Breas iSleep 20 User Manual

1Table of Contents
iSleep 20 clinician’s manual
Doc. 003923 En-Us V-2
Table of Contents
1 Intended Use of the iSleep 20 ........................................................................................ 3
1.1 What is the iSleep 20?......................................................................................3
1.2 Indications for Use ............................................................................................4
1.3 Contraindications .............................................................................................. 4
1.4 About this Manual .......................................................................................... 5
2 Safety Information........................................................................................................... 7
2.1 General User Precautions ............................................................................... 7
2.2 Electrical Safety ............................................................................................8
2.3 Environmental Conditions ............................................................................... 9
2.4 Usage of Patient Circuit ................................................................................. 10
2.5 Usage of Filters............................................................................................... 11
2.6 Cleaning and Maintenance ............................................................................. 11
2.7 Adverse Patient Symptoms............................................................................. 12
2.8 Usage of the HA 01 Humidifier ...................................................................... 13
2.9 Usage of Oxygen ........................................................................................... 14
3 Product Description....................................................................................................... 15
3.1 Main Components........................................................................................... 15
3.2 Accessories ........................................................................................... 17
3.3 The iSleep 20's Front Panel .................................................................... 19
3.4 The iSleep 20's Side Panels .................................................................... 20
3.5 Equipment Designation and Safety Label .................................................... 21
4 Functions and Parameters of the iSleep 20.................................................................. 22
4.1 Settings........................................................................................................... 22
4.2 Home and Clinical Mode................................................................................. 23
5 Using the iSleep 20....................................................................................................... 24
5.1 Checking the iSleep 20 before Use................................................................. 24
5.2 Switching the iSleep 20 On and Off ................................................................ 24
5.3 Using the Menu ............................................................................................. 25
5.4 Transferring Data between the iSleep 20 and a PC ....................................... 27
5.5 Using the integrated HA 01 Humidifier ........................................................ 28
5.6 Using an External Battery ............................................................................... 29
6 Preparing the iSleep 20 for Use.................................................................................... 31
6.1 Installing the iSleep 20.................................................................................... 31
6.2 Placing the iSleep 20 .................................................................................... 32
6.3 Connecting the iSleep 20 to the Power Source ............................................. 32
6.4 Connecting the Patient Circuit ........................................................................ 33
7 Setting up the iSleep 20 ............................................................................................. 34
7.1 Settings Applicable for iSleep 20 .................................................................. 35
7.2 Setting the Parameters ................................................................................... 35
7.3 Viewing Device Information ......................................................................... 37
8 Internal Function Error .................................................................................................. 39
9 Cleaning the iSleep 20 and Replacement of Accessories ............................................ 40
9.1 Cleaning the iSleep 20 ................................................................................... 40

Breas iSleep 20 Specifications

General

Pressure Range	4-20 cmH2O
Power Supply	100-240 V AC, 50/60 Hz
Display	LCD
Ramp Function	Yes
Altitude Adjustment	Automatic
Data Storage	SD Card
Ramp Time	0-45 minutes
Device Type	CPAP
Humidifier	Integrated
Therapy Mode	CPAP
Heated Humidifier	Yes

Summary

Intended Use of the iSleep 20

What is the iSleep 20?

Basic definition and purpose of the iSleep 20 CPAP system.

Indications for Use

Specifies the intended patient population and conditions for using the iSleep 20.

Contraindications

Lists medical conditions where the iSleep 20 therapy should not be prescribed.

About this Manual

Provides general information about the manual's purpose, audience, and conventions.

Safety Information

User, Electrical, and Environmental Safety

Covers general user, electrical, and environmental safety guidelines for the iSleep 20.

Patient Circuit, Filter, and Cleaning Procedures

Guidelines for using patient circuits, filters, cleaning the device, and replacement.

Adverse Symptoms, Humidifier, and Oxygen Usage

Addresses patient symptoms, and specific usage of humidifier and oxygen.

Product Description

Main Components

Identifies and describes the primary components of the iSleep 20 system.

Accessories

Lists and illustrates various optional and recommended accessories for the iSleep 20.

The iSleep 20's Front Panel

Details the buttons, displays, and controls located on the front of the iSleep 20 device.

The iSleep 20's Side Panels

Describes the ports and features found on the side panels of the iSleep 20.

Equipment Designation and Safety Label

Explains the symbols and labels used on the iSleep 20 for identification and safety.

Functions and Parameters of the iSleep 20

Settings

Overview of the adjustable parameters and functions available on the iSleep 20.

Home and Clinical Mode

Explains the two operational modes and their differences for patient and clinician use.

Using the iSleep 20

Pre-Use Checks and Power Operations

Checklist for device readiness and instructions for powering on/off.

Using the Menu

Guide to navigating the device's menu system and using its controls.

Transferring Data between the iSleep 20 and a PC

Procedures for connecting the device to a PC for data download and management.

Using the integrated HA 01 Humidifier

Instructions on how to set up and use the optional integrated humidifier.

Using an External Battery

Information on powering the iSleep 20 using external battery sources.

Preparing the iSleep 20 for Use

Installation and Placement

Initial setup steps and guidance on the correct and safe placement of the iSleep 20.

Connecting Power and Patient Circuit

Instructions for safely connecting the device to power and the patient circuit.

Setting up the iSleep 20

Settings Applicable for iSleep 20

Table detailing the adjustable settings, their ranges, and resolutions.

Setting the Parameters

Detailed instructions on how to adjust key operational parameters like CPAP and Ramp.

Viewing Device Information

How to access and view device operating times, firmware version, and other info.

Internal Function Error

Internal Function Error Codes and Handling

Describes error codes, indications, actions, and reset procedures for internal device errors.

Cleaning and Replacement

Main Unit Cleaning

Detailed steps for cleaning the main unit of the iSleep 20 device.

Filter Maintenance

Instructions for cleaning washable filters and replacing disposable filters.

Patient Change Procedures

Procedure for preparing the device for a new patient, including filter and circuit changes.

Maintenance Procedures

Regular Checks and Service

Guidelines for routine checks, troubleshooting, and authorized service or repair.

Storage and Disposal

Instructions for properly storing the iSleep 20 and its humidifier, and end-of-life disposal.

Technical Specifications

System Description and Data

Overview of the iSleep 20 system's components, functions, and technical data parameters.

Standards Compliance

Lists the safety and medical device standards to which the iSleep 20 complies.

Delivery Settings Summary

Summary of default and typical delivery settings for modes and parameters.

Accessories

Breas Accessories List

A comprehensive list of available accessories for the iSleep 20 with their part numbers.