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RAUMEDIC NeuroSmart - User Manual

RAUMEDIC NeuroSmart
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RAUMED NeuroSmart Instruction Manual
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
zwo-541EN Rev 3 / 2022-05-03
Page 1 of 61
Instruction manual
RAUMED
®
NeuroSmart
®
REF 095284-001 and
RAUMED
®
NeuroSmart
®
logO
095294-001
Edition with GUI Revision g3.22.
This document is for information only

Table of Contents

Questions and Answers

Summary

General Information

Intended Use

Device intended for monitoring invasive physiological pressures and patient temperatures.

Operational Environment

Specifies where the device can be used, including clinical environments and during transport.

Indications

Conditions under which the NeuroSmart can measure and monitor physiological parameters.

Contra-indications

Situations where the NeuroSmart should not be used, such as in CT or MRI environments.

Safety Instructions

General Safety Instructions

Crucial guidelines for safe operation, including user qualifications and proper handling.

Cyber and Data Security

Instructions for protecting data and ensuring system security, including software updates.

Device Safety Symbols

Explains symbols on the device and their meanings for safe operation and compliance.

Packaging Safety Symbols

Details symbols found on the packaging, indicating handling and storage precautions.

Operation

Operating Functions

Overview of the device's main and important functions for monitoring and data management.

Start-up Procedures

Steps for initial device setup, including visual inspection and connection diagrams.

Operating Concept and Screen Layout

Describes the device's interface, including hard keys, touch display areas, and view arrangements.

Starting and Managing Measurements

Guides on initiating measurements, selecting functions, setting limits, and handling data.

Settings and Configuration

Instructions for adjusting system settings like language, scaling, date/time, and graphics.

Alarm System Management

Details on alarm types, visual/audible indicators, and settings for managing alarms.

Data Forwarding

How to connect and forward measured data to external devices via analogue outputs.

Expanded Physiological Parameters

Information on calculating and using advanced parameters like PRx, ORx, and CPPopt.

Error Handling and Troubleshooting

Information for Technical Support

Guide on accessing and providing device information to service personnel for error resolution.

Cleaning and Care

NeuroSmart Device Cleaning

Procedures for cleaning the main device unit, including disinfection and sterilization limitations.

Cable Maintenance

Guidelines for cleaning, disinfecting, and sterilizing cables to maintain functionality and safety.

Adapter Cleaning

Instructions for cleaning the power adapter, emphasizing avoiding immersion in liquids.

Electromagnetic Compatibility (EMC)

Measuring Accuracy and EMC

Performance characteristics related to electromagnetic disturbance phenomena and approved deviations.

General EMC Information

Guidance on using the device in environments with potential electromagnetic interference and precautions.

Electromagnetic Emissions

Classification of electromagnetic emissions and conformity standards for industrial and hospital use.

Electromagnetic Immunity

Details on immunity test levels for various electromagnetic interference scenarios.

Inspections and Maintenance

Safety Checks (SC)

Operator's obligation and recommendations for performing safety checks on medical devices.

Measurement Checks (MC)

Requirements and recommendations for performing measurement checks to ensure accuracy and compliance.

Technical Parameters (Specifications)

Technical Data Overview

Comprehensive technical specifications including dimensions, power, connectivity, and measurement ranges.

Environmental and Operating Conditions

Specifies operating, storage, and transport conditions, including temperature, humidity, and air pressure.

Environment and Disposal

Liability and Warranty

Appendices

RAUMEDIC NeuroSmart Specifications

General IconGeneral
CategoryMedical Equipment
ManufacturerRAUMEDIC
Resolution0.1 mmHg
Sensor LocationIntracranial
Sensor TypePressure sensor
UsageSingle-use
Temperature Range10°C to 40°C
DimensionsVaries by component
WeightVaries by component
CertificationsCE

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