Personal MedSystems CardioSecur Manual Download Page 16 | Manualshive

Page: 16 / 26

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16

V6.0

EN

Note the instructions provided on the backside of the 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 City, Jiangsu Province
China

Made in Malaysia

P-00-S/xx

YD43-6-W

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Summary of Contents for CardioSecur

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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