MiiS Horus Scope Wound Care System Smart Wound Carer MPD 100 Wound Care Platform SC 3 User Manual DOC. No. TBD Ver. TBD Date of issue: October. 2020 Copyright@2020 MiiS Inc. All right reserved.
Contents PREPARATIONS ..................................................................3 BEFORE USE ............................................................................ 3 USAGE CAUTIONS AND NOTES..................................................... 4 NAMES OF COMPONENTS ........................................................ 10 BATTERY .............................................................................. 14 MPD 100 OPERATION ..................................................... 15 SETUP..
Before use Prior to installation and start-up of the Horus Scope MPD 100 and SC 3, carefully read the user manual. As with all technical devices, the proper function and safety operation of this device depend on the user complying with the safety recommendations described in these operating instructions. In addition, please make sure that it does not appear damaged or broken. If there are breaks on the outer casing or other visual defects, please contact the manufacturer or a certified service facility.
the camera to malfunction or prevent recording: • Dropping or hitting the camera against a hard surface. • Exerting excessive force on the lens or the monitor. Once the smart card reader slot cover is removed, the camera is not dust resistant, splash resistant, or waterproof. Avoid using the camera in places with excessive dust or sand, or where water can come into contact with the camera.
Do not use the camera near radio transmitters or high-voltage lines. Never leave the camera and the battery in a car or on a car hood in the summer. Doing so may cause leakage of the battery electrolyte, overheating, fire, or a battery explosion due to the high temperature. If the camera gets wet, do not attempt to dry with a heater, microwave, autoclave, or UV light. Do not extend the supplied cables. Do not keep the power cord near any heat source.
low temperatures and when the battery has not been used for some time. The battery will get warm during charging and for some time thereafter. The battery will be drained completely if not used for long periods of me, even after being charged. Only use Li-ion Battery 3.7V / Capacity 3900mAh which shall be provided by the manufacturer or distributors. The battery has designed the protection circuit.
managed responsibly. Protection Do not attempt to remove the cover from the product to prevent the product from malfunctioning. No modification of this device is allowed. The performance would be subject to any modification and may cause hazardous radiation exposure.
It is recommended to clean the cover lens with a clean cloth and solvent (clean water with 75% alcohol) NOTE The device is not intended to be sterilized. Disinfect the device with CaviWipes that is a commercial product and be manufactured by THORLABS Inc. (www.thorlabs.com). Maintenance Please check MPD 100 once every 3 months. It is the health care provider to protect patient health information and to meet regulatory and HIPAA compliance.
• Shock: 30G, duration 6ms • Bump: 10G, duration 6ms NOTE It is recommended to remove the battery if the device is stored over two weeks. Regulations Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. This device has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2: 2014.
The device can only be updated or processed by original factory or a legally authorized distributor. Do not allow unauthorized persons or users to update or process the software with any memory card. Users must keep patient information in a safe place. Physically destroyed the memory card when abandoned. Connection of SC 3 or MPD 100 to an IT-Network that includes other equipment could result in previously unidentified risks to patients, operators or third parties.
Intended for use Wound Care System comprised a digital hand-held wound care device and proprietary software used to record digital photographs, inspect dimensions, area, depth and the condition of wound, determine the boundary of the wound and classify the tissue types of wound and manage the wound care information.
MPD 100 - Outline Flash LED Earphone Front Camera Power indicator Proximity Sensor ** Power on/off Push power button around 10 seconds. Function Function Volume + I/O plug Power button Touch Panel Micro Phone Return Enter Home Function Audio Jack USB-C Smart Card Reader Plug ** One the plus is removed, the smart reader slot cannot be waterproof anymore.
Rear View 3D -Depth Camera Rear Camera Thermal Camera Flash LED Battery strap Hand strap Interface Battery Package Speaker ** Please do not look the 3D depth camera and Flash LED directly.
Battery Always charge before first use Prior to first use, insert the battery into the control unit and close the battery cover referred to the below section. Connect USB connector to the power adapter. Let the battery charged for at least five hours. Battery replacement Please do not touch the electrode with a finger or something pointed. • Remove: Pull the battery strap up and remove the battery from battery room. • Installation: Place the battery into battery room and lock the battery strap to secure it.
MPD 100 Operation Getting start Start up the APP “WoundCareRTC” Log in • Type in your user name and password. • Select login time. (8 hrs. / 1 day. / 3 days.) Note: • In order to secure the personal information, please logout after using the device. • The device will return to the access page after logout successfully.
User interface Function Bar • Patient list • Remote call • Wound care system • Setting • Reference target detector • Flashlight Patient Information Patient ID Wound location Thermal image live view Color image live view Depth image live view User Information User name Non-upload file Preview Capture button 16
Taking wound image and analysis Step 1. Select patient ID. Step 2. Select wound location. Step 3. Capture wound image. Step 4. Wound analysis and data management. Select Patient ID Users can enter/select patient IDs by the following ways. • Past records: the last 10 patient IDs. • Consultation number. • Medical record number. • Identity card number.
Note: The device provides Barcode scanning and OCR to identify the medical record number and ID card number directly. Select wound location User can select the location of the wound by tapping the icon of the human model.
Capture wound image • Move the device to let the wound image in the center of screen and make all the necessary areas visible. • Check the distance between the device and the wound is around 30cm ~ 60cm. • Click “capture” button to get color, thermal, and depth image at the same time. • The image will show in the preview window after capturing. Note: All dressings and coverings should be removed before capturing the image. The distance between device and the wound should be around 30cm ~ 60cm.
sunlight impact) and has adequate lighting. Wound analysis and data management • Click “preview” at the bottom right corner of the screen and get into the preview page. The wound image will be in groups according to patient ID and sorted by date. • Select the image, and the APP will get into detail information page. User can check and modify the patient information and wound position in this page. • Click “wound analysis” at the top right corner of the screen to get into the wound analysis page.
Wound region adjust • If the device is connected to SC 3, user can also select the “AI” button to calculate the wound region and tissue distribution by the online AI model. • Click “done” to save the result and finish the analysis. Note: The AI wound analysis only works when the log-in account has the access authority and the device is connected to the internet.
Data upload Step 1. Check WIFI is connected. Step 2. Click setting button. Step 3. Select “upload wound information”. • After the upload process is completed, the number of unuploaded files will become 0. • User can check the uploaded file in SC 3 wound care platform.
Online diagnostic Case reminder User can tap the remote call button to send a reminding message with patient information to notify the SC 3 wound care platform user (doctor or nurse) and get the medical suggestions.
SC 3 Operation System requirement Before SC 3 installation and operation, please make sure the system meets the following minimum hardware requirements: Hardware Software CPU RAM GPU Intel i7 (Intel VT-x supported) 8GB Nvidia Geforce (RTX 2060 ~ RTX 2080TI) 2.5TB (2MB/per image) MS Windows 10 Pro/Server (or Ubuntu 16.04) Hard Disk Operating system Browser Chrome、Firefox Java 1.7 Spring framework, Tomcat, Video Conference Docker, python-based AI Tomcat 7.
Getting start Enter the SC 3 wound care platform. Log in • The system will guide to hospital’s user interface. • Tap wound care platform (SC 3).
Main page The view of patient care information 27
No. Function 1 Patient / image list 2 Basic patient information 3 Patient wound location 4 Visit date selection 5 Wound image browsing 6 Main function buttons 7 Wound information / graph display Description This provides a list of untreated / closed patients, and a list of wound images of unclassified patients. According to the patient number, the corresponding basic information is displayed. (including name, ID number, age, gender, etc.
Search Patient care information Search by the patient identification number. Step 1. Input the searching content such as medical record number, identity card number, and visit number in English letters and numbers only. Step 2. Click the “search” button. Note: If there is no existing data in the platform, the notification window will jump out and inform the user to create the new patient information.
Step 3. The system displays the updated basic patient information automatically.
Wound location tracking list User can see a list of the wound sites closed and not closed, and click the wound image to view the full course of treatment information. The column in the list shows whether the case is closed, the date of the wound image and the wound location. Click the icon on the up-right corner of the list, then user can delete /edit /add the contents of the fields in the following format: (1) Common parts: user can select the wound location.
The view of wound location tracking list. Wound image preview side by side User can check images in different consultation dates of the same wound side by side. In addition, User can browse the wound images by switching left and right pictures, and see the detailed wound images under the zoom view. The operation procedure of wound image browsing is as follows: Step 1. Select the wound image to be viewed by the capturing date.
Note: for the first time open the wound site during the course of medical information than the region will text mode informs the user must click to see the doctor dates to display than the control sheet). Step 2. Select one of the thumbnail images. The enlarged image of the selected one will show on the screen. ** Slip rat placed in a large region inside may be utilized Movies roller zoom image. The view of wound images presented side by side.
Wound record form The view of wound record form. Wound record form In all fields in the record form, users can manually check / fill in and store relevant measurement data according to the wound detection situation of the patient on the current day (except for the wound size and tissue ratio can be obtained by the system performing wound circle analysis Out of results ) . Step 1: Click the Wound Record button.
The health information The health information Step 1: Choose health education category. Step 2: Choose health education category. Step 3: Check the required health education method as a follow-up key item of wound attention.
The medical order The view of medical order. Step 1: Click the Disposal (medical order) button. Step 2: Provide fields such as application method, other methods, size, quantity and frequency f or the user to record the treatment content. Step 3: Display the current disposal method (can also be used to count the use of dressing), and provide users to edit / delete.
Wound radar chart The view of wound process radar chart. User can see several days wound quantitative data radar chart, showing the way mining display recently four times the state back to the clinic; the date on the top of the radar chart for each data analysis represents the date. The radar chart browsing process is as follows: Step 1: User can click the radar chart button in the function list of the wound history page. Step 2: User can see the recovery radar chart of the patient's wound site.
Wound summary export The view of wound summary export. Step 1: Click the Export Electronic File button to open the image preview screen. Step 2: After confirming that the report content is correct, click Download. Step 3: Get the downloaded PNG image file in the local default download folder. Step 4: Place the picture in the patient report record of the hospital standard, and provide follow-up processing for health insurance application.
Miscellaneous Technical description MiiS Horus Scope MPD 100 Display - 5” (1280*720), TFT LCD - 500 nit (typ.) With Direct optical bonding for sunlight readable - Projective Capacitive Multi-touch Processor Qualcomm Kryo 260CPU,Octa-core,up to 2.2GHz System Memory 3GB SDRAM Storage Wireless External I/O Control Button Touch Panel LED indicator Audio 32GB eMMC, Additional storage available with optional storage card. WLAN: 802.11 a/b/g/n/ac 1 x Micro SD card slot 1 x USB-C 3.0 (Spec.
Battery 3.7V 3900mAh Li-ion removable battery Power Adapter Input Spec.: 100-240Vac, 0.6-0.3A, 50-60Hz; Output Spec.: 5V DC, 1.2A External Power Source: 100~240 VAC, 50/60 Hz Working Range 30cm~60cm. Viewing area Typ. 24.5 x 18.5 cm at 30cm working distance. Typ. 49.1 x 36.9 cm at 60cm working distance. Thermal image Scene range 28°C ~ 40°C Tissue classification 4 type (epithelium/granular/slough/eschar) 3D wound Accuracy ± 2.5mm measurement Dimensions (W x L x 85.9 x 163.2 x 26 mm (Typ.
Liability Manufacturer considers itself responsible for the effects on safety, reliability, and performance of the device only if The device can be reused only if it is reconditioned under the responsibility of the manufacturer to comply with the general safety and performance requirements. Assembly operations, extensions, readjustments, modifications or repairs are carried out by persons authorized. The electrical installation of the relevant room complies with the requirements.
Symbols and standards Symbols CAUTION The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data. Operating Instructions for Use. Manufacturer Date of Manufacture CE-mark Note: Minimum height of CE is 5mm.
Global Trade Item Number Lot number Serial Number GS1 Data Matrix Medical Device Direct current Power button Recycling lithium-ion batteries Specific Battery Recycling Disposal of noncontaminated electrical and electronic equipment This product had an internal rechargeable battery with a Class II power supply.
Keep away from sunlight Hand with care Fragile This side up Fragile, handle carefully Lithium-ion battery Flammable material Follow instructions for use 44
Standards Electrical safety EMC and regulatory compliance Ophthalmic instruments Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments IEC 60601-1:2005+A1:2012 (EN 60601-1:2006+A1:2013) IEC 60601-1-2:2014 (EN 60601-1-2:2015) ISO 15004-1:2006 Federal Communications Commission (FCC) National Communications Commission (NCC) Equipment connected to the analog or digital interfaces must be certified according to the representative appropriate national
Federal Communications Commission (FCC) This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: This device may not cause harmful interference. This device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of FCC Rules.
L’appareil est conçu et testé pour respecter les limites applicables aux fréquences radio (RF) exposition établie par la Federal Communications Commission (États-Unis). Taux d'absorption; (SAR) fait référence à la vitesse à laquelle le corps absorbe de l'énergie RF. La distance DAS minimale autorisée est de 5 mm et la limite DAS maximale admissible est de 4,0 W / kg, avec une moyenne de 10 grammes de tissu pour le périphérique.
EMC (IEC 60601-1-2: 2014) Guidance and manufacturer's declaration - electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function.
Guidance and manufacturer's declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test Electrostatic Discharge (ESD) IEC 61000-4-2 IEC 60601 test level ±8 kV contact ±2, 4, 8, 15 kV air ±2 kV Electrical fast for power supply lines transient/burst IEC ±1 kV 61000-4-4 for input/output lines Surge IEC 61000-4-5 ±0.
Guidance and manufacturer's declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Electromagnetic environment Immunity test IEC 60601 test level Compliance level guidance Conducted RF IEC 61000-4-6 3 Vrms at 0.15 – 80 MHz & 6V at ISM Frequency 3 Vrms at 0.
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Test specifications for enclosure port immunity to RF wireless communications equipment Test frequency (MHz) Banda MHz Servicea Modulationb Maximum power (W) Distance (m) Immunity test level (V/m) 385 380-390 TETRA400 Pulse modulationb 18 Hz 1.8 0.
Medimaging Integrated Solution Inc. 3F., No.24-2, Industry E. Rd.IV, Hsinchu Science Park, Hsinchu,Taiwan 30077, R.O.C. Tel: +886-3-5798860 / 5798865 Fax: +886-3-5798821 Web: http://www.miis.com.tw/ US Local Representative Company AcmeBiotechs Consulting Name Incorporation – US Agent 19630 Pilario Street Address Rowland Heights , CA US 91748 Email Acmebiotechs@Gmail.
