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Weinmann MEDUVENT Standard - User Manual

Weinmann MEDUVENT Standard
188 pages
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MEDUVENT Standard
Ventilator
Instructions for Use for Devices from Software Version 2.1
Read these instructions for use before using the product. Ignoring the
instructions for use might lead to serious injury or death.

Table of Contents

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Weinmann MEDUVENT Standard Specifications

General IconGeneral
TypeEmergency and transport ventilator
Target groupAdults and Children
Ventilation modesCPAP
Respiratory rate5 - 60 /min
Power supply100 – 240 V AC, 50/60 Hz
Patient TypesAdults, Children, Infants
Oxygen Inlet Pressure2.7 to 6 bar

Summary

1 Introduction

1.1 About this document

Details the scope and purpose of the instructions for use document.

1.2 Explanation of warnings

Defines the meaning of safety symbols like DANGER, WARNING, CAUTION, and NOTICE.

2 Safety

2.1 Intended purpose

Specifies the indications, target patient groups, and intended users for the MEDUVENT Standard ventilator.

2.2 Clinical benefit of the product

Outlines the medical benefits of ventilation therapy provided by the device compared to manual methods.

2.3 Requirements on the user

Details the qualifications and training necessary for operating the ventilator.

2.4 Using the device safely

Provides critical safety instructions for operating the ventilator to prevent injury.

3 Description

3.1 Overview

Provides an illustrated overview of the MEDUVENT Standard device components.

3.2 Control panel and display

Describes the device's control panel buttons and the main display elements.

3.3 Symbols in the display

Explains the meaning of various symbols shown on the device display.

3.4 Accessories and other parts

Lists and describes the accessories and additional parts compatible with the device.

3.5 Rechargeable battery and battery status indicator

Details the integrated rechargeable battery and how its status is indicated.

3.6 Transport options

Presents various portable units for transporting the device and its accessories.

4 Preparation

4.1 Mounting the device

Instructions for mounting the device on portable units or in emergency vehicles.

4.2 Connecting a power supply

Guidance on safely connecting the device to a power source for operation and charging.

4.3 Connecting the breathing circuit

Steps for connecting both reusable and disposable breathing circuits to the device.

4.4 Connecting the oxygen supply

Detailed instructions for connecting the device to an oxygen source safely and correctly.

4.5 Converting the device

Procedures for converting the device for use with disposable or reusable breathing circuits.

5 Function check

5.1 Intervals

Specifies the recommended intervals for performing function checks on the device and circuit.

5.2 Preparing for the function check

Outlines the necessary preparation steps before conducting a device function check.

5.3 Performing the function check

Step-by-step guide on how to execute the device's function check procedure.

5.4 Checking reusable breathing circuit

Instructions for checking the reusable breathing circuit for proper function and integrity.

6 Operation

6.1 Switching on the device

Procedure for powering on the MEDUVENT Standard and its initial self-test.

6.2 Navigating in the device

Explains how to use the navigation knob and menu buttons for device interaction.

6.3 Starting ventilation

Detailed steps for initiating ventilation for patient groups or new patients.

6.4 Changing ventilation mode

Instructions on how to select and adjust ventilation modes during operation.

6.5 Changing ventilation parameters

Guide on how to modify ventilation parameters like Vt, Freq., PEEP, and pMax.

6.6 Changing patient group

Procedure for selecting and switching between patient groups (Infant, Child, Adult).

6.7 Supplying oxygen

Instructions for setting oxygen concentration and calculating operating time.

6.8 Switching off the device

Steps for safely powering down the MEDUVENT Standard device.

6.10 After use

Procedures to follow after the device has been used, including disconnection and cleaning.

7 Hygienic reprocessing

7.1 Hygienic reprocessing intervals

Defines the required intervals for hygienic reprocessing of device parts.

7.2 Preparing for hygienic reprocessing

Steps for preparing the device and accessories for cleaning and disinfection.

7.3 Disassembling;assembling the reusable breathing circuit

Detailed instructions for taking apart and reassembling the reusable breathing circuit.

7.4 Cleaning parts manually

Guidance on manual cleaning procedures for various device and circuit components.

7.5 Disinfecting parts by wiping

Instructions for disinfecting specific parts using wiping methods.

7.6 Disinfecting parts by immersion

Procedures for disinfecting parts by immersion in cleaning solutions.

7.8 Reprocessing parts mechanically

Describes mechanical cleaning and disinfection methods for approved parts.

7.9 Steam-sterilizing parts (optional)

Guidelines for steam sterilization of parts according to EN 285 standards.

7.10 Preparing parts for reuse

Steps to ensure parts are ready for reuse after hygienic reprocessing.

7.11 Cleaning and disinfection plan

Details the levels of disinfection and specific cleaning/disinfection procedures.

8 User menu

8.1 Navigating the user menu

Explains how to access and navigate through the user menu options.

8.2 User menu structure

Provides a diagram illustrating the hierarchy and available options within the user menu.

8.3 Settings in the user menu

Details how to adjust settings such as Emergency mode, Alarm limits, and Ventilation mode.

9 Operator menu

9.1 Activating the operator menu

Instructions for accessing the operator menu using an access code.

9.2 Operator menu structure

Diagram showing the organization and options available in the operator menu.

9.3 Device settings

Allows configuration of device parameters like date/time, brightness, and supply gas.

9.4 Patient presets

Defines default ventilation parameters for different patient groups (Infant, Child, Adult).

9.5 Changing the access code

Procedure for modifying the access code used to activate the operator menu.

9.6 Options

Enables or disables specific ventilation modes or features for the device.

9.7 Importing;exporting data

Handles the transfer of service data and configurations via SD card.

9.8 Software update

Instructions for updating the device's software using an SD card.

9.9 Device information

Provides details about the device, serial numbers, and software version.

9.10 Battery information

Displays detailed information regarding the rechargeable battery's status and specifications.

10 Description of the modes

10.1 IPPV

Intermittent Positive Pressure Ventilation: Mandatory volume-controlled ventilation.

10.2 CPAP

Continuous Positive Airway Pressure: Pressure-controlled ventilation for spontaneous breathing.

10.3 CPAP + PS (optional)

CPAP with Pressure Support: Enhances spontaneous breathing with pressure support.

10.4 PRVC + PS (optional)

Pressure-Regulated Volume-Controlled Ventilation with Pressure Support.

10.5 SIMV (optional)

Synchronized Intermittent Mandatory Ventilation: Combines mandatory and spontaneous breaths.

10.6 S-IPPV (optional)

Synchronized Intermittent Positive Pressure Ventilation: Variable mandatory minute volume.

10.7 Manual

Manual mode for triggering breaths via MEDUtrigger, used for resuscitation.

11 Alarms and faults

11.1 Alarm messages

Details high, medium, and low priority alarms, their causes, and remedies.

11.2 Faults

Lists common device faults, their causes, and suggested solutions.

12 Maintenance

12.1 Intervals

Specifies the maintenance intervals for the device, battery, circuits, and filters.

12.2 Maintenance reminder

Explains the device's maintenance reminder system and how to suppress it.

12.3 Maintaining the reusable breathing circuit

Instructions for maintaining the reusable breathing circuit components.

12.4 Replacing the hygiene filter

Procedure for safely removing and replacing the hygiene filter.

12.5 Replacing the rechargeable battery

Step-by-step guide for replacing the device's rechargeable battery.

12.6 Sending in parts

Instructions for sending parts for maintenance, including cleaning requirements.

13 Storage

14 Disposal

14.1 Electronic waste

Guidance on the proper disposal of electronic waste, including the device and charger.

14.2 Rechargeable battery

Instructions for the correct disposal of used rechargeable batteries.

14.3 Plastics

Recommendations for proper disposal of plastic components.

14.4 Hygiene filter

Guidance on the proper disposal of used hygiene filters.

14.5 Contaminated parts

Instructions for the safe disposal of contaminated parts.

15 Scope of supply

15.1 Standard scope of supply

Lists the standard configurations and included parts for the MEDUVENT Standard ventilator.

15.2 Accessories and other parts

Details accessories and other parts, including breathing circuits, masks, and portable units.

16 Technical data

16.1 Device

Provides technical specifications for the MEDUVENT Standard device, including dimensions and environmental ranges.

16.2 Rechargeable battery

Technical specifications for the rechargeable battery, including capacity and service life.

16.3 Power supply unit and charger

Technical specifications for the 100 W power supply unit and charger.

16.4 Breathing circuits

Technical data for reusable and disposable breathing circuits, including dead space volumes.

16.5 Block diagram

Illustrates the functional connections and airflow within the MEDUVENT Standard.

16.6 Electromagnetic compatibility (EMC)

Information regarding EMC compliance and precautions for interaction with other medical devices.

16.7 Calculating tidal volume on the basis of height

Explains how tidal volume is calculated based on patient height and ideal body weight.

16.8 Exported service data

Describes the structure and content of service data exported to an SD card.

16.9 Alarm delay times

Specifies the delay times for various alarm conditions.

17 Symbols and labels

17.1 Labels on the device

Identifies and describes various labels and symbols found on the device itself.

17.2 Labels on the accessories

Details the symbols and labels present on the breathing circuit and other accessories.

17.3 Labels on the packaging

Shows symbols found on the packaging of breathing circuits, indicating important information.

18 Warranty

19 EC Declaration of Conformity on Medical Devices

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