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Adaptica 2WIN-S, Руководство оператора

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6 

 

 

 

 

3

 

Intended use of the device 

Instrument  for  the  measurement  of  binocular  and  monocular  refraction  based  on  infrared  (IR) 
photorefraction. 

 

4

 

Classification and Applied Standards 

Classification 

according 

MDD 

93/42/EEC, 

Annex 

IX, 

and MDR 2017/745 EU, Annex VIII 

Class IIa. 

Classification and type of applied parts 

Class I, Type B. 

IP classification 

IPX0 (degree of protection provided by the external plastic shells with reference to the penetration of any 
special material or water). 

Electromagnetic compatibility 

This device has been classified as class B according to the standard

 

IEC 60601-1-2. 

Applied standards 

EN 60601-1; EN 60601-1-2; EN ISO 15004. 

 

 

Содержание 2WIN-S

Страница 1: ...1 2WIN S 2WIN S Plus OPERATOR MANUAL ...

Страница 2: ...on date 2022 02 17 Hardware configuration Version 37 1 Rev Num 10 0_EN General notes Family 2WIN VISION ANALYZER Family intended use Portable instruments for the measurement of binocular and monocular refraction based on infrared photorefraction Models 2WIN 2WIN S 2WIN S PLUS ...

Страница 3: ...7 6 QUICK USER GUIDE 9 6 1 MAIN APPLICATIONS 9 6 2 EXAM CONDITIONS 9 6 3 MEASUREMENT TIPS 10 7 DESCRIPTION OF THE DEVICE 10 7 1 2WIN AND 2WIN S 10 7 2 2WIN S 10 7 3 PACKAGE LABELLING 12 7 4 2WIN S LABELING 13 7 5 INTERFACES 15 8 OPERATIVE INFORMATION 16 8 1 OPERATING CONDITIONS 16 8 2 UNPACKING 17 8 3 ACCESS TO 2WIN 17 8 4 BEFORE OPERATION 18 8 5 DATA MANAGEMENT DISCLAIMER 18 8 6 IMPORTANT NOTES O...

Страница 4: ...AUTOMATIC UPDATE PROCEDURE 50 15 DISINFECTION 51 16 MAINTENANCE AND CLEANING INSTRUCTIONS 52 16 1 HOW TO CLEAN THE SYSTEM 52 16 2 STORAGE INSTRUCTIONS 52 16 3 INSTRUCTIONS FOR THE CORRECT DISPOSAL OF THE DEVICE 52 16 4 INSTRUCTIONS FOR CORRECT DISPOSAL OF 2WIN S PACKAGING 52 16 5 SEPARATE COLLECTION FOR ELECTRICAL AND ELECTRONIC EQUIPMENT 52 17 TROUBLESHOOTING 54 18 ADDITIONAL INFORMATION 55 18 1 ...

Страница 5: ...entification data Date of manufacturing Electrical electronic device subject to the WEEE Directive on waste disposal CE mark this device complies the base requirements of the Medical Device Directive 93 42 CEE Direct current DC Warning necessary information for safety Important information Read user manual before use Indoor use only Polarity of the power supply plug Applied part comes into contact...

Страница 6: ...x IX and MDR 2017 745 EU Annex VIII Class IIa Classification and type of applied parts Class I Type B IP classification IPX0 degree of protection provided by the external plastic shells with reference to the penetration of any special material or water Electromagnetic compatibility This device has been classified as class B according to the standard IEC 60601 1 2 Applied standards EN 60601 1 EN 60...

Страница 7: ...this equipment Operation with non approved equipment or unshielded cables is likely to result in interference to radio and TV reception The user is cautioned that changes and modifications made to the equipment without the approval of manufacturer could void the user s authority to operate this equipment Portable and mobile RF communications equipment such as cell phones can affect medical electri...

Страница 8: ... safety should the device be opened repairs carried out third party s software be installed or parts be replaced by unauthorized persons Inside the 2WIN SD memory card is stored the patient data This information can contain personal information such as name surname age This information management is responsibility of the operator Only the power adapter provided by Adaptica with the system can be u...

Страница 9: ...rument that measures refraction on the basis of eccentric infrared IR photo refraction also photo retinoscopy Both eyes are measured at the same time while fixating at 1 meter It is battery operated non invasive fast and easy to use It automatically measures binocular refraction pupil distance pupil size direction of gaze and fixation abnormalities Binocular refraction of children from 3 years of ...

Страница 10: ...ions pertaining to the binocular visual function in some specific patients including accommodating children the 2WIN S measurements may vary 7 Description of the device 7 1 2WIN and 2WIN S 2WIN S comprises the 2WIN and the accessory tube KALEIDOS A number of additional features of the 2WIN S could be handled only approaching the 2WIN device Please refer to the 2WIN Operator Manual for these option...

Страница 11: ...s The 2WIN S moreover is able to detect the refraction only of patients which eyes permit good Purkinje images Anomalies in such images due for example to eye surgery interventions or intraocular lenses IOL do not allow an accurate measurement The 2WIN S is portable battery powered equipped with a computing integrated unit and controlled through an Android tablet 2WIN S data is saved inside KALEID...

Страница 12: ...acturer identification Data name and address Fragile handle with care This side up do not reverse Keep dry Storage minimum and maximum temperature Lithium ion batteries contained or packed with device Call 39 049 773 968 for more information 39 049 773 968 ...

Страница 13: ... CE mark and Notified Body identification code Electrical electronic device subject to the WEEE Directive on waste disposal Read manual strictly before operation Turn on device 1 Button 1 see Section 9 1 2 Button 2 see Section 9 1 Battery fully charged Battery discharged Serial number IP00 Not protected against ingress of objects and water Year of production Applied part type B ...

Страница 14: ...14 BACK INDOOR CONTROL PANEL UPPER SIDE ...

Страница 15: ...ated legacy feature C POWER BUTTON Short press to switch the system on Press for 2 sec to switch the system off Long press the button to force the power off D BATTERY LEVEL BUTTON Short press to see the 2WIN S battery level 2WIN Inside the USB SD connection door there are a Micro USB port which connect the 2WIN camera to the KALEIDOS tube and a MicroSD card holder For a summary of the functions of...

Страница 16: ...uration otherwise the functionality of BUTTON D will be different Refer to Section 7 4 and 9 7 of 2WIN Operator Manual for further information The JOYSTICK features contextual functions push CENTER to enter menu or to say OK the other four direction allow operator to navigate in the menu Please refer to the 2WIN Operator manual for further information 8 Operative information 8 1 Operating conditio...

Страница 17: ...further instructions on how to operate the device For further information regarding 2WIN and its Applications please refer to video tutorials that can be found in the Adaptica s YouTube channel https www youtube com user AdapticaSrl 8 3 Access to 2WIN To have access to the 2WIN device the rear hinged lid of the KALEIDOS tube has to be opened Removing the MicroSD memory card First remove the USB ca...

Страница 18: ...IN S present a disclaimer related to the management of data telemetry of the instrument The operator is asked to read the document and accept the terms if not 2WIN S will work but some functionalities will be disabled Telemetry and Remote access You can read the document at the end of this manual Appendix A for all the details 8 6 Important notes on Battery The device must be charged at least once...

Страница 19: ...tooth tablet application KALEIDOS App is briefly described in the following At first use it is necessary to pair the 2WIN S to the tablet following these instructions Install the KALEIDOS App on your tablet Check that Bluetooth is enabled on the tablet Switch the 2WIN S on Run KALEIDOS App on tablet Tap on the Bluetooth icon on the KALEIDOS App to start available Bluetooth devices search A window ...

Страница 20: ...hutting down Connection ongoing Wi Fi BT Fixed Yellow Firmware updating 2WIN S not connected to the application Flashing blue Pairing ongoing with application Button Power 1 Measure 2 Connection Function Short press System power up Long press 2 sec system shut down More force power off 2 sec start stop a measurement the exam is automatically saved 2 sec until flashing yellow WiFi BT connection res...

Страница 21: ... date of birth is set the age range is automatically selected Then set the type of the measurement right eye left eye or both eyes As alternative you can just select the patient age range without the patient s personal data Choose what kind of Eye measurement you want to perform binocular both or monocular left or right Press the START button The measurement starts and a progress bar is displayed ...

Страница 22: ...taken while a two beep sound indicates that the measurement has been correctly processed this is an option selectable from the 2WIN inside 2WIN S in Menu Measurement Sound Alerts Ending Beep If an error occurs during the measurement and the message appears the causes could be the following Pupil s too small or large High IR noise Unstable conditions of the data due to other eye problems Other unex...

Страница 23: ...ly pupil diameters horizontal and vertical in this order offset angles of the average position of the corneal reflex on respect of the center of the detected pupil The Gaze is also graphically depicted for each eye in the two bottom corners of the display in the form of a cloud of dots and an averaging cross inside two concentric blue circles When the cross is inside the smaller circle the attenti...

Страница 24: ...24 From the results screen the options are 1 Press on the Image button on the top right of the results window to visualize the patient s eyes and pupils images ...

Страница 25: ...reening results press on the Info button on the top right 3 Tap on the PDF icon below the screening results table to generate the PDF report of the exam As an alternative tap on the PDF icon on measurement results window ...

Страница 26: ...26 4 Click on the three dots on the top right corner to save or repeat the measurement a dropdown menu appears If you repeat the measurement current patient data will be kept ...

Страница 27: ...s the description of the PDF report The number of prints before the device starts rewriting the oldest files is 1000 Moreover if the SD card is inserted in the 2WIN a set of 3 files for each examination are saved in it into the folder 2WIN Exams A subfolder named Exam number date is created The subfolder contains at least 3 files with the same name of the folder but different extensions pdf examin...

Страница 28: ...e between the corneal reflex and the geometric center of the pupil The corneal reflex is represented on the graph in an inverted position if the corneal reflex is nasal to the center it is represented as temporal in the diagram The direction of gaze as measured by this tool is not directly related to the measurement in cover test This graphical representation suggests the presence of tropias and s...

Страница 29: ... Chapter 12 for the pairing instructions The Bluetooth connectivity can be enabled from the 2WIN inside 2WIN S in Menu Settings Bluetooth The Bluetooth icon is shown on 2WIN s display Bluetooth connectivity is enabled by default on the device Refer to Section 10 1 of 2WIN Operator Manual for further information 10 2 Wi Fi connectivity A 2WIN S device that is equipped only with the Wi Fi module can...

Страница 30: ...iring and transferring a 2WIN S exam to VisionFit SC In the following it will be described the pairing procedure between 2WIN S and VisionFit SC This is a deprecated legacy feature described only for backwards compatibility VisionFit SC is a mobile and wearable subjective refractor which can be used in combination with 2WIN S Once 2WIN S is paired it is possible to transmit its objective refractio...

Страница 31: ...31 2 From VisionFit SC s tablet application enter Settings and set 2WIN Connection type BT 3 Afterwards select 2WIN Connection The pairing starts automatically ...

Страница 32: ...circle appears on 2WIN s icon To transfer a 2WIN S measurement to VisionFit SC follow the steps below 1 Perform a test using 2WIN S and save it 2 Enter the Reference area in VisionFit SC s tablet application and tap on the 2WIN button 3 2WIN S data will appear instantly on the Reference area in VisionFit SC s application ...

Страница 33: ...IN S from an Android tablet through Wi Fi connection However it is an unsupported legacy feature reported only for backwards compatibility Further information could be found in our website at Products 2WIN S Manuals Download Otherwise feel free to contact support adaptica com 12 Remote control KALEIDOS App The KALEIDOS App allows to remotely control a 2WIN S from an Android tablet through Bluetoot...

Страница 34: ...ey could compromise the KALEIDOS App s functioning 12 1 KALEIDOS App installation and configuration To use the KALEIDOS App the device and the application must be paired for the first time as follows 1 Install the KALEIDOS App on your tablet 2 Check that Bluetooth is enabled on the tablet 3 Switch the 2WIN S on 4 Run the KALEIDOS App 5 Tap on the Bluetooth icon on the KALEIDOS App to start the ava...

Страница 35: ...ontrol 2WIN S and it does not allow 2WIN remote control KALEIDOS App is compatible with 2WIN S having software version 5 4 2 or higher and hardware version 29 1 or higher In the 2WIN S Plus configuration the provided tablet is already paired with the device Respecting the General Data Protection Regulation GDPR to use the KALEIDOS App a screen lock mechanism must be enabled on the tablet If such m...

Страница 36: ...h eyes left eye or right eye Corneal Reflexes exams instead are marked with a CR Mode label Refer to Chapter 13 2WIN S Plus for further information on the Corneal Reflexes exam Clicking on Refraction exams it is possible to review the exam s Screening Table and to open share and print the PDF report Clicking on CR exams it is possible to open the PDF report that can be also shared or printed Click...

Страница 37: ...NERAL tab the following information are displayed Status Wi Fi status Battery status KALEIDOS mode Version 2WIN S software version 2WIN S hardware version 2WIN S BT protocol version 2WIN S serial number System the button SHUT DOWN allows you to switch the 2WIN S off WI FI STATUS From the WI FI STATUS tab it is possible to get information about 2WIN S Wi Fi connection Wi Fi status Wi Fi strength Ne...

Страница 38: ...ab it is possible to scan for the available Wi Fi networks and to connect to them CUSTOMIZATION From the CUSTOMIZATION tab it is possible to personalize the PDF report s footer and set up the EMR connection for the latter refer to Section 13 3 ...

Страница 39: ...rior Segment Anterior Segment Hint AI App is an innovative Artificial Intelligence AI based algorithm running on Adaptica Cloud developed to give to the user additional information on possible anterior segment anomalies where 2WIN S is not able to refract the patient Anterior Segment Hint is already active if you are using a 2WIN S Plus To activate the AI App whether not having the Plus configurat...

Страница 40: ...ed during the 2WIN S Refraction exam are instantly processed by Anterior Segment Hint AI algorithm When the exam is processed the cloud icon on Measurement result window turns from blue to green If 2WIN S is not able to refract the patient and any suspect anomaly of the anterior segment is detected the warning Possible anomaly of the Anterior Segment is given to the operator with the indication of...

Страница 41: ... occurs during the connection to Adaptica Cloud or during the upload of the pupils images the cloud icon changes to cloud error icon 13 2 CR App corneal reflexes application From KALEIDOS App it is possible to select Corneal Reflexes CR measurement mode CR measurement mode provides information regarding the corneal reflexes position giving hints about possible phorias and tropias The procedure wil...

Страница 42: ... distributor To enable Corneal Reflexes measurement mode tap on the standard measurement mode icon infinite symbol on the home page of the application Measurement Type dialogue window appears Select the desired mode and press the SAVE button When the Corneal Reflexes mode is selected the Application icon in the home page of KALEIDOS App changes and displays the CR icon ...

Страница 43: ...er tests under an infrared occluder The patient must look at the white LED that turns on during the measurement To perform a Corneal Reflexes measurement follow these steps 1 Select CR mode as described above 2 Tap on Start a new measurement 3 Enter the patient s name and date of birth If needed patient data insertion can be skipped 4 Click on Start and the Corneal Reflexes measurement window open...

Страница 44: ... tests use the IR occluder provided by Adaptica to cover the contralateral eye Other occluders are forbidden 6 When all the needed measurements are completed the button RESULTS appears Tap on the button to see the patient s pupils shots and the exam results You can repeat each measurement as many times as you wish just tapping on the corresponding button After you press RESULTS you cannot modify t...

Страница 45: ...the CR Measurement results 8 Create the exam report by pressing on the PDF button on the CR Measurement Result window 9 To save the measurement press the SAVE button on the CR Measurement Result window When the saving is complete a confirmation message appears You can also start a CR exam just after a 2WIN S Refraction exam by tapping on the CR button in exam s Measurement Result window The CR exa...

Страница 46: ...ntion to fit 2WIN S aperture ambient light must not enter the device during the exam CR Exam Results In the CR Measurement Result window three pairs of pupil images are displayed The images represent from top to bottom see point 7 of previous section Both eyes free not covered Right eye free Left eye covered Right eye covered Left eye free The covered eye is highlighted by a grey square From the p...

Страница 47: ...sunderstood as a diagnosis The measurement shall in any case be used to refer the patient to an eye care professional for further evaluation The default output also shows a value for the K angle Horizontal K angle labelled as kx the output is when the corneal reflex lays nasal to the center of the pupil 0 when the corneal reflex coincides with the geometrical center of the pupil when the corneal r...

Страница 48: ...e a folder on the EMR system PC and share it on the network This folder will be the Shared Folder If you create the Shared Folder as a subfolder you must share the subfolder only 3 Run the KALEIDOS App and tap on App device setup then select CUSTOMIZATION 4 In the Shared Folder section set the following values o Server IP the EMR system PC s IP address o Share name the name of the Shared Folder to...

Страница 49: ...er the import is completed the app will delete the CSV input file from the Shared Folder KALEIDOS App is checking the Shared Folder approximately every 2 sec for a new input file 3 If the patient data displayed in KALEIDOS App are correct start the measurement 4 Save the exam The CSV output file containing the exam results is created in the Shared Folder and it is retrieved by the EMR system Then ...

Страница 50: ...file inside the root folder of the MicroSD card 14 2 Automatic update procedure To exploit the automatic update 2WIN S must be connected to a Wi Fi network with Internet connection An automatic software update procedure is available for 2WIN S When a new software version is released and the 2WIN S is connected to a Wi Fi network with internet access the update is notified on the screen of the 2WIN...

Страница 51: ...date Press the CANCEL button to delay it the update will take place at the next 2WIN S reboot 15 Disinfection It is always necessary to disinfect the area where the face of the patient will touch the device before any change of patient Disinfection should be achieved by means of single use disinfecting pads such as individually wrapped sterile Alcohol Wipes with 70 ethyl alcohol or other single us...

Страница 52: ...as plastics aluminum electronic parts in case of disposal separate the materials and follow the laws and regulations effective in your own country 16 4 Instructions for correct disposal of 2WIN S packaging 2WIN S packaging is made of expanded polyethylene foam present inside the device s suitcase and between the suitcase and the shipment box Such foam is eco friendly and 100 recyclable 16 5 Separa...

Страница 53: ...e cardiovascular system and kidneys It accumulates and is very toxic for animals plants and micro organisms Cadmium accumulates with a half life of 30 years and can damage the kidneys and cause cancer Mercury it is easily accumulated in organisms and concentrates through the food chain It has chronic effects and can cause brain damage Chromium Hexavalent easily absorbed into cells with toxic effec...

Страница 54: ...he central fixation target 5 A warning Hint check Gaze appears on the display There may be a strabismus problem It is suggested to measure eyes singularly in two different measurements 6 A warning Possible strong Anisocoria appears on the display The two eyes have very different pupil diameters It is suggested to measure eyes singularly in two different measurements 7 The measurement never ended c...

Страница 55: ...t precision for pupil diameter 0 2 mm Measuring range for inter pupillary distance 30 to 120 mm step 0 1 mm Measurement precision for inter pupillary distance 1 mm 18 2 Rechargeable batteries specifications 2WIN S Type of Cell Lithium ion Cylindrical Cells 4 x Panasonic NCR18650B Rated capacity 4 x 3400 mAh 13600 mAh Rated voltage 4 x 3 7V 14 8V Not replaceable by user Battery Pack Input specifica...

Страница 56: ...net supported USB 2 0 Full Speed for data and power source Operates in 2 4 GHz Frequency bands Model LM Technologies LM820 Compliance IEEE 802 11b g n d e h i standards Bluetooth v2 1 EDR v3 0 and v4 0 standards Wi Fi 802 11 b g n Bluetooth v4 0 Backwards compatible with Bluetooth v2 0 v2 1 and v3 0 WPA WPA PSK WPA2 WPA2 PSK and WEP 64bit 128bit Encryption schemes Full speed Bluetooth Piconet and ...

Страница 57: ... Adaptica suggest this option the customer operator is asked to activate the Remote Control option of the 2WIN S This option can be enabled only in the 2WIN S with Wi Fi connection Through the use of this option a direct connection between the 2WIN S and the IT department of Adaptica will be enabled in order to give direct support The operator will be contacted by the IT department of Adaptica by ...

Страница 58: ...also the data saved on the SD card might theoretically be downloaded from the system should such card be left inserted in the instrument at the moment of the activation of the temporary session despite this additional information is of no interest for Adaptica S r l and will neither be acquired nor treated by it it is however advisable to remove the SD card or delete any sensitive data before such...

Страница 59: ...cerned the specific rights that are set out in Article 7 of the Privacy Code purely by way of example and without limitation these include the right to ask for and obtain confirmation of whether or not Telemetry Data of one s own exist and to ascertain their origin the purposes and modalities of the processing and the updating rectification and where required integration of the said Telemetry Data...

Страница 60: ... Use different Shared Folders for different 2WIN S Input file A file generated by your EMR system to provide patient information prior to a measurement screening This file must be named emr_input csv and it must be saved in the Shared Folder Output file A file generated by the KALEIDOS App after a measurement screening that has been performed or has been aborted i e an inconclusive measurement scr...

Страница 61: ...nput file Same contact as provided in input file Spherical measurement value of the right eye in diopters dpt Cylindrical measurement value of the right eye in diopters dpt Axis measurement value of the right eye in degrees deg Pupil diameter measurement value of the right eye in millimeters mm Spherical measurement value of the left eye in diopters dpt Cylindrical measurement value of the left ey...

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