RAUMEDIC MPR1 - General notes; Safety-related information; Description of the device; 2.1 Intended purpose

Instructions for Use MPR1 DATALOGGER
Manufacturer: zwo-399EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16
Page 2 of 98
Table of contents
0
General notes ......................................................................................................................................... 5
1 Safety-related information .................................................................................................................... 6
2 Description of the device ...................................................................................................................... 8
2.1 Intended purpose ............................................................................................................................. 8
2.1.1 Description ................................................................................................................................ 8
2.1.2 Intended use ............................................................................................................................. 8
2.1.3 Operational environment .......................................................................................................... 8
2.2 Indications ........................................................................................................................................ 8
2.2.1 Conditions ................................................................................................................................. 8
2.2.2 Body parts or types of issue interacting with the unit ............................................................... 8
2.2.3 Frequency of use ...................................................................................................................... 8
2.2.4 Physiological purpose ............................................................................................................... 8
2.2.5 Patient population ..................................................................................................................... 8
2.2.6 Application in connection with electrosurgical units ................................................................. 9
2.3 Contraindications ............................................................................................................................. 9
2.4 Main operating functions .................................................................................................................. 9
2.5 Operating elements, connections, displays ..................................................................................... 9
2.5.1 Keys with dedicated functions ................................................................................................ 10
2.5.2 Keys with context-sensitive functions ..................................................................................... 10
2.6 Information and warning symbols .................................................................................................. 13
2.6.1 Information and warning symbols on the front side ................................................................ 13
2.6.2 Information and warning symbols on the bottom side and the type plate of the unit ............. 14
2.6.3 Remark- and warning symbols on the packaging label .......................................................... 15
2.7 Abbreviations ................................................................................................................................. 16
2.8 Code designations on the connection sockets of the MPR1 ......................................................... 16
2.9 Catheter location and signal designations ..................................................................................... 16
3 Patient monitoring ............................................................................................................................... 17
3.1 ECG ............................................................................................................................................... 17
3.2 Cabled invasive pressure measurement ....................................................................................... 18
3.2.1 General aspects ...................................................................................................................... 18
3.2.2 Preparation of the invasive pressure measurement ............................................................... 19
3.2.2.1 Preparation of the invasive pressure measurement with external transducer .................. 19
3.2.2.2 Preparation of the invasive pressure measurement with micro-chip precision
pressure catheter .............................................................................................................. 20
3.2.2.3 Zero calibration ................................................................................................................. 21
3.2.2.3.1 Zeroing RAUMEDIC catheter ..................................................................................... 21
3.2.2.3.2 Retention of zero value .............................................................................................. 22
3.2.2.3.3 Conventional zeroing ................................................................................................. 22
3.3 Telemetric measurement of the ICP .............................................................................................. 23
3.3.1 General ................................................................................................................................... 23
3.3.2 Preparation for telemetric measurement of the ICPT ............................................................. 23
3.4 Measurement of the body temperature.......................................................................................... 25
3.4.1 Preparing the temperature measurement .............................................................................. 25
3.4.2 Cleaning, disinfecting and sterilising the temperature sensor ................................................ 26
3.5 Analogue outputs ........................................................................................................................... 26
3.6 Interface for the extension of the apparatus .................................................................................. 26
3.7 PC interface ................................................................................................................................... 27
4 Operation of the MPR1 ........................................................................................................................ 28
4.1 General aspects ............................................................................................................................. 28
4.1.1 Switching on the apparatus .................................................................................................... 28
4.1.2 Screen selection ..................................................................................................................... 28
4.1.2.1 Information field................................................................................................................. 28
4.1.2.2 Navigation field ................................................................................................................. 28
4.1.2.3 Data field ........................................................................................................................... 29
4.2 Start screen .................................................................................................................................... 29
4.2.1 General notes on the key functions ........................................................................................ 30
4.2.2 Deleting the memory .............................................................................................................. 30
4.2.3 Open a new patient documentation ........................................................................................ 31
This document is for information only