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

Application information
Electrode placement
2
Page 5
Bipolar electrodes
according to Nehb
The Nehb leads are recorded with the following electrodes:
R
Red
Right sternal base of the second rib (NST)
L
Yellow
Site of projection of the cardiac apex on the left
axillary line (Nax)
F
Green
Over the cardiac apex (Nap)
N
Black
Above the right leg
The combination of the three electrodes R, L, F at these positions yields leads D, A,
J.
Placing the electrode
cables
Correct Incorrect
For a fault
-
free ECG, it is important to place the electrode cables properly.
Distortions due to electromagnetic fields caused by live cables and loads can be
reduced through appropriate arrangement of the electrode cable by minimising the
loop size responsible for the interference.

Warnings
3
Page 6
General safety
information

CardioPort
Four
may only be operated in accordance with these instructions for
use. Any other use is at the operator's responsibility.
 For maintenance measures, expansions, readjustments or modifications, the
provisions of the German Medical Devices Act (MPG) and the Medical Device
Operator Ordinance apply.
 According to the Medical Device Operator Ordinance, medical devices may be
set up, operated and used only by persons who have the necessary training or
knowledge and experience to do so.
 The device may not be used for the exclusive monitoring of vital signs.
 During use, skilled medical staff must monitor the patient.
Safety information
for
set up and installation

The environmental conditions indicated in the "Technical information" chapter
must be observed.
 The device may not be operated in a wet, humid or dusty environment. Avoid
exposing the device to direct sunlight or heat from other heat sources. Acidic
vapours or liquids should not come into contact with the device under any
circumstances, since irreparable damage could occur.
 CardioPort Four is not intended for sterile use.
 The device may not be used if there are any doubts regarding the insulation to
ground or the proper condition of the connection cable.
 Before connecting devices to the mains supply, it should be checked whether
the mains voltage and mains frequency indicated on the identification plate
match the values of the mains supply. If there are any deviations, devices
should not be connected to the mains supply.
 No extension cables with multiple sockets should be used to supply power to
devices used.
Hazards to persons

Conductive parts of electrodes and connector systems of the applied parts
connected to them, including the neutral electrode, may not come into contact
with any other conductive parts, including ground.
 It should be ensured that neither the patient nor the conductive parts of the
patient connection or the electrodes (including the neutral electrode) come into
contact with other conductive objects (even if these are grounded) or persons.

Warnings
3
Page 7
Connection with other
devices

Additional equipment connected to the analogue and digital interfaces of the
CardioPort Four must demonstrably meet its corresponding EN specifications
(e.g. EN 60950 for data-processing devices and EN 60601 for electromedical
devices). In addition, all configurations must satisfy the system standard
EN 60601-1. Anyone connecting additional devices to signal inputs or signal
outputs is a system configurer and thus responsible for ensuring compliance with
system standard EN 60601-1.
 Devices may only be connected to each other or with parts of systems if it is
ensured that the safety for the patient, the user and the environment is not
impacted by this coupling.
 It should be ensured that each device is connected to a wall socket.

Provided that safe coupling is readily apparent from the device data, the user
must ensure, by contacting the respective manufacturers or inquiring with a
qualified person, that the necessary safety for the patient, the user and the
environment is not impaired by the intended coupling.
 For this reason, also be aware of a possible hazard due to accumulation of
leakage currents.
 The use of components (including software) which is not included in the scope of
delivery or not approved by Zimmer MedizinSysteme for CardioPort Four may
lead to measurement errors and malfunctions.
 Only original accessories and original spare parts from Zimmer MedizinSysteme
may be used.

CardioPort Four – in brief
Range of services / Intended use
4
Page 8
What is
CardioPort
Four?
CardioPort
Four
is an electrocardiograph for the acquisition of ECG signals which
are visualised, saved and evaluated in connection with the PC software
"DiagnostikSuite".
What does
CardioPort
Four do?
CardioPort
Four
achieves excellent signal quality and is favoured because of its fast
and safe handling.
What are the benefits
of CardioPort Four?

ECG signals in excellent quality are transferred to the
CardioPort
Four
using a
short patient cable.
 CardioPort Four is connected to the PC via a USB or wireless connection.
 In the case of a USB connection, the PC provides the energy supply.
 CardioPort Four devices connected wirelessly to the PC have an internal
battery for wireless transmission of ECGs to the PC during ECG recording.
 The battery can be charged via the USB connection and also inductively
wirelessly.
 CardioPort Four, together with its ECG signal cables, is equipped with surge
protection against defibrillation voltages.
 CardioPort Four can be used as a portable device and also as a stationary
desktop device.
 CardioPort Four enables flexible use – in the medical office, in the hospital, in
emergency situations as well as during house calls, because the system can
also be operated with a notebook/laptop.
Note on
DiagnostikSuite

The modern and intuitively operated analysis
software "DiagnostikSuite" is easy
to learn and it provides high-quality results.
 The installation, start-up and operation of the PC software DiagnostikSuite is
described in its instructions for use.
Intended use
The electrocardiograph
CardioPort
Four
is used to record 12
-
channel resting and
stress ECGs.
Note:
The application of the device is reserved for edical professionals (such as
physicians and health paraprofessionals).

S
tart
up
System requirements / PC connection
5
Page 9
System requirements
During the ECG recording, CardioPort
Four
sends the ECG signals at a high speed
to the PC. There the ECG signals are received, processed, filtered, analysed and
displayed in a user-friendly fashion in real time. For this reason, there are high
performance requirements on the data transmission and on the PC.
The exact hardware and software requirements for the PC can be found in the
DiagnostikSuite instructions for use.
USB connection to PC
CardioPort
Four
can be connected to the PC via a USB cable.
Due
to the high data
rate during an ECG transmission, the ECG amplifier must be directly connected to
the PC. USB hubs or other devices connected in between the amplifier and PC are
not permitted since they may impair safe operation.
During initial USB connection of the CardioPort Four to the PC, any necessary
drivers will be loaded by Windows.
Bluetooth connection
to PC
CardioPort
Four
can optionally send the ECG signals to the PC via Bluetooth. If the
PC does not have any internal Bluetooth interface, a Bluetooth USB stick can be
used. To do this, install the corresponding device driver on the PC.
Coupling with the PC
 Remove any USB cable that may be connected to CardioPort Four (1) and
switch on CardioPort Four at its On/Off switch (2). The connection LED ( ) will
then be lit and blue.
 Start "Devices and Printers" in the Windows control panel or directly via the
context menu of the Bluetooth symbol in the toolbar of the Windows function
"Add a Bluetooth device".
 In the Windows dialogue box "Add a device", chose "Bluetooth". CardioPort Four
is now listed as "CardioPort" with an appended serial number. After selecting
"CardioPort" the connecting process starts. The device is undergoing additional
setup and will be paired. A pairing code is not used.
 Bluetooth devices coupled with the PC are listed in "Control Panel | Hardware
and Sound | Devices and Printers | Bluetooth Devices".
 The type of coupling of a Bluetooth device may vary, depending on the Windows
version.
Interface configuration

Start the "DiagnostikSuite" ECG analysis software on the PC. As ECG device,
select "CardioPort Four" and adjust the associated device interface.
 Devices connected via USB will be shown as "file://LW:\". "LW" stands for a
Windows driver letter.
 Devices connected via Bluetooth are displayed with their Bluetooth address, the
device name and their serial number. (Example: "bth://00:12.f :2 :d5:ba
(CardioPort 1420011060)")

Operation instructions
Record ECG / Charge battery
6
Page 10
Switch device on
USB operation
 If CardioPort Four is connected to the PC via a USB cable, CardioPort Four
automatically switches on and off with the PC.
 Pressing the On/Off switch will restart the CardioPort Four.
Wireless operation
 In the case of wireless operation, CardioPort Four is switched on using the
on/off switch (2). To do this, hold down the on/off switch (2) for about 1 second.
If CardioPort Four is switched on, the connection LED is lit ( ).
Check battery capacity

During wireless operation, the internal battery provides the necessary energy.
The battery LED (4) indicates the available battery capacity.
 During battery operation, ensure prior to every ECG recording that the battery
has sufficient capacity, that is, that the battery LED is lit and green or yellow.
 If the battery LED is lit and red, there is a risk that the battery capacity will
become depleted during the ECG recording and the ECG will need to be
repeated.
Start ECG recorder

Start the analysis s
oftware "
DiagnostikSuite" on the PC
.
 Open the data of the desired patient and in the "NEW" register of the navigation
menu within the "ECG examination" panel, start the function "New resting ECG"
or "New cardiac stress test".
 By pressing the toolbar button "Start", the ECG recorder is started and the ECG
is recorded.
 The connection LED ( ) flashes during an ECG recording.
Place electrodes

Now apply the ECG electrodes to the patient.
 DiagnostikSuite assists you in this by displaying which electrodes are placed on
the patient and which electrodes have not yet been applied. The cables of
electrodes which are not placed are marked in DiagnostikSuite by a red line.
Perform examination

Now perform the desired electrocardiographic examination using
DiagnostikSuite, analyse the ECG and save the results.
 After concluding the examination, remove the electrodes from the patient.
Switch device off
USB operation
 In USB operation, CardioPort Four is switched off by the PC.
Wireless operation
 In wireless operation, hold down the on/off switch for about 6 seconds to switch
off the CardioPort Four.
Charge battery

To charge the battery via the USB connection (1), a PC or a USB plug
-
in power
supply can be used (see chapter 11).
 Alternatively, an inductive receiver coil (5) and an inductive charging pad which
meets the Qi standard can be used. To do this, place the CardioPort Four in the
middle of the charging pad. During inductive charging, it is not possible to record
an ECG.
 While the battery is being charged, the battery LED flashes red, green or yellow,
depending on the charge status of the battery.

Technical information
Technical data / Storage and transport
7
Page 11
Power supply
USB:
+5VDC, 500 mA
Lithium polymer battery, + .7 V, 1250 mAh, 4.625 Wh
Battery charging
Corded via USB
Inductive via a Qi loading coil
Power consumption
Max. 500 mA (2.5 W)
Dimensions (LxWxH)
115 mm x 90 mm x mm (W x L x H)
Weight
Approx
.
200 grams
Environmental
conditions
Operation
Temperature
Air pressure
Relative humidity without condensation
+10°C to + 0°C
700 hPa...1060 hPa
25%... 95%
Environmental
conditions
Storage and transport
Temperature
Air pressure
Relative humidity without condensation
-
10°C to +50°C
700 hPa...1060 hPa
10%...90%
Interfaces
USB 2.0, connector type A
Bluetooth 2.1 EDR, class 1, frequency 2402 - 2480 MHz, max. output power 6 dBm /
4 mW
Electrode connection
10 kOhm defibrillation protective resistor in each electrode cable
Signal transmission
Number of ECG channels
12 leads from Einthoven I, II, Wilson C1
-
C6
Sampling rate
500 Hz
Signal
bandwidth
0.05 to 150 Hz
Detection of pacemaker pulses
Pulse duration 0.1 to 2 ms
Amplitude  2 mV to  700 mV
Input impedance of the signal inputs
> 50 M
AD converter
16 / 24 bit, depending on the sampling
rate
Accuracy
According to EN
60601
-
2
-
25
Electrical safety
Patient input circuit
Fully isolated and galvanically separated,
defibrillation-resistant
Defibrillation protection
Yes (5000 V)
Applied part (entire device)
Type
C
F according to EN
60601
-
1
Device class
IIa according to MPG
Protection class
II / Internal supply
Subject to technical changes
Storage and transport
Please keep
the packaging. The device may be shipped and stored only in the
original packaging.

Cleaning and disinfection
Housing / patient cable
8
Page 12
CardioPort
Four
and also any accessory
parts should be regularly cleaned; they
should be cleaned daily if used correspondingly.
General information

Before cleaning, the device must be switched off and the USB cable should be
disconnected.
 No high-temperature sterilisation (such as autoclaves) should be performed, nor
should sterilisation with electromagnetic radiation or gamma rays be performed.
 Do not use any cleaning agents or disinfectants which contain alcohol or
solvents.
 Under no circumstances should the device be immersed in a cleaning fluid or
subjected to heat sterilization with water, steam or air.
 CardioPort Four has no special protection against leaking liquids or the
penetration of water or other liquids. If CardioPort Four was immersed in a liquid
or a liquid was spilled on it, it should in no case be put back into operation. If
liquid penetrated the device, pull out the USB cable and contact Zimmer
customer service.
 If used as intended on healthy, non-injured skin, the device is considered to be
"uncritical" according to the RKI guideline.
Cleaning the housing
and patient cable

Water and soap or commercially available, solvent
-
free plastic cleaning agents
can be used for cleaning.
 Clean the housing of the CardioPort Four carefully using a soft, lint-free cloth
moistened with mild, non-acidic (!) cleaning agent. Then dry using an antistatic
cloth.
 Ensure that no liquid penetrates the device.
 Aggressive cleaning agents or solvents (acetone, paint thinners, diluted acids,
bases, etc.) should not be used either for cleaning or for disinfection!
Disinfection of
housing and cables
The device and the patient cable can be disinfected with alcohol
-
free and solvent
-
free disinfectants. To do so, wipe the surface with a cloth moistened with disinfectant.

CE mark
9
Page 13
The device has the CE mark
012
in accordance with the EC directive 9 /42/EEC.

Scope of delivery / accessories /
consumables
10
Page 14
Scope of delivery
Item no.*
Number
Description
17 0
-
D01
17 5-D01
1
1
CardioPort
Four
Bluetooth device
or
CardioPort Four USB device
51 00 010
1
ECG patient cable incl. 10 kOhm protective resistors
79 050 5 0
1
Cable, USB A/A, m
10 102 594
1
CardioPort
Four
instructions for use
10 102 292
1
CardioPort
Four
guarantee
10 101 867
1
Long
-
term guarantee
Accessories
Item no.*
Number
Description
9202
1
DiagnostikSuite, basic software
9205
1
DiagnostikSuite, ECG, module P
9205
-
01
1
Automatic measurement
and interpretation of resting ECGs
for DiagnostikSuite, ECG
9205
-
02
1
Ergometry for DiagnostikSuite, E
C
G
68 00 211
65 00 510
1
1
Adapter cable HDMI
-
DSUB 15 for ECG suction systems,
including protective cap
75 79 921
1
Galvanic network isolator 5 kV, gigabit
79 060 650
1
USB isolator 4 kV
42
1
Disposable electrodes (multipack)
422
1
Extremity clip electrodes (4 pc.)
421
1
Chest suction electrode
4 1
1
Pushbutton adapter (1 pc.)
Additional accessories are available from Zimmer
MedizinSysteme.
Consumables
Item no.*
Number
Description
42
1
Disposable electrodes (multipack)
*Subject to technical changes.