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Spacelabs Healthcare BleaseSirius User Manual

Spacelabs Healthcare BleaseSirius
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BleaseSirius User Manual
1
BleaseSirius
Anesthesia Systems
U S E R M A N U A L
073-0212-00 Rev. E | www.spacelabshealthcare.com

Table of Contents

Questions and Answers:

Spacelabs Healthcare BleaseSirius Specifications

General IconGeneral
BrandSpacelabs Healthcare
ModelBleaseSirius
CategoryMedical Equipment
LanguageEnglish

Summary

Section 1 - BleaseSirius Anesthetic Machine

1.1 Introduction

Overview of the manual's content and safety precautions.

1.2 Description

Detailed breakdown of the machine's components and design.

1.2.1 General

General description of the anesthesia machine's purpose and compliance.

1.3 Specification

Technical specifications including dimensions, loading, and electrical details.

1.3.1 Physical

Machine and work surface dimensions, monitor shelf dimensions.

1.3.2 Maximum Loading

Weight limits for different parts of the machine.

1.3.3 Pneumatics

Specifications for gas lines, electrical cables, and miscellaneous pneumatic data.

1.3.4 Technical/Performance Specifications

Details on controls, ventilator integration, alarms, and electrical parameters.

1.3.5 Ancillary and Optional Features

Lists standard, required, and optional features of the system.

1.4 Installation

Step-by-step instructions for installing components like cylinders and pipelines.

1.4.1 Install the Cylinders

Procedures for installing gas cylinders onto the machine.

1.4.2 Connect the Pipelines

Instructions for connecting gas supply pipelines.

1.4.3 Connect the Oxygen Transducer

Steps for connecting the oxygen sensor to the machine.

1.4.4 Install the Selectatec Vaporizers

Guidance on fitting vaporizers to the backbar manifold.

1.4.5 Install the CAS Absorber

Procedure for mounting and attaching the CAS absorber.

1.4.7 Patient Airway Flow Sensor

Instructions for connecting and setting up the patient airway flow sensor.

1.4.8 Suction Controller

Details on fitting, testing, and cleaning the suction controller system.

1.5 Theory of Operation

Explains how the machine's pneumatic systems and safety features function.

1.5.1 C.G.O. Pressure Relief Valve

Description of pressure limiting devices for patient and user safety.

1.5.2 Oxygen System and Oxygen Failure Warning Device

How the oxygen supply and failure warning system operate.

1.5.5 Controls

Overview of the machine's control functions, including On/Off switch and flow controls.

1.5.5.1 On/Off Switch

Description and function of the main On/Off switch.

1.5.5.2 Flow Controls

Details on mechanical and electronic flowmeters.

1.6 User Maintenance Schedule

Recommended maintenance frequency and procedures for the machine.

1.7 Pre-Use Checks

Daily checks to ensure the ventilator is functioning correctly before patient use.

1.7.1 Gas Supply Hoses and Probes Check

Inspection of gas hoses and probes for damage or wear.

1.7.2 Cylinder and Pipeline Supplies Check

Verification of cylinder mounting and pipeline connections.

1.7.3 Flowblock Assemblies Check

Checking gas flows on flowblock assemblies.

1.7.4 Oxygen Failure Warning System Check

Testing the oxygen failure warning and related alarms.

1.7.5 Leak Test -Vaporizers

Procedure to check for leaks in vaporizers.

1.7.6 C.G.O. Safety Valve

Test procedure for the Common Gas Outlet safety valve.

1.7.8 General

Final checks on vaporizers, APL valve, ventilator, and alarms.

1.8 Full System Test

Comprehensive tests to verify the entire system's functionality.

1.8.1 Leak Test

Procedure to detect leaks in the system.

1.8.2 On/Off Switch and Warning System Checks

Testing the main switch and system warning indicators.

1.8.3 Mechanical Hypoxic Guard Test

Verifying the function of the mechanical hypoxic guard.

1.8.7 Ventilator Test

Steps to test the integrated ventilator.

Section 2 - 700/900 Series Ventilators

2.1 Description of the Ventilator

Overview of the ventilator's design, control system, and applications.

2.1.1 Overview

General description of the ventilator's design and intended use.

2.1.2 Features

Available features dependent on the operating mode.

2.2.2.1 Controls and Indicators

Description of controls and indicators on the ventilator's touch screen.

2.2.2.2 Microprocessor Control

Benefits of the built-in microprocessor for upgrades and customization.

2.2.2.3 Dual Mode Ventilation

Explanation of flow and pressure generator modes and patient applications.

2.2.2.4 Pressure Limit Control

Safety feature to prevent barotrauma by setting a pressure limit.

2.2.2.5 Built-in Ventilator Pre-use Test

System for ensuring accurate ventilator delivery regardless of back-pressure.

2.2.2.6 Comprehensive Pressure Monitoring and Alarms

Selectable functions for monitoring pressure, flow, and alarms.

2.1.2.7 Waveforms and Spirometry

Display options for set and monitored volumes and waveforms.

2.1.2.8 Battery Back Up

Information on internal battery charging, operation time, and charging duration.

2.1.3 Operating Modes

Description of mechanical ventilation modes available on the ventilator.

2.1.3.1 Volume Control

Explanation of the time-cycled mode for delivering set volumes.

2.1.3.2 Precision Pressure Control

Explanation of the time-cycled mode for maintaining set inspiratory pressure.

2.1.3.3 SIMV-PC + PSV and SIMV-VC + PSV Modes

Extensions of PSV mode with mandatory breaths and optional pressure support.

2.1.3.4 Inspiratory Pause

Feature to create a plateau phase before the expiratory phase.

2.1.3.5 Sigh

Method to increase delivered tidal volume with set percentage breaths.

2.1.3.6 Advanced Pressure Support

Mode where patient controls ventilation timing with optional pressure support.

2.1.5 Parameters

List of parameters that can be set and monitored during ventilator operation.

2.1.5.1 PEEP

Monitoring and setting of Positive End Expiratory Pressure.

2.1.5.2 Trigger

Level of negative flow to initiate ventilator assistance for spontaneous breaths.

2.1.5.5 Oxygen

Monitoring and calibration of oxygen concentration using a fuel cell sensor.

2.1.5.6 Tidal Volume

Volume to be delivered by the ventilator in each breath.

2.1.5.11 Pressure Limit

Setting the breathing system's maximum pressure limit.

2.1.6 User Interface

Description of the front panel controls and indicators.

2.1.6.1 Front Panel

Controls and indicators on the 700/900 series ventilator's front panel.

2.1.6.2 Normal Screen

Layout of the normal display screen with four areas.

2.1.6.3 Activity Display Area

Graphical display of the breathing cycle in real time.

2.1.6.4 Alarms Display Area

Listing of active alarms with priority levels.

2.1.6.5 Measurements Display Area

Area for displaying user-selected monitored measurements.

2.1.6.6 Parameter Display Area

Windows showing selected parameters or operating levels.

2.1.6.6 Trak Wheelâ„¢ & Touch Screen

Operation of the Trak Wheel and touchscreen for navigation and setting changes.

2.1.7 Battery Status LEDs

Indication of mains failure and battery status via LEDs.

2.1.8 Menu Tree

Visual representation of the ventilator's menu structure.

2.1.8.1 Setup Menu

Navigation through the setup options.

2.1.8.2 Defaults Menu

Options for saving, recalling, and managing default settings.

2.1.8.3 Alarm Setup

Configuration of alarm limits, mute times, and apnea settings.

2.2 Using the Ventilator

Instructions on starting, stopping, testing, and configuring the ventilator.

2.2.1 Power On the Ventilator

Procedure for turning on the ventilator system.

2.2.2 Start the Ventilator

Steps to initiate ventilation mode.

2.2.3 Stop the Ventilator

Procedure to stop ventilation and switch to bag mode.

2.2.5 End of Case

Steps to conclude a ventilation case.

2.2.6 Power Off the Ventilator

How to turn off the ventilator system.

2.2.7 Pre-use Testing

Essential tests to perform before connecting the ventilator to a patient.

2.2.7.1 System Check

Verifying all breathing system components after leak and compliance checks.

2.2.8 Pre-Use Test Error Messages

Descriptions and solutions for common errors encountered during pre-use testing.

2.2.9 Absorber Not Installed

Troubleshooting steps if the absorber is not correctly fitted.

2.2.11 Standby/ Bag Modes

Explanation of the standby and bag modes for the ventilator.

2.2.13 Oxygen Calibration

Procedure for calibrating the displayed oxygen concentration.

2.2.13.1 O2 Calibration with A.C.G.O. System

Specific oxygen calibration steps for the A.C.G.O. system.

2.2.14 The Measurements Menu

How to assign parameters to monitored buttons.

2.2.15 Adult and Pediatric Modes

Methods for selecting patient modes (Adult or Pediatric).

2.2.17 Types of Flow Sensors

Information on available adult and pediatric flow sensors.

2.2.18 The Waveform Select Menu

Options for selecting spirometry loops and waveforms.

2.2.19 Save a Spirometry Loop

Procedure for saving waveform data.

2.2.19.1 Recall a Spirometry Loop

How to retrieve previously saved waveform data.

2.2.19.2 Example Spirometry Loops

Examples of pressure/volume and flow/volume loops.

2.2.21 Ventilation Mode Menu

Selecting different ventilation modes on the ventilator.

2.2.21.1 Pause

Setting the inspiratory pause percentage.

2.2.22 Setting Parameters

Steps to adjust operating parameters like BPM, I:E ratio, and pressure limits.

2.2.23 Alarms

Information on pre-set and user-defined alarms for monitoring.

2.2.23.1 Alarms Summary

Overview of available alarms, their priority, and settings.

2.2.23.2 Pre-set Alarms

Details on factory-set alarms like "Absorber Not Fitted" and "Low Supply Gas Pressure".

2.2.25 Auto Alarms

Functionality for automatically setting alarm parameters.

2.2.26 The Alarms Setup Menu

Defining high and low ranges for alarms.

2.2.26.1 Set the Alarms

Procedure for adjusting alarm limit values.

2.2.26.2 Alarm Mute

How to mute alarms temporarily.

2.2.26.3 Set the Apnea Time Alarm

Configuring the time duration for the apnea alarm.

2.2.27 The Defaults Menu

Options for managing settings, defaults, and names.

2.2.27.1 Save Hospital Default Settings

Procedure to change default startup settings, which is password protected.

2.2.27.2 Save and Recall Settings

Saving and recalling ventilator settings configurations.

2.2.27.3 Change Names

Defining user names for saving settings.

2.3 Installation

Safety precautions and general installation guidelines.

2.3.1 Pre-Use Checks

Steps to verify correct connections and check for leaks before use.

2.3.2 Discharged Battery

Information on battery discharge and charging.

2.3.3 Installing the Adult Bellows

Steps for installing the adult bellows unit.

2.3.4 Pre-use Test

Procedures for fresh gas compensation and compliance testing.

2.3.4.1 Fresh Gas

Calculating delivered volume compensation for fresh gas flow.

2.3.4.2 Compliance Test

Measuring system compliance to calculate TV compensation.

2.4 Routine User Maintenance

Schedule and procedures for regular user maintenance.

2.4.1 Monthly Check

Monthly checks for the control unit, including power and gas supply alarms.

2.4.1.1 Control Unit

Checks for the control unit, including power on and MAINS FAIL alarm.

2.4.2 Six-Month Check

Six-month inspection of bellows assemblies.

2.4.2.1 Bellows

Inspection of bellows assemblies for damage and deterioration.

2.4.4 Cleaning and Sterilization

Procedures for cleaning ventilator surfaces and patient flow sensors.

2.4.4.1 Ventilator Surfaces

Cleaning instructions for external surfaces of the ventilator.

2.4.4.2 Patient Flow Sensor and Tubing

Cleaning and sterilization of flow sensors and tubing.

2.5 Troubleshooting

Table of common faults, their causes, and recommended actions.

2.6 Performance Data

Technical specifications and performance ranges of the ventilator.

2.6.1 Notes on Performance Data

Factors affecting compliance and performance data interpretation.

2.7 Associated Equipment and Accessories

List of compatible equipment and accessories with part numbers.

2.8 External Communication Specification

Details on RS232 setup, protocol, and message types for data transmission.

2.8.1 Data Transmission Settings

RS232 communication parameters like baud rate and stop bits.

2.8.2 Protocol

Description of the communication protocol and message types.

2.8.4 Set Messages

Commands for setting various ventilator parameters via external communication.

2.8.5 Breathing Modes

List of breathing modes communicated via external interface.

2.8.7 Measured Value Messages

Formats for reporting measured values.

2.9 Alarm Messages

Comprehensive list and description of all alarm messages and their bit definitions.

Section 3 - CAS I/II Absorber

3.1 Description

Introduction to the CAS I and CAS II absorber models and their components.

3.1.1 Introduction

Overview of the absorber's design, materials, and optional accessories.

3.1.2 Principles of Operation

Explanation of spontaneous breathing, CO2 bypass, scavenging, and absorbent function.

3.1.2.1 Spontaneous Breathing

How the absorber works with spontaneously breathing patients.

3.1.2.4 Absorbent

Information on soda lime indicator and replacement.

3.2 Installation

Steps for installing the absorber onto the machine and filling canisters.

3.2.1 Install the Absorber on the Machine

Procedure for physically mounting the absorber.

3.2.2 Fill the Soda Lime Canister(s)

Instructions for filling reusable or disposable soda lime canisters.

3.2.2.1 For Disposable Soda Lime Canister(s)

Steps for installing disposable soda lime canisters.

3.2.2.2 For Reusable Soda Lime Canister(s)

Procedure for filling and installing reusable soda lime canisters.

3.2.4 Attach the Breathing Circuit Tubing

Connecting patient breathing circuit and bag tubing to the absorber.

3.2.5 Pre-Use Checks

Inspections and tests required before using the absorber.

3.2.5.1 Compliance Test

Performing the compliance test as per ventilator instructions.

3.2.5.2 Spontaneous Breathing Setup

Steps to set up the absorber for spontaneous breathing.

3.3 Absorber Maintenance

Routine maintenance tasks for the absorber.

3.3.1 Change the Canister Soda Lime

Procedures for replacing soda lime in reusable or disposable canisters.

3.3.1.1 Replace the Reusable Canister Soda Lime

Step-by-step guide for replacing soda lime in reusable canisters.

3.3.1.3 When to Replace the Soda Lime

Indicators for when soda lime needs replacement.

3.3.2 Cleaning and Sterilization

Procedures for cleaning and sterilizing absorber components.

3.3.3 Routine Maintenance Checks

Checks for non-return valve discs and annual maintenance.

3.3.3.1 Replace the Non-return Valve Discs

Steps to replace the non-return valve discs.

3.4 Spare Parts and Accessories

List of available spare parts and accessories with part numbers.

3.5 Manometer

Information on installing and removing the manometer.

3.6 Oxygen Sensor

Location and use of the oxygen sensor port.

3.7 CAS I/II Absorber Condenser

Description and maintenance of the absorber condenser.

3.8 CAS I/II Absorber Lock Option

Using the absorber lock mechanism to secure the unit.

Section 4 - Notices & Important Information

4.1 Product Improvement

Manufacturer's policy on product updates.

4.2 Responsibilities of the User

User's obligations for safe installation, use, and maintenance.

4.3 Responsibilities of the Manufacturer

Manufacturer's responsibilities regarding safety, reliability, and performance.

4.4 Disclaimer

Statement voiding warranties for unauthorized tampering.

4.5 Technology Disclaimer / Tamper Proof Seal

Information on warranty invalidation and restricted access to technical data.

4.6 Note to Service Personnel

Guidelines for qualified technical engineers performing servicing.

4.9 Hazard Notices

Important hazard information for users before operating the machine.

Warning Notices

Notices denoting potential health and safety hazards for users and patients.

Caution Notices

Notices denoting potential hazards to equipment integrity, not personnel.

Appendix 1: EMC Compliance Tests

Emissions

Guidance on electromagnetic emissions and their compliance levels.

Power Immunity

Immunity test levels for various electrical disturbances.

Radiated Immunity

Guidance on separation distances for RF communications equipment.

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