Custo Med Holter User manual

1234
Safety Hardware Software Hygiene
Operating characteristics:
for 3-channel holter
recordings,
24 hours to 7 days
MHW 0007 – DK 1694
Version 002 – 15/07/2019
Operating Manual
Holter
Part 2: Hardware, description of device for custo flash 500/510/510V/501/501L

MHW 0007 – DK 1694 | Version 002 – 15/07/2019 | custo med GmbH [2] Holter hardware, custo flash 500/510 / 510V / 501/501L | page 2
© 2019 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.
CAUTION:
This Operating Manual is part of a modular system, consisting of four parts. All
four parts must be downloaded from the Internet or from a CD to ensure the
Operating Manual is complete.

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Table of contents
2.1 Symbols on the device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
2.2 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
2.3 Part names, components for the recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
2.4 Display and control elements on the recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
2.5 Charging the rechargeable battery, operating the charger . . . . . . . . . . . . . . . . . . . . . . . .9
2.6 Starting the recorder and applying it to the patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.7 Patient instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
2.8 Technical data and system requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
2.9 Manufacturer’s declaration regarding EMC
(electromagnetic compatibility)
according to DIN EN 60601-1-2:2016-05 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
2.10 EC Declaration of Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
2.11 List of product components and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
1234
Safety Hardware Software Hygiene
Operating Manual
Holter
Part 2: Hardware, description of device for custo flash 500/510/510V/501/501L

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Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
2.1 Symbols on the device
Manufacturer:
custo med GmbH, Maria-Merian-Str. 6, 85521 Ottobrunn, Germany
CE mark
Observe the Operating Manual
Separate collection of electrical and electronic equipment,
do not dispose with domestic waste
Recyclable material
Medical electrical equipment classification
according to DIN EN 60601-1 (Type BF)
The device is not suitable for children weighing
under 10 kg
Labels in the recorder indicating the correct direction of insertion
of the custo multiday card

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Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
501/L
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
2.2 Intended use
custo flash 500/510/510V/501/501L is a portable Holter device with an internal
power supply which is used to record a 3-channel ECG signal over a period ranging
from 24 hours to seven days.
custo flash 500/510 /510V/ 501/501L is perfectly safe for patients with a pace-
maker. The ECG recording is not affected by pacemaker pulses.
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 un-
derstanding and following the instructions given are not allowed to use the device.
This applies in particular to senile patients or patients suffering from dementia.
custo flash 500 / 510 / 510V / 501 / 501L is not suitable
for intracardiac use.
custo flash 500 / 510 / 510V / 501 / 501L is not suitable
for children weighing less than 10 kg.
Characteristics of the recorder types
custo flash...
recording time max. 24 h
recording time max. 7 Tage
pacemaker detection
ANS diagnostics
for holter online (sender)
with Software custo diagnostic light
500
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
510
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
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


510V






501



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


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Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
2.3 Part names, components for the recording
custo flash 500/510 /510V/ 501/501L holter recorder1)
Rechargeable battery for custo flash 5xx
custo multiday card (standard SD card 256 MB)
Carrying case
Neck strap
Chest belt for carrying case, standard 60 – 110 cm
custo flash 5xx protect
custo sensive disposable electrodes
Starterkit (for custo flash 500/510/510V)
Charger for custo flash 5xx rechargeable battery
Rechargeable battery for custo flash 5xx
Power supply unit custo flash 5xx
USB card reader with extension cable
1) Depending on the recorder type, the scope of delivery varies, see chapter „2.11 List of product components
and accessories“. For custo flash 501 and 501/L, e.g. charger and power supply unit are included in the set,
in other versions, these parts are available separately as a starter kit.

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Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
LED display
The LED display provides information on the status of the recorder, the rechargeable
battery, the custo multiday card and the recording. A table with the possible LED
display states and their meaning can be found on the next page.
Event key
This key can be pressed to mark events during the recording. The patient should
make a note of the reason for pressing this key in his recording diary – e.g. health
problems, stress, agitation or similar.
Release key (located on the rear of the recorder)
This key is used to remove the rechargeable battery from the recorder. Firmly press
the release key and pull the rechargeable battery upwards.
Note on the rechargeable battery
Always remove the rechargeable battery when the recorder is not in use.
The recorder starts as soon as the rechargeable battery is inserted.
2.4 Display and control elements on the recorder
The release key is located on the rear
of the recorder

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Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
LED display during a normal recorder start
Further LED states, error display
RED
GREEN
RED
GREEN
RED
RED
GREEN
2 x flashing
fast flashing
(2- 3 times / sec.)
8 x flashing
slow flashing
(1 time / 2 sec.)
slow flashing
steady
steady
no LED
custo multiday card was detected.
The custo multiday card configuration is in progress,
the process may take several minutes.
The custo multiday card configuration is complete.
The device is in recording mode.
The rechargeable battery is almost empty.
When starting for the first time:
The custo multiday card is defective, recording not possible.
With very many new starts:
The maximum number of starts has been reached (60).
Recording is only possible after reading the custo multiday card.
Software error, the custo multiday card does not respond
The custo multiday card is full, the maximum recording duration
has been reached or the capacity of the rechargeable battery
is exhausted.

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Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
2.5 Charging the rechargeable battery, operating the charger
Notes on the rechargeable battery
It is a lithium ion battery without memory effect. The rechargeable battery can be
charged at any time, irrespective of the discharging times. A fully charged recharge-
able battery lasts for a recording of seven days.
Always use a fresh and fully charged rechargeable battery for a recording.
The rechargeable battery must only be charged at an ambient temperature between
10 – 45°C. The rechargeable battery must not be charged when exposed to direct
sunlight or on the radiator.
Charging the rechargeable battery
Connect the charger to the mains using the power supply unit
Insert the rechargeable battery into the charger as shown below
The LED display of the charger shows the state of the rechargeable battery:
The maximum charging time is approx. 4 hours
To remove the rechargeable battery, keep pressed the release key
on the rear of the charger and pull out the rechargeable battery.
Yellow LED

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
Green LED

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

Battery state
without battery
without battery
battery inserted,
charging in progress
battery inserted,
completely charged
Charger state
PSU inserted?
Ready for operation

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Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
2.6 Starting the recorder and applying it to the patient
For a recording you need: a custo flash 5xx recorder, a programmed custo multiday
card (see „Part 3, Software Description“), a freshly charged battery, a clean neck
strap, a clean carrying case, three electrodes.
For multi-day recordings (additional material for the patient): three electrodes per
day, one hygiene bag per day, quick guide for patients.
Make sure that the custo multiday card is writable. If the write protection is
active, no ECG can be saved on the SD card. To save data to the SD card, the write
protect lock must be in the upper position as shown.
Insert the programmed custo multiday card into the recorder. Make sure that
the direction of insertion is correct (see the label in the recorder).
Assemble the rechargeable battery and the recorder (press until the re-
chargeable battery engages). The direction of insertion is based on the position
of the contacts. Once the device has been put together, it takes approx. one
minute for the recording to start. During this period the custo multiday card
is configured. LED display during configuration:
2 x red. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . custo multiday card detected
green, fast. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . custo multiday card configuration
8 x red. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Configuration completed
green, slow. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Recording in progress
Put the recorder into its case. Make sure that the inspection window of the
case is on the front of the recorder and that the LED display is visible through the
inspection window.
Material for the
recording
Deactivating the
custo multiday card
write protection
Carrying case
and neck strap
Assembling and
starting the
recorder

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Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
Attach the neck strap to the recorder. If a fabric carrying case is used, pull the
loops of the neck strap through the holes at the top of the carrying case. To do
so, feed the length adjusters of the strap loops through the holes. Place the loops
around the strap holders of the rechargeable battery and pull them tight. Place the
recorder around the patient‘s neck. Adjust the neck strap so that the recorder is
placed centrally on the patient‘s chest.
Shave, clean (e.g. with custo prep ECG cream) and dry the electrode application
points. Connect the electrodes to the ECG leads of the recorder. We recommend
using custo sensive electrodes. Adhesive electrodes of other manufacturers can also
be used, provided that they are approved by the respective manufacturer for this
purpose.
Remove the protective films from the electrodes. Apply the top two electrodes
(, ) under the collarbone, if possible not on a muscle. Apply the bottom electrode
() below the heart or on the breastbone. The electrodes can be applied at a slightly
different position within the blue frame.
IMPORTANT: High grade electrodes, careful preparation of the patient and correct
electrode application improve the quality of the recording and facilitate evaluation.
Provide the patient with a printout of the patient diary (print via custo diagnostic
or use the provided master copy) and explain how to use the event key. Explain the
patient instructions.
Tip for fixing the recorder: To reduce movement artefacts in the recording, you
can fix the recorder to the patient. To do so, use adhesive strips with low adhesive
residue, e.g. Leukosilk.
Carrying case
and neck strap
Applying
the electrodes
Hints for
the quality of
recording

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Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
2.7 Patient instructions
Handling the recorder
The recording period selected should be as normal as possible (not a holiday, no
out-of-the-ordinary events).
Protect the recorder against humidity and spray water. Do not immerse the recorder
in liquids. Do not wear the recorder in the shower, bath, sauna or similar wet envi-
ronments. Protect the recorder against extreme cold, heat, excessive dust develop-
ment and impact or being dropped.
The patient is not allowed to remove the rechargeable battery, or modify the device
in any way.
During the recording no radiological examinations must be performed. The quality
of the recording may be influenced by other electrical devices (e.g. mobile phones).
Do not leave small children unattended with the device. Risk of strangulation with
provided cables and belts, risk of suffocation from small parts that could be swal-
lowed.
The LED display flashes green during recording (approximately once every 2 sec-
onds). If this is not the case, contact the medical practice. To avoid incorrect record-
ings the LED display should be checked regularly.
Notes on applying the electrodes
In the case of known allergies, e.g. against substances in the adhesive electrodes,
the further procedure must be agreed with the physician before the commencement
of recording.
In the case of multi-day recordings, the electrodes and the hygiene case must be
replaced daily. To achieve correct measuring results, the electrodes must be applied
according to the specified electrode positions.
If electrodes become detached during the recording, they must be attached again.
Otherwise the ECG recording will not be possible. Patients should contact their
medical practice for assistance with reattaching the electrodes.
The electrodes must not be applied to moist skin. The application positions for the
electrodes must be dry and free of grease. The application positions must be free of
personal care products.
If patients experience physical problems (e.g. severe skin irritations) or any other
form of discomfort during the recording, the recorder can be taken off and they
should contact their physician.

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Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
Taking off and putting on the recorder,
during multi-day recordings, e.g. for taking a shower or bath
Detach the ECG leads from the electrodes, do not pull on the cables!
Remove the neck strap together with the recorder over the head.
Store the recorder in a safe and dry place.
Remove the electrodes from the body.
Dry thoroughly after taking a shower or a bath.
Apply new electrodes as shown and attach them firmly.
Change the hygiene case; the inspection window must be
on the front of the recorder so that the LED display is visible.
Put on the recorder and connect the ECG leads with electrodes.

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Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
2.8 Technical data and system requirements
custo flash 500/510/510V/501/501L
Recording channels 3
Sampling rate 2.5 ms ± 0.1% per channel
Amplitude quantification 5.6 μ V/Bit ± 1% at a total of 10 bit
Frequency response 0.05 – 45 Hz
Input resistance ≥10 MΩ
Common-mode rejection at 50 Hz 80 dB
Power supply Rechargeable lithium-ion battery 3.7 V, >1800 mAh
Rechargeable battery lifespan approx. 500 charging cycles
Dimensions approx. 95
*65 *17 mm (L *W *H)
Patient leads 160 mm
Weight approx. 105 g (including rechargeable battery and belt)
Operating conditions Temperature +10°C ... 45°C
Air humidity 10 ... 95% rH without condensation
Air pressure 700 ... 1060 hPa
Transport and storage Temperature -20°C ... +40°C
conditions Air humidity 10 ... 95% rH without condensation
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

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Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
General system requirements
Operating system Windows 7 SP1 – with current updates
(32 bit and 64 bit operating system)
Windows 8 (32 bit and 64 bit operating system)
Windows 8.1 (32 bit and 64 bit operating system)
Windows 10 (32 bit and 64 bit operating system)
Windows Server 2003 (32 bit and 64 bit operating system)
Windows Server 2008 (32 bit and 64 bit operating system)
Windows Server 2008 R2
Windows Server 2012
Windows Server 2012 R
older versions are not supported
PC The PC hardware should meet the minimum requirements of the
operating system used. Provide additional RAM (1 GB) for
custo diagnostic. Please 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 EN 60950 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 ECG: 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 port

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Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
Recommended system requirements
Computer Intel Core i3-CPU with HD graphics 4400
4 GB RAM
256 GB SSD or SSHD (for single-position systems 2TB HDD)
1 GBit network connection (not for single-position systems)
Fanless Dual-DVI (or DP) graphics card (for CPET)
Windows 8.1 x64 (PRO version for joining a domain)
Ports One USB 2.0 port per USB device (preferably not USB 3.0)
One COM port each for ergometer and treadmills (serial)
At least Version 4.0 if Bluetooth is installed
otherwise can be deactivated in the BIOS
Monitor 20“ TFT with DVI or DP port
Full HD resolution
Dual-TFT for CPET
Printer 600 dpi
Monochrome (colour recommended for CPET)
USB 2.0 port or network connection
PCL-enabled (increases printing speed with the suitable driver)

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Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
2.9 Manufacturer’s declaration regarding EMC (electromagnetic compatibility)
according to DIN EN 60601-1-2:2016-05
Length of the patient leads: 160 mm
Manufacturer's declaration – electromagnetic emissions
The custo flash 500/510 /510V/ 501/501L holter recorder is designed for use in the electromagnetic environ-
ment stated below. The customer or user of the custo flash 500/510 /510V/ 501/501L should make sure that it
is used in such an environment.
Manufacturer’s declaration – electromagnetic immunity
The custo flash 500/510 /510V/ 501/501L holter recorder is designed for use in the electromagnetic environ-
ment stated below. The customer or user of the custo flash 500/510 /510V/ 501/501L should make sure that it
is used in such an environment.
COMMENT: UTis the alternating supply voltage prior to application of test levels
Emission measurements
RF emissions according to CISPR11
RF emissions according to CISPR11
Harmonics according to IEC61000-3-2
Voltage fluctuations/flickers according to IEC61000-3-3
Compliance
Group 1
Class B
Not applicable
Not applicable
Electromagnetic environment - guidelines
custo flash 500/510/510V/501/501L uses RF energy only
for its internal function. Its level of RF emission is there-
fore very low and is unlikely to be sufficient to interfere
with other electronic devices.
custo flash 500/510/510V/501/501L is designed for use in
all establishments, including domestic establishments and
those directly connected to the public low voltage power
supply network that supplies buildings used for domestic
purposes.
Immunity tests
Static electricity discharge (ESD)
according to IEC 61000-4-2
Quick transient electric interference factors / bursts
according to IEC 61000-4-4
Surges
according to IEC 61000-4-5
Voltage drops, brief interruptions
and fluctuations in supply voltage
according to IEC 61000-4-11
Magnetic field at supply frequency (50/60 Hz)
according to IEC 61000-4-8
IEC 60601- test level
± 8 kV contact discharge
± 15 kV air discharge
± 2 kV for net wires
± 1 kV for input and
Output leads (SIP/SOP)
± 1 kV lead against lead
± 2 kV lead against end
< 5% UTfor 0.5 periods
(> 95% drop)
40% UTfor 5 periods
(60% drop)
70 % UTfor 25 periods
(30% drop)
< 5% UTfor 5 s
(> 95% drop)
30 A/m
Compliance level
± 8 kV contact discharge
± 15 kV air discharge
Not applicable
Not applicable
Not applicable
30 A/m

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Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
Manufacturer’s declaration – electromagnetic immunity
The custo flash 500/510 /510V/ 501/501L holter recorder is designed for use in the electromagnetic environ-
ment stated below. The customer or user of the custo flash 500/510 /510V/ 501/501L should make sure that it
is used in such an environment.
1) The ISM bands (EN: Industrial, Scientific and Medical, i.e. frequency bands used for industrial, scientific and
medical purposes) between 0.15 MHz and 80 MHz are 6.765 to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957
MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz; 3.5 MHz to 4.0 MHz;
5.3 MHz to 5.4 MHz; 7 MHz to 7.3 MHz; 10.1 MHz to 10.15 MHz; 14 MHz to 14.2 MHz; 18.07 MHz to
18.17 MHz; 21 MHz to 21.4 MHz; 24.89 MHz to 24.99 MHz; 28 MHz to 29.7 MHz and 50 MHz to 54.0 MHz.
Immunity tests
Conducted disturbances, induced by high-frequency fields
according to IEC61000-4-6
Radio-frequency electromagnetic fields
according to IEC61000-4-3
IEC 60601- test level
3 Veffective value
0.15 MHz to 80 MHz
6 Veffective value
in ISM frequency bands1)
between 0.15 MHZ and 80 MHz
80% AM at 1 kHz
10 V/m
80 MHz to 2.7 GHz
80 % AM at 1 kHz
Compliance level
not applicable
10 V/m
80 MHz to 2.7 GHz
80 % AM at 1 kHz

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Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
Recommended protective distances between portable
and mobile RF telecommunication devices and custo flash 500 / 510 /510V / 501/501L
custo flash 500 /510 /510V /501/501L is designed for use in an electromagnetic environment in which the RF
transients can be controlled. The user can help avoid electromagnetic interference by maintaining the minimum
distance between portable and mobile RF telecommunication devices (transmitters) and the device – depending
on the power output of the communication device, as indicated below.
WARNING: Wearable RF communication devices (radio devices) (including their accessories, e.g. antenna cables
and external antennas) should not be used at distances of less than 30 CM (12 inches) from the custo flash
500 /510 /510V /501 /501L parts and leads described by the manufacturer. Failure to observe this warning can
compromise the performance of the device.
WARNING: Use of this device directly next to other devices or stacked together with other devices should be
avoided, as this could result in fault operation. If the devices must nonetheless be used as described above, this
device and the other devices should be monitored to ensure proper functionality.
a) For some radio services, on the frequencies for the radio connection of mobile communication devices to the
base station (uplink) were included in the table.
COMMENT on protection clearances: The minimum clearances for increased immunity test levels must be
calculated using the following equation:
where P is the maximum output in Watt (W), d the minimum clearance in metres (m) and E the immunity test
level in Volt per metre (V/m).
General COMMENTS:
These guidelines may not apply in every case. The propagation of electromagnetic variables is influenced by
absorptions and reflections of buildings, objects and people.
ൌ͸
כξ
Frequency banda) MHz
380 to 390
430 to 470
704 to 787
800 to 960
1700 to 1990
2400 to 2570
5100 to 5800
Radio servicea)
TETRA 400
GMRS 460, FRS 460
LTE Band 13, 17
GSM 800/900,
TETRA 800, iDEN 820,
CDMA 850, LTE Band 5
GSM 1800, CDMA 1900,
GSM 1900, DECT,
LTE Band 1, 3, 4, 25,
UMTS
Bluetooth,
WLAN 802.11 b/g/n
RFID 2450, LTE Band 7
WLAN 802.11 a/n
Maximum output in W
1.8
2
0.2
2
2
2
0.2
Clearance in m
0.3
0.3
0.3
0.3
0.3
0.3
0.3
Immunity test level in V/m
27
28
9
28
28
28
9

MHW 0007 – DK 1694 | Version 002 – 15/07/2019 | custo med GmbH
2
[2] Holter hardware, custo flash 500/510 / 510V / 501/501L | page 20
Holter
Hardware, description of device for custo flash 500 / 510 / 510V / 501 / 501L
2.10 EC Declaration of Conformity