Related Manuals for Precipoint iO:M8
Summary of Contents for Precipoint iO:M8
- Page 1 2023/05/25 iO:M8 Instructions for Use (User Manual) 2023/05/25 Revision 3.0 PP00051672 04262402090010...
- Page 2 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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Page 3: Table Of Contents
Table of Contents General Information ........................................7 Abbreviations and Definitions ................................7 Pictograms/Symbols ....................................8 Overview of the Device ......................................9 Name or Trade Name of the Device ..............................9 Name or Trade Name of the Manufacturer ............................9 Other Unique Identifiers of the Device..............................9 Intended Purpose / Intended Use ...............................9 Intended Environment ....................................10 Intended User .......................................10 Contra-indications .....................................10... - Page 4 Operating Environmental Conditions .............................17 Transport and Storage Conditions..............................17 Disposal ..........................................18 4.5.1 Disposal of Packaging ...................................18 4.5.2 Disposal of Device and Trays ..............................18 4.5.3 WEEE........................................18 Initial Set-up ..........................................19 General Information ....................................19 Wiring and Connections ..................................19 Starting the Computer.....................................23 Starting the Software ....................................24 Shutting Down the Software................................25 Shutting Down the Device ..................................25 Software Basic Menu Structure ..................................26...
- Page 5 6.2.10 Toolbar Help .......................................36 6.2.11 Image Quality Guide ..................................37 Sidebar (Annotation List) ..................................39 6.3.1 Global Style Adjustments ................................40 6.3.2 Markers .........................................41 Other Buttons and Actions ..................................42 6.4.1 Full Screen ......................................42 6.4.2 Appearance Settings ..................................43 6.4.3 General Settings ....................................45 6.4.4 Info Screen ......................................46 Accessories ........................................47 Additional Software Functions ................................47 6.6.1...
- Page 6 11.2 Accessories ........................................56 11.3 General iO:M8 Microscope Specifications ............................57 11.4 iO:M8 Microscope Dimensions ................................57 11.5 Environmental Conditions ..................................58 11.6 Objective Information ....................................58 11.7 Camera Information ....................................58 11.8 Compliance Specifications ..................................59 12 Warranty Description ......................................59 13 Shortcut List ..........................................60 14 Support, Service, and Sales ....................................64 15 Notice ............................................64...
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Page 7: General Information
1 General Information 1.1 Abbreviations and Definitions The following abbreviations appear on your product or in this user manual: Unique Device Identification Reference Number WEEE Waste of Electrical and Electronic Equipment FFPE Formalin-fixed Paraffin-embedded Electromagnetic Compatibility PE-foam Polyethylene-foam RoHS Restriction of Hazardous Substances Mini Display Port Display Port Pixel per Micrometer... -
Page 8: Pictograms/Symbols
1.2 Pictograms/Symbols The following symbols may appear on your product or in this user manual: Instructions for Use Consult Caution Manufacturer Date of manufacture Catalogue number Unique device identifier medical device In-vitro diagnostic Keep dry Temperature limit Humidity limitation Fragile, handle with care Separate waste disposal for electric and electronic equipment (WEEE) Electrical grounding 2023/05/25... -
Page 9: Overview Of The Device
2 Overview 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. -
Page 10: Intended Environment
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. -
Page 11: Device Classification As Per Ivdr
2.14 Device Classification as per IVDR In accordance with IVDR (EU) 2017/746 Art 2 (2) the iO:M8 is defined as an in-vitro diagnostic medical device and classified following ANNEX VIII Classification Rules, Rule 5 (b) as class A. The iO:M8 is used as an instrument during an in-vitro diagnostic procedure, the rapid microscopic analysis of a specimen. -
Page 12: Precautions And Warnings
Before unpacking, ensure the transportation box is not damaged. If there is any damage, please contact PreciPoint GmbH immediately. Do not place the device upside down or sideways. Ensure you open the device from the side indicated on the packaging. - Page 13 PreciPoint’s service contract obligations. Any fuses in the system must only be replaced by PreciPoint staff or personnel authorized by PreciPoint. The system may only be operated with the indicated voltage.
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Page 14: Scope Of Delivery
3 Scope of Delivery Before using the device, make sure that all listed parts are included and none of the equipment is damaged. In case of damage or missing parts, do not use the device and immediately inform PreciPoint GmbH. 3.1 Contents •... -
Page 15: Unpacking, Transport, Storage, And Disposal
The device is heavy (25 kg). We recommend unpacking the device along with a colleague. Be careful when using sharp objects to open the carton box; you might damage the device or the components. Steps to unpack the iO:M8: 1. Remove strappings, plastic edge protectors, and tapes from the carton. - Page 16 Figure 4-1: Remove Accessories Box Figure 4-2: Lift Microscope Out of the Box Figure 4-3: Remove Lateral Foam Figure 4-4: Lift Microscope from Base Figure 4-5: Remove Transport Fixation of XY-stage For unpacking of computer and monitor, please read the respective handbooks. 2023/05/25 Page 16 of 69 Revision 3.0...
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Page 17: Transport
Chapters 11.4 4.4 Transport and Storage Conditions The iO:M8 parts are equipped with sensitive mechanical parts and electronic components. To maintain the function and functionality of the device, transport and storage conditions should be suitable for electronic devices. For more information, see Chapter 11.5... -
Page 18: Disposal
This device may not be disposed in unsorted residual and domestic waste. For disposal of the device, the customer must send the device back to PreciPoint. For this, either create a ticket in the Support System or contact Customer Support. Contact details are provided in Chapter 14. -
Page 19: Initial Set-Up
After each component has been turned on and the software has been started, the XY-stage and the Z-axis will be initialized. The start-up is successful if the initialization is complete. If initialization fails, switch all devices off, check all connections, and restart the system. Should that fail, please contact PreciPoint Support, see Chapters 10 and 14. - Page 20 Figure 5-1: Rear Side of iO:M8 with All Important Connections 2023/05/25 Page 20 of 69 Revision 3.0...
- Page 21 Figure 5-2: Connection Diagram 2023/05/25 Page 21 of 69 Revision 3.0...
- Page 22 Figure 5-3: Left Rear Side View of iO:M8 The stage cable is delivered pre-connected. Do not unplug the cable. Z-Axis XY-Stage Figure 5-4: Left Side View 2023/05/25 Page 22 of 69 Revision 3.0...
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Page 23: Starting The Computer
Figure 5-6: Optical Components in Stage 5.3 Starting the Computer Once the computer has been started according to indications in the computer and monitor user manuals, there iO:M8-User will be a Windows start screen where the operator can log into the user account iO:M8-User Log in passwords for can be found on the extra sheet with log in details. -
Page 24: Starting The Software
5.4 Starting the Software The system provides one basic mode: Standard Operation mode which is set by default in the “MicroPoint” software. 1. Turn the device on. Double-click on the white desktop icon “MicroPoint”. “ ” Figure 5-7: Desktop Icon MicroPoint (Operating Software) 2. -
Page 25: Shutting Down The Software
Selected slides are indicated with green surroundings. 5. With “Start microscopy” under the virtual tray, the iO:M8 will start to acquire low-resolution overview images with the overview camera of the selected slides. -
Page 26: Software Basic Menu Structure
6 Software Basic Menu Structure The main feature is Live-Stitching. It is the concatenation of individual pictures taken at the maximum resolution of the objective within seconds to a full single picture. Thus, it combines the advantages of a large field of view from a scan and the speed, and reactivity of a digital live view. -
Page 27: Main View
6.1.1 Microscopic View Figure 6-2 shows the core functionality of the iO:M8 with the starting screen. It displays a bird’s eye view of the selected sample. To view the sample in higher magnification, zoom into it using the scrolling wheel. Navigation left, right, up, and down the slide is executed via the mouse by dragging the sample. -
Page 28: Overview Map
6.1.2 Overview Map The “Overview Map” is for quick navigation across the sample and to a different slide. It displays the overview image. By clicking on the gray arrow at the right side of the overview map, the entire overview area can be hidden. -
Page 29: Scalebar And Current Magnification
Figure 6-4: Show Label Area 6.1.4 Scalebar and Current Magnification The bottom left corner displays the “Scalebar”, which can be moved by dragging and dropping it to the preferred position. The bottom right corner displays the current magnification, the objective magnification, and the corresponding pixel per micrometer value (ppm). -
Page 30: Toolbar
The “Magnification Buttons” provide the opportunity to zoom quickly to the desired magnification. A magnification of 5x to 60x is only available for iO:M8 configuration with a 40x objective. For a 20x objective, only magnifications from 5x to 40x are available. -
Page 31: Illumination Correction
6.2.2 Illumination Correction Figure 6-9: Illumination Correction “Illumination Correction” (IC) is used to adjust the exposure time during image generation, performs white balancing, removes uneven illumination, and thus it improves the quality of the images. By clicking on the “IC” button, a dialog with a red square and a live image area appears in the middle of the screen. -
Page 32: Auto Focus
6.2.3 Auto Focus Figure 6-11: Auto Focus The “Auto Focus” (AF) offers an automatic adjustment of the Z-axis looking for the best sharpness in the region of interest to provide you with a focused image. The “Auto Focus” button will focus on the center of the main screen. The AF can be triggered with a click on the mouse wheel, then the focus is performed at the position of the mouse cursor. -
Page 33: Create Screenshot
Figure 6-13: Manual Focus View In case the manual focus also does not achieve a sharp image, please contact the PreciPoint Support team. 6.2.5 Create Screenshot Figure 6-14: Create Screenshot To create a screenshot, click on the “Create Screenshot” button. By clicking the button, the current state of the working area is acquired. -
Page 34: Fit To Screen
6.2.6 Fit to Screen Figure 6-15: Fit To Screen The “Fit To Screen” button re-centers and zooms out the image in the microscopic view until the complete slide is visible. 6.2.7 Marker (Annotation Mode) Figure 6-16: Marker The “Marker” button activates the “Annotation” mode. To indicate this, an orange frame is displayed around the Viewport and the “Sidebar”... -
Page 35: Device Working
Figure 6-18: Annotation Mode; Working Area is Highlighted in Orange For more information on Markers, Annotations and the Sidebar see Chapter 6.3. 6.2.8 Device Working Figure 6-19: Device Working While the device is running, the message “Device working” is displayed in blue on the right side of the toolbar with a progress ring. -
Page 36: Change Tray (Slides)
6.2.9 Change Tray (Slides) Figure 6-20: Change Tray (Slides) By pressing the “Change Tray (Slides)”, the microscope goes into the start position and a new window appears where the user is prompted to either change the tray and press the continue button on the right-side bottom of the window (for more information on how to change trays, see Chapter 7) or cancel the operation and go back to the current slide. -
Page 37: Image Quality Guide
The “Toolbar Help” starts a short, guided tour through the user interface and highlights buttons and features used to control the system. 6.2.11 Image Quality Guide The “Image Quality Guide” is intended to guide you through the steps required to optimize the display quality of the sample you are viewing under the microscope. - Page 38 Figure 6-25: Image Quality Guide whilst in Progress on the Top Right Figure 6-26: Image Quality Guide Once Completed on the Top Right 2023/05/25 Page 38 of 69 Revision 3.0...
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Page 39: Sidebar (Annotation List)
6.3 Sidebar (Annotation List) The “Sidebar”, also called “Annotation list”, shows the current drawn annotations and gives the user the possibility to change their appearance. Further information for adding annotations can be found in Chapter 6.2.7. By clicking on the gray arrow at the left side of the “Sidebar”, the user can hide and open it again. Figure 6-27: Annotation List The “Annotation list”... -
Page 40: Global Style Adjustments
6.3.1 Global Style Adjustments Figure 6-28: Annotation List Global Style With the upper section of the list, the user can adjust all annotations at once: With the “Delete All” button, the user can delete all annotations at once. With the “Delete Selected” button selected, annotations can be deleted. For selecting an annotation, click on an empty area in the desired annotation. -
Page 41: Markers
By using the reset button on the top right corner of the “Global Style” area, all changes can be reset to default. The lower sections show the specific annotations that were made in the sample. 6.3.2 Markers The “Marker” sections show different parameters of the marker and it is shown with a white flag symbol in the upper left corner of the section. -
Page 42: Other Buttons And Actions
Figure 6-30: Marker with Added Description The “Style” button hides and unhides the different parameters that can be adjusted for the selected marker. Color: Color changes the color of the marker. Thickness: Thickness of the lines shown in the marker in pixels. Text Size: Text size of the text shown above the marker in pixels. -
Page 43: Appearance Settings
Further Settings Figure 6-33: Further Settings With the “Further Settings” button, the user can make some more settings for the system. 6.4.2 Appearance Settings With the “Appearance” settings, the user can switch between light mode and dark mode by clicking on the toggle button. - Page 44 Figure 6-35: Dark Mode Figure 6-36: Light Mode 2023/05/25 Page 44 of 69 Revision 3.0...
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Page 45: General Settings
6.4.3 General Settings With the “General” settings, the user can select from three options and change the default settings: Change the language of the application. Change how often the “Image Quality Guide” dialog will appear. Adjust the mouse wheel zoom in/out speed. Set to exit annotation mode automatically or not. -
Page 46: Info Screen
6.4.4 Info Screen By clicking the “Info” button on the top bar, the user can open an information screen displaying details about the system. Figure 6-38: Info Button Figure 6-39: Information Screen 2023/05/25 Page 46 of 69 Revision 3.0... -
Page 47: Accessories
6.5 Accessories The following accessories are additional and are dependent on the order placed: • Mouse and Keyboard • Monitor • Cables 6.6 Additional Software Functions 6.6.1 Tooltip The “Tooltip” is a small pop-up window in the application. It will show a description of an element of the graphical user interface. -
Page 48: Changing Slides And Tray
7 Changing Slides and Tray Before every use, ensure that the optical components of the device and the inserted slides are clean. For cleaning instructions, see Chapter 8. 7.1 Slide Dimensions Use only slides with the following dimensions: Length 75 mm – 76 mm Width 25 mm –... -
Page 49: Place Tray Into Xy-Stage
7.3 Place Tray into XY-stage In the start position of the iO:M8 or the “Slide Selection” window of “MicroPoint”, the XY-stage and the Z-axis move, so that the tray can be easily placed into its designated opening. The magnets in the tray ensure a correct placement. -
Page 50: Remove Tray From Xy-Stage
7.4 Remove Tray from XY-stage To remove the tray from the XY-stage, use the indentation on the right to reach under the tray and gently pull it upward (as seen in Chapter 7.3, Figure 7-2). 7.5 Remove Slides from Tray To remove the slide from the tray, hold the tray and gently push the label side towards the spring . -
Page 51: Change Slide And Tray
“Change Tray (Slides)” button. Figure 7-5: Button for Changing Tray Do not use the device with other trays than those provided by PreciPoint. 7.7 Slide Tray The “Slide Tray” is a portable holder where a maximum of 4 slides can be inserted and fixed with a mechanical spring and placed into the XY-stage. -
Page 52: Device Care And Cleaning
• As the microscope uses LED for primary illumination, lamp replacement is rarely required. Please contact the PreciPoint GmbH Support if you experience problems. • Please check the conditions for storage and operation environment of the device in Chapter 11.5... -
Page 53: Performance Characteristics
9 Performance Characteristics If the device does not perform like mentioned in this chapter, contact PreciPoint Support. See Chapter 14 for contact information. 9.1 Analytical Performance Characteristics Parameter iO:M8 20x iO:M8 40x Flatness of main illumination across FoV Minimum intensity value is Minimum intensity value is ≥98%... -
Page 54: Troubleshooting
In case of further questions, please visit https://precipoint.com/support/ (scan the QR-code provided here), contact PreciPoint GmbH (contact details in Chapter 14), your local vendor, or certified PreciPoint Partner. For common operational advice and troubleshooting, read the text in the pop-ups in “MicroPoint”. Else, please contact PreciPoint Support. - Page 55 FAQ4: Illumination correction error message. For error messages regarding the illumination correction, follow the instructions in the pop-up window. In case, errors still occur, please contact PreciPoint Support. FAQ5: Auto Focus does not work correctly. Ensure illumination correction is performed. Afterwards, set focus manually via the “Manual Focus”.
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Page 56: Specifications And Dimensions
11 Specifications and Dimensions 11.1 Components Component Description Microscope PreciPoint iO:M8 Digital Light Microscope MicroPoint MicroPoint Version “MicroPoint 2.0.1 - IVD” is the operating system of the microscope which runs on the computer connected to the microscope. It represents the user interface and contains the software steering the iO:M8 functions. -
Page 57: General Io:m8 Microscope Specifications
11.3 General iO:M8 Microscope Specifications Feature Details Item Number iO:M8 PP00050742 Power Plug C14 power plug Electrical Consumption Max. 84 W Power Supply 110 V – 240 V AC, 50 Hz– 60 Hz 11.4 iO:M8 Microscope Dimensions Max. Width: 42 cm Max. -
Page 58: Environmental Conditions
Humidity (Operating) 20 % – 80 % Altitude (Operating) -15 m – 2.000m 11.6 Objective Information Feature Details Main Objective iO:M8 20x Olympus UPLFLN20X-2; 0.5 NA Main Objective iO:M8 40x Olympus UPLFLN40X-2; 0.75 NA Overview Objective Lensagon B10M7224 11.7 Camera Information... -
Page 59: Compliance Specifications
12 Warranty Description The iO:M8 and its components (the device) are only allowed to be operated with techniques and processes described in this user manual. The device must not be modified by the user, unless instructed to do so by the manufacturer. -
Page 60: Shortcut List
13 Shortcut List Command General: Alt + Enter Full screen mode on/off Alt + F4 Close the application Slide Selection: Number Key 1 Toggle selection of slide 1 Number Key 2 Toggle selection of slide 2 Number Key 3 Toggle selection of slide 3 Number Key 4 Toggle selection of slide 4 Ctrl + A... - Page 61 Toolbar Start “Illumination Correction” Close “Illumination Correction” dialog (if the dialog is open, else disabled) F2 or NumPad 5 Perform “Auto Focus” at the Viewport center Mouse Middle Button Perform “Auto Focus” at the current mouse position Open/Close “Manual Focus” “Create Screenshot”...
- Page 62 Navigation Ctrl + 1 or NumPad 1 Zoom Viewport to 0.2x magnification Ctrl + 2 Zoom Viewport to 1.25x magnification Ctrl + 3 Zoom Viewport to 2.5x magnification Ctrl + 4 Zoom Viewport to 5x magnification Ctrl + 5 Zoom Viewport to 10x magnification Ctrl + 6 Zoom Viewport to 20x magnification Ctrl + 7...
- Page 63 Annotations Delete all selected annotations 2023/05/25 Page 63 of 69 Revision 3.0...
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Page 64: Support, Service, And Sales
Installation of hardware should only be performed by a PreciPoint Service Engineer or a PreciPoint Partner. 15 Notice Any serious incident that involves or has occurred in relation to the iO:M8 must be reported to PreciPoint and the competent authorities responsible for the user and/or the patient. 2023/05/25 Page 64 of 69 Revision 3.0... -
Page 65: Index
16 Index accident ................17 Fit to Screen ............... 34, 61 account ................23 flag ..................41 Add description ..............41 Focus Plane ..............61 annotation ............35, 39, 40, 41 Fullscreen ................. 42 application ................ 47 Further Settings ..............43 arrow ................ - Page 66 parameters ............40, 41, 42 square ..............31, 32, 33 performance ..............52 staff .................. 13 pixel ................7, 29 stage ................22, 51 plug ................... 14 storage ..............19, 52, 58 position ..............29, 36, 41 supply ................. 18, 54 preview picture ..............
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Page 67: List Of Figures
Figure 4-5: Remove Transport Fixation of XY-stage ..........................16 Figure 4-6: Lifting and Holding the iO:M8 ..............................17 Figure 5-1: Rear Side of iO:M8 with All Important Connections ..................... 20 Figure 5-2: Connection Diagram ..................................21 Figure 5-3: Left Rear Side View of iO:M8 ..............................22 Figure 5-4: Left Side View ..................................... - Page 68 Figure 6-21: Toolbar Help Button ..................................36 Figure 6-22: Toolbar Help Tour in Progress ............................... 36 Figure 6-23: Image Quality Guide in Toolbar ............................. 37 Figure 6-24: Center Screen Dialog Asking to Start the Image Quality Guide ................. 37 Figure 6-25: Image Quality Guide whilst in Progress on the Top Right ..................38 Figure 6-26: Image Quality Guide Once Completed on the Top Right ..................
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Page 69: Version History
Updated Chapter “3.2 Materials Required but not Provided” Updated Chapter “4.1 Unpacking” Updated Chapter “5.2 Wiring and Connections” Updated Chapter “7.1 Slide Dimensions” Updated Chapter “11.1 Components” Updated Chapter “11.3 General iO:M8 Microscope Specifications” Updated Chapter “11.6 Objective Information” 2023/05/25 Page 69 of 69 Revision 3.0...
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