ADU Users Reference Manual March 2003

Table of contents

Table of contents About this manual

1

Related Documents... 1 Trademarks... 2

1

Safety

3

Intended Use... 3 General Requirements... 3 Warnings and Cautions... 3 System Safety... 5 Equipment Classification... 5 Classification according to IEC 60601-1... 5 Classification according to IEC 529... 5 Classification according to the EU Medical Device Directive... 5 Responsibility of the Manufacturer... 6 ADU - Compliance with safety standards... 6 ADU Safety Features... 7

2

System description

9

Front view of the ADU...10 Rear view of the ADU... 11 Rear connection panel...12 Auxiliary mains outlets and gas supply inlets...13 Gas delivery system... 14 Vaporizer...15 Anesthesia Delivery Unit without N2O...16 Anesthesia Delivery Unit with neutral color coding... 17 Parts of the ADU affected by the neutral color coding... 17 Ventilator...20 Ventilator bellows unit...20 Bag-in-bottle principle...21 Breathing phases...22 Tidal volume compensation...24 Ventilator with compact patient circuit...25 Compact block...26 Ventilator with Standard Patient circuit...28 Module Frame Rack...29 Monitoring...30 Backup systems...31 Battery backup...31 Symbols...34 Equipment safety symbols...34 Other symbols...34 Symbols for Datex-Ohmeda Compact Block with Compact Canister...36

3

Assembly and preparations

37

Connecting gas and power supply...37 Assembling ventilator bellows block...38

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Datex-Ohmeda ADU Assembling the patient circuit...42 Compact patient circuit description...43 Standard Patient circuit description...52 Water traps...58 Bain and Jackson Rees breathing systems...59 Electronically controlled vaporizer and Aladin cassettes...61 Filling Aladin cassettes...63 Preparation for Patient SpirometryTM monitoring (Datex-Ohmeda monitors)...68 Selecting spirometry sensor...68 Connecting the spirometry sensor...69 Sampling gas...70

4

System check

71

General... 71 The System Check procedure...72 Performing a full System Check...73 Full System Check step by step...73 Performing separate checks...75 N2O delivery and hypoxic mixture control check...75 Agent delivery check...76 AUTO ventilation check...77 MAN ventilation check...78 Checklist...79 Checklog...80 Bypass check...81 Failed checks...82 Failed N2O delivery check...82 Failed agent delivery check...83 Failed AUTO Ventilation check...84 Failed Manual ventilation check...86 Leak detection...88 Leakage limits of ADU...88 System Check performed on an ADU without N2O...89

5

Operating and adjusting the settings

91

ADU controls...91 Display/keys...92 Handling the menus...95 Moving in menus...95 Start of case...96 Reset of previous case...96 Fresh gas delivery...96 Fresh gas display...96 O2, N2O and Air...97 02 flush...98 Anesthetic agent...99 Safety...100 CO2 absorber...100 Spontaneous ventilation...101 Manual ventilation...102 Controlled mechanical ventilation (Auto)...103 ii

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Table of contents Volume Controlled Ventilation, VCV...104 Synchronized Intermittent Mandatory Ventilation, SIMV...104 Pressure Controlled Ventilation, PCV...105 Ventilator settings...106 Monitoring...115 Measuring conditions...116 Sampling gas...116 Setup... 117 Set the screen layout... 117 Set time and date...121 Change Install settings... 122 Service menus...124 End of case... 125 Gas usage... 125 Gas disconnection... 126 Battery charge... 126

6

Alarms

127

Alarm Signals and Sequences...127 Alarms and alarm limits... 128 French and Japanese Version settings... 128 Oxygen failure alarm... 128 Alarms setups and adjustments... 129 Adjust limits... 130 Default limits... 130 Cancel changes... 130 Alarm volume...131 Audio On/Off... 132 Alarm history... 132 Silencing alarms... 133 Silencing auditory alarms temporarily... 133 Disabling auditory alarms... 133 Unexpected Reset... 134 Display description... 134 Recommended actions... 134

7

Trends

135

Graphical trend pages... 135 Numeric trend pages... 136 Changing trend pages...137 Trend cursor... 138 Graphical trend length... 139 Scales... 139 Resetting trend data...140

8

Cleaning and maintenance

141

General...141 Cleaning and disinfection methods...142 Cleaning...142 Intermediate level disinfection...142 High level disinfection...143 Document No. 8501700-2

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Datex-Ohmeda ADU Disinfection frequency...143 Disinfection methods table...144 Patient circuit tubing, manual bag tubing & connectors...145 Cleaning and disinfection...145 Compact Blocks...146 Compact Block I and Compact Block II...146 Mechanical cleaning and disinfection in washer-disinfector...147 Manual cleaning...149 High level disinfection...151 Before reusing the compact block...152 Standard Circuit absorber and valve...153 Canister assembly...153 Inspiration valve assembly...153 Expiration valve assembly...153 Disassembling...154 Emptying condensed water...154 Disinfection...154 The unidirectional valves...154 Reassembling the absorber and valve...155 Ventilator bellows assembly...157 Disassembling before cleaning...157 Cleaning and disinfection...161 Bellows and manual ventilation bag...163 Aladin cassette...164 Disinfection...164 Storing...164 Service...164 Sampling adapters...164 Sampling line...164 Recommended periodic maintenance...165 Check and maintenance schedule...165 Service...165 Health and safety declaration form...166

9

Troubleshooting

167

Leak detection and correction...167 Leakage limits of the ADU...167 Leakage during ventilation...167 Patient circuit hoses...168 Compact block...169 Standard Circuit valve and absorber assembly...169 Bellows...170 Bellows chamber positioning...170 Overflow valve...172 Bellows block bottom plate gasket...173 Manual bag and bag hose...173 Alarm messages... 174 System status messages...175 Electronic ventilator messages...175 Electronic vaporizer messages...176 Other messages...177

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Table of contents

10 Technical specifications

179

General...179 Dimensions...179 Environmental conditions... 180 Electrical requirements... 180 Electrical connections... 180 Display...181 Trends...181 Alarms... 182 Gas delivery... 183 Gas supply... 183 Fresh gas control unit... 184 Electronically controlled vaporizer and Aladin cassette... 185 Ventilation...187 Electronic ventilator including bellows block...187 Patient breathing systems...191 Scavenging...191 Vaporizer output graphs... 192 Anesthetic agent concentration output... 192

11 Glossary

197

Abbreviations...197 Units... 198 Anesthesia machine vocabulary... 199

12 Appendices

205

Appendix A – Compressible volume... 205 Compensation for compressible volume in the delivery system... 205

13 Brief instructions

207

Datex-Ohmeda ADU... 207 Front view of the ADU... 207 Preparing the ADU... 208 Daily System Check... 209 Setting alarms...211 Adjusting fresh gas delivery...212 Returning sampled gas...213 Starting ventilation...213 Monitor integration...215 Disinfection methods table...216

Index

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About this manual

About this manual This User’s Reference Manual describes all necessary functions for the safe use of the Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU) and AS/3 ADU from S/N: 40 000 000 and onwards. Some of the described functions may work in alternative ways. In those cases the alternatives are described. Be sure to follow the relevant description. In this manual, both the S/5 ADU and the AS/3 ADU will be referred to as “ADU” only. Before using your ADU, please read this User’s Reference Manual thoroughly. Pay special attention to WARNINGS and CAUTIONS. Information about the terms used throughout the manual is found in chapter 11, Glossary. Design of anesthetic system is largely controlled by relevant international or regional standards. Depending on the area in which the system will be used, IEC (international), ASTM (US), or other standards may apply. In this User’s Reference Manual the pictures and text refer to an ADU designed according to IEC standards.

Related Documents User’s Guide, UG The “User’s Guide“ describes the most common features and functions for the use of the equipment. The Guide is intended to be a complement to the reference manuals and support the user in the daily work. The guide has a table of contents, index and tabs with headings for a quick and easy way to find desired information.

Cleaning Instructions Poster The “Cleaning Instructions Poster” describes how to clean the most common parts of the equipment. The poster is a complement to the User’s Reference Manual and the User’s Guide.

Technical Reference Manual, TRM The “Technical Reference Manual” contains information required to service and repair the equipment. It is intended for service personnel and engineers who have been trained to perform maintenance procedures.

Related clinical information For related clinical information, refer to the following documents:

• • • • •

Quick Guide, Patient Spirometry Appliguide, Patient Spirometry Appliguide, Patient Oxygen Appliguide, First Steps in CO2 Monitoring Appliguide, Optimizing low and minimal flow anesthesia

Monitoring functions are explained in more detail in:

• •

Datex-Ohmeda S/5 Anesthesia Monitor User’s Reference Manual Capnomac Ultima Operator’s Manual

Conventions used Names of touch keys are entered in a larger and bold typeface, for example Setup. Software menu items are entered in bold italic typeface, for example Gas Usage.

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Datex-Ohmeda ADU Menu access is described from top to bottom. For example, the selection of the Screen Layout menu item and the CO2 Setup menu item below would be written as Screen Layout-CO2 Setup. Messages (alarm messages, informative messages) displayed on the screen are entered inside single quotes, for example ‘PEEP high’. When referring to different documents, sections or paragraphs, the name is entered in italic typeface and enclosed in double quotes, for example “User’s guide”.

Trademarks Datex®, Ohmeda® and other trademarks S/5, AS/3, CS/3, D-lite, D-lite+, Pedi-lite, Pedi-lite+, D-fend, D-fend+, MemCard, ComWheel, PatientO2, Patient Spirometry and Tonometrics, are property of Instrumentarium Corp or its subsidiaries. All other product and company names are property of their respective owners.

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1 Safety

1 Safety Intended Use The Anesthesia Delivery Unit (ADU) is intended for administration of anesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia. It is intended for all patient categories.

General Requirements The ADU must only be operated by qualified Anesthesia personnel, and it must be connected to mains electrical power and gas supplies which meet the requirements specified in section 10 Technical Specifications. The ADU is not MRI compatible.

Warnings and Cautions Throughout this manual, a WARNING indicates a hazardous situation which - if not corrected - may result in patient injury or death. A CAUTION indicates a situation in which the ADU or devices connected to it, may be damaged. Any WARNINGS or CAUTIONS in the text of this User’s Reference Manual, are placed in such a way that they are clearly identifiable with the relevant situation.

WARNING

The ADU is only to be operated by, or on the order of a physician.

WARNING

The constant attention of qualified personnel is required whenever a patient is under anesthesia and connected to the ADU.

WARNING

To prevent hazards arising from incorrect delivery of gases, the ADU shall always be used with the following monitoring:

WARNING

•

O2 monitor according to ISO 7767/EN 12598

• •

Agent monitor according to ISO 11196/EN ISO 11196 CO2 monitor according to ISO 9918/EN 864

•

Expired volume monitor according to IEC 60601-2-13/EN 740

Hazard related to explosion, fire, and burns. To avoid the risk of explosion, fire, or burns, the following precautions must be observed: •

•

•

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Flammable anesthetic gases such as ether and cyclopropane must not be used with this workstation. Only agents which comply with the requirements for non-flammable anesthetic agents according to IEC 60601-1, shall be used. There is always a risk wherever anesthetic agents are used and handled. Do not use the ADU in insufficiently ventilated areas, thus avoiding raised concentrations of anesthetic agents in operating rooms. Use gas scavenging at all times. As this workstation is not to be used with flammable anesthetic agents, the use of antistatic breathing tubes and face mask is not recommended. Burns

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Datex-Ohmeda ADU

•

• WARNING

Electric shock hazard. To avoid the risk of electric shock hazard, the following precautions must be observed: •

• • • WARNING

may occur if antistatic or electrically-conductive breathing tubes are used while high-frequency electric surgery equipment is in use. High pressure or pure oxygen may cause explosion or burn strongly when reacting with organic material such as lubricants, paint, greasy fingerprints, dirt, dust fluff, and other organic waste. No oil, grease, or silicone-based lubricants must be used. Only PTFE-based, oxygen compatible lubricants are allowed.

In order to reduce the risk arising from excessive leakage currents, and in accordance with EN 740, an anesthetic workstation shall not be provided with more than four operator accessible auxiliary mains socket outlets. The connection of equipment to auxiliary mains socket outlets may increase the patient leakage currents to values exceeding the allowable limits in the event of a defective protectice earth conductor. Always unplug the electric power cord before cleaning or maintenance of the ADU When cleaning the exterior - make sure that no liquid enters the interior of the ADU. Do not autoclave any part of the ADU system except those specified in this manual, with steam or ethylene oxide.

Do not connect external equipment to the ADU system other than those specified by Datex-Ohmeda. (Also see the Installation section in the Datex-Ohmeda ADU Technical Reference Manual).

Electromagnetic compatibility (EMC) Most medical electrical devices emit electromagnetic radiation disturbances which may interfere with other equipment used in their vicinity. Likewise, most electrical medical devices are susceptible to electromagnetic disturbances. The ADU has been designed such that it does not emit electromagnetic radiation disturbance levels exceeding the limits specified in IEC 60601-1-2, and in order to ensure the safe function of the device, it is important that it operates in an electromagnetic environment which complies with the requirements of IEC 60601-1-2. Mobile telephones and other equipment which emit radiated fields, should be switched off in the vicinity of the ADU.

CAUTION

The function of this machine may be adversely affected by the operation of equipment such as high frequency surgical apparatus or short-wave therapy equipment in the vicinity.

CAUTION

The function of this anesthetic workstation or module, as applicable, may be adversely affected by electromagnetic interference exceeding the levels specified in IEC 60601-1-2.

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1 Safety

System Safety When the ADU is used together with, or connected to other equipment, it is important that the whole system complies with the safety requirements of IEC 60601-1-1: Safety requirements for medical electrical systems. Compliance with IEC 60601-1-1 means that any other equipment forming part of the system, should meet the requirements of IEC 60601-1. The use of an extra isolation transformer may also be considered. Please contact your local technical service personnel to verify system safety.

CAUTION

In order to prevent overheating of the ADU while in operation, sufficient space should be left around the machine.

Equipment Classification Classification according to IEC 60601-1 CLASS I EQUIPMENT according to the type of protection against electrical shock. TYPE B equipment according to the degree of protection against electrical shock. EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR or with OXYGEN or NITROUS OXIDE. CONTINUOUS OPERATION according to the mode of operation.

Classification according to IEC 529 Degree of protection against ingress of water as detailed in IEC 529: IPX1

Classification according to the EU Medical Device Directive The Datex-Ohmeda Anesthesia Delivery Unit is classified as IIb.

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Responsibility of the Manufacturer The Datex-Ohmeda Division, Instrumentarium Corp. is responsible for the effects on safety, reliability and performance of the equipment only if:

•

Personnel authorized by Datex-Ohmeda carry out assembly, operations, extensions, readjustments, modifications, periodical service or repairs.

• •

The electrical installation of the relevant room complies with the appropriate requirements. The equipment is used in accordance with this User’s Reference Manual.

ADU - Compliance with safety standards With the deviations listed below the ADU complies with the following standards: • IEC 60601-1:1988 - General requirements for safety • IEC 60601-2-13:1998 - Particular requirements for the safety of anaesthetic workstations • EN 740:1998 - Anaesthetic workstations and their modules - Particular requirements • ISO 8835-3:1997 - Inhalational anaesthesia systems - Anaesthetic gas scavenging systems Receiving and transfer systems NOTE: Units sold in Canada also comply with CSA standards 601.1 and 601.2.13

Deviations

6

Standard

Deviation

EN 740

Cross connection between the ventilator port and the reservoir bag port is prevented by means of incompatible connectors and not by labelling.

EN 740 and IEC 60601-2-13

With an active scavenging ejector in combination with extreme inspiratory flow settings the time-weighted average input flow required by the ADU for each gas type may exceed 60 l/min at a pressure of 280 kPa (41 psi) measured at the gas inlet port.

ISO 8835-3

The resistance to extract flow of the transfer and receiving system is 29 cmH2O at 25 l/min (required max 20 cmH2O).

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1 Safety

ADU Safety Features The safety features listed below are incorporated in the Anesthesia Delivery Unit. Gas supply

• O2, N2O and Air supply failure alarm • Overpressure limitation for wall inlets O2, Air and N2O at 900 kPa (130 psi)

Gas mixer

• Electronic O2/N2O/AA ratio control and N2O cut-off • Automatic switching from N2O to Air if N2O pressure is lost

Vaporizer: Aladin Cassette

• Overfilling protection • The Desflurane cassette is equipped with a special over-pressure relief valve. • Automatic cassette identification • Prevents delivery of more than one agent at a time • Automatic vaporizer shut-off

- in case fresh gas flow is lost - in case cassette is removed

Ventilator

• With loss of primary ventilator driving gas (Air or O2) automatic switch to the

secondary driving gas. (O2 or Air)

• Visible rising bellows allow fast and easy leakage detection • Adjustable maximum pressure release in AUTO mode (mechanical ventilation),

Pmax Release with automatic switch to expiration

• Overpressure release valve in fresh gas outlet at 80 cmH2O • Single switch operation of the ventilator • High pressure alarm in the breathing system • Low pressure alarm in the breathing system • Sustained pressure alarm • APL valve in the manual breathing circuit

Datex-Ohmeda Compact Patient circuit (optional)

• Absorber locking mechanism allows easy canister/absorber replacement during

operation.

• Clearly visible absorber canister and vertical one-way valves

Other safety features

• Mains power failure alarm • Full battery back up for 20 minutes *) • Optional reserve gas cylinders

*) NOTE: The backup battery supplies power only to the ADU, not to the patient monitor unless outfitted with a UPS

system.

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2 System description

2 System description The Anesthesia Delivery Unit is designed to mix and dose respiratory gases and to ventilate the patient. The delivery unit is the basis for a flexible anesthesia system with full monitoring and data management capabilities. The ADU anesthesia system enables you to design an optimal system for each operating room by adding or interchanging modules. Additionally, it is designed to include future products.

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Datex-Ohmeda ADU

Front view of the ADU 6 5

7

4

8

3

9 10 11

12 2 17 13 14

1

15

16

(1) (2) (3) (4) (5) (6) (7) (8) (9)

Fresh gas outlet (Optional gas flow indicator) Compact patient circuit Ventilator bellows block Fresh gas flow controls Setup keys ADU LCD display Ventilator “quick” function keys Anesthesia Monitor (optional LCD display) ComWheel

(10) Aladin Vaporizer Cassette (11) Agent wheel (12) Switch for On / Standby (13) Anesthesia Monitor central unit and modules (option) (14) Vaporizer cassette storage slots (optional) (15) Drawers (optional) (16) O2 flush button (17) O2 flush button (early version)

NOTE: The ADU can be used with a 10.4” display. See “Display/keys” on page 92 for further information.

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2 System description

Rear view of the ADU 4 3 2 1 5

1

(1) (2) (3) (4) (5)

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Auxiliary gas and vacuum outlets (optional) Cylinder yokes (optional) Auxiliary mains outlets (optional) Gas supply and scavenging connectors Scavenging ejector (optional) or scavenging flow indicator (optional)

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Datex-Ohmeda ADU

Rear connection panel

1

3

4 2

5

6

(1) (2) (3) (4) (5) (6)

12

Product labels. Contains information on type of device, Serial No. (S/N), year of manufacture and electrical requirements. ADU mains power cord (or connection cord for box of Auxiliary Mains Outlets). Auxiliary main outlets Mains fuses to Auxiliary main outlets (two fuses per outlet) Auxiliary Mains Outlets box Potential Equalization Terminal

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2 System description

Auxiliary mains outlets and gas supply inlets The three mains socket outlets are reserved for monitors and other electrical devices mounted on the ADU.

WARNING

In order to reduce the risk arising from excessive leakage currents, and in accordance with EN 740, an anesthetic workstation shall not be provided with more than four operator accessible auxiliary mains socket outlets.

1

2 4

Figure 1

Auxiliary main outlets

Figure 2

Scavenging ejector with indicator (1) (2) (3)

5

Gas supply connectors

7

6

Figure 3

3

Figure 4

Scavenging flow indicator

Nitrous oxide inlet Air inlet O2 inlet

(4) Gas scavenging outlet (EVAC) (5) Vacuum outlet (optional) Each connector is designed to be coupled to its corresponding hose. The connectors and hoses are color-coded. (6) Optional - Built-in scavenging ejector with indicator. Max. flow is achieved by adjusting the flow ejector knob according to the indicator response. (7) Optional - Built-in scavenging indicator.

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