisition form
and surgical left over are properly transported with no chance of mistakes.
TissueSAFE Operation Manual 12/60
Rev 02-2010
4. OPERATING TISSUE SAFE
When the TissueSAFE unit is switched on, the control panel will appear as shown in Fig 1.
Fig 1
The operator can access the functionality of the unit through the panel, which controls all
the parameters involved in the bio-specimens preservation process.
4.1. CONTROL PANEL
The following picture describes the buttons on top of the control panel.
Fig 2
1
2
6
3
4
5
Control panel description:
1. Force sealing.
2. Interrupt a vacuum process.
3. Program selection.
4. Minus.
5. Plus.
6. Display.
TissueSAFE Operation Manual 13/60
Rev 02-2010
4.2. USER LOG IN
When the system is switched on, the operator is logged in as BASIC USER by default.
The BASIC USER is allowed to:

Run a default program (from P1 to P4).

Seal a plastic bag without vacuum, pressing the “” button (1) of fig. 2.

Interrupt a vacuum process, pressing the “STOP” button (2) of fig. 2.
Only ADMINISTRATOR (or SERVICE) can modify a preset program or create a new
program.
To log in as Administrator, reboot the unit, keeping pressed the “” button (1) of fig. 2.
When the “Welcome” screen disappears, insert the password as explained below:
Press:

“+”: to increase the digit,

“–“: to decrease the digit,

“SEL”: to change the digit to insert,

Press “SEL” again to confirm.
ADMINISTRATOR password issued as a separate document included in this operator
manual.
TissueSAFE Operation Manual 14/60
Rev 02-2010
4.3. SELECT A PROGRAM
TissueSAFE is able to memorize up to 30 different protocols. To move from P01 to
another protocol, press the PLUS button (5) to move forward or the MINUS button (4) to
go back to previous program (see fig. 2).
The right programs selection must be done according to the Vacuum Selection
Guide of the Operation Manual (see APPENDIX B).
4.4. RUN A PROGRAM
After the user log in, the following screen appears:
In the above picture the display is showing P1. It means that the unit is ready to start the
vacuum program n.1.
After the excision of the organ by the surgeon, it should be placed in the appropriate (by
dimension) Milestone plastic bag (fig.3). The operator can use the designed shelf on the
right of the vacuum cavity.
Fig 3
Fig 4.
The plastic bag with the specimen has to be placed with the open side directed toward
the operator, exactly as shown in the picture above (Fig 4).
TissueSAFE Operation Manual 15/60
Rev 02-2010
Make sure of using plastic bags of the appropriate size
(Small/Medium/Large/Extra-large) according to the specimen dimensions.
Use of inappropriate plastic bag size (too small) may cause spill
out of the specimen.
After the organ excision, in case of bleeding organ, remove the excess of
blood (or any other organic fluid) with a medical cloth. This to avoid any
putrefactive effect caused by the blood/organic fluid stagnation.
The plastic bag must be placed with the metallic sealing bar between the two
white lines (see picture below).
The operator has to manually close the cover (fig. 5). When the cover is closed, the
vacuum pump will start creating the vacuum inside the chamber (fig 6).
Fig 5
Fig 6
TissueSAFE Operation Manual 16/60
Rev 02-2010
Human Organs : vacuum selection guide
P1
P2
P3
P4
Kidney
Lung
Brain
Cyst
> 10cm in diameter
Breast
Placenta
Eye
Uterus
Prostate
Cyst
<10cm in diameter
Liver
Gall bladder
Muscle
Thyroid
Thymus
Skin
Tongue
Spleen
Colon
Bowel
Pancreas
Bladder
Testis
This guide is intended for specimens directly packaged with vacuum sealed
plastic bags.
When sealing very soft specimens (For ex: Ovarian Cyst), we suggest the use of
plastic containers P/N 68093-94 with perforated lids (see Par 6 for details). In
this case the specimen dimension must not exceed 2/3 of the container inner
volume.
ONLY perforated lids can be used to seal specimens containers.
TissueSAFE Operation Manual 17/60
Rev 02-2010
The vacuum progression inside the chamber is shown on the control panel display.
TissueSAFE will reach the pre-set value of vacuum within 20 secs.
Fig 7
After the vacuum step, the vacuum bag is sealed.
Fig 8
On completion of the sealing procedure, an audible alarm will advise the user and the
cover will automatically open (fig. 10).
Fig 9
Fig 10
TissueSAFE Operation Manual 18/60
Rev 02-2010
Now the nurse of the Operating Room can annotate the patient data, writing on the label
of the plastic bag (fig. 11).
Fig 11
Fig 12
At the end of the surgical operation, the MD requesting the histological examination will
fill the “Requisition Form”. This document needs to be placed in the external pocket on
the right of the label where the nurse reported the first annotation (fig. 12).
At this point, the MD can seal the requisition form in order to avoid any accidental
separation from the specimen (fig. 13).
Fig 13
The plastic bag containing the specimen needs now to be placed into an appropiate
refrigerator and transported to the Anatomical Pathology Department under controlled
temperature conditions, according to the following scheme.
TissueSAFE Operation Manual 19/60
Rev 02-2010
On the base of your Hospital organization, the correct SPECIMENS
TRANSPORT PROCEDURE is described in the following scheme:
OPERATING
ROOM
SEALING
TRANSPORT
CONDITIONS
MAX 30MIN
HISTOLOGY
LAB
FRIDGE
+4°C
GROSSING
FRIDGE
+4°C
GROSSING
FRIDGE
+4°C
GROSSING
THERMAL BAG
COOL PACKS +4°C
SEALING
SEALING
FRIDGE
2Hr ,+4°C
MOBILE
REF +4°C
MAX 3 HOURS
THERMAL BAG
COOL PACKS +4°C
> 3 HOURS
MOBILE
REFRIGERATOR +4°C
1.
If the time required by the courier for the specimens’ transportation to the
Anatomical Pathology Department is less than 30 minutes, Milestone S.rl.
recommends putting the specimens in the Thermal bag with the cool packs at
+4°C.
2.
If the time required by the courier for the specimens transportation to the
Anatomical Pathology Department is less than 3 hours, Milestone S.rl.
recommends to put the specimens into the refrigerator ), close to the TissueSAFE
for at least 2 Hr (pre-cooling procedure) and later to place them in the Thermal
bag with the cool packs at +4°C.
3.
If the time required for the specimens’ transportation exceeds 3 hours, Milestone
S.rl. recommends the use of the Mobile refrigerator connected to an external
power supply (12/24Vdc, 115/230Vac).
For details on refrigerators models available from Milestone s.r.l., see Chapter 5
TissueSAFE Operation Manual 20/60
Rev 02-2010
Operator must take care that the total transportation time does not
exceed 72 hours (including time spent in both O.R:/Histology Lab
refrigerators).
For a correct preservation of the specimens’ morphology, they have to be
placed and maintained at a temperature of +4°C , ±2°C ( 39,2 °F, ±35,6°F).
For further details about the complete TissueSAFE system and its
accessories, see Paragraph 5 “ACCESSORIES”.
4.5. MODIFY A PROGRAM
TissueSAFE can memorize up to 30 protocols.
Only ADMINISTRATOR (or SERVICE) is allowed to modify programs as follows:
Protocol
P01–P03
P04–P30
Administrator


User




Allowed
NOT allowed
To modify a program, log in as Administrator (see Cap 4.2 for details). Select the
program of interest using the button (4) and (5) shown in fig. 14 and press the “SEL”
button (3) to open the program customization screen.
Fig 14
1
2
6
3
4
5
TissueSAFE Operation Manual 21/60
Rev 02-2010
The program customization screen will appear as shown in Fig. 15. Move through the
parameters using the “SEL” button (3) and set the relative value using the button (4) and
(5) shown in fig. 14.
Fig 15
Every program is characterized by 5 parameters :
1 VACUUM PERCENTAGE.
Insert the correct vacuum value, according to the Organ Selection Guide (see
APPENDIX B).
2 SEALING TIME.
The plastic bags provided by Milestone s.r.l. are correctly sealed with a sealing
time of 2,4 sec.
It is strongly recommended NOT to modify this sealing time for use with
standard bags provided by Milestone
TissueSAFE Operation Manual 22/60
Rev 02-2010
3 PROGRAM ENABLED.
If you choose:
“Yes” the BASIC USER can use the protocol
“No” the BASIC USER cannot use the protocol
4 PROGRAM NAME.
It is possible to insert a short name for each program (generally according to the
most used organ). You have 16 alphanumeric characters (“0”–“9”, “A”–“B”).
Pressing the “SEL” button (3) once more, the system goes back to the main screen and
the program is shown with the name you have selected
TissueSAFE can now operate the program following the parameter inserted by the
Administrator.
The instrument is shipped by the manufacturer with 4 factory preset
protocols (P1, P2, P3 and P4). From P5 to P30 default parameters are
inserted and can be modified.
Do not modify any TissueSAFE protocol without Milestone s.r.l.
authorization. A protocol with inappropriate parameters may damage
tissues.
Do not leave the software logged in as Administrator, to prevent any
accidental programs modification made by basic users.
4.6. STOP A PROGRAM
Press the “STOP” button (2) on the control panel (fig. 14), to stop a program while the
vacuum process is already started. The vacuum process will be immediately stopped
and the vacuum chamber will be opened.
4.7. SEAL A PLASTIC BAG
Press the “” button (1) shown in fig. 14, to seal the plastic bag (and to stop the vacuum
cycle) while the process is running. The vacuum cycle will be immediately stopped, the
plastic bag will be sealed and the vacuum chamber will be opened.
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4.8. SERVICE MENU
Service menu allows setting “WATCH” and “LANGUAGE” of the unit.
Log in as Administrator (see Cap. 4.2 for details) and press the “” button (1) shown in
fig. 14, to open the menu.
Fig 16
Move through the parameters using the buttons (4) and (5) shown in fig. 14 and press
the “SEL” button (3) to open the relative function.
4.8.1
Watch
Set the proper value using the buttons (4) and (5) shown in fig. 14 and then press the “SEL”
button (3) to confirm the setting and move to the next parameter:
Day.....: 12
Month.....:01
Year......:10
Hour......:17
Minutes...:29
The time format is: 2010–01–12, 17.29.
4.8.2
Fig 17
Language
Set the proper language using the buttons (4) and (5) shown in fig. 14 and then press the
“SEL” button (3) to confirm the setting.
Fig 18
On completion of the settings, press the “” button to exit the menu.
TissueSAFE Operation Manual 24/60
Rev 02-2010
5. ACCESSORIES
The specimens under vacuum must be stored at a temperature of +4°C
(39,2°F).
Milestone S.r.l. provides a set of optional accessories to maintain temperature under
control, according to the Specimen Transport Procedure (see Chap. 4.4) :
5.1. NON MOBILE REFRIGERATOR
P/N
DESCRIPTION
68064
68090
Refrigerator laboratory type 140 Litres 230Volt complete
Refrigerator laboratory type 140 Litres 115Volt complete
Milestone suggests positioning the
Fig 19
TissueSAFE close to a controlled
refrigerator.
In Fig 19, the refrigerator is shown on
A
the left side (A). In this type of
refrigerator, the temperature is kept at
approx +4°C (39,2°F). The operator
can easily place the under vacuum
B
specimens and the cool packs (B) in
the refrigerator.
Main Characteristics:

ECT-F Control® : with Hi/Low Temp. alarm, door ajar, ON/OFF w/password.

Automatic condensate water evaporation.

Internal cabinet with shelves/drawers interchangeable.

Auto-defrosting type.
For further information, see specific instruction manual included in the shipment.
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5.2. THERMAL BAG
P/N
DESCRIPTION
68084
Kit Refrigerator box in PS 32 litres complete with
N.4 cool packs
When the Courier is ready to transport the specimens to the Anatomical Pathology
Department, the under vacuum specimens must be placed in the Thermal Bag,
appropriately closed and then transported (fig. 19 a/b).
Fig 19a
Fig 19b
The operator must take care of placing at least 1, 2 or 3 Cool Packs at +4°C inside the
thermal bag, according to the inner volume of the thermal bag used (fig. 20).
Fig 20
TissueSAFE Operation Manual 26/60
Rev 02-2010
For an optimal specimens preservation, Milestone S.r.l. recommend to
keep the Cool Packs in the refrigerator close to the TissueSAFE, at a
temperature value of +4°C , ±2°C ( 39,2 °F, ±35,6°F).
Do not keep and transport any Cool pack inside the Thermal bag at
temperature values lower than 2°C (35,6°F). Frozen Cool packs could damage
the specimens during their transportation.
Cool packs are extremely important to keep the temperature inside the
transportation bag. Do not transport any specimens in a Thermal bag without
using the cool packs.
After transportation, specimens are ready for grossing procedure (fig. 21).
Fig 21
TissueSAFE Operation Manual 27/60
Rev 02-2010
5.3. PORTABLE REFRIGERATOR 26 LITRES
P/N
DESCRIPTION
68083
Kit Portable Refrigerator 26 Litres with trolley with folding handle.
Power supply 12-24V & 110-230V.
Ideal for long term transportation by car.
It is also possible to use the mobile refrigerator (A) as shown in the picture below
(Fig. 22). This device is ideally suited for long term transportation by car.
See also Table in Appendix C
Fig 22
A
TissueSAFE Operation Manual 28/60
Rev 02-2010
With this type of portable refrigerator, cool packs are not required because the
temperature is monitored by a thermometer. In this case there is an easy-to-use basket
that perfectly fits in the refrigerator (fig. 22a,b).
Fig 22a
Fig 22b
The portable refrigerator:

P/N 68083: PORTABLE REFRIGERATORS C 26 (capacity: 26 litres).
Main Characteristics:

Voltage allowed: 12-24V, 110-240V - 50Hz/60Hz.

Digital electronic thermostat with audible and visual alarm system (not for power
failure).
The weight of the C26 mobile refrigerator, when empty, is 15 Kg (33lbs).
For further information, see specific instruction manual included in the shipment
TissueSAFE Operation Manual 29/60
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5.4. KIT PORTABLE REFRIGERATOR 65 LITRES
This mobile refrigerator with its mobile cart, as shown in the picture above, is ideally
suited for easy transportation inside the Hospital. See also Table in Appendix C
NOTE: Model at 230V is supplied also with UPS
P/N
68081
68082
DESCRIPTION
Kit Portable Refrigerator 230V - 65 litres with trolley and UPS (*)
Kit Portable Refrigerator 115V - 65 litres with trolley (NO UPS included)
(*) UPS Technical Specifications:
Capacity:
1000VA/600W
Voltage:
220/230/240VAC – 50/60Hz
Recharge Time:
For first installation, connect at least for 10 hours.
Afterwards, 10 hours to 90% after complete discharge.
Autonomy in Battery Mode (UPS): 4 hours with minimum load
(tested with a sample of 0.5 litre volume)
1 hour with maximum load
(tested with 20 litres organic material at 37°C)
Operating Environment:
0-40°c, 0-80% Relative Humidity (non-condensing)
Dimensions:
(DxWxH) (mm): 405x205x145
Net Weight:
9.6 Kg
For further information, see specific instruction manual included in the shipment
TissueSAFE Operation Manual 30/60
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P/N
DESCRIPTION
REFRIGERATORS
68084
Kit Refrigerator box in PS 32 litres complete with
N.4 cool packs
68083
Kit Portable Refrigerator 26 Litres with trolley with folding handle.
Power supply 12-24V & 110-230V.
Ideal for long term transportation by car.
68081
68082
Kit Portable Refrigerator 230V - 65 litres with trolley and UPS
Kit Portable Refrigerator 115V - 65 litres with trolley (NO UPS included)
68064
68090
Refrigerator laboratory type 140 Litres 230Volt complete
Refrigerator laboratory type 140 Litres 115Volt complete
TissueSAFE Operation Manual 31/60
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5.5. KIT PRINTER
The kit allows printing of a label with indication of date and time of packing/sealing of the
sample, for enhanced traceability.
Label must be positioned on the vacuum bag including specimen
P/N
DESCRIPTION
KIT PRINTER
68120
Kit Printer at 230V for Tissue Safe Bags
68118 Roll of paper for Kit Printer at 230V for Tissue Safe
68119 Spare Blades (Kit 2 pieces) for Kit Printer at 230V for Tissue Safe
5.6. BAG OPENER
Suitable to facilitate opening of the vacuum bag for easy insertion of the sample/organ.
PN 68112 BagOpener
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5.7. TEMPERATURE MONITORING SYSTEM
P/N
DESCRIPTION
TEMPERATURE MONITORING KIT
68075
RFID controller plus reader:
F
Including:
A. Palm Pc Touch-screen PDA
B. RFID Datalogger card (q.ty 10)
C. RFID smart card SDIO reader
D. RFID Desktop Reader USB
E. Power Supply for PDA
F: N. 100 Protection Bags for Palm Pc Touch-screen PDA
The software program requires the installation of Microsoft Excel
(minimum version 2002 SP3).
68100 RFID Datalogger card
68036 N. 100 Protection Bags for Palm Pc Touch-screen PDA
Milestone s.r.l. provides this dedicated system to continuously monitor and document the
specimens temperature during their transportation, through a Radio Frequency
Identification Device (RFID) smart card (according to the scheme of chapter 4.4).
The system ensures a permanent monitoring of temperature-sensitive specimens and
enables a fast documentation of process and storage temperatures through the easy
handling. It measures temperature data by means of a calibrated sensor and stores them
directly on the chip.
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TEMPERATURE MONITORING KIT INCLUDES :
1. RFID smart card SDIO reader (P/N 68103, fig. 23) and controller (P/N 68101,
fig. 24), provided with Milestone user-friendly software interface.
Fig 23
Fig 24
Main Characteristics:



Connector type: SDIO
Operating frequency: 13,56MHz
Air Interface protocol: ISO 15693-3
Please make sure that:
-
Palm PC Touch-Screed PDA (P/N 68101) is operated with specific protection bag.
Protection bag is changed after each transportation cycle to avoid contamination
For protection bag disposal, see Chapter 8 “Waste Disposal”.
2. RFID smart card data logger (P/N 68100, fig 25).
Main Characteristics:
Fig 25
 Dimensions: 54mm X 86mm.
 Thickness: 1.80 mm.
 Construction: multilayer body of different
synthetic materials.
 Back side cover: adhesive backside.
 Flexible and environmental friendly.
 Single and multi use.
 Dynamic bending stress. In accordance to EN ISO/IEC 10536-1 “identification cards –
Contactless integrated circuit(s) cards – Close coupled cards” respectively ISO/ IEC
JTC/SC17 N 1480.
 Temperature transponder in ID1-format (credit card size).
 Storage conditions: at room temperature, higher than 30% relative humidity.
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Technical data:
Data points
700 values (rate automatically adjusted by sw).
Operating temperature -20°C up to 50°C
Operating frequency
13,56MHz
Air Interface protocol
ISO 15693-3
Temperature accuracy
Typical 0,3 K (-20°C to +30°C)
Time accuracy
Better than ±3%
Memory
8kBit EEPROM
Battery
MnO2Zn - printed battery (1,5V ... 1,1V)
Battery Life
Up to 25 recording cycles (4°C), max 1 year
TissueSAFE Operation Manual 35/60
Rev 02-2010
3. RFID smart card desktop reader (P/N 68102, fig. 26) and Milestone RFID data
recording software.
On completion of the recording procedure (at the end of the trip or other monitoring
episode), the tag information can be downloaded by the PC of the Histology Lab with
RFID desktop shown below (fig 26).
Fig 26
Desktop reader main characteristics:

Interoperable with ISO 14443 A&B, ISO 15693.

USB interface.

USB bus powered (no external power source).

Supports Windows® 98, Mn, 2000, XP

Serial communication driver for easier PC-linked application development.

Embedded evaluation kit.

Cryptographic security management for picopass® chips.

Transparent mode preserves open.

Connection with contactless interfaces.
Minimum requirements for general use with PC:
The PC must have Microsoft Windows XP SP2 (or later)/Vista and Microsoft
Excel 2002 SP3 (or later). An USB port and a CD reader are also required.
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Drivers Installation instructions:
To install the Data Recording software please follow the points below:
1) Insert the Installation CD-ROM in the PC.
2) Connect the Card Desktop Reader in one of the USB ports of the PC.
3) Automatically the Windows Wizard opens the following window, select “No, not
this time” and then press “Next”.
4) Now select “Installation from a list of specific location” and press “Next”.
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5) Select “Include this location in the search:” and choose the folder in the CD-ROM
named “RFID Desktop Reader Driver”. Click “Next” to continue.
6) Press the icon “Continue anyway” to skip Windows Logo testing.
7) The Wizard has successfully installed the files, press “Finish” to proceed.
8) Repeat again the installation procedure starting from point 3, to install the USB
port driver.
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Data Recording software installation instructions:
1) From the installation CD-ROM, open the folder “PC 1.0.0“. Then select and double
click on the icon “Milestone TissueSAFE setup.exe”.
2) The installation Window Wizard will appear. Press “Next” to continue.
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3) Leave the default installation Folder (C:\Program Files\Milestone TissueSAFE)
and press “Next” to continue.
4) Click “Next” again to start the installation procedure.
5) On completion of the procedure, click “Close” to exit from the Wizard. At this point,
you will find a new “Milestone TissueSafe” icon on your desktop. By clicking on it
the Milestone data recording software will appear as shown below.
If you cannot correctly visualize the Main Menu, you need to modify the Macro
settings of Microsoft Office. To do this operation, select from the file menu
SettingMacroProtection and then set as “Low” the Protection Level.
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5.8. HOW TO OPERATE THE TEMPERATURE MONITORING SYSTEM
A.
How to activate the RFID card data logger in the PREOPERATING ROOM:
1. Switch on the PDA, the Tissue SAFE software will automatically start. The main
screen will appear, as shown in fig. 27:
Fig 27
Please make sure that:
-
Palm PC Touch-Screed PDA (P/N 68101) is operated with specific protection bag.
Protection bag is changed after each transportation cycle to avoid contamination
For protection bag disposal, see Chapter 8 “Waste Disposal”.
To facilitate explanation of the functionalities, PDA is shown in this chapter
without protection bag
2. Click on “Start Cold Chain Log” to activate the smart card (see arrow in fig. 27).
3. Place the smart card data logger close to the smart card reader as shown in the
pictures 28a, b.
Fig 28a
Fig 28b
Do not move the card during the reading procedure.
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4. When the reader has detected the smart card, it activates the temperature/time
monitoring with the message shown in Fig. 29.
Fig 29
The smart card activation needs to be done upon the packaging of the FIRST
specimen received by the Operating Room.
If you want to stop the card reading and clear all the data, press on “Clear
card” (fig. 27). A message will confirm the operation. In this case the card is
still ready for a next data recording procedure.
Under “Settings” section, it is possible to set the data recording time of the
smart card (fig. 27).
Click on “Settings” and insert the password 0039 to edit the data recording time (use the
plus/minus buttons to modify the time).
Select the record time that you need to monitor and then press OK.
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A. Indicate the recording time of the card,
(1 = one hour). If 1 hour recording time
A
is selected, temperature is read every
6sec. According to the recording time
B
C
selected,
the
sampling
time
is
automatically adjusted.
D
B. Current data and time: press the arrows
E
F
to adjust them.
C. If checked before programming the
card,
the
software
advises
extra
information, like completion time of the
temperature monitoring.
D. If checked, additional information can
be added to the graph, like the
description of the batch transported.
E. If you press Exit the application will be
closed.
F. Press OK to confirm the modification.
This PDA is conceived only for operation with Milestone Software.
Do not install other programs on it.
It is also possible to check the status of the smart card battery, by pressing
“Battery” (fig. 27).
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When the card has been activated, the operator must place it into the external pocket of
the plastic bag of the FIRST specimen that has been sealed under vacuum that day,
together with the Requisition Form (fig. 30a,b).
Fig 30b
Fig 30a
Now, the operator can seal the external pocket to prevent any accidental separation of
the card from the specimens (fig.31).
Fig 31
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The plastic bag, containing the smart card, should be now placed into the refrigerator
close to the Tissue SAFE or directly into the Thermal Bag (see fig. 32a,b, according to
the scheme of the chapter 4.4).
Fig 32b
Fig 32a
For an optimal specimen’s temperature monitoring, Milestone recommends to
keep the smart card far away from the cooling elements of the refrigerator.
B.
SPECIMENS TRASPORTATION: from the surgery suites to the
Pathology Lab.
When the Courier is ready to transport the specimens to the Anatomical Pathology
Department, the smart card together with the under vacuum specimens must be placed
in the Thermal Bag, appropriately closed and then transported (fig. 33).
Fig 33
TissueSAFE Operation Manual 45/60
Rev 02-2010
The operator must take care of placing at least 1, 2 or 3 Cool Packs at +4°C inside the
thermal bag, according to the inner volume of the thermal bag used (fig. 34).
Fig 34
For
an
optimal
specimens
temperature
monitoring,
Milestone
S.r.l.
recommend to keep the smart card among the under vacuum specimens, on
the opposite side of the Cool packs.
C.
How to handle specimens upon their arrival in the HISTOLOGY
LAB.
Upon its arrival in the Histology Lab, the thermal bag is opened and the RFID card is
removed from the plastic bag (fig. 35a,b).
Fig 35a
Fig 35b
TissueSAFE Operation Manual 46/60
Rev 02-2010
Then the card is read on a standard PC through the RFID smart card desktop reader (fig
36 red circle).
Fig 36
Please be sure to correctly position the card on the desktop reader as shown
in fig. 36. In case of wrong card positioning, the system will not read the RFID
card data.
Position the RFID on the smart card desktop reader and click on “Read Card” (fig 37, red
circle). A single reading takes less than 30 seconds, even for a tag that is completely full
of data.
Fig 37
On completion of the data reading procedure, the card will be deactivated and
the temperature log stopped.
TissueSAFE Operation Manual 47/60
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The time/temperature curve from the time of the smart card activation until arrival in the
Histology Lab is shown in fig. 38.
Fig 38
By pressing “Save Report” is possible to save the complete Log (fig. 37, green circle). If
required, for documentation purposes, the complete log can be printed. Press the “Print
Preview” button to confirm the printing operation (fig. 37, blue circle).
Upon arrival, bags are sequentially opened as shown in fig. 39a,b.
Once opened, specimens are ready for the grossing procedure.
Fig 39a
Fig 39b
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Rev 02-2010
6. CONSUMABLES
P/N
VACUUM BAGS
Double welding for enhanced vacuum seal
68047SS Special vacuum bag 140μ - Size SMALL (Q.ty 200)
Dimensions: external 250 x 300 mm – internal: 230 x 125 mm
68055SS Special vacuum bag 140μ -Size MEDIUM (Q.ty 200)
Dimensions: external 340 x 385 mm – internal 320 x 150 mm
68054SS Special vacuum bag 140μ -Size LARGE- (Q.ty 200)
Dimensions: external 340 x 550 mm – internal 320 x 320 mm
68046SS Special vacuum bag 140μ - Size EXTRA-LARGE (Q.ty 200)
Dimensions: external 340 x 550 mm – internal 320 x 500 mm
P/N
DESCRIPTION
VIALS
68058
Kit 200 plastic vials, capacity 1,5 ml with perforated lid
Suitable for small needle biopsies.
For use only in our Vacuum Bags.
POLYSTYRENE CONTAINERS WITH PERFORATED LID
68093
Kit 10 pieces of polystyrene containers, capacity 200ml
Suitable for small delicate (soft) specimens.
For use only in our Vacuum Bags.
68094
Kit 10 pieces of polystyrene containers, capacity 30ml
Suitable for small delicate (soft) specimens.
For use only in our Vacuum Bags.
68125
Kit 200 polystyrene containing trays including:
- N. 50 of polystyrene trays dim. 235 x 150 x h44 mm
- N. 50 of polystyrene trays dim. 255 x 180 x h36 mm
- N. 50 of polystyrene trays dim. 290 x 215 x h40 mm
- N. 50 of polystyrene trays dim. 330 x 260 x h52 mm
For use only in our Vacuum Bags.
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6.1. POLYSTYRENE CONTAINERS WITH PERFORATED LIDS
The use of polystyrene containers and
vials with perforated lids is suggested
when sealing very soft specimens (For ex:
Ovarian Cyst). The container with the
sample must be then positioned inside the
vacuum bag for sealing.
Capacity 200ml
Capacity 30ml
In this case the specimen dimension must not exceed 2/3 of the container
inner volume.
6.2. POLYSTYRENE CONTAINING TRAYS
Conceived to facilitate the introduction and the
handling of the sample in the vacuum bag,
these trays are suggested for sealing of organs
like small and large bowel.
See details on the organs that can be
positioned in these trays in table of
Appendix C, column P1 only.
NOT suitable for very soft tissues
(like brain). Risk of damaging the
sample.
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7. MAINTENANCE
Maintenance of the TissueSAFE must be done at two levels.
1. The first is at laboratory level: simple routine cleaning maintenance can prevent
the likelihood of more serious problems occurring at a later stage.
2. The second is technically more detailed and is beyond the scope of normal
laboratory personnel.
Attention: check with local distributor or with Milestone offices directly
(customersupport@milestonemedsrl.com) how to perform Preventive Maintenance
and regular inspections in order to maintain your Tissue Safe within safe operative
standards.
OPERATING ROOM PERSONNEL
Minimal routine maintenance is required by Operating Room personnel. The following is
recommended to ensure optimal performance of the TissueSAFE.
A. DAILY:
Clean and disinfect the instrument every day, following the procedure described in the
APPENDIX A.
Ensure that TissueSAFE is generally kept clean after each use, but do not use
abrasives or sharp instruments that may damage acid/solvent resistant coating
etc.
Daily check the covers and the edge surface of the vacuum chamber.
Traces of organic residues must be removed to ensure the optimum closing of
the cover.
The incorrect closing of the cover prevents the possibility of creating the
vacuum.
Daily sterilization can prevent cross contamination of the specimens.
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B. MONTHLY:
Check the oil level of pump on the back side of the instrument ( see 1 in fig 40). A level
under the minimum can cause degradation on performance vacuum level and the
damage of the pump.
Fig 40
1
When oil became dark muddy and/or emulsify, it loses the lubricant properties and it is
required a substitution (service personnel only).
7.1. CARBON/HEPA FILTER REPLACEMENT
SERVICE PERSONNEL
TissueSAFE is equipped with a Carbon/HEPA filter. This type of filter is used to filter the
vapours coming from the biological specimens.
The filter should be replaced every 6 months during the Preventive Maintenance action
performed by authorized and trained service personnel or when the following warning
appears (see picture below) on the Tissue Safe display (in this case, contact your local
representative or manufacturer).
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8. WASTE DISPOSAL
8.1. WASTE DISPOSAL OF VACUUM BAGS
The vacuum bags supplied by Milestone s.r.l. are preventively irradiated with β rays
before the use. After its use, treat empty vacuum bag as biohazardous.
Waste material should be disposed in an approved incinerator in compliance with all
federal, provincial and local government regulations.
8.2. WASTE DISPOSAL OF PROTECTION BAGS FOR PDA
The protection bags for PDA supplied by Milestone s.r.l. must disposed after each use
and must be treated as biohazardous.
Waste material should be disposed in an approved incinerator in compliance with all
federal, provincial and local government regulations.
8.3. WASTE DISPOSAL OF ELECTRICAL AND ELECTRONIC
EQUIPMENT
Removal of equipment from use for disposal:
1) Switch OFF the panel PC. Disconnect the main plugs of the panel PC from the main
socket outlets
2) Switch off the camera power supply. Disconnect the main plug of the camera power
supply from the main socket outlet.
3) Disconnect all accessories (foot pedal, keyboard, bar-code reader, camera, camera
power supply).
4) Clean and disinfect all parts of the equipment according to the manufacturer
specification.
5) Dispose all electric and electronic parts of the equipment according to the
manufacturer:
Complying with directive 2002/96/EC of the European Parliament and of the Council of
27 January 2003 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 2002/96/EC or of the local law which acknowledge it can
have potential effects on the environment and human health
Before the disposal, the unit must be disinfected and oil of the pump must be removed
from the unit according to the procedure described in Appendix A. Oil removed must be
disposed separately according to your local regulations.
This symbol indicates separate collection for electrical and electronic equipment
For this and any possible clarification or any request for assistance please contact:
customersupport@milestonemedsrl.com
TissueSAFE Operation Manual 53/60
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APPENDIX A
DECONTAMINATION PROCEDURE
SAFETY PRECAUTIONS
The personnel involved in the TissueSAFE decontamination procedure must wear the
appropriate individual protective devices, in particular:

Single use, HI-RISK protective gloves (100% hi-risk latex or equivalent ).
Individual protection device that meets the standard EN 374 and the Directive
89/686/CEE.

Antibacterial mask face for operating room and plastic apron. Individual
protection device, meets the standard EN 149 Grade FFP3D and the Directive
89/686/CEE.

Protective eyeglasses. Individual protection device, meets the standard EN
166 and the Directive 89/686/CEE.
For safety reason, any operation without the individual protective devices must
be avoided.
TissueSAFE Operation Manual 54/60
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DECONTAMINATION PROCEDURE
Please follow the instructions below on how to carry out a correct cleaning and
decontamination procedure.
Do not remove the side panels of the unit during the cleaning operations.
The decontamination procedure can be performed only when the unit is cool.
Before doing any operation disconnect the power supply. Do not use direct or
high-pressure water to clean the instrument.
It is recommended the use of enzymatic detergents and polyphenolic based disinfectants
or chlorine substitutes to clean and disinfect the instrument.
For further information, please contact the manufacturer: medical@milestonesrl.com
Germicidal efficacy of polyphenolic based disinfectant agents:
Biocide efficacy (in minutes)
In alternative, to decontaminate the instrument, the use of a solution of 1:10 Bleach
(recommended by the CDC for disinfecting) is also allowed.
TissueSAFE Operation Manual 55/60
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HOW TO OPERATE:
1. Remove the spacers from the working area and wash them separately with an
appropriate detergent. After that, spray the disinfectant solution and leave the
solution for at least 5 minutes. Clean the spacers surfaces with a dry cloth or
paper.
2. Remove, with an appropriate detergent, any organic residual from the inner
surfaces of the chamber and from the external surfaces of the instrument.
3. Remove, with an appropriate detergent, any organic residual from the soldering
bar connectors. Remove also polyester residuals from soldering bar (if any).
TissueSAFE Operation Manual 56/60
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4. Spray the disinfectant solution on the external surfaces and the steel parts of the
unit and leave the solution for at least 5 minutes. After that clean the surfaces with
a dry cloth or paper.
5. Spray the disinfectant solution on the inner surfaces of chamber and leave the
solution for at least 5 minutes. After that, clean the surfaces with a dry cloth or
paper.
6. Spray the disinfectant solution on the Plexiglas cover (internal/external surface)
and leave the solution for at least 5 minutes. After that, clean the surfaces with a
dry cloth or paper.
TissueSAFE Operation Manual 57/60
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7.
Clean also the rubber gasket so that it can correctly adheres to the steel surface
of the working area. Maintain also clean the inhaling bushing inside the working
area (see red circle).
8.
Before removing gloves, wash them with soap, water and disinfectant.
9.
Wash your hands.
10. Remove the individual protection devices.
11. Protect the instrument as required by specific protocols for your department and /
or service (in containers, medical grade paper, etc.).
12. Make sure the contaminated material is packed and disposed in an approved
incinerator in compliance with all federal, provincial and local government
regulation.
On completion of the cleaning operations, wait at least 5 minutes before using
the unit (connecting the power supply cable).
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APPENDIX B
Human Organs : Vacuum Selection Guideline
P1
P2
P3
P4
Kidney
Lung
Brain
Cyst
> 10cm in diameter
Breast
Placenta
Eye
Uterus
Prostate
Cyst
<10cm in diameter
Liver
Gall bladder
Muscle
Thyroid
Thymus
Skin
Tongue
Spleen
Colon
Bowel
Pancreas
Bladder
Testis
This guide is intended for specimens directly packaged with vacuum sealed
plastic bags.
When sealing very soft specimens (For ex: Ovarian Cyst), we suggest the use
of plastic containers with perforated lids (P/N 68093-94). In this case the
specimen dimension must not exceed 2/3 of the container inner volume.
ONLY perforated lids can be used to seal specimens’ containers
TissueSAFE Operation Manual 59/60
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APPENDIX C
Specimens Transportation Guidelines
OPERATING
ROOM
SEALING
TRANSPORT
CONDITIONS
MAX 30MIN
HISTOLOGY
LAB
FRIDGE
+4°C
GROSSING
FRIDGE
+4°C
GROSSING
FRIDGE
+4°C
GROSSING
THERMAL BAG
COOL PACKS +4°C
SEALING
SEALING
FRIDGE
2Hr ,+4°C
MOBILE
REF +4°C
MAX 3 HOURS
THERMAL BAG
COOL PACKS +4°C
> 3 HOURS
MOBILE
REFRIGERATOR +4°C
1. If the time required by the courier for the specimens’ transportation to the
Anatomical Pathology Department is less than 30 minutes, Milestone S.rl.
recommends putting the specimens in the Thermal bag with the cool packs at
+4°C.
2. If the time required by the courier for the specimens transportation to the
Anatomical Pathology Department is less than 3 hours, Milestone S.rl.
recommends to put the specimens into the refrigerator ), close to the TissueSAFE
for at least 2 Hr (pre-cooling procedure) and later to place them in the Thermal
bag with the cool packs at +4°C.
3. If the time required for the specimens’ transportation exceeds 3 hours, Milestone
S.rl. recommends the use of the Mobile refrigerator connected to an external
power supply (12/24Vdc, 115/230Vac).
For details on refrigerators models available from Milestone s.r.l., see Chapter 5
Milestone s.r.l.
TissueSAFE Operation Manual 60/60