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V6.0

DIN EN 550112

Industrial, scientific and medical high frequency devices (ISM devices)
Radio frequency interference – limit values and measuring procedure

Interference emission

Limit value class

Result

Interference voltage

n/a

RFI field strength (not accredited testing)

DIN EN 60601 1-1-2

Medical electrical equipment
Part 1-2: General requirements for safety:

Collateral standard: electromagnetic compliance; requirements and testing

DIN EN 60601 1-2-47

Medical electrical equipment
Part 2-47: Specific requirements for safety including essential performance characteristics for
outpatient electrocardiographic systems

Содержание CardioSecur

Страница 1: ...ty Information 8 5 Connecting the CardioSecur ECG Cable 13 6 Disposable Electrodes 14 7 Serial Number and Contact Address 17 8 Technical Data and Operation Conditions 19 9 Care and Maintenance 21 10 E...

Страница 2: ...est list is available for you at www cardiosecur com For reasons of simplicity we refer herein exclusively to smartphone and CardioSecur Additional information can be found at www cardiosecur com en a...

Страница 3: ...directive for medical devices 93 42 EWG Item number Please refer to user manual Warning Warning concerns safety relevant information Attention Attention concerns information of high relevance Informat...

Страница 4: ...ely after operating life in order to prevent negative environmental impact Send CardioSecur and its accessories with sufficient postage and if possible in its original packaging to Personal MedSystems...

Страница 5: ...r ence reading is stored in the CardioSecur app The user may perform the reading himself or under medical supervision A control reading may be performed immediately in the case of symptoms or at regul...

Страница 6: ...nd of the sternum on the bone Red electrode In the middle of the right axillae at the height of the lower end of the sternum the same height as the yellow electrode Green electrode In the middle of th...

Страница 7: ...octor s visit for clarification Red result indicates severe irregularities compared to the reference ECG CardioSecur recommends seeing a doctor instantly In accordance with applicable guidelines of th...

Страница 8: ...ings by CardioSecur are not able to detect all changes indicative of cardiac disease If you notice changes to your state of health contact your physician instant ly In case of prevailing symptoms for...

Страница 9: ...linked to directly This is especially important in the case of an emergency Warning Before performing a reading with CardioSecur sit calmly for a minimum of 3 minutes Ensure that your posture is relax...

Страница 10: ...se disposable electrodes that are unused have not expired and are at room temperature in order to ensure sufficient signal quality and prevent distorted results Warning Remove all disposable electrode...

Страница 11: ...the device Warning Do not open take apart or repair CardioSecur Do not transform CardioSecur CardioSecur does not contain any parts that need to be maintained by the user Warning Store and use Cardio...

Страница 12: ...G from 3 leads read with 4 electrodes Deviations might arise in comparison to a 12 lead ECG read with 10 elec trodes Attention Ensure that date and time in your smartphone are set correctly Attention...

Страница 13: ...n jack e g iPhone 4S A CardioSecur with 30 Pin connector can be plugged into an iPhone with Lightning jack e g iPhone 7 only by means of the Apple Lightning adapter A CardioSecur with Lightning connec...

Страница 14: ...optimal signal quality Intended Use YD43 6 W and P 00 S xx are disposable electrodes designed for recording electrocardiograms ECGs Warning Only use disposable electrodes if the expiry date has not pa...

Страница 15: ...putting pressure on the middle part see diagram section 3 Intended Use Remove the disposable electrodes carefully from your skin after performing a read ing Careless removal may cause damage to your s...

Страница 16: ...disposable electrodes pouch Manufacturer Information Ambu A S Baltorpbakken 13 DK 2750 Ballerup Denmark Yancheng Tianrun Medical Instrument Factory Hequiao Industrial Area West Qingnian Road Yancheng...

Страница 17: ...V6 0 17 EN 7 Serial Number and Contact Address Press the Menu icon Press Information and then About CardioSecur 2 1...

Страница 18: ...isplayed on the information page Software version of your iPhone Android app Hard and software version of your CardioSecur ECG cable Serial number of your CardioSecur ECG cable Personal MedSystems Gmb...

Страница 19: ...on Band width 0 05 to 40 Hz sampling rate 250 Hz Type of protection IP22 Storage 10 000 readings Electrical safety Application unit type BF Power supply through Smartphone Temperature and humidity ope...

Страница 20: ...lames Places subject to physical shocks Places subject to high electromagnetic radiation Information Keep the original packaging of CardioSecur and its accessories in order to identify the product in...

Страница 21: ...thinner or concentrated alcohol To disinfect CardioSecur wipe it off with a disinfectant For disinfecting CardioSecur use a non aggressive solution Recommended disinfectants for superficial disinfecti...

Страница 22: ...nts for EMC and prevent unsafe product situations This norm defines the de grees of immunity against electromagnetic interference and the maximum electromagnetic emission levels for medical devices Ca...

Страница 23: ...ference voltage n a RFI field strength not accredited testing B OK DIN EN 60601 1 1 2 Medical electrical equipment Part 1 2 General requirements for safety Collateral standard electromagnetic complian...

Страница 24: ...voltages unsym 2 kV n a sym 1 kV 1 kV n a Conducted disturbances induced by high fre quency mains 3 V 10 V n a I O 3 V n a Energy related frequency Magnetic field 50 Hz Helmholtz coil housing 3 A m 3...

Страница 25: ...tes that after its lifetime CardioSecur must not be disposed together with ordinary household refuse Dispose of Cardi oSecur separately so that harm to the environment or human health is not caused by...

Страница 26: ...Str 41 60329 Frankfurt am Main Germany Phone 49 0 69 9072013 0 Fax 49 0 69 9072013 99 E Mail info cardiosecur com Website www cardiosecur com Refer to our customer support in case of queries regarding...

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