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ATsens AT-Patch ATP-C70, Руководство пользователя

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AT-Patch User Manual

 

Product Disposal 

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This product is a medical device for single use only. Reuse is prohibited. 

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Disposal of ATP-C70 and battery must comply with local waste disposal regulations. Non-
compliance with waste disposal regulations may result in environmental pollution. 

 
 

 

Содержание AT-Patch ATP-C70

Страница 1: ...al device for single use only Reuse is prohibited This product is a medical device The warranty period is 12 months from the date of manufacture AT Patch User Manual MODEL ATP C70 UM C 002 Ver 2 0_08...

Страница 2: ......

Страница 3: ...ons for Operating and Attaching the Device ATP C70 11 Instructions for Installing the App AT Note 15 Specifications 17 Product Disposal 18 Labeling and Packaging 19 Labeling 19 Packaging 20 How to Use...

Страница 4: ...Components Device Components Basic Components AT Patch Pad Paper Sealing Bag Quick Guide Symptom Note Gift Box Sub Patch Figure 1 1 AT Patch Basic Components Classification Electrocardiographic Holter...

Страница 5: ...to be provided to the users A product with a test report or a certificate issued by national or accredited offices is used A dedicated BLE dongle used when connecting the device with PC S W through BL...

Страница 6: ...Hard disk space Main SSD 512GB Back up HDD 1TB Graphics card DirectX 9 or later with WDDM 1 0 driver Display 1920 x 1080 24 inch Full HD Monitor OS Windows 10 64bit Instructions for Use ATP C70 is a d...

Страница 7: ...d technicians are allowed to repair or disassemble ATP C70 Make sure to be fully aware of how to use the product through sufficient training before using it Avoid use at locations where wireless commu...

Страница 8: ...e device Patients with sensitive skin or skin allergy Patients with wounds on the skin that contact the device Pregnant women breastfeeding mothers infants or children Patients with pacemakers defibri...

Страница 9: ...wing measures are being taken to ensure the safety of information Administrative Measures Annual personal information protection act training Technical Measures Encryption of personal information inst...

Страница 10: ...torage Conditions for Use Temperature range 10 45 Relative humidity range 10 95 non condensing Atmospheric range 700hPa 1060hPa Dustproof and waterproof grade IP44 Conditions for Storage Temperature r...

Страница 11: ...ton turns the power ON and the power status can be confirmed through LED 4 Main Patch Main Patch attaches to the surface of the skin Medical grade adhesive tape is used 5 Sub Patch Sub Patch allows fi...

Страница 12: ...and three beep bebeep sounds During the initial connection process the connection between the device ATP C70 and AT Report PC S W Hookup or the App must be established at least once Otherwise the conn...

Страница 13: ...t a 45 degree angle If necessary remove possible obstructions like hair using a razor etc as shown in the shave the patch attachment site figure Figure 1 3 Attachment preparation step Confirming attac...

Страница 14: ...ce so that it is tilted toward the left nipple area using the line in the middle between the two clavicles as the center However if the patient has a fuller chest or if diagonally attaching the device...

Страница 15: ...shown in Figure 1 6 search for either AT Note ATsens AT Patch in the Android market Google Play https play google com store search field 2 As shown in Figure 1 6 click Install to download and install...

Страница 16: ...in Figure 1 7 search either AT Note or ATsens in the iOS App StoreSM https www apple com ios app store search field 2 As shown in Figure 1 7 click Install to download and install the App once the sea...

Страница 17: ...RF Frequency Band of TX 2 4GHz Bandwidth of the Receiver 2400 2480MHz S W CPU ARM Cortex M4 Supported App Up to Android 5 x or iOS 11 x Supported PC S W Version Window 10 64bit Power Requirement Power...

Страница 18: ...This product is a medical device for single use only Reuse is prohibited Disposal of ATP C70 and battery must comply with local waste disposal regulations Non compliance with waste disposal regulatio...

Страница 19: ...ct 2 Date of manufacture 3 For European Authorized Representative 4 Keep dry 5 Protected against solid objects bigger than 1mm Water splashing from all directions 6 Caution The equipment may be damage...

Страница 20: ...t 1EA Paper Scissors Tape Bag Sealing Gift ATP C70 1EA BAG GIFT Scissors Sub Patch 1EA Handling Symptom Note 1EA Vellum paper Handling Quick Guide 1EA Vellum paper Handling PC S W Accessories Classifi...

Страница 21: ...red data in a two dimensional form Screen with the App AT Note Icon Initial Run Screen Figure 1 8 AT Note_App icon installed intro screen No Item Description 1 App AT Note Icon The App AT Note can be...

Страница 22: ...shows up 2 Device PSN information input field Input field where the PSN information of the device to connect is entered 3 Connect to device icon Once the icon is clicked connecting to the device with...

Страница 23: ...icon Icon that leads to the Symptom Note entry screen 3 The Day number of using the App AT Note and current date output section A section displaying the Day number of using the App AT Note and curren...

Страница 24: ...Use the AT Note App LIVE Display Screen 24 AT Patch User Manual LIVE Display Screen Figure 1 11 Live display screen left zoomed in ECG graph section top right zoomed in 3 axis data graph section botto...

Страница 25: ...is data being measured in real time 10 Record real time data icon Icon for recording the ECG and 3 axis data being measured in real time 11 ECG graph zoom out icon Icon for shrinking the ECG graph bei...

Страница 26: ...reen Figure 1 12 Screen displayed after the Record button is clicked Upon tapping the Record icon in the left screen of the Figure 1 12 above the Record icon is replaced with the Stop icon and recordi...

Страница 27: ...r of date time of occurrence of given symptom type of symptom activity status and other opinions Once a Symptom Note entry is made the list of Symptom Note entered is displayed in the main page Figure...

Страница 28: ...lessly via Bluetooth to the App and the App receives the event information from the device As shown in the screen on the right a dialog box is displayed to ask whether to record the symptoms immediate...

Страница 29: ...creen for Symptom Note entries made using the App No Item Description 1 Go Back icon Icon for the Go Back command 2 Time Symptom occurrence start time and end time 3 Symptom type Displays symptom type...

Страница 30: ...only the symptom start time All other content hasn t been set yet Because the Symptom Note entry is incomplete the Symptom Note entry completion status is displayed in black Through the details scree...

Страница 31: ...sion icon area for each item indicated Upon tapping each revision icon or revision icon area the previously selected values for the items are displayed on the screen Since there are no values set for...

Страница 32: ...mptom occurrence start time revision 2 Symptom occurrence end time revision icon area Area serving as the command icon for symptom occurrence end time revision 3 Symptom type revision icon Area servin...

Страница 33: ...g data can be accessed through the screen that lists the registered Symptom Note entries for a Day number of using the App The ECG recording data does not include Symptom Note contents only ECG data T...

Страница 34: ...h the 3 axis sensor 9 Y axis graph Graph of the recorded Y axis measurement through the 3 axis sensor 10 3 axis data output section A section displaying the 3 axis data output being measured in real t...

Страница 35: ...Seongnam daero 331beon gil Bundang gu Seongnam si Gyeonggi do Republic of Korea Factory 13637 Point Town 803 11 Gumi ro Bundang gu Seongnam si Gyeonggi do Republic of Korea Email sales atsens com Tel...

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