Precipoint IO:M8 Bedienungsanleitung

2023/05/25 Revision 3.0

04262402090010



PP00051672

iO:M8

Instructions for Use (User Manual)

2023/05/25

2023/05/25 Revision 3.0

04262402090010



PP00051672

Complete reading of the user manual before operating is required.

This user manual must be stored and/or kept within reach of the device. Staff responsible

for operating the device must read the user instructions before working with the product.

If the equipment is used in a manner not specified by the manufacturer, the protection

provided by the equipment may be impaired and the warranty invalidated.

 
 
 
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Table of Contents 
1General Information ................................................................................................................................................................................................7
1 Abbreviations and Definitions ................................................................................................................................................................7
2 Pictograms/Symbols...................................................................................................................................................................................8
2Overview of the Device..........................................................................................................................................................................................9
1 Name or Trade Name of the Device...................................................................................................................................................9
2 Name or Trade Name of the Manufacturer....................................................................................................................................9
3 Other Unique Identifiers of the Device..............................................................................................................................................9
4 Intended Purpose / Intended Use.......................................................................................................................................................9
5 Intended Environment............................................................................................................................................................................10 
6 Intended User...............................................................................................................................................................................................10 
7 Contra-indications .....................................................................................................................................................................................10 
8 Test Principle.................................................................................................................................................................................................10 
9 Calibrators, Controls, and Limitations of Their Use..................................................................................................................10 
10 Reagents and Limitations of Their Use ..........................................................................................................................................10 
11 Other Required General-purpose Equipment and Facilities..............................................................................................10 
12 Stability.............................................................................................................................................................................................................10 
13 Sterility..............................................................................................................................................................................................................10 
14 Device Classification as per IVDR.......................................................................................................................................................11 
15 Collection, Handling, and Preparation of the Specimen......................................................................................................11 
16 Automation....................................................................................................................................................................................................11 
17 Precautions and Warnings ....................................................................................................................................................................12 
3Scope of Delivery ...................................................................................................................................................................................................14 
1 Contents..........................................................................................................................................................................................................14 
2 Materials Required but not Provided...............................................................................................................................................14 
4Unpacking, Transport, Storage, and Disposal.........................................................................................................................................15 
1 Unpacking ......................................................................................................................................................................................................15 
2 Transport.........................................................................................................................................................................................................17 

 
 
 
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3 Operating Environmental Conditions.............................................................................................................................................17 
4 Transport and Storage Conditions....................................................................................................................................................17 
5 Disposal............................................................................................................................................................................................................18 
5.1 Disposal of Packaging...................................................................................................................................................................18 
5.2 Disposal of Device and Trays....................................................................................................................................................18 
5.3 WEEE.......................................................................................................................................................................................................18 
5Initial Set-up..............................................................................................................................................................................................................19 
1 General Information..................................................................................................................................................................................19 
2 Wiring and Connections .........................................................................................................................................................................19 
3 Starting the Computer.............................................................................................................................................................................23 
4 Starting the Software ...............................................................................................................................................................................24 
5 Shutting Down the Software................................................................................................................................................................25 
6 Shutting Down the Device ....................................................................................................................................................................25 
6Software Basic Menu Structure .....................................................................................................................................................................26 
1 Main View........................................................................................................................................................................................................27 
1.1 Microscopic View ............................................................................................................................................................................27 
1.2 Overview Map....................................................................................................................................................................................28 
1.3 Show Label Area..............................................................................................................................................................................28 
1.4 Scalebar and Current Magnification.....................................................................................................................................29 
2 Toolbar..............................................................................................................................................................................................................30 
2.1 Magnification Buttons ..................................................................................................................................................................30 
2.2 Illumination Correction................................................................................................................................................................31 
2.3 Auto Focus..........................................................................................................................................................................................32 
2.4 Manual Focus ....................................................................................................................................................................................32 
2.5 Create Screenshot..........................................................................................................................................................................33 
2.6 Fit to Screen.......................................................................................................................................................................................34 
2.7 Marker (Annotation Mode).........................................................................................................................................................34 
2.8 Device Working ................................................................................................................................................................................35 
2.9 Change Tray (Slides)......................................................................................................................................................................36 

 
 
 
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2.10 Toolbar Help.......................................................................................................................................................................................36 
2.11 Image Quality Guide......................................................................................................................................................................37 
3 Sidebar (Annotation List)........................................................................................................................................................................39 
3.1 Global Style Adjustments............................................................................................................................................................40 
3.2 Markers .................................................................................................................................................................................................41 
4 Other Buttons and Actions....................................................................................................................................................................42 
4.1 Full Screen...........................................................................................................................................................................................42 
4.2 Appearance Settings.....................................................................................................................................................................43 
4.3 General Settings ..............................................................................................................................................................................45 
4.4 Info Screen..........................................................................................................................................................................................46 
5 Accessories....................................................................................................................................................................................................47 
6 Additional Software Functions............................................................................................................................................................47 
6.1 Tooltip....................................................................................................................................................................................................47 
6.2 Help in Dialogs and Controls ....................................................................................................................................................47 
7Changing Slides and Tray..................................................................................................................................................................................48 
1 Slide Dimensions ........................................................................................................................................................................................48 
2 Insert Slides into Tray ...............................................................................................................................................................................48 
3 Place Tray into XY-stage.........................................................................................................................................................................49 
4 Remove Tray from XY-stage.................................................................................................................................................................50 
5 Remove Slides from Tray .......................................................................................................................................................................50 
6 Change Slide and Tray.............................................................................................................................................................................51 
7 Slide Tray.........................................................................................................................................................................................................51 
8Device Care and Cleaning.................................................................................................................................................................................52 
9Performance Characteristics...........................................................................................................................................................................53 
1 Analytical Performance Characteristics.........................................................................................................................................53 
2 Other Performance Characteristics .................................................................................................................................................53 
Troubleshooting.....................................................................................................................................................................................................54 
Specifications and Dimensions......................................................................................................................................................................56 
1 Components .................................................................................................................................................................................................56 

 
 
 
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2 Accessories....................................................................................................................................................................................................56 
3 General iO:M8 Microscope Specifications....................................................................................................................................57 
4 iO:M8 Microscope Dimensions...........................................................................................................................................................57 
5 Environmental Conditions.....................................................................................................................................................................58 
6 Objective Information..............................................................................................................................................................................58 
7 Camera Information..................................................................................................................................................................................58 
8 Compliance Specifications....................................................................................................................................................................59 
Warranty Description ...........................................................................................................................................................................................59 
Shortcut List..............................................................................................................................................................................................................60 
Support, Service, and Sales...............................................................................................................................................................................64 
Notice...........................................................................................................................................................................................................................64 
Index..............................................................................................................................................................................................................................65 
List of Figures ...........................................................................................................................................................................................................67 
Version History........................................................................................................................................................................................................69 
 
 

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1General Information

1.1 Abbreviations and Definitions

The following abbreviations appear on your product or in this user manual:

UDI

Unique Device Identification

REF

Reference Number

WEEE

Waste of Electrical and Electronic Equipment

FFPE

Formalin-fixed Paraffin-embedded

EMC

Electromagnetic Compatibility

PE-foam

Polyethylene-foam

RoHS

Restriction of Hazardous Substances

MDP

Mini Display Port

Display Port

ppm

Pixel per Micrometer

Illumination Correction

Auto Focus

QHD

Quad High Definition

UHD

Ultra High Definition

Mega Pixel

GLP

Good Laboratory Practice

IVDR

In-Vitro-Diagnostic Device Regulation

Line Pairs

Pixel

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1.2 Pictograms/Symbols

The following symbols may appear on your product or in this user manual:

Consult

Instructions for Use

Caution

Manufacturer

Date of manufacture

Catalogue number

Unique device identifier

In-vitro diagnostic

medical device

Keep dry

Temperature limit

Humidity limitation

Fragile, handle with care

Separate waste disposal for electric and electronic equipment (WEEE)

Electrical grounding



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2Overview of the Device

The iO:M8 is a digital light microscope system. The iO:M8 digital light microscope system is intended for the in-

vitro diagnostic use to provide digital images of surgical pathology slides prepared from frozen tissue and

cytology preparations that can be used to aid the pathologist to review and interpret physiological or

pathological states. The iO:M8 consists of a microscope and the corresponding control software “MicroPoint”

running on the host PC. This manual is applicable for the configuration with a 20x and 40x objective, which are

required by PreciPoint. The iO:M8 is controlled by a healthcare professional and can only be used as a complete

system. The device creates a magnified image of a specimen by optical magnification. This virtual image is

digitized by a camera sensor and transmitted to the host PC. The digital image is then displayed to the user

through the control software on a computer screen. The pathologist uses the device to analyze the digital

image of a specimen. All this is part of the procedure of rapid microscopic analysis of a specimen. The

measurement is qualitative.

2.1 Name or Trade Name of the Device

iO:M8

2.2 Name or Trade Name of the Manufacturer

PreciPoint GmbH

2.3 Other Unique Identifiers of the Device

UDI-DI: 04262402090010

2.4 Intended Purpose / Intended Use

The iO:M8 digital real time light microscope system is intended for the in-vitro diagnostic use to provide digital

images of surgical pathology slides prepared from frozen tissue and cytology preparations that can be used to

aid the pathologist to review and interpret physiological or pathological states.

The iO:M8 consists of a digital microscope and corresponding control software “MicroPoint” running on the

host computer.

The iO:M8 device itself is not intended to diagnose, treat, prevent, mitigate, or cure disease or medical

conditions.

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2.5 Intended Environment

The iO:M8 device is intended to be used in healthcare facilities.

The iO:M8 is used at point-of-care laboratory testing. The facilities and environmental conditions should be

suitable for laboratory activities and should not adversely affect the validity of results. The laboratory should

monitor, control, and record environmental conditions that influence the validity of the test results. The

laboratory should comply with local laws and standards.

For details about the environmental conditions, see Chapter 11.5

2.6 Intended User

The intended users are a Pathologist (Medical Expert) and Medical Technical Assistant.

2.7 Contra-indications

There are no contra-indications for this device.

2.8 Test Principle

The operation principle of the system aims to enable a healthcare professional to quickly inspect and analyze

a series of pathological specimens by looking at a digital image of the specimens displayed on a computer

screen. To achieve this, the control software “MicroPoint”guides the medical expert through a workflow for

digitizing areas of interest of a specimen using the iO:M8 microscope.

2.9 Calibrators, Controls, and Limitations of Their Use

The iO:M8 is calibrated by the manufacturer and does not require recalibration by the user.

2.10 Reagents and Limitations of Their Use

No reagents are applicable to the iO:M8.

2.11 Other Required General-purpose Equipment and Facilities

Ensure an adequate environment for the iO:M8. See Chapters 2.5, 4.3, and 11.5 for more information.

Ensure an adequate power connection for the iO:M8. See Chapters 5.2 and 11.3 for more information.

2.12 Stability

There is no shelf life for the iO:M8 since the device is shipped directly after calibration. For details on storage

and operating conditions, see Chapter 11.5. A minimum lifetime of 3 years is expected.

2.13 Sterility

The iO:M8 does not require sterility. For details on cleaning the device, see Chapter 8.

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