Zimmer CardioPort Four User manual

Instructions for Use
CardioPort Four
EN

Schematic illustrations
View and LED displays
-A-
Figure 1
Device and
1
USB connection to PC or USB power supply
2
On/Off switch
operating elements
Connection LED
4
Battery LED
5
Inductive
receiver coil according to Qi
standard (rear side)
6
Connection for ECG patient cable
or for
ECG suction systems
LED displays
Operating statuses
Connection LED
No connection, device is off
Off
Self
-
test when device is switched on
Steady blue light for approx. 5 sec.
Wireless data connection (Bluetooth) is
established with PC.
Steady blue light
Active, wireless data transmission
Flashing blue light
USB data connection is established with
PC.
Steady green light
Active USB data transmission
Flashing green light
Operating statuses
Battery LED
No charging or discharging of the battery
Off
Battery is fully charged.
Steady green light
Battery is fully charged and is being charged.
Flashing green light
Battery is half charged.
Steady orange light
Battery is half charged and is being charged.
Flashing orange light
Battery is empty.
Steady red light
Battery is empty and is being charged.
Flashing red light
Battery capacity is
fully depleted.
Rapidly flashing red light
2
4
6
1
5

Description of symbols
-B-
Caution, take note of
accompanying documents /
Follow instructions for use
On/Off switch
Applied part type C
F with
defibrillation protection
Connection LED
USB connection to computer
Battery LED
Follow instructions for use.
Instructions for use
Caution
!
In the instructions for use this
symbol indicates "Caution“ with
regard to possible damage of the
device.
012
CE mark according to
MDD (9 /42/EEC)
Serial number Item number
Manufacturer Date of manufacture
Products marked with the
adjacent symbol must not be
disposed of with household
waste.

Brief start
up instructions
-C-
Placement

CardioPort
Four
can be operated in the vicinity of the patient.
Software installation

Install the DiagnostikSuite software with all necessary components on the
intended computers and activate the DiagnostikSuite.
Cable connection to
computer

For cable
-
based data transmission, CardioPort
Four
is connected with the
computer using the USB cable provided.
 If the computer to which the CardioPort Four is connected via a USB cable is not
a medical PC and does not have any equivalent isolation, a USB isolator with an
isolation barrier of at least 1.5 kV must be used between the CardioPort Four
and the computer.
 If the computer to which the CardioPort Four is connected via a USB cable is
connected to a network, there must be an insulation barrier of at least 1.5 kV
between the CardioPort Four and the network.
 If CardioPort Four is wirelessly connected to the computer, the wireless
connection is the necessary isolation barrier.
Cable connection,
electrode application

Connect the patient cable or, using an adapter cable, connect an available
electrode suction system, if necessary, to the CardioPort Four.
 If a patient cable is used, connect the ECG electrodes to it.
 Apply the ECG electrodes to the patient.
Interface
configuration

Start the ECG analysis software "DiagnostikSuite" on the PC, select the
"CardioPort Four" as ECG device and configure the associated interface.
Select patient

Start the DiagnostikSuite and select the "Open" entry in the navigation
menu
.
Double-click to select the desired patient.
Record ECG

Start the recording of the ECG using the ECG analysis software.
Save ECG

Stop the recording using the "Stop" button and save the ECG using the "Save"
button.

Content
Page
CardioPort
Four
Schematic illustration
A
Description of symbols
B
Brief start
-
up instructions
C
1
Indications / contraindications / side effects 1
2
Application information
Electrode placement
3
Warnings 6
4
CardioPort Four – in brief
Range of services / Intended use
8
5
Start up
System requirements / PC connection
9
6
Operation instructions
Record ECG / Charge battery
10
7
Technical information
Technical data / Storage and transport
11
8
Cleaning and disinfection
Housing / patient cable
12
9
CE mark 1
10
Scope of delivery / accessories / consumables 14
11
Device combinations 15
12
Safety and maintenance 16

Content
13
Legal notice 17
14
Functional test 18
15
Sources of defects / troubleshooting / disposal 19
16
Manufacturer's EMC declaration 22
17
Index 26
Valid for
CardioPort
Four
USB and BT. Bluetooth functionality is only available for
CardioPort Four BT.
These instructions for use are an integral part of the device. They must be stored
with the device and kept accessible at all times for anyone authorised to operate
this device.
Last updated: December 2018
We reserve the right to revise this
document at any time or change product specifications described
herein without any obligation to provide information externally in this regard.

Indications / contraindications / side
effects
1
Page 1
Indications
Resting ECG
Electrocardiography is one of the most frequently used methods to derive bioelectric
signals in diagnostics. By analysing the shape, time and frequency of these signals,
statements can be made about cardiac activity and pathological changes to the
heart.
Indications
Stress ECG
Stress
tests
are among the most important cardiodiagnostic procedures. This non
-
invasive method also enables statements on prognosis to be made. Through
dynamic stress, an increase in cardiac output (stroke volume and increase in heart
rate) and oxygen consumption are reached under controlled conditions which do not
lead to any objective pathological findings or subjective symptoms in healthy
persons. In the case of significant coronary heart disease, the blood supply to the
myocardium is insufficient. The consequences of this are the occurrence of
pathological ST segment changes and/or angina pectoris symptoms.
General
contraindications

Do not apply electrodes to injured skin, areas of eczema
, open wounds or other
skin diseases.
 During longer periods of application with a high vacuum, haematomas may
develop. *1)
 Do not apply a high vacuum in the case of patients with sensitive skin. *1)
 In patients with a bleeding tendency of any aetiology, haematomas may also
develop even with a low vacuum. *1)
 During longer periods of application, stasis-induced skin damage may develop.
1*)
 In case of a known allergy or hypersensitivity to the materials used or to one of
the ingredients, these materials or ingredients should not be used.
*1) Note: Only applies if used in connection with an electrode suction system.
Contraindication
Stress examination
The device should not be used if any anomalies or malfunctions which could affect
the test results are present or appear possible.
(Source: German Cardiac
Society (DGK) -
Cardiovascular Research)
If the presence of one of the diagnoses listed below is suspected, no stress test
should be performed.
Absolute
contraindications

Acute myocardial infarct
 Unstable angina pectoris
 Cardiac arrhythmias with symptoms and/or limited haemodynamics
 Active endocarditis
 Symptomatic severe aortic stenosis
 Decompensated heart failure
 Acute pulmonary embolism, acute myocarditis, acute pericarditis, acute aortic
dissection
 Physical disability that precludes safe and adequate testing

Indications / contraindications / side
effects
1
Page 2
Relative
contraindications

Left main coronary artery stenosis
 Valve disease of moderate severity
 Known electrolyte imbalances
 Arterial hypertension (BP >200 mmHg
syst
>110 mmHg
diast
)
 Tachyarrhythmia or bradyarrhythmia
 Hypertrophic cardiomyopathy and other forms of outflow tract obstruction
 High-grade AV block
 Recent stroke or transient ischaemic attack
 Uncorrected medical conditions, such as significiant anamie, important
electrolyte imbalance, and hyperthyroidism
Criteria for
discontinuing
ergometric stress:
Indications for discontinuing the stress ECG
 Maximum exertional heart rate reached
 Occurrence of angina pectoris
 ST depressions by more than 0.25 mV horizontally or descending
 Arrhythmias (extrasystoles or salvos)
 2nd or rd degree AV block
 Atrial fibrillation or flutter
 Complete bundle branch block
 Blood pressure increase over 2 0/120 mmHg systolic/diastolic
 Technical problems (faulty ECG recording, monitor breakdown)
To be able to promptly identify these criteria, the ECG must be continuously
observed on a monitor during and after the stress.
Take note of the indications and contraindications listed in the medical literature as
well.
CardioPort
Four
may only be used to conduct and evaluate resting and stress ECGs
and for functional diagnostic investigations of the cardiovascular system.
The device is not intended for monitoring vital signs.
Side effects
If an electrode suction system used with a longer period of application of the suction
electrodes (approx. more than 1 hour, depending on the patient) and high vacuum,
haematomas may develop. Never turn the vacuum dial to the upper range in the
case of patients with sensitive skin.

Application information
2
Page 3
Prior to using the device on a patient, the user should become familiar
with the
instructions for use and individual examination methods to be used as well as the
indications/contraindications, warnings and application information. Additional
sources of information about the application should be followed.

All patient inlets are protected against defibrillation voltages.
 ECG electrodes must be applied at a distance of at least 15 cm from defibrillator
electrodes.
 There is no hazard if the CardioPort Four is used on cardiac pacemaker patients
or if other stimulation devices are also used. However a certain degree of
caution should be used. The stimulation devices should only be used at an
adequate distance from the lead electrodes. In cases of doubt, the patient
should be disconnected from the recording device.
 Electrostimulation devices and/or cardiac pacemakers can cause the ECG signal
to be distorted.
 For example, overloading the ECG amplifier during or directly after a
defibrillation is shown by red lines instead of the ECG waves.
 The heartbeat and heart rate display can be impaired by the pulse from a
cardiac pacemaker or by atrial fibrillation.
CardioPort
Four
is not intended for use during HF surgery.
CardioPort
Four
is not suitable for direct application on the heart.
Prior to the examination, patients should be informed of the objectives and course
of
the examination as well as their cooperative participation.
The power supply of the computer must correspond to the international device
standard IEC 60950 or European standard EN 60950.
Caution!
Prior to use, it should be ensured that the necessary isolation barriers between
CardioPort Four and the mains as well as any connected networks are in place.
 If the computer to which the CardioPort Four is connected via a USB cable is not
a medical PC and does not have any equivalent isolation, a USB isolator with an
isolation barrier of at least 1.5 kV must be used between the CardioPort Four
and the computer.
 If the computer to which the CardioPort Four is connected via a USB cable is
connected to a network, there must be an insulation barrier of at least 1.5 kV
between the CardioPort Four and the network.
 If CardioPort Four is wirelessly connected to the computer, the wireless
connection is the necessary isolation barrier.
Caution!
Magnetic and electrical fields can affect the function of the device.
For this reason,
do not operate CardioPort Four in the vicinity of devices which generate strong
electromagnetic fields (X-ray or diathermy equipment, MRI machines, transformers,
motors). Please keep a safe distance of several meters.
CardioPort
Four
is not suitable for use in areas with an explosive, flammable or
combustive atmosphere.
To avoid the risk of electric shock, the USB connection must be disconnected from
the mains supply before performing any cleaning or maintenance activities.
Inspect the device before use. If there is any damage, it must not be used.

Application information
Electrode placement
2
Page 4
Skin preparation
Careful electrode placement is required to ensure a fault
-
free ECG. For this reason,
you should pay particular attention to the "electrode placement" chapter.
The signal quality improves if problematic hair is shaved off and the skin surface is
rubbed with fine fleece or fabric. Alcohol can be used for cleaning. (Concentration
max. 0%).
Extremity electrodes
To record the cardiac action potential from the extremiti
es, electrode clips with
electrode cream or electrode gel, plate electrodes with electrode gel, disposable
ECG electrodes or an electrode suction system are especially suitable.
If plate electrodes are used, the electrode gel is applied to the contact surface of the
plate electrodes and put on the intended site. The electrodes with a tensioning strap
are to be secured so tightly that they cannot shift on their own and that no vessels
are pinched.
Extremity electrodes during a resting
ECG
To record extremity leads, the extremity electrodes should be applied as follows:
R
Red
Right arm electrode
L
Yellow
Left arm electrode
F
Green
Left foot electrode
N
Black
Right foot electrode
Extremity electrodes during a stress ECG
During ergometry, the electrodes should not be applied over active muscles.
Appropriate placement sites for the extremity electrodes N and L are above the left
and right iliac crest. The R and L electrodes are best applied to both shoulder blades.
Chest electrodes
according to Wilson
To
sense
the cardiac action potential from the chest wall, chest suction electrodes,
disposable ECG electrodes or an electrode suction system (CardioAir, Zimmer
MedizinSysteme) are especially suitable.
To record Wilson leads, the electrode connections C1 to C6 should be placed at the
following sensing sites:
C1
Red
Right sternal edge in the 4th intercostal space
C2
Yellow
Left sternal edge
in the 4th intercostal space
C
Green
Between C2 and C4 on the left on the 5th rib
C4
Brown
Left midclavicular line in the 5th intercostal space
(approximately at the cardiac apex)
C5
Black
Left anterior axillary line in a line
running horizontally through C4
C6
Purple
Left mid axillary line in a line
running horizontally through C4