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
3
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
4
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
5
Safety
Hardware Software Hygiene
Ambulatory Blood Pressure Measurement ABPM
∙custo screen 300/310
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