Breas Medical PV 10 User Manual

PV 10 Clinician’s Manual Table of Contents
Doc. No. 003379 En S-1 BREAS MEDICAL 1
Table of Contents
1 Intended Use of the PV 10 .............................................................................................3
1.1 What is the PV 10?............................................................................................4
1.2 Indications for Use.............................................................................................4
1.3 Contraindications...............................................................................................5
1.4 About this Manual..............................................................................................6
2 Important Safety Information ...........................................................................................7
2.1 General User Precautions .................................................................................7
2.2 Electrical Safety................................................................................................. 8
2.3 Environmental Conditions .................................................................................8
2.4 Usage of Patient Tube and Mask ....................................................................10
2.5 Usage of Filters ............................................................................................... 11
2.6 Cleaning and Maintenance.............................................................................. 11
2.7 Adverse Patient Symptoms .............................................................................12
2.8 Usage of a Humidifier......................................................................................12
2.9 Usage of Oxygen............................................................................................. 13
3 Product Description .......................................................................................................14
3.1 Main Components ...........................................................................................14
3.2 Front and Setting Panel...................................................................................16
3.3 Rear Panel ......................................................................................................19
3.4 Equipment Designation and Safety Label .......................................................20
3.5 Output Connector for Data Transfer ................................................................21
4 Preparing the PV 10 for Use .........................................................................................23
4.1 Installing the PV 10 ......................................................................................... 23
4.2 Placing the PV 10............................................................................................23
4.3 Connecting the PV 10 to the Mains Supply..................................................... 24
4.4 Connecting the Patient Tube and Mask ..........................................................24
4.5 Checking the PV 10 before Use ...................................................................... 26
5 Setting up the PV 10 ..................................................................................................... 27
5.1 Description of the CPAP and Ramp functions .................................................27
5.2 Setting the CPAP Pressure .............................................................................27
5.3 Setting the Ramp Time....................................................................................28
5.4 Locking/Unlocking the Setting Panel ...............................................................28
5.5 Setting the Default Display ..............................................................................29
5.6 Setting the Alarm Clock...................................................................................30
5.7 Setting the Actual Time ...................................................................................31
6 Using the PV 10 ............................................................................................................32
6.1 Switching the PV 10 On and Off......................................................................32
6.2 Starting and Stopping a Ramp Period.............................................................33
6.3 Displaying the Operating Time ........................................................................34
6.4 Displaying the Internal Firmware Version........................................................35
7 Cleaning the PV 10 and Replacing the Filters...............................................................36
7.1 Cleaning the PV 10 .........................................................................................36
7.2 Cleaning the Patient Tube and Mask ..............................................................36
7.3 Cleaning and Replacing the Patient Air Filter..................................................37

Breas Medical PV 10 Specifications

General

Therapy Modes	CPAP
Operating Mode	Continuous
Modes	CPAP
Pressure Range	4-20 cmH2O
Alarms	Low pressure

Summary

Intended Use of the PV 10

What is the PV 10?

Describes the PV 10 CPAP system, its operation, and key features like pressure sensing and data logging.

Indications for Use

Outlines the intended use of the PV 10 for CPAP therapy in adults and appropriate clinical settings.

Contraindications

Lists specific diseases and conditions that preclude the use of PV 10 therapy.

About this Manual

Guides on reading the manual, its intended audience, and explains icons used for clarity.

Important Safety Information

General Safety Precautions

Covers user precautions, electrical safety, environmental conditions, and oxygen usage safety.

Device Usage and Maintenance Safety

Safety related to patient tube, mask, filters, cleaning, and humidifier usage.

Adverse Patient Symptoms

Lists potential symptoms during therapy and advises consulting a physician for assessment.

Product Description

Main Components

Lists and illustrates the main components included in the PV 10 standard package, noting latex-free.

Front and Setting Panel

Shows and labels the front panel of the PV 10, detailing buttons, display, and indicator LEDs.

Rear Panel

Illustrates and describes the connectors and ports on the rear panel for power and data.

Equipment Designation and Safety Label

Explains the various symbols and information found on the PV 10's equipment designation and safety label.

Output Connector for Data Transfer

Details the output connector for connecting to remote controls, PCs, or diagnostic equipment for data transfer.

Preparing the PV 10 for Use

Installing and Placing the PV 10

Initial setup steps including installation and proper placement of the PV 10 unit.

Connecting Power and Patient Accessories

Instructions for connecting mains supply, patient tube, and mask to the PV 10.

Pre-Use Checks

Essential checks to perform before operating the PV 10 to ensure safety and functionality.

Setting up the PV 10

CPAP and Ramp Function Setup

Setting up core therapy functions like CPAP pressure and ramp time.

Panel Lock and Display Settings

Configuring panel lock and customizing the default display options.

Clock and Time Settings

Adjusting the alarm clock and setting the actual time on the PV 10.

Using the PV 10

Switching the PV 10 On and Off

Instructions for powering the PV 10 on and off using the I/O button.

Starting and Stopping a Ramp Period

Details how to manually initiate and terminate a ramp period for patient comfort.

Displaying the Operating Time

Explains how to view machine and patient operating hours on the PV 10.

Displaying the Internal Firmware Version

Guides on how to check the PV 10's current internal firmware version.

Cleaning the PV 10 and Replacing the Filters

Cleaning the PV 10

Provides instructions for cleaning the exterior of the PV 10 unit safely.

Cleaning the Patient Tube and Mask

Details the daily cleaning procedure for the patient tube and mask for hygiene.

Cleaning and Replacing the Patient Air Filter

Explains how to clean and replace the air filters for the PV 10 to ensure proper function.

Alarms

Power Failure Alarm

Describes the audible alarm and device behavior during power interruptions or failures.

Function Error Alarm

Explains the audible alarm and device shutdown for internal faults or malfunctions.

Maintenance

Regular Maintenance Control

Explains that regular inspections are usually not required if the device is maintained as per manual.

Service and Repair

States that service and repair must only be carried out by authorized personnel.

Disposal

Instructs on proper disposal of the PV 10 and accessories according to local environmental regulations.

Accessories

BREAS Accessories List

Lists available BREAS accessories for the PV 10 with corresponding part numbers.

Using an External Battery with the PV 10

Explains how to operate the PV 10 using an external battery source for portable use.

Using a Remote Control with the PV 10

Details how to use the optional remote control with the PV 10 for convenient operation.