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