MM074-004_TissueSAFE_Operation_Manual (1)

MILESTONE
H E L P I N G
P A T I E N T S
TissueSAFE
(Under Patent)
High Vacuum Biospecimens Transfer System
Operator Manual
MM074-004 (February 2013)
Milestone s.r.l. MM074-004 – Operation Manual
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
Please read the user manual before using the instrument.
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SUMMARY
SUMMARY ................................................................................................................................................... 4
1. INTRODUCTION ................................................................................................................................... 6
1.1. Symbols used in this manual ........................................................................................................ 6
1.2. Designated uses ........................................................................................................................... 6
1.3. Safety ............................................................................................................................................ 7
2. SETTING UP THE INSTRUMENT ........................................................................................................ 8
2.1. Site requirements .......................................................................................................................... 8
2.2. Electrical requirements ................................................................................................................. 8
2.3. Unit overview ................................................................................................................................ 9
2.4. Installation ................................................................................................................................... 10
2.4.1. Fume extraction system ...................................................................................................... 10
2.4.2. Switch ON and OFF ............................................................................................................ 11
3. MILESTONE VACUUM BAGS ............................................................................................................ 12
4. OPERATING TISSUESAFE ................................................................................................................ 13
4.1. Control panel .............................................................................................................................. 13
4.2. Select a program ........................................................................................................................ 13
4.3. Run a program ............................................................................................................................ 14
4.4. Modify a program ........................................................................................................................ 17
4.5. Basic User and Administrator log in ........................................................................................... 17
4.6. Create a program ........................................................................................................................ 18
4.7. Stop a program ........................................................................................................................... 19
4.8. Seal a plastic bag without vacuum ............................................................................................. 19
5. ACCESSORIES................................................................................................................................... 20
5.1. Non mobile refrigerator ............................................................................................................... 20
5.2. Termic bag .................................................................................................................................. 21
5.3. Portable refrigerator 26L ............................................................................................................. 22
5.4. Kit Portable Refrigerator 65L ...................................................................................................... 23
5.5. Summary table of refrigerator models ........................................................................................ 24
5.6. Kit Printer .................................................................................................................................... 25
5.7. BAG OPENER ............................................................................................................................ 25
6. TEMPERATURE MONITORING SYSTEM ......................................................................................... 26
6.1. General descriptions ................................................................................................................... 26
6.1.1. Parts of the system ............................................................................................................. 26
6.2. Instructions for the installation of the RFID card reader and the touch-screen PDA.................. 27
6.2.1. When the Tablet (Ref. P/N 68142/A) is available ............................................................... 27
6.2.2. When the Tablet (Ref. P/N 68142/A) is NOT available ...................................................... 28
6.2.2.1 If the PC operating system is Windows7 ............................................................................ 28
6.2.2.2 If the PC operating system is XP ........................................................................................ 33
6.3. TissueTemperatureLog – “SENDER” mode – Sending samples ............................................... 36
6.4. TissueTemperatureLog – “RECEIVER” Mode – Receiving samples ......................................... 41
6.5. Medical Tablet complete ............................................................................................................. 48
6.5.1. Install the battery ................................................................................................................ 49
6.5.2. Connecting the adapter to the Tablet ................................................................................. 50
6.5.3. Battery status of the Tablet ................................................................................................. 51
6.5.4. External connections of the Tablet ..................................................................................... 52
6.5.5. Cleaning and decontamination of the Tablet ...................................................................... 52
6.6. Troubleshooting .......................................................................................................................... 53
7. CONSUMABLES ................................................................................................................................. 54
7.1. Milestone vacuum bags .............................................................................................................. 54
7.2. Polystyrene containers ............................................................................................................... 57
7.2.1. Polystyrene containers with perforated lid .......................................................................... 58
7.2.2. Polystyrene containing trays ............................................................................................... 58
8. MAINTENANCE .................................................................................................................................. 59
8.1. Operating room personnel .......................................................................................................... 59
8.1.1. Daily .................................................................................................................................... 59
8.2. Service personnel ....................................................................................................................... 59
9. WASTE DISPOSAL ............................................................................................................................. 60
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9.1. Waste disposal of Vacuum bags ................................................................................................ 60

9.2. Waste disposal of electrical and electronic equipment .............................................................. 60
10. DECONTAMINATION AND CLEANING ........................................................................................ 61
10.1. Safety precautions ...................................................................................................................... 61
10.2. TissueSAFE decontamination and cleaning procedure ............................................................. 62
10.2.1. Detergents .......................................................................................................................... 62
10.2.2. Procedure ........................................................................................................................... 63
10.3. Decontamination and cleaning procedure of accessories (if present) ....................................... 65
10.3.1. Medical Tablet (Ref. P/N 68142) ........................................................................................ 65
10.3.2. RFID data logger (Ref. P/N 68138) .................................................................................... 65
10.3.3. RFID reader USB (Ref. P/N 68143) ................................................................................... 65
A. APPENDIX A .................................................................................................................................. 66
B. APPENDIX B .................................................................................................................................. 67
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1. INTRODUCTION
1.1. Symbols used in this manual
Please read carefully this instruction.
Please read carefully the Service 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.
CE logo: This instrument complies with European community directives.
WEEE European directive symbol (2002/96/EC):

Electric/electronic device do not throw out in the environment.
1.2. Designated uses
The Milestone TissueSAFE is a vacuum system which is designed to perform the following applications in
histopathology laboratories:
• Preservation and transportation of biological specimens and their supports and/or containers
• Long term specimen preservation (with an appropriate fixative into the vacuum plastic bag)
The Milestone TissueSAFE must be operated exclusively as reported in this manual.
Any other use of the instrument is considered improper.
The manufacturer reserves the right to change and/or improve specifications without notice and without
incurring in any obligation.
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1.3. Safety
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 (vacuum bags)
described in this manual, supplied by Milestone s.r.l.
For details, see the chapter 7.1. For disposal, see the chapter 9.1.
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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.
2.1. Site requirements
- The physical dimensions are: W 45cm (18”) x D 60cm (24”) x H 135cm (54”).
- Extra space required: back 15cm (6’’), sides 5cm (2’’) each.
- Floor perfectly flat, vibration-free and made of non flammable material.
- Floor must be able to support the weight (74Kg, 163Lbs).
- Room temperature constantly between +15°C (59°F) a nd +30°C (86°F).
- Relative humidity maximum 80% (non condensing).
- Avoid exposure to direct light and strong changes in temperature.
The Milestone TissueSAFE system, if dealing with Formalin

fixed specimens, must be connected to the fume extraction
system of the Laboratory to guarantee a healthy environment.
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 label includes:

- SN: serial number
- Power supply
- Power frequency: frequency of the power supply
- Power input: the TissueSAFE requires 115Vac/230Vac 3kWp.
See the chapter 1.1 for symbols.
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2.3. Unit overview
1
6
2
7
3
8
4
9
5
10
CABINET FRONT CABINET BACK

1. Working area cover 6. HEPA12 filter
2. Control panel 7. Charcoal filter (Formalin),
(if available)
3. Drawer 8. Instrument label with SN
4. Metallic shelf (if available) 9. Connector for fume extraction
5. Removable shelves 10. Pump oil level indicator
(if available)
Space for RFID Space for plastic bags

(if available) (if available)
The back side of the unit (where the filters are positioned shown at the points 6 and 7 above), is
accessible only by the Service Personnel.
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2.4. Installation
Connect the instrument to the fume extraction system (when possible) before turning
on the Unit.
2.4.1. Fume extraction system
The TissueSAFE can be connected to an external fume extraction system through the built-in connector
(see the arrow below).
The Milestone TissueSAFE system, if dealing with Formalin fixed specimens, must be
connected to the fume extraction system of the laboratory to guarantee a healthy
environment.
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2.4.2. Switch ON and OFF
The main switch is located on the control panel (see (A) in the picture below). Make sure the power
switch (A) is in position "0" (OFF) before connecting the power cord.
The electrical plug is located on the back of the unit (see the red square in the picture below).
Connect the cable (Ref. P/N 50036) provided by Milestone s.r.l Shuko terminated, as showed in the
following pictures.
It is now possible to switch the unit on by pressing the main switch (A) located on the control panel.
The same main switch must be used to switch the unit off.
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3. MILESTONE VACUUM BAGS
The TissueSAFE system utilizes specifically designed plastic vacuum bags, which are not included and
must be purchased separately.
The use of the TissueSAFE system is allowed with Milestone proprietary plastic
vacuum bags ONLY.
For details, see the chapter 7 “Consumables”.
An annotation label is placed on the outside of each bag.

Normally such notes are taken by the operator in the
Operating Room while the surgical operation is going on.
At the end of the surgical operation, the user can fill the
request form and place it inside the document pocket.
The requisition form can be sealed inside the dedicated

pocket. In this way requisition form and surgical specimen
are properly transported with no chance of mistakes.
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4. OPERATING TISSUESAFE
Specimens under vacuum have to be placed and maintained at a temperature of +4°C

(39.2°F).
4.1. Control panel
When the TissueSAFE unit is switched on, the control panel will appear as shown below.
The operator can access the functionality of the unit through the panel, which controls all the parameters
involved in the bio-specimens preservation process.
1 2 3 4 5 6
Control panel description:

1. Forced sealing
2. Interrupt a vacuum process
3. Display
4. Programs selection
5. Minus
6. Plus
4.2. Select a program
When the unit is switched on, the operator can run a default protocol (from P01 to P04) appearing on the
display (3) of the control panel.
TissueSAFE is able to memorize up to 30 different protocols.
To move from P01 to another protocol, press the button:

+ (Plus) to move forward,
– (Minus) to go back to previous program.
The right program selection must be done according to the Vacuum Selection Guide
of the Operation Manual (see Appendix A).
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4.3. Run a program
After the user log in, the following screen appears:
In the above picture the display is showing P01. 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. The operator can use the designed shelf (if available) on the right of the
vacuum cavity (left figure below).
The vacuum bag with the specimen has to be placed with the open side directed toward the operator,
exactly as shown in the picture above.
Make sure of using plastic bags of the appropriate size according to the specimen
dimensions. Use of inappropriate plastic bag size (too small) may cause spill out of
the specimen and a non correct vacuum phase and/or sealing.
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).
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If the median axis of the sample does not fit with the height of the sealing bar, remove
one or both of the spacers from the cavity (see pictures below).
The operator has to manually close the cover, as shown below. When the cover is closed, the vacuum
pump will start creating the vacuum inside the chamber.
The vacuum progression inside the chamber is shown on the control panel display.
After the vacuum step, the vacuum bag is sealed.
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On completion of the sealing procedure, an audible alarm will sound, the following screen will appear and
the cover will automatically open.
Now the operator can annotate the patient data, by writing on the label of the plastic bag.
At the end of the surgical operation, the operator 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 first annotation is written.
At this point, the operator can seal the requisition form in order to
avoid any accidental separation from the specimen.
The plastic bag containing the specimen now needs to be placed into an appropriate
refrigerator under controlled temperature conditions (at 4°C, 39.2°F).
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4.4. Modify a program
Do not modify any TissueSAFE protocol without Milestone s.r.l. support, contact our
specialists at application@milestonemedsrl.com. A protocol with inappropriate
parameters may damage tissues.
Do not leave the software logged in as Administrator, to prevent any accidental

program modification made by basic users.
TissueSafe can be used with customized protocols.
The instrument has 4 default protocols (from P01 to P04). The protocoIs from P05 to P30 are provided
with default input parameters (preset by the manufacturer) that can be modified.
TissueSAFE can memorize up to 30 protocols.
TissueSafe can be used with protocols customized by the Administrator (or by Technical Support). For
details on how to log in as Administrator, see the chapter below.
PROTOCOL BASIC ADMINISTRATOR TECHNICAL

USER SUPPORT Allowed to modify
P01–P04 NOT allowed to
P05–P30 modify
4.5. Basic User and Administrator 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 standard protocol (from P01 to P04) by pressing the buttons + and – (plus and minus),
• Seal a vacuum bag without vacuum by pressing the “ ” button (1) on the control panel,
• Interrupt a vacuum process by pressing the “STOP” button (2) on the control panel.
Only Administrator (or Technical Support) can create a new program (P05-P30), the Technical Support
can also modify a preset program (P01-P04).
To log in as ADMINISTRATOR, turn the unit off, turn it on again while

depressing the " " button (1) on the control panel. When the “Welcome”
screen disappears, insert the password as explained below.
To insert the password press:

• “+”: to increase the digit,
• “–”: to decrease the digit,
• “SEL”: to change the digit to insert,
• “SEL”: to confirm.
ADMINISTRATOR password issued as a separate document included in

the operator manual.
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4.6. Create a program
Select the program of interest using the buttons (5) and (6) shown in figure below and press the “SEL”
button (4) to open the program customization screen.
1 2 3 4 5 6
The following screen appears.

Select the parameter to set using the button “SEL” (4) and set the desired value using the “+” and “-“
buttons (5) e (6).
Every program is characterized by 5 parameters:
A. VACUUM PERCENTAGE: the system automatically suggests the absolute value of E9. To modify it
correctly please contact Milestone at: application@milestonemedsrl.com.
B. GAS: value cannot be changed or used, please leave it set at 0%.
C. 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.
D. PROGRAM ENABLING:
If you choose YES, the BASIC USER can use the protocol modified by the Administrator,
If you choose NO, the BASIC USER cannot use the protocol modified by the Administrator.
E. PROGRAM NAME: the system allows a short name to be assigned to each modified program, if
desired (generally according to the most used organ). The following alphanumeric characters are
available:“0”–“9”, “A”–“Z” and the space.
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Pressing the “SEL” button (4) once more, the system goes back to the main screen and the modified
program is shown with the name you have selected. In the example below the name is “LIVER”.
4.7. Stop a program
Press the “STOP” button (2) on the control panel 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.
4.8. Seal a plastic bag without vacuum
Press the “ ” button (1) on the control panel to seal the plastic bag while the process is running. The
vacuum cycle will be immediately stopped, the plastic bag will be sealed without vacuum inside and the
vacuum chamber will be opened.
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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 control over temperature, according to
the Specimen Transport Procedure (see the APPENDIX B).
5.1. Non mobile refrigerator
Ref. P/N DESCRIPTION
68064 Refrigerator laboratory type 140L 230Vac complete

68090 Refrigerator laboratory type 140L 115Vac complete
Dimensions: 52cm (20.5in) x 63.5cm (25in) x 83.5cm (32.9in)

Weight: 54Kg (119.05Ibs)
Milestone suggests positioning the TissueSAFE close to a controlled refrigerator, as shown in the picture
below (A).
In this type of refrigerator, the temperature is kept at approx +4°C

(39.2°F). The operator can easily place the vacuum sealed
specimens and cool packs (B) in the refrigerator.
A
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.
B
For further information, see specific instruction manual included in the shipment.
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5.2. Termic bag
68084 Kit Refrigerator box in PS, 32L complete with N.4 cool
packs
Dimensions: 48cm (18.9in) x 26cm (10.2in) x 39cm (15.4in)
Weight: 2kg (4.41Ibs)
When the Courier is ready to transport the specimens to the Anatomic Pathology Department, the
vacuum sealed specimens must be placed in the Thermal Bag with 1, 2, 3 or 4 cool packs (according to
the inner volume of the bag used) at +4°C (39.2°F), appropriately closed and then transported (figures
below).
For optimal specimen preservation, Milestone S.r.l. recommends 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 c ould 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.
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5.3. Portable refrigerator 26L
68083 Kit Portable Refrigerator 26L with trolley with folding handle
Power supply 12-24Vdc / 110-230Vac
Dimensions: 51cm (20.1in) x 35cm (13.8in) x 39cm (15.4in)
Weight: 16kg (35.27Ibs)
It is also possible to use the mobile refrigerator (A) as shown in the picture below. This device is ideally
suited for long-term transportation by car.
See also the Table in APPENDIX B.
With this type of portable refrigerator, cool packs are not required because the temperature is monitored.
In this case there is an easy-to-use basket that

perfectly fits in the refrigerator (see below).
Main Characteristics:
• Voltage allowed: 12/24Vdc, 110-240Vac - 50Hz/60Hz.
• Digital electronic thermostat with audible and visual alarm system (not for power failure). It needs a
continuous power supply, then connect to the car battery.
22
For further information, see specific instruction manual included in the shipment.
5.4. Kit Portable Refrigerator 65L
68081 Kit Portable Refrigerator 230Vac – 65L with trolley and supplied with UPS (*)
68082 Kit Portable Refrigerator 115Vac – 65L with trolley (NO UPS included)
This mobile refrigerator with its mobile cart, as shown in the picture above, is ideally suited for easy
transportation inside the Hospital.
See also the table in APPENDIX B.
(*) UPS Technical Specifications:
Capacity: 1000VA/600W (minimum)
Voltage: 220/230/240Vac – 50/60Hz depending on the power supply
Recharge Time: For first installation, connect at least for 10 hours.
Autonomy in Battery 4 hours with minimum load (tested with a sample of 0.5 litre volume
Mode (UPS): 1 hour with maximum load (tested with 20 litres organic material at 37°C)
Operating 5-40°C (41-104°F), 10-80% Relative Humidity (non-co ndensing)

Environment:
Dimensions: 40.5cm (15.9in) x 20.5cm (8.1in) x14.5cm (5.7in)
Weight: 10Kg (22.05Ibs)
For further information, see specific instruction manual of the refrigerator included in
the shipment.
23
5.5. Summary table of refrigerator models
68084 Kit Refrigerator box in PS, 32L complete with N.4 cool packs
68083 Kit Portable Refrigerator 26L with trolley with folding handle
Power supply 12-24Vdc & 110-230Vac
Ideal for long-term transportation by car.
68081 Kit Portable Refrigerator 230Vac - 65L with trolley and UPS.
68082 Kit Portable Refrigerator 115Vac - 65L with trolley (NO UPS
included).
68064 Refrigerator laboratory type 140L - 230Vac complete

68090 Refrigerator laboratory type 140L - 115Vac complete
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5.6. 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.
68120 Kit Printer at 230V
5.7. BAG OPENER
Suitable to facilitate opening of the vacuum bag for easy insertion of the sample/organ.
Ref. P/N 68112
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6. TEMPERATURE MONITORING SYSTEM
6.1. General descriptions
Milestone s.r.l. provides the RFID Temperature Monitoring Kit (Ref. P/N 68140) to be used with
TissueSAFE Unit. It’s a dedicated system, ideal 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 the chapter 6.3).
The system ensures a permanent monitoring of temperature-sensitive specimens and enables a fast
documentation of process and storage temperatures through an easy handling. It measures temperature
data by a calibrated sensor and stores them directly on a chip.
It is also possible to control the received samples (up to 32 codes) by using an automatic comparing of
the codes inserted in the card by the “sender” (see the chapter 6.3) and the codes of the samples actually
received in pathology lab, as explained in the chapter 6.4, point C.
6.1.1. Parts of the system
The RFID Temperature Monitoring Kit (Ref. P/N 68140) includes:

1) Ref. P/N 68138: RFID Data logger (Qty 10),
2) Ref. P/N 68143: RFID reader USB (Qty 2), complete with cable USB and CD with Milestone data
recording software (Ref. P/N 68139),
as shown in the figure below.
1. RFID data logger Ref. P/N 68138
Main characteristics:
• Dimensions: 89mmx69mmx4.5mm (3.5’’x2.72’’x0.18’’)
• Weight: 34g (0.07Ibs)
• Operating temperature: from -10°C (14°F) to 40°C ( 104°F)
• Frequency: 13,56MHz (ISO15693)
• Resolution: 1°C (1.8°F)
• Temperature accuracy: ±1°C (±1.8°F)
• Accuracy time: better than 0.1%
• Battery: 10 months in continuos at 25°C (77°F) and 10 minutes of sampling
• Discharge after 5 years of non-use, in the state of deactivation
For cleaning and decontamination of the RFID data logger, refer to the chapter 10.3.2.
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2. RFID reader USB (Ref. P/N 68143) and Milestone data recording software
On completion of the recording procedure, the tag information can be downloaded by the PC of the
Histology Lab with the RFID reader USB shown on the right figure.
Main characteristics:
• Dimensions: 145mmx85mmx31mm (5.71’’x3.35’’x1.22’’)
• Weight: 200g (0.44Ibs)
• USB interface (self-powered)
• Operating frequency: 13.56MHz
• Power transmitted: 0.5W
• Operating temperature: from 5°C (41°F) to 40°C (10 4°F)
• Storage temperature: from -25°C (-13°F) to 70°C (1 58°F)
• Compatible with XP SP3 32bit and Windows 7 32/64bit.
For cleaning and decontamination of the reader, refer to the chapter 10.3.3.
6.2. Instructions for the installation of the RFID card reader and the touch-screen
PDA
This chapter provides the instructions in case is available the Tablet (Ref. P/N 68142/A) supplied as
accessory or any other hardware.
6.2.1. When the Tablet (Ref. P/N 68142/A) is available

Connect the RFID reader USB (Ref. P/N 68143) to the Tablet.
In this case it’s not required to follow any installation procedure because the Tablet is supplied with the
drivers of the RFID reader and the Milestone data recording software pre-installed.
Now the Tablet is ready to use: follow the instructions reported on the chapters 6.3 and 6.4.
27
6.2.2. When the Tablet (Ref. P/N 68142/A) is NOT available

When the Tablet supplied by Milestone is not available, it’s required to install on the hardware available
the drivers of the RFID reader and the Milestone data recording software, as explained in this chapter.
Minimum essential requirements of the PC:

• Operating system Windows 7 (32 or 64 bit) or Windows XP,
• Processor intel atom Z690 or superior (in general a processor than can support Windows 7
Professional),
• RAM 2GB,
• 1xUSB 2.0 or more,
• Hard disk 64GB or superior.
The hardware has to be able to support Java Runtime 1.7 Update 4 without any limitations.
The package is provided by Milestone.
Additional drivers: RFID reader USB (Ref. P/N 68143)
The software without the libraries and/or drivers does not comply the proper installation and it is
considered as incomplete.
Connect the RFID reader USB to the hardware. Follow the instructions below, reported in the section
6.2.2.1 if the PC operating system is Windows7, reported in the section 6.2.2.2 if the PC operating system
is XP.
6.2.2.1 If the PC operating system is Windows7

Instructions for the installation of the RFID reader USB
Insert the installation CD-ROM into the PC (supplied with the Unit).
• Connect the RFID Reader in one of the USB ports of the PC.
• From the installation CD-ROM, open the folder “Tissue temperature log – PC software 12.05”, as
shown in the next figure.
• Open the folder “OBID USB-Driver Win7” to install the drivers (green circle in the next figure).
• Open the folder “setup_obidusb_v.2.50(build20100112)”.
28
• Double click on “setup”.
• The screen below appears, press “Next”.
• Accept the terms of the License Agreement and press “Next” in the following screens.
• Press “Install” as shown in the next figure. Then confirm a message that appears to install the
software.
29
• Press “Next” and then “Finish” as shown in the figures below.
• Press “YES” to confirm the message.
Data Recording software installation instructions
• From the installation CD-ROM, open the folder “Tissue temperature log – PC software 12.05“, as
shown below.
• Select and double click on “TTLsetup”.
30
• Press “Next” in the following screen.
• Tick the box “Create a desktop icon” and press “Next”.
• Select “Install”.
For its operation the software requires the installation of Java Runtime 1.7 Update 4 and Jasperviewer; if
not present on your PC, the setup starts automatically.
31
• Press “Finish” as shown below.
• At this point, a new “Tissue Temperature Log” icon appears on your desktop. Click on it by the right
mouse button and select "Properties" from the menu. The following screen appears, then press on
"Compatibility".
• The figure shown below on the left appears. Tick the box “Run this program as an administrator” (see
the circle) and then press “Change settings for all users” (indicated by the arrow). The figure shown
below on the right appears: tick the box “Run this program as an administrator” and press “OK” to
confirm.
32
6.2.2.2 If the PC operating system is XP

Instructions for the installation of the RFID reader USB
• Insert in the PC the installation CD-ROM (provided with the instrument).

• Connect the RFID Reader in one of the USB ports of the PC.
• Automatically the Windows Wizard opens the following window, select “No, not this time” and press
“Next”.
• Now select “Installation from a list of specific location” and press “Next”.
• Select “Include this location in the search”, press “Browse” (left figure below). The figure shown on
the right appears: from the installation CD-ROM, select the folder “OBID USB-Driver”, that is included
in the folder “Tissue temperature log – PC software 12.05” and then press “OK”. Press “Next” on the
left figure below.
33
• On completion of driver installation, the next screen appears. Press “Finish”.
Data Recording software installation instructions:
• From the installation CD-ROM, select the folder “Tissue temperature log – PC software 12.05”, as
shown below.
• Double click on “TTLsetup” to install the data recording software.
• Press “Next” in the figure below.
34
• Tick the box “Create a desktop icon” and press “Next”.
• Select “Install”.
For its operation the software requires the installation of Java Runtime 1.7 Update 4 and Jasperviewer; if
not present on your PC, the setup starts automatically.
• Press “Finish” as shown below and automatically the data recording software will appear.
• A new “Tissue Temperature Log” icon appears on your desktop.
35
6.3. TissueTemperatureLog – “SENDER” mode – Sending samples
If the Tablet supplied by Milestone is available (Ref. P/N 68142/A), the data recording software starts
automatically when it is turned on.
If the Tablet is NOT available, launch the software “Tissue Temperature Log 12.05” by clicking the
corresponding icon on your desktop.
A. Settings
Select Tools\Settings to open the settings window, as shown in the circle below.
A window appears:
• Insert the Institute or Department name in the relative field,
• Do not change the other fields (“Save report directory”, “Macropath/Macroview compatible” and
“Macropath/Macroview images directory”) because they are effective only in “Receiver” Operative
mode,
• Verify that “Sender” is selected as operative mode (if not, check the corresponding box),
• Press “Save and close” to save the settings and to come back to the starting screen.
Before operating the software, from the starting screen showed above, set the desired frequency to read
the temperature indicated by the arrow in the box.
For correct operation, DO NOT select 1 minute (demo mode).
B. How to activate a card (RFID data logger Ref. P/N 68138)

Place the card on the RFID reader USB (the PC model showed in the figure below is only an example).
36
Select “Search Card”.
As showed in the figure below, in the left side of the screen appear the card data, as:
• “Card unique ID” (the identification number).
• “Status” of the card (in “Sender” Operative mode it will be NOT ACTIVATED).
• “Battery level” (refer to the section 6.1.1, number 1) for details about its duration).
• “Card FW / lot” (firmware of the card / lot number).
When the battery level displays “low”, it’s recommended that card use be discontinued. The card may not
contain sufficient power to complete a full temperature recording.
The figure below shows an example of a “low” battery indication.
Then enter the identification codes (up to 32) of the samples to be sent together with the card through a
bar code reader or insert them directly by keyboard into the field (shown in the circle in the figure below).
When the codes are entered manually (without a barcode reader), you must press the button "Add code
to list" (indicated by the arrow below) to insert it into the list of samples.
To remove a code, select a code number and press "Remove selected".
37
When the codes are entered manually and it’s available the Tablet supplied by Milestone, that has no
keyboard, press the corresponding icon on the status bar of the screen (showed by the arrow below). See
below.
A keyboard automatically appears on the screen; to close it, press the red close icon in the upper right
corner, as shown by the arrow in figure below.
Once all the codes of the samples have been inserted in the card, press "START LOG" to start monitoring
the temperature.
38
The following screen appears for a few seconds.
At the end of the activation procedure the “Status” of the card becomes “ACTIVATED”, as shown below in
the circle.
Now it’s possible to open the report containing all the log information; press the “Report” icon (follow the
arrow in the figure above) and it will automatically appear.
39
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
(figure below).
Now, the operator can seal the external pocket to prevent any accidental separation of the card from the
specimens.
The plastic bag, containing the smart card, should now be placed into the refrigerator close to the Tissue
SAFE or directly into the Thermal Bag (see figure below, according to the scheme of Appendix B).
For an optimal temperature monitoring, Milestone recommends to keep the smart

card far away from the cooling elements of the refrigerator.
40
6.4. TissueTemperatureLog – “RECEIVER” Mode – Receiving samples
A. Settings
Select Tools\Settings to open the settings window, as shown in the circle below.
In the previous screen it’s possibile to add the following information:

• “Institute name / Department”
• ”Saved report directory”: shows the storage location of the data read from the card; for example
C:\Program Files\Tissue Temperature Log\Saved.
• ”Macropath / Macroview compatible”: if selected, the compatibility with programs
Macropath/Macroview installed on the PC is activated. Each temperature curve will be saved in JPEG
format in all cases Macropath/Macroview that have the same name of a barcode entered. If there is
no case having the same name of a barcode entered, a new case is created containing the JPEG of
the temperature curve.
• ”Macropath / Macroview images directory”: shows the storage location of the data read from the card
when the compatibility is activated, for example: C:\Program Files\Tissue Temperature
Log\MacroSaved
• “Operative mode”: check the box “Receiver” as operative mode.
• Press “Save and close” to save the settings and to come back to the starting screen.
Exit the software and then open it again to make effective the setting to operate as “Receiver”
mode. This operation should be done only once at the installation time.
If you press “?” and “About”, it’s possibile to see the software version of the Data Recording software.
41
Upon its arrival in the Histology Lab, the thermal bag is opened and the RFID card is removed from the
plastic bag.
B. How to read the card
Position the card on the USB RFID reader.
Press “Search card”.
42
The screen shown below displays: the “status” of the card is “ACTIVATED”, since it has been previously
activated when the samples were shipped, as described in the section 6.3.
Select "Stop log", as shown in the circle in figure below.
In the field "Current card" on the left upper part of the screen (see the arrow in figure below) it’s possibile
to check the card data and its status.
Check the battery level: when it’s "low" it’s required to replace the card.
Press “Read Card”.
43
It‘s now possible to look at the temperature curve and the Log information. Press the “Save” button
indicated by the circle in figure below.
C. Bar code monitoring
Upon arrival, bags are sequentially opened as shown below. Once opened, specimens are ready for the
grossing procedure.
It is possible to control the received samples by using an automatic comparing of the codes inserted in
the card by the “sender” and the codes of the samples actually received.
Select “Sample codes”, as indicated by the circle in figure below.
44
The following screen appears. Read the codes from the card by pressing “Read codes from the card”.
See the arrow below.
Insert the received sample codes in the corresponding field in the right part of the figure below by
keyboard or through a bar code reader. Insert the code and press also “Add code to received” when are
inserted by keyboard.
The software checks in real time the consistency of the lists. Inconsistencies are highlighted in red. See
below the arrow.
When all codes are inserted, press “Save and close”.
45
D. Report
Press “Report” to automatically create a document that contains all of the information read from the card
(see the arrow below).
The first page of the report shows the card temperature graphic and the result of the received codes
control (next figure on the left).
The second page shows the details regarding the codes (next figure on the right):
1. “Delivered and received sample-codes”: samples correctly sent and received,
2. “Delivered but not received sample-codes”: samples correctly sent but not received,
3. ”Sample-codes with not certifiable origin”: samples received but with no information regarding their
origin.
When there is a complete consistency of the lists the codes are all marked in green.
46
In this case, the report shows the correct match by the sentence: “all sample codes match”, shown by the
arrow in figure below. In this case the second page of the report contains only the field: “Delivered and
received sample-codes”.
It is possible to print the report and save it in different formats (PDF suggested), as shown below.
47
6.5. Medical Tablet complete
The Tablet (Ref. P/N 68142/A) is supplied as accessory (it’s optional, not included in the RFID
Temperature Monitoring Kit Ref. P/N 68140) and it’s composed by:
• Medical Tablet (Ref. P/N 68142)
• Hub adapter 4 USB (Ref. P/N 360038)
Main features Tablet:

• Operative System Windows XP
• Touch screen of 10.4” LCD (1024 x 768)
• Processor Intel® Atom™: Z530 (1.6GHz)
• DDR2 SODIMM of 2 GB ; HDD 1 x 1.8" SATA 120GB
• 1 X mini USB
• Adaptor hub 4 USB
• Ingress protection IP54
• Fanless
• Lithium-ion battery (3760mAh)
• CE, FCC, UL
• Medical Standard (UL60601-1, IEC/EN60601-1)
• Dimensions (L x H x P) 258.4mmx258.3mmx42.75mm (10.17’’x10.17’’x1.68’’)
• Weight 1.5kg
• Power adapter 100-240V ~ 50/60Hz
• Audio: speaker x 1, microphone x 2
• Stylus pen x 1
48
6.5.1. Install the battery
The Tablet is supplied with a rechargeable battery. To install, maintain or replace it follow the instructions
in this section.
Do not attempt to replace the battery with any others than the models recommended
and manufactured specifically for the MICA product. Contact the local distributor or
directly the Milestone Service personnel (customersupport@milestonemedsrl.com) to
have more detailed information.
Before using the Tablet, please connect the adapter to it to charge the battery and
backup battery at least 24 Hrs.
Under normal conditions, a fully charged battery will power the PC for up to 5 hours. Normally, it requires
2.5 hours to fully charge a new battery.
To install or replace the battery pack:

1. Turn off the PC.
2. Press with your thumb positioned as in figure below, then remove the battery.
3. Remove the battery from the system (when you have to replace it).
4. Install the battery pack into the slot until you hear a click sound.
49
5. Once the battery has been inserted, press the power switch button then the system will power on as
showed in the figure below.
6. When the Tablet is turned on, the data recording software starts automatically.
7. It’s possible to use the pen locked in place on the back side of the tablet and needs to be pulled out
with fingers for usage.
6.5.2. Connecting the adapter to the Tablet
Follow these procedures in order:

1. Connect the end of the AC Adapter cord to the DC Power inlet of the Tablet (step 1 in figure).
2. Connect the female end of the power cord to the AC inlet of the AC Adapter (step 2 in figure).
3. Connect the 3-pin male plug of the power cord to an electrical outlet (step 3 in figure).
3 2
50
In the following figure are indicated the Power inlet of the Tablet (1) where to insert the adapter (Step 1
described above) and the mini-USB (see the arrow below).
It’s required to connect the adapter to the tablet in the following cases:
1. before using the Tablet, when it’s necessary to to charge the battery at least 24 Hrs as described in
the section 6.5.2,
2. when there is a “Low battery” status, as described in the following section.
6.5.3. Battery status of the Tablet
The Tablet is equipped with Light Emitting Diodes (LEDs) located along the panel that indicate the battery
status, as indicated in the circle below.
The LEDs take three different colors depending on the state of the battery:
• GREEN: Full charge
• ORANGE: Low battery
• GREEN+ORANGE: Battery charging
When the LEDs indicate a “Low battery” status, it’s required to connect the adpter to the Tablet, as
explained in the section 6.5.2.
51
6.5.4. External connections of the Tablet

A USB transfer cable is bundled in the accessory box of the Tablet: insert it in the mini USB of the PC, as
shown in the figures below.
A USB hub is needed for additional USB devices (up to 4). Connect the hub to the transfet cable.
Now it’s possible to connect to the Tablet up to 4 addictional external devices, as a RFID reader USB
(Ref. P/N 68143) to read the card temperature data and a bar code reader (supplied by Milestone Ref.
P/N 370059).
6.5.5. Cleaning and decontamination of the Tablet
For the cleaning and decontamination of the Tablet refer to the section 10.3.1.
52
6.6. Troubleshooting
When operating with a card and a RFID reader (for reading the card status and its data, activation,
deactivation) both in “SENDER” and in “RECEIVER” mode (respectively described in chapeters 6.3 and
6.4), a message “Error reading the card” could appear, as showed in the figure below.
In this case follow the instructions below:

1. check that the card is properly positioned on the RFID reader and that it has not been removed
during the reading, then try again. If the problem persists, go to the next step.
2. check that the RFID reader is properly connected; perform this task verifying the correct insertion of
the cable (both at the PC side and at the reader side) and also checking in the software the
connection status of the reader. A screen status bar, lower left corner, indicates the connection state
with either, "Reader connected" in green or "Reader not connected" in red, example below.
If a card reading error occurs (“Error reading the card”), verify the connection by clicking the connection
state status bar in the lower left corner (“Reader connected” or “Reader not connected”). This will allow
the user to “Refresh” the connection through a pop up window, example below.
If the reader is properly connected the status should be green and indicating “Reader connected”.
3. If the reader is properly connected but the message "Error reading the card" persists, use a different
card.
If the RFID reader is properly connected but its connection status in the software is
red and indicating "reader not connected", please contact your local distributor or the
technical service at customersupport@milestonemedsrl.com.
53
7. CONSUMABLES
7.1. Milestone vacuum bags
The particular design and the special multi-layer of TissueSafe Vacuum bags, in
combination with a dedicated sealing bar (supplied by an electrical intensity specific
for thickness and material), allow a perfect double sealing, that resists even in case of
accidental fall or external compression. Therefore the use of MILESTONE vacuum
bags is to be considered exclusive to the TissueSafe instrumentation. The use of
such bags for a different type of instrumentation or the use of vacuum bags not
provided by MILESTONE for the above-mentioned instruments preclude the safety of
use, resulting in biological risk for the operator and risk of impairment of quality for
the sample, making void the manufacturer's warranty and the CE-IVD.
Milestone S.r.l. provides the following four types of Vacuum bags:
Ref. P/N 68047SS Ref. P/N 68055SS Ref. P/N 68054SS Ref. P/N 68046SS

Vacuum Bag 140µm – Size SMALL (Qty 200)
68047SS Dimensions:
External 250mmx300mm (9.84’’x11.81’’) – Internal: 230mmx125mm (9.05’’x4.92’’)
Vacuum Bag 140µ – Size MEDIUM (Qty 200)
68055SS Dimensions:
External 340mmx385mm (13.38’’x15.16’’) – Internal 320mmx150mm (12.6’’x5.91’’)
Vacuum Bag 140µ - Size LARGE (Qty 200)
68054SS Dimensions:
Vacuum Bag 140µ - Size EXTRA-LARGE (Qty 200)
68046SS Dimensions:
Note: the vacuum bags Ref PN 68054SS and Ref PN 68046SS have the same external dimensions (as
showed in the picture) but differ in the useful internal section:
68054SS → internal 320mmx320mm (12.6’’x12.6’’)
68046SS → internal 320mmx500mm (12.6’’x19.68’’)
54
The four types of vacuum bags described above differ only in size. Their common characteristics are:
• Disposable bags
• High mechanical strenght, thickness 140µm
• With applied sealable pocket for documents
• Double barrier layer, polyamide inner and outer high-density polyethylene
• Wrapped in packs of 5 and treated with β rays
In addition Milestone S.r.l. provides the bag Zip Lock Vacuum Bags suitable for Tissue Safe unit. It’s self-
standing and easily resealable thanks to a zip-lock.

Zip Lock Vacuum Bags for Tissue Safe (Qty 200)
68020SS Dimensions:
External 498mm x 298mm (19.61’’x11.73’’) – Internal 400mm x 280mm (15.75’’x11.02’’)
Characteristics:
• Disposable bags
• Self-standing
• High mechanical strenght, thickness 220µm
• With applied sealable pocket for documents
• Double barrier layer, polyamide inner and outer high-density polyethylene
• Wrapped in packs of 5 and treated with β rays
• Easily resealed by a zip-lock and then and reopened and resealed
This model of zip lock vacuum bags zip locked is suitable for the resealing of specimens.
In fact, after receipt of under vacuum samples at the AP lab, the sealed part can be cut out, as shown in
the picture below.
55
Thanks to the zip-lock, the same bag can be resealed and reused with the fixative to carry out fixation
and then to archive the sample.
The same bag with ID will follow the specimen during the complete diagnostic process.
Easily resealable and reopenable, with no need of any additional instrumentation.
As shown in the figure above, the Zip Lock Vacuum Bag is self-standing when filled with specimen and
fixative.
56
7.2. Polystyrene containers
VIALS
68058 Kit 200 plastic vials, capacity 1.5ml 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.
68094 Kit 10 pieces of polystyrene containers, capacity 30ml.

Suitable for small delicate (soft) specimens.
POLYSTYRENE CONTAINING TRAYS
68125 Kit 200 polystyrene containing trays including:

- N. 50 of polystyrene trays dim. 235mm x 150mm x h44mm
(9.25’’x5.91’’x1.73’’)
- N. 50 of polystyrene trays dim. 255mm x 180mm x h36mm
(10.04’’x7.09’’x1.42’’)
- N. 50 of polystyrene trays dim. 290mm x 215mm x h40mm (11.42’’x8.46’’x1.57’’)
- N. 50 of polystyrene trays dim. 330mm x 260mm x h52mm (12.99’’x10.27’’x2.05’’)
57
7.2.1. Polystyrene containers with perforated lid
The use of polystyrene containers and vials with perforated lids is suggested when sealing very soft
specimens (example: 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.
7.2.2. 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 A, column P1 only.
NOT suitable for very soft tissues (like brain). Risk of damaging the sample.
58
8. 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.
8.1. Operating room personnel
Minimal routine maintenance is required by Operating Room personnel. The following is recommended to
ensure optimal performance of the TissueSAFE.
It’s recommended:
8.1.1. Daily
Decontaminate and clean the instrument following the procedure described in the chapter 10.
Ensure that TissueSAFE is cleaned and disinfected, but do not use abrasives or sharp
instruments that may damage the coating.
Check the cover 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.
8.2. Service personnel
TissueSAFE is equipped with a Carbon filter (if present) and a 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.
59
9. WASTE DISPOSAL
9.1. Waste disposal of Vacuum bags
The vacuum bags supplied by Milestone s.r.l. should be treated as biohazardous after their
use.
Waste material should be disposed in an approved incinerator in compliance with all federal,
provincial and local government regulations.
9.2. Waste disposal of electrical and electronic equipment
Removal of equipment from use for disposal:
1) Switch OFF the unit. Disconnect the power supply.

3) Disconnect all the accessories (printer, tablet,..), if available.
4) Clean and disinfect all parts of the equipment according to the manufacturer specification.
5) Dispose all electric and electronic parts of the equipment.
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.
This symbol indicates separate collection for electrical / electronic equipment.
60
10. DECONTAMINATION AND CLEANING
The procedure described in this chapter must be performed daily.
10.1. Safety precautions
The personnel involved in the decontamination procedure of TissueSAFE and its accessories (if present)
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 reasons, any operation without the individual protective devices must be
avoided.
61
10.2. TissueSAFE decontamination and cleaning procedure
10.2.1. Detergents
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.
For the decontamination and cleaning do not use procedures different than those
explained in this chapter.
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. In alternative the use of a solution of 1:10 Bleach
(recommended by the CDC for disinfecting) is also allowed.
DO NOT use alcohol-based detergents.
For further information, please contact the manufacturer at: application@milestonemedsrl.com.
Germicidal efficacy of polyphenolic based disinfectant agents:
• 30 seconds: Mycobacterium bovis (TB).

• One minute: Acinetobacter baumannii, Avian Influenza A, Canine Parvovirus,
Enterobacter aerogenes, Enterococcus faecalis Vancomycin resistant (VRE), Escherichia
coli ESBL, Feline Panleukopenia Virus, Hepatitis A Virus (HAV), Hepatitis B Virus (HBV),
Hepatitis C Virus (HCV), Herpes Simplex Virus (HSV-2), Human Immunodeficiency Virus
Type 1 (HIV-1), Influenza A Virus, Klebsiella pneumoniae, Norovirus, Poliovirus Type 1
(Mahoney), Pseudomonas aeruginosa, Rhinovirus, Rotavirus, Salmonella enterica
(formerly choleraesuis), Staphylococcus aureus, Staphylococcus aureus Methicillin
resistant (MRSA), Streptococcus pyogenes, Trichophyton mentagrophytes (Athlete’s Foot
Fungus).
62
10.2.2. Procedure
1. Spacers
• Remove the spacers from the working area.
• Spray a disinfectant solution following the instructions reported above in the section 10.2.1 and
leave it for at least 30 minutes.
• Wash under tap water to remove the disinfectant.
• Wash with an appropriate detergent and, if necessary, remove any organic trace with a non-
abrasive tool.
• Wash under tap water to remove the detergent.
• Dry with paper or with a clean cloth.
2. Cavity
• Spray in the cavity (without spacers) a disinfectant solution following the instructions reported
above in the section 10.2.1 and leave it for at least 30 minutes.
• Clean the surface with a cloth moistened with water to remove the disinfectant.
• Use an appropriate detergent to clean the cavity and to remove any organic trace with a a dry cloth
or paper towel.
• Clean the cavity with a cloth moistened with water to remove the detergent.
• Dry the surface with paper or with a clean cloth.
During the procedure described above for the decontamination and cleaning of the cavity, pay
particular attention to the sealing bar and its connectors (indicated by arrows in the figure below).
63
Do not spray the disinfectant and the detergent directly on the bushing inside the working area (see the
arrow in figure below).
3. Cover
• Spray on the internal and external surface of the plexiglass cover a disinfectant solution following
the instructions reported above in the section 10.2.1 and leave it for at least 30 minutes.
• Clean the surfaces with a cloth moistened with water to remove the disinfectant.
• Use an appropriate detergent to clean the cover and to remove any organic trace with a a dry cloth
or paper towel.
• Clean the surfaces with paper or with a clean cloth to remove the detergent.
• Dry with paper or with a clean cloth.
• Dab with particular attention the silicon bar (indicated by the symbol A in the figure below) by a dry
cloth or paper towel.
• Run a P01 vacuum program without using any bag to facilitate the drying of the silicon bar. If
necessary do it a second time and then wipe with paper.
• Dry the silicon bar with paper or with a clean cloth.
During the procedure described above for the decontamination and cleaning of the cavity cover, pay
particular attention to the black rubber placed on the inner surface of the cover (indicated by the symbol B
in the picture above). It is important that it’s clean and dry so that it fits tightly to the steel surface of the
working area during the execution of a vacuum program.
4. External surfaces
• Spray on the external surfaces of the unit a disinfectant solution following the instructions reported
above in the section 10.2.1 and leave it for at least 30 minutes.
• Do not spray on the back panel of the unit.
• Clean the surfaces with a cloth moistened with water to remove the disinfectant.
• Use an appropriate detergent to clean the surfaces.
• Clean the cavity with a cloth moistened with water to remove the detergent.
• Dry the surface with paper or with a clean cloth.
64
5. Final steps
• Place the spacers in the cavity.
• Before removing gloves, wash them with soap, water and disinfectant.
• Wash your hands.
• Remove the individual protection devices.
• 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).
10.3. Decontamination and cleaning procedure of accessories (if present)
10.3.1. Medical Tablet (Ref. P/N 68142)

The Tablet should be cleaned regularly.
Please follow the following steps:
1. Wipe the Tablet with a clean cloth that has been moistened in a appropriate solution.
2. Prepare the cleaning solution on the base of the laboratory protocol in use (if compatible with
following specifications)
3. Wipe thoroughly with a clean cloth.
Do not immerse or rinse the Tablet or its peripherals. If you accidentally spill liquid on the
device, disconnect the unit from the power source. Contact your Service Personnel
regarding the continued safety of the unit before placing it back in operation.
Do not spray cleaning agent on the chassis.
Do not use disinfectants that contain phenol.
Do not autoclave or clean the Tablet or its peripherals with strong aromatic, chlorinated,
ketone, ether, or esther solvents, sharp tools or abrasives.
Never immerse electrical connectors in water or other liquids.
10.3.2. RFID data logger (Ref. P/N 68138)
For the decontamination of the RFID data logger follow the procedure described in the previous section
for the Tablet (Ref. P/N 68142).
10.3.3. RFID reader USB (Ref. P/N 68143)
For the decontamination of the RFID reader USB follow the procedure described above for the Tablet
(Ref. P/N 68142).
Do not spray any solution directly to the port where the cable USB is inserted.
65
A. APPENDIX A
Human Organs: Vacuum Selection Guideline
P1 P2 P3 P4
Cyst
Kidney Lung Brain
> 10cm in diameter
Breast Placenta Eye
Cyst
Uterus Prostate
<10cm in diameter
Liver Gall bladder
Muscle Bowel
Thyroid Testis
Thymus Appendix
Skin
Tongue
Spleen
Colon
Bone
Pancreas
Bladder
This guide is intended for specimens directly packaged with Milestone vacuum sealed
plastic bags.
When sealing very soft specimens (For ex: ovarian cyst and lymph nodes), we
suggest the use of plastic containers with perforated lids (see the chapter 7). In this
case the specimen dimension must not exceed 2/3 of the container inner volume.
When using plastic containers with perforated lids (see the chapter 7), choose the
protocol depending on the type of organ following the table above.
66
B. APPENDIX B
Specimens Transportation Guidelines
OPERATING TRANSPORT HISTOLOGY

ROOM CONDITIONS LAB
SEALING FRIDGE GROSSING

MAX 30 MIN +4°C
THERMAL BAG
COOL PACKS +4°C
SEALING FRIDGE MAX 3 HOURS FRIDGE GROSSING

2Hr - +4°C +4°C
THERMAL BAG
COOL PACKS +4°C
SEALING MOBILE FRIDGE GROSSING

REF +4°C > 3 HOURS +4°C
MOBILE
REFRIGERATOR +4°C
If the time required by the courier for the specimens’ transportation to the Anatomical Pathology
Department is:
1. less than 30 minutes: put the specimens in the Thermal bag with the cool packs at +4°C (39.2°F),
2. less than 3 hours: put the specimens into the refrigerator, close to the TissueSAFE, for at least 2 Hr
(pre-cooling procedure) and later place them in the Thermal bag with the cool packs at +4°C (39.2°F),
3. more than 3 hours: use of the Mobile refrigerator connected to an external power supply (12/24Vdc,
115/230V~).
For details on refrigerators models available from Milestone s.r.l., see the Chapter 5 or contact directly the
distributor or the local support.
With the system at controlled temperature designed by Milestone s.r.l. is ensured a

perfect preservation of the morphology, antigenicity, DNA/RNA and proteins are
preserved up to 72 hours in an optimal manner.
In none of the three cases described above the total time of the transport must exceed
72 hours (including the time spent in the Operating Room/Refrigerator of the
Laboratory of Histology). For proper preservation of the morphology, the samples
must be packed and stored at 4°C ± 2°C (39.2°F ± 33 .8°F).
For more details on TissueSAFE accessories, see the chapter 5.
67
MILESTONE
Milestone Srl - via Fatebenefratelli 1/5 - 24010 Sorisole (BG) - Italy
H E L Phone
P I N +39
G 035 4128264 - Fax +39 035 575498
e-mail: medical@milestonesrl.com - web: www.milestonemedsrl.com
P A T I E N T S

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MILESTONE

Please read the user manual before using the instrument.

9.1. Waste disposal of Vacuum bags ................................................................................................ 60

1.1. Symbols used in this manual

Please read carefully this instruction.

Please read carefully the Service Manual.

An instruction accompanied by this symbol provides a cautionary statement:

An instruction accompanied by this symbol provides a caution against electric shock.

CE logo: This instrument complies with European community directives.

WEEE European directive symbol (2002/96/EC):

1.2. Designated uses

The Milestone TissueSAFE must be operated exclusively as reported in this manual.

Any other use of the instrument is considered improper.

Do not remove any instrument and/or accessory panel or cover.

2. SETTING UP THE INSTRUMENT

2.1. Site requirements

The Milestone TissueSAFE system, if dealing with Formalin

2.2. Electrical requirements

The label includes:

See the chapter 1.1 for symbols.

2.3. Unit overview

CABINET FRONT CABINET BACK

Space for RFID Space for plastic bags

2.4.1. Fume extraction system

2.4.2. Switch ON and OFF

3. MILESTONE VACUUM BAGS

For details, see the chapter 7 “Consumables”.

An annotation label is placed on the outside of each bag.

The requisition form can be sealed inside the dedicated

Specimens under vacuum have to be placed and maintained at a temperature of +4°C

4.1. Control panel

Control panel description:

4.2. Select a program

TissueSAFE is able to memorize up to 30 different protocols.

To move from P01 to another protocol, press the button:

4.3. Run a program

After the user log in, the following screen appears:

After the vacuum step, the vacuum bag is sealed.

At the end of the surgical operation, the operator requesting the

4.4. Modify a program

Do not leave the software logged in as Administrator, to prevent any accidental

TissueSafe can be used with customized protocols.

PROTOCOL BASIC ADMINISTRATOR TECHNICAL

4.5. Basic User and Administrator log in

To log in as ADMINISTRATOR, turn the unit off, turn it on again while

To insert the password press:

ADMINISTRATOR password issued as a separate document included in

4.6. Create a program

The following screen appears.

B. GAS: value cannot be changed or used, please leave it set at 0%.

4.7. Stop a program

4.8. Seal a plastic bag without vacuum

The specimens under vacuum must be stored at a temperature of +4°C (39.2°F).

5.1. Non mobile refrigerator

Ref. P/N DESCRIPTION

68064 Refrigerator laboratory type 140L 230Vac complete

Dimensions: 52cm (20.5in) x 63.5cm (25in) x 83.5cm (32.9in)

In this type of refrigerator, the temperature is kept at approx +4°C

5.2. Termic bag