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Human HumaVision User Manual

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HumaVision
| User Manual
REF 17660/1

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Summary of Contents for Human HumaVision

  • Page 1 HumaVision | User Manual REF 17660/1...
  • Page 3 01/2024-11 First Edition SYSTEM VERSION COPYRIGHT Copyright 2024, HUMAN Gesellschaft für Biochemica und Diagnostica mbH, Wiesbaden, Germany. All rights re- served. No part of this documentation may be reproduced in any form, nor processed, copied or distributed by means of electronic systems, without prior permission of HUMAN in writing.
  • Page 5 CONTENTS CONTENTS TABLE OF CONTENTS 1 SAFETY INSTRUCTIONS 1.1 INTRODUCTION 1.2 USER WARRANTY 1.3 USE OF THE INSTRUMENT 1.4 GENERAL SAFETY WARNINGS 1.4.1 Electromagnetic considerations 1.4.2 Lithium polymer battery 1.4.3 Radio communications 1.5 DISPOSAL MANAGEMENT CONCEPT 1.6 BIOHAZARD WARNING 1.7 INSTRUMENT DISINFECTION 1.8 SYMBOLS 2 SYSTEM DESCRIPTION 2.1 INTENDED PURPOSE...
  • Page 6 4.3 MEASURING PROCEDURE 4.4 MICROSCOPY RESULTS USING HUMAVISION (FOR INVESTIGATIONAL USE ONLY) 4.5 WEEKLY MAINTENANCE 4.6 DATABASE 4.7 MICROSCOPY OF URINE SAMPLES WITHOUT USING HUMAVISION 4.8 QUALITY ASSURANCE 4.8.1 Microscope sensor check 4.8.2 Refresh sensor data 4.8.3 Quality control 5 SETTING UP THE HUMAVISION 5.1 SETTINGS MENU...
  • Page 7 6 OPERATING AND MAINTENANCE INSTRUCTIONS 6.1 PROHIBITIONS ON USE 6.2 SERVICE LIFE 6.3 USAGE LOCATION 6.4 CLEANING 6.4.1 External cleaning 6.4.2 Cleaning the sensor and measuring chamber 6.5 TRANSPORTATION/ STORAGE 6.6 DECOMMISSION 6.7 DISPOSAL 7 TECHNICAL SPECIFICATIONS 7.1 HUMAVISION SPECIFICATIONS 7.2 ACCESSORIES...
  • Page 8 HumaVision | User manual...
  • Page 9 Service in the event of instrument failure or other dif- ficulties with the instrument. 1.2 User Warranty HUMAN warrants that instruments sold by one of its au- thorised representatives shall be free of any defect in ma- terial or workmanship, provided that this warranty shall...
  • Page 10 HUMAN, not regularly maintained, used with equipment not approved by HUMAN or used for purposes for which it was not designed. 1.3 Use of the Instrument The instrument must be used for its intended purpose (see chapter 2.1 Intended Purpose).
  • Page 11 SAfETy INSTruCTIONS Do not power the instrument in environments that are po- tentially explosive or at risk of fire. Prior to cleaning and/or performing maintenance on the instrument, switch off the instrument and remove the power cord. Only cleaning materials described in this man- ual may be used, as other materials may damage parts.
  • Page 12 In such cases, the instrument must be checked at the manufacturer’s premises. HumaVision is designed for use in a professional health- care facility environment. It is likely to perform incorrectly if used in a home healthcare environment. If it is suspect-...
  • Page 13 SAfETy INSTruCTIONS The instrument has been tested in accordance with EN IEC 62311:2020 and EN 62479:2010. The instrument is not known to expose the user to any electromagnetic ra- diation above the level of the basic restrictions for general public exposure specified by these standards. 1.4.2 LITHIUM POLYMER BATTERY The instrument is equipped with a lithium polymer bat- tery, which has been tested in accordance with IEC 62133-...
  • Page 14 WLAN connection. Furthermore, a decrease in the data transfer rate may be expected in such cases. HUMAN is not responsible for the loss, interception or misuse of data sent or received when using the instrument’s wireless communication methods.
  • Page 15 SAfETy INSTruCTIONS 1.5 Disposal management concept The applicable local regulations governing disposal must be observed. It is the user's responsibility to arrange for proper disposal of the individual components. All parts which may contain potentially infectious materi- als must be disinfected by suitable, validated procedures (autoclaving, chemical treatment) prior to disposal.
  • Page 16 1.6 Biohazard warning Analytical instruments for in vitro diagnostic application involve the handling of human samples and controls which should be considered at least potentially infectious. There- fore every part and accessory of the respective instrument which may have come into contact with such samples must equally be considered as potentially infectious.
  • Page 17 SAfETy INSTruCTIONS 1.8 Symbols When you TABLE 1 It means... see... Weight Dimensions Follow the instruction in the manual related to the symbol to avoid potential biocontami- nation. Follow the instruction in the manual related to the symbol to avoid personnel injury. Follow the instruction in the manual related to the symbol to avoid analyzer damage and failure, or unreliable analysis results.
  • Page 18 Humidity level for storage Atmospheric pressure level for storage Consult the user manual HumaVision | User manual...
  • Page 19 It is intended to acquire holographic images of different cell types and microorganisms in human urine samples for the qualitative human urine examination. It is used as an aid to diagnosis of the general health status. For laboratory professional use only.
  • Page 20 As the coherent light passes through the urine sample, it interacts with the microscopic objects in the urine, such as cells, bacteria, crystals, and other cellular components. These microscopic objects diffract the light, causing it to change direction and create complex interference patterns. HumaVision | User manual...
  • Page 21 FIGURE 3 HumaVision microscopic image by LED A photosensitive sensor is used to record the hologram. It captures the intensity of the interference pattern...
  • Page 22 Specialized mathematical algorithms are used to analyze the hologram and reconstruct the image of the microscopic objects. These algorithms use the principles of diffraction and interference to decode the information contained in the hologram. FIGURE 4 Microscopic image before and after reconstruction HumaVision | User manual...
  • Page 23 (built-in) cleaning) FIGURE 5 HumaVision product set components Note: Check that the product set is complete, based on the delivery note. Use only products and accessories that have no defects. Report any damage to HUMAN's Service department immediately.
  • Page 24 Accessories No. Name Description TABLE 3 Urine Sample Carrier Slide used for the meas- 17661 HumaVision urements (microscopy) Set of 12, see chapter Cleaning Sticks 6.4.2 Cleaning the 17662 HumaVision sensor and measuring chamber HumaVision | User manual...
  • Page 25 SET up 3 SET UP 3.1 Placement and use HumaVision is a compact portable instrument that can be carried with one hand. For measurements, the HumaVision shall be placed on a flat and stationary working surface, that is free of vibrations.
  • Page 26 Not following this instruction can cause per- manent battery damage or may cause the battery to act as a source of ignition. 1. Place the HumaVision on a stable, level, secure, fire- resistant surface. 2. Plug the supplied USB charger into a mains socket.
  • Page 27 3.4 Switching on the instrument Note: In order to be able to switch on the HumaVision, either charge the instrument's battery (partially or fully) or connect the USB charger to the instrument (see chapter 3.3 Charging the built-in battery).
  • Page 28 2. Wait for the instrument to start, which takes about 40 seconds. The start-up is complete when the main menu (see Figure 7) appears on the display. The HumaVision is now ready for operation. FIGURE 7 Main menu of HumaVision...
  • Page 29 (e.g., as a result of a non-responsive instru- ment), select [error shutdown]. Normal shutdown (recommended): 1. Press and hold the power button on the HumaVision for approx. one second until a selection menu (“Shut down the instrument – Yes/ No”) appears on the dis- play.
  • Page 30 First, it dims the display after a set period of inactivi- ty. Then it turns off the backlight to enter energy-saving mode. Apart from the display of the graphical user inter- face, the HumaVision is fully functional in this mode. Energy-saving mode: Automatically activates after 2 minutes of inactivity.
  • Page 31 CArryINg OuT mEASurEmENTS 4 CARRYING OUT MEASUREMENTS 4.1 Preliminary remarks If the HumaVision or the Urine Sample Carriers have been stored at an ambient temperature ≤ 5 °C, they must be unpacked and allowed to adjust to room temperature before measurements are carried out. The instrument's cover must be closed all the time when no measurement is taking place.
  • Page 32 This application is not yet intended for in vitro diagnostic purposes but for investigational use only. Classification For more information about this function, please request the document "HumaVision - Urine Sediment Parameters" from HUMAN's Service department. HumaVision | User manual...
  • Page 33 CArryINg OuT mEASurEmENTS 4.2 Sample handling 4.2.1 GENERAL REMARKS Sample source: The HumaVision is used to take micros- copy images of human urine samples. Carry out the measurement within the first 2-6 hours after sample collection (see Kouri TT, Hofmann W, Falbo R, Oyaert M, Schubert S, Gertsen JB, Merens A, Pestel-Caron M;...
  • Page 34 It helps to understand instrument operation to achieve accurate analysis results. To use the Sample Preparation Guide: 1. On the HumaVision main menu navigate to “Micro- scope”. 2. Tap on the “Sample preparation guide” button HumaVision | User manual...
  • Page 35 CArryINg OuT mEASurEmENTS FIGURE 9 Set sample parameters 3. Tap on to move forward through the pages. FIGURE 10 Sample carrier should be kept in vertical position only for the time necessary for the analysis. 4. Tap on [<] to move backward through the pages. 5.
  • Page 36 2. Make sure the sample carrier holder is correctly placed in the measuring chamber. If unsure, use the sample carrier holder key to remove it. Then re-insert the sam- ple carrier holder into the measuring chamber until it clicks into place. HumaVision | User manual...
  • Page 37 CArryINg OuT mEASurEmENTS FIGURE 13 Removing the sample carrier holder with the key 3. From main menu navigate to “Microscope”. FIGURE 14 Main menu of HumaVision...
  • Page 38 5. Take a Urine Sample Carrier from the supply box. Touch only the lower part of the Urine Sample Carrier. 20µL Urine Sample Carrier FIGURE 15 How to touch the Urine Sample Carriers HumaVision | User manual...
  • Page 39 CArryINg OuT mEASurEmENTS 6. The sample must be thoroughly homogenized by in- verting the tube filled with urine sample ten times. FIGURE 16 Inverting the urine sample 7. Aspirate 20 μl from the lower third of the sample. FIGURE 17 Aspiration of sample volume 8.
  • Page 40 Note: Chapter 4.2 Sample handling contains important instructions for sample preparation. 9. Insert the Urine Sample Carrier into the slot on the HumaVision. Measure the urine right after filling the Urine Sample Carrier. This avoids errors from sample evaporation. FIGURE 19...
  • Page 41 CArryINg OuT mEASurEmENTS 11. The results are shown on the display. FIGURE 21 Result of microscopic image 12. The measurement results can be saved in internal memory (see chapter 4.6 Database). FIGURE 22 Database of microscopic images...
  • Page 42 This application is not yet intended for in vitro diagnostic purposes but for investigational use only. For more information about this function, please request the document “HumaVision - Urine Sediment Parameters” from HUMAN's Service department.
  • Page 43 Only the Cleaning Sticks HumaVision (REF 17662) should be used to clean the HumaVision sensor. The use of any other sticks is not recommended, and any potential harm caused thereby is not the responsibility of HUMAN. The...
  • Page 44 Follow the detailed steps of the cleaning procedures described in chapter 6.4 Cleaning. 4.6 Database The Database (history) function of the HumaVision contains all the saved measurements (microscopic images). They can be sorted, filtered, deleted, and called up by tapping on the given item from the list.
  • Page 45 CArryINg OuT mEASurEmENTS Printout solution: Exporting the results as PDF file After taking the measurement (microscopic image), the result can be exported as a PDF file. From main menu navigate to “Database”. 1. From the listed data in “Database”, select the respec- tive document from which the printout/PDF is to be created.
  • Page 46 In case this function is not available, check the “Connectiv- ity for PDF export” in the settings (chapter 5.7 Connectiv- ity for PDF export). There is the possibility to add a labo- ratory name on the PDF, see chapter 5.8 Customize the print-out or PDF. HumaVision | User manual...
  • Page 47 CArryINg OuT mEASurEmENTS Delete measurements HumaVision allows to delete either one or multiple meas- urements from the Database. 1. Select the checkboxes of all items to be deleted from the Database. 2. Tap on the Delete icon Note: To prevent data...
  • Page 48 Figure 30. After manually focusing on the focal plane, it is possible to display objects contained in the urine. Note that during analysis in the HumaVision, the Urine Sample Carrier is vertical and there is slow sedimentation of the cells and particles in the urine.
  • Page 49 Checking the sensor status is a quality control procedure for maintaining the HumaVision's measuring functionality and resolution. 1. Open the settings menu of the HumaVision by tapping the settings icon 2. Tap on the menu item [Maintenance]. 3. Tap on the menu item [Microscope sensor check].
  • Page 50 4. Tap on [Start sensor check]. FIGURE 32 Sensor status before starting the check 5. After a few seconds, the result of the sensor check ap- pear underneath the green button. FIGURE 33 Sensor status "OK" HumaVision | User manual...
  • Page 51 FIGURE 34 Sensor status "Dirty" - cleaning required Note: The HumaVision can only be used for further measurements if the sensor status “OK” is displayed. If the sensor status does not show “OK”, even after re- peated cleaning of the sensor, stop using the HumaVision...
  • Page 52 If no Urine Sample Carrier is detected, recalibrate the associated sensor, even if the Urine Sample Carrier appears to be positioned correctly. 1. Open the settings menu of the HumaVision by tapping the settings icon 2. Tap on the menu item “Maintenance”.
  • Page 53 4.8.3 QUALITY CONTROL Running a quality control is not mandatory for the routine use of the HumaVision microscopy function. An external quality control can be used for testing purpose or if required by local regulations.
  • Page 54 HumaVision | User manual...
  • Page 55 Click on the settings icon ( ) to access the settings menu. The settings can be accessed from any menu. The HumaVision is supplied pre-configured. Hence, configuration of the settings is not necessary, although it may be useful. FIGURE 37...
  • Page 56 5.2.1 DESCRIPTION OF OPERATING MODES Note: Setting up the WLAN adapter is not necessa- ry for the basic, standalone use of the HumaVision. However, full configuration of the WLAN adapter is re- commended to benefit from software updates on the HumaVision.
  • Page 57 Note: Obstacles such as walls, glass windows, ma- chines and liquid containers located between the HumaVision and the WLAN access point (e. g., router) or a network device in hotspot mode may affect the quality of the WLAN connection, reduce the data transfer rate and...
  • Page 58 5.2.2 WLAN MODE To connect the HumaVision to an existing WLAN: 1. Open the settings menu of the HumaVision by tapping the settings icon 2. Tap on the switch to the right of [Wi-Fi]. When the switch turns green, WLAN mode is enabled (this disa- bles hotspot mode).
  • Page 59 (hotspot) using HumaVision. Add other WLAN- enabled devices to this network to allow communication with the instrument. 1. Open the settings menu of the HumaVision by tapping the settings icon 2. Tap the switch to the right of [Hotspot]. When the switch turns green, hotspot mode is enabled (this disa- bles WLAN mode).
  • Page 60 The following chapter describes how to disable the HumaVision WLAN adapter if the WLAN or hotspot function has been enabled. 1. Open the settings menu of the HumaVision by tapping the settings icon 2. Tap on the switch to the right of [WLAN] so that it is grayed out.
  • Page 61 Updates always require the consent of the user. Note: In order to receive software updates for the in- strument, it is necessary for the HumaVision to be con- nected to a WLAN and be authorized to access the inter- net. If in doubt, consult a network administrator in order to permit internet access for the HumaVision.
  • Page 62 Updates are only possible if the instrument is configured in WLAN mode and integrated within a WLAN with internet access (see chapter 5.2.2 WLAN mode): 1. Open the settings menu of the HumaVision by tapping the settings icon once. 2. Tap on the menu item [Updates].
  • Page 63 Italian Russian It is possible to set a different display language as follows: 1. Open the settings menu of the HumaVision by tapping the settings icon 2. Tap on the menu item [Language]. 3. Select the desired display language by tapping on the relevant name.
  • Page 64 5.5 Time and date settings It is important that HumaVision has the correct time and date to create a correct time and date stamp for every measurement. If HumaVision has access to Wi-Fi, the time and date is set automatically using details provided by the network to adjust the date and time.
  • Page 65 5.7 Connectivity for PDF export Make sure the HumaVision is connected to the same Wi-Fi as the PC the PDF file should be exported to. Navigate to “Settings” and click on “Data Transfer”, to set up a con- nection.
  • Page 66 5.8 Customize the printout or PDF file The printouts or PDF files can be customized by following the steps below: 1. Open the settings menu of the HumaVision by tapping the settings icon FIGURE 39 Top bar of main menu 2.
  • Page 67 SETTINg up ThE humAVISION FIGURE 41 Laboratory settings The printout or PDF file can be customized by adding the name of the laboratory name, the address, and for further information in the header of the PDF, the field “More De- tails”...
  • Page 68 By enabling the data upload, only raw sensor data and classification results are shared with the manufacturer for support purposes. No personal or identifiable information is collected or transfered. The data is securely sent to the manufacturer's cloud storage. FIGURE 43 Provide support data HumaVision | User manual...
  • Page 69 The technical parameters are specified in chapter 7 Technical specifications. 6.2 Service life The HumaVision is suitable for 24/7 use. Portable use is limited by the battery life. The 24/7 operating mode requires a connected external power supply. If the battery...
  • Page 70 If the power supply unit fails, a replacement power sup- ply unit should be requested from the local distributor. 6.3 Usage location The HumaVision is designed for indoor use in accordance with the conditions specified in chapter 7.1 HumaVision specifications. The instrument can be operated outdoors if the conditions specified in chapter 7.1 HumaVision...
  • Page 71 If necessary, consult a physician. WARNING Electrical hazard Before cleaning, disconnect the HumaVision from the main power supply. The instrument must always be switched off during cleaning. 6.4.1 EXTERNAL CLEANING If the urine sample is spilled on the instrument, wipe it off immediately and apply disinfectant.
  • Page 72 These may damage the display coating. If alcohol is used as a cleaning agent, do not apply it directly to the HumaVision. Moisten a cloth with the cleaning agent and then wipe the HumaVision. CAUTION...
  • Page 73 The measuring chamber should be cleaned weekly in order to maintain the instrument’s measuring performance. Only use the Cleaning Sticks HumaVision (REF 17662) to clean the HumaVision sensor. The use of other sticks is not recommended, and any potential harm caused thereby is not the responsibility of HUMAN.
  • Page 74 2. Turn over the instrument so that the measuring cham- ber's opening faces downward. Tap gently on the back of the HumaVision so that any dust or loose particles fall out. 3. Use the Cleaning Sticks HumaVision to clean the sen- sor surface first, then clean the LED.
  • Page 75 3. Clean the measuring chamber with a soft microfibre cloth moistened with 99 % isopropanol. 4. Clean the sensor surface and the LED with the Cleaning Sticks HumaVision moistened with 99 % isopropanol without exerting excessive pressure. WARNING Biohazard Sample residues in the measuring chamber may lead to contamination of the user.
  • Page 76 (chapter 6.4 Cleaning). 6.6 Decommission If the HumaVision is not used for a period of > 3 months, store the instrument in the storage box to minimize damage and contamination. Before the HumaVision is placed out of service, clean it in accordance with chapter 6.4 Cleaning.
  • Page 77 Disposal via municipal collection points is not permitted. Note: Follow the safety instructions in chapter 1.4 Ge- neral safety warnings when handling the HumaVision. The Urine Sample Carrier used for measuring purposes must be disposed of after use in accordance with the customer’s own laboratory regulations.
  • Page 78 These samples may be contaminated with pathogenic germs or viruses and must be handled as potentially hazardous. WARNING Biohazard Always wear gloves when working with Urine Sample Carrier to avoid any potential hazards, e. g., contamination with infectious material. HumaVision | User manual...
  • Page 79 TEChNICAl SpECIfICATIONS 7 TECHNICAL SPECIFICATIONS 7.1 HumaVision specifications Power supply TABLE 6 Mains voltage 100-240 VAC (for charger) Mains frequency 50/ 60 Hz (for charger) Input current (for charger) 0.35 A Operating voltage 5 VDC HumaVision Max. current consumption 1.5 ADC Max.
  • Page 80 ø > 12.5 mm of solid foreign bodies IPX0 ≙ No protection against ingress of water Dimensions (L HumaVision 128 mm x 94 mm x 33 mm Weight HumaVision 240 g Microscope assembly Resolution Particle size: 3 μm-100 μm HumaVision | User manual...
  • Page 81 TEChNICAl SpECIfICATIONS 7.2 Accessories Name REF number Description TABLE 7 USB power supply 17660/105 Accessory HumaVision unit, external, type 31507W USB connection 17660/106 Length: 1.8 m cable [type A to type C]; 1.8 m Urine Sample 17661 4x25 sample carriers in...
  • Page 82 HumaVision | User manual...
  • Page 84 HUMAN Gesellschaft für Biochemica und Diagnostica mbH Max-Planck-Ring 21 • 65205 Wiesbaden • Germany Tel.: +49 6122/9988 0 • Fax: +49 6122/9988 100 eMail: human@human.de • www.human.de...