User Manual
104 Pages
Preview
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BleaseFocus Anesthesia Systems
User Manual 073-0187-00/Rev. E BleaseFocus User Manual
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BleaseFocus User Manual
BleaseFocus Anesthesia Machine
User Manual MODIFICATIONS LABEL REV
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PR022893
PR023860
PR026651
PR033840
PR034400
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Spacelabs Healthcare Ltd. (Anesthesia Delivery and Ventilation Division) 1 Harforde Court • John Tate Road • Hertford • SG13 7NW • United Kingdom Tel:
+44 (0)1992 507700
Fax:
+44 (0)1992 501213
e-mail (enquiries): [email protected] e-mail (technical): [email protected] www.spacelabshealthcare.com
BleaseFocus User Manual
Part Number: 073-0187-00 Rev. E July 2013
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BleaseFocus User Manual
Notices
IMPORTANT Warning Notices Warning notices denote a potential hazard to the health and safety of users and/or patients. These notices clearly state the nature of the respective hazard and the means by which it can be avoided. Warning notices appear in full in the preliminary pages and are repeated at their points of application in the manual. Caution Notices Cautionary notices denote a potential hazard to the physical integrity of equipment/software but NOT a danger to personnel. These notices clearly state the nature of the hazard and the means by which it can be avoided. Relevant or helpful information
The user must be familiar with the machine and its various functions before using it on a patient.
Incorrect use of the equipment described in this manual may result in injury to the patient. Read this manual before operating the machine. You must be familiar with the machine and its functions before you use it on a patient. Pay special attention to warnings, cautions and notes within the manual. A complete list of these important notices can be found in Section 8 of this manual.
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BleaseFocus User Manual
Contents
Table of Contents Chapter 1 - Introduction ... 15 1.1
Introduction ... 19
1.2
System Description ... 20
1.2.1
General Description ... 20
1.2.2
The Frame ... 24
1.2.3
Pneumatic Assembly... 24
1.2.4
Flowblock Assembly... 24
1.2.5
The Monitor Shelf... 24
1.2.6
Detachables ... 24
1.3
System Specifications ... 25
1.3.1
Physical... 25
1.3.2
Pneumatics ... 26
1.3.3
Miscellaneous ... 26
1.3.4
Common Gas Outlet (CGO)... 26
1.3.5
Technical/Performance Specifications ... 26
1.3.6
Alarms/Indicators ... 27
1.3.8
Regulator Safety Valve Settings ... 27
1.3.9
Supplies ... 28
1.3.10
Environment ... 28
1.4
Ancillaries and Optional Features ... 28
1.4.1
Standard Features ... 28
1.4.2
Optional Fittings ... 29
1.5
Accessories... 29
1.6
Vaporizers ... 30
1.7
Suction ... 30
Chapter 2 - Installation ... 31 2.1
System Installation ... 33
2.1.1
Install the Cylinders... 33
2.1.2
Connect the Pipelines ... 35
2.1.3
Connect the Oxygen Sensor and Cable ... 36
2.1.3.1 Guidelines for Handling... 37 2.2
Install the Selectatec Vaporizers ... 37
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Contents 2.3
Install the CAS 1kg or CAS 2kg Absorber ... 38
2.4
Connect the Breathing System ... 39
2.4.1
Install the Suction Controller (Optional) ... 40
2.5
Attach the Flow Sensor Tubing ... 41
2.6
Connect the Drive Gas Tubing ... 41
2.7
Connect the Absorber Switching Cable ... 41
2.8
Attach Ancillary Equipment (Optional) ... 42
2.9
Ventilators ... 42
2.10
Post-Installation Check ... 42
Chapter 3 - System Operation ... 43 3.1
System Operation ... 45
3.2
Oxygen System and Oxygen Failure Warning Device ... 48
3.3
Nitrous Oxide System ... 50
3.4
Medical Air System (Optional)... 51
3.5
System Controls... 51
3.5.1
On/Off Switch ... 51
3.5.2
Flow Controls ... 52
3.5.3
Oxygen Flush ... 52
3.5.4
Hypoxic Guard ... 52
3.5.5
Vaporizers ... 53
Chapter 4 - Oxygen Monitor Option ... 55 4.1
Oxygen Monitor System (Optional) ... 57
4.1.1
Principles of Operation... 57
4.1.2
Oxygen Monitor Technical Specification ... 57
4.2
Oxygen Monitor Components ... 59
4.3
Oxygen Monitor Calibration ... 62
4.3.1
Calibrate the O2 Monitor. ... 63
4.3.2
Automatic Calibration to Room Air ... 64
4.3.3
Factors Influencing Calibration ... 64
4.3.3.1
Effects of Temperature ... 64
4.3.3.2 Effect of Pressure ... 65 4.3.3.3 Effect of Humidity ... 65
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BleaseFocus User Manual
Contents 4.4 4.4.1
Using the Integrated O2 Monitor ... 66 Set the Low O2 Flow Alarm ... 66
4.4.2
Set the High O2 Flow Alarm ... 66
4.4.3
Check the Oxygen Concentration of a Sample Gas ... 67
4.4.4
Alarm Conditions for Oxygen Concentration... 67
4.4.5
Troubleshooting the Oxygen Monitor ... 68
4.5
Replace the Oxygen Sensor ... 68
4.6
Inspect the Oxygen Monitor ... 68
Chapter 5 - User Maintenance ... 69 5.1
User Maintenance Schedule ... 71
5.1.1
Check Overall Performance ... 71
5.1.2
Pre-Use Check... 71
5.1.3
Full System Check ... 71
5.1.4
Cleaning ... 72
5.1.5
Sterilization ... 72
Chapter 6 - Pre-Use Check ... 73 6.1
Check the Cylinder and Pipeline Supplies ... 75
6.2
Check the Flowblock Assemblies... 76
6.3
Check the Oxygen Failure Warning System ... 76
6.4
Perform the Leak Test - Vaporizers ... 77
6.5
General Checks ... 77
Chapter 7 - Full System Check ... 79 7.1
Leak Test... 81
7.2
On/Off Switch and Warning System Check ... 82
7.3
Mechanical Hypoxic Guard Test ... 83
7.4
Oxygen Flush Test ... 83
7.5
Auxiliary High Pressure Outlet Test ... 83
7.6
Ventilator Drive Test (if a Ventilator is installed) ... 84
7.7
Vaporizer Test ... 84
7.8
Oxygen Monitor Test (if installed)... 84
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Contents
Chapter 8 - Notices & Important Information ... 85
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8.1
Product Improvement... 87
8.2
Responsibilites of the User ... 87
8.3
Responsibilities of the Manufacturer ... 87
8.4
Note to Service Personnel ... 88
8.5
Contact Information... 89
8.6
Copyright... 89
8.7
CE Marking ... 89
8.8
Trademarks and Acknowledgements ... 90
8.9
Hazard Notices ... 91
BleaseFocus User Manual
Figures
List of Figures Figure 1 - BleaseFocus Anesthesia Machine ... 21 Figure 2 - Lower Rear of BleaseFocus Machine ... 23 Figure 3 - Installing the Cylinders ... 33 Figure 4 - Oxygen Sensor-Cable Connections... 36 Figure 5 - Oxygen Sensor-Absorber Connection ... 36 Figure 6 - Vaporizer Lock in “Unlocked” Position ... 37 Figure 7 - Vaporizer Lock in “Locked” Position ... 38 Figure 8 - Absorber Brackets ... 38 Figure 9 - Breathing System Connections ... 39 Figure 10 - Suction Controller Mounting ... 40 Figure 11 - Patient Airway Flow Sensor ... 41 Figure 12 - Absorber Switch Cable Connections ... 41 Figure 13 - Pneumatic Circuit for 3-Gas Systems ... 47 Figure 14 - Oxygen Monitor ... 58
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BleaseFocus User Manual
BleaseFocus Anesthesia Machine
How to Use This Manual
This manual provides the information required to properly operate the BleaseFocus Anesthesia System. Use this manual as a reference after you are familiar with the system and its operation. Unless otherwise stated, all references to ventilator or ventilator components in this manual pertain to the Blease 700/900 Series Ventilators. System descriptions in this manual refer to the three-gas, maximum configured system. Depending on the configuration ordered, your system may or may not have all the components described. Because two different system models are available, some pictures used in this manual may not match your system. The differences between the models are cosmetic only. Therefore, the information given in this manual does pertain to both Focus models. When setting up the system for the first time, read all of the chapters starting with Chapter 2-Installation. If you have used the BleaseFocus Anesthesia System before, but need a reminder on how to use the system, refer to Chapters 2-Installation and 3-System Operation. Chapter-5 User Maintenance provides information on routine system maintenance.
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BleaseFocus User Manual
BleaseFocus Anesthesia Machine
Chapter 1 Introduction
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BleaseFocus User Manual
Chapter 1 - Introduction
Symbols Used CAUTION - Consult accompanying documents
IEC symbol for alternating current
Consult instructions for use
Equi-Potential
IEC symbol denoting type B applied part
End of case
WARNING: There is danger of personal injury to the user or patient
Serial number
Further relevant or helpful information
Oxygen Flush
Turning the control in the direction of the thickening line produces an increase in that parameter
Where this sign is shown, latex free material is used
Power Off
Exhaust
Power On
This way up
Confers approval under the European Medical Device Directive and the notified body number.
Manufacturer
Date of Manufacture
Patient flow sensor tubing connection
Bellows drive gas
Oxygen sensor cable connection
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Chapter 1 - Introduction
Abbreviations Used APL
Airway Pressure Limiting
l/m lpm
Liters per minute
BPM bpm
Breaths per minute
ml
Milliliters
cmH2O
Gauge pressure expressed in centimeters of water
LCD
Liquid Crystal Display
CO2
Carbon Dioxide
LED
Light Emitting Diode
CPAP
Continuous positive airway pressure
N 2O
Nitrous Oxide
hPa
hectoPascal
O2
Oxygen
L
Liters
Intended Use The BleaseFocus Anesthesia Machine is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician. This machine is designed to be used to treat pediatric through adult patients.
The references made to sterilization within this manual do not indicate that the anesthesia machine and its components are sterile as supplied or are required to be sterile for their operation.
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BleaseFocus User Manual
Chapter 1 - Introduction
1.1
Introduction
This manual describes the BleaseFocus anesthesia machine and provides the instructions required to install, set up, operate and maintain this machine. Before you attempt to set up, use or operate this machine, carefully read this manual and all associated documentation to familiarize yourself with the BleaseFocus Anesthesia System. Be sure to read the manuals for any optional monitors and accessories installed in the system. Pay special attention to the Hazard Notices Section (8.9) in Chapter 8 of this manual and any Warnings and Cautions that appear throughout this manual. Note that any adaptation, modification or procedure not recommended by Spacelabs Healthcare Ltd. or their agents may affect any warranty relating to this machine. Address any requests for advice, assistance or servicing facilities to Spacelabs Healthcare Ltd. or an authorized Spacelabs Healthcare agent. Read the User Responsibility statement located in Chapter 8. It describes your responsibilities for proper handling of the system. Read the Responsibilities of the Manufacturer (Product Warranty) also in Chapter 8. It describes the responsibility of Spacelabs Healthcare Ltd in case of a functional defect. Keep this manual with the system as a reference for any questions that may arise about system operation, maintenance or, if necessary, repair. All pictures shown in this manual represent the BleaseFocus machine. The BleaseFocus system is latex free. Do not install any replacement parts that contain latex.
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Chapter 1 - Introduction
1.2
System Description
1.2.1
General Description
The BleaseFocus anesthesia machine contains all the pneumatic circuitry, controls, monitoring, ancillaries and storage required to control, distribute and mix medical gases and anesthetic agents to deliver them to a patient system. The references to sterilization within this manual do not indicate that the anesthesia machine and its components are sterile as supplied or are required to be for their operation. The BleaseFocus Anesthetic machine is designed to comply with IEC 60601-1 and IEC 60601-2-13. Shown in Figure 1 on the next page, the BleaseFocus machine consists of five subsystems: a Frame (J) and Monitor Shelf (B), a Pneumatic Assembly (G), Breathing Circuit and optional Ventilator (C) Flowblock assembly (T) and a set of detachables. WARNING: There may be some differences between the specifications in this manual and those for ANSI-specification BleaseFocus machines. To operate the BleaseFocus machine in compliance with IEC 80601-213, the system should be equipped with the following devices. Please refer to the appropriate user manuals for operational instructions: • • • • •
blood oxygen monitor CO2 alarm blood pressure alarm ECG alarm anesthesia agent concentration.
This machine must be equipped with an anesthetic gas scavenging transfer and receiving system, that complies with ISO 8835-3 or applicable local standard before being put into service. If the integrated oxygen monitor is not installed, an oxygen monitor complying with ISO 7767 shall be used when the anesthetic machine is in service. A CO2 monitor complying with ISO 9918 shall be used when the anesthetic machine is in service. Adult breathing systems used with the anesthetic machines shall comply with ISO 8835-2. Always have a bag valve mask available whenever the machine is in use. 20
BleaseFocus User Manual