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02 Label and location | ID Label/Location Info | 349.35 KiB | December 02 2020 | |||
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01 Authorization Letter | Cover Letter(s) | 167.37 KiB | December 02 2020 | |||
1 2 | 04 Block Diagram 20201201 | Block Diagram | December 02 2020 | confidential | ||||
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1 2 | 13 5G Software Security 20201201 | Operational Description | December 02 2020 | confidential |
1 2 | 03 User manual 20201201 | Users Manual | 2.10 MiB | December 02 2020 |
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. 1 Contents PREPARATIONS .................................................................. 3 BEFORE USE ............................................................................ 3 USAGE CAUTIONS AND NOTES..................................................... 4 NAMES OF COMPONENTS ........................................................ 10 BATTERY .............................................................................. 14 MPD 100 OPERATION ..................................................... 15 SETUP.................................................................................. 15 GETTING START ..................................................................... 15 USER INTERFACE .................................................................... 16 TAKING WOUND IMAGE AND ANALYSIS ....................................... 17 DATA UPLOAD ....................................................................... 23 ONLINE DIAGNOSTIC ............................................................... 24 OTHER SETTING ..................................................................... 24 SC3 OPERATION .............................................................. 25 SYSTEM REQUIREMENT ........................................................... 25 GETTING START ..................................................................... 25 USER INTERFACE .................................................................... 26 MISCELLANEOUS ............................................................. 39 TECHNICAL DESCRIPTION ......................................................... 39 LIABILITY .............................................................................. 41 DISPOSITION ......................................................................... 41 SYMBOLS AND STANDARDS ...................................................... 42 2 Preparations Before use s n o i t a r a p e r P 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. Caution: Federal law restricts this device to sale by or on the order of a healthcare professionals, and other countries shall be follow. Indication for use Intended for qualified healthcare professionals who trained in its use. The device is intended to be used in hospital or clinic. The device may be used on any human group. The device does not provide a diagnosis or therapy. The clinical benefit is for healthcare professionals, helping deliver state-of-
the-art care to their patients. Contraindications This instrument must not be used for the following patients:
Patients who are hypersensitive to light. Patients who recently underwent photodynamic therapy (PDT). Patients taking medication that causes photosensitivity. Patients with a history of migraines. Patients with a history of photosensitive epilepsy. Patients with any kind of disease which could be induced by flash or strong light. Camera handling Protect the camera from excessive vibration, force, or pressure. Avoid using the camera under the following conditions, which may damage the lens, the monitor, or the control unit and may also cause 3 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. Avoid using the camera under the following conditions, which present the risk that sand, water, or foreign material may enter the camera through the lens or gaps around buttons. Be especially careful because these condition may damage the camera, and such damage may not be repairable:
Operate in extremely dusty or sandy places Exposing the camera to rain or moisture Condensation (When the lens or the monitor is fogged up) Condensation may occur when the camera is exposed to sudden changes of temperature or humidity. Avoid these conditions because they may soil the lens or the monitor, cause mold, or damage the camera. If condensation does occur, turn o the camera and wait for about two hours before using it. Once the camera adjusts to the surrounding temperature, the fogging will clear naturally. No compensation for missed shots We cannot compensate for missed shots if technical problems with the camera or card prevent recording. Usage cautions and notes When in use The camera may become warm if used for long periods of time, but this is not its fault. Keep the camera as far away as possible from electromagnetic equipment (such as microwave ovens, TVs, video games, etc.). 4 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, re, 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. Plug of the power adapter is the disconnect device from the Mains power source. When the camera is not in use, please disconnect the power plug and keep it in a safe place. The eye cannot be exposed to the illumination light at operation. Please remove the battery if the device is not in use for a long time. Before use the device, please make sure that the voltage of the power supply meets the product specifications. The product needs to be installed in a location where it can be easily unplugged its power. The performance criteria of the following description were accepted when operating the device: short-term function abnormal but can be resumed after restarting without operator intervention. Unless basic safety cannot be achieved. Caution Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. Complies with FDA performance standards for laser products except for conformance with IEC 60825-1 Ed. 3., as described in Laser Notice No. 56, dated May 8, 2019. Charging the battery The time required for charging varies depending on the conditions of battery usage. Charging takes longer at high or 5 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. To ensure the safety of the product operation, if the battery reaches its life time, please contact the manufacturer or distributor to buy the spare battery. NOTE The battery cannot be aected by external force impact. Its appearance cannot be damaged. If the battery is broken or damaged by external force, DO NOT USE to avoid dangerous. Memory cards If you purchase dierent memory capacity of memory card, must be preceded format to FAT32. To prevent damage to cards and data:
Avoid high temperatures, direct sunlight, electromagnetic elds, and static electricity. Do not bend, drop, or expose to strong impacts. Do not touch the terminals or allow them to become dirty or wet. When operating this device, please do not remove or insert the memory card. When disposing of/transferring memory cards:
If using the format or delete functions on your camera or computer, this only changes the le management information and does not completely delete the data from the memory card. When disposing of or transferring your memory cards, we recommend physically destroying them or using commercially available computer data erasing software to completely delete the data from the card. Data on memory cards should be 6 managed responsibly. Protection Do not attempt to remove the cover from the product to prevent the product from malfunctioning. No modication of this device is allowed. The performance would be subject to any modication and may cause hazardous radiation exposure. EMC (electromagnetic compatibility) During installation and operation of the device, observe the following instructions:
When operating the device simultaneously with other electronic equipment, please make sure the distance between the device and other electronic equipment is no closer than 30 cm (12 inches) to any part of the device, including cables specified by the manufacturer. Do not use or stack the device near, on, or under other electronic equipment to avoid electromagnetic interference with the operation of the device. Do not use the system with portable and mobile radio frequency communication systems because that may have an adverse eect on the operation of the device. Do not use cables or accessories that are not specied for the device because that may increase the emission of electromagnetic waves from the device and decrease the immunity of the device to electromagnetic disturbance. The product is not an RF electromagnetic energy medical product for the purpose of transmitting or receiving. Cleaning and disinfection The device is a precision photo electronic instrument that shall be handled with specic care. Please note the following cleaning instructions:
Turn o the device before cleaning it. Disinfect the camera with CaviWipes and maintain 3~5 mins. Wait for the cleaning liquid to dissolve before turning the power on and connecting USB cable or other device to the camera. 7 It is recommended to clean the cover lens with a clean cloth and solvent (clean water with 75% alcohol) The device is not intended to be sterilized. Disinfect the device is a commercial product and be with CaviWipes that manufactured by THORLABS Inc. (www.thorlabs.com). NOTE 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. The images on MPD 100 & SC 3 may contain identifiable patient information and it is the responsibility of the health care provider to ensure that data safeguards are implemented to protect patient health information. Please note that the actual controls and components, menu items, and other information of your camera may dier from those in the illustrations provided in these instructions. Operating Environment Ambient temperature:
Relative humidity:
Atmospheric pressure:
Shock (without packing):
Environment for Storage Ambient temperature:
Relative humidity range:
Atmospheric pressure:
Environment for Transportation Ambient temperature:
Relative humidity range:
Atmospheric pressure:
Vibration, sinusoidal:
8 10C to +35C 30% to 90%
800hPa to 1013hPa 10G, duration 6ms
-10C to +55C 10% to 95%
700hPa to 1013hPa
-40C to +70C 10% to 95%
500hPa to 1013hPa 10Hz to 500 Hz: 0.5G 30G, duration 6ms 10G, duration 6ms Shock:
Bump:
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. These limits are designed to provide reasonable protection against harmful interference in a standard medical installation. If this device does cause harmful interference to other devices, which can be determined by turning the system o and on, the user is encouraged to try to correct the interference through one or more of the following measures: Reorient or relocate the receiving device. Connect the device to an outlet on a circuit dierent from that to Increase the separation between the system and other devices. which the other device(s) are connected. Consult the manufacturer or eld service technician for help. The International Electrotechnical Commission sets the essential requirements for electrical and electronic equipment that may disturb or be disturbed by other equipment. The device complies with these requirements as shown in the tables in Symbols and standards: EMC. Follow the guidance in the tables for use of the device in an electromagnetic environment. IT Network Security Computers used to connect to the device should be note the following security instructions:
Make sure anti-virus software is installed in personnel computer before connecting the device to it and keep the latest version. Recommended anti-virus software, Android: Norton Mobile Security Windows: Norton Internet Security 9 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. The responsible organization which operates SC 3 and MPD 100 should identify, analyze, evaluate and control the risks when the devices connect to an IT-Network. Subsequent changes to the IT -NETWORK could introduce new RISKS and require additional analysis. These changes include:
Changes in the IT-Network configuration. Connection of additional items to the IT-Network. Update of equipment connected to the IT-Network Upgrade of equipment connected to the IT-Network. Names of components Scope of Delivery Product Name Model Name Accessories Smart Wound Carer MPD 100 Wound Care System 1. Battery 2. Power adapter 3. USB (Type C) cable 1.0m
(Shielded) Wound Care Platform SC 3 N/A The Wound Camera MPD series can only be used with SC 3 platform for wound care. NOTE 10 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. 11 Flash LED Earphone Power indicator Front Camera Proximity Sensor
** Power on/off Push power button around 10 seconds. MPD 100 - Outline Function Volume
Function I/O plug Power button Touch Panel Micro Phone Audio Jack USB-C Return Enter Home Function Smart Card Reader Plug
** One the plus is removed, the smart reader slot cannot be waterproof anymore. 12 Rear View 3D -Depth Camera Rear Camera Hand strap Interface
** Please do not look the 3D depth camera and Flash LED directly. 13 Thermal Camera Flash LED Battery strap Battery Package Speaker Battery Always charge before rst use Prior to rst 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 ve hours. Battery replacement Please do not touch the electrode with a nger 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. Pull up Pull up Pull down Pull down Battery buckle Released Battery buckle Locked Pull battery up 14 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. 15 User interface Patient Information Patient ID Wound location Thermal image live view Depth image live view User Information User name Non-upload file Function Bar Patient list Remote call Wound care system Setting Reference target detector Flashlight Color image live view 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. 17 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. 18 19 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 Click capture button to get color, thermal, and depth image at the The image will show in the preview window after capturing. 30cm ~ 60cm. same time. Note:
All dressings and coverings should be removed before capturing the The distance between device and the wound should be around 30cm ~
image. 60cm. The most accurate condition for image analysis is indoors (without 20 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 APP will mark the wound region automatically, and user can re-
the wound analysis page. adjust the region manually. The wound dimensions, area and tissue distribution ratio will show at the lower side of the screen, user can re-adjust the result manually. 21 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. 22 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. 23 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. Remind message on SC3 24 SC 3 Operation System requirement Before SC 3 installation and operation, please make sure the system meets the following minimum hardware requirements:
Hardware CPU RAM GPU Software Hard Disk Operating system 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) ChromeFirefox Java 1.7 Spring framework, Tomcat, Video Conference Docker, python-based AI Tomcat 7.x TortoiseSVN 1.13.x SQL Server 2012 1. 802.11 a/b/g/n/ac Browser Programming language Server Software version control Database WLAN Network Bluetooth Bluetooth 5.0 IP Open ports: 8080, 443, 8007, 8180
** The hardware system is suggestion specification. 25 Getting start Enter the SC 3 wound care platform. Log in The system will guide to hospitals user interface. Tap wound care platform (SC 3). 26 Main page The view of patient care information 27 No. Function Description 1 Patient / image list 4 Visit date selection Basic patient information Patient wound location Wound image browsing Main function buttons 2 3 5 6 7 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.) This provides a list of wound records of multiple parts of the patient, and the medical staff can choose one part to view the detailed information. According to the wound location, a menu of records corresponding to the date of visit is provided, and the medical staff can view the detailed record information at any point. The left and right blocks each provide an image preview function of the wound, and the user can slide/enlarge the image at will to grasp the current healing state of the wound. The left block is an additional function button, which corresponds to the related chart information of the daily medical record, and the right button of the right block contains the export of electronic drawing files, wound analysis and storage. This displays the wound information, recovery process radar chart, health education information and treatment methods of each medical record. Wound information
/ graph display 28 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. After the patient information is created and saved, the system will display the information on the platform screen automatically. The view of patient information search Basic patient information preview and edit User can see and edit basic patient information, including medical record number (uncorrectable), ID card, name, age, related disease history, and other notes. Because the medical record number is the key value (search condition), when the user updates the patient data, the system is forced to edit it to ensure the integrity and consistency of the data. After the patient's basic data is updated and saved, the screen will display the latest information simultaneously. The operation sequences are as follows:
Step 1. Click the Edit button. Step 2. Fill in/update the contents of the field (only the medical record number cant be modified). Confirm the update information, and click the Save button. If the contents are not updated, click the Cancel button. 29 Step 3. The system displays the updated basic patient information automatically. 30 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.
(2) Date of Occurrence: the date can be selected through the calendar.
(3) Case closed: user can select whether the case is closed. The operation procedure of the wound location list (take patient wound list management as an example) is as follows:
Step 1. Check the initial screen of patient wound list Step 2. Click one column of the wound list and click the Add/Edit/Delete button. Step 3. Fill in / update the contents of the field (common parts, date of occurrence and whether the case is closed). Step 4. Confirm that the update information is correct, and then click the Save button. If not updated, click the Cancel button. The system will automatically display update / addition records on the wound location list. 31 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. After the date is selected, the thumbnail and enlarged image will be displayed on the screen. 32 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. The view of wound images presented side by side
(different dates). 33 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. Step 2: Check/enter wound related information (Size and organization can be brought in by APP) Step 3: Fill in sneaky deep hole records (with functions such as creation/editing/deletion) Step 4: After confirming that the information is filled in correctly, click the Save button to save the data. 34 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. 35 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. 36 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. Graphical display of wound recovery status. 37 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.
** Users can export the wound information to wound summary report file formats (PNG). 38 Miscellaneous Technical description MiiS Horus Scope MPD 100 Display Processor System Memory Storage Wireless External I/O Control Button Touch Panel LED indicator Audio
- 5 (1280*720), TFT LCD
- 500 nit (typ.) With Direct optical bonding for sunlight readable
- Projective Capacitive Multi-touch Qualcomm Kryo 260CPU,Octa-core,up to 2.2GHz 3GB SDRAM 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. TBD) 1 x Audio Jack 1 x Smart card reader slot 1 x Volume +/-
1 x Power button 2 x Function button 4 x Front Key 10-Point multi touch, support /Hand/Gloves and Rain Mode on, On-screen QWERTY keyboard 1 x LED indicator Orange: The battery is charging. Green: The battery is full charged. No light: The battery is not in charging status. 2 x Built-in Microphone 1 x Speaker 1 x Front Receiver 39 Battery Power Adapter External Power Working Range Viewing area 3.7V 3900mAh Li-ion removable battery Input Spec.: 100-240Vac, 0.6-0.3A, 50-60Hz;
Output Spec.: 5V DC, 1.2A Source: 100~240 VAC, 50/60 Hz 30cm~60cm. Typ. 24.5 x 18.5 cm at 30cm working distance. Typ. 49.1 x 36.9 cm at 60cm working distance. Accuracy 2.5mm Scene range 28C ~ 40C Thermal image Tissue classification 4 type (epithelium/granular/slough/eschar) 3D wound measurement Dimensions (W x L x H) Weight (g) Expected service life
(dened by manufacturer) 5 years from the date of initial operation
*Proper maintenance is necessary. 85.9 x 163.2 x 26 mm (Typ.) 340g +/- 5%
40 Liability Manufacturer considers itself responsible for the eects 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, modications or repairs are carried out by persons authorized. The electrical installation of the relevant room complies with the The equipment is used in accordance with these instructions for use. requirements. Disposition Follow the local governing ordinances and recycling plans regarding disposal or recycling of device components, especially when disposing of the lithium ion battery, circuit board, plastic parts that contain brominated ame retardant, LCD, or power cord. Follow the local governing ordinances and recycling plans when disposing of the circuit board with the lithium battery. Inappropriate disposal may contaminate the environment. When disposing of packing materials, sort them by material and follow local ordinances and recycling regulations. Inappropriate disposal may contaminate the environment. When disposing of eyecup, follow the disposal procedures for medical waste such as needles, infusion tubes, and metal instruments for surgery as specied by your medical facility to avoid infection outside the facility and environmental pollution. 41 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. Non-ionizing electromagnetic radiation The identification number assigned by the Federal Communication Commission 2AFB3M-MPD100 Certification for Taiwan NCC ID: CCXXxxYYyyyZxW European Authorized Representative Catalogue Number 42 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. CLASS 1 LASER PRODUCT 43 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 General radio compliance 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 standards (such as EN 60601-1 and IEC 60601-1). Furthermore, all congurations shall comply with the system standard IEC 60601-1. Anyone who connects additional equipment to the signal input part or signal output-part congures a medical system and is therefore responsible for the system complying with the requirements of the system standard IEC 60601-1. If in doubt, consult the technical service department of your local representative. NCC 45 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. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy. If not installed and used in accordance with the instructions, it may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try and correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna Increase the distance between the equipment and the receiver Connect the equipment to an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio/TV technician for help The correction of interference caused by such unauthorized modification, substitution, or attachment will be the responsibility of the user. SAR The device is designed and tested to meet the applicable limits for radio frequency (RF) exposure established by the Federal Communications Commission (U.S.A.) Specific Absorption Rate; (SAR) refers to the rate at which the body absorbs RF energy. The minimum allowable SAR distance is 5 mm, and the maximum allowable SAR limit is 4.0 W/kg, averaged over 10 gram of tissue for the device. The following SAR values were measured during product certification, 1.060 W/kg with a (0mm gap) a value well below the maximum allowable limit of 4.0 W/kg. 46 Lappareil est conu et test pour respecter les limites applicables aux frquences radio (RF) exposition tablie par la Federal Communications Commission (tats-Unis). Taux d'absorption; (SAR) fait rfrence la vitesse laquelle le corps absorbe de l'nergie RF. La distance DAS minimale autorise 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 priphrique. Les valeurs de DAS suivantes ont t mesures lors de la certification du produit, 1,060 W / kg avec un
(cart de 0 mm), une valeur bien infrieure la limite maximale autorise de 4,0 W / kg. EMC (Electromagnetic Compatibility) The device complies with the International Electrotechnical Commission standards (IEC 60601- 1-2: 2014) for electromagnetic compatibility as listed in the tables below. Follow the guidance in the tables for use of the device in a Professional Healthcare Environment. 47 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 RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Class A *1 Voltage fluctuations/
Flicker emissions IEC 61000-3-3
*2 Electromagnetic environment -
guidance The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings domestic purposes. used for
*1 For the regions where the rated voltage is 220 V or greater, this device complies with class A. For the regions where the rated voltage is 127 V or less, this standard is not applicable.
*2 For the regions where the rated voltage is 220 V or greater, this device complies with this standard. For the regions where the rated voltage is 127 V or less, this standard is not applicable. 48 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 IEC 60601 test level Compliance level Electromagnetic environment - guidance Floor should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrostatic Discharge (ESD) IEC 61000-4-2 8 kV contact 2, 4, 8, 15 kV air 8 kV contact 2, 4, 8, 15 kV air Electrical fast transient/burst IEC 61000-4-4 2 kV for power supply lines 1 kV for input/output lines 2 kV for power supply lines 1 kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 0.5, 1 kV line(s) to line(s);
0.5, 1, 2 kV Line to ground 0.5, 1 kV line(s) to line(s);
0.5, 1, 2 kV Line to ground Mains power quality should be that of a typical commercial or hospital environment. Voltage, dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 0% UT for 0.5 cycle
(1 phase) 0% UT for 1 cycles 70% UT for 25/30 cycles
(50/60 Hz) 0%
UT for 250/300 cycles (50/60Hz) 0% UT for 0.5 cycle (1 phase) 0% UT for 1 cycles 70% UT for 25/30 cycles (50/60 Hz) 0% UT for 250/300 cycles (50/60Hz) Power frequency
(50 or 60 Hz) magnetic field IEC 61000-4-8 30 A/m (50 or 60 Hz) 30 A/m at 50 Hz NOTE: UT is the a.c. mains voltage prior to application of the test level. Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 49 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 IEC 60601 test level Compliance level Conducted RF IEC 61000-4-6 3 Vrms at 0.15 80 MHz & 6V at ISM Frequency 3 Vrms at 0.15 80 MHz & 6V at ISM Frequency Electromagnetic environment -
guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol:
Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.7 GHz 80% AM at 1kHz 3 V/m 80 MHz to 2.7 GHz 80% AM at 1kHz NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above 3V/m., the device should be observed to verify normal operation. If 50 810 870 930 1720 1845 970 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) 385 380-390 TETRA400 1.8 0.3 Pulse modulationb 18 Hz FMc5kHz deviation 1 kHz sine Pulse modulationb GMRS460, FRS460 LTE band 13,17 450 430-470 2 0.3 710 704 -787 0.2 0.3 Immunity test level
(V/m) 27 28 9 745 780 Test specifications for enclosure port immunity to RF wireless communications equipment 28 800-960 GSM 800/900, TETRA800, i 217 Hz Pulse modulationb 18 Hz 2 0.3 1700-1990 GSM 1800; CDMA 1900;
Pulse modulationb 217 Hz DEN 820, CDMA 850, LTE Band 5 GSM 1900; DECT; LTE Band 1,3,4,25; UMTS 2 0.3 28 2450 2400-2570 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 Pulse modulationb 217 Hz 2 0.3 28 5100-5800 WLAN 802.11 a/ n 5240 5500 5785 a For some services, only the uplink frequencies are included. b The carrier shall be modulated using a 50 percent duty cycle square wave signal. c As an alternative to FM modulation, 50 percent pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. Pulse modulationb 217 Hz 0.2 0.3 9 WARNING Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. The minimum separation distance for higher immunity test levels shall be calculated using the followin equation: , where P is the maximum power in watts
(W),d is the minimum separation distance in meters [m), and Fis the immunity test level in V/m. Please visit www.miis.com.tw for more information. 51 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 Name Address Email AcmeBiotechs Consulting Incorporation US Agent 19630 Pilario Street Rowland Heights , CA US 91748 Acmebiotechs@Gmail.Com MedNet EC-REP GmbH Borkstrasse 10, 48163 Mnster, Germany
1 2 | 02 Label and location | ID Label/Location Info | 349.35 KiB | December 02 2020 |
Medimaging Integrated Solution Inc. Label and Label location Brand Name:
Model Name: MPD 100 1. SN Label on the MPD 100 rear side: Label size is 42mm x 12.5mm 2. Product Label on the battery room of MPD 100: Label size is 40mm x 20mm 1. S/N label: 42x12.5mm 2. Product label: 40x20mm Highly Confidential Page 1 Copyright@2020 MiiS Inc. All rights reserved
1 2 | 01 Authorization Letter | Cover Letter(s) | 167.37 KiB | December 02 2020 |
Medimaging Integrated Solution Inc. 3F, No. 24-2, Industry E. Rd. IV, Hsinchu Science Park, Hsinchu, Taiwan 30077 Date: Oct. 15, 2020 Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 To whom it may concern:
I, the undersigned, hereby authorize Underwriters Laboratories Taiwan Co., Ltd. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by Underwriters Laboratories Taiwan Co., Ltd. on our behalf shall have the same effect as acts of our own. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing Underwriters Laboratories Taiwan Co., Ltd. as our representative, we still recognize that we are responsible to:
a) comply with the relevant provisions of the certification pro gram;
b) make all necessary arrangements for the conduct of the evaluation, including provision for examining documentation and access to all areas, records (including internal audit reports) and personnel for the purposes of evaluation (e.g. testing, inspection, assessment, surveillance, reassessment) and resolution of complaints;
c) Make claims regarding certification only in respect of the scope for which certification has been granted;
d) Do not use our product certification in such a manner as to bring the Certification Division into disrepute and not make any statement regarding our product certification which the Certification Division may consider misleading or unauthorized;
e) Upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and return any certification documents as required by the Certification Division;
f) Use certification only to indicate the products are certified as being in conformity with specified standards;
g) Endeavor to ensure that no certificate or report nor any part thereof is used in a misleading manner;
h) ensure that any reference to our product certification in communication media such as documents, brochures or advertising, complies with the requirements of the Certification Division;
1) keep a record of all complaints made known to us relating to the products compliance with requirements of the relevant standard and to make these records available to the when requested;
j) take appropriate action with respect to such complaints and any deficiencies found in products or services that affect compliance with the requirements for certification;
k) Document the actions taken. This authorization is valid until further written notice from the applicant. Sincerely Yours, Signed by:
eu Company Name: Medimaging Integrated Solution Inc. Contact Name / Title of Person: Luu Hsu / Vice President Tel: +886 3 5798860 #1700 Fax: +886 3 579 8011 Email: luu@miis.com.tw |
Address: 3F, No. 24-2, Industry E. Rd. IV, Hsinchu Science Park, Hsinchu, Taiwan 30077
1 2 | 07 FCC Request for confidentiality letter ( long term ) | Cover Letter(s) | 72.45 KiB | December 02 2020 |
Medimaging Integrated Solution Inc. 3F, No. 24-2, Industry E. Rd. IV, Hsinchu Science Park, Hsinchu, Taiwan 30077 Date: 2020/10/15 Federal Communications Commission Office of Engineering and Technology Laboratory Division 7435 Oakland Mills Rd. Columbia MD 21046 Subject: Request for Confidentiality FCC ID : 2AFB3M-MPD100 To whom it may concern:
Pursuant to the provisions of Sections 0.457 and 0.459 of the Commissions rules (47 CFR 0.457, 0.459), Medimaging Integrated Solution Inc. hereby requests confidential treatment for documents filed with the Commission in connection with the application for equipment authorization referenced above. Permanent Confidentiality e Schematics Diagrams e Block Diagram e Operation Description Above mentioned document contains detailed system and equipment description are considered as These materials contain trade secrets and proprietary information and are not customarily released to the public. The public disclosure of this information might be harmful to the company and provide unjustified benefits to our competitors. Sincerely, su Company Name: Medimaging Integrated Solution Inc. Contact Name: Luu Hsu Title of Person: Vice President Tel: +886 3 5798860 #1700 Email: luu@miis.com.tw v1.0
1 2 | 12 Declaration Letter WLAN Ch 12-13 | Cover Letter(s) | 39.24 KiB | December 02 2020 |
Medimaging Integrated Solution Inc. 3F, No. 24-2, Industry E. Rd. IV, Hsinchu Science Park, Hsinchu, Taiwan 30077 Date: Oct. 15, 2020 We, Medimaging Integrated Solution Inc., declare that the device does not support channel 12 ~ 13 in 2.4GHz band and any non-US channels in all the operational mode(s) for the following product. FCC ID: 2AFB3M-MPD100 If you should have any question(s) regarding this declaration, please dont hesitate to contact us. Thank you!
Sincerely yours, mpany Name: Medimaging Integrated Solution Inc. Contact Name / Title of Person: Luu Hsu / Vice President Tel: +886 3 5798860 #1 700 Fax: +886 3 579 8011 E-mail: luu@miis.com.tw
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2020-12-02 | 2412 ~ 2462 | DTS - Digital Transmission System | Original Equipment |
2 | 5745 ~ 5825 | NII - Unlicensed National Information Infrastructure TX |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2020-12-02
|
||||
1 2 | Applicant's complete, legal business name |
Medimaging Integrated Solution Inc.
|
||||
1 2 | FCC Registration Number (FRN) |
0024731028
|
||||
1 2 | Physical Address |
3F, No. 24-2, Industry E. Rd. IV, Hsinchu Science Park
|
||||
1 2 |
3F, No. 24-2, Industry E. Rd. IV
|
|||||
1 2 |
Hsinchu, N/A
|
|||||
1 2 |
Taiwan
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
L******@ul.com
|
||||
1 2 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 2 | Grantee Code |
2AFB3
|
||||
1 2 | Equipment Product Code |
M-MPD100
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
L****** H******
|
||||
1 2 | Telephone Number |
+886 ******** Extension:
|
||||
1 2 | Fax Number |
+886 ********
|
||||
1 2 |
l******@miis.com.tw
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | DTS - Digital Transmission System | ||||
1 2 | NII - Unlicensed National Information Infrastructure TX | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | MiiS Horus Smart Wound Carer | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Grant Comments | Power is conducted. This device has 20 MHz and 40 MHz bandwidth modes. The highest reported SAR for body-worn accessory and simultaneous transmission exposure conditions is 1.10 W/kg, and 1.10 W/kg, respectively. | ||||
1 2 | Power is conducted. This device has 20 MHz, 40 MHz and 80 MHz bandwidth modes. The highest reported SAR for body-worn accessory and simultaneous transmission exposure conditions is 1.09 W/kg, and 1.09 W/kg, respectively. | |||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
Underwriters Laboratories Taiwan Co., Ltd.
|
||||
1 2 | Name |
R**** C******
|
||||
1 2 | Telephone Number |
886-2********
|
||||
1 2 | Fax Number |
+886-********
|
||||
1 2 |
R******@ul.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | CC MO | 2412.00000000 | 2462.00000000 | 0.0810000 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15E | CC MO | 5180 | 5240 | 0.015 | |||||||||||||||||||||||||||||||||||
2 | 2 | 15E | CC MO | 5745 | 5825 | 0.013 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC