Custo Med custo cardio 400 BT User manual

Operating Manual
Resting and stress ECG
custo cardio 400 accu
custo diagnostic 5.8
CMA 0019 ∙ DK 2133 ∙ Version 1 ∙2022/10/25

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© 2022 custo med GmbH
This operating manual may not
be copied in its entirety or in part,
duplicated in any form or by any means or translated into another
language without the prior written consent of custo med GmbH.
The manufacturer reserves the right to change the information in this
operating
manual without prior notice. The current version can be
downloaded from our website:
www.customed.de
.

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Hardware Software Hygiene
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Table of Contents
1Safety ..................................................................................................5
1.1 General notes.......................................................................................................5
1.1.1 Symbols used in this Operating Manual............................................ 5
1.1.2 Laws and regulations applicable to the product............................. 6
1.1.3 Disclaimer .................................................................................................7
1.1.4 Warranty.................................................................................................... 7
1.1.5 Support ..................................................................................................... 7
1.2 Safety installations and safe working ............................................................ 8
1.2.1 Putting into operation, setup............................................................... 8
1.2.2 Ambient conditions, handling of the devices................................... 8
1.2.3 Patient safety .........................................................................................10
1.2.4 System and data security....................................................................11
1.2.5 Information on EMC (Electromagnetic Compatibility).................13
1.2.6 Maintenance (regular safety checks)................................................13
1.3 Safety instructions for resting and stress ECGs..........................................14
1.4 Residual risks resting and stress ECG...........................................................15
2Hardware...........................................................................................16
2.1 Intended use ......................................................................................................16
2.1.1 Indications and contraindications....................................................16
2.1.2 Device types and functions.................................................................17
2.2 Symbols on the devices and packaging ......................................................18
2.3 Technical data and system requirements...................................................19
2.4 Putting out of operation, storage, transport, disposal.............................22
2.5 Components for the recording ......................................................................23
2.6 Mounting, preparing the device ....................................................................24
2.6.1 Getting to know the operating elements on the custo move
extension arm ........................................................................................24
2.6.2 Mounting the custo move extension arm........................................25
2.6.3 Operating the custo move extension arm.......................................28
2.6.4 Removing the custo move extension arm, disassembly..............29
2.6.5 Attaching electrode suction tubes to the device...........................30
2.7 Device operation...............................................................................................31
2.7.1 Charging custo cardio 400 accu ........................................................31
2.7.2 Restoring shipping mode....................................................................32
2.7.3 Safety mode ...........................................................................................33
2.7.4 Display and control elements ............................................................33
2.7.5 States of the suction level and status display ................................34
2.7.6 Device states in standard operation.................................................36
2.7.7 Further states and special functions ................................................37
2.7.8 custo cardio 400 accu troubleshooting ...........................................39
2.8 Procedure of an examination.........................................................................41
2.9 Attaching the recorder to the patient ..........................................................43
2.9.1 Positions of the electrodes .................................................................43
2.9.2 Notes on stress with treadmill ...........................................................44
2.9.3 Safe use of treadmills...........................................................................45
3Software............................................................................................46

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3.1 custo diagnostic program structure.............................................................46
3.2 custo cardio 400 accu connection to the PC..............................................47
3.2.1 Connecting and configuring custo cardio 400 ...............................47
3.2.2 Further device settings for custo cardio 400...................................49
3.2.3 Connecting training devices for stress ECG ....................................50
3.2.4 Configuring a training device for stress ECG...................................51
3.2.5 Extended ECG settings.........................................................................52
3.3 Perform resting ECG recording......................................................................54
3.4 Resting ECG rhythm strips ..............................................................................59
3.5 Perform stress ECG recording........................................................................60
3.6 Opening evaluations........................................................................................70
3.6.1 Opening an evaluation via the evaluation search.........................70
3.6.2 Opening an evaluation via the evaluation main menu................72
3.7 Resting ECG evaluation ...................................................................................73
3.7.1 Evaluation structure .............................................................................73
3.7.2 Navigation in the evaluation ..............................................................74
3.7.3 Resting ECG evaluation screens ........................................................75
3.7.4 Resting ECG with additional function Sport ECG ..........................77
3.8 Stress ECG evaluation......................................................................................79
3.8.1 Evaluation structure .............................................................................79
3.8.2 Navigation in the evaluation ..............................................................80
3.8.3 Screens of the stress ECG evaluation ...............................................81
3.9 Confirming the evaluation..............................................................................83
3.10 Optional: Reporting with approval process................................................84
3.11 Ending the evaluation......................................................................................85
4Hygiene .............................................................................................86
4.1 Important notes ................................................................................................86
4.2 Hygienic reprocessing......................................................................................87
4.3 Recommended cleaning agents and disinfectants ..................................90
4.4 Disposal of the electrodes ..............................................................................91
5Appendix ...........................................................................................92
5.1 Values and formulas in the ECG evaluation................................................92
5.2 Keyboard navigation and shortcuts .............................................................95
5.3 Manufacturer’s declaration regarding EMC ................................................97
5.4 EC Declaration of Conformity ........................................................................99
5.5 Product components and accessories ......................................................100
5.6 List of Figures...................................................................................................101

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1Safety
1.1 General notes
1.1.1 Symbols used in this Operating Manual
Safety warning symbol, in case of dangerous situations with
high and medium risk level, which may result in personal
injuries
IMPORTANT:
absolutely necessary working steps
INFORMATION:
for the correct and safe use of the system.
TIP:
contains practical information to assist you with your work
custo
Words highlighted in colour indicate buttons or click paths to
the corresponding program point, e.g.:
Examination, Settings

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1.1.2 Laws and regulations applicable to the product
INFORMATION:
Strict compliance with the safety instructions protects against personal injury
and property damage during device operation. This Operating Manual is
designed to accompany the product and must be kept ready to hand close to
the device. As either the operator or user of this device you should have read
and understood the Operating Manual, in particular the safety instructions.
Should serious incidents occur in connection with a custo med product, they
must be reported by the user and/or patient to the manufacturer and the
competent authority of the Member State in which the user and/or patient is
established.
custo med devices are designed in accordance with the Medical Device
Directive 93/42/EEC and Medical Devices Regulation (MDR 2017/745), class IIa
and meet the requirements of protection class I or II, depending on the power
supply unit used or they are devices with an internal power supply, type BF or
CF according to IEC 60601-1. Other devices which are part of the system must
meet the requirements of the Standard for Information Technology Equipment
(IEC 62368) or the Standard for Electrical Medical Devices (IEC 60601-1).
The electrical installations in the rooms in which the system is used must meet
the requirements of the applicable safety standards.
For users outside the Federal Republic of Germany, the respective national
accident prevention measures, regulations and requirements apply.

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1.1.3 Disclaimer
The manufacturer will not be held liable for improper operation, non-
compliance with safety instructions and negligently skipped instructions.
custo med only assumes responsibility for the safety and reliability of the device
if all changes, enhancements, repairs and other work on the device or system
have been performed by an authorised custo med distributor or custo med and
the Operating Manual has been observed during device operation.
1.1.4 Warranty
Our product philosophy is committed to providing you with faultless products
which meet your expectations. Should you have reason to complain we aim to
rectify any defects immediately or provide a replacement delivery.
This does not include damage that can be attributed to usual wear and tear,
improper use, unauthorised modification of parts and the use of violent force.
After the warranty period has expired, only use original spare parts and
accessories supplied by custo med. Only this will ensure the safe and problem-
free operation of your device.
1.1.5 Support
If you have any questions or problems which are not dealt with here, please do
not hesitate to contact your authorised custo med distributor. A list of
authorised custo med distributor can be found on the Internet at:
www.customed.de, under Contact, Distributors.
You can also contact custo med GmbH directly at any time. We will be pleased
to provide you with information about your authorised custo med distributor or
contact your authorised custo med distributor and forward your queries.

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1.2 Safety installations and safe working
1.2.1 Putting into operation, setup
custo med systems must only be used in a technically perfect condition.
Regularly carry out a visual inspection of the devices and their associated
components. Only use accessories approved by custo med. The use of
accessories other than those specified may result in increased emissions or
decreased immunity.
A PC with peripherals is required to operate the custo med devices. For
assembly it is recommended to use portable multiple socket outlets approved
by custo med, e.g. medical protector. The following must be noted:
→Portable socket outlets must not be laid on the ground.
→Portable multiple socket outlets which are supplied with the system are to
be used only for supplying devices which are part of the system.
→Additional portable multiple socket outlets, lines and other equipment,
which are not part of the system, must not be connected to the system.
→When using a multiple socket outlet, the maximum permitted load is 3200
VA.
→Slots which are not used in the delivered system (portable multiple socket
outlets) must be provided with covers.
1.2.2 Ambient conditions, handling of the devices
Emissions
The custo med devices/systems are not suitable for use in rooms or areas with a
risk of explosion.
For installation and operation of the devices/systems, the EMC
(electromagnetic compatibility) instructions in the Operating Manual must be
observed.
Strong electromagnetic sources in the immediate vicinity of the custo med
device/system may result in recording errors. The custo med device/system
must not be stored or used in the vicinity of X-ray equipment, diathermy units or
magnetic resonance devices (MRT). Other electrical devices such as mobile
phones or radio transceivers may impair the quality of the recording.
Other devices may interfere with the custo med devices/systems, even if the
other devices comply with the applicable emissions requirements according to
CISPR.
Mechanical impact
No modifications may be made to the custo med devices/systems. Contact your
authorised custo med distributor for repairs.
custo med devices for outpatient use (recorder, transmitter) must be protected
from heat, moisture, dust and dirt. The devices may not function properly if they
come into contact with liquid.
It is not permitted to wear the devices in a swimming pool, in the sauna,
bathtub, shower or similar wet rooms. Do not submerge the custo med devices.
The custo med devices must be protected from mechanical impact, such as
falls or transport damage. Avoid heavy mechanical loads.

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Rechargeable batteries
Some custo med devices contain an integrated lithium polymer battery
(permanently installed in the housing). Any mechanical stress which is beyond
the intended use must be avoided. Do not use force to open the devices.
Some custo med devices contain a lithium-ion battery or other batteries that
can be removed. Remove the rechargeable battery when the device is not in
use. Do not expose the rechargeable battery to extreme temperatures, fire and
moisture. Do not immerse in liquids. Observe the operating and storage
conditions. Do not subject the rechargeable battery to strong shocks or drop it.
The rechargeable battery must not be disassembled, modified or short
circuited. Only use the supplied charger to charge the rechargeable batteries.
Do not remove battery compartment covers or other covers during use.
USB cable
Some custo med devices have a USB cable. This cable must not be kinked. Do
not step on the USB cable, only roll up the cable loosely and allow it to hang
freely during operation. Always hold the USB cable by the plug in order to
disconnect it from the PC.
Memory cards
Some custo med devices contain memory cards. custo med recommends that
you leave the supplied memory cards (if present) in the respective recorders to
ensure that they cannot get lost and to prevent dirt from entering the opening.
Do not insert or remove memory cards unless the device is switched off. The
supplied memory cards are only intended for the respective device. Do not use
the card to store any other data.
Only use the original memory card. Additional memory cards are available as
accessories.
Use the supplied memory card case to send in defective memory cards. If using
multiple recorders and/or memory cards, be careful not to confuse them.

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1.2.3 Patient safety
Fig. 1: Safety distances at the patient area
Without medical protective devices, for example medical protector, the PC and
all the non-medical devices connected to the system (e.g. the monitor and
printer) must be set up and used at a distance of at least 1.5 m to the patient
unit (see the orange area in the figure) as leakage currents can occur.
During examination or routine maintenance, do not touch non-medical
equipment and the patient at the same time (risk of electric shock). Make sure
that the electrode contacts do not come into contact with other conductive
parts.
All results achieved by automatic analysis and the resulting unconfirmed
reports produced by the system must be considered as suggestions only. For
diagnosis and therapy purposes it is essential that the results are checked and
assessed by a qualified physician.

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1.2.4 System and data security
IMPORTANT: Patient data must be handled in accordance with the legal
requirements of the respective country (this includes the General Data
Protection Regulation (GDPR)). custo diagnostic offers functions to help you
meet these requirements (e.g., user administration, password assignment).
Manufacturer’s note for users/customers for the integration of
programmable electronic medical systems (PEMS) into existing IT
networks
The custo med products and systems are programmable electronic medical
systems (PEMS). The integration of custo med products into an IT network that
includes other devices can lead to risks for patients, operators or third parties
that were not previously known. The responsible organisation should identify,
analyse, evaluate and control these risks. Subsequent changes to the IT
network can lead to new risks, and therefore require additional analysis.
Changes to the IT network include the following: Changes to the IT network
configuration, connecting additional items to the IT network, removing items
from the IT network, updates/upgrades of devices that are connected to the IT
network.
custo diagnostic
The device must only be used with the supplied custo med software (custo
diagnostic).
As the operator you are responsible for ensuring regular data backups (patient
databases, evaluations etc.) and system backups. We recommend that you
backup the data at the latest before new installations, updates and far-reaching
system configurations.
custo diagnostic new installations, updates and system configurations may only
be performed by your authorised custo med distributor.
Only change data generated in custo diagnostic within custo diagnostic itself
and not in your surgery IT system or your hospital information system (HIS).
custo med does not accept any responsibility for any changes to data in your IT
system or your HIS which were made after the export from custo diagnostic.
To ensure the safe operation of custo diagnostic, deactivate the screensaver
and energy management options on your PC. Set up your operating system in
such a way to prevent the PC from being switched off either accidentally or
automatically during the examination (standby mode/idle mode).
custo connect
When you use custo connect to integrate additional medical devices in the
custo med system, for automatic PDF printouts from the connected medical
device, check whether the PDF file belongs to the current patient. Do not trigger
any PDF printouts in other programs during the PDF printout in the connected
medical device.
If you use custo connect to integrate additional medical devices in the custo
med system, on starting the connected medical device check whether the
patient’s name was taken over correctly.

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Allocation of case and job numbers
If case or job numbers are manually entered into the system or they are
changed in the system, there is a risk of confusing patients and subsequent
misdiagnosis if an incorrect entry is made by a user. Always make sure that case
or job numbers are entered correctly!
Scanning or manually entering patient, case or job numbers does not relieve
the user of the obligation to check the patient to be physically treated.
Data management in custo diagnostic: Assign evaluation (allocate
evaluation)
If an examination was conducted with incorrect patient data, the evaluation can
be subsequently allocated to the correct patient. Make sure that the evaluation
is definitely allocated to the correct patient. Incorrect allocation can lead to
misdiagnosis. Please note that data which has already been exported to an
external system (e.g., surgery IT system) cannot be changed.
custo diagnostic is preset with the Assign evaluation function deactivated;
however, it can be reactivated via user rights if necessary. Only the Supervisor
can configure user rights. If the Assign evaluation function is activated, it can be
found in the evaluation search or in open evaluations in the Options menu.
We recommend configuring user rights in custo diagnostic so that only
authorised persons can execute the Assign evaluation function.

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1.2.5 Information on EMC (Electromagnetic Compatibility)
The use of other accessories, other converters and leads than those indicated,
except for the converters and leads sold by custo med as spare parts for inner
components, can lead to increased electromagnetic emissions or to a reduced
electromagnetic immunity of the system. For connecting the device to other
equipment, only specially screened cables supplied by custo med must be
used.
1.2.6 Maintenance (regular safety checks)
The operator is responsible for maintenance.
Observe the legal regulations for checking electrical systems and equipment
(e.g., Regulation 3 “Accident Prevention Regulation” of the German Social
Accident Insurance (DGUV) in the Federal Republic of Germany).
The functionality and the state of accessories must be checked at regular
intervals. If damaged or heavily soiled, the complete system must no longer be
used.
After each system or device repair, modification or conversion, your authorised
custo med distributor must perform a safety and conformity assessment.

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1.3 Safety instructions for resting and stress ECGs
The device must be protected from dust and liquids.
The custo med ECG devices are protected against defibrillation only in
connection with the manufacturer's patient cable.
In the event of defibrillation, take note of the manufacturers' instructions
regarding the safe and proper use of the defibrillator.
Defibrillation has an interfering effect on the ECG recording. custo cardio ECG
devices have a recovery time of less than five seconds.
For ECG recordings with custo cardio 400 in connection with the extension arm,
the plug coupling (power supply cable at the bottom end of the extension arm)
and the patient must NOT be touched at the same time.
Make sure that the electrode contacts do not come into contact with other
conductive parts.
If electrodes become detached from the patient during an ECG recording or the
electrode contact is too weak, a red signal line will be displayed on the
corresponding ECG channel in custo diagnostic. Below the ECG recording a hint
will appear (in red letters) indicating which electrodes are concerned. Reattach
them. The appearance of red signal lines in custo diagnostic does not indicate
that the patient has an asystole.
custo diagnostic provides pacemaker detection. Here, the pacemaker pulse
from the ECG signal (in two channels at least) is detected and then projected
into the ECG recording as an (artificial) spike, precisely timed.
However, the pulse width of the pacemaker is not calculated with the
pacemaker detection in custo diagnostic in conjunction with custo cardio
100/110/130/200. These devices are not suitable for binding pacemaker checks.
In case of doubt, use the device approved by the pacemaker manufacturer (see
the patient's pacemaker record).
custo cardio 400 accu is not suitable for intracardiac use.
custo cardio 400 accu has no protection against possible influences from high-
frequency (HF) surgical devices.
custo cardio 400 accu must not be used in the vicinity of HF surgical devices.
Use of the custo cardio 400 accu in conjunction with life-support equipment is
not permitted. The device is not suitable for intensive care or as an alarm
system for life-sustaining body functions.

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1.4 Residual risks resting and stress ECG
CAUTION
Skin irritations and hematomas due to negative pressure.
Skin irritations and hematomas due to negative pressure possible during
operation with higher suction levels.
→
Ensure that the suction level is set correctly.
→
If the patient suffers from diseases, e.g. arterial occlusive disease or severe
blood coagulation disorders, the physician must decide on the use of the
device
WARNING
Risk of injury due to changes in acceleration, speed or incline of the
treadmill.
Unexpected, abrupt stopping or sta
rting of the treadmill can cause injury to the
patient. Bruises, strains or fractures from tripping and falling.
→
Inform patient before making any change in acceleration, speed or incline.
→
Do not make changes until the patient has adjusted.

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2Hardware
2.1 Intended use
custo cardio 400 accu is a 12-channel PC ECG device designed for the creation,
analysis and evaluation of ECG recordings in medical practices and hospitals.
custo cardio 400 accu has an integrated electrode application system. The
electrode application system uses underpressure to attach the electrodes to the
body of the patient.
The device must be operated by suitably trained and qualified personnel in
medical practices, laboratories, rehab centres and hospitals. This includes, in
particular, doctors and medical-technical assistants.
custo cardio 400 accu can be used safely on patients with pacemakers.
custo cardio 400 accu is not suitable for intracardiac use.
Use of the custo cardio 400 accu in conjunction with life-support equipment is
not permitted. The device is not suitable for intensive care or as an alarm
system for life-sustaining body functions.
2.1.1 Indications and contraindications
Indications Resting ECG
→Suspected cardiovascular system disorder (e.g. MI, CHD, cardiac
insufficiency, arterial hypertension, hypertrophy, myocarditis, pericarditis)
→Supervision and monitoring of patients with acute or chronic
cardiovascular disorders (e.g. MI, CHD, cardiac insufficiency, arterial
hypertension, hypertrophy, myocarditis, pericarditis)
→To assess a preoperative risk
→To assess a postoperative intervention
→To assess and supervise medication therapy (in particular for
cardiologically active substances such as tricyclic antidepressants,
neuroleptics, etc.)
→To assess structural heart problems with cardiac arrhythmia (especially
sinus tachycardia and sinus bradycardia)
→Suspicion or monitoring of (cardiac) hypertrophy
→To check for comorbidities (for example with chronic respiratory disease)
→As part of pacemaker therapy
→For angina pectoris
→For suspected or diagnosed arterial sclerosis
→For suspected or diagnosed PAD (peripheral arterial disease)
→For diagnosed renal arterial stenosis
→To assess patients as part of a rehabilitation program
→Acute coronary syndrome with no ST segment elevation (NSTE-ACS)
Indications Stress ECG
→For CHD diagnosis
→Post-myocardial infarction
→Before and after revascularisation measures for progress monitoring
Sauer, G. et al. (2005) ‘[Position
paper to the taking of quality
controls for resting, exercise,
and long-term-ECG].’, Zeitschrift
fur Kardiologie, 94(12), pp. 844–
857. doi: 10.1007/s00392-005-
0320-4.

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→For patients with diagnosed or suspected arrhythmia
→For patients with arterial hypertension
→To record physical resilience
Contraindications Stress ECG
Absolute:
→Acute myocardial infarction
→Unstable angina pectoris
→Cardiac arrhythmia with symptomatology and/or impaired
haemodynamics
→Symptomatic severe aortic stenosis
→Decompensated cardiac insufficiency
→Acute lung embolism
→Acute myocarditis
→Acute perimyocarditis
→Acute aortic dissection
Relative:
→Main stem stenosis
→Moderate valvular disease
→Diagnosed electrolyte disorder
→Arterial hypertension (syst. 200, diast. > 110 mmHg)
→Tachyarrhythmia or bradyarrhythmia
→Hypertrophic obstructive cardomyopathy and other outflow tract
obstructions
→Higher-degree atrioventricular blockage
→Physical and/or mental impairments
2.1.2 Device types and functions
Type
Connection to PC
Power supply
custo cardio 400 BT
USB (3 m) and Bluetooth 2.1 EDR
12 V power supply
custo cardio 400 accu
USB (3 m) and Bluetooth 2.1 EDR
Lithium polymer battery, 12 V
power supply unit

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2.2 Symbols on the devices and packaging
Manufacturer: custo med GmbH, Maria-Merian-Str. 6,
85521 Ottobrunn, Germany
Date of manufacture (YYYY-MM, e.g., 2022-01)
CE mark
Serial number
Follow the Operating Manual!
Protection class designation of a medical electrical device
according to DIN EN 60601-1 (type CF, defibrillation protected)
Non-ionising electromagnetic radiation, device contains a HF
transmitter (the radio unit is only active with Bluetooth models)
Separate collection of electrical and electronic equipment, do not
dispose with domestic waste.
Hygiene seal of the German Society of Hospital Hygiene

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2.3 Technical data and system requirements
custo cardio 400 accu
Number of ECG channels
12
Frequency response
0 to 0.262 *
Sampling frequency [HZ]
Sampling frequency
1000, 2000, 4000, 8000, 16000 (only with USB), 32000 (only
with USB) Hz
Sampling rate
1.0 ms / 0.5 ms / 0.25 ms / 0.125 ms / 0.0625 ms (only with
USB) / 0.03125 ms (only with USB)
Deviation
< 1.5%
A/D conver
ter
24 bit
Input impedance
> 50 MΩ
Amplitude quantification
1.526 µV/bit
CMRR
> 93 dB
Impedance measurement
At all electrode leads (not N) with automatic quality
indication
Defibrillation protection
Electrical strength 5000 V
Recovery time
after defibrillation < 5 s
Suction output
Level 0 = 0 mbar
Level 1 = 60 mbar
Level 2 = 100 mbar
Level 3 = 140 mbar
Level 4 = 180 mbar
Level 5 = 220 mbar
Level 6 = 280 mbar
Power supply
Lithium
-polymer battery/12 V power supply
Battery
specifications
Charging time: approx. 4.5 hours at 1.5 A charging current
in standby, extended charging time with simultaneous
operation
Running time: approx. 9 hours (at pressure level 3), varies
depending on pressure level and leaks
Service life: at leas
t 500 charging cycles
Max. Power consumption
19 watts (charging in standby)
IT connection
USB (3 m) and Bluetooth 2.1 EDR
Radio frequency band
Bluetooth 2.1 EDR: 2.402
- 2.480 GHz (ISM band)
Radio transmission power
Bluetooth 2.1 EDR: max. 10 dBm
Bluetooth range
typ. 10 m, depending on ambient conditions
Time to standby mode
1)
after disconnection from USB: 30 min
after last BT communication: 30 min
after last manual configuration: 30 min
Energy saving mode
after 1 minute of inactivity
IP
protection class
IPX0 (not protected against water penetration)
Dimensions
250 * 110 * 60 mm (L * W * H)
Weight (without cables)
approx. 940 g
Electrode suction tubes
approx. 1200 mm, approx. 1450 mm, approx. 1650 mm
Operating conditions
Temperature +
10°C ... +40°C
Humidity 30 ... 75 % rH
Air pressure 700 ... 1060 hPa
Transport and storage conditions
Temperature
-20°C ... +45°C
Humidity 30 ... 95 % rH
Air pressure 700 ... 1060 hPa
Classification
Device with internal power supply
Class IIa,
application part type CF
Applied standards
DIN EN 60601
-1, DIN EN 60601-1-2, DIN IEC 60601-2-25
1) In standby mode, the pump
and valve are deactivated.
Communication via USB/BT
and manual configuration of
the system is still possible.
Standby mode is not activated
during an ECG recording.

CMA 0019 ∙ DK 2133 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
20
Safety
Hardware Software Hygiene
Resting and stress ECG
∙custo cardio 400 accu
General system requirements
Operating system
The custo diagnostic software is only suitable for
installation on Microsoft Windows systems.
custo
diagnostic 5 is a client/server combination. The
custo diagnostic 5 server can only run on 64
-bit systems.
For proper operation it is necessary to use the operating
system/software combinations tested and approved by
custo med for the respective custo
diagnostic version
(also custo diagnostic server and client for custo
diagnostic 5). These can be obtained from the authorised
custo med dealer or directly from custo med.
PC
The PC’s hardware must be compatible with Intel
products and fulfil the minimum
requirements for the
operating system used.
Provide additional RAM (1 GB) for custo diagnostic. Ensure
that there is sufficient free space on the hard disk for the
custo diagnostic evaluations.
The PC must meet the requirements of the safety
standard DIN E
N 62368 for information technology
equipment.
File sizes of the evaluations
Holter: approx. 15 MB (max. 60 MB)
ABPM: approx. 128 KB (max. 512 KB)
Holter
-ABPM: approx. 20 MB (max. 25 MB)
Resting ECG: approx. 200 KB (for an ECG of approx. 10
sec.)
Stress EC
G: approx. 6 MB (for an ECG of approx. 20 min.)
CPET: refer to stress ECG
Spirometry: approx. 50 KB (max. 256 KB)
Rehab: approx. 6 MB (for approx. 45 min. of exercise)
Hardware & ports
DVD or CD
-ROM drive
USB connection