Custo Med Holter ECG with custo flash 500 User manual

Operating Manual
Holter
custo flash 500/510/510V
custo diagnostic 5.8
CMA 0021 ∙ DK 2135 ∙ Version 1 ∙2022/10/25

CMA
0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
2
© 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
.

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
3
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
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 ...........................................................................................9
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 Holter .........................................................................14
1.4 Residual risks holter .........................................................................................15
2Hardware...........................................................................................16
2.1 Intended use ......................................................................................................16
2.1.1 Indications and contraindications....................................................17
2.1.2 Overview holter software and recorder ...........................................18
2.2 Symbols on the devices and packaging ......................................................19
2.3 Technical data and system requirements...................................................20
2.4 Putting out of operation, storage, transport, disposal.............................24
2.5 Components for the recording ......................................................................25
2.6 Charging process ..............................................................................................26
2.7 Display and control elements ........................................................................27
2.8 Procedure of an examination.........................................................................29
2.9 Attaching the recorder to the patient ..........................................................30
2.10 Patient instructions, handling of the device...............................................33
3Software............................................................................................35
3.1 custo diagnostic program structure.............................................................35
3.2 custo flash 500/510/510V connection to the PC........................................36
3.3 Performing a holter recording .......................................................................37
3.3.1 Select device for recording .................................................................37
3.3.2 Selecting and configuring analysis parameters.............................38
3.3.3 Selecting a patient for the recording................................................39
3.3.4 Transferring the recording parameters to the device...................40
3.4 Read in and display the recording ................................................................41
3.5 Opening evaluations ........................................................................................43
3.5.1 Opening an evaluation via the evaluation search.........................43
3.5.2 Opening an evaluation via the evaluation main menu ................45
3.6 Evaluation structure.........................................................................................46
3.6.1 Workflow for writing the report for an evaluation .........................47
3.6.2 Context menu ........................................................................................48
3.6.3 Options menu ........................................................................................48
3.7 Screens of the evaluation ...............................................................................50

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
4
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
3.7.1 Holter overview .....................................................................................50
3.7.2 Analysis....................................................................................................51
3.7.3 Trend/ECG ..............................................................................................53
3.7.4 Examples.................................................................................................54
3.7.5 Further standard functions.................................................................55
3.7.6 Professional functions .........................................................................58
3.7.7 Optional functions................................................................................61
3.8 Printing the evaluation ....................................................................................62
3.9 Confirming the evaluation ..............................................................................63
3.10 Optional: Reporting with approval process................................................64
3.11 Ending the evaluation......................................................................................65
4Hygiene .............................................................................................66
4.1 Important notes ................................................................................................66
4.2 Hygienic reprocessing......................................................................................67
4.3 Recommended cleaning agents and disinfectants ..................................68
4.4 Disposal of contaminated consumables.....................................................69
5Appendix ...........................................................................................70
5.1 Set custo flash 500/510/510V recorder time...............................................70
5.2 Calculation methods in the Holter ...............................................................71
5.3 Keyboard navigation and shortcuts .............................................................73
5.4 Manufacturer’s declaration regarding EMC ................................................76
5.5 EC Declaration of Conformity ........................................................................78
5.6 Product components and accessories ........................................................79
5.7 List of Figures.....................................................................................................80

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
5
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
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

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
6
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
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.

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
7
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
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.

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
8
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
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.

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
9
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
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.
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

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
10
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
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.

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
11
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
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.

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
12
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
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.

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
13
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
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.

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
14
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
1.3 Safety instructions for Holter
The device must be protected from dust and liquids.
It is not permitted to wear the devices in a swimming pool or in the bath. Do not
submerge the devices in liquid.
Make sure that the electrode contacts do not come into contact with other
conductive parts.
custo wing disposable adhesive electrodes must not be used on infants or small
children. Use suitable neonatal or paediatric electrodes.
Disposable adhesive electrodes must be changed daily to avoid skin irritation.
In the case of known allergies, e.g. against substances in the adhesive
electrodes or custo belt, the further procedure must be agreed with a doctor
before the commencement of recording. If patients experience discomfort
during a recording, they must contact their physician.
The custo med Holter systems are perfectly safe for patients with a pacemaker.
In Holter systems without pacemaker detection, disturbances in the ECG signal
may be incorrectly interpreted as a pacemaker.
Notes on custo diagnostic holter software options
The custo diagnostic function “ANS diagnostics” (balance of the autonomic
nervous system) serves as a supporting measure. A correct evaluation of the
holter recording must always be preceded.
If the patient has cardiac arrhythmia (especially atrial fibrillation), HRV analysis
(RR variability) is not suitable for diagnostic purposes.
The HRV parameters shown in custo diagnostic are to be considered in the
individual overall context (general condition and life situation of the patient).
The evaluation of the results by a qualified physician is essential.
For an improved informative value, it is advisable to repeat the examination so
that a development of the condition can be seen.

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
15
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
1.4 Residual risks holter
DANGER
Risk of strangulation due to supplied straps and cables.
→
Do not leave infants or small children unattended during recording.
→
Store out of reach of children when not in use.
DANGER
Choking hazard due to small parts
→
Keep small parts away from children.
CAUTION
Allergic reactions on the skin due to substances in adhesive electrodes
(acrylate adhesive, Ag/AgCl).
→
Clarify further procedure with the physician before recording.
CAUTION
Skin irritations and skin injuries caused by custo wing electrodes
Applying custo wing electrodes to injured skin areas causes skin irritation and
impairs wound healing.
Patients with skin diseases or blood coagulation disorders may suffer skin
injuries when custo wing electrodes are removed.
→
custo wing electrodes may only be used on patients with intact skin.
→
In patients with skin diseases or blood coagulation disorders, the
responsibility for the use of custo wing electrodes lies with the attending
physician.
→
In patients with skin diseases or blood coagulation disorders, the
application and removal of the custo wing electrode must be carried out by
medical professionals if there is a risk that the patient could injure
him/herself when applying or removing the electrodes independently.
→
If skin injuries are likely to occur during removal of the custo wing
electrodes, the application method with custo belt electrode belt shou
ld be
considered.

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
16
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
2Hardware
2.1 Intended use
custo flash 500/510/510V is a portable holter device with internal power supply
and is used to record a 3-channel ECG signal for 24 hours up to seven days.
custo flash 510/510V features pacemaker detection.
custo flash 500/510/510V can be used safely on patients with pacemakers.
The system is intended for use by trained specialist staff or physicians in clinics
and medical practices. Patients are only allowed to use the recording device
after receiving instruction by trained specialist staff. Patients who are not
capable of understanding and following the instructions given are not allowed
to use the device. This applies in particular to senile patients or patients
suffering from dementia.
The system is not suitable for electrocardiographic monitoring of patients as
per DIN EN 60601-2-27, e.g. use in intensive care.
The device is not suitable for intracardiac use.
custo flash 500/510/510V is not suitable for children with a body weight
below 10 kg.
Features of the recorder types
custo flash...
500
510
510V
501
501/L
Recording time max. 24 h
✓
✓
✓
✓
✓
Recording time max. 7 days
✓
✓
✓
–
–
Pacemaker detection
–
✓
✓
–
–
ANS diagnostics
–
–
✓
–
–
For holter online (sender)
–
–
–
✓
–
With software custo diagnostic light
–
–
–
–
✓

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
17
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
2.1.1 Indications and contraindications
Indications for Holter ECG1)
→Symptoms that may be related to arrhythmias
→Syncope
→Presyncope
→Dizziness with an otherwise unexplained cause
→Recurrent palpitations or tachycardia
→Unexplained episodes of dyspnoea, chest pain and fatigue
→In the context of antiarrhythmic therapy
→Verification of efficacy
→Evidence of possible proarrhythmic events
→Verification of rate control in atrial fibrillation
→In asymptomatic patients
→For postinfarction risk stratification
→In patients with severe left ventricular dysfunction (dilated
cardiomyopathy, secondary ischaemic cardiomyopathy)
→For diagnosis of intermittent atrial fibrillation
→In patients with hypertrophic obstructive cardiomyopathy
→Therapy monitoring
→In patients with antibradycardia or antitachycardia therapy systems
→Syncope, presyncope or frequent palpitations
→If systemic dysfunction is suspected that cannot be diagnosed by
pacemaker/ICD monitoring
→Holter ECG recording with heart rate variability analysis in
→Post-infarction patients with left ventricular dysfunction
→Patients with severe chronic heart failure (dilated cardiomyopathy,
secondary ischaemic cardiomyopathy)
→In patients with hypertrophic obstructive cardiomyopathy
→Patients with cardiac involvement of another extracardiac underlying
disease, e.g. diabetes
1) The indications for
performing a Holter ECG are
based on
"Z Kardiol 94:844-857 (2005),
DOI 10.1007/s00392-005-0320-4,
Positionspapier zur
Durchführung von
Qualitätskontrollen bei Ruhe-,
Belastungs- und Langzeit-EKG"
[Position paper on the taking of
quality controls for resting,
exercise, and Holter ECG],
Tab. 7.

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
18
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
2.1.2 Overview holter software and recorder
Holter ECG software versions & recorders
Software function
Software light1)
custo flash 501/L recorder
Software standard
all recorders
2)
Software professional
all recorders
2)
Comparison of evaluations
✓
✓
✓
Analysis (edit templates)
✓
✓
✓
Trend/ECG
✓
✓
✓
Examples
✓
✓
✓
Trend overview
–
✓
✓
Total ECG
–
✓
✓
Export as a PDF file
–
✓
✓
Reduction of the data volume
–
✓
✓
Movement data3) – guard holter, watch
✓
guard holter, watch
✓
Combined recording with
ABPM3)
screen 300/310/4004)
✓
screen 300/310/4004)
✓
screen 300/310/4004)
✓
multiday evaluation, up to 7
days or 3 days 3)
– flash 500/510/510V, guard
holter, watch
✓
flash 500/510/510V, guard
holter, watch
✓
pacemaker analysis3) – – flash 510/510V, guard holter
✓
Event system
–
–
✓
ST measurement
–
–
✓
QT measurement
–
–
✓
HRV
–
–
✓
AF diagnostics
–
–
✓
HRT
–
–
✓
ANS diagnostics5) – flash 510V, guard holter, screen
400, watch
✓
flash 510V, guard holter, screen
400, watch
✓
12-channel recording5) – EDAN SE-2012
✓
EDAN SE-2012
✓
CSV export RR-Interv.
5)
–
✓
✓
1) The product version custo tera light with custo flash 501/L is described in another user manual.
2) For the software versions standard and professional all custo med holter recorders can be used, except custo flash 501 and 501/L.
3) Only possible with the specified recorder type.
4) custo screen 300 is a pure ABPM recorder. If it is connected to the patient at the same time as a custo med holter recorder, the two
recordings are displayed as a combined evaluation due to the common recording period.
5) Optional, independent of the software version – but possibly with restrictions due to the recorder type.

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
19
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
2.2 Symbols on the devices and packaging
custo flash 500/510/510V
Manufacturer: custo med GmbH, Maria-Merian-Str. 6,
85521 Ottobrunn, Germany
CE mark
Follow the Operating Manual!
Separate collection of electrical and electronic equipment, do not
dispose with domestic waste.
Recyclable material
Safety class classification of medical electrical equipment
according to DIN EN 60601-1 (Type BF)
The device is not suitable for children weighing less than 10 kg
Protection class of electrical equipment. Protected against solid
foreign bodies, 12.5 mm diameter and larger. Protected against
dripping water when the enclosure is tilted up to 15°.
Sticker in the recorder to indicate the correct insertion direction
of the custo multiday card

CMA 0021 ∙ DK 2135 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
20
Safety
Hardware Software Hygiene
Holter
∙custo flash 500/510/510V
2.3 Technical data and system requirements
custo flash 500/510/510V holter recorder
Number of ECG channels
3
Sampling rate
2.5 ms ± 0.1 % per channel
Amplitude quantification
5.6 µ V/bit ± 1 % at 10 bit total
Frequency response
0.05
- 45 Hz
Input resistance
≥10 MΩ
Common mode rejection at 50 Hz
80 dB
Connection to PC
Standard SD card, USB card reader
Status display
LED
Power supply
Lithium-ion battery 3.7 V, >1800 mAh
Battery life
approx. 500 charging cycles
Dimensions
approx. 95 * 65 * 17 mm (L * W * H)
Patient leads
160 mm
Weight
approx. 105 g (incl. battery and strap)
Ingress
protection level
IP22
Operating conditions
Temperature: +10°C ... +45°C
Humidity: 10 ... 95 % rH without condensation
Air pressure: 700 ... 1060 hPa
Transport and storage conditions
Temperature:
-20°C ... +40°C
Humidity: 10 ... 95 % rH without condensati
on
Air pressure: 700 ... 1060 hPa
Classification
Device with internal power supply, Class IIa, Type BF
Applied standards
DIN EN 60601
-1, DIN EN 60601-2-47, DIN EN 60601-1-11