Milestone LOGOS One Operator's Manual

Download

Page 1

LOGOS One

All-in-one Rapid Tissue Processor

Operator Manual

MM098

MILESTONE

HELPING PATIENTS

Page 2

Page 3

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Thank you for having selected our system and welcome to the ever growing world club of users for Milestone laboratory instrumentation. We are sure that you will be completely satisfied with this new tool entering your laboratory. We invite you to read carefully this operator manual and to keep it in reach for convenient and fast consulting. For any possible clarification or any request for assistance please contact either our Representative in your country:

Or contact Milestone s.r.l.

Via Fatebenefratelli, 1/5 24010 Sorisole (BG) Italy Tel. +39.035.412 8264 Fax +39.035.575498 web site www.milestonemedsrl.com e-mail [email protected]

Please read the user manual before using the device.

MM098-002 – LOGOS ONE – Operator Manual 2015-07

Page 4

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

SUMMARY

SUMMARY .................................................................................................................................................. 4

1 INTRODUCTION ................................................................................................................................ .. 6

1.1 Symbol used................................................................................................................................. 6

1.2 Designated uses ........................................................................................................................... 7

1.3 Technical specifications ................................................................................................................ 7

1.3.1 Touch control terminal .............................................................................................................. 7

1.4 Transportation and storage conditions ................................................................ .......................... 8

1.5 Warning information...................................................................................................................... 9

1.6 Labeling explanation ................................ ................................................................ ....................10

1.7 Compatible reagents ....................................................................................................................10

1.8 Waste disposal of the equipment .................................................................................................11

2 INSTALLATION ...................................................................................................................................12

2.1 Space requirements.....................................................................................................................12

2.2 Unpacking and checking list .........................................................................................................13

2.3 Placement ...................................................................................................................................15

2.3.1 Unit overview ................................................................ ........................................................... 15

2.4 Fumes extraction system .............................................................................................................16

2.5 Power supply ...............................................................................................................................17

2.6 Electrical installation ....................................................................................................................17

2.6.1 Back side connection plate 230V Version .................................................................................18

2.6.2 Back side connection plate 115V Version .................................................................................18

2.6.3 Main power supply connection .................................................................................................19

2.6.4 Power supply connection (NO UPS mode) ...............................................................................19

2.6.5 Power supply connection (Local UPS mode) ............................................................................20

2.7 Remote alarm connection ............................................................................................................22

2.8 Internet connection ...................................................................................................................... 22

2.9 Reagents .....................................................................................................................................24

2.10 Log in and log out ........................................................................................................................24

2.10.1 Create a new user ................................................................................................................25

2.11 Set system date and time ............................................................................................................27

2.12 Set language ...............................................................................................................................27

2.13 Load LOGOS ONE with wax ........................................................................................................28

2.13.1 Wax heating setting .............................................................................................................30

2.14 Load LOGOS ONE with reagents ................................................................................................32

2.14.1 Set up LOGOS ONE with reagents.......................................................................................33

2.14.2 Cleaning procedure for cleaning tanks .................................................................................39

2.15 Most used programs ....................................................................................................................39

2.16 Owner settings ............................................................................................................................41

3 OPERATE WITH LOGOS ONE ............................................................................................................44

3.1 Loading cassettes into the rack ....................................................................................................44

3.1.1 Rack loading-unloading tool .....................................................................................................45

3.2 Run a program ............................................................................................................................46

3.2.1 Run of the most used program ................................ ................................................................ .46

3.2.2 Run a standard program .......................................................................................................... 54

3.2.3 Run two processes simultaneously ..........................................................................................57

3.2.4 Run a program using the STEP START function ......................................................................59

3.2.5 Run a DELAYED PROGRAM ..................................................................................................60

3.2.6 Add WAX .................................................................................................................................63

3.2.7 Screen saver ...........................................................................................................................64

3.3 Run a cleaning cycle of the main cavity ........................................................................................65

3.3.1 Tanks for process and main cavity cleaning .............................................................................66

3.4 Reagents group and programs.....................................................................................................68

3.5 Run a cleaning cycle of the WAX .................................................................................................69

3.6 Retrieving saved processes .........................................................................................................71

3.6.1 How to delete a saved process ................................................................................................74

3.7 Modify a program .........................................................................................................................74

3.7.1 Modify a standard program ......................................................................................................75

3.7.2 Correlation between racks and programs .................................................................................76

Page 5

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

3.7.3 Modify a main cavity cleaning program.....................................................................................78

3.7.4 Modify a WAX cleaning ............................................................................................................79

4 REAGENTS MANAGEMENT ...............................................................................................................80

4.1 Reagents reuse life ......................................................................................................................80

4.1.1 Reagents settings ....................................................................................................................81

4.1.2 Recommendations for reuse life ...............................................................................................82

4.2 Reagents replacement procedure ................................................................................................83

4.2.1 ....................................................................................................................................................83

4.2.2 Reagent NOT USED FOR RINSING ........................................................................................84

4.2.3 Reagent USED FOR RINSING ................................................................................................86

4.2.4 Change reagents during a WAX phase ................................................................ ....................87

4.3 Wax replacement procedure ........................................................................................................88

5 SAFETY MODE PROCEDURE ............................................................................................................90

5.1 Power failure ...............................................................................................................................90

5.2 Regent loading time-out ...............................................................................................................92

6 REPORTING ................................................................ ....................................................................... 94

6.1 Export processing from the terminal to the USB key .....................................................................94

6.2 Install and operate with the LogViewer .........................................................................................95

6.2.1 Open process ..........................................................................................................................95

6.2.2 Print process............................................................................................................................97

6.2.3 Send process to customer support (Milestone) .........................................................................98

6.2.4 Change settings .......................................................................................................................99

6.2.5 Other functions ........................................................................................................................99

6.3 Reagents Log and Events Log from the terminal to the USB key ................................................100

7 MAINTENANCE .................................................................................................................................102

7.1 Introduction ...............................................................................................................................102

7.2 After each run ............................................................................................................................102

7.2.1 Rack cleaning procedure .......................................................................................................102

7.3 Every 5 runs ..............................................................................................................................104

7.4 Weekly ................................................................................................ ...................................... 104

7.5 Monthly .....................................................................................................................................105

7.6 Yearly ........................................................................................................................................107

7.7 How to start the remote assistance ............................................................................................107

8 OPTIONAL ........................................................................................................................................108

9 GOOD TISSUE PROCESSING PRACTICE .......................................................................................112

9.1 Specimens ................................................................................................................................112

9.2 Fixation .....................................................................................................................................112

9.3 Beware ...................................................................................................................................... 113

9.4 Reagents ...................................................................................................................................114

9.4.1 Alcohols quality ......................................................................................................................114

9.5 Tissue processing selection guidelines ......................................................................................115

9.6 Presoaking guidelines ................................................................................................................116

A. Appendix ................................................................................................ ....................................... 118

A.1. TISSUE PROCESSING THROUBLESHOOTING GUIDE ...........................................................118

A.2. OVERVIEW OF HISTOPROCESSING TROUBLE SHOOTING..................................................125

B. Appendix ................................................................................................ ....................................... 126

B.1. HOW TO MANAGE AN ALARM .................................................................................................126

C. Appendix .......................................................................................................................................128

C.1. HOW TO MANAGE SAMPLES WHILE AN ALARM IS OCCURRING .........................................128

Page 6

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

1 INTRODUCTION

1.1 Symbol used

An instruction accompanied by this symbol provides a quite important and require more attention.

An instruction accompanied by this symbol provides a cautionary statement: failure to follow the instruction may endanger the operator 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: be careful when you execute the procedure marked with this symbol: danger of biohazard contamination.

Surfaces identified with this symbol are at danger temperature (more than 70°C/158°F).

Potentially flammable.

Please read SERVICE Manual (operation for SERVICE only).

CE logo: this instrument complies to European Community directives.

IVD medical device according to 98/79/EC directive.

WEEE European directive symbol (2002/96/EC): Electric/electronic device do not throw out in the environment.

Manufacturer.

Fragile.

Page 7

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

1.2 Designated uses

The Milestone LOGOS ONE and its accessories have been engineered for laboratory use and can therefore withstand the harshest laboratory conditions for continuous use in Histological sample preparation procedures.

The instrument is intended for laboratory use (indoor use) only. The Milestone LOGOS ONE is specifically designed to automatically (when an automatic run is selected) or

semi-automatically (when a dual run is selected) execute these processes for histopathological applications:

 Fixation, Post-fixation  Dehydration and Clearing  Drying  Paraffin wax infiltration

The Milestone LOGOS ONE must be operated exclusively with the reagents listed in section Compatible reagents 1.7.

1.3 Technical specifications

CODE 61500/R: Power supply input: 230V~ 50Hz 2000W, CODE 61501/R: Power supply input: 230V~ 60Hz 2000W.

Working Temperature: 15°C – 30°C (59°F – 86°F) Humidity (relative): up to 80% Maximum altitude: 2000m Fan air flow range: 54–58m3/h (cube meter per hour).

1.3.1 Touch control terminal

The following picture shows the Touch Control terminal of the LOGOS ONE unit. It is possible to operate the unit by simply touching the icons on the screen.

Two USB PORTS are located on the right side of the Touch Control Terminal.

Please refer to chapter 9.4.1 for purity grade of reagents.

Any other use of the instrument is considered improper and may void the warranty provided by the manufacturer.

Page 8

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Characteristics: TK-WIN10CEi-TFT-LCD color display Resolution 800x600 pixels, 8’’ Touch screen Mass storage CF 512MB RAM 256 MB CPU 500MHz Windows™ CE.NET 6.0 Programs: Multiple pre-stored programs, with customizable user defined programs I/O-Interface: 2x USB port 2.0, 1x LAN Ethernet 10/100 Mbps RJ-45

1.4 Transportation and storage conditions

Temperature: –20°C up to +60°C Humidity: up to 80% (up to 50% at 40°C – 104°F) non-condensing

The manufacturer reserves the right to change and/or improve specifications without notice and without incurring any obligation.

Before turning LOGOS ONE on (when coming from a storage room), let the unit reach working environmental conditions (at least half an hour).

Page 9

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

1.5 Warning information

Should the equipment be used in different ways than those specified by the manufacturer, the warranty provided by the manufacturer may be void. Main power plugs are considered disconnecting device. Disconnect all plugs from the socket outlet before assembling of the system, before connection of the accessories and before cleaning. Equipment shall be connected to a main power socket outlet which is accessible and visible by the operator. Equipment is provided with replaceable fuses, however their replacement is to be performed by properly authorized service personnel. If the system is not properly working, please contact the local authorized and trained service representative of the manufacturer. All parts of the equipment and all accessories must be supplied only by the manufacturer.

DO NOT OPEN THE CHASSIS. Failure to follow the instruction in the documentation might lead to a reduction of device safety. If the equipment is not working properly, please contact your supplier or the manufacturer.

Do not remove the instrument, accessories, panels 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 for safety and good laboratory practices are applied. Always use common sense and the best known practice when operating the instrument. Failure to follow the instructions in the documentation might lead to a reduction of device safety. The Competent Authority owning the instrument has primary responsibility for accident-free operation together with designated personnel who operates SERVICE or repair it.

To avoid damage to the instrument, use only the reagents listed in section 1.7 Compatible reagents. Failure to follow the instructions in the documentation might lead to a reduction of device safety.

Use caution when handling hot, molten WAX.

METAL PARTS Never introduce metal parts into the MAIN CAVITY. High voltage discharges may cause uncontrolled increases of temperature, which could damage the unit and result in incorrect tissue processing also. Failure to follow the instructions in the documentation might lead to a reduction of device safety.

Be careful: exhaust reagents are toxic and carcinogenic. Handle with care and follow the local standard regulations.

Page 10

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

1.6 Labeling explanation

For symbols explanation see Chapter 1.1.

1.7 Compatible reagents

Fixatives

Holding

Dehydration

Clearing

Impregnation

Other

Cleaning

Milestone FineFIX®

PBS buffer

Milestone

JFC® solution

WAX, Histology

grade

Alcohol/water

(60/40) solution

(Flushing)

Xylene

Formalin, buffered or unbuffered

Alcohol/water

(70/30)

solution

Milestone

Prowave®

solution

Isoparaffin

Milestone

MileGREEN®

solution

Ethanol

Isopropanol

Water

Xylene

Isoparaffin

Milestone

MileGREEN®

solution

Please refer to chapter 9.4.1 for purity grade of reagents.

DO NOT USE REAGENTS DIFFERENT FROM THOSE LISTED ABOVE. In case of doubts please contact: [email protected].

Page 11

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

1.8 Waste disposal of the equipment

This instrument is an in-vitro medical device and it is usually installed in a laboratory where specimens and other biological tissues are present. For your safety, it is therefore required to clean and disinfect before entering in contact with it. You must also wear gloves when operating the system. In case of return it is required that the unit is cleaned and disinfected before sending it back to Milestone. Non-disinfected devices will be no longer accepted and you will be contacted to pay the relative disinfection cost. International health rules require that shipments of biohazard materials are not done in standard packages (risk of sanctions).

It is recommended to use enzymatic detergents and polyphenolic based disinfectants or chlorine substitutes to clean and disinfect the instrument. In alternative, to decontaminate the instrument, the use of a solution of 1:10 Bleach (recommended by the CDC for disinfecting) is also allowed. For further information, please contact the manufacturer: [email protected].

In addition, 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 acknowledges it can have potential effects on the environment and human health.

This symbol indicates separate collection

for electrical and electronic equipment

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 to such requirements.

Waste disposal of reagents

For further information please refer to the MSDS (Material Data Safety Sheet) provided by your supplier.

Do not remove the side panels of the unit during the cleaning operations.

Before doing any operation disconnect the power supply. Do not use direct or high-pressure water to clean the instrument.

For safety reason, any operation without the individual protective devices must be avoided.

Handle with care and store in a cool dry space using a tightly closed container. Vapors may collect in empty containers. Treat empty containers as hazardous. Waste material should be disposed of in an approved incinerator or in a designated landfill site, in compliance with all federal, provincial and local government regulations. Some reagents can have potential health effects and cause environmental pollution if not correctly disposed.

Page 12

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

2 INSTALLATION

Milestone LOGOS ONE is a precision instrument that requires the utmost care when it is unpacked and installed. Move LOGOS ONE to its final location. Make sure that the floor is level and is made of nonflammable material. The following pictures show the dimensions of LOGOS ONE and the space required:

2.1 Space requirements

LOGOS ONE is delivered in a wood box with these dimensions:

Width: 920mm (36.2in)

Height: 1320mm (52in)

Depth: 1500mm (59in)

The space dimensions required to locate the unit are the following (drawer and covers opened):

Width: 1100mm (43in)

Height: 1600mm (63in)

Depth: 1200mm (47in)

LOGOS ONE is a heavy instrument. Contact a structural engineer before placing the unit (analyze the building structure).

LOGOS ONE Weight (read carefully):

LOGOS ONE FULL (all tanks): 320kg (706lb) (wax and all reagents loaded in proper tanks). LOGOS ONE EMPTY: 250kg (552lb) (no reagents; no Paraffin Wax histological grade). Unit density 640kg/m2 (0.9lb/in2).

1500mm

1090mm

695mm

760mm

Page 13

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

2.2 Unpacking and checking list

When unpacking, check that all parts correspond to the packing list included in the shipment. Utmost care must be made during unpacking of LOGOS ONE, to avoid any scratch or damage to the external surface.

CODE

DESCRIPTION

INCLUDING

Power supply input

61506/R

LOGOS ONE COMPLETE PACKAGE

61502/R

115V~ 60Hz 2000W

61503/R

Starter Kit LOGOS ONE

61506/R-USA

LOGOS ONE COMPLETE PACKAGE

61502/R

115V~ 60Hz 2000W

61503/R-USA

Starter Kit LOGOS ONE-USA

61504/R

LOGOS ONE COMPLETE PACKAGE

61500/R

230V~ 50Hz 2000W

61503/R

Starter Kit LOGOS ONE

61505/R

LOGOS ONE COMPLETE PACKAGE

61501/R:

230V~ 60Hz 2000W

61503/R

Starter Kit LOGOS ONE

The LOGOS ONE COMPLETE PACKAGE includes:

A. The LOGOS ONE unit (with power supply cable) including the following items:

1. Nr. 1 WAX draining tube CODE 62497

2. Nr. 1 Tanks labels CODE 65633

3. Nr. 1 CD with LOGOS ONE Operator Manual (MM098), Maintenance Instructions, LOGOS ONE

Quick Start Guide (MM101).

B. The Starter Kit LOGOS ONE (CODE 61503/R) includes the following items:

CODE

DESCRIPTION

Q.ty

IMAGE

66105

Rack Transfer Kit

66165A/210

Split Rack 210 cassettes

62348

Antiscratching Spatula to remove wax traces

62160

USB Data Traveler containing the LogViewer Software

Page 14

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

61597

Exhaust Tube complete

The Starter Kit LOGOS ONE (CODE 61503/R-USA) includes the following items:

CODE

DESCRIPTION

Q.ty

IMAGE

66105

Rack Transfer Kit

66165A/210

Split Rack 210 cassettes

62348

Antiscratching Spatula to remove wax traces

62160

USB Data Traveler containing the LogViewer Software

61597

Exhaust Tube complete

70170

Tank 5 liters capacity 9

61550/F

External exhaust FORMALIN fumes filter kit, including one spare filter

Page 15

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

2.3 Placement

Now LOGOS ONE unit can be positioned in its final place of use. When the instrument is positioned, push down the lever of the wheels (CODE 66464) to block them.

2.3.1 Unit overview

MAIN CAVITY on the LEFT WAX CAVITY on the RIGHT.

To open the MAIN CAVITY cover: push the button, then rotate the handle (clockwise), then flip up the cover. To open the WAX CAVITY cover: push the button, then rotate the handle (clockwise), then flip up the cover.

In the bottom of the main cavity (left) there is a mesh filter to block the eventual floaters and dirty parts.

Block the four lateral wheels (indicated with green arrow the two frontal) BUT do not block the central one of the drawer (indicated with yellow arrow).

Page 16

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Refer to chapter 7.5 for its maintenance.

2.4 Fumes extraction system

LOGOS ONE is vented, to comply with CAP regulations, through the external exhaust outlet positioned on the back of the instrument, with a hose dedicated to the external fume extraction system (if any).

The customer is required to adapt the hose connector. The plastic hose supplied has these characteristics:

 Length: 3m (110”)  External diameter: 69mm (2.72”)  Internal diameter: 60mm (2.36”)

Insert the exhaust tube (CODE 61377) on the proper outlet (back panel).

Use the metal cable clamp (CODE 50051) to fix the hose to the exhaust fume pipeline.

The external fume extraction system must be properly installed at all times, according to local regulations in force on laboratory safety.

The external fume extraction system must permit an air flux of 58 m3/h (cube meter per hour).

There is no air filter on the unit exhaust system.

It is possible to connect an external exhaust fumes filter kit. See chapter 8 for information about this optional (CODE 61550).

Page 17

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Now connect the other side of tube to the fume extractor of the laboratory.

2.5 Power supply

Power supply line must have a ground connection (yellow/green, green or bare wire). Do not use the blue/white wire (neutral of power line). Power supply neutral has to be referred to ground.

Carefully check that:

 A strong ground connection is made available in the lab to assure the unit works correctly. Do not

connect a Milestone unit without ground connection.

 A dedicated ground connection direct from the main electric box (cabinet) of the laboratory to our

unit is ideal to eliminate any possible interference/electronic noise originated by other instruments supplied with the same line.

 Power supply line wires (their size and distance from the switch board) used in the laboratory are

compliant with the label positioned on the back side of our units.

 Plug/socket is visible during the normal use and easily accessible.

Power line protection:

 115V: Miniature circuit breaker curve C, 20A, interruption more than 6000A.  230V: Miniature circuit breaker curve C, 16A, interruption more than 6000A.

Residual current device: 30mA (Class I device). Only 230V version: a schuko terminated power cord is provided.

The 115V version is not terminated.

2.6 Electrical installation

Before connecting the plug to the laboratory’s socket CHECK that the power supply voltage of the unit matches the power supply line of the laboratory. Damages occur when wrong power supplies the instrument.

Page 18

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

2.6.1 Back side connection plate 230V Version

On the back side of the LOGOS ONE are positioned the connection plates:

Description:

1. Speaker

2. Remote/external alarm connector

3. Ethernet/LAN plug

4. UPS side supply (controller power supply input)

5. UPS supplier socket (energy output to local ups unit)

6. Main power supply

2.6.2 Back side connection plate 115V Version

On the back side of the LOGOS ONE are positioned the connection plates:

Description:

1. Speaker

2. Remote/external alarm connector

3. Ethernet/LAN plug

4. UPS side supply (controller power supply input)

5. UPS supplier socket (energy output to local ups unit)

6. Main power supply

As separable power cord, it is strictly required to use power cord with wire size at least of

1.5mm² (equal to minimum AWG12). A size less of 1.5mm² (AWG12) cannot guarantee a proper functionality of the unit and overheating of the power cord.

See also the Label of the instrument that provides some important information. Always communicate the Serial Number of the unit to Customer Support.

1 2 3 6 5

Page 19

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

2.6.3 Main power supply connection

ONLY FOR 115V VERSION, add plug to the cable:

Connect the two black wires to power pins of the plug and the yellow/green to ground’s pin. Diameter approx. 10mm, size of wires AWG12.

ONLY FOR 230V VERSION, connect the cable to connector 1 (see the chapter 2.6.1).

2.6.4 Power supply connection (NO UPS mode)

There are two ways to connect the LOGOS ONE to power supply line.

Characteristic: This is the easier way to supply the LOGOS ONE, but it does NOT protect the unit from power supply failure.

In fact, in case of power failure, user cannot remove samples from LOGOS ONE nor do any other operations.

For this reason, Milestone s.r.l. does NOT suggest this type of connection. Make sure to inform the customer that in this way a power supply failure inhibits any operation with LOGOS ONE

NEVER DIRECTLY CONNECT LOGOS ONE TO THE SWITCHBOARD. IT IS REQUIRED TO USE A SEPARABLE PLUG, WITHOUT A LOCKING DEVICE to mate with the socket-outlet in the laboratory.

As separable power cord, it is strictly required to use power cord with wire size at least of

1.5mm² (equal to minimum AWG12). A size less of 1.5mm² (AWG12) cannot guarantee a proper functionality of the unit and overheating of the power cord.

Page 20

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Connect the by-pass cable (CODE 66643) from (5) UPS supplier socket to (4) UPS side supply. Then connect the socket to main power supply (6): now it is possible to turn the LOGOS ONE “ON”.

Do not connect UPS supplier socket (4) directly to the laboratory socket power supply: this input power supply complies to CISPR 11 class A and may cause electromagnetic interference to other devices.

2.6.5 Power supply connection (Local UPS mode)

Characteristic: Milestone s.r.l. strongly recommends this type of connection as it protects the LOGOS ONE from power supply failure. In this case, in fact, LOGOS ONE cannot process, but can execute all other procedures. In fact “UPS side supply” provides energy at logic circuits.

Even when LOGOS ONE is directly plugged into the main hospital UPS line or power emergency line, we observed occurring of delays or discontinuity of a few seconds/ minutes of the power supply. In this case, LOGOS ONE stops working and the standard power failure procedure, that puts tissues in safety, is not activated. For this reason, we highly recommend to install a UPS module on any LOGOS ONE unit.

Milestone can supply only UPS at 230Volt-50/60Hz (CODE 66100) with the following technical specifications:

230V version (CODE 66100)

 Voltage input 230V 50/60Hz according to your power supply  Power 1000VA/600W (minimum)  Capacity 15 minutes @ 500W (minimum)  Output 230V±10% 50/60±1Hz  Transfer time 6ms (max)  With cord set for connections   Weight: 9.6 kg (if provided locally: max 20kg - 44lb)

UPS unit at 115Volt-60Hz must be provided locally with the following minimum technical specifications:

115V version

 Voltage input 115V 60Hz according to your power supply  Power 1000VA/600W (minimum)  Capacity 15 minutes @ 500W (minimum)  Output 230V±10% 60±1Hz  Transfer time 6ms (max)  With cord set for connections  Footprint max 190x600 mm  Weight max 20kg (44lb)

Before using the UPS, charge the battery according to the manufacturer's specifications. Before connecting the UPS to the Unit, mount the UPS holder supplied with the Unit as shown below.

Page 21

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Do not load more than 15Kg on the UPS holder.

Connect the “UPS supplier socket” (connector type IEC320–C13), (refer to figure below) to the UPS power input. Maximum current 4A (230V), frequency same as local (refer to figure below-A).

Connect the UPS power output to the “UPS side supply” (connector type IEC320-C14) (refer to figure belowB).

Finally connect the socket to main power supply connector input (6): now it is possible to turn LOGOS ONE

ON.

Wrong connections of UPS prejudice the functionality of safety procedures detailed in the chapter 5.1.

Page 22

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

2.7 Remote alarm connection

LOGOS ONE is also provided with two auxiliary outputs in order to connect external devices:

2.8 Internet connection

It is necessary to connect LOGOS ONE to Internet to get Remote Assistance services.

IT IS NOT ADVISED TO RUN PROGRAMS WITH LOGOS ONE WHILE USING THE REMOTE ASSISTANCE CONNECTION. PROCESSES IN REMOTE ASSISTANCE ARE FOR TESTING USE ONLY, NEVER PLACE SPECIMENS INSIDE LOGOS ONE.

In order to access the remote assistance (as described in the chapter 7.7), you need to get the following data from the Information Technology Department/Network Administrator of the customer:

 LAN connection with standard RJ45 Ethernet cable and connector,  Dedicated IP address and Subnet Mask (strongly preferred to DHCP service); only port 80 has to be

enabled without limitations,

 LAN gateway and DNS server addresses,  At least 150kb/s real transfer rate (uploading and downloading).

When connecting LOGOS ONE to remote assistance, it is necessary that Firewall, traffic data filters and all software are disabled. Milestone s.r.l. suggests to fix the IP address in order to properly set up the LAN defenders.

From Log-in screen click on ADMINISTRATOR. Insert ADMINISTRATOR password (issued as a separate document inserted in the Operator Manual) and press enter.

Output

Contact

Status

Identifies the LOGOS ONE alarm

switch

Normally CLOSED

Normally OPEN

COMMON

Identifies the LOGOS ONE end

program

Normally OPEN

COMMON

For safety reasons and for preventing any damage to the internal relays, any external devices that need to be connected to LOGOS ONE unit must have a maximum Voltage lower than 40 VDC – 1A.

Page 23

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Press “Settings” to access the administrator screen.

Then press “Owner” and choose the “Remote Connection” tab:

Select “Specify an IP address”. Enter the data required supplied by the Network Administrator.

For example:

IP Address

192.168.1.235

Subnet Mask

255.255.255.0

Default Gateway add.

192.168.1.6

DNS server address

192.168.1.7

WINS

Not required

Each time you click on a white box, a num-pad appears; enter the number required and press enter. Fill all the white boxes with the data network. At the end Press HOME button to store the data.

Page 24

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

2.9 Reagents

Complete the set up with reagents, by providing at least: PROCESSING REAGENTS:

 1 tank of 5l (or 1US gal) Formalin 10% or FineFIX  1 tank of 5l (or 1US gal) Flushing solution (60% absolute alcohol/40% tap water)  1 tank of 5l (or 1US gal) Absolute Ethanol  2 tanks of 5l (or 1US gal) Absolute Ethanol for rinsing  1 tank of 5l (or 1US gal) Absolute Isopropanol  4kg (8,82 lb) Paraffin, Histology grade  If you want to process fatty tissues larger than 3mm, it is suggested to provide also a second

isopropanol tank: 1 tank of 5l (or 1US gal) Absolute Isopropanol

Alternative to isopropanol:

 1 tank of 5l (or 1US gal) JFC® - for processing of larger fatty tissues (3mm and larger), use of

Milestone JFC solution is recommended.

 1 tank of 5l (or 1US gal) MileGREEN® - for processing of larger fatty tissues (3mm and larger), use

of Milestone MileGREEN® solution is recommended.

If an isopropanol alternative is used, a flushing in isopropanol after xylene/JFC or isoparaffin before paraffin is ALWAYS REQUIRED.

CLEANING REAGENTS:

 1 tank of 5l (or 1US gal) Xylene or Isoparaffin (MileGREEN®)  1 tank of 5l (or 1US gal) Absolute Ethanol  1 tank of 5l (or 1US gal) tap Water.

2.10 Log in and log out

As a default, when the system is switched on, the LOG IN screen appears. Press “Administrator” button,

enter the password (issued as a separate document inserted in the Operator Manual) and press “Enter”.

The above reagents must be onsite and available at time installation of unit.

Refer to chapter 9.4.1 for purity grade of reagents.

Tank to be filled with tap water must be either supplied locally and in this case it is required to use a clean tank, or can be purchased directly from the manufacturer (for details see Chapter 8).

Page 25

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

The Administrator HOME PAGE appears showing, as a default, the main functions grouped by different colors.

In whatever screen you are, press the “Home” button to return to the HOME PAGE. You can customize the HOME PAGE under the USERS settings, choosing between “Favorites” and “Main functions” (see below).

2.10.1 Create a new user

Go to the Settings screen and select Users to create a NEW USER.

The USERS setting screen appears, as shown below. Click on Add, a keyboard appears. Enter the NEW USER name and press Enter.

SERVICE Log-in is available for authorized personnel only. ADMINISTRATOR can access to a restricted SERVICE functions. SERVICE has complete access to the unit functionalities.

Page 26

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Now select and configure the parameters of the NEW USER choosing the:

 USER CATEGORY.  USER PASSWORD: click on the password box, a num-pad appears as shown below, enter the

password (max 6 numbers) and confirm.

 USER CONFIGURATION (HOME PAGE): select the Set Favourites as HOME Page checkbox to

have FAVOURITES PROGRAMS as default.

Now select the appropriate FUNCTIONS for the NEW USER:

Pressing the arrow (see figure below, circle) it is possible to choose the appropriate ACCESS LEVEL in the program startup (here automatically Ask for USER and PASSWORD). The following window will appear:

WHEN MARKED the new USER can:

Create and modify programs

Replace the exhausted reagents

Set the tanks status (empty/fill the tank), open the reagents list and modify the reagents details (ex: max number of processed cassettes)

Set as ready the WAX when the WAX heating status icon becomes YELLOW

Run a program starting from any phase, even not the first one of the list

Page 27

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Selecting:

Ask password for processing

procedure

The software recognizes (through a password system) who is performing some operations during the processing (who starts the program, unloads the cassettes, aborts the program).

Ask password for reagent

management procedure

The software recognizes (through a password system) who is performing some operations during the reagent management (who replaces the reagents manually).

2.11 Set system date and time

From the HOME PAGE, go into the “Settings” screen and select “Date/time” (see figure below).

In the time setting window, it is possible to set the TIME ZONE, thus activating the automatic update of time during the year.

2.12 Set language

From the HOME PAGE, go into the “Settings” screen and select “Language” (see figure below).

Choose the language required from the drop down menu then press YES and the system automatically reboots to enable changes.

After changing this setting, please reboot the system.

Page 28

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

2.13 Load LOGOS ONE with wax

Log in as Administrator to switch on the Wax heating power and reset wax loading date. Enter in Reag./Cons. screen: a RED icon appears over the WAX CAVITY and the word Replace is RED.

Select the WAX CAVITY and press Replace reagent button (figure below).

The screen below appears, showing the WAX replacement procedure. Follow the procedure displayed on the screen.

A message reminds that this operation will reset WAX management count to zero. Press YES to confirm.

Page 29

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

HOW TO OPERATE:

Lift up the frontal panel

Lock the tube on the unit

Place the other end of the hose into a wax waste container

Turn the lever down to open

At the end of the discharge close the wax valve and remove the hose

Lift down the frontal panel

Open the right cover of LOGOS ONE and place paraffin in the cavity.

We suggest to clean the cavity with paper before insert new paraffin.

In LOGOS ONE it is possible to load solid as well as already molten new WAX.

It is necessary to fill the LOGOS ONE WAX CAVITY (right side cavity) with approximately 4kg of histology grade WAX.

MAX and MIN levels for the MOLTEN WAX are etched on the LOGOS ONE WAX CAVITY wall. Strictly maintaining the molten WAX level between these markings assures the appropriate coverage of all three cassette layers of the rack during process.

Page 30

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Wait until the new solid wax you have loaded has melted (100 minutes). If molten wax is loaded, the Wax status icon becomes yellow. Check the wax status (fully molten) and press “Set as ready” button.

2.13.1 Wax heating setting

From the “Settings” screen select the “Heating” button (left figure below) or from the “Main menu” select the

WAX icon on the status bar (right figure below).

The “heating settings” screen appears displaying information about the Heating Status and the Cavity Level. (Main processing chamber on the left and WAX chamber on the right in the same screen).

After the replacement, the software resets wax loading date automatically to the current date and turns WAX HEATING ON.

By default WAX reuse life is checked by number of days (maximum 14 days). If you want to change it, follow the instructions reported in the chapter 4.1.1.

Page 31

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Only when the WAX is ready for use (fully molten), the graph shows the lower level sensor as active (green/covered) and the maximum level sensor as inactive (red/uncovered), as shown in the figure above.

OTHER FUNCTIONS:

The Molten Time is a pre-set value. Milestone s.r.l. strongly recommends NOT to modify it. The maintaining temperature is a default value set according to Milestone s.r.l. standard programs. The modification of this value is only allowed under direct control of Milestone applicative support. LOGOS ONE software will indicate with an alarm if the WAX level is incorrect. See paragraphs 2.13 and 3.5 for how to manage the WAX, its reuse life and when proceeding with the WAX cleaning protocol. ADMINISTRATOR/SERVICE can modify all parameters of these fields; incorrect use of these settings may lead to system malfunction. Use only under direct control of Milestone s.r.l. technical support.

The WAX heating status icon indicates through a change in color the:

 WAX levels.  WAX “Temperature to maintain”.

The reagent status icon indicates status of WAX (and all the other reagents) and shows through a change

in color the reagent status based on n° of cassettes processed and/or cycles performed and/or expiration date. Please refer to chapter 4.

USER can only “Set as ready” the WAX (if allowed by the ADMINISTRATOR in the USER

Settings) when the WAX heating status icon becomes YELLOW and the “Set as ready”

button becomes active (see the figures below).

It is only possible to “Set as ready” the WAX when its temperature is 4°C lower than the

preset temperature value, so a process can be immediately started.

In any case, it is necessary that operator checks actual status of the WAX inside the CAVITY before setting “wax as ready”.

WAX is kept at this temperature when ON

Time to completely melt the WAX

WAX heating time remaining before use

WAX CAVITY stirrer speed

Restore WAX default settings

Page 32

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

2.14 Load LOGOS ONE with reagents

LOGOS ONE drawer hosts 9 tanks. It’s possible to use commercial tanks (already filled with reagents) or clean tanks (to be filled with reagents) which must be either supplied locally or purchased directly from the manufacturer. For details see Chapter 8: tanks 5 liters capacity (CODE 70170) and tanks 5 liters capacity xylene proof (CODE 70170F).

Milestone medical application staff suggests the following use of the tanks IF HistosMATE is not in use in the laboratory to clean the rack:

Milestone medical application staff suggests the following use of the tanks IF HistosMATE is in use in the laboratory to clean the rack:

It is possible to process up to 3 layers of the Split rack with 5 liters tanks and up to 2 layers with 1 US gallons (3.8 liters).

Do not insert tanks with a capacity lower than 3.8 liters because the reagent will be too much contaminated. Do not use tanks higher than 30cm because the length of the pipes will not be enough. See the chapter 2.14.1.

Tank nr.

Reagent type

Reagent name

Tank nr. 1

Fixative

Formalin\FineFIX®

Tank nr. 2

Flushing

Tank nr. 3

Rinsing reagent #1

Ethanol

Tank nr. 4

Dehydration

Ethanol

Tank nr. 5

Clearing

Isopropanol

Tank nr. 6

Clearing

Isopropanol2

Tank nr. 7

Cleaning

Cleaning Xylene\Isoparaffin (MileGREEN®)

Tank nr. 8

Cleaning

Cleaning Ethanol

Tank nr. 9

Cleaning

Cleaning Water

Tank nr.

Reagent type

Reagent name

Tank nr. 1

Fixative

Formalin\FineFIX®

Tank nr. 2

Flushing

Tank nr. 3

Rinsing reagent #1

Ethanol

Tank nr. 4

Rinsing reagent #2

Ethanol

Tank nr. 5

Dehydration

Ethanol

Tank nr. 6

Clearing

Isopropanol

Tank nr. 7

Clearing

Isopropanol2

Tank nr. 8

Cleaning

Cleaning Xylene\Isoparaffin (MileGREEN®)

Tank nr. 9

Cleaning

Cleaning Ethanol

Page 33

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

2.14.1 Set up LOGOS ONE with reagents

Select “Reag./Cons.” from the MAIN FUNCTIONS screen. In alternative, press directly the “Reagents status”

icon on the STATUS BAR of the HOME PAGE.

The REAGENTS CONFIGURATION screen appears (figure below), showing the default settings of the tanks. Select the tank in position NUMBER 1.

 Start set up of the tanks from hose number 1, as shown below.

It is necessary to first load the tanks with reagents before operating the unit.

Before continuing with next operations, open the drawer where the processing tanks have to be inserted.

Page 34

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Pipe number 1, 2, 4, 5, 7, 8 are provided with a RAPID CONNECTOR to simplify insertion/extraction. Just press the rapid connector to easily insert/extract any pipes from each tank, as shown below.

Pipe number 3, 6 and 9 are not provided with rapid connectors, they are the longest pipes with the possibility to simplify insertion/extraction without complete detaching of the pipe.

 Press the rapid connector corresponding to the tube number 1, as shown below.

 Choose the plastic ring suitable for the reagent you want to use in each position (in case of position

Nr. 1, Formalin is suggested) as follows: press “Reagents list” from the Reagents configuration screen, look to the color and the short name of the reagent (Formalin), then choose the corresponding plastic ring.

The PLASTIC RING that corresponds to Formalin reagent (position 1) is white with the short name “FOR”. Now insert it in the metallic pipe.

There are numbered stickers 1-9 on each pipe and their position.

It’s suggested to insert the Formalin tank in position number 1 and the Flushing tank in position number 2. TANK POSITION IS strongly suggested only for formalin and flushing. Other tanks can be positioned according to user’s preference request.

PRESS

HERE

Page 35

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

The image below shows the final configuration.

 Insert the tank containing fresh reagent (Formalin in this case) in the correct position (hose number 1

in this case), then insert the rapid connector in the corresponding position (number 1 in this case).

Milestone suggests to make manually an hole into the original cup of the tank, as shown below.

If you make an hole into the cup, it is required that the diameter hole is minimum 6mm larger than the metallic pipe.

Always check that you have properly entered the rapid connectors.

Plastic ring

Hole into the original

cup of the tank

≥3mm

Pipe

Cup’s hole

Page 36

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

 Only after positioning of the tank in the drawer, in the REAGENTS CONFIGURATION screen select

the tank in position NUMBER 1 and press “Fill the tank”.

 The following message appears, click YES. The screen on the right appears showing the REAGENT

REPLACEMENT PROCEDURE; press Done to confirm and follow the steps:

 Select the reagent to insert in the drop-down menu (Ethanol in this case).

Page 37

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

It is possible to insert in that field the REAGENT LOT CODE. This function is not compulsory. If a bar code reader is connected to LOGOS ONE, the code can be automatically read. If not, press the field window, a keyboard appears to allow entry of the LOT number.

When the code is inserted, the following screen appears: the lot number is shown into the field.

Press “Done” to complete the replacement

procedure.

The Lot Code is saved in the Reagents Log under “Log Book” icon.

The Lot Code is reported under the new column LOT CODE.

Lot code is not compulsory. So if not needed, follow the regular procedure to replace a reagent, by pressing “Done” without inserting any code before.

Refer to the chapter 6.3 to get instructions on how to export the Reagent log list.

Page 38

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Repeat the same procedure for all other tanks. Now you are ready to process.

TANK NUMBER

REAGENT

SHORT NAME

COLOR

Formalin

FOR

White

Flushing

FLU

Yellow

It’s required to insert the tanks with the order of the numbers showed in figure below. For example the tank referring to the tube number 3 and to the position number 3 (see the circle in figure below) must be inserted in the position 3 showed by the arrow below. The same concept is required for all the other tanks.

It’s required to insert the tanks with the orientation showed in figure below: the tank number 1 has the cup on

the right, not on the left (see the arrow). The same concept is required for all the other tanks.

The tanks as displayed by the software, with their numbers, short names and colors, correspond to the real tanks as positioned in the drawer with their plastic rings.

1 2 3 4 5 6 7 8 9

Page 39

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

2.14.2 Cleaning procedure for cleaning tanks

TO BE PERFORMED AFTER EVERY CHANGE OF CLEANING REAGENTS

 Reagents required: Xylene, Isoparaffin or substitute and Ethanol.  Purpose of cleaning: is performed on all CLEANING tanks that have potential contamination from WAX

residues.

 When to clean: to be performed EVERY TIME cleaning reagents are changed.  Removal of tanks: open the drawer, press the rapid connectors and extract the tanks to be cleaned.

Dispose of reagent according to lab practices appropriate for that reagent.

 Cleaning procedure: perform a rinse in Xylene or Isoparaffin or substitute (close tank and shake for a few

minutes), dispose of waste reagents and follow with two quick rinses in Ethanol.

 Reinstalling of tanks and reagent replacement: load tanks with fresh cleaning reagents, put the pipes,

then insert the tanks and the rapid connectors in the corresponding position. Complete replacement of reagent that resets reagent management counts.

2.15 Most used programs

This function allows inserting FAVOURITE programs in the HOME PAGE.

1. Press “Settings” from the MAIN FUNCTIONS screen and select “Set favourites”.

It’s required to execute the cleaning procedure when the cleaning tanks are not

commercial but either supplied locally or purchased directly from the manufacturer because it’s possible to reuse them several times.

When the cleaning tanks are severely contaminated on the basis of their use change them. Tank xylene proof CODE 70170F (for details see Chapter 8).

Page 40

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

2. Click on NOT DEFINED icon:

3. Select the CAVITY LEVEL, the PROTOCOL, the PROGRAM and the BUTTON COLOR to change

TEXT and BACKGROUND COLOR. Preview is displayed on bottom left.

4. Press Save Favourite to save changes.

5. The program icon is now listed in the Choose the Favourite to Set screen.

Page 41

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

If USER HOME PAGE is set as FAVOURITES (figure below left), press the button to return to the Main functions screen. If HOME PAGE is set as MAIN FUNCTIONS, press Favourites to open the FAVOURITES SCREEN (figure below right)

2.16 Owner settings

This function is available only for SERVICE and ADMINISTRATOR. Press Settings from the MAIN FUNCTIONS screen, then Owner.

The OWNER SETTINGS screen appears as shown in the picture below.

Page 42

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

GENERAL Select General to modify:

Institute and Department name where unit is installed. Reagent Cassettes Alert Status: this number indicates that the reagent status is near expiration (on the

base of the number of cassettes processed) and the reagents status icon turns from green to yellow (see chapter 4). Reagent Cycles Alert Status: this number indicates that the reagent status is near expiration (on the base of the cycles run) and the reagents status icon turns from green to yellow (see chapter 4). Reagent Days Alert Status: this number indicates that the reagent status is near expiration (on the base of the days of use) and the reagents status icon turns from green to yellow (see chapter 4).

VENTILATIONS Select Ventilations to manage exhaust fumes fans of cavity (working area) and tanks (holder), choose either:

Always active: both exhaust fans are activated at the switching ON of the unit. Always off: both exhaust fans are always OFF, even during the processing.

NOT SUGGESTED. Risk of fumes in the laboratory environment.

Processing and cover opening: the cavity ventilation is activated only during the processing and when

opening the covers while the tanks ventilation is always active.

REMOTE CONNECTION Select Remote connection to edit and modify the network settings for remote assistance.

Data required must be supplied by the Laboratory Network ADMINISTRATOR (Primary WINS not required).

FIXATION LIMITS Select Fixation limits to set Minimum and Maximum Fixation time. When enabled, before starting a protocol,

the software warns USER if the total fixation time is under or over the limits set and manages the Holding solution. Refer also to chapter 3.2.5 and 4.1.1.

RUN ID If Run ID is ticked, software requires user to enter the Run ID before running a program.

For further details see chapter 2.8.

Enable or disable Run ID check according to your internal laboratory practice (Good Laboratory Practice, GLP).

Page 43

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

RINSINGS Select Rinsings and set if user needs to:

 Load 1 or 2 rinsing tanks in the reagents configuration screen.  Modify rinsings’s processed cassettes limit.

VOLUME By default the settings is NORMAL, it is possible to lower or increase volume BUT for safety it is not possible

to totally silence it.

By default the Unit is set up to work with 1 rinsing tank. If you want to work with 2 rinsing tanks, please contact Milestone Application department to change the group of program.

Dehydration limit x2: this is a default value for the expiration of rinsing reagent, please don’t modify it. If you need more information please contact Milestone Application department.

Page 44

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

3 OPERATE WITH LOGOS ONE

LOGOS ONE is controlled by the Touch Control Terminal, which is a Windows CE 6.0 based. It is a rapid TISSUE PROCESSOR for histology laboratories that guarantees high standard results. It can be

used in automatic or in dual mode depending on the laboratory demands. The Resistance power output is automatically controlled by a PID (Proportional Integrative Derivative)

system, which allows the operator to set up the desired real parameters (Time and Temperature) by simply drawing a curve. If a pre-stored program is used, it is only required to adjust the time of the procedure in relation to the application specifications.

Thanks to the TIME at TEMPERATURE working procedures, LOGOS ONE allows consistency and reproducibility of high quality results. The unit will always reproduce the same conditions of temperature in the set times by automatically adjusting the Resistance power level.

LOGOS ONE has two cavities: a MAIN cavity and a WAX cavity. This feature allows user to run a process in two different ways:

- AUTOMATIC mode: wax will be automatically pumped from the WAX cavity to the MAIN cavity for the impregnation phase.

- DUAL mode: USER is required to MANUALLY move the RACK from the MAIN to the WAX CAVITY. A new process can immediately be started in the MAIN CAVITY without waiting for the end of the impregnation step. This allows for significant TIME SAVING.

The following section shows how to create, store, modify and run a program with the Touch Control Terminal.

3.1 Loading cassettes into the rack

The Split Rack is made by 3 separate layers; each layer holds 70 cassettes for a total of 210 cassettes (figure below). Load the 3 layers of the SPLIT RACK CODE 66165A/210 with cassettes. Each LAYER comes in a split design of two halves for simultaneous, convenient use in different grossing rooms and embedding stations. Each layer is provided with a locking mechanism (circles in figure below) to assure perfect closing of the two halves.

Fully load each layer with cassettes, starting from the bottom layer first and avoid random placement of cassettes over the three layers.

Start loading cassettes into a new layer only when the layer in use is full, thus avoiding a possible “low reagent” situation in the cavity.

Page 45

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Position the CASSETTE FIXING DISK on top of the last layer in use and load the rack into the LOGOS ONE.

3.1.1 Rack loading-unloading tool

Recommended to unload the rack at the end of the processing cycle, to avoid dripping of melted paraffin.

Recommended also to load rack with cassettes when it is wet, in order to avoid dripping of formalin or other solutions on the floor or on the LOGOS ONE unit.

The first rack layer must be blocked in that position:

Do not insert the layer from the column: this will avoid stirrer rotation.

The fixing disk must always be used, with either 1, 2 or full layer rack in order to avoid possible spilling out of cassettes from the rack during the processing.

If you position paper between the rack and the tool to keep it clean, remember to don’t

leave the rack dirty by wax up to the paper for many minutes because in that case the paper will be attached to the rack.

Page 46

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

3.2 Run a program

3.2.1 Run of the most used program

Select a Favourite program (figure below) out of the list of FAVOURITE PROTOCOLS (see chapter 2.15).

The following screen appears: enter the Run ID of the process to be run (if required).

The window below appears.

WAX and REAGENTS status bar: see chapter 4 how to manage them.

Page 47

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Enter the number of cassettes to be processed (see the figure below), up to 140 if two layers has been

selected (up to 210 for three layers). Press “Enter”.

The “Reagents” (in this case: “Eth-Iso”) and the “Program” (in this case “Up to 1mm”) are automatically

displayed, according to the Favorite protocol selected (figure below).

It is not possible to change the rack of a favourite program because the rack is set in the program, so pressing RACK SELECTION you will come back to the Home screen.

At the start of a non favourite program the software automatically remembers the last rack selected, if another rack model must be selected press RACK SELECTION and all the rack models will be displayed.

In this example, a 2 layers favourite was selected

- Rack Layer: 2

- Cavity Level: 2

Page 48

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Choose the Run Mode: AUTOMATIC or DUAL RUN.

A. AUTOMATIC: at the end of the last phase in the MAIN CAVITY, WAX is AUTOMATICALLY pumped

from the WAX CAVITY into the MAIN CAVITY.

B. DUAL RUN: at the end of the last phase in the MAIN CAVITY, an audio alarm warns USER to

MANUALLY move the rack from the MAIN to the WAX CAVITY, where WAX phase will be executed.

Choose the STARTING way: GO or GO DELAY (for details see chapter 3.2.6).

A. GO: the run is started immediately. B. GO DELAY: start of the run is delayed so that program automatically starts and is completed by the

time set by the USER.

The following screen appears. All the details of the process are shown, like the Run duration and the Completion time. Press “Start Run” to run the cycle NOW.

The following message appears, read carefully the message on the screen and press OK to start the process.

The heating fixation phase is included as default; if not required, select “Exclude” to skip

it. It’s suggested to include the heating fixation phase in the process to standardize the

results.

Page 49

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

In both AUTOMATIC and DUAL RUN modes, on completion of first reagent loading, a graph is displayed on the screen with detailed processing information, while the program is running. Refer to following paragraphs for run mode details: automatic or dual.

3.2.1.1 Automatic run mode

If AUTOMATIC run mode is selected, the following RUN SUMMARY screen appears, displaying all details of the process, like RUN DURATION and the COMPLETION TIME. Press Start run to run the cycle NOW.

On completion of first reagent loading, a graph is displayed on the screen with detailed processing information.

To assure safety of samples, in fact, it is necessary that operator stays close to the unit at the beginning of a new process until loading of the first reagent is completed and the graph is displayed on the screen.

WAIT…

LOADING COMPLETED

UNIT CAN NOW BE UNATTENDED

Page 50

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

GRAPH DISPLAYED DURING PROGRAM RUNNING

Picture on the left: EXECUTING PHASE NUMBER and NAME, phase graph with pre-set (blue) / real (red) temperature. Under the graph: PROTOCOL type, NUMBER OF CASSETTES processed, THICKNESS, RUN MODE and processing COMPLETION TIME.

For further information, press the arrow on the right of the MAIN CAVITY graph: Picture on the right: REAGENT TEMPERATURE, STIRRER SPEED, time DETAILS of the current phase

(highlighted in blue) and RUN DETAILS of the total program. On the bottom left all phases of the program are displayed with the completed or actual in blue.

To return to the left screen press the arrow in the top right.

If necessary in every moment it is possible to press ABORT to stop the program, unload reagent and cassettes (Extract the rack).

Page 51

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

An AUTOMATIC process ends with WAX impregnation performed in the MAIN CAVITY (left cavity and part of the screen, with PINK background), as shown below. In this case WAX is AUTOMATICALLY pumped from the WAX CAVITY (right) to the MAIN CAVITY (left).

An audio alarm warns when program is over; press Unload reagent, then Extract the rack.

After every WAX phase it is suggested to check the wax level (image above left), to be ready with the right quantity of wax in the next run.

Now press: Exit to perform later the MAIN CAVITY CLEANING CYCLE.

Start Cleaning to perform immediately the MAIN CAVITY CLEANING CYCLE.

Page 52

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

3.2.1.2 Dual run mode

If DUAL RUN run mode is selected, the following RUN SUMMARY screen appears, displaying process details, like RUN DURATION, COMPLETION TIME and also TIME TO MOVE THE RACK, that shows exactly when the presence of USER is required to MANUALLY MOVE THE RACK to WAX CAVITY (see below). Press Start run to run the cycle NOW.

On completion of first reagent loading, a graph is displayed on the screen with detailed processing information.

On completion of the process, it is necessary to carry out a MAIN CAVITY CLEANING CYCLE (for further information, see the chapter 3.3). Failure to do this, will prevent user from starting a new process in the MAIN CAVITY.

During the main cavity cleaning is not possible to use the unit for processing and it is

therefore suggested to run in parallel a wax cleaning cycle, by pressing the icon “Wax

cleaning” in the right part of the screen. The duration of the main cavity cleaning and the

wax cleaning is more or less the same.

Page 53

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

GRAPH DISPLAYED DURING PROGRAM RUNNING

For further information, press the arrow on the right of the MAIN CAVITY graph (green circle): Picture on the right: REAGENT TEMPERATURE, STIRRER SPEED, time DETAILS of the current phase

(highlighted in blue) and RUN DETAILS of the total program. On the bottom left all phases of the program are displayed with the completed or actual in blue.

To return to the left screen press the arrow in the top right (yellow circle).

At TIME TO MOVE THE RACK USER is required to MANUALLY MOVE THE RACK to WAX CAVITY (RIGHT).

Last phase of a DUAL process is WAX impregnation performed in the WAX CAVITY (right cavity and part of the screen, with YELLOW background), as shown below. An audio alarm warns that program is over; press Extract the rack.

If necessary in every moment it is possible to press ABORT to stop the program, unload reagent and cassettes (Extract the rack), refer to chapter 3.2.1.1.

Page 54

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

3.2.2 Run a standard program

Press PROCESSING from the MAIN FUNCTIONS screen. For further details refer to chapter 3.2.1.

The following screen appears: enter the Run ID of the process to be run (if required).

After MANUAL movement of the rack to the WAX CAVITY, the DUAL mode allows USER to immediately start a new process (AUTOMATIC or DUAL) in the MAIN CAVITY, without waiting for the end of the WAX phase of the previous process run.

DUAL mode does NOT require a final MAIN CAVITY CLEANING CYCLE, as requested instead by the AUTOMATIC mode. In fact, in this case, WAX phase is directly performed in WAX CAVITY, leaving the MAIN CAVITY uncontaminated by WAX.

Should the operator not be present at TIME TO MOVE THE RACK, AFTER 10 MINUTES THE DUAL PROCESS TURNS TO AUTOMATIC and WAX is AUTOMATICALLY pumped into the MAIN CAVITY to keep samples safe. For further details see the chapter 3.2.3.

Page 55

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

The window below appears.

The window shown below appears, enter number of cassettes (60 in this case) to be processed: up to 140 two layers would be selected, up to 210 three layers. Press “Enter”.

In the example, 60 cassettes have been selected, so the software automatically sets a process of 2 layers rack and the following posts appear (figure below):

- Rack Layer: 1

- Cavity Layer: 2 (Default)

At the start of a program the software automatically remembers the last rack selected, if another rack model must be selected press RACK SELECTION and all the rack models will be displayed.

Page 56

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

To force the cavity level press the Cavity icon, as shown below. The following screen appears.

It is possible to force the cavity level at an upper level, as indicated in the previous figure, even if the number of cassettes is only 60.

Refer to chapter 3.2.5.1 for further details.

Normally the software automatically sets a process with: SPLIT RACK

 “Rack Layer: 1” – “Cavity Level: 2” if from 1 to 70 cassettes are inserted  “Rack Layer: 2” – “Cavity Level: 2” if from 71 to 140 cassettes are inserted  “Rack Layer: 3” – “Cavity Level: 3” if from 141 to 210 cassettes are inserted

SUPERMEGA RACK

 “Rack Layer: 1” – “Cavity Level: 2” if from 1 to 12 supermega cassettes are inserted  “Rack Layer: 2” – “Cavity Level: 3” if from 13 to 24 supermega cassettes are inserted

RB300 (Random Basket 300)

 “Cavity Level: 3” if from 1 to 300 cassettes are inserted

Therefore when using:

 SPLIT RACK, it is possible to force the Cavity Level at 3 (when starting a program with Cavity Level 2),  SUPERMEGA RACK, it is possible to force the Cavity Level at 3 (when starting a program with Cavity

Level 2),

 RB300, it is NOT possible to force the Cavity Level because it only works with 3 layers of reagent,

It is possible to force an upper custom level at the start of a standard program. This function is NOT available when starting a Favourite program. Below the instructions.

When starting a program in “Delay Mode”, it is possible to add extra cassettes during the pre-soaking phase, as explained in the chapter 3.2.5 (remember that it is possible only in

this phase). The number of cassettes, that is allowed to add, depends of the “Cavity level”

of the process.

If you insert a number of cassettes that corresponds to “Cavity level: 2”, it will be possible

to force the cavity level only to 3 layers.

The programs available will be that of the layer chosen, so it won’t be possible to start a ONE LAYER program if the TWO LAYERS is forced

Page 57

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

If you select a CUSTOM level (for example “Cavity Level: 2” as shown below), the color displayed is orange.

The following description will be performed by using the “Cavity level: 2 (Default)”. When you insert the number of cassettes, the following screen appears. Choose the “Reagents” (for example “Eth-Iso”) and the “Program” (in this case “UP TO 1mm”), as shown below. The following screen appears.

To run the process follow the instructions reported above, in the chapter 3.2.1.

3.2.3 Run two processes simultaneously

In DUAL RUN mode (described in the chapter 3.2.1.2), an audio alarm warns the operator that the last phase in the MAIN CAVITY has been completed.

1. The following screen appears, with an audio alarm that requires USER to press OK to unload the reagent from the MAIN CAVITY.

A. If operator presses OK, immediately the UNLOADING of the last reagent starts. B. If operator does not press OK, the UNLOADING of the last reagent AUTOMATICALLY starts after 4

minutes.

When running parallel processing, it is required to perform the pre-soaking outside the unit. Refer to chapter 9.6 for Presoaking guidelines.

Page 58

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

2. On completion of the UNLOADING (and of vaporization, if required by the program in use), it is necessary to MANUALLY move the RACK from the MAIN CAVITY to the WAX CAVITY. A message with an audio alarm warns the operator:

A. If operator does not press OK within 3 minutes, WAX is automatically loaded in the MAIN CAVITY.

Removal of the rack must be done within 3 minutes. Should this not be done, the system AUTOMATICALLY pumps WAX in the MAIN CAVITY to preserve samples.

If the RUN MODE becomes AUTOMATIC, after it is required to run a MAIN CAVITY CLEANING.

B. If operator presses OK this message appears with an audio alarm:

A. If operator presses OK, WAX IMPREGNATION starts immediately IN WAX CAVITY. B. If operator does not press OK, after 1 minute WAX IMPREGNATION starts IN WAX CAVITY.

NOW MOVE MANUALLY THE RACK IN THE WAX CAVITY (right).

Page 59

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

While the WAX phase is running in the WAX CAVITY, it’s possible to start a new process in the MAIN

CAVITY, as shown below. During the WAX impregnation phase in wax cavity, 3 icons are displayed on the left screen as shown above.

It’s possible to start a new process in the MAIN CAVITY. Press:

 Processing: to run a standard or a modified protocol, as described in the chapter 3.2.2.  Favourites: to run a Favourite protocol, as described in the chapter 3.2.1.  MAIN CAVITY Cleaning: to run a cleaning of the MAIN CAVITY, as described in the chapter 3.3.

3.2.4 Run a program using the STEP START function

In the starting screen listing all process details (“Run Summary”), select the starting phase you require, as

shown below.

In the example, “Ethanol” is selected as the starting phase (so, phase number 5), and then press “Start Run”.

It is not required to clean the main cavity because the wax is not moved in case of dual run.

The software automatically calculates the WAX availability.

If WAX must be cleaned after this run the software automatically calculates WAX cleaning program time and wax availability.

Page 60

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

3.2.5 Run a DELAYED PROGRAM

The window below appears, if either a Favorite program (see chapter 3.2.1) or a Standard program (see chapter 3.2.2) is selected. Enter the exact number of cassettes in the box, choose if fixation phase must be excluded or not, select the Run Mode and press “Go delay”.

The following window appears: set the completion time. In fact, “Delay Start” function allows setting when the

program has to finish, without modification of the existing protocol. The system keeps samples immersed in:

• Pre-soaking reagent (formalin at room temperature)

• Holding reagent (flushing mix at room temperature)

By default Pre-soaking reagent is selected, if you want to keep the specimens immersed in Holding solution, select its icon.

If you leave selected “Pre-soaking” (see above that is thicked by the arrow ) as reagent to keep the specimens: the “Holding time” is zero.

If you press the grey arrow (figure above, yellow circle), the fixation protocol details are displayed:

• “Pre-soaking time”: it depends on the starting time to complete the processing as set by user.

• “Fixation time at temperature”: the duration of the heated fixation phase of the protocol.

• “Total fixation time”: the sum of the two times above.

If you select “Holding” (see below that is thicked by the arrow ) as reagent to keep the specimens:

See the chapter 4.1.1 to set Pre-soaking and Holding reagent.

Page 61

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

the “Holding time” is NOT zero (as the previous case), but it depends on the starting time to complete the

processing as set by user. The “Holding time” is indicated by the figure above left, yellow circle.

If you press the grey arrow (figure above right, yellow circle), the fixation protocol details are displayed:

• “Pre-soaking time”: it is zero because “holding” is the reagent set to keep the specimens, not pre-

soaking.

• “Fixation time at temperature”: the duration of the heated fixation phase of the protocol

• “Total fixation time”: the sum of the two times above.

By selecting “Enable Limits” and entering Min and Max fixation times (see chapter 2.16 and figure below

right), when starting a program the system calculates the time necessary to keep samples in HOLDING SOLUTION (default reagent Flushing MIX). In fact, on the base of the:

-external time in fixative (value entered by user, requested only if fixation limits are enabled)

-fixation time at temperature (value set in the program)

the software calculates by difference the necessary pre-soaking time to reach the Max fixation limit set. Moreover software keeps samples in HOLDING SOLUTION up to the start of the program.

When enabling the control of the “Total Fixation Time” in “Owner Settings”, the

specimens will be automatically kept in pre-soaking reagent and, only in case the Total fixation time is exceeded, the holding reagent will be used, as explained below in detail.

Page 62

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Please refer to chapter 4.1.1 for how to set the reagent to be used as PRESOAKING and HOLDING.

3.2.5.1 Add extra cassettes

When starting a program in “Delay Mode”, it is possible to add extra cassettes during the pre-soaking or holding phase, as explained in the chapter 3.2.5.

The number of cassettes, that is allowed to add, depends of the “Cavity level” of the process. In the example reported in this chapter, the “Cavity level” is “2” and so it will be possible in the pre-soaking or holding phase to add cassettes up to 140 cassettes (here 50 cassettes have been selected and so only 90 cassettes is allowed to add to arrive at 140 cassettes).

Pressing “Add extra cassettes”, the right screen appears: enter number of cassettes to be added and press

OK to continue processing.

Failure to press the OK button, automatically the software will continue the processing after 30 minutes of pausing adding the cassettes entered.

This function is active ONLY in the pre-soaking or holding phase of a DELAYED PROGRAM.

It is possible to open the cover without any alarm.

The formalin is not unloaded in the tank, it remains in the cavity without heating.

Page 63

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

At the start of a program it is possible to force an upper cavity level, if more cassettes are required to be inserted, press the Cavity icon, as shown in the circle below. The following screen appears.

Refer to chapter 9.6 Presoaking guidelines. Refer to chapter 3.2.2 for how to force an upper custom level at the start of a program.

 If you press “Set to 2 (CUSTOM)”, the process will be executed with 2 levels of reagents and so it will be

possible to add cassettes to fill 2 layers of the rack. The tag “CUSTOM” means that the cavity level chosen (“2” in this case) does NOT correspond to the rack layer.

 If you press “Set to 3 (CUSTOM)”, the process will be executed with 3 levels of reagents and so it will be

possible to add cassettes to fill 3 layers of the rack. The tag “CUSTOM” means that the cavity level

chosen (“3” in this case) does NOT correspond to the rack layer.

3.2.6 Add WAX

While the wax cavity is not active there is a button ADD WAX, in case the level of wax is low, it is possible to add it. Pressing also the button ADD WAX a timer of 20 minutes starts allowing the new wax added melting. The wax icon change the color from RED (low level) to YELLOW (melting time) to GREEN when the 20 minutes melting time is reached. If already totally melted before the end of the 20 minutes, it is possible to set it AS READY having immediately the green color.

Page 64

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

3.2.7 Screen saver

When the LOGOS ONE is running after 5 minutes of inactivity the screen saver comes out automatically. It is possible to recall it in every moment pressing the icon on the status bar.

The screen saver gives very useful information during a program: for example when a cavity is free for a new process is written “ready for new process”.

To exit from the screen saver simply touch the screen and insert the access password. This is a very useful function for samples and user safety.

Page 65

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

3.3 Run a cleaning cycle of the main cavity

At the end of an automatic process (see the chapter 3.2.1.1), it is required to carry out a MAIN CAVITY CLEANING, as this has been filled with WAX. Unload the reagent and extract the rack by pressing the corresponding icons in the figure below (yellow circles); download the cassettes and start the cleaning protocol in the processing screen, press START CLEANING and run directly a cleaning program.

The CLEANING REAGENTS set in the Group of Programs page (SERVICE ONLY) are the only one that are visualized in the cleaning page.

Choose the default program according to the cleaning reagents loaded in the REAGENT CONFIGURATION: Only one program can be chosen by default and will be the one that starts automatically after an automatic run that moves the paraffin in the main cavity. All the calculation for cavity availability are done on that cycle duration.

The CLEANING REAGENTS set in the Group of Program page are the only one that are visualized in the cleaning page.

Only one program can be chosen by default and will be the one that starts automatically after an automatic run that moves the paraffin in the main cavity.

The same for the Wax Cleaning cycle, only one is set by default and all the calculation for wax and chambers availability are done on that cycle.

Page 66

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Rack CANNOT be positioned inside the cavity when running the “FAST” cleaning cycle,

but it must be cleaned outside the cavity.

The cleaning procedure based on the 2 tanks cleaning reagents (“Isopar-Eth” or “Xyl-Eth”) is suggested when all other 7 tanks positioned in the LOGOS ONE drawer are already in use for processing, and this makes impossible the use of 3 tanks for cleaning.

To start the cleaning cycle later, press “Exit” and go to the Main menu. When ready to start the cleaning cycle, press “Cleaning” from the Main Menu, then “Main cavity cleaning”. Only one program can be chosen by default and will be the one that starts automatically.

The same for the Wax Cleaning cycle, only one is set by default and all the calculation for wax and chambers availability are done on that cycle.

3.3.1 Tanks for process and main cavity cleaning

CASE 1:

- HistosMATE available to clean the rack only 2 cleaning tanks required AND

- Specimens to be processed include big routine samples  2 isopropanols are required in overnight run

In this case it is suggested to choose: GROUP WITH 2 RINSINGS

TANK NR.

TANK REAGENT

REAGENT

FORMALIN

FLUSHING MIX

ETHANOL from 60% to 70%

RINSING 1

ETHANOL 100%

RINSING 2

ETHANOL 100%

ETHANOL

ETHANOL 100%

ISOPROPANOL

ISOPROPANOL 100%

ISOPROPANOL 2

ISOPROPANOL 100%

CLEANING ISOPARAFFIN or XYLENE

ISOPARAFFIN or XYLENE

CLEANING ETHANOL

ETHANOL from 96% to 100%

It is also possible to clean the rack (WITHOUT cassettes) inside the Main cavity, for further information see the chapter 7.2.1.

If you perform a cleaning cycle with 3 tanks, “Isopar-Eth-Water” or “Xyl-Eth-Water”, it’s required to use a clean tank (to be filled with tap water), which must be either supplied locally or purchased directly from the manufacturer (for details see Chapter 8).

If you perform a cleaning cycle with only 2 tanks, “Isopar/Eth” or “Xyl/Eth”, without the step of water, at the end of the cleaning protocol it is required to dry the Main cavity using paper towel.

If you perform a cleaning cycle with only 2 tanks, without the step of water, make sure to leave the Main cavity cover open for at least 30 minutes before starting a new processing run.

Page 67

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

CASE 2:

- HistosMATE available to clean the rack only 2 cleaning tanks required AND

- Specimens to be processed include only little samples

In this case it is suggested to choose: GROUP WITH 2 RINSINGS

TANK NR.

TANK REAGENT

REAGENT

FORMALIN

FLUSHING MIX

ETHANOL from 60% to 70%

RINSING 1

ETHANOL 100%

RINSING 2

ETHANOL 100%

ETHANOL

ETHANOL 100%

ISOPROPANOL

ISOPROPANOL 100%

ISOPROPANOL (spare)

ISOPROPANOL 100%

CLEANING ISOPARAFFIN or XYLENE

ISOPARAFFIN or XYLENE

CLEANING ETHANOL

ETHANOL from 96% to 100%

CASE 3:

- HistosMATE NOT available to clean the rack 3 cleaning tanks required AND

- Specimens to be processed include big routine samples  2 isopropanols are required in overnight run

In this case it is suggested to choose: GROUP WITH 1 RINSING

TANK NR.

TANK REAGENT

REAGENT

FORMALIN

FLUSHING MIX

ETHANOL from 60% to 70%

RINSING 1

ETHANOL 100%

ETHANOL

ETHANOL 100%

ISOPROPANOL

ISOPROPANOL 100%

ISOPROPANOL 2

ISOPROPANOL 100%

CLEANING ISOPARAFFIN or XYLENE

ISOPARAFFIN or XYLENE

CLEANING ETHANOL

ETHANOL from 96% to 100%

CLEANING WATER

WATER

Page 68

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

CASE 4:

- HistosMATE NOT available to clean the rack 3 cleaning tanks required AND

- Specimens to be processed include only little samples

In this case it is suggested to choose: GROUP WITH 1 RINSING

TANK NR.

TANK REAGENT

REAGENT

FORMALIN

FLUSHING MIX

ETHANOL from 60% to 70%

RINSING 1

ETHANOL 100%

ETHANOL

ETHANOL 100%

ISOPROPANOL

ISOPROPANOL 100%

ISOPROPANOL (spare)

ISOPROPANOL 100%

CLEANING ISOPARAFFIN or XYLENE

ISOPARAFFIN or XYLENE

CLEANING ETHANOL

ETHANOL from 96% to 100%

CLEANING WATER

WATER

3.4 Reagents group and programs

The system allows (ONLY TO SERVICE PERSONNEL) to select the Group of programs, the Reagents for Processing and for Cleaning and the Special Programs, that are visualized and /or hidden in the unit.

LOGOS ONE Default

GROUP OF PROGRAMS: Group 101 /1 rins REAGENTS PROCESSING: Eth – Iso REAGENTS CLEANING: Isopar – Eth SPECIAL PROGRAMS: none

Isopropanol and isopropanol2 are the same reagent but they are named in different ways because used in different phases with different properties.

Page 69

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

3.5 Run a cleaning cycle of the WAX

WAX for expiration is controlled using the REAGENT LIST.

By default it is checked for “Expiration date”: 14 days, but the Administrator can change the setting in the

Wax settings of the reagents list.

WAX for cleaning is controlled under the icon WAX CLEANING. From this icon there are the WAX cleaning setting and also the possibility to run the cleaning cycle.

By default WAX for cleaning is checked for “Performed cycles”: 5 cycles, but the Administrator can change the setting in the WAX cleaning window. The cleaning cycle will block the starting of a processing run, if the cleaning setting limits are reached.

There are the “traffic lights” colors for cleaning or expiration, green, yellow and red, but the message on the

WAX cavity will be different, TO CLEAN when the WAX reaches the CLEANING limit (it takes 90 minutes):

The cleaning cycle will block the starting of a processing run, if the cleaning setting limits are reached.

Page 70

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Another way to run a “Wax cleaning” protocol is to select “Cleaning” from the MAIN FUNCTIONS screen and

then “Wax cleaning”, as shown below.

When a wax cleaning cycle has been COMPLETED, the wax values reported in the Reagent Configuration screen under the WAX cleaning icon (number of cassettes processed, performed cycles and loading date) are RESET to zero but not the EXPIRATION LIMITS in the reagent configuration screen.

DO NOT load LOGOS ONE rack during the “WAX cleaning procedure”.

Wax must be completely replaced (and NOT cleaned) at least twice a month, depending on the use of LOGOS ONE. See the chapter 2.13 for the wax replacement procedure.

REPLACE when the WAX reaches the EXPIRATION limit:

Page 71

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Refer to chapter 2.13 Load LOGOS ONE with wax.

3.6 Retrieving saved processes

Select “LOG Book” button from the MAIN FUNCTIONS screen (figure below) then select “Saved Runs”.

The following screen appears (figure below) showing on the left all the SAVED PROCESSING FILES, sorted by DATE. The dates are automatically created by the software.

Select one date (in the example below “4-Sep-2014”) and the cycle(s) saved that day will appear on the right.

WAX exchange resets to zero also WAX cleaning counters.

If WAX must be cleaned after a program the software advises to clean it at the end of the last wax available program.

Page 72

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

File names indicate type of program and cavity where ended.

FINISH

TYPE

Date

End time

M= finished in MAIN CAVITY

Nothing= processing

W= finished in WAX CAVITY

Cleaning= cleaning program

Page 73

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Click on the file name to see the details. Press Open to visualize the graphs of the highlighted file (figure above).

Click the icons (figure below) to see the graphs of the different saved processing PHASES. Heated phases graphs show up to 2 colored lines, describing the PRESET TEMPERATURE (blue) and the REAL TEMPERATURE (red) output values about the current step (In this case: Fixation). Not heated phases graphs show only 1 colored line, the REAL TEMPERATURE red. Details are directly explained on the graph.

Press Protocols details to see them, if required.

Press Phase details to see them, if required.

Page 74

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Press the icon to go back to the Saved processing screen.

3.6.1 How to delete a saved process

Select a Date and press Delete to cancel all processes saved that day (left figure). Select a Process and press Delete to cancel ONLY the process highlighted (right figure).

Alternatively press Delete All to cancel ALL programs stored on LOGOS ONE. Press HOME to return to the MAIN MENU.

3.7 Modify a program

DEFAULT PROTOCOLS: the Owner is MILESTONE and USER can only COPY them. USER PROTOCOLS: the Owner is USER and he can MODIFY, DELETE and COPY them (if any).

This function is NOT to create a NEW PROGRAM. For this, it is necessary to choose the default program that most fits your requirements, make a copy and modify its details.

Before making any modifications to a program, please contact our Application support:

[email protected].

Modification of a USER’s protocol does NOT require copying it before making the changes

required.

Take care to modify ONLY the Time At Temperature part of the curve. Do not modify the Ramp - up time.

Page 75

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

3.7.1 Modify a standard program

Select Programs button from the MAIN FUNCTIONS screen. SEE NEXT PAGE FOR PICTURES:

1. This screen lists all the existing programs divided by REAGENTS.

2. Select the REAGENT PROGRAM to be copied.

3. Select the PROGRAM to be copied, then press Copy.

4. The copy program screen is open.

5. RENAME the program using the keyboard and press enter.

6. Choose the parameters to be modified.

7. To ADD a step, select the last step, then press ADD. To DELETE a step, select it, then press

DELETE.

8. Modify the PHASE DETAILS.

9. Press HOME button and YES to save changes.

10. Choose the REAGENT PROGRAM just modified, your protocol is saved there.

Page 76

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

3.7.2 Correlation between racks and programs

At the star of a program, programs proposed by the software are related only to the selected rack.

In the “Modify program” section it is possible to change the association between a program and the rack,

following this logic:

LAYERS

LOGOS ONE

CAVITY LEVEL AND RACK

NOT PRESENT

-Split RACK (1 – 140 cassettes)

-Super Mega RACK (1 – 12 cassettes)

The max number of phases in a process is 15. The max number of steps in a phase is 10. The max length of a step is 24 hours. Consequently the max length of a phase is 240 hours.

It is not possible to set temperatures out of this range: 20-85°C during a program modification.

Page 77

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

-Split RACK (141 – 210 cassettes)

-Super Mega RACK (13 – 24 cassettes)

-RB 300 (1-300 cassettes)

Because of the correlation between rack and program also a favourite program is correlated to one rack, that is automatically selected in the favourite program. In the following example a favourite program for SuperMega rack (SM) is set, so when the favourite is started automatically the rack type is selected.

If a change of rack is necessary, it means that the program selected is not correct, pressing RACK SELECTION, the Home Page is shown.

Page 78

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

3.7.3 Modify a main cavity cleaning program

Select Cleaning from the MAIN FUNCTIONS screen, then press Modify Cleaning Program.

The following screen appears (figure below left), showing all existing programs for the MAIN CAVITY (on the left) and for the WAX (on the right): default protocols as well as protocols created by the USER (if any).

Choose the program of your interest (figure below right, arrow). Press Copy button (figure below right, rectangle), re-name the program and modify the fields.

This function is NOT to create a NEW PROGRAM. For this, it is necessary to choose the default program that most fits your requirements, make a copy and modify its details.

Before making any modifications to a cleaning program, please contact our Application support: [email protected].

For optimum CLEANING RESULTS, Milestone strongly recommends using the CLEANING default programs.

For safety reasons, the factory pre-stored protocols cannot be directly modified or deleted.

Page 79

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

3.7.4 Modify a WAX cleaning

Select Cleaning from the MAIN FUNCTIONS screen, then press Modify Cleaning Program. The screen on the right appears, showing the existing cleaning programs for the MAIN CAVITY(on the left)

and for the WAX (on the right): default protocols as well as protocols created by the USER (if any). Choose the program of your interest (figure below, arrow). Press Copy button (figure below, rectangle), re-

name the program and modify the fields.

Take care to modify ONLY the Time At Temperature part of the curve. Do not modify the Ramp - up time.

The Modify and Delete buttons are made available only for already copied protocols.

For safety reasons, the factory pre-stored protocols cannot be directly modified or deleted.

The Modify and Delete buttons are made available only for already copied protocols.

Take care to modify ONLY the Time At Temperature part of the curve. Do not modify the Ramp - up time.

Page 80

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

4 REAGENTS MANAGEMENT

4.1 Reagents reuse life

Select “Reag./Cons.” from the MAIN FUNCTIONS screen or press directly the “Reagents status icon” on the STATUS BAR of the HOME PAGE.

The REAGENTS MANAGEMENT window appears, showing the settings and the status of all the reagents loaded in the unit (Wax included). It is possible to check the reagents STATUS by selecting the relative TANK (or WAX CAVITY) in the upper part of the screen.

The PARAMETERS of the reagent selected are shown in details (figure below) on the lower part of the screen.

Page 81

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

The REUSE LIFE (red square, figure above, for further details see the chapter 4.1.1) of the reagent can be checked by:

1. Expiration Date. This date shows the reagent EXPIRING DATE, according to requirements set into the Reagent List.

2. Performed cycles. This field automatically shows the cycles already completed.

3. Processed cassettes. This field automatically shows the cassettes already processed.

Additional information is shown on the right side of the windows (green square) and refers to the REAGENT SETTINGS edited into the “Reagent list” (figure above, arrow).See chapter 4.1.1 for further clarifications.

4.1.1 Reagents settings

From the REAGENT CONFIGURATION, select the “Reagent List” icon: the LIST of preset reagents appears.

Default reagents settings of LOGOS ONE (expiration date, max number of cassettes and max number of cycles) refer to use of tanks of 5 liters/US gallons capacity and to processing without papers and sponges. In any other case, like use of different tanks capacity or use of sponges, please contact our Application Dept at

[email protected] to get proper instructions.

Page 82

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

REUSE LIFE of each reagent can be defined using the check boxes (see figure above on the right, yellow square): Check the expiration date. Tick this box to check the reagent expiration date, according to your requirements. Check the performed cycles. Tick this box to check the maximum number of cycles to be carried out with the reagent in use. Check the processed cassettes. Tick this box to check the maximum number of cassettes to be processed with this reagent. Use for PRE-SOAKING phases. Tick this box to set the reagent to be used as PRE-SOAKING reagent (refer to chapter 3.2.5). Use for HOLDING phases. Tick this box to set the reagent to be used as HOLDING reagent (refer to chapter 3.2.5).

Use for FLUSHING phases. Tick this box to set the reagent to be used as FLUSHING reagent. Use for RINSING phases. Tick this box to set the DEHYDRATION reagent to be used also as RINSING

reagent. Click on the relative Check boxes to activate the settings described above (points 1,2,3 in the chapter 4.1)

regarding date of next change, number of maximum processing runs and/or processed cassettes performed with any reagent, so that the system automatically warns before the process starts.

“Add” a new reagent or “Delete” it (figure below, yellow square) by pressing on the relative icon. Every new added reagent can be used for any phase. Once added, it is possible to set the reagent’s short name, color, check its expiration date, its performed cycles and its processed cassettes and set the maximum values.

4.1.2 Recommendations for reuse life

The following recommendations are conceived as a guideline to ensure quality processing.

For safety reasons, factory pre-stored reagents cannot be deleted.

Default reagents settings are factory set, to assure optimal results. Don’t modify them. For any possible clarification or any request for assistance please contact either our application support: [email protected] to get proper instructions.

Page 83

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

REAGENT CHECKED FOR:

REAGENT

MAX

DAYS

MAX

CYCLES

MAX CASSETTES

5lt tanks

MAX

CASSETTES

3.8lt tanks

USE FOR

Flushing MIX

840

672

Holding/Flushing

WAX exchange

840

WAX cleaning

7 5 420

420

FineFIX

1000

800

Formalin

1000

800

Presoaking

Ethanol

420

336

Rinsing

Prowave

420

336

Prowave2

550

440

Isopropanol

420

336

Isoparopanol2

550

440

JFC

550

440

Xylene

630

504

Isoparaffin

630

504

Cleaning Ethanol

\ \

Cleaning Isoparaffin

\ \

Cleaning Water

\ \

Cleaning Xylene

\ \

The REAGENTS SETTINGS makes the REAGENTS STATUS icon turn from GREEN to YELLOW to RED, depending on the remaining reuse life of the reagents (for example 1 day, 1 cycle and/or 1 full cassette rack, as described in the chapter 2.16).

Example, if reagent cassettes alert status is set at 210 and a reagent checked for the processed cassettes has a limit of 630, the REAGENTS STATUS icon is green until 419 cassettes (one full rack before reaching the limit); then turns to yellow from 420 to 629 and then to red at 630 cassettes. When RED, processing cannot be launched. Reagent status icon with different colors is shown below.

4.2 Reagents replacement procedure

4.2.1

Handle with care and store in a cold dry space using a tightly closed container. Vapors may collect in empty containers. Treat empty containers as hazardous. Waste material should be disposed of in an approved incinerator or in a designated landfill site, in compliance with all federal, provincial and local government regulation. Some reagents can have potential health effects and cause environmental pollution if not correctly disposed. For further information please refer to the MSDS (Material Data Safety Sheet) provided by your supplier.

In case a reagent is used in at least 2 tanks, only when it has expired in all the tanks where this is in use, the reagent status icon becomes red. For the correct use of tanks please refer to chapter 2.14.

Page 84

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

4.2.2 Reagent NOT USED FOR RINSING

When a reagent NOT used for rinsing has expired its reuse life (in this case: number of processed cassettes), a RED symbol appears over the corresponding tank and the word REPLACE blinks in red. The reagents STATUS ICON also turns from green to RED (figure below).

Select Reagents from the MAIN FUNCTIONS screen. In alternative, press directly the Reagents status icon on the STATUS BAR of the HOME PAGE. The REAGENTS CONFIGURATION screen appears (figure below). automatically the expired tank in position NUMBER 2 blinks. Select the EXPIRED reagent (in this case Flushing MIX) and press the Replace Reagent button (figure below).

Click YES on the message displayed and the screen on the right appears showing the REAGENT REPLACEMENT PROCEDURE. Follow the steps written below:

Remove the EXPIRED TANK from the position indicated by the software (number 2 in this case) and press Done (see next figure) to confirm.

Before continuing with next operations, open the tanks holder doors where the processing tanks are inserted.

Page 85

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Dispose of the exhausted reagent. Load the tank with the FRESH REAGENT (Flushing MIX in this case). Put the tank containing fresh reagent into the position indicated by the software (number 2 in this case).

Select the reagent in the drop-down menu. The software, as a default, suggests filling with the same reagent already loaded into the tank. To load a different reagent, select it from the drop-down menu (figure below, circle). Press Done to confirm and return directly to the REAGENT CONFIGURATION screen.

Close the tanks holder doors and check the reagent level (working label). Settings are automatically saved by the software. After the replacement, the software resets the reagent management count to zero and the loading date

automatically changes to the current date (figure below). The reagents status icon also turns from red to GREEN (figure below).

The software always suggests the last reagent loaded.

Make sure tank fitting is correctly inserted in its relative housing, and that the tank is aligned with the others.

Page 86

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

4.2.3 Reagent USED FOR RINSING

When a reagent USED ALSO for rinsing (in this case Ethanol) has expired its reuse life (in this case the number of processed cassettes) a RED symbol appears over the ETHANOL reagent BUT the word Replace blinks in red over the RINSING 1 reagent.

1. Select the blinking RINSING 1 reagent and press the Replace Reagent button (see figure below).

2. Follow the procedure how to replace the reagent described in chapter 4.2.1.

3. After the replacement, the software resets the reagent management count to zero and renames the

old RINSING1 reagent as new DEHYDRATION reagent (figure below). The software renames the other tanks containing the reagent used also for rinsing as Rinsing 1 reagent and Rinsing 2 reagent, according to the number of cassettes already processed.

This procedure has been conceived to increase shelf life of Ethanol allowing more use as Rinsing despite the expiration as dehydration reagent.

At the end of the procedure it is possible to check the correspondence between the tanks as diplayed by the software, with their numbers, names and colors, and the real tanks as positioned inside the drawer.

Page 87

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

4.2.4 Change reagents during a WAX phase

During a WAX phase, both in MAIN and WAX cavity, it is now possible to perform the reagents replacement procedure from the “Reagents status” icon on the STATUS BAR.

The icons that are active are colored, the inactive are grayed out.

During the reagents replacement procedure, a padlock appears on the WAX tank because it is the only reagent in current use and cannot be changed until the wax is completed.

In this way during the WAX phase it is possible to change the other reagent tanks and start a new run in the main cavity.

Page 88

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

4.3 Wax replacement procedure

When WAX needs to be changed because heavily contaminated, dirty or smells of alcohols that a WAX standard cleaning cycle (see the chapter 3.5) cannot eliminate, replace it as follows:

1. If WAX reuse life has expired, a RED icon appears over the WAX CAVITY (REAGENT

CONFIGURATION screen) and the word Replace is RED. Select the WAX CAVITY and press Replace reagent button (figure below).

2. The screen below appears, showing the WAX replacement procedure. Follow the procedure

displayed on the screen.

A message reminds that this operation will reset WAX management count to zero. Press YES to confirm.

Page 89

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

HOW TO OPERATE A. Lift the front panel.

B. Lock the tube on the unit as shown in figure below. C. Place the other end of the hose into a WAX waste container. D. Turn the lever down to open.

After the replacement, the software resets WAX management count to zero and the loading date automatically changes to the current date.

3. Wait until the new solid WAX loaded has melted (100 minutes). If molten WAX is loaded, the WAX

status icon becomes yellow. Check the WAX status (fully molten) and press Set as ready button, as indicated in the chapter 2.13.

In LOGOS ONE it is possible to load solid as well as already molten new WAX.

Page 90

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

5 SAFETY MODE PROCEDURE

5.1 Power failure

LOGOS ONE can be equipped with an external UPS system, as described in the chapter 2.6.5, so that, in case of power failure, the software can put the specimens rack in “Safe mode”. In case of power failure during any phase, the program turns to Pause mode and this screen appears:

The MAIN POWER FAILURE ALARM is audible for 3 minutes with an intermittent audio signal. The insulation of the cavities assures that the reagent loaded and the WAX are kept warm during this period.

DURING THE 3 MINUTES COUNTDOWN

An auxiliary connector exit on the back of the unit is activated: here it is possible to connect an external light/sound alarm or a beeper to call the hospital service assistance to remove the specimens rack from LOGOS ONE (see the chapters 2.7).

In case of power failure, these functions are interrupted:

- Main cavity heating

- Wax heating

- Tissue processing

The terminal and the built-in stirrers remain operative in order to put the samples in the “safety position”. The Terminal Computer remains active during the countdown, BUT:

 If during this time the main power comes back on, the system will restart from the point the

program stopped.

 Instead, if the system goes in “Power failure procedure” at the end of the countdown (3

minutes), at the next start up the system will advise of what happened, showing the details of the step where the program stopped, thus allowing, through a STEP START program (for further details see chapter 3.2.4), to end the interrupted program. When the power supply comes back ON after a power failure, the system will automatically reboot and the following screen appears:

The screen reports that a power failure occurred, with following details:

 Date and Time: when the program stopped  Processing Cycle: Run ID, protocol name and size  Interrupted phase  Interrupted after

The operator is then able to Unload Reagent, Unload cassettes and then CONTINUE the processing by STEP START (for further details see chapter 3.2.4), according to

the indications of the last step performed by the unit prior to power failure.

Should the main power supply turn on during the 3 minutes of Main Power Failure alarm mode, the program will automatically re-start from the point it was interrupted.

Page 91

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

AFTER THE 3 MINUTES WITHOUT POWER, WITH UPS

The system automatically puts the specimens rack in “Safe mode”, according to the following schedule:

PHASE

CONDITION

POWER FAILURE

PROCEDURE

PHASE1

POWER FAILURE

PROCEDURE

PHASE2

POWER FAILURE

PROCEDURE

PHASE3

 Fixation  Flushing  Rinsing1/2  Dehydration  Clearing  Wax  Cleaning

MAIN CAVITY

FINISH LOADING

N.A.

 Fixation  Flushing  Rinsing1/2  Dehydration  Clearing  Wax  Cleaning WAX

PHASE RUNNING

STOP THE PHASE

N.A.

 Cleaning

MAIN CAVITY

PHASE RUNNING

STOP THE PHASE

TIMED UNLOADING

N.A.

 Fixation  WAX

UNLOADING THE SOLUTION

FINISH UNLOADING

LOADING SAME REAGENT

N.A.

 Flushing  Rinsing1/2  Dehydration  Clearing

UNLOADING THE SOLUTION

IF NEXT PHASE EXISTS AND IS NOT WAX

IF NEXT PHASE EXISTS AND IS WAX AVAILABLE

IF NEXT PHASE EXISTS AND IS WAX NOT AVAILABLE

FINISH UNLOADING

LOADING NEXT REAGENT

LOADING WAX IN MAIN CAVITY

RELOADING SAME REAGENT

 Cleaning

MAIN CAVITY

UNLOADING THE SOLUTION

FINISH UNLOADING

N.A.

Since WAX cannot be melted in “Power failure procedure”, operator is required to wait till

the completion of WAX remaining heating time, before removing the specimens.

In case of power failure during the WAX impregnation in MAIN CAVITY or in WAX CAVITY, the rack cannot be unloaded until the WAX heating time is completed (by default 100 minutes melting time). The specimens are safe anyway in the solid WAX, so there is no risk of damage if they are not removed.

In case of power failure during the transfer of WAX between the two cavities, it is impossible to start a new process until the WAX heating time is completed (by default 100 minutes melting time).

Page 92

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

5.2 Regent loading time-out

In case of reagent loading time out, if a processing tank is empty or if the reagent quantity isn’t enough to

cover the appropriate level sensor, the program turns to PAUSE mode and this screen appears:

The LOADING TIME-OUT ALARM is audible for 20 minutes with an intermittent audio signal. During this period the reagent loaded (if any) will be kept into the cavity.

DURING THE 20 MINUTES COUNTDOWN

If the operator is in the Laboratory during this phase, he can: Silent the audio alarm (figure above) and in the meantime check that the reagent level of the processing

tank isn’t too low and eventually fill the tank with new reagent (see chapter 2.14 for details). Only maintaining the right reagents level assures the coverage of all the cassettes.

Clear the audio alarm (figure above) and Abort the processing to unload the rack with specimens from the unit. Then check that the reagent level of the processing tank isn’t too low and eventually fill the tank with new reagent (see chapter 2.14 for details). Only maintaining the right reagents level assures the coverage of all the cassettes.

After this check, the operator can continue the processing with the STEP START function, starting from the phase not executed (see chapter 3.2.4 for details).

AFTER THE 20 MINUTES

If Reagent Loading Time-Out occurs when nobody is in the Laboratory, after 20 minutes the system starts the Safety mode procedure and automatically puts the specimens in “safe mode” following this schedule:

 In case of reagent loading time-out, the unit (after 20 minutes) will enter in SAFETY MODE

procedure, unloading the reagent (if any) and loading the previous reagent of the protocol used. The previous reagent and its fumes prevent samples from drying.

 In case of reagent loading time-out of the FIRST reagent of the protocol used, the reagent

movement will be stopped and the rack remains into the cavity. The reagent and its fumes prevent samples from drying.

This function assures that samples are kept soaked in the reagent until the arrival of the operator and the software will advise what happened and at which stage the process has been stopped.

The screen will display that Safety Mode Procedure has been activated, with following details:

- Date and Time: when the program stopped

- Processing Cycle: Run ID, protocol name and size

- Phase loading step

When the operator is back in the Laboratory, he can Unload Reagent, Unload cassettes and then CONTINUE the

processing by STEP START (for further details see chapter

3.2.4), according to the indications of the last phase not executed prior to loading time out.

Page 93

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

The following message appears every time a program is started, read carefully the message on the screen and press OK to start the process.

The following logic is for every phase:

Stop the loading If previous reagent exist

Timed unloading

Timed loading previous reagent

If previous reagent do not exist

Do nothing

So if the phase is the first, the previous reagent does not exist, this is the reason why it is it is necessary that operator stays close to the unit at the beginning of a new process until loading of the first reagent is completed and the graph is displayed on the screen, this lasts no more than 2 minutes in normal conditions.

WAIT…

LOADING COMPLETED

UNIT CAN NOW BE UNATTENDED

Page 94

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

6 REPORTING

LOGOS ONE provides the documentation necessary for the report activity of the Laboratory. In fact it is possible to export a document including all necessary information like the real time and temperature performed by the unit, the reagent management and the Events Logs.

6.1 Export processing from the terminal to the USB key

Insert the USB memory stick into its slots placed on the right side of the terminal (figure below).

Select “Log Book” button from the MAIN FUNCTIONS screen and then select “Autosaved programs”.

The following screen appears.

Page 95

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

This allows you to export all the saved processed graphics: select the file of interest and press “Export” or

“Export All” to copy the whole Hard Disk content.

After exporting plug the USB in a PC, a folder named “Logos_ONE_S.N.” is present containing the folder

“Saved”: here are the folders listed by date including all the processes saved of that day.

Alternatively choose “Delete” or “Delete All” if you want to definitely eliminate one file only or every file

saved, respectively.

6.2 Install and operate with the LogViewer

The USB key provided with the unit contains the LogViewer folder. Double click on the “SetupLogViewer.exe” icon to install the program. The LogViewer software is now ready to work. Microsoft.NET Framework 4.0 is a prerequisite to this application, the setup will install it if not present on your PC. Christal Report Runtime is a prerequisite to this application the setup will install it if not present on your PC.

6.2.1 Open process

Plug the USB memory stick on the LOGOS ONE terminal where all processes are stored and export them on the key, as described in chapter 6.1.

• Open the LogViewer software (go to “Start Menu\All programs\Milestone srl\Milestone LogViewer” or

click on the “LogViewer” icon created on your desktop).

• Plug the USB key in your PC and “Open” a process by clicking on the relative icon (green circle).

• Select the USB folder with saved processes of interest (see the example below).

Page 96

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

• Now all the process phases are shown. Data available are listed in the following fields:

PROCESS INFO: all details of that process. PHASES: all details of different phases. Click on "Show step list" for details of the selected STEP

(green circle).

GRAPH LINES: info and selection.

• For an enlarged view of a processing curve, click directly on it (blue circle figure above).

• Click on “Prev Phase” or “Next Phase” arrow (red circles figure below) to view phases before or after

it respectively.

Page 97

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

6.2.2 Print process

• Preview/printing of the curves is possible by selecting the “Print” icon (green circle).

• Select the appropriate printing format from the drop down menu:

Print summary: this print preview includes all phases (without graphs) with process and unit

information.

Print current phase: this print preview includes phase selected with process and unit data. Print full process: this print preview includes all phases (with graphs) with process and unit

information.

• When the print preview required has been selected, click on the “Print” icon from the bar in the upper

left of the preview page (green rectangle).

Page 98

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

Enlarged view of the “Print” icon from the bar in the upper left of the preview page.

6.2.3 Send process to customer support (Milestone)

• Click on the icon “Send process to customer support” (green circle) to forward an automatic

message to Milestone customer support e-mail.

• This message opens:

Page 99

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

• Press OK and check your e-mail, a preset message appears with the following information:

TO: [email protected] OBJECT: Milestone UNIT NAME (Serial number) TEXT: To Milestone Customer Support...

• Just send the e-mail.

6.2.4 Change settings

• Select “Settings” icon (green circle), to change the settings configuration.

• All settings are displayed as follows:

Graph style: modify the color of the X/Y axes, show/hide the grid, get axes displayed as dotted. Process curves style: modify color and thickness of the Pre-set and Real values lines (temperature

and power).

Printing options: modify pages header.

6.2.5 Other functions

1. About Milestone LogViewer

2. View help (HOW TO)

3. Exit Application

1 2 3

Page 100

Milestone s.r.l.

MM098-002 – LOGOS ONE – Operator Manual

100

6.3 Reagents Log and Events Log from the terminal to the USB key

Insert the USB memory stick into its slots placed on the right side of the terminal. Select Log Book button from the MAIN FUNCTIONS screen and then select Reagents Log. The following

screen appears where it is possible to export the List of Reagent Movements: press Export to copy it.

After exporting plug the USB in a PC, a folder named “Logos_ONE_S.N.” is present containing the file

“ListOfMovements.s3db.

Select Log Book button from the MAIN FUNCTIONS screen, then Events Log. The following screen appears where it is possible to export the Events Log: press Export to USB to copy it.

These functions are available only for SERVICE and ADMINISTRATOR personnel.