Page 1: Table Of Contents
Index Additional Information Symbols Intended Use Safety Information Connecting the CardioSecur ECG Cable Disposable Electrodes Serial Number and Contact Address Technical Data and Operation Conditions Care and Maintenance Electromagnetic Compliance (EMC) Disposal Labelling Contact V6.0...
Page 2: Additional Information
Additional Information This following user handbook describes the usage of CardioSecur Active on iPhone 4S, 5/5S/5C, 6/6 plus, 7/7 plus (iPhone is a registered trademark of Apple Inc.) as well as on chosen Android smartphones. The latest list is available for you at www.cardiosecur.com. For reasons of simplicity we refer herein exclusively to smartphone and CardioSecur.
Page 3 Symbol Meaning This product complies with the requirements of the 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 Information Information concerns details that are worth knowing Manufacturer’s data V6.0...
Page 4 For single use only Latex-free CardioSecur and its accessories - like any other electronic device – contain metal and synthetic parts, which need to be disposed of separately 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 GmbH for disposal free of charge.
Page 5: Intended Use
The user is required to record a personal reference reading when symptom-free. The refer- 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 regular intervals (e.g.
Page 6 White electrode: At the upper end of the sternum (on the bone) Yellow electrode: At the lower end 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 the left axillae at the height of the lower end of...
Page 7 The user may store, print and manage all ECG readings (reference and control readings) taken with CardioSecur by means of a personal user account on the CardioSecur database, an op- tional service by Personal MedSystems. In addition users may self-select a physician to view personal ECG data for informational purposes.
Page 8: Safety Information
CardioSecur contains personalized data. It must only be used by the individual whose personal reference ECG is stored. Warning: The results provided by CardioSecur are not to be used as the basis for beginning or changing therapeutic measures without an independent medical examination. Warning:...
Page 9 Warning: CardioSecur serves the purpose of detecting new ischemia and arrhythmias of the heart. CardioSecur is not designed for continuous ECG monitoring, but merely evaluates a short time window of your heart’s activity. Warning: Note that a physician may only receive your ECG recordings and your attached comments if you are actively linked to the physician through the CardioSecur database.
Page 10 Remove all disposable electrodes after performing a reading, as prolonged adhe- sion may cause skin irritation. Warning: Do not use CardioSecur in case of sensitive skin or allergies. This could cause rash, irritation of the skin or eczema. Warning: Only use the ECG cable as described in this user manual and provided by Personal MedSystems GmbH.
Page 11 Do not expose CardioSecur to any electrostatics. Discharge any electrostatics out of your body before touching CardioSecur. Warning: Do not expose CardioSecur to any physical shocks or vibrations. Do not drop it on the floor or step on it. Warning: Do not place anything onto CardioSecur, as this may damage the device.
Page 12 Warning: CardioSecur utilizes an ECG method computing a 15-lead ECG 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.
Page 13: Connecting The Cardiosecur Ecg Cable
Connecting the CardioSecur ECG Cable Connect the CardioSecur ECG cable to your smartphone. A CardioSecur with 30-Pin connector can be A CardioSecur with 30-Pin connector can be plugged directly into an iPhone with 30-Pin plugged into an iPhone with Lightning jack jack (e.g.
Page 14: Disposable Electrodes
Disposable Electrodes Disposable electrodes are the link between your body and CardioSecur. They are of critical importance for the technology’s proper function. Personal MedSystems GmbH cooperates with highly specialized manufacturers for disposable electrodes in order to ensure optimal signal quality.
Page 15 Remove the protective foil from the First connect the 4 ECG electrode connectors disposable electrodes and attach them to an unused disposable electrode. without touching the adhesive side and without putting pressure on the middle part (see diagram section 3, Intended Use).
Page 16 Note the instructions provided on the backside of the disposable electrodes’ pouch. Manufacturer Information Ambu A/S Made in Malaysia Baltorpbakken 13 P-00-S/xx DK-2750 Ballerup Denmark Yancheng Tianrun Medical Instrument Factory YD43-6-W Hequiao Industrial Area, West Qingnian Road Yancheng City, Jiangsu Province China V6.0...
Page 17: Serial Number And Contact Address
Serial Number and Contact Address Press „Information“ then Press the „Menu“ icon ( "About CardioSecur”. V6.0...
Page 18 The following information is displayed 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 GmbH contact details •...
Page 19: Technical Data And Operation Conditions
Technical Data and Operation Conditions Parameter Description Model CardioSecur Lead method Bipolar, 3 lead Reading quality 15-lead ECG with 4 electrodes Pulse range 18 to 256 beats/minute Precision Band width: 0,05 to 40 Hz, sampling rate: 250 Hz Type of protection...
Page 20 • Places subject to high electromagnetic radiation Information: • Keep the original packaging of CardioSecur and its accessories in order to identify the product in the case of recall. • We reserve the right to change technical data without prior notice.
Page 21: Care And Maintenance
Please follow the instructions from the manufacturer to clean and maintain your smartphone. Cleaning and Disinfection of CardioSecur Clean your CardioSecur with a slightly dampened towel. In most cases cleaning with water and soap will be sufficient. Liquids on the casing must instantly be wiped off with a dry towel.
Page 22: Electromagnetic Compliance (Emc)
A minimum distance of 2 meters is recommended. If the distance is less than 2 meters CardioSecur may not perform properly. In accordance with the norm IEC60601-1- 2:2001, contact our customer support (see section 13, Contact) to request further documen- tation.
Page 23 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 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;...
Page 24 Testing accuracy Interference immunity against Result normative tested Static electrical discharge 8 kV 8 kV contact 6 (8) kV 8 kV High frequency electromagnetic fields housing 3 V/m 10 V/m (80 – 2500 mHz) mains 2 kV 2 kV Fast transient disturbances (chest) 1 kV unsym.
Page 25: Disposal
Warning: Ensure proper disposal of CardioSecur (electronic waste). Labelling on CardioSecur, its packaging and this user manual indicates 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 uncon- trolled disposal.
Page 26: Contact
13 Contact Personal MedSystems GmbH Wilhelm-Leuschner-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 CardioSecur. Phone: +49-(0) 69-9072013-0 E-mail: info@cardiosecur.com V6.0...