Related Manuals for SamanTree Medical Histolog Scanner v2
Summary of Contents for SamanTree Medical Histolog Scanner v2
- Page 1 Instructions for use Histolog® Scanner v2 Histolog® Dish 1223 version 1.11_EN (2022-05-26)
- Page 2 SamanTree Medical. Histolog is a registered trademark of SamanTree Medical. All other trade names and trademarks are the property of their respective holders.
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Page 3: Revision History
2019-06-21 Removed §11. Improve image quality for print. Add description of symbol for “quantity in package”. 2020-08-31 Update SamanTree Medical’s address. 2020-11-16 Update list of compatible cleaning agents. Change contact information. Update patent protection statement with latest issued patents. 2021-09-15 Update for European Directive EU 2015/863. -
Page 4: Table Of Contents
2. Table of contents 1. Revision history 2. Table of contents 3. Description of symbols 4. Introduction 5. Safety instructions 5.1. Warnings 5.2. Cautions 5.3. Laser safety 6. Intended purpose 6.1. Intended use 7. Product information 7.1. Overview 7.2. Accessories 7.2.1. - Page 5 12.2. Fuse replacement 13. Disposal 13.1. Histolog® Dish 13.2. Histolog® Scanner 13.3. Histolog® Dip 14. Troubleshooting 14.1. Test procedure 14.2. Troubleshooting 14.3. Export logs 15. Product catalog codes 16. Device specifications/technical information 16.1. Technical specifications 16.1.1. Histolog® Scanner 16.1.2. Histolog® Dish 16.2.
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Page 6: Description Of Symbols
3. Description of symbols Batch Code Temperature limit Catalog Number Atmospheric Pressure Limitation Serial Number Humidity Limitation In vitro diagnostic medical device Fragile; handle with care Manufacturer This way up Manufacturing date Keep dry Consult instructions for use Do not reuse Standby or power indicator Use-by (expiry) date Orientation mark... -
Page 7: Introduction
4. Introduction These instructions for use describe the set-up, use and maintenance of SamanTree Medical’s Histolog® Scanner device, including its Histolog® Dish accessory. ◼ Read these instructions for use before setting up and using the device the first time. These instructions for use contain important information for the safe use of the device. -
Page 8: Safety Instructions
Use only for the purpose described in these instructions for use. Do not use the device if it is not working properly, or if it has suffered any damage. Misuse can cause electrocution, burns, fire and other hazards. Prior to first use, the Histolog® Scanner device is to be put in service by SamanTree Medical authorized service personnel. -
Page 9: Laser Safety
5.3. Laser safety The Histolog® Scanner is a Class 1 laser product, as per IEC 60825-1:2014-05. Laser radiation in the visible wavelength range is emitted from the imaging window [G] during imaging. The Histolog® Scanner embeds a Class IIIB laser component with the following characteristics: Wavelength: 488 ±... -
Page 10: Intended Purpose
6. Intended purpose 6.1. Intended use The Histolog® Scanner is a confocal microscopy device intended for imaging the surface of excised human tissue specimens to visualize morphological microstructures. The Histolog® Scanner is intended to be used in combination with the following accessory devices: ■... -
Page 11: Product Information
Touchscreen monitor Histolog® Scanner Software Application ON/OFF power switch USB port Ethernet port (only for maintenance purposes, under guidance of SamanTree Medical authorized service personnel) Orientation mark Imaging window Handles Swivel caster wheels with brakes Appliance power inlet with fuse compartment... -
Page 12: Accessories
) from the Histolog® Scanner device. USB storage device is not provided by SamanTree Medical. It is recommended to use a USB 3.0 (or better) storage medium with read/write speeds of at least 300 MB/s and with storage capacity of at least 256 GB. -
Page 13: Use Of The Histolog® Scanner
8. Use of the Histolog® Scanner Prior to first use, the Histolog® Scanner device must be put in service by SamanTree Medical authorized service personnel. 8.1. Before use 8.1.1. Installing in use location 1. Move the Histolog® Scanner to the desired location with level ground. -
Page 14: After Use
8.2. After use 8.2.1. Switching OFF Quit the Histolog® Scanner Software Application: 1. Tap the button. If User Authentication mode is used in the Histolog® Scanner Software Application, then select the “Turn off” option in the graphical popup control. 2. Confirm the action by tapping “Turn off” to shutdown the device. Or tap on “Cancel”... -
Page 15: Imaging A Tissue Specimen
8.3. Imaging a tissue specimen WARNING When handling potentially infectious tissue specimens, avoid skin contact by wearing gloves or other protective equipment. CAUTION ■ If the information about the tissue specimen orientation is critical, the tissue specimen should be marked for orientation before starting the imaging procedure with the Histolog®... -
Page 16: Cleaning
9. Cleaning WARNING ■ Cleaning when the device is connected to the mains power may be hazardous to the operator and/or destructive to the device. The device may be cleaned with conventional alcohol-based disinfecting agents for medical devices. Read and follow the instructions supplied with the cleaning product. -
Page 17: Moving
10. Moving Before moving the Histolog® Scanner, please ensure that: 1. The power cord [P] is disconnected from the mains outlet and secured on the cable winder [O]. 2. The brakes of all four of the caster wheels [J] are released (in upwards position). Use only the handles [H], and not other parts of the device, for pushing/pulling. -
Page 18: Storage
11. Storage After use of the device, follow the instructions of §8.2 . The device can then be moved to the storage area. When in place, lock the four wheel brakes [J] in downward position to prevent unintended movement of the Histolog® Scanner. -
Page 19: Maintenance
The components located in the inner cavity of the device are not intended to be manipulated by the user. The interior of the Histolog® Scanner may be serviced only by SamanTree Medical authorized service personnel. 12.1. Update of Histolog® Scanner Software Application Update of Histolog®... -
Page 20: Disposal
13. Disposal 13.1. Histolog® Dish Dispose of the Histolog® Dish according to local procedure for handling biomedical waste. 13.2. Histolog® Scanner Follow the local regulations for separate collection of electrical and electronic equipment. 13.3. Histolog® Dip Dispose of the Histolog® Dip in accordance with the information contained in its instructions for use. 1223 version 1.11_EN (2022-05-26) Page 20 | 30... -
Page 21: Troubleshooting
) and try the test again. III. If the failure persists, stop using the device, note the displayed message and contact SamanTree Medical authorized service personnel for technical support (contact information may be found on page 1223 version 1.11_EN (2022-05-26) -
Page 22: Troubleshooting
14.2. Troubleshooting Issue Cause Action(s) to take Device does not power up Power cord [P] is not Verify that the power cord [P] is connected to the Histolog® connected Scanner appliance power inlet [K] and to the mains power outlet. ON/OFF power switch [C] is Verify that the Histolog®... - Page 23 If the issue cannot be resolved with the above instructions, stop using the device. Shut down and prepare for storage as per §8.2 . Contact SamanTree Medical service personnel for technical support (contact information may be found on page ). If an error message is displayed, please note the error code and message, and communicate it to the service personnel.
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Page 24: Export Logs
The Histolog® Scanner offers means to export technical data (“logs”) on the use and status of the device to a USB storage device. These fully anonymized logs contain technical information for troubleshooting and may be requested by SamanTree Medical authorized service personnel within the frame of technical support. To export the logs: 1. -
Page 25: Product Catalog Codes
15. Product catalog codes To purchase replacement parts from SamanTree Medical or from an authorized distributor, please use the following product catalog numbers. Products Product Catalog Code Description (REF) Histolog® Scanner v2 Histolog® Dish Histolog® Dip Replacement Parts Part Number Description (T6.3 AH 250VAC 5mm ⨉... -
Page 26: Device Specifications/Technical Information
16. Device specifications/technical information 16.1. Technical specifications 16.1.1. Histolog® Scanner HISTOLOG® SCANNER Dimensions (W x D x H) 0.76 m x 0.76 m x 1.56 m Weight 95 kg Electrical Power Input 100–240 VAC, 50/60 Hz Maximum Rated Power 305 W Power Cord Length USB port standard Ethernet port connector... -
Page 27: Histolog® Dish
Images Image area 48 mm × 36 mm Time to image approx. 10 seconds for images at resolution of 10 µm per pixel approx. 1 minute for images at resolution of 2 µm per pixel Operating Conditions Area of application Indoor use only Pollution degree 2 (as per IEC 61010-1:2010) -
Page 28: Electromagnetic Immunity
16.2. Electromagnetic immunity Guidance and manufacturer’s declaration – Electromagnetic immunity The Histolog® Scanner is intended for use in the electromagnetic environment specified below. The customer or the user of the Histolog® Scanner should ensure that it is used in such an environment. Immunity test IEC 61326-2-6 Compliance level... - Page 29 Guidance and manufacturer’s declaration – Electromagnetic immunity The Histolog® Scanner is intended for use in the electromagnetic environment specified below. The customer or the user of the Histolog® Scanner should ensure that it is used in such an environment. Immunity test IEC 61326-2-6 Compliance level Electromagnetic environment...
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Page 30: Electromagnetic Compatibility
Recommended separation distances between portable and mobile RF communications equipment and the Histolog® Scanner The Histolog® Scanner is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer of the user of the Histolog® Scanner can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Histolog®...
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