®

CardioScreen 1000
Device Manual

0197

Tel. +49 - 36 77 – 46 29 0 info@medis-de.com Medizinische Messtechnik GmbH

Fax +49 - 36 77 – 46 29 29 http://www.medis-de.com W.-v.-Siemens-Str. 8, D-98693 Ilmenau
Germany
CardioScreen® 1000 Device Manual
Copyright © 2013 medis. Medizinische Messtechnik GmbH, Ilmenau, Germany
Document revision 1.4
The complete documentation of the CardioScreen® 1000 device consists of:

• Device Manual
• Software Manual “Cardio Vascular Lab”

Before using the CardioScreen® 1000 device read both manuals carefully
and completely to ensure that you operate the system correctly.

The CardioScreen® 1000 device works computer supported. The Software “Car-
dio Vascular Lab” is required.

When you set up the device for the first time, check to see if it has suffered any
damage during transportation.

According to the Medical Device Directive (MDD) the Cardio-

Screen® 1000 device belongs to class IIa and, therefore, is not in-
tended for monitoring of vital physiological parameters, where the
nature of variations is such that it could result in immediate danger
to the patient.

The Federal law requires that the CardioScreen® 1000 device should
be used only by or on the order of a physician. Generally, all persons
using the device must be qualified and understand the measuring
method and the operation of the device.

2
If you need additional information or if you have any technical, methodical or
clinical questions please contact:

medis. Medizinische Messtechnik GmbH

Werner-von-Siemens-Strasse 8
D-98693 Ilmenau
Germany
Tel. +49 - 36 77 - 46 29-0
Fax +49 - 36 77 - 46 29-29
support@medis-de.com
www.medis-de.com

In the case of a request we would ask you to inform us about the serial number of
your device which you can find on the type plate on the back or bottom side of the
device.

In case of a software request the serial number of the software is needed which
can be found in the Hardware-Info screen. Press F5-Options in the Patient data
screen and then the F1-Hardware button.

3
4
Table of contents
1 Introduction ................................................................................................... 7
1.1 Applications ............................................................................................ 7
1.2 Precautions and limitations ..................................................................... 9
1.3 Safety requirements............................................................................... 10
1.4 Explanation of used symbols ................................................................ 12
2 Description of the device............................................................................. 13
3 Commissioning of the device and preparing a measurement ................. 15
4 Maintenance ................................................................................................ 16
4.1 Safety tests ............................................................................................ 16
4.2 Cleaning and disinfection...................................................................... 16
5 Technical data ............................................................................................. 17
6 Scope of delivery.......................................................................................... 19
7 medis Standard / Extended Warranty ...................................................... 20
8 Troubleshooting .......................................................................................... 22
9 Annex............................................................................................................ 23
9.1 Manufacturer guidelines and declarations ............................................ 23
9.2 Commissioning of medical systems...................................................... 28
9.3 Test report for medical systems ............................................................ 31

5
6
1 Introduction
1.1 Applications
The CardioScreen® 1000 device is used for non-invasive haemodynamic meas-
urements and monitoring of haemodynamic parameters using methods of imped-
ance cardiography (ICG).

In impedance cardiography, pulse synchronous variations of the blood flow and

volume in the thoracic aorta are determined and used for calculating different
haemodynamic parameters. More specifically, with each beat of the heart, the
volume and velocity of blood in the aorta changes. This produces a change in the
electrical resistance (impedance) of the thorax to electrical alternating current. The
change in impedance over time can be used to calculate stroke volume and several
other important haemodynamic parameters. The CardioScreen® 1000 device uses
four dual sensors, which are placed on the patient’s neck and thorax. The most
upper and lower gel pads of these sensors (the outer sensors) are used to apply a
very low constant and alternating current (1.5 mA, 86 kHz) which is impercepti-
ble to the patient. The other four gel pads are used to receive the applied current
and ECG signal. The ACM (Arterial Compliance Modulation) earlobe-sensor
provides additional information about the aortic compliance to improve the pa-
rameters measured with ICG:

Note that the ECG measured with the ICG-channel is not a standard lead and
is for triggering purpose only. It is not intended for diagnoses of any kind.

7
Different terms are used interchangeably when discussing impedance cardiogra-
phy, electrical bioimpedance or thoracic electrical impedance (TEB). In this man-
ual the term impedance cardiography or ICG is used.

Impedance cardiography allows the measurement of following haemodynamic

parameters:

• Thoracic fluid content (inverse to thoracic basic impedance)

• Pre-Ejection Period
• Left Ventricular Ejection Time
• Indexes of contractility: Velocity Index, Acceleration Index
• Heart Rate

Following parameters can be calculated:

• Stroke Volume, Cardiac Output

• Heather Index
• Systolic Time Ratio
• Systemic Vascular Resistance (requires blood pressure value)
• Left Cardiac Work (requires blood pressure value)

With reference to body surface area the following indexed parameters can be cal-
culated:

• Stroke Volume Index, Cardiac Index

• Systemic Vascular Resistance Index
• Left Cardiac Work Index

The CardioScreen® 1000 device can be used for following clinical applications:

• Non-invasive monitoring of the above haemodynamic parameters includ-

ing trend analysis
• Determination and checking of the haemodynamic state of a patient in-
cluding management of heart failure and hypertension therapy
• Cardiologic diagnosis using haemodynamic parameters and waveform
shape analysis
• Optimisation of pacemaker settings

Additional information and a detailed description of the measuring method, the

parameters, the application of impedance cardiography, and its limitations are
given in the Software Manual.

8
1.2 Precautions and limitations
The measuring device allows the examination of adult patients in a resting posi-
tion. The measured parameters can be used only if the ECG and ICG waveforms
have sufficient signal quality and are without artefact.

If the waveforms are of questionable quality, display the Waveform screen and
ensure that the key reference markers on the waveforms are accurately placed.
Note the hints in the Software Manual.

The method of impedance cardiography (ICG) is based on a theoretical model of

blood flow movement in the thorax (aorta). If the physiological and clinical condi-
tions of the patient are not in accordance with the assumptions of the model, inac-
curacies in the parameters may occur (see section “Basics of the methods: Imped-
ance Cardiography (ICG)” in the Software Manual).

The following conditions may adversely affect the accuracy of ICG systems and
are relative contraindications for the use of ICG systems:

• Septic shock
• Aortic valve regurgitation and defect of septum
• Severe aortic sclerosis, aortic prosthesis
• Severe hypertension (MAP > 130 mmHg)
• Cardiac arrhythmia
• Tachycardia with a heart rate higher than 200 bpm
• Patient heights below 120 cm (48″) or above 230 cm (90″)
• Patient weights less than 30 kg (67 lbs.) or greater than 155 kg (341 lbs.)
• Patient movement
• Aortic balloon or aortic balloon pump
• Simultaneous use of electrical cautery systems during surgical procedures

During operations on the opened thorax the current distribution can be distorted
and can lead to inaccuracies.

The device is designated to monitor adults. When measuring infants and neonates
the measuring results might not be reliable because only insufficient experiences
exist for this group of patients.

9
1.3 Safety requirements
According to the Medical Device Directive (MDD) the measuring
device belongs to class IIa and, therefore, is not intended for moni-
toring of vital physiological parameters, where the nature of varia-
tions is such that it could result in immediate danger to the patient.

The Federal law requires that the measuring device should be used
only by or on the order of a physician. Generally, all persons using
the device must be qualified and understand the measuring method
and the operation of the device.

The measuring device can only be used in combination with a PC or a notebook

and a printer. This constitutes a medical system device, which must be in accor-
dance with the standard IEC 60 601-1-1. It must especially be ensured that the
leakage current does not exceed safety standards (also under failure conditions).
This must be measured and filed. More information can be found in the section
“Commissioning of medical Systems”.

If the limits are exceeded special arrangements have to be taken. For instance, an
isolating transformer with an insulation voltage of 4 kV can be used.

For the compliance with these requirements the installer of the system is responsi-
ble.

The measuring device belongs to the application class BF (Body Floating). There-
fore, the sensors can be freely placed on the body surface. A direct contact with
the heart or vessels is not allowed.

Only connect one patient at the same time to the device.

The sensors must not have a direct contact to other electrically conductive materi-
als.

Because of hygienic reasons only disposable electrodes/sensors should be used.

Before monitoring patients with pacemakers, ensure that the function of the pa-
cemaker cannot be influenced by the measuring current used for impedance car-
diography. In the case of minute ventilation pacemakers the use of the ICG device
is not allowed if the minute ventilation function of the pacemaker is activated.

The device is not intended to be used while exposing the patient to high frequency
current.

10
Handle the patient cable and lead wires carefully and position them so that they do
not cross over each other or other cables or power cords to avoid signal interfer-
ence.

Do not expose the cables to mechanic or thermic impact. Avoid temperatures

above 40 °C (100 °F).

The measuring unit should neither be placed on a surface, which emits heat nor
exposed to direct sunlight.

The device is not protected against splashing water. Therefore, do not operate in
bathrooms or other areas where water damage is possible.

The device is not protected against explosive substance. Therefore, do not use the
measuring device in the presence of flammable anaesthetics or gases.

The device is protected against accidentally ingress of liquids. Nevertheless, in

case that water or other liquids ingress into the case, the device must be discon-
nected immediately.

To ensure that the measurement system functions safely, do not subject it to high
levels of humidity or to strong electrical or electromagnetic interference fields.

To connect the measuring system to an external network a Medical network insu-

lation module (N1107) is required. The direct connection of the measuring system
to an external network is prohibited if a patient is connected to the measuring de-
vice.

The combination of the measuring device with other medical devices is only al-
lowed if any harm to the patient can be excluded.

The measurement system must always be kept in safe and reliable working order
and must be checked regularly.

The ICG channel is protected against cardiac defibrillations. No preparation is

needed before the application of the defibrillator. The device will return to the
standard operation within 10s after discharge.

11
1.4 Explanation of used symbols
Caution, consult accompanying documents!

Do not dispose with residual waste

Device type BF, Defibrillator-proofed

Insulation class II

USB-Connector

12
2 Description of the device
The following illustration shows the front side of the device:

1. USB connection cable

2. Status LEDs
3. ICG patient cables and ACM connector socket

The USB-interface (1) may only be connected to computers and must not be
connected to other medical devices.

Ensure that the ACM sensor is connected with the device. Otherwise the
measurement can not be started.

The type plate is located on the back side and lists important information about
the device, including the serial number. This number is required to obtain techni-
cal service assistance and warranty repairs.

The device can only be operated if connected to the USB interface of an external
computer with installed PC software “Cardio Vascular Lab”. The power supply is
provided via USB interface.

Located on the front side there is a green and orange indicator LED (2) which
gives information about the device. Depending on the current status the following
can be indicated:

13
green orange Description of function

The device is disconnected or the PC is switched off (no voltage

○ ○ on the USB port)

☼ ○ Device is ready to use, but the measurement has not been started

● ○ Measurement is running; sensor contact is good

Bad contact between sensors and patient: at least one lead wire is
● ☼ disconnected or not properly fixed; sensors are too dry (eventu-
ally new sensors are necessary)
Insufficient contact between sensors and patient: at least one
● ● lead wire is disconnected or not properly fixed; sensors are too
dry (new sensors are necessary)

Device has power but no access to the software (e.g. if the soft-
○ ☼ ware is not started yet)

Legend: ○ LED off ☼ LED flashing ● LED on

14
3 Commissioning of the device
and preparing a measurement
To place the measuring device into operation carry out the following steps:

1. The device should be placed near the patient and fixed in such a way that
the device cannot fall down if someone pulls on the cables. Note that all
devices, which are placed in the patient environment of 1.5 m must meet
the requirements of the MDD (see also section “Safety requirements”).
2. It is necessary to install the “Cardio Vascular Lab” software before con-
necting a device to the PC the first time (see section “Installation of the
PC-Software” in the software manual). The required USB drivers will be
installed during software installation.
3. Connect the device with the computer using the USB interface.
4. Place the ACM earlobe-sensor and the ICG sensors to the patient and con-
nect them to the device. For more information see the “Cardio Vascular
Lab” software manual section “Impedance Cardiography (ICG)”.
5. Launch the software and choose the type of measurement. Before starting
the measurement, the patient data must be entered. Please note also the
hints in the Software Manual.
6. At the end of the measurement, go back to the patient data screen in the
software and stop the measurement before switching off the device and
removing the applied parts from the patient.

15
4 Maintenance
4.1 Safety tests
The measuring device is a self-calibrating system so that external calibration is
not necessary. The proper function of the system can be checked using a special
signal generator (part no. N1104).

The measurement system must always be kept in safe and reliable working order
and should be checked regularly, at least once a year. The check should cover a
function test and the measurement of leakage currents.

If you discover that the measurement system is faulty and/or unsafe (for example,
if any of the lines have insulation or breakage defects), repair the system and/or
replace faulty cables immediately.

Repairs may only be carried out by persons or workshops authorised to do so by

the manufacturer. Otherwise, general liability for improperly operating the meas-
urement system and for injury, damage and consequential damage resulting there-
from will be passed on to the operator or to the persons or workshops that have
not been expressly authorised by the manufacturer.

4.2 Cleaning and disinfection

It is recommended to clean and to disinfect the device and its cables regularly.

Warning! Disconnect the device before cleaning or disinfection.

Clean the device and the cables with a soft cloth. Do not use any abrasive or cor-
rosive substances. We recommend neutral cleaning agents or disinfecting sub-
stances, like ethanol (70 … 80 %), propanol (70 … 80 %) or aldehyde (2 … 4 %).
Ensure that no disinfectant gets onto the contact points of the plugs and sockets,
and that no liquid seeps into the device.

Caution! Never gas-sterilise the patient cables. They are covered with a PVC
shroud that can react with the gas-sterilisation procedure to form a highly toxic
ethyl nitrite. Sterilisation in an autoclave, with ultrasound or gamma rays is also
not permitted.

16
5 Technical data
Mains Supply via USB: 4,75V - 5,25V
Supply frequency Direct current
Power input < 1,5 W

Electrical safety IEC 601-1 (EN 60 601-1)

MDD class IIa
Insulation class II
Classification for patient protection BF

Electromagnetic compatibi- EN 55011 - class B

lity EN 60601-1-2
Insulation voltage Patient - Signal I/O: 4 kVeff ; 1 min; 50 Hz

Dimensions (W x H x D) 75 x 25 x 130 mm
Weight approx. 130 g

Signal I/O USB interface

Transport and storage con- Temperature: 0 – 50 °C

ditions Humidity: 15 – 95 % (non condensing)
Altitude: 0 - 3000 m
Operating conditions Temperature: 10 – 40 °C
Humidity: 30 – 75 % (non condensing)
Altitude: 0 - 3000 m

17
ICG - Impedance Cardiography
Measuring principle Bioimpedance-Plethysmography
defibrillator safe
Sensors 4 medis-Z-TECT™ disposable sensors
(solid gel)
Measuring current 1.5 mAeff; 85 kHz; Sinus
Basic impedance 0 – 60 Ω; 0 – 1.5 Hz
Pulse wave ±1 Ω; 0.2 – 160 Hz

ECG
Max. input voltage ±10 mV AC voltage
defibrillator safe
Frequency range 0.2 – 120 Hz
Common mode rejection > 90 dB
ratio
Noise voltage < 10 µV

18
6 Scope of delivery
To the scope of delivery of the measuring device CardioScreen® 1000 the follow-
ing components belong:

• Measuring device CardioScreen® 1000

• ACM sensor
• CardioScreen® 1000 Device Manual
• Software manual “Cardio Vascular Lab”
• Software-CD “Cardio Vascular Lab”

The necessary computer is not a component of the scope of delivery. Please con-
sider the safety-relevant requirements in section “Safety requirements”. If you
have any question our support is at your disposal.

Accessories and expendable items

• medis-Z-TECT™ sensors (part number N1201-5)
• ACM sensor (N1314)
• ICG / ECG simulator for function control of the measuring system (N1104)
• Medical network insulation module (N1107)

19
7 medis Standard / Extended
Warranty
medis Medizinische Messtechnik GmbH (“medis”) warrants that the measuring
System (“System”) and the System Software (“Software”) shall be free from er-
rors / defects in materials, workmanship, and programming that cause the System
not to function in accordance with the accompanying written specifications pro-
vided with the System at the time of installation. medis will provide this Standard
Warranty on each System for a period of thirteen (13) months from the original
medis invoice date. This Standard Warranty shall exclude the System external
patient cable(s) and (if applicable) the external inflatable blood pressure cuff(s),
hose(s) and sensors, which shall be covered under warranty for ninety (90) days
from the original medis invoice date. medis’ and/or its Distributors’ liability and
obligation, and the End User’s sole remedy shall be, at medis’ option, to either
repair or replace software and/or System or any part thereof. It is the responsibil-
ity of the End User to notify medis or medis’ Distributor (if medis requests the
End User to notify its Distributor) by telephone or in writing of any problem ex-
perienced by the End User within the thirteen (13) month Standard Warranty Pe-
riod and no later than thirty (30) days after the expiration of the warranty period.
This Standard Warranty does NOT apply to dual sensors, fuses, ink cartridges or
other consumable or disposable items that are used in conjunction with the System.

An Extended Warranty is available for sale, which provides the same warranty
coverage as the Standard Warranty in twelve (12) month increments. Under Ex-
tended Warranty, the System external patient cable(s) and (if applicable) external
inflatable blood pressure cuff(s) and hose(s) are not covered.

Standard / Extended Warranty Coverage:

• Customer / Technical Support is available Monday through Friday, 8 a.m.
to 5 p.m. German Time, at +49 - 36 77 - 46 29 - 0.
• medis will repair or replace any components of the System that cause the
System to not function in accordance with the written materials provided
with the System at time of sale.
• medis will provide free shipping and freight charges for warranty repairs
performed at medis or a medis Authorised Service Centre.
• medis will provide subsequent operational software upgrade disks and in-
stallation instructions at no charge to the customer.

20
Standard / Extended Warranty Service is void if:
• The System and/or Software has been maintained, repaired, modified or
altered by any person other than an authorised medis representative or
without prior approval from an authorised medis representative.
• The System and/or Software has not been properly operated or maintained
in accordance with medis’ then applicable written operating and mainte-
nance manuals.
• The configuration of the System and/or Software has been altered by, but
not limited to, the addition of any other computer software to the System.
• The failure of the System and/or Software has resulted from accident, abu-
se, or misapplication.
• Note: There are no user-serviceable components in the measuring system.

All units must be returned to medis or a medis Authorised Service Centre for re-
pair or replacement.

medis does not warrant (either expressed or implied) the correctness or va-
lidity of any output information or data provided by the System, including,
but not limited to, any information relating to any medical diagno-
sis/treatment or to the health and safety needs of patients. medis does not
warrant that any output of the System will meet the standards or require-
ments of the End User’s medical practice. End User expressly acknowledges
that End User is solely responsible for verifying that any results produced by
the System are free from error and suitable for the applications for which
they are to be used.

medis and its authorised Distributors shall not be liable for any special, incidental,
indirect or consequential damages arising out of the use of or inability to use the
System. Under no circumstances shall medis and its Distributors’ liability under
this Limited Warranty exceed the purchase price of the System and/or Software
paid by the End User.

21
8 Troubleshooting
The following overview serves for fast diagnosis and remedy of smaller problems.
If a problem should exist further, then please contact your dealer or the technical
support.

The status indicator LEDs of the CardioScreen® 1000 are off.

Check if the device is probably connected to the USB-port of the PC and that the
PC is switched on. If necessary use a different USB-port of the PC.

A measurement cannot be started because the button F9 - Start

in the software is disabled (grey).
The software did not find the CardioScreen® 1000 device. Please check, if:

• the examination type “ICG” is selected

• the USB cable is connected correctly
• the ACM sensor is connected to the CardioScreen® 1000

The examination type “ICG” is not available or can not be se-

lected.
The serial number of the PC software is wrong. Please click onto the button F5 -
Options in the Patient data screen and compare the serial number in the program
with the serial number which is printed on the delivered software CD.

22
9 Annex
9.1 Manufacturer guidelines and declara-
tions
Electromagnetic emissions
The device is intended for use in the electromagnetic environment specified be-
low.
The customer or the user of the device should assure that it is used in such an en-
vironment.
Electromagnetic environment
Emissions test Compliance
guidance
The device uses RF energy only for its internal
RF emissions function. Therefore, its RF emissions are very low
Group 1
CISPR 11 and are not likely to cause any interference in
nearby electronic equipment.
RF emissions
Class B
CISPR 11
Harmonic The device is suitable for use in all establishments
emissions Complies other than domestic establishments and those di-
IEC 61000-3-2 rectly connected to the public low-voltage power
supply network that supplies buildings used for
Voltage fluctu- domestic purposes.
ations/flicker
Complies
emissions
IEC 61000-3-3

Electromagnetic immunity
The device is intended for use in the electromagnetic environment specified be-
low.
The customer or the user of the device should assure that it is used in such an en-
vironment.
IEC 60601 Compliance Electromagnetic environment
Immunity test
test level level guidance
Electrostatic ±6kV con- ±6kV con- Floors should be wood, concrete
discharge (ESD) tact tact or ceramic tile. If floors are cov-

23
IEC 61000-4-2 ±8kV air ±8kV air ered with synthetic material the
relative humidity should be at
least 30 %.
±2kV for ±2kV for
power sup- power sup-
Electrical fast Mains power quality should be
ply lines ply lines
transient / burst that of a typical commercial or
±1kV for ±1kV for
IEC 61000-4-4 hospital environment.
input/output input/output
lines lines
±1kV dif-
±1kV differ-
ferential Mains power quality should be
Surge ential mode
mode that of a typical commercial or
IEC 61000-4-5 ±2kV com-
±2kV com- hospital environment.
mon mode
mon mode
<5% UT
<5% UT
(>95% dip
(>95% dip
in UT) for ½
in UT) for ½
cycle
cycle
40% UT Mains power quality should be
40% UT
Voltage dips, (60% dip in that of a typical commercial or
(60% dip in
short interrup- UT) for 5 hospital environment. If the user
UT) for 5
tions and voltage cycles of the device requires continued
cycles
variations on operation during power mains
power supply 70% UT interruptions, it is recommended
70% UT
input lines (30% dip in that the device be powered from
(30% dip in
IEC 61000-4-11 UT) for 25 an uninterruptible power supply
UT) for 25
cycles or a battery.
cycles
<5% UT
<5% UT
(>95% dip
(>95% dip
in UT) for
in UT) for 5s
5s
Power frequency magnetic fields
Power frequency
should be at levels characteristics
(50 Hz) mag-
3 A/m 3 A/m of a typical location in a typical
netic field IEC
commercial or hospital environ-
61000-4-8
ment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.

24
Electromagnetic immunity
The device is intended for use in the electromagnetic environment specified be-
low.
The customer or the user of the device should assure that it is used in such an en-
vironment.
IEC
Immunity 60601 Compliance Electromagnetic environment
test test level guidance
level
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than
the recommended separation distance cal-
culated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:

d=1,2 √P

3 Vrms
Conducted 150
RF kHz to
IEC 80 d=1,2 √P for 80 MHz to 800MHz
61000-4-6 MHz 3 Vrms
d=2,3 √P for 800 MHz to 2,5 GHz
Radiated 3 V/m 3 V/m
RF 80 Where P is the maximum output power
IEC MHz to rating of the transmitter in watts (W) ac-
61000-4-3 2,5 cording to the transmitter manufacturer and
GHz d is the recommended separation distance
in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,¹ should be less than the compliance
level in each frequency range,² Interference
may occur in the vicinity of equipment
marked with the following symbol:

25
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic pro-
pagation is affected by absorption and reflection from structures, objects and peo-
ple.
¹ Field strengths from fixed transmitters, such as base stations for radio (cellu-
lar/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electro-
magnetic site survey should be considered. If the measured field strength in the
location in which the device is used exceeds the applicable RF compliance level
above, the device should be observed to verify normal operation. If abnormal per-
formance is observed, additional measures may be necessary, such as re-orienting
or relocating the device.

²Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
3 V/m.

26
Recommended separation distances
Recommended Separation Distances Between Portable and Mobile RF Communi-
cations Equipment and the device
The device is intended for use in the electromagnetic environment in which radi-
ated RF disturbances are controlled. The customer or the user of the device can
help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and
the device as recommended below, according to the maximum output of the
communications equipment.
Separation distance according to frequency
of transmitter
in meters
Rated maximum output po-
wer of transmitter 150 kHz to 80 MHz to 800 MHz to
80 MHz 800 MHz 2,5 GHz
W d = 1,2 √P d = 1,2 √P d = 2,3 √P

0,01 0,11 0,11 0,23

0,1 0,37 0,37 0,75
1 1,2 1,2 2,3
10 3,7 3,7 7,4
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recom-
mended separation distance d in meters (m) can be estimated using the equation
applicable to the frequency of the transmitter, where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufac-
turer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher fre-
quency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic pro-
pagation is affected by absorption and reflection from structures, objects and peo-
ple.

27
9.2 Commissioning of medical systems
Before commissioning of the device the combination of device, PC and additional
peripheral devices must be tested and documented. If the system is not supplied
completely by the manufacturer the tests must be performed by the distributor.
Depending on the application electrical test have to be performed and documented
in the „Test report for medical systems“.

Application 1
Description
• CardioScreen 1000 is connected
to the patient
• CardioScreen 1000 is connected
to a computer via USB
• Only the CardioScreen 1000 is in
the patient environment of 1,5m
around the patient

Additional requirements
• None
Commissioning
• Documentation

Application 2
Description
• CardioScreen 1000 is connected to the patient
• CardioScreen 1000 is connected to a computer
via USB
• CardioScreen 1000 and computer are in the pa-
tient environment of 1,5m around the patient
• Computer is running on battery

Additional requirements
• No network is connected to the computer (otherwise a network insulation
must be used)
Commissioning
• Documentation

28
Application 3
Description
• CardioScreen 1000 is connected to the patient
• CardioScreen 1000 is connected to a computer
via USB
• CardioScreen 1000 and computer are in the pa-
tient environment of 1,5m around the patient
• Computer is connected to mains

Additional requirements
• The computer is of protection class I (with protective earth connector)
• No network is connected to the computer (otherwise a network insulation
must be used)
Commissioning

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Application 4
Description
• CardioScreen 1000 is connected to the patient
• CardioScreen 1000 is connected to a computer via
USB
• CardioScreen 1000 and computer are in the patient
environment of 1,5m around the patient
• Computer and peripheral devices are connected via a
multiple socket outlet to mains

Additional requirements
• Every device (except the CardioScreen1000) is of protection class I (equip-
ped with a protective earth connector)
• No network is connected to the computer (otherwise a network insulation
must be used)
• No standard connection cable fits into the multiple socket outlet
or
• the connections are only accessible with a tool
Commissioning

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9.3 Test report for medical systems
The medical system consists of: Tested by:

CardioScreen 1000 Dev. No: .................................

CardioScreen 2000 Dev. No: .................................
Computer Type: .................................
Printer Type: .................................
Others Type: .................................

Application 1
• no additional measures necessary

Application 2
• no additional measures necessary

Application 3

Earth leakage current (ELC): Highest touch current (TC):

µA µA

Measures taken:
Isolating transformer installed Type:
(if ELC > 500 µA or TC > 100µA)

Application 4
Earth leakage current (ELC): Highest earth leakage current (hELC): Highest touch current (TC):
(in multiple socket outlet) (each device, only if ELC > 500µA)

µA µA µA

Measures taken:
Isolating transformer installed Type:
(if hELC > 500 µA or TC > 100µA)

Additional protective earth connection Connected to:

(if ELC > 500 µA, hELC < 500 µA and TC < 100µA)

Comments: Test passed

Test not passed

Date Name of tester Signature

8 medis. Medizinische Messtechnik GmbH

Werner-von-Siemens-Str. 8, 98693 Ilmenau, Tel. 03677 / 4629 0, Fax 4629 29, www.medis-de.com

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