Operator's Manual

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NICCI Technology

PURPOSE

This document is the master of instructions for use for NICCI technology.

SCOPE

n/a

REFERENCES

Ref Doc ID Version Document Title

[1] LAB-000194 04 NICCI System instructions for use set-up and design

specification

[2] SDS-000056 06*

CNAP - Alarms & Messages

[3] REQ-000036 05 PR00678 Default Parameter

[4] SDS-000062 01*

UI Integration Manual - User Interaction Specifications

The IFU contents are according to Polarion baseline 23.07.2019.

Every message is listed only once in the IFU (despite the different error codes).

CHANGE HISTORY

Version

Edit Date Description Issuer

Reference to the

project (DCC, DCP)

01 28 May 2019 First release I. Sichna VIENNA

02 27 July 2019 1. Update of ‘Alarms and messages’

according to SDS-000056-05.

2. Changes in the SW description:

• Explanation of grey bars in the

pressure parameter field;

• Addition of the term ‘CO calibration’ to

the index;

• Explanation of the curve icon in the

NIBP history table.

• Format improvements in chapter ‘D2

NICCI Sensor activation’.

• Changes in the description of ‘NIBP

only’ mode (chapter new ‘E2 NIBP

only measurement’)

3. Minor wording/pictures improvements

in the chapter ‘Setup&start’.

4. Updates according to LAB-000194-02:

• chapter A1-3 (impact of RAC-000498-

06).

• chapter B3 (impact of REQ-000065-08

and REQ-000036-05)

• chapter A4-6: transfer of

new/removing/update of

warnings/cautions/notes

• appendix O (addition of rated range of

the sensor cuffs pressure 0-280

mmHg)

I. Sichna VIENNA

Summary of content (13 pages)

PAGE 1
PURPOSE This document is the master of instructions for use for NICCI technology. SCOPE n/a REFERENCES Ref [1] Doc ID LAB-000194 Version 04 Document Title NICCI System instructions for use set-up and design specification [2] SDS-000056 06*2 CNAP - Alarms & Messages [3] REQ-000036 05 PR00678 Default Parameter [4] 1 SDS-000062 01* UI Integration Manual - User Interaction Specifications *1 The IFU contents are according to Polarion baseline 23.07.2019.
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03 13 Aug. 2019 1. Minor wording/pictures improvements in the chapter ‘Setup&start’. 2. Appendix O: addition of rated measurement range (20-250mmHg). 3. Update of ‘Alarms and messages’ according to SDS-000056-06. I. Sichna VIENNA 04 5 Sept. 2019 1. Chapter K: update according to LAB000194-03 (update of cleaning and disinfection agents, impact of REQ000065-09). I. Sichna VIENNA 05 18 Sept. 2019 1. Table 15 (electromagnetic immunity): update of ESD test level and ESD compliance level I.
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MASTER NICCI Technology Operator’s Manual
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NICCI components Table 1 – NICCI components NICCI components NICCI Module Component variants Article numbers NICCI Module PC6500 NICCI Mouse PC6510 NICCI Upper Arm Cuff, S NICCI Upper Arm Cuff, M NICCI Upper Arm Cuff, L NICCI Upper Arm Cuff, XL PC6531 PC6532 PC6533 PC6534 NICCI Sensor S, single use NICCI Sensor M, single use NICCI Sensor L, single use PV6550 PV6551 PV6552 Connected to the host monitor PulsioFlex PC4000 NICCI Mouse* Connected to the NICCI Module NICCI Upper Arm Cuff* Connected to
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About this manual This manual is an extension to the PulsioFlex operator’s manual (PC406*) that specifically describes the NICCI technology integrated into the PulsioFlex monitor PC4000. Both manuals need to be considered. * plus two digit language code according to ISO 639-1 This icon indicates a hazardous situation that, if not avoided, could result in death or serious injury. It may also describe potential serious adverse reactions and safety hazards.
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Contents NICCI components ..................................................................................................................................................... III About this manual ...................................................................................................................................................... IV Contents .......................................................................................................................................................
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3 4 Measurement via PulsioFlex........................................................................................................................... 23 Measurement via NICCI Module..................................................................................................................... 24 E NIBP measurement modes............................................................................................................................... 25 1 NIBP modes for continuous NICCI measurement ....
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Q Appendix - Technical specifications - Near Field Communication The NICCI uses Near Field Communication (NFC) technology to enable communication between the NICCI Mouse and NICCI Sensor without electrical connection. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation’.
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• • • current patient data modifications date of first use current date of use Technical description In general, a radio frequency module is (usually) a small electronic device used to transmit and receive the radio signals between two devices. The radio frequency module is a part of NICCI Mouse printed circuit board. It contains the NFC reader chip with an integrated antenna, which send and receive the data from a transponder.
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Information PULSION Medical Systems SE Hans-Riedl-Straße 17 85622 Feldkirchen GERMANY Phone: +49 – (0)89 – 45 99 14 – 0 Fax: +49 – (0)89 – 45 99 14 – 18 E-mail: info@pulsion.com Internet: www.getinge.
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Getinge is a global provider of innovative solutions for operating rooms, intensive care units, sterilization departments and for life science companies and institutions. Based on our fi rsthand experience and close partnerships with clinical experts, healthcare professionals and medtech specialists, we are improving the everyday life for people - today and tomorrow. www.getinge.