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IEM Mobil-O-Graph PWA User Manual

IEM Mobil-O-Graph PWA
385 pages
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Gebrauchsanweisung
DE
Operating manual
EN
Manual de instrucciones
ES
Mode d’emploi
FR
Istruzioni per l'uso
IT
Gebruiksaanwijzing
NL
Mobil-O-Graph
®
PWA
Mobil-O-Graph
®
NG

Table of Contents

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IEM Mobil-O-Graph PWA Specifications

General IconGeneral
BrandIEM
ModelMobil-O-Graph PWA
CategoryBlood Pressure Monitor
LanguageEnglish

Summary

1 Introduction

1.1 Preliminary note

Provides initial information about the Mobil-O-Graph device, its features, and benefits for 24-hour measurement.

1.2 About this operating manual

Explains the purpose, structure, and how to use this operating manual for the Mobil-O-Graph.

1.3 Clinical trials

Details the device's compliance with standards from ESH, BHS, and ISO 81060-2:2013.

1.4 CE Mark

Lists the directives (MDD, RED, RoHS) the device conforms to and bears the CE Mark.

2 Directions for use

2.1 Intended use

Specifies the device's purpose for 24-hour blood pressure and pulse wave analysis under medical supervision.

2.2 Improper use

Lists prohibited uses, contraindications (e.g., unsound mind, children under 3), and unsafe environments.

2.3 Essential performance features

Defines key performance criteria such as error tolerances and pressure supply according to standards.

2.4 Indication

Outlines medical conditions like hypertension or hypotension for which the device is indicated.

2.5 Side effects of long-term blood pressure measurement

Describes potential side effects like petechial bleeding or haematomas from cuff pressure.

2.6 Safety

Provides crucial safety instructions and warnings for proper and safe device operation.

2.6.1 Defining the signal words used

Explains the meaning of signal words (WARNING, ATTENTION) and associated symbols for danger.

2.6.2 Defining general notes

Clarifies the meaning of 'Note' and 'External reference' symbols used in the manual.

2.7 Important safety instructions for the doctor

Details critical safety precautions for medical professionals, covering patient risks and device handling.

3 Product description

3.1 Description

Overview of the system's two main components: the Mobil-O-Graph monitor and the HMS CS evaluation software.

3.2 Unpacking

Instructions for checking the delivery package contents for completeness and functionality upon receipt.

3.3 Description of device

Details the physical components and features of the Mobil-O-Graph blood pressure monitor.

3.3.1 Blood pressure monitor

Lists and identifies the various external components of the blood pressure monitor unit.

3.3.2 Buttons

Explains the function and operation of each button (ON/OFF, START, DAY/NIGHT, EVENT) on the device.

3.3.3 The display

Describes the information conveyed by the LCD display for measurement data and errors.

3.3.4 Audible signals

Explains the different tone burst sequences emitted by the device and their meanings.

3.3.5 Cuff connection

Details the physical connection point for the cuff tube and its importance for measurement accuracy.

3.3.6 Data socket

Describes the location and function of the data socket for connecting the PC interface cable.

3.3.7 Infrared interface

Explains the wireless interface for data transfer using an IR-Med adapter.

3.4 Preparation for measurement

Guides the user through essential setup steps before initiating a blood pressure measurement.

3.4.1 Switching on

Describes the power-on sequence, including initial device tests and display checks.

3.4.2 Clearing the memory

Instructions for deleting stored measurement data from the device's memory.

3.4.3 Setting the time/date

Details how to set the device's internal time and date, either manually or via software.

3.4.4 Transferring patient data (ID)

Explains transferring patient information via HMS CS for accurate data allocation during readout.

3.4.5 Specifying the desired measurement log

Guides on selecting and configuring measurement logging intervals for data recording.

Setting the logs via software

Instructions for configuring measurement logs and parameters using the HMS CS evaluation software.

3.4.6 Putting on the blood pressure monitor and starting measurement

Step-by-step guide on correctly applying the cuff and initiating the first measurement.

3.5 Position and conduct of the patient

Provides guidance on optimal patient positioning and behaviour during measurement for accuracy.

3.6 Technical data

Lists the technical specifications, measurement ranges, accuracy, and operating parameters of the device.

3.7 Symbols

Explains various symbols and labels found on the device, its accessories, and within the manual.

4 Care and maintenance

4.1 Disinfection and cleaning

Instructions for proper cleaning and disinfection of the cuff sleeve, balloon, monitor, and bag.

4.2 Maintenance plan

Outlines the recommended maintenance schedule, including weekly checks and biennial metrological checks.

5 Troubleshooting

5.1 Main sources of error

Identifies common causes for inaccurate measurements or unwanted results, such as patient movement or incorrect settings.

5.2 Transmission error

Details error codes (e.g., E004) related to data transmission issues between the device and PC.

5.3 Checklist

Provides a step-by-step checklist for diagnosing and resolving common device errors and connection problems.

5.4 Mobil-O-Graph® error description

Lists specific error messages (Err 1-10), their possible causes, and recommended corrective measures.

6 Power packs/batteries

6.1 Operation with power packs

Guidance on using and charging the recommended rechargeable NiMH power packs for optimal performance.

6.2 Operating with ALKALINE batteries

Instructions for using disposable alkaline batteries and their proper disposal after use.

7 Warranty and repair conditions

Warranty:

Outlines the terms, duration, and conditions for the two-year warranty on the Mobil-O-Graph hardware.

Repairs:

Information on contacting specialists or IEM GmbH for device repairs and shipping instructions.

Metrological checks:

Details the requirement for biennial metrological checks to ensure continuous compliance with regulations.

Liability clause:

Legal disclaimer regarding IEM's liability for damages, negligence, or defects not covered by warranty.

Appendix

Appendix 1 Important patient information

Provides essential safety and usage information for patients using the Mobil-O-Graph for 24-hour monitoring.

Patient safety instructions

Details specific safety guidelines for patients, including cuff placement, device interruption, and avoiding kinks.

Appendix 2 EMC Guidelines and Manufacturer's Declaration

Presents technical documentation on electromagnetic compatibility and manufacturer's declarations for the device.

Guidelines and Manufacturer's Declaration – electromagnetic emissions

Details electromagnetic emissions compliance and environmental guidelines as per CISPR and IEC standards.

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