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Lowenstein Medical prisma30ST User Manual

Lowenstein Medical prisma30ST
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Sleep therapy devices
prisma20C prisma25S-C
prisma20A prisma25ST
prismaCR prismaLAB
prisma25S prisma30ST
EN Instructions for use for devices of type WM 100 TD

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Lowenstein Medical prisma30ST Specifications

General IconGeneral
BrandLowenstein Medical
Modelprisma30ST
CategoryMedical Equipment
LanguageEnglish

Summary

Introduction to the WM 100 TD Therapy Device

Intended Use of WM 100 TD Devices

WM 100 TD devices for treating sleep disordered breathing or respiratory insufficiency via mask.

Device Functionality and Operation

Device sucks ambient air, compresses it, and routes it to the patient via hose and mask.

User Qualifications and Responsibilities

Defines the 'user' as the person operating the device, distinct from the 'patient'.

Indications for Therapy Device Use

Details the indications for specific prisma models like 20C, 20A, CR, 25S, 25S-C, 25ST.

Contraindications for Therapy Device

Lists contraindications for use, such as acute cardiac decompensation and severe hypotension.

Potential Side Effects of Therapy

Describes potential undesirable side effects like pressure marks, nasal congestion, and dry nose.

Safety Guidelines for Therapy Device Operation

Essential Safety Information and Warnings

Provides essential safety guidelines and warnings for device operation and handling.

General Safety and Usage Information

Covers third-party products, repairs, connections, EMC, and general usage precautions.

Understanding Document Warning Symbols

Explains the meaning of DANGER, WARNING, CAUTION, NOTICE, and information symbols.

Product Description and Features

Therapy Device Components and Layout

Provides a labeled diagram of the therapy device and descriptions of its parts.

Device Display Modes and Information

Details the device display information for Standby, Therapy, and Energy-saving modes.

Therapy Device Accessories

Lists and describes various accessories for the therapy device, such as humidifiers and hoses.

Device Preparation and Setup

Setting Up the Therapy Device

Instructions for placing the device, ensuring ventilation, and keeping plugs accessible.

Connecting the Power Supply

Guidance on safely connecting the power supply unit to the device and mains power.

Connecting the Respiration Hose

Instructions for connecting the respiration hose to the device outlet and mask.

Operating the Therapy Device

Navigating the Device Menu

Explains how to navigate the device's menu using buttons and the touchscreen.

Switching On the Therapy Device

Details the process of switching on the device for the first time and its modes.

Switching Off the Therapy Device

Describes how to switch off the device to save energy or put it into standby mode.

Starting a Therapy Session

Steps to start the therapy session, including connecting components and breathing into the mask.

Ending the Therapy Session

Instructions on how to end the therapy session manually or automatically using autoSTART-STOP.

Performing a Mask Test

Guide on using the mask test function to ensure proper mask fit and minimize leaks.

Managing the softSTART Function

Explains how to activate or deactivate the softSTART function for comfortable pressure adjustment.

Setting the Respiratory Air Humidifier

Details on switching the humidifier on/off and setting its level for optimal therapy.

Setting Device Alarms and Wake-up Time

Instructions for setting the wake-up time and managing alarms on the therapy device.

Viewing Therapy Data and Device Info

How to access and view therapy usage, mask fit, therapy quality, and device information.

Using the SD Card for Data Storage

Guidance on inserting, saving data to, and removing the SD card from the device.

Configuring Settings in the Menu

Configuring Comfort Settings

Configuration of comfort settings like autoSTART-STOP, mask test pressure, softSTART pressure, and time.

Configuring Accessory Settings

Settings related to accessories, such as tube type and air filter change notification.

Configuring Time and Alarm Settings

Adjusting current time, time zone, and wake-up time settings for the device.

Configuring Device Parameters

Configuration of device-specific settings like display brightness, leakage alert, and audio volumes.

Hygienic Preparation Procedures

General Hygienic Preparation Guidelines

General guidelines on product use, protective equipment, and disinfectant handling.

Cleaning and Replacement Schedule

Schedule for cleaning and replacing components like the therapy device, hose, and filters.

Hygienic Preparation of the Therapy Device

Detailed instructions for cleaning and disinfecting the therapy device and its parts, including air filters.

Hygienic Preparation of the Respiration Hose

Instructions for cleaning and disinfecting the respiration hose.

Function Check Procedures

Function Check Intervals

Specifies the frequency for performing function checks: after preparation, repair, and every 6 months.

Performing a Function Check

Step-by-step guide for performing a functional check of the therapy device before use.

Alarms and Error Message Handling

Understanding Device Alarms

Categorizes alarms into priority levels and lists common alarm messages and their remedies.

Troubleshooting Device Faults

Troubleshooting guide for common faults and their causes and remedies.

Interpreting Display Error Messages

Lists error codes, their causes, and the recommended remedies for display messages.

Device Maintenance Information

Transport and Storage Guidelines

Proper Disposal of the Device

Appendix: Technical Data and Compliance

Technical Specifications of the Therapy Device

Detailed technical specifications of the therapy device, including dimensions, weight, and operating ranges.

Electromagnetic Interference Emission Declaration

Declaration regarding the device's compliance with standards for electromagnetic interference emission.

Electromagnetic Interference Immunity

Declaration regarding the device's immunity to electromagnetic interference.

ME Equipment and Systems EMI Immunity

Immunity specifications for ME equipment and ME systems according to standards.

Device and Accessory Labels and Symbols

Explanation of labels and symbols found on the therapy device, its packaging, and accessories.

Scope of Delivery and Accessories

Details the standard parts included with the device and available accessories/spare parts.

Manufacturer's Warranty Information

Information on the manufacturer's limited warranty period for the device and its components.

Declaration of Conformity Statement

Manufacturer's statement of compliance with relevant medical device directives.

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