Custo Med custo screen 300 User manual

Operating Manual
ABPM
Part 2: Hardware, description of device for custo screen 300/310/400/pediatric
1234
Safety Hardware Software Hygiene
Operating characteristics:
For automatic
ABPM measurements
lasting up to 72 hours
MHW 0005 – DK 1664
Version 004 – 30/03/2020

MHW 0005 – DK 1664 | Version 004 – 30/03/2020 | custo med GmbH [2] ABPM Hardware, all custo screen devices | page 2
© 2020 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 devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
2.2 Intended use
2.2.1 custo screen 300/310/400. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
2.2.2 custo screen pediatric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
2.2.3 Functional features of custo screen recorder types. . . . . . . . . . . . . . . . . . . . . . .6
2.3 Part names, components for the recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
2.4 Device operation, for all types of recorders
2.4.1 Inserting batteries or rechargeable batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
2.4.2 Display and operating elements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
2.4.3 Elements in the display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.4.4 Error codes and their causes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.5 Attaching the recorder to the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
2.6 Patient instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
2.7 Technical data and system requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.8 Manufacturer’s declaration regarding EMC
(electromagnetic compatibility)
according to DIN EN 60601-1-2:2016-05 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
2.9 EC Declaration of Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
2.10 List of product components and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Operating Manual
ABPM
Part 2: Hardware, description of device for custo screen 300/310/400/pediatric
1234
Safety Hardware Software Hygiene

2
ABPM
Hardware, description of device for custo screen 300/310/400/pediatric
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2.1 Symbols on the devices
Manufacturer:
custo med GmbH, Maria-Merian-Str. 6, 85521 Ottobrunn, Germany
CE mark
Safety class classification of medical electrical
equipment according to DIN EN 60601-1 (Type BF)
custo screen 300/310/400: The device is suitable for children aged ten and older
(not for new-borns and small children).
custo screen pediatric: The device is suitable for children aged
between three and twelve years (not for new-borns and small children).
Non-ionising electromagnetic radiation, device contains an RF transmitter
(Radio unit is only active with custo screen 400)
Symbol on the custo screen 400 recorder for the insertion direction
of the standard SD card1)
The sticker specifies the date when the next metrological check is due.
Contact your authorised custo med dealer.
Observe the operating manual
Separate collection of electrical and electronic equipment,
do not dispose with domestic waste
1) Applies to devices from serial number CG2019 00885. Older versions with mini SD card.
Ottobrunn
gültig bis:
MTK
7
6
5
4
3
2
1
14
15
16
17
18
19
12
11
10
9
8

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2.2 Intended use
2.2.1 custo screen 300/310/400
custo screen 300/310/400 is an ABPM recorder with an internal power supply which
is used to record and evaluate the blood pressure behaviour of a patient (from age
of 10 years on). The recording time can last for up to 72 hours. The recorder types
300/310/400 are characterised by different functions, see chapter 2.2.3 Functional
features of custo screen recorder types.
The custo screen devices are perfectly safe for use by patients with a pacemaker.
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.
The device is not suitable for unsupervised use
with unconscious patients.
2.2.2 custo screen pediatric
custo screen pediatric is an ABPM recorder with an internal power supply which is
used to record and evaluate the blood pressure behaviour of children1) (from 3 to 12
years). The recording time can last for up to 72 hours.
custo screen pediatric is intended for use by general practitioners and medical spe-
cialists and also designed for hospitals and clinics. custo screen pediatric is intended
for use on children1). The device is not suitable for new-borns and small children
(patients must be aged at least 3 years).
Before an examination can be carried out, a physician's approval must be obtained
and one of the parents must have received detailed instruction by trained specialist
staff. The device must not be used for recordings on child patients who are not able
to endure the examination.
The device is not suitable for unsupervised use
with unconscious patients.
It is only permitted to carry out an examination if it is ensured that
the child patient is supervised during the entire period of recording
as there is a risk of strangulation.
1) Definition according to
DIN EN 80601-2-30:2016-02:
New-borns < 1 month
Toddlers < 3 years
Children > 3 years

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Recorder functions and properties
ABPM recording, max. 72 h
Holter ABPM recording, max. 24 h
Evaluation with central blood pressure (from 19 y.)
Spot measurement (from 19 y.)
Suitable for children from 3 to 12 years
Suitable for adults / patients over 10 years
custo diagnostic software options
Diagnosis with phenotypes (optional, from 19 y.)
Risk stratification (optional, from 16 y.)
2.2.3 Functional features of custo screen recorder types
300
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310
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400
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pediatric
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custo screen...

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2.3 Part names, components for the recording
custo screen 300/310/400/pediatric ABPM recorder
custo screen 400 with standard SD card
1)
custo screen pediatric with child-friendly motifs on the battery
compartment cover, scope of delivery contains four different motifs
Cuff with retainer standard
additional cuff sizes available, see Chapter
2.7 Technical data... and 2.10 List of product components...
in case of custo screen pediatric additionally cuff wrap small, child
and cuff wrap pediatric
Carrying case for the ABPM recorder
Carrying belt, depending on the type of recorder in different lengths:
custo screen 300/310/400: 127 cm, optionally 155 cm
custo screen pediatric: child belt 96 cm
Batteries (set of 3) Mignon 1.5 Volt, type AA
Infrared interface custo com IR
or optional custo multi com (infrared interface with SD card reader)
USB extension cable 2.0, type B mini, 2.0 m
1) Applies to devices from serial number CG2019 00885. Older versions with mini SD card.

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Tip: custo screen protect hygiene set
Six washable fleece pads – for more hygiene
and comfort when wearing the blood pressure cuff.
Worn underneath the cuff with the soft side on the skin.

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2.4 Device operation,
for all types of recorders
2.4.1 Inserting batteries or rechargeable batteries
Open the battery compartment as depicted and
insert three commercially available batteries. The
direction of insertion is shown on the illustrations in
the battery compartment.
2.4.2 Display and operating elements
On/off switch:
for switching the recorder on and off
I = on
0 = off
Infrared interface
for transmitting data between
custo screen 300/310/400/pediatric and PC
Cuff port (BNC)
Only with custo screen 400:
Card slot for standard SD card1)
with symbol for insertion direction of the card
Function key
for starting and stopping measurements
Display
for displaying results
and messages
1) Applies to devices from serial number CG2019 00885.
Older versions with mini SD card.

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2.4.3 Elements in the display
Sys: Systolic blood pressure
Dia: Diastolic blood pressure
P: Pulse
Battery: Lights up if the batteries are weak
If the blood pressure measurement
has been carried out successfully...
systole, diastole and pulse will be displayed
three times in succession
During the data transmission between the recorder and the PC...
"PC" is shown on the display (the light-emitting diode
of the custo com IR infrared interface flashes)
In the event of erroneous measurements...
an error code is shown on the display, e.g. "E06"

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Error when reading or writing the time
Internal electric double-layer capacitor (energy store for the time) discharged
Insert batteries, switch device on
Thresholds are fallen below or exceeded
Sys: <70mmHg >270mmHg, Dia: <40mmHg >155mmHg
Sys - Dia: <15mmHg
HR: <35/min >220/min
Measurement is repeated automatically
Pressure discharge rate outside the given limits
Valve is leaking or defective
Customer service
Disturbed measurement
Too many movement artefacts
Cuff slipped or not tight enough
Attach the cuff carefully and keep the arm steady during the measurement
Battery voltage too low
Insert new batteries or freshly charged rechargeable batteries into the recorder
Pressure sensors transmit different values
Cuff tube kinked
BNC port at the recorder or cuff tube dirty
One of the pressure sensors is faulty
Remove cuff from device, connect it again and repeat procedure
If the error persists, call customer service
Pressure increase is too slow
Cuff is not connected or cuff/valve is leaking/defective
Connect cuff if necessary
Check cuff (sealing ring in connection present/OK?)
If the error persists, call customer service
2.4.4 Error codes and their causes

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Pressure increase is too fast
Cuff tube is kinked, valve system is clogged
Align the cuff tube
If the error persists, call customer service
Discharge period is too long
Cuff tube is kinked, valve is defective
Customer service if multiple occurrences during a recording
Error when determining diastole
Cuff attached incorrectly, marking is not situated on the artery,
movement artefacts
Attach the cuff carefully and keep the arm steady during the measurement
Error when determining systole
Cuff attached incorrectly, marking is not situated on the artery,
movement artefacts
Attach the cuff carefully and keep the arm steady during the measurement
In the event of an erroneous measurement, the measurement is repeated after two
minutes. If errors occur that are not listed here, switch the device off and back on
again. Repeat the desired step. If the error persists, contact your authorised custo
med dealer.

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2.5 Attaching the recorder to the patient
Attaching the blood pressure cuff
Make sure to select the correct cuff size for the
patient. Each cuff contains information for which arm
circumference it is suited, e.g. standard 24 – 32cm.
Attach the cuff to the left upper arm, two to three
centimetres above the crook of the arm. Apply the
cuff in such a way that the marking is situated on the
brachial artery. The cuff must not be attached too
firmly. It should still be possible to fit approximately
two fingers between the arm and the cuff.
Lay the cuff tube from the left shoulder over the right
shoulder to the right hip. There the recorder will be
placed later.
Fix the cuff and the tube to the patient’s body. This
serves to avoid erroneous measurements due to
incorrect positioning of the cuff or tube. Use pro-
fessional fixing aids with a low level of adhesive
residues.
Attaching the belt with the carrying case
Attach the carrying case to the carrying belt. Put
the carrying belt on the patient. The case should be
positioned on the patient’s right hip. Put the switched-
on recorder into the carrying case and close it with the
hook and loop fastener.
Connect the cuff tube to the recorder as illustrated.
Sample measurement
Press the function key in order to carry out a sample
measurement. Take care that the patient keeps still
during the measurement. In the event of an erroneous
measurement, improve the fitting of the cuff and the
tube. If the sample measurement is successful, patient
and recorder are ready for recording.

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2.6 Patient instructions
Handling of the recorder
The day on which the recording is made should be planned as normally as possible
(no day off, no exceptional events).
The switched-on recorder and the cuff must also be worn during the night.
No x-rays must be taken on the day of recording. Sources of interference, such as
stimulation current devices, are to be avoided.
Each measurement is announced with a beep (unless this function is deactivated
in custo diagnostic). Using default settings, the measurements are performed every
15 minutes during the day and every 30 minutes during the night.
The recorder must be protected against extreme cold, heat, moisture, dirt and
mechanical impact. No showers, no visits to the swimming pool and sauna.
The patient is not allowed to remove the batteries or rechargeable batteries or
modify the device in any way.
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 swallowed.
Avoiding erroneous measurements
The patient must keep still during the measurement.
The cuff tube must not be kinked.
A repeat measurement is automatically performed two minutes after an erroneous
measurement. If several measurements are erroneous (especially E6, E21-24 and
E25-28), it should be checked if the cuff is still positioned correctly. The marker
should be located on the brachial artery and the cuff should be positioned on the
arm so that approximately two fingers fit between the cuff and the arm. For further
causes of erroneous measurements, see Chapter 2.4.4 Error codes and their causes
Discomfort during the recording
If the patient experiences discomfort during a recording, e.g. caused by a too high
cuff pressure, the patient must contact his/her physician. The patient can stop the
measurements at any time by pressing the function key or by opening the cuff’s
hook and loop fastener. Pregnant women should consider their individual physical
endurance and contact their physician, if necessary.

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2.7 Technical data and system requirements
custo screen 300/310/400/pediatric
Measurement method Oscillometric measurement procedure,
Automatic zero balancing
Measuring range custo screen pediatric
Heart rate 35 – 220 beats / min
Systolic blood pressure 50 – 160 mmHg
Diastolic blood pressure 30 – 110 mmHg
custo screen 300/310/400
Heart rate 35 – 220 beats /min
Systolic blood pressure 70 – 270 mmHg
Diastolic blood pressure 40 – 155 mmHg
Measurement accuracy [mmHg] custo screen pediatric Systole Diastole MAP
Deviation from the average value -1.4 -0.7
Standard deviation 3 3.2
custo screen 300/310/400*
Deviation from the average value -0.5 -0.1
Standard deviation 4.5 3.3
Central blood pressure**
Deviation from the average value 0.71 2.96 0.19
Standard deviation 5.95 5.21 3.78
*)
Meets the requirements of the ESH International Protocol 2010
**) Ref: Invasive Validation of Antares, a New Algorithm to Calculate
Central Blood Pressure from Oscillometric Upper Arm Pulse Waves
Marcus Dörr , Stefan Richter , Siegfried Eckert , Marc-Alexander Ohlow,
Fabian Hammer, Astrid Hummel, Vivien Dornberger, Elisabeth Genzel
and Johannes Baulmann
Max. number of measurements 500
Max. recording time 72 hours for ABPM recordings
24 hours for Holter ABPM recordings (custo screen 400)
Duration of one measurement approx. 30 seconds
Measuring intervals Can be set from 5 to 90minutes in the software
Standard: every 15min. during the day, every 30min. at night
Cuff pressure custo screen pediatric max. 200 mmHg
custo screen 300/310/400 max. 300 mmHg
Cuff sizes ped. 3xx/400
and compatibility with the Cuff D-Ring standard 24 – 32 cm 
recorder types Cuff D-Ring x-large 32 – 40 cm  
Cuff D-Ring xx-large 38 – 50 cm  
Cuff Wrap pediatric 14 – 20 cm 
Cuff Wrap small, child 20 – 24 cm 
Cuff Wrap standard 24 – 32 cm 
Cuff Wrap xx-large 38 – 50 cm 

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Data transmission Infrared interface with USB port (IrDA standard)
Standard SD card for Holter ABPM (custo screen 400)
Power supply 3 Mignon 1.5V, type AA
3 rechargeable batteries, Ni-MH, 1.2V, min.1500mAh
Operating conditions Temperature +10°C ... +45°C
Air humidity 10 ... 95% rH
Air pressure 700 ... 1060 hPa
Transport and storage Temperature -20°C ... +45°C
conditions Air humidity 10 ... 95% rH
Air pressure 700 ... 1060 hPa
Dimensions Size approx. 100
*66 *26 mm (L *W *H)
Weight approx. 159 g (without batteries)
Classification Device with internal power supply
Type BF
Class IIa
Applied standards DIN EN 60601-1,
DIN EN 60601-1-2,
IEC 80601-2-30,
DIN EN 60601-2-47 (only applies to custo screen 400),
Directive 93/42/EEC

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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 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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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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Manufacturer's declaration – electromagnetic emissions
The custo screen 300/310/400/pediatric ABPM recorder is designed for use in the electromagnetic environment
stated below. The customer or user of the custo screen 300/310/400/pediatric should make sure that it is used
in such an environment.
Manufacturer’s declaration – electromagnetic immunity
The custo screen 300/310/400/pediatric ABPM recorder is designed for use in the electromagnetic environment
stated below. The customer or user of the custo screen 300/310/400/pediatric should make sure that it is used
in such an environment.
COMMENT: UTis the alternating supply voltage prior to application of test levels
2.8 Manufacturer's declaration regarding EMC (electromagnetic compatibility)
according to DIN EN 60601-1-2:2016-05
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 screen 300/310/pediatric uses RF energy only for
its internal function. Its level of RF emission is therefore
very low and is unlikely that adjacent electronic devices
will be disturbed.
custo screen 400 uses the frequency band in the range
2.4 GHz for communication with the custo guard ECG
transmitter. RF emissions are very low and it is unlikely
that adjacent electronic devices will be disturbed.
custo screen 300/310/400/pediatric 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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Manufacturer’s declaration – electromagnetic immunity
Thecustoscreen300/310/400/pediatric ABPMrecorderisdesignedforuseintheelectromagneticenvironmentstated
below. The customer or user of custo screen 300/310/400/pediatric 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
3 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