User Manual CorX Smartwatch (Model: SMD1800) FCC ID:2AT4JSMD1800 File No:CE-01-08.4 Version: 3.
1 CONTENTS 1 CONTENTS........................................................................................................................................................................ 2 2 INFORMATION ABOUT THIS MANUAL ............................................................................................................................. 4 3 TECHNICAL FEATURES .........................................................................................................................................
20 SHEET MACHINE .......................................................................................................................................................... 45 21 DISCLAIMERS ............................................................................................................................................................... 46 22 TRADEMARK AND COPYRIGHT INFORMATION ............................................................................................................
2 INFORMATION ABOUT THIS MANUAL This documentation supporting the use of the device, is not intended for sales; its partial or total reproduction is forbidden without the express permission. The information contained in this document is subject to change without notice for reasons of a technical trade. It ensures, however, that this manual corresponds to your device delivered. The offsets will be included in new editions.
3 TECHNICAL FEATURES The CorX Smartwatch(Model: SMD1800, Hearinafter shortened as CorX) are conform to the general rules on electrical safety of Electrical Appliances for medical use EN 60601-1, and also to detailed and collateral use applicable. The manufacturer reserves the right to make product changes without notice according to the evolution of technology and standards. 3.
SpO2 SpO2 range SpO2 accuracy (Arms) PR range PR accuracy Wavelength / Power 70% to 100% 80-100%: +/-2%, 70-79%: +/-3% 30 to 250 bpm +/-2 bpm 660nm & 880nm / 6.5 mV & 9.5 mV Technical specifications of the battery charger cable: Weight Dimensions (charging head) Cable length 17g 18.45x9x6.
4 DESCRIPTION CorX – The CorX is a class IIa medical device that satisfies the electrical safety requirements required by international standards. The CorX is designed to perform exams with one derivation ECG, with a particularly fast procedure, which uses a graphical interface controllable tablet or smartphone. This procedure records and collects all the information from while performs the data entry with personal data of the patient.
WARNINGS The diagnosis of lower myocardial infarction without the use of precordial leads could cause false positives. • • • • • • • • The use of this device / system is not substitute for over methods of diagnosis. Do not change any medication or treatment without consulting your doctor. This device cannot detect a heart attack. If you are not feeling well, need consulting your doctor. The Telemedicine diagnosis may not be appropriate for certain diseases.
4.1 Basic Structure CorX Smartwatch(Model: SMD 1800) is mainly comprised of LCD Display, Watch, Watch Strap, Rechargeable Lthium Battery and CorX SaluberMD app. Watch Strap Stainless Steel Case Charger Port SpO2 / HR sensor Crown / Home button. Press to return to Home screen. LCD Display Side electrode (housing case) Front view Watch Strap EKG back electrodes SpO2 / HR sensor Crown Wrist HR sensor Rear view Note: - Swipe left / right to navigate different page features.
4.2 Watch Functions Diagram 4.3 Intended Use The CorX is intended to be used for measuring, displaying, reviewing, and storing of ECG and oxygen saturation and pulse rate in a home or personal setting. The device is intended for adult use only. The physiological data is wirelessly transmitted to a remote server that can be reviewed by a healthcare practitioner.
5 FIRST USE Check for signs of damage on the packaging, if they were not, remove the device from the case holding it firmly to void the risk of an accidental impact. WARNINGS If there are obvious signs of damage on the packaging NOT USE THE DEVICE and contact Customer Service of Saluber MD. Do not dispose of the anti-collision packaging, as it could be reused during a possible transport and / or in case of inactivity of the device.
6 SANITATION OF THE DEVICE The device must be sanitized / disinfected periodically (see table maintenance).
7 LIST OF ACCESSORIES Battery charging cable P/N J5301-0025-01-AA DESCRIPTION CorX Charging Cable WARNINGS The use of not original accessories may be a source of serious risks for PATIENT OR OPERATOR. CAUTIONS The use of not original accessories may damage the DEVICE. Keep away from metal contact when the USB is plugging on any devices to prevent short circuit NOTE The use of not original accessories will void any form of WARRANTY Product.
8 WORKING ENVIRONMENT AND STORAGE The device cannot be used in environments that aren’t conform to the specifications given in paragraph ENVIRONMENTAL CHARACTERISTICS (3.2) In accordance with CEI EN 60601-1-11 sections 1.1 and 3.
Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below. WARNINGS The user must ensure that it is used in that specific environment. Failure to observe may generate risk situations.
Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below. WARNINGS The user must ensure that it is used in that specific environment. Failure to observe may generate risk situations.
Recommended separation distances between portable and mobile communications equipment and the device. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are under control.The user can help prevent electromagnetic interference by maintaining a minimum distance between communication devices portable and mobile RF (transmitters) and the device as recommended below, in relation to the maximum output power of the communications equipment.
9 ORDINARY AND EXTRAORDINARY PREVENTIVE MAINTENANCE CLEAN AND CARE • Regularly clean your strap and wrist—especially after working out or sweating. Rinse the strap with water. Do NOT use hand soap, body soap, dish soap, hand sanitizers, cleaning wipes or household cleaners, which could get trapped beneath the band and irritate skin. Instead use a soap-free cleanser to clean the wristband. Always dry the band well before putting it back on.
to providing circuit diagrams, parts lists and anything else necessary to calibration and repairs the device, only to a qualified and authorized personnel in those activities. WARNINGS All interventions must be recorded in Table sheet machine in order to ensure the maximum safety of the device.
WARNINGS In order to ensure the safety of the patient and / or operator the legislation provides instrumental tests of currents leakage and electrical safety.
10 ENABLE STAFF FOR THE USE OF THE DEVICE The use of the device is only for authorized staff: • • • MEDICAL / PARAMEDIC who has specific knowledge of the product and enabled by law. UNPROFESSIONAL STAFF (as the standard CEI EN 60601-1-11 point 3.3) that obtained authorization from SALUBER MD. Private user. CAUTIONS The Saluber MD declines all responsibility arising from the use of the device by unauthorized staff and from a misuse of the CorX.
11 PRECAUTIONS Before making an examination, the operator must verify the absence of contraindications reported in section 12 of this manual. WARNINGS During operation of any operation, intervention and / or displacement not explicitly provided for in this manual can cause malfunctioning of the device establishing danger both for the subject treated and the operator. WARNINGS Before use of the device, visually inspect: • Charging cables and integrity of device.
12 CONTRAINDICATIONS - The CorX Smartwatch (Model: SMD1800) cannot be used by children under 18 years old. Do not use this device if you are pregnant or obese. - The device is not intended to substitute for a hospital diagnostic ECG device, and also not to be used on patients with implanted cardiac devices, such as pacemakers and/or implanted cardio-defibrillators (IDCs). WARNINGS Do not apply the electrodes on: • Cuts; • Wounds; • Solution of continuity of the skin.
13 ASSOCIATION WITH OTHER EQUIPMENT It is not expected the simultaneous use of other equipment that are delivering electric fields or other forms of energy. It is not recommended therefore concurrent use of the device with other devices, the fact that, given the unpredictability of the interference that may occur, could establish situations of risk to the patient subjected to an examination (unless otherwise prescribed).
14 HOW TO USE Place the device stably and safely. Read the entire manual carefully. After considerable inactivity of the CorX (over 30 days), fully charge the batteries. Before you can use the CorX you need to download and install on your Android device, iOS the control software CorX.
To return to the main screen at any time or turn the CorX on again, just press the button on the lower right side. 14.2 Connecting the CorX with the SaluberMD app Please check that the Bluetooth function on your phone is turned on and wear the CorX on your wrist. Open the app and enter your username or email and password to log in. Choose the “Wellness Service" section from the general menu. Click on “Manage CorX” to scan and connect the watch with the app.
14.3 Setting up the CorX In this page the first step to execute is to check the Firmware Update so assure to setup the last version. In the case the app download the last version of the watch firmware and upload it on the watch. Then it is possible to setup the user’s preference as: - Unit Setting, - Clock Format, - Step Goal, - HR measure interval (minutes). It is possible also Find the Bracelet and Restore the factoring settings.
14.4 Taking your medical test Choose a quiet place, sit comfortably with legs uncrossed and avoid speaking during the 45 seconds of medical data measurement. If possible, place your forearm on a table to keep the measurement steady. The sensors are positioned on the top right and bottom left of in addition to sensors on the back of the device, therefore, the CorX must be worn and not just resting on the wrist. If necessary, apply slight, but not excessive, downward pressure on the CorX.
The screen will show “Successful” when the test is complete, and the 3 measured values, HR – Sp02 – Respiration, will appear briefly on the screen. You can see them by swiping from right to left. If you require more time to see your results, push the “Medical Test” icon again, and swipe your finger across the screen from right to left until the “Test Result” icon appears. Push this, and swipe again from right to left.
14.5 How to get “Wellness data” Go to the app’s main menu and click on "Wellness" > “Wellness data” and click on the blue "Get data" button. You will have to do this only once, at the time of initial setup of your CorX. This allows the app to make the connection with your CorX Smartwatch. A green banner on the upper side will appear after the successful synchronization, but no data will be collected at this time.
14.6 Smartwatch functions The other smartwatch functions are: - Activity: where the user can control the number of daily steps, the burned Calories and the walked Miles - Notifications: where the user can read the notification from the social apps (e.g.
- Change face: where the user can change the watch face It is possible to use the smartwatch CorX as an Emergency phone. Tapping on the menu in the picture, if the phone is BT connected with the CorX, it will start a phone call at the phone number defined in the User profile.
14.7 Using the SaluberMD app The SaluberMD app will connect to the CorX automatically. To take the measures the user selects My Health File / Medical Device DataMedical In this menu it possible execute all the tests with CorX: - EKG - SpO2 In the EKG menu it is possible to see the list of the past measurements.
The will connect to the CorX SaluberMD app The SaluberMD app will connect to the CorX automatically and it is ready to execute the EKG. During the examination test the user can see the trace of the EKG. Choose a quiet place, sit comfortably with legs uncrossed and avoid speaking during the 45 seconds of medical data measurement. If possible, place your forearm on a table to keep the measurement steady.
Once the measurement has been downloaded, the data will be visible in the app and recorded in the My Health Profile as the following indexes calculated by the SaluberMD algorithms. The user will be able to follow the complete path of the EKG, Heart rate, EKG-Blood Pressure (not a clinical reading), Stroke Volume, Cardiac output and date of this measurement by pushing on the date/hour line. The app evaluate the data of the Stress Indexes of the user and other data as the Respiratory Rate and the SpO2.
The user will be able to follow the complete path of the Pulmonary Indexes and date of this measurement by pushing on the date/hour line.
Profile as the following indexes calculated by the SaluberMD algorithms. The user will be able to follow the indexes score as Cardiac and Respiratory Indexes, Blood Pressure Index, Activity Index, Stress Index, Insurance Index. Your measurements will also be available within your "My Medical File" in the "Medical info"> EKG section.
You can view more information about your Health data by pressing the question mark next to the number (shown in the image above, on the screen at far right). The EKG list will be updated and saved in historical order after each measurement. The watch will display the most recent measurement at the top of the list.
Warining： (1) This device may not cause harmful interference (2) this device must accept any interference received, including interference that may cause undesired operation. (3) Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
15 TROUBLE SHOOTING CorX malfunctions PROBLEM CAUSE ACTION Charge the battery System turns off immediately after turning on Low battery Defective battery (ex: Not charging) The charger does not work properly Software malfunction Low battery Hardware configuration error The system does not turn off Software malfunction Contact the dealer The system does not respond to the WiFi radio requests Hardware problem (ex: the WiFi module is broken) Sensors not properly connected to the electrodes Electrodes
If you are using Apple device, you should go to phone settings, check bluetooth connection need to un-pair or disconnect device, press forget device. Then go to SaluberMD app, go to manage CorX, scan device to get correct CorX ID and connect it.
16 ADDITIONAL INFORMATIONS Disposing of the device or part of it NOTE As required by Directive 96/2002 is required to not disposing the devices and / or parts of it, including consumable materials, such as household waste. It must be carried out separate collection of all assemblies.
17 RESPONSIBILITY The Manufacturer shall not be responsible for the safety, reliability and performance of the device if: The device is not used according to the instructions in this manual. The electrical system where the machine (using the charge) is used does not comply with safety standards. Repairs and periodic inspections are not carried out by the manufacturer or by an approved laboratory.
18 LABELING These symbols may appear on the device or packaging labels.
19 SHEET MACHINE ITEM MOTIVE ASSISTANCE DESCRIPTION OF INTERVENTION 45 DATE SIGN
20 DISCLAIMERS Warning: Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
21 TRADEMARK AND COPYRIGHT INFORMATION SaluberMD LLC (Hereinafter called SaluberMD) owns the intellectual property rights to this CorX product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of SaluberMD, nor the rights of others, intends to maintain the contents of this manual as confidential information.
