Summary of Contents for SaluberMD CorX SMD1800
- Page 1 User Manual CorX Smartwatch (Model: SMD1800) FCC ID:2AT4JSMD1800 File No:CE-01-08.4 Version: 3.0 Issue Date: Apr, 2019 Revised on 19, Jul, 2019...
-
Page 2: Table Of Contents
13 ASSOCIATION WITH OTHER EQUIPMENT ........................24 14 HOW TO USE ................................25 14.1 CorX SaluberMD app registration ....................... 25 14.2 Connecting the CorX with the SaluberMD app .................... 26 14.3 Setting up the CorX ............................ 27 14.4 Taking your medical test ..........................28 14.5 How to get “Wellness data”... - Page 3 20 SHEET MACHINE ................................45 21 DISCLAIMERS ................................46 22 TRADEMARK AND COPYRIGHT INFORMATION ......................47...
-
Page 4: Information About This Manual
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. -
Page 5: Technical Features
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. - Page 6 SpO2 SpO2 range 70% to 100% SpO2 accuracy (Arms) 80-100%: +/-2%, 70-79%: +/-3% PR range 30 to 250 bpm PR accuracy +/-2 bpm Wavelength / Power 660nm & 880nm / 6.5 mV & 9.5 mV Technical specifications of the battery charger cable: Weight Dimensions (charging head) 18.45x9x6.6 mm...
-
Page 7: Description
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. - Page 8 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.
-
Page 9: Basic Structure
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 SpO2 / HR sensor Port Crown / Home LCD Display button. Press to return to Home screen. -
Page 10: Watch Functions Diagram
Watch Functions Diagram 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. -
Page 11: First Use
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. -
Page 12: Sanitation Of The Device
SANITATION OF THE DEVICE The device must be sanitized / disinfected periodically (see table maintenance). Unplug the charger; • • Do not use compressed air or nebulized products; a possible infiltration of any fluid may compromise the device; • Don’t try to open the device and remove the material penetrated in case of accidental infiltration of liquids or extraneous materials inside the casing, but please contact the technical service and not use the device;... -
Page 13: List Of Accessories
LIST OF ACCESSORIES Battery charging cable DESCRIPTION J5301-0025-01-AA 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. -
Page 14: Working Environment And Storage
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 3.2 can be used: PROFESSIONAL HEALTHCARE STRUCTURES (hospitals, medical offices, surgical •... - Page 15 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. Test Level Immunity Test Conformity Electromagnetic Environment - Guidance IEC 60601 Floors should be made of wood, concrete or +6 kV in contact...
- Page 16 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. Test Level Immunity Test Conformity Electromagnetic Environment - Guidance IEC 60601 Communications equipment to portable and mobile RF should compliant...
-
Page 17: Sdoc Of Fcc (Federal Communications Commission)
These guidelines may not apply in all situations. Electromagnetic propagation is affected by the absorption and reflection from structures, objects and people. SDoC of FCC (Federal Communications Commission) Declaration of Conformity Trade Name : CorX Smartwatch Model : SMD 1800 Responsible party : SaluberMD LLC. Address : 209 Capitol Street, Charleston WV 25301,USA Telephone Number :1-416-573-2307... -
Page 18: Ordinary And Extraordinary Preventive Maintenance
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. - Page 19 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.
- Page 20 WARNINGS In order to ensure the safety of the patient and / or operator the legislation provides instrumental tests of currents leakage and electrical safety.
-
Page 21: Enable Staff For The Use Of The Device
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. -
Page 22: Precautions
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. -
Page 23: Contraindications
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). -
Page 24: Association With Other Equipment
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). -
Page 25: How To Use
Switch it on by pressing on the button positioned on the lower right side of the device for 3 seconds. At this point, you will see the initial setup screen, and will need to pair the device with the SaluberMD App and your phone. -
Page 26: Connecting The Corx With The Salubermd App
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"... -
Page 27: Setting Up The Corx
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,... -
Page 28: Taking Your Medical Test
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. - Page 29 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”...
-
Page 30: How To Get "Wellness Data
A green banner on the upper side will appear after the successful synchronization, but no data will be collected at this time. Now you are able to collect your first Wellness data, and the SaluberMD app will connect to the CorX. Once the measurement has been downloaded, the data will be visible in the app. -
Page 31: Smartwatch Functions
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. Whatsapp, Facebook, Twitter, LinkedIn, Skype, Viber, SMS, Calls, Line QQ;... - Page 32 - 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.
-
Page 33: Using The Salubermd App
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.vice Data... - Page 34 SaluberMD app will connect to the CorX 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.
- Page 35 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.
- Page 36 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. Once the measurement has been downloaded, the data will be visible in the app and recorded in the My Health...
- Page 37 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.
- Page 38 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.
- Page 39 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.
-
Page 40: Trouble Shooting
3. Rub your finger to increase circulation, or test with another finger. 1. The bluetooth symbol 1. Go to SaluberMD app, go to manage CorX cannot connect to the disappear on watch display. CorX, scan device to get correct CorX ID and SaluberMD App for Android 2. - Page 41 Then go to SaluberMD app, go to manage CorX, scan device to get correct CorX ID and connect it. Cannot be powered up Low battery Charge the watch (around 2.5 hours to fully...
-
Page 42: Additional Informations
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. The manufacturer declares its availability to provide for free disposal, information on this can be obtained directly from: via e-mail... -
Page 43: Responsibility
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. -
Page 44: Labeling
18 LABELING These symbols may appear on the device or packaging labels. Symbol Meaning Serial number Manufacturer Manufacture date (production year) CE marking: In conformity with Directive 93/42/EEC for Medical Device Indicates separate collection for electrical and electronic equipment (WEEE) Authorized representative in the European Community FCC mark: Indicates that the electromagnetic interference from the device is under the limits approved by the FCC... - Page 45 19 SHEET MACHINE DESCRIPTION OF ITEM MOTIVE ASSISTANCE DATE SIGN INTERVENTION...
- Page 46 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.
- Page 47 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. Disclosure of the information in this manual in any manner whatsoever without the written permission of SaluberMD is strictly forbidden.
Need help?
Do you have a question about the CorX SMD1800 and is the answer not in the manual?
Questions and answers