SaluberMD CorX SMD1800, User Manual

Page 1: ...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: ...NFORMATIONS 42 17 RESPONSIBILITY 43 18 LABELING 44 19 DECLARATION OF CONFORMITY 17 3 1 General technical features 5 3 2 Environmental characteristics 5 3 3 Technical features of the CorX 5 4 1 Basic S...

Page 3: ...3 20 SHEET MACHINE 45 21 DISCLAIMERS 46 22 TRADEMARK AND COPYRIGHT INFORMATION 47...

Page 4: ...provides information for the installation and proper use of the device and is recommended its accurate reading Failure even partial of the recommendations contained in it may lead to malfunction and d...

Page 5: ...of a mixture of flammable anesthetic with oxygen or nitrous oxide Expected Service Life The expected service life is 2 years The mating cycle of USB cable is 1000 cycles 3 2 Environmental characteris...

Page 6: ...curacy 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 17g Dimensions charging he...

Page 7: ...es are contained in the housing of the watch that converts the information to electronic signals that are processed by the software to display different parameters Measurement and recording of these p...

Page 8: ...he system is considered to be aimed at supporting actions low level as the cardiological screening secure disposal home monitoring Do not use the device in a magnetic resonance MR environment This dev...

Page 9: ...pp Note Swipe left right to navigate different page features Short tap long tap on touch screen to select confirm Wrist HR sensor EKG back electrodes SpO2 HR sensor Crown Watch Strap Front view Rear v...

Page 10: ...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...

Page 11: ...Place the appliance stably and safely Do not use the device in potentially explosive environments ex the presence of anesthetic gases or in environments with high humidity see table Technical Features...

Page 12: ...omise 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 technica...

Page 13: ...ot 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 pluggin...

Page 14: ...nvironment in wichthe device can be used Electromagnetic Emissions The device is intended for use in the electromagnetic environment specified below WARNINGS The user must ensure that it is used in th...

Page 15: ...typical commercial or hospital environment applies to the step of charging the batteries 2 kV in common mode compliant CEI EN 61000 4 11 Voltage dips short interruptions and voltage variations on pow...

Page 16: ...field from fixed trasmitterssuch as base stations for telephones radio cellular and cordless and land mobile radios amateur radio AM and FM radio transmitters and TV transmitters can not be predicted...

Page 17: ...3 2 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 20 1 20 2 30 10 3 80 3 80 7 30 100 12 12 23 For transmitters specified for a maximum output power output is not shown above the separation distance recom...

Page 18: ...oms persist longer than 2 3 days of not using your device contact a dermatologist If you sweat for more than two hours while wearing your device be sure to wash your strap and your wrist using the dir...

Page 19: ...mmary of the maintenance operations TYPE ACTION AUTHORITY FREQUENCY Preventive Visual inspection of the integrity of the charging cable if there is deterioration contact the technical support service...

Page 20: ...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: ...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...

Page 22: ...f 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...

Page 23: ...e 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 o...

Page 24: ...ivering 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 o...

Page 25: ...p you must register your device On the registration screen enter your personal data and contact details Choose any username and then in the code field enter your user code Your password must have at l...

Page 26: ...ce section from the general menu Click on Manage CorX to scan and connect the watch with the app On the Medical Device Data screen click on the blue SCAN button located in the center Wait for the app...

Page 27: ...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...

Page 28: ...urement 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 nece...

Page 29: ...left CAUTIONS Sit down calmly keep still and do not move during 45 second medical test measurement Slightly movement including fingers hands and body will impact the stability of measurement result Th...

Page 30: ...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...

Page 31: ...ly 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 WeCha...

Page 32: ...one 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 In the settings menu the user can see the I...

Page 33: ...nect 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 p...

Page 34: ...ible 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 mus...

Page 35: ...ated 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 measure...

Page 36: ...e 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 re...

Page 37: ...atory 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 Each time you want a...

Page 38: ...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 di...

Page 39: ...y energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a pa...

Page 40: ...still and test again 3 Finger touch on the SpO2 sensor lens softly EKG waveform drifts or disappear 1 The rear electrodes from the watch bottom not touch the skin 2 The thumb may not touch to the side...

Page 41: ...om low edge and hold the finger on the screen for iPhone X then swipe away the Saluber MD app The App crash or hang up App not stable Server down No Internet access Make sure there is Internet access...

Page 42: ...er declares its availability to provide for free disposal information on this can be obtained directly from via e mail via phone at the number via fax at the number The manufacturer in order to decrea...

Page 43: ...cal 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 The Ma...

Page 44: ...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...

Page 45: ...45 19 SHEET MACHINE ITEM MOTIVE ASSISTANCE DESCRIPTION OF INTERVENTION DATE SIGN...

Page 46: ...e 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...

Page 47: ...he written permission of SaluberMD is strictly forbidden Contents of this manual are subject to changes without prior notice All information contained in this manual is believed to be correct SaluberM...