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RAUMEDIC MPR1 - User Manual

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Instructions for Use MPR1 DATALOGGER
Manufacturer: zwo-399EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16
Page 1 of 98
Instructions for Use
MPR1 DATALOGGER
REF 094474-001 and 094474-002
Firmware versions
2.10.0070 and 2.10.0070 HW2
This document is for information only

Table of Contents

Questions and Answers

Summary

General notes

Safety-related information

Description of the device

2.1 Intended purpose

Details the device's intended use, applications, and operational environment.

2.2 Indications

Lists the conditions and patient types for which the MPR1 is indicated.

2.3 Contraindications

Specifies situations where the device should not be used.

2.4 Main operating functions

Outlines the primary functions and operations of the device.

2.5 Operating elements, connections, displays

Describes the physical interface, buttons, and displays of the device.

2.6 Information and warning symbols

Explains symbols used on the device for information and warnings.

2.7 Abbreviations

Lists common abbreviations used in the manual.

2.8 Code designations on the connection sockets of the MPR1

Details the naming conventions for device connection ports.

2.9 Catheter location and signal designations

Provides designations for catheter locations and signal types.

Patient monitoring

3.1 ECG

Covers ECG monitoring capabilities and usage.

3.2 Cabled invasive pressure measurement

Explains how to perform invasive pressure measurements using cables.

3.3 Telemetric measurement of the ICP

Details telemetric measurement of Intracranial Pressure (ICP).

3.4 Measurement of the body temperature

Describes how to measure body temperature using the device.

3.5 Analogue outputs

Explains the function and use of the device's analogue outputs.

3.6 Interface for the extension of the apparatus

Details interfaces for expanding device functionality.

3.7 PC interface

Describes the connection and use of the PC interface.

Operation of the MPR1

4.1 General aspects

Covers general operational considerations and initial setup.

4.1.1 Switching on the apparatus

Provides instructions on how to power on the MPR1 device.

4.1.2 Screen selection

Explains how to navigate and select different screens on the device.

4.1.2.1 Information field

Details the data displayed in the device's information field.

4.1.2.2 Navigation field

Describes the navigation field and its context-sensitive function keys.

4.1.2.3 Data field

Explains the purpose and content of the data field.

4.2 Start screen

Describes the initial welcome or start screen of the MPR1 device.

4.2.1 General notes on the key function

Provides general information about the device's key functions.

4.2.2 Deleting the memory

Instructions on how to delete stored data from the device's memory.

4.2.3 Open a new patient documentation

Guides on how to start a new patient record or documentation.

4.2.4 Selecting the memory mode

Explains how to choose between different data storage (memory) modes.

4.2.5 No storage

Describes the "No storage" memory mode and its advantages.

4.2.6 View last measurement

Instructions on how to view the data from the last recorded measurement.

Alarm limit selection

Connecting the transducer

4.4.1 Operating instructions - connection cable

Provides guidance on connecting and handling cables for transducers.

4.4.2 ECG

Details the ECG connection, display, and basic settings.

4.4.2.1 ECG settings

Explains how to configure ECG-specific settings like signal filtering.

4.4.2.2 ECG alarms

Describes how ECG alarms are indicated and their possible causes.

4.4.2.3 ECG graphics

Shows how to display and adjust ECG graphics.

4.4.2.4 Heart rate trend

Explains how to view the heart rate trend data.

Transducer for invasive pressure measurement

4.4.3.1 Invasive pressure measurement settings

Covers settings for invasive pressure measurements, including alarm limits.

4.4.3.2 Changing limiting alarm value settings for invasive pressure measurement

Details how to adjust upper and lower alarm limits for pressure measurements.

4.4.3.2.1 Changing the pressure limiting value

Step-by-step guide to modifying pressure alarm thresholds.

4.4.3.2.2 Activating and deactivating the alarms

Instructions on enabling or disabling alarms for pressure measurements.

4.4.3.3 Connecting analogue outputs

Explains how to connect analogue outputs for data transfer.

4.4.3.4 Pressure graphics

Describes how to display and interpret pressure measurement graphics.

4.4.3.5 Invasive pressure trend

Details how to view the trend data for invasive pressure measurements.

4.4.3.6 Measuring the CPP

Explains how to measure Cerebral Perfusion Pressure (CPP).

Transducer for temperature measurement

4.4.4.1 Changing the temperature settings

Covers how to adjust temperature measurement settings and alarms.

4.4.4.1.1 Setting the limiting temperature values

Provides steps for setting temperature alarm limits.

4.4.4.1.2 Activating and deactivating the temperature alarms

Instructions on enabling or disabling temperature alarms.

4.4.4.2 Temperature graphics

Explains temperature display in graphics mode.

4.4.4.3 Temperature trend

Details viewing temperature trend data.

Telemetric pressure measurement

4.4.5.1 Making ICPT settings

Covers initial settings for telemetric ICP measurement.

4.4.5.2 Changing ICPT alarm limit settings

Details how to adjust alarm limits for telemetric ICP measurement.

4.4.5.3 ICPT chart

Describes the ICPT chart display.

4.4.5.4 ICPT trend

Details viewing ICPT trend data.

4.4.5.5 Measuring the CPP using the ICPT

Explains how to measure CPP using telemetric ICP data.

Configuring the graphics display

Device setup

4.6.1 Combine analogue outputs

Explains how to combine analogue outputs with third-party systems.

4.6.2 Device diagnostics

Guides on performing device diagnostics and checking system status.

4.6.3 Setting the LCD contrast

Instructions for adjusting the contrast of the device's LCD screen.

4.6.4 Setting the language version

Details how to change the device's display language.

4.6.5 Setting date and time

Provides steps to set the device's date and time.

4.6.6 Modifying the scaling

Explains how to adjust the scaling of measurement signals.

Activating the key lock

Switching on the LCD background illumination

Alarm system

4.9.1 Physiological alarms

Explains physiological alarms, their priorities, and monitored values.

4.9.2 Factory settings

Lists factory default settings and ranges for physiological alarms.

4.9.2.1 Factory settings and adjustment ranges for physiological alarms

Detailed table of factory alarm settings and adjustable ranges.

4.9.2.2 Inactivate alarm signal switch

Instructions on how to inactivate alarm signals.

4.9.3 Saving the alarm settings

Explains how to save modified alarm settings.

4.9.4 Technical alarms

Describes technical alarms related to device and sensor malfunctions.

4.9.4.1 Apparatus alarms

Details alarms related to the device itself, like battery status.

4.9.4.2 Sensor alarms

Describes alarms triggered by sensor issues (disconnection, defect).

4.9.5 limitations

Notes limitations regarding ECG signal alarms.

4.9.6 Summarisation

Diagram illustrating alarm cause, signal, and muting/reset dependencies.

4.9.7 Verifying the alarm system

Instructions on how to verify the proper functioning of the alarm system.

Power supply

5.1 Mains power supply

Information on using the device with the mains power adapter.

5.2 Displays when operating on mains power

Describes the displays and indicators when powered by mains.

5.3 Battery operation

Details the device's operation using its internal battery.

5.4 Displays when operating on battery

Describes the displays and indicators when powered by battery.

5.5 Influence of the storage conditions on the battery operation

Explains how storage conditions affect battery performance and maintenance.

5.6 Battery maintenance

Provides guidelines for maintaining the device's battery pack.

5.7 Information on how to handle battery packs

Offers advice on handling and disposing of battery packs.

Troubleshooting

6.1 Special instructions for the telemetric measurement of ICP

Addresses specific faults related to telemetric ICP measurement.

6.2 Error - Zero calibration of pressure channel

Troubleshooting steps for errors during pressure channel zero calibration.

6.3 Internal error - pressure channel

Addresses internal errors within the pressure channel.

6.4 Internal error - temperature

Addresses internal errors within the temperature channel.

6.5 Memory full

Troubleshooting steps when the device's memory is full.

6.6 Residual operating time - battery pack

Information regarding the remaining battery operating time.

6.7 Pressure sensor has been removed

Troubleshooting steps when a pressure sensor is disconnected.

6.8 Temperature sensor has been removed

Troubleshooting steps when a temperature sensor is disconnected.

6.9 ECG cable disconnected

Troubleshooting steps when the ECG cable is disconnected.

6.10 Grave error A

Describes "Grave error A" indicating device settings reset.

6.11 Grave error B

Describes "Grave error B" indicating a system defect.

6.12 Internal error - analogue output

Troubleshooting steps for internal errors in analogue outputs.

6.13 Defective fuses

Information about identifying and handling defective fuses.

6.14 Reaction to fault messages and indications

Explains how to react to fault codes and messages displayed by the device.

Fault S03

Troubleshooting for temperature sensor removal or defect.

Fault S05

Troubleshooting for telemetry connection interruption.

Fault S06

Troubleshooting for reader disconnection.

Fault T01

Troubleshooting for internal defects in pressure channels.

Fault T02

Troubleshooting for internal defects in temperature channels.

Fault T04

Troubleshooting for data saving errors.

Fault T05

Troubleshooting for low battery warning.

Fault T06

Troubleshooting for pressed alarm key error.

Fault T07

Troubleshooting for keyboard failure.

Fault T23

Troubleshooting for simultaneous catheter and reader connection.

Fault T24

Troubleshooting for simultaneous catheter and reader connection (ICP).

Fault T25

Troubleshooting for no data from reader or technical defect.

Fault T26

Troubleshooting for telemetry connection loss with other DMI.

Fault T27

Troubleshooting for implant hardware fault.

Fault T28

Troubleshooting for implant data error.

Fault T29

Troubleshooting for incompatible implant software.

Fault 30

Troubleshooting for inconsistency in reader data.

Fault T31

Troubleshooting for incompatible reader software.

Fault T33

Troubleshooting for no telemetric connection, check antenna positioning.

Fault T34

Troubleshooting for internal ICPT measurement error.

Fault T35

Troubleshooting for internal RFID reader error.

Fault T99

Warning for nearly full data memory.

Messages on the MPR1 when saving data to the PC

Messages displayed during PC data saving and download process.

Cleaning and maintenance

7.1 Cleaning the MPR1

Instructions for cleaning the MPR1 device itself.

7.2 Cleaning, disinfecting and sterilising the cables and sensors

Procedures for cleaning, disinfecting, and sterilizing cables and sensors.

7.2.1 Cleaning

Specific steps for cleaning cables and sensors.

7.2.2 Disinfection

Procedures for disinfecting cables and sensors.

7.2.3 Sterilisation

Notes on sterilization limitations for cables and electrodes.

7.3 Cleaning the mains adaptor

Instructions for cleaning the mains adapter.

Inspections, Safety and Measurement Checks

8.1 General

General requirements for inspections and safety checks.

8.2 Safety check (SC)

Details the procedures for performing safety checks on the device.

8.3 Measurement check (MC)

Outlines the process for metrological control and measurement checks.

Accessories

Electromagnetic compatibility

10.1 Manufacturers declaration on the EMC requirements according to IEC 60601-1-2:2014

Manufacturer's statement on EMC compliance with IEC 60601-1-2:2014 standard.

10.1.1 Accuracy under the influence of electromagnetic interference phenomena

Explains how accuracy is affected by electromagnetic interference.

10.1.2 General information

General advice regarding EMC and equipment placement.

10.1.3 Electromagnetic emissions

Details the electromagnetic emissions characteristics of the device.

10.1.4 Electromagnetic immunity

Specifies the electromagnetic immunity test levels for the device.

10.2 Manufacturers declaration on the EMC requirements according to IEC 60601-1-2:2007

Manufacturer's statement on EMC compliance with IEC 60601-1-2:2007 standard.

10.3 Electromagnetic emissions

Details the electromagnetic emissions characteristics of the device.

10.4 Electromagnetic immunity

Provides guidelines and declarations for electromagnetic immunity.

Guidelines and manufacturer declaration - electromagnetic immunity

Specific guidelines and manufacturer declarations for EMC immunity.

Technical parameters (Specification)

11.1 Technical data

Lists detailed technical specifications for ECG, temperature, and pressure.

Telemetry channel pressure

Technical parameters for telemetric ICP measurement.

Analogue outputs

Technical specifications for analogue outputs.

Interface for the expansion of the apparatus

Technical details for the RS232 interface.

PC interface

Technical details for the USB PC interface.

General data

General technical data including dimensions, mass, and power supply.

Environmental conditions

11.2.1 Operating and storage temperature

Specifies operating and storage temperature ranges for the device.

11.2.2 Humidity

Details the required humidity levels for operation and storage.

11.2.3 Atmospheric pressure

Specifies the atmospheric pressure requirements for the device.

Environment and disposal

Liability and warranty

Index

Enclosures

Extract from the EU Declaration of Conformity according to MDD

Declaration of Conformity for Medical Devices Directive (MDD).

Extract from the EU Declaration of Conformity according to AIMDD

Declaration of Conformity for Active Implantable Medical Devices Directive (AIMDD).

RAUMEDIC MPR1 Specifications

General IconGeneral
BrandRAUMEDIC
ModelMPR1
CategoryData Loggers
LanguageEnglish