Personal MedSystems CardioSecur User manual

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Index
1!Additional Information 2!
2!Symbols 2!
3!Intended Use 5!
4!Safety 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!Electromagnetic Compliance (EMC) 22!
11!Disposal 25!
12!Labelling 25!
13!Contact 26!

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1 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.
Additional information can be found at www.cardiosecur.com/en/active-manual.
2 Symbols
Packaging included in the scope of delivery or this user manual may display the following
symbols (color and size can vary):
Symbol
Meaning
Use disposable electrodes before the displayed date of expiry
Lot denomination

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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

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Symbol
Meaning
Store at indicated temperature with unbroken seal
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.
Application unit of type BF. An application unit of type BF grants protection
against electric shock, in particular with regard to permissible discharge current,
according to the requirements of norm EN 60601-1.

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3 Intended Use
CardioSecur is intended to record, evaluate and store a resting electrocardiograms (ECG) for
adults.
CardioSecur is a medical electronic system, comprising an ECG cable and an app for a
smartphone. CardioSecur can record, evaluate and store a complete 15-lead ECG using 4
electrodes. CardioSecur is able to detect arrhythmias and ischemia of the heart by comparing
a reference reading to a control reading. CardioSecur serves the purpose of self-monitoring
heart activity.
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. every other day), independent of symptoms.
The user is not required to have previous medical knowledge or special training to use Cardi-
oSecur. CardioSecur is recommended for individuals with a known or suspected heart condi-
tion or risk factors for cardiac disease (e.g. hypertension, diabetes mellitus or increased
cholesterol levels). Patients and individuals taking precautionary measures may use CardioSe-
cur.
In order to record an ECG (reference and control ECG), disposable electrodes need to be
positioned on the user’s thorax according to the following diagram:

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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
the sternum (the same height as the yellow electrode)

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Prior to a reading the user is required to sit calmly and relax for a minimum of 3 minutes.
During a reading (duration ca. 1 minute) the user must continue sitting calmly and relax
without talking or coughing.
CardioSecur performs a comparative evaluation between the reference reading and a control
reading and thereupon provides the user with a recommendation to act:
• White result: indicates “no changes” compared to the personal reference ECG. There is
generally no need for action.
• Yellow result: indicates “minor irregularities” compared to the personal reference ECG.
CardioSecur recommends planning a doctor’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 the European Society of Cardiology, CardioSecur
recommends visiting a doctor instantly whenever symptoms or discomfort prevail for more
than 20 minutes. This recommendation applies even when the result given by CardioSecur
shows “no changes” or “minor irregularities” compared to the reference ECG.
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.

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4 Safety Information
Take note of the following warnings and information. In case of non-compliance you run the
risk of causing malfunction, damage or bodily injury.
Warning: Only use CardioSecur in accordance with its intended use (see section 3, Intended
Use).
Warning: 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: ECG readings 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 more than 20 minutes, contact your doctor instantly,
even if the results provided by CardioSecur show no or minor irregularities compared to your
reference ECG.
Warning: Do not attempt to make a diagnosis on the basis of the results and analysis pro-
vided by CardioSecur. Always check with your physician. Self-diagnosis may cause a deteriora-
tion of your state of health or medical condition.
Warning: Results provided by CardioSecur reflect the moment of a recording. Your state of
health may change rapidly. In case you notice a change in your state of health, contact a
physician.

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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.
Transmission of ECG data to the linked physician is not guaranteed. In addition, when your
ECG data is received by your physician, this does not guarantee that he or she will look at the
data or establish a diagnosis. It is recommended that you contact the physician you are 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 relaxed. Being seated with a straight back is ideal. Do
not cough or speak during a reading. Body movements may cause interference influencing the
evaluation.
Warning: Do not perform readings when subjected to vibrations, e.g. in a moving vehicle,
train or plane.
Warning: Do not perform ECG readings if the attachment points of the electrodes on your
skin are wet, e.g. due to sweat or after bathing.
Warning: Proper functioning of the disposable electrodes is influenced by large amounts of
body hair, cream or oily skin. Regularly remove hair from your skin at the attachment points
of the electrodes and ensure that your skin is free of cream and fat. Do not clean your skin
with alcohol.

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Warning: Do not record a reference ECG with incorrectly positioned or transposed elec-
trodes, as a correct evaluation of subsequent control ECGs is not possible.
Warning: Renew your reference ECG after every acute event, intervention (e.g. heart
attack, cardioversion in case of arrhythmia, heart bypass intervention, heart pacemaker
implantation, cardiac catheter intervention, heart valve intervention), medication change or
when recommended by your physician.
Warning: Only use the disposable electrodes recommended by Personal MedSystems (YD43-
6-W or P-00S/xx).
Warning: Only use 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 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.
Warning: Do not use CardioSecur when using an external defibrillator (CardioSecur is not
defibrillator proof).
Warning: During use of CardioSecur,do not connect any other device or computer via an
adapter to your smartphone and/or to the headset jack of your smartphone.

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Warning: Do not perform readings in places exposing CardioSecur to high electromagnetic
radiation (e.g. TV sets, monitors, dishwashers, dimmer).
Warning: 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.
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 CardioSecur only under the conditions described under the section
8, Technical Data and Operation Conditions.
Warning: Do not sterilize CardioSecur in a steam sterilizer (autoclave) or in a gas sterilizer
(ethylene oxide, formaldehyde, ozone etc.).
Warning: Do not use CardioSecur in the vicinity of combustible anaesthetics, drugs or pres-
surized oxygen.
Warning: Only use CardioSecur if it has no apparent damage.
Warning: Note the information in section 9, Care and Maintenance.

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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.
Attention: Contact our customer support if you are unable to perform a firmware update.

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5 Connecting the CardioSecur ECG Cable
Connect the CardioSecur ECG cable to your smartphone.
A CardioSecur with 30-Pin connector can be
plugged directly into an iPhone with 30-Pin
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 connector can
be plugged directly into an iPhone with
Lightning jack (e.g. iPhone 7).
A CardioSecur with micro-USB connector
can be plugged directly into an Android
smartphone (e.g. Samsung Galaxy S7).

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6 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.
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 passed.
Warning: Only use disposable electrodes if they have reached room temperature.
Warning: Only store disposable electrodes with an unbroken seal and at temperatures
between 10°C and 25°C.
Operating Instructions
Use disposable electrodes YD43-6-W or P-00-S/xx according to the subsequent steps:

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First connect the 4 ECG electrode connectors
to an unused disposable electrode.
Remove the protective foil from the
disposable electrodes and attach them
without touching the adhesive side and
without 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 skin. Should you encounter diffi-
culties in removing the disposable electrodes, dissolve the adhesive agent of the
electrodes with water. Remaining gel may be removed from your skin with paper
tissues or water.
3
1
2

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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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7 Serial Number and Contact Address
Press the „Menu“ icon ().
Press „Information“ and then
"About CardioSecur”.
2
1

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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
• Product certification
3

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8 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
IP22
Storage
10,000 readings
Electrical safety
Application unit type BF
Power supply
through Smartphone
Temperature and humidity operation
+5 to +45°C, 10 to 95 %, non-condensing
Temperature and humidity storage
-20 to +45°C, 10 to 95 %, non-condensing
Air pressure for operation
700 - 1060 hPa
Electrodes
Disposible electrodes, Typ YD43-6-W or P-00-S/xx

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Warning: Do not store CardioSecur under the following conditions:
• Direct sunlight
• Wet or damp places
• Dusty places
• In the vicinity of fire or open flames
• 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 the case of recall.
• We reserve the right to change technical data without prior notice.
• No safety-related controls are necessary during the product’s lifetime.