Custo Med custo screen 300 User manual

Operating Manual
Ambulatory Blood Pressure
Measurement ABPM
custo screen 300/310
custo diagnostic 5.8
CMA 0016 ∙ DK 2130 ∙ Version 1 ∙2022/10/25

CMA 0016 ∙ DK 2130 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
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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
.

CMA 0016 ∙ DK 2130 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
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Safety
Hardware Software Hygiene
Ambulatory Blood Pressure Measurement ABPM
∙custo screen 300/310
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
1.2.7 Metrological checks..............................................................................13
1.3 Safety instructions for Ambulatory Blood Pressure Measurement
(ABPM).................................................................................................................14
1.4 Residual risks Ambulatory Blood Pressure Measurement (ABPM)........15
2Hardware...........................................................................................16
2.1 Intended use ......................................................................................................16
2.1.1 Indications and contraindications....................................................17
2.1.2 Recorder types and functions ............................................................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.............................23
2.5 Components for the recording ......................................................................24
2.6 Device operation...............................................................................................26
2.6.1 Inserting the batteries or rechargeable batteries..........................26
2.6.2 Display and control elements ............................................................27
2.6.3 Elements in the display .......................................................................28
2.6.4 Error codes and causes .......................................................................29
2.7 Procedure of an examination.........................................................................31
2.8 Attaching the recorder to the patient ..........................................................32
2.9 Patient information: Removing and attaching the device ......................33
2.10 Patient instructions, handling of the device...............................................34
3Software............................................................................................36
3.1 custo diagnostic program structure.............................................................36
3.2 custo screen 300/310 connection to the PC...............................................37
3.3 Performing an ABPM recording .....................................................................38
3.4 Downloading the ABPM recorder..................................................................41
3.5 Opening evaluations........................................................................................44
3.5.1 Opening an evaluation via the evaluation search.........................44
3.5.2 Opening an evaluation via the evaluation main menu................46
3.6 Evaluation structure.........................................................................................47
3.7 Navigation in the evaluation ..........................................................................48
3.8 Screens of the evaluation ...............................................................................49

CMA 0016 ∙ DK 2130 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
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Safety
Hardware Software Hygiene
Ambulatory Blood Pressure Measurement ABPM
∙custo screen 300/310
3.8.1 Overview “Standard”............................................................................49
3.8.2 Overview “Central Blood Pressure” ..................................................51
3.8.3 Evaluation screen “Table”...................................................................53
3.8.4 Evaluation screen “Diagram” .............................................................54
3.8.5 Evaluation screen “Comparison” ......................................................55
3.8.6 Evaluation screen “Trend” ..................................................................56
3.8.7 Dialogue “Automatic report”..............................................................57
3.9 Printing the evaluation ....................................................................................58
3.10 Confirming the evaluation..............................................................................59
3.11 Optional: Reporting with approval process................................................60
3.12 Ending the evaluation......................................................................................61
3.13 Risk stratification ..............................................................................................62
3.13.1 Configuring workflows .........................................................................63
3.13.2 Defining evaluation guidelines ..........................................................64
3.13.3 Print settings for risk stratification....................................................65
3.13.4 Recorder start with risk stratification ...............................................66
3.13.5 Downloading an evaluation with risk stratification ......................67
3.13.6 Evaluation overview with risk stratification ....................................68
3.13.7 If the risk stratification is not displayed...........................................69
3.13.8 Unconfirmed report with risk stratification ....................................70
3.13.9 Definition of the blood pressure severity grades...........................71
3.14 Spot measurement...........................................................................................72
4Hygiene .............................................................................................74
4.1 Important notes ................................................................................................74
4.2 Hygienic reprocessing......................................................................................75
4.3 Recommended cleaning agents and disinfectants ..................................76
4.4 Disposal of contaminated consumables.....................................................77
5Appendix ...........................................................................................78
5.1 Limit values for adults......................................................................................78
5.2 Limit values for children and adolescents ..................................................79
5.3 Abbreviations in the evaluation.....................................................................84
5.4 Keyboard navigation and shortcuts .............................................................85
5.5 Manufacturer’s declaration regarding EMC ................................................87
5.6 EC Declaration of Conformity ........................................................................89
5.7 Product components and accessories ........................................................90
5.8 List of Figures.....................................................................................................91

CMA 0016 ∙ DK 2130 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
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Safety
Hardware Software Hygiene
Ambulatory Blood Pressure Measurement ABPM
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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

CMA 0016 ∙ DK 2130 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
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Safety
Hardware Software Hygiene
Ambulatory Blood Pressure Measurement ABPM
∙custo screen 300/310
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 0016 ∙ DK 2130 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
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Safety
Hardware Software Hygiene
Ambulatory Blood Pressure Measurement ABPM
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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.

CMA 0016 ∙ DK 2130 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
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Safety
Hardware Software Hygiene
Ambulatory Blood Pressure Measurement ABPM
∙custo screen 300/310
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 0016 ∙ DK 2130 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
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Safety
Hardware Software Hygiene
Ambulatory Blood Pressure Measurement ABPM
∙custo screen 300/310
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.

CMA 0016 ∙ DK 2130 ∙ Version 001 ∙ 2022/10/25 ∙ www.customed.de
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Safety
Hardware Software Hygiene
Ambulatory Blood Pressure Measurement ABPM
∙custo screen 300/310
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.