CellPath TruSlice Digital CBA-0200-00A User manual

I N AT I O N IN CE L L U L A R PAT H O L O G YN OV
CBA-0200-00A
‘TruSlice’ Digital -
Specimen Cut Up System
Dissection Equipment
SureCut
Instructions for Use
00.977.657 V1

1 - Intended Use
2 - Storage and Handling
3 - Warnings and Precautions
4 - Instrument Installation
4.1 - General
4.2 - Action upon delivery
4.3 - Site preparation prior to installation
4.4 - Bringing into operation
5 - Theory of Operation
6 - Functions
7 - Performance of IVD Instrument
8 - Limitations of Use
9 - Preparation Prior to Operation
9.1 - Training
9.2 - Materials required
9.3 - Ordering information for consumables
10 - Operating Procedure
11 - Control Procedure
I N AT I O N I N C E L L U L A R PAT H O L O G YN OV
Tel:
CellPath Ltd
80 Mochdre Enterprise Park,
Newtown, Powys
SY16 4LE, UK Website:
Fax:
Email:
[email protected]
[phone]
www.cellpath.co.uk
[phone]
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Contents
Page 2 of 16 00.977.657 V1

I N AT I O N I N C E L L U L A R PAT H O L O G YN OV
Tel:
CellPath Ltd
80 Mochdre Enterprise Park,
Newtown, Powys
SY16 4LE, UK Website:
Fax:
Email:
[email protected]
[phone]
www.cellpath.co.uk
[phone]
12 - Shut-Down Procedure
12.1 - Switching it off
12.2 - Temporarily taking it out of operation
13 - Disposal Information
14 - Maintenance
14.1 - Preventative maintanence
14.2 - Instructions for cleaning
14.3 - Sterilization, decontamination or disinfection
14.4 - Disassembly and reassembly of the system
14.5 - Components
14.6 - Servicing contact information
14.7 - Recommended spare parts and consumables
15 - Troubleshooting
16 - References to scientific literature
17 - For use with TruSlice / TruSlice Digital Calibration Set - CBA-0300-00C
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Page 3 of 16 00.977.657 V1

Dear Customer,
Thank you for purchasing this piece of dissection equipment. To get the best perfor-
mance from your equipment and for you own safety please read these instructions
carefully before use.
General Notes
1. This product is designed for laboratory use only. Always follow good laboratory
practice.
2. If this product is not used in accordance with these instructions then basic health
and safety may be affected.
3. Before using any cleaning or decontaminating method please refer to the Mainte-
nance and Cleaning section to ensure the proposed method will not damage the
unit or any accessories.
Amendments
Issue 1: September 2015 (Initial Issue)
Symbols
This symbol appears in documents and on labels to warn
the user that the blade edge is very sharp.
This symbol appears in documents to warn the user that the
instructions must be followed to ensure correct or safe
operation.
SHARP
!
!
I N AT I O N I N C E L L U L A R PAT H O L O G YN OV
Tel:
CellPath Ltd
80 Mochdre Enterprise Park,
Newtown, Powys
SY16 4LE, UK Website:
Fax:
Email:
[email protected]
[phone]
www.cellpath.co.uk
[phone]
Page 4 of 16 00.977.657 V1

1 - Intended Use
This piece of equipment will aid in accurate and consistent grossing of specimen
samples during the cut up procedure prior to processing. Providing assurance to
the method and enabling rapid processing.
2 - Storage and Handling
Even though the product is within recommended lifting guidelines please lift with
care and handle in accordance with internal health and safety policies.
3 - Warnings and Precautions
Keep hands away from the moving blade by using the ‘TruSlice’
immobilisation plates to immobilise the specimen during cut up.
4 - Instrument Installation
4.1 - General
The ‘TruSlice’ Digital Specimen Cut Up System is supplied with a 12 month warranty
on hardware parts and labour only excluding general wear and tear.
This excludes accessories which are sold as consumables:
Cutting Insert
50mm Immobilisation Plate
75mm Immobilisation Plate
These accessories will be covered under CellPath’s standard return policy which can
be read at www.cellpath.co.uk/returns.
4.2 - Action upon delivery
Please ensure that the security seal is intact upon delivery.
SHARP
!
I N AT I O N I N C E L L U L A R PAT H O L O G YN OV
Tel:
CellPath Ltd
80 Mochdre Enterprise Park,
Newtown, Powys
SY16 4LE, UK Website:
Fax:
Email:
[email protected]
[phone]
www.cellpath.co.uk
[phone]
Page 5 of 16 00.977.657 V1

Open the case by placing flat on a surface with the product label on top, when
opening please make sure that all components are present using the following list:
1 x TruSlice Digital
1 x TruSlice / TruSlice Digital – 50mm Immobilisation Plate
1 x TruSlice Digital - 75mm Immobilisation Plate
1 x Sample of 10 Inch (250mm) Lung Knife
1 x Supa Mega MotherShip Sample Pack
1 x Supa Mega Slim Sample Pack
Please check for damage to any component and advise us of any discrepancies on
receipt of delivery or as soon as possible straight after.
4.3 - Site preparation prior to installation
Make space available within the cut up area of a Histopathology Laboratory. We
recommend that this device is used over a down draft extraction cut up bench.
The dimensions of the device are 346mm x 145mm x 195mm. Please ensure that
sufficient space is allowed around the instrument for ease of use.
4.4 - Bringing into operation
The device will be set up prior to despatch, but it will be recommended to cut a few
test slices to ensure accuracy of the system. When taking the test slices please ensure
the system is set onto a flat and even surface. If the system is not within tolerance of
±1mm then please set up according the following instructions:
Step 1: Turn on the digital rule.
Step 2: Insert a knife into the knife guide.
Step 3: Rotate the handle at the back in a clockwise direction to
bring the knife into contact with the back plate.
Step 4: When the knife is touching the back plate press the zero
button on the digital rule.
This completes the visual calibration of the system. Please refer to these instructions
should you wish to recalibrate.
!
I N AT I O N I N C E L L U L A R PAT H O L O G YN OV
Tel:
CellPath Ltd
80 Mochdre Enterprise Park,
Newtown, Powys
SY16 4LE, UK Website:
Fax:
Email:
[email protected]
[phone]
www.cellpath.co.uk
[phone]
Page 6 of 16 00.977.657 V1

5 - Theory of Operation
The basic principle of the technology used in this unit is a simple screw thread
mechanism. As the wheel is turned at the rear of the unit the knife guide moves
accordingly and the digital rule reads the displacement.
6 - Functions
The digital rule has several buttons.
The units can be changed between mm and inches by pressing the blue button.
The digital rule can be turned on/off by pressing the red button.
The digital rule can be zeroed by pressing the yellow button.
7 - Performance of the IVD Instrument
The tolerance of the system is regarded as ±1mm.
If the maintenance instructions in section 14 are followed correctly the risk of cross
contamination should be minimal. Please ensure that all laboratory standards are
followed and blades are wiped down after every use.
8 - Limitations of Use
This device has been designed to use the CellPath MacroKnife
range of knives, other brands of knife may not fit in the guide
and could therefore, cause damage to the system.
9 - Preparation Prior to Operation
9.1 - Training
No official training will be required, although the user may feel it necessary to take a
few sample slices to get used to the device.
!
I N AT I O N I N C E L L U L A R PAT H O L O G YN OV
Tel:
CellPath Ltd
80 Mochdre Enterprise Park,
Newtown, Powys
SY16 4LE, UK Website:
Fax:
Email:
[email protected]
[phone]
www.cellpath.co.uk
[phone]
Page 7 of 16 00.977.657 V1

9.2 - Materials required
The materials the user will require to use the device correctly are listed below:
1 x TruSlice/ TruSlice Digital - 50mm Immobilisation Plate
1 x TruSlice Digital - 75mm Immobilisation Plate
1 x Suitable length knife (We recommend the 6 inch (150mm) trimming knife if
the user will use a guillotine motion, 10 inch (250mm) lung knife if the user
will use a slicing motion, the 8 inch (200mm) macro knife or the 12 inch
(300mm) brain knife could also be considered dependent upon the tissue size
and user preference).
Paper Towels
Access to running water for cleaning
9.3 - Ordering information for consumables
The plastic cutting insert on the system is a consumable and will wear with time
dependent upon how often the unit is used. Please note that this component can be
rotated through 180 degrees to get full use out of it. We recommend that it is
replaced at least monthly.
CBA-0200-05D - TruSlice Digital - Cutting Inserts - Pack of 5
Should any damage occur to the immobilisation plate/s or it/they are lost the
re-order codes are:
CBA-0300-00A - TruSlice/ TruSlice Digital - 50mm Immobilisation Plate
CBA-0200-00B - TruSlice Digital - 75mm Immobilisation Plate
MacroKnife ordering information:
CAA-0601-01A – 6 Inch (150mm) Trimming Knife – Pack of 10
CAA-0801-01A – 8 Inch (200mm) Macro Knife – Pack of 10
I N AT I O N I N C E L L U L A R PAT H O L O G YN OV
Tel:
CellPath Ltd
80 Mochdre Enterprise Park,
Newtown, Powys
SY16 4LE, UK Website:
Fax:
Email:
[email protected]
[phone]
www.cellpath.co.uk
[phone]
Page 8 of 16 00.977.657 V1

CAA-1001-01A – 10 Inch (250mm) Lung Knife – Pack of 10
CAA-1201-01A – 12 Inch (300mm) Brain Knife – Pack of 10
CAA-9901-01A – Assorted Knives (2 x Each size including 4 inch)
10 - Operating Procedure
Step 1: Turn the digital rule on.
Step 2: Rotate the handle at the rear of the unit until the digital rule
reads the required thickness of cut.
Step 3: Ensure that the specimen has a flat perpendicular face to begin
with, if the specimen does not it is advised that you cut a slice to
achieve this.
Step 4: Orientate the specimen on the bed correctly and place against the back wall.
Step 5: The use of the most appropriate sized immobilisation plate is recommended
for health and safety purposes as well as for stabilizing the tissue. Small specimens
could be held with forceps as this may provide the user more control than the use of
immobilisation plates.
Step 6: Insert the chosen size macroknife into the guide and slice in a single stroke
through the specimen.
Step 7: Remove the knife safely and place to the side of the system.
Step 8: Remove the slice of the sample that should be uniform thickness either place
to one side or place straight into the processing cassette.
Repeat this operation as many times as desired on each sample to produce a
selection of slices. Please ensure that you follow correct cleaning instructions after
use as stated in section 14.2.
When use of the system is complete turn off the digital rule.
11 - Control Procedure
Visual checks of sliced specimens can be used to validate the system. We recommend
that the visual checks are carried out by placing a UKAS calibrated ruler against the
sample and measuring the thickness of the slice.
!
I N AT I O N I N C E L L U L A R PAT H O L O G YN OV
Tel:
CellPath Ltd
80 Mochdre Enterprise Park,
Newtown, Powys
SY16 4LE, UK Website:
Fax:
Email:
[email protected]
[phone]
www.cellpath.co.uk
[phone]
Page 9 of 16 00.977.657 V1

If the specimen is incorrect thickness then please recalibrate the system according to
the operating procedure in section 6.4. We recommend setting the 'base'
measurement weekly to ensure accuracy with the cut.
A calibration set is sold separately; this will enable the user to calibrate the system to
UKAS standard which is in recommendation from ISO 15189.
12 - Shut-Down Procedure
12.1 - Switching it off
Please ensure that the digital rule is turned off by pressing the on/off button when
not in use to preserve battery life.
12.2 - Temporarily taking it out of operation
If the item will not be in use for a long time period we would recommend removing
the battery from the digital rule.
13 - Disposal Information
All accessories and knives should be disposed of in line with existing laboratory
disposal policies as well as local and national regulations.
14 - Maintenance
14.1 - Preventative maintenance
Not applicable.
14.2 - Instructions for cleaning
The device should be wiped down after each specimen. The base can be removed
easily from the system to allow the user to place under running water and apply soap.
This should be wiped thoroughly.
I N AT I O N I N C E L L U L A R PAT H O L O G YN OV
Tel:
CellPath Ltd
80 Mochdre Enterprise Park,
Newtown, Powys
SY16 4LE, UK Website:
Fax:
Email:
[email protected]
[phone]
www.cellpath.co.uk
[phone]
Page 10 of 16 00.977.657 V1

We recommend that the system should be disassembled (please see section 14.4)
and decontaminated weekly or in line with standard laboratory cleaning practices.
To clean the immobilisation plates please use soapy water or alcohol based solvents
only. Wipe with a non-abrasive cloth to avoid damage to the accessory.
Warning – Do not use xylene or acetone to clean the immobilisation plates.
14.3 - Sterilization, decontamination or disinfection
Please remember to remove the digital rule before any cleaning activities.
To decontaminate the system disassemble (please see section 19.4) and wipe down
each metal component with a solvent or soapy water.
If you wish to sterilize and disinfect the system please use standard sterilization
practices such as the use of an autoclave. The use of 70% alcohol would be proficient.
To decontaminate the immobilisation plates please use soapy water or alcohol based
solvents only. Wipe with a non-abrasive cloth to avoid damage to the accessory.
Warning – Do not use xylene or acetone to clean the immobilisation plates.
14.4 - Disassembly and Reassembly of the system
Please follow the steps below to disassemble the system:
Step 1 – Remove the bed from the base, this will require lifting it upwards and then
pulling it out from the back plate.
Step 2 – Retrieve the Allen key from the back of the system.
Step 3 – Remove the digital rule from the side of the system by unscrewing the 3
screws.
Step 4 – Remove the screws from the back plate.
Step 5 – Keep turning the handle to the end of the thread and remove the moving
guide.
Step 6 – All components should come apart easily.
I N AT I O N I N C E L L U L A R PAT H O L O G YN OV
Tel:
CellPath Ltd
80 Mochdre Enterprise Park,
Newtown, Powys
SY16 4LE, UK Website:
Fax:
Email:
[email protected]
[phone]
www.cellpath.co.uk
[phone]
Page 11 of 16 00.977.657 V1

To reassemble the systems please follow the below:
Step 1 – Insert the adjustment handle into the radius of the back plate.
Step 2 – Insert the threaded bar into the central hole of the back plate.
Step 3 – Thread the bar into the handle to make it as one unit.
Step 4 – Screw the back plate to the sides of the system using the 4 screws that were
removed.
Step 5 – Screw the digital rule onto the side.
Step 6 – Replace the Allen key to the magnet at the back of the system.
Step 7 – Place the bed on the base by slotting the pins into the back plate and down
into the top locators.
14.5 - Components
Not applicable.
14.6 - Servicing contact information
Not applicable.
14.7 - Recommended spare parts and consumables
I N AT I O N I N C E L L U L A R PAT H O L O G YN OV
Tel:
CellPath Ltd
80 Mochdre Enterprise Park,
Newtown, Powys
SY16 4LE, UK Website:
Fax:
Email:
[email protected]
[phone]
www.cellpath.co.uk
[phone]
Page 12 of 16 00.977.657 V1
CBA-0200-00B
TruSlice Digital - 75mm Immobilisation Plate
CBA-0200-05D
TruSlice Digital - Cutting Inserts
CBA-0200-00F
TruSlice Digital - Spare Screw Set
CBA-0300-00A
TruSlice / TruSlice Digital - 50mm Immobilisation Plate
CBA-0300-00C
TruSlice / TruSlice Digital - Calibration Set
CBA-0601-01A
6 Inch (150mm) Trimming Knife
CBA-0801-01A
8 Inch (200mm) Macro Knife
CBA-1001-01A
10 Inch (250mm) Lung Knife
CBA-1201-01A
12 Inch (300mm) Brain Knife
CBA-9901-01A
Assorted Knives (2 x Each Size including 4 Inch)

15 - Troubleshooting
Incorrect thickness - Reset the base line for the system following the steps in section
4.4.
16 - References to scientific literature
Orchard GE, Shams M et al. Development of new and accurate measurement devices
(TruSlice and TruSlice Digital) for use in histological dissection: an attempt to improve
specimen dissection precision. Br J Biomed Sci 2015; 72 (3): 140-145
I N AT I O N I N C E L L U L A R PAT H O L O G YN OV
Tel:
CellPath Ltd
80 Mochdre Enterprise Park,
Newtown, Powys
SY16 4LE, UK Website:
Fax:
Email:
[email protected]
[phone]
www.cellpath.co.uk
[phone]
Page 13 of 16 00.977.657 V1

17 - For use with TruSlice / TruSlice Digital Calibration Set
CBA-0300-00C
17.1 - Intended Use
To provide quality assurance of the equipment.
To comply with UKAS regulations ISO- 15189, it may be considered necessary
to calibrate the TruSlice systems at regular intervals.
17.2 - General Information
The gauge blocks supplied are 2mm, 3mm, 4mm and 5mm. These blocks are
calibrated to ISO: 3650 (grade 2) and are supplied with the UKAS accredited
certificate.
The serial number is located on the block it begins with CP....
17.3 - TruSlice Digital Procedure
1 - Move the knife guide to greater than 5mm.
2 - Place a knife in the knife guide, sharp edge down.
3 - Place the 5mm gauge block vertically into the space between the knife blade
and the face of the insert.
4 - Bring the guide back so that the knife surface touches the block surface.
4 - Visually check that the blade has contact with the face of the gauge block.
It is recommended that the gauge block is tested at each end of the guide.
Should there be any discrepancies with the reading then please re-calibrate with the
steps in section 4.4.
Alternatively if the user is consistently cutting to the same thickness, it is possible to
calibrate against a specific gauge block by using the steps above and setting the digital
rule to zero at the point of touching.
I N AT I O N I N C E L L U L A R PAT H O L O G YN OV
Tel:
CellPath Ltd
80 Mochdre Enterprise Park,
Newtown, Powys
SY16 4LE, UK Website:
Fax:
Email:
[email protected]
[phone]
www.cellpath.co.uk
[phone]
Page 14 of 16 00.977.657 V1

Page 15 of 16
I N AT I O N I N C E L L U L A R PAT H O L O G YN OV
Tel:
CellPath Ltd
80 Mochdre Enterprise Park,
Newtown, Powys
SY16 4LE, UK Website:
Fax:
Email:
[email protected]
[phone]
www.cellpath.co.uk
[phone]
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CellPath Ltd.
80 Mochdre Enterprise Park,
Newtown, Powys,
SY16 4LE, Mid Wales, UK
Tel:
Fax:
Email:
Internet:
[email protected].uk
www.cellpath.co.uk
[phone]
[phone]