Aisys Users Reference Manual Sw Rev 6.X

Datex-Ohmeda, Inc., a General Electric Company, doing business as GE Healthcare.

User Responsibility This Product will perform in conformity with the description thereof contained in this User’s Reference manual and accompanying labels and/or inserts, when assembled, operated, maintained, and repaired in accordance with the instructions provided. This Product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted, or contaminated should be replaced immediately. Should repair or replacement become necessary, Datex-Ohmeda recommends that a telephonic or written request for service advice be made to the nearest Datex-Ohmeda Customer Service Center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by Datex-Ohmeda and by Datex-Ohmeda trained personnel. The Product must not be altered without the prior written approval of Datex-Ohmeda. The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Datex-Ohmeda.

CAUTION

U.S. Federal law restricts this device to sale by or on the order of a licensed medical practitioner. Outside the U.S.A., check local laws for any restriction that may apply. Datex-Ohmeda products have unit serial numbers with coded logic which indicates a product group code, the year of manufacture, and a sequential unit number for identification. The serial number can be in one of two formats.

AAAX11111 The X represents an alpha character indicating the year the product was manufactured; H = 2004, J = 2005, etc. I and O are not used.

AAAXX111111AA The XX represents a number indicating the year the product was manufactured; 04 = 2004, 05 = 2005, etc.

Aisys, Carestation, Easy-Fil, Advanced Breathing System, ComWheel, D-fend, EZchange, Disposable Multi Absorber, Reusable Multi Absorber, PSVPro, SmartVent, Aladin, and Aladin2 are registered trademarks of Datex-Ohmeda, Inc. Other brand names or product names used in this manual are trademarks or registered trademarks of their respective holders.

Table of Contents 1 Introduction Intended use... 1-2 Symbols used in the manual or on the equipment... 1-4 Typeface conventions used... 1-7 Abbreviations... 1-7

2 System Controls and Menus System overview... 2-2 Advanced breathing system (ABS) components... 2-5 Optional ABS components... 2-7 Non-circle circuit... 2-8 ACGO (optional)... 2-9 Scavenging the ACGO sample flow... 2-9 Scavenging from an auxiliary manual breathing circuit 2-10 Scavenging a gas monitor sample flow... 2-10 Aladin cassette controls... 2-11 Display controls... 2-12 Anesthesia system display... 2-13 Waveform fields... 2-15 Digit field... 2-15 Using menus... 2-16

3 Operation Turning on the system... 3-2 Start case (start gas flow)... 3-3 Using default settings... 3-4 Using customized settings... 3-4 Minimum Alveolar Concentration (MAC)... 3-5 End case... 3-6

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Aisys Ventilator setup... 3-7 Using quick keys... 3-7 Using Vent Setup menu... 3-8 Changing ventilator modes and settings... 3-8 Gas setup... 3-9 Using quick keys... 3-9 Using Gas Setup menu... 3-9 Changing gas and settings... 3-9 Changing circuit type... 3-10 Spirometry... 3-11 Setting loop type... 3-12 Scaling... 3-13 Spirometry setup... 3-14 Setting patient and sensor type... 3-14 Selecting a data source... 3-15 Setting spirometry split screen... 3-15 Main Menu... 3-16 Trends... 3-17 Cardiac bypass... 3-18 Fresh gas usage... 3-19 Screen configuration... 3-20 Select page... 3-20 Screen setup... 3-21 Alarm setup... 3-23 Setting alarm limits... 3-23 Volume apnea... 3-24 MV/TV alarms... 3-24 CO2 alarms... 3-24 Auto MV limit... 3-25 Alternate O2 control... 3-26 EZchange canister (optional)... 3-27 Condenser (optional)... 3-28 Passive AGSS (optional)... 3-29

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Table of Contents Active AGSS (optional)... 3-30 Connecting active AGSS with a flow indicator... 3-31 Connecting active adjustable AGSS... 3-31

4 Preoperative Checkout Every day before your first patient... 4-2 Before every patient... 4-3

5 Preoperative Tests Inspect the system... 5-2 Aladin cassette installation... 5-3 Flow and pressure calibration... 5-4 Circuit compliance compensation... 5-4 Checkout menu... 5-5 Leak < 250 ml... 5-5 No... 5-5 Yes... 5-5 Machine check... 5-6 Machine check - system... 5-6 Machine check - circuit... 5-7 Machine check - circuit O2... 5-7 Machine check - monitor... 5-7 Individual checks... 5-8 System... 5-8 Circuit... 5-8 Circuit O2 cell... 5-9 Low P leak... 5-9 Low P leak (machines with ACGO)... 5-9 Agent delivery... 5-10 Positive low pressure leak test (ACGO systems only)... 5-11

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Aisys 6 Airway Modules Airway modules... 6-2 Connection to a patient... 6-4 Parameters setup... 6-5 Data source... 6-5 CO2 setup... 6-5 O2 setup... 6-5 Agent setup... 6-5 Spirometry setup... 6-5 Automatic agent identification... 6-6 Calibration... 6-6

7 Alarms and Troubleshooting Alarms... 7-2 Alarm priorities... 7-2 Silencing alarms... 7-2 Display changes during alarms... 7-2 De-escalating alarms... 7-3 Battery indicator... 7-3 Internal failure... 7-3 List of alarms... 7-4 Alarm ranges... 7-13 Alarm tests... 7-15 Breathing system problems... 7-17 Electrical problems... 7-18 Pneumatic problems... 7-19

8 Setup and Connections Setup warnings... 8-2 Canister setup... 8-4 When to change the absorbent... 8-5 Removing a canister... 8-6 Removing an EZchange canister... 8-6 Reusable Multi Absorber canister filling... 8-7

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Table of Contents Electrical connections... 8-9 Mains inlet... 8-9 Outlets... 8-9 Patient monitoring battery backup... 8-9 Serial port... 8-10 Pneumatic connections... 8-11 Pipeline inlets... 8-11 Scavenging... 8-11 Sample gas return port... 8-12 Pneumatic power outlet... 8-12 Vacuum suction regulator (optional)... 8-13 Venturi suction regulator (optional)... 8-13 Auxiliary O2 flowmeter (optional)... 8-14 How to install gas cylinders... 8-15 Pin indexed cylinder yokes... 8-15 DIN cylinder connections... 8-15 High-pressure leak test... 8-16 How to attach equipment to the top of the machine... 8-17

9 User Maintenance Repair policy... 9-2 Maintenance summary and schedule... 9-2 Datex-Ohmeda approved service... 9-3 Circuit O2 cell replacement... 9-4 Calibration menu... 9-5 Flow and pressure calibration... 9-5 Circuit O2 cell calibration... 9-6 21% O2 calibration... 9-6 100% O2 calibration... 9-6 Airway gas calibration... 9-6 Backlight test... 9-7 How to help prevent water buildup... 9-7

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Aisys 10 Parts Flow sensor module... 10-2 Breathing circuit module... 10-3 Bellows... 10-4 Complete Advanced Breathing System... 10-5 Absorber canister... 10-6 Exhalation valve assembly... 10-7 AGSS... 10-8 EZchange canister system... 10-9 Condenser... 10-10 Test tools and system parts... 10-11

11 Specifications and Theory of Operation System pneumatic circuits... 11-2 Gas supplies... 11-4 O2 flow... 11-4 Air and N2O... 11-4 Mixed gas... 11-4 EZchange canister... 11-5 Condenser... 11-5 Pneumatic specifications... 11-5 Gas supplies... 11-5 ACGO Port relief... 11-5 Non-circle circuit relief... 11-5 Pneumatic power outlet... 11-6 Electrical block diagram... 11-7 Electrical power... 11-9 Power cord... 11-9 Battery information... 11-10 Flow specifications... 11-10 Breathing system specifications... 11-11 Gas scavenging... 11-12 Physical specifications... 11-13 Environmental requirements... 11-13

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Table of Contents Airway module specifications... 11-14 Gas specifications... 11-14 Typical performance... 11-15 Suction regulators (optional)... 11-16 Ventilator theory... 11-17 O2 monitoring theory of operation... 11-18 Ventilation modes... 11-18 Ventilation modes factory default settings... 11-26 Ventilation mode transition... 11-26 Ventilator operating specifications... 11-27 Pneumatics... 11-27 Fresh gas compensation... 11-27 Pressure... 11-27 Volume... 11-27 Oxygen... 11-27 Ventilator accuracy data... 11-28 Electronically controlled vaporizer and Aladin cassette . . 11-29 Aladin2 cassettes... 11-30 Aladin cassettes... 11-31 Electromagnetic compatibility (EMC)... 11-32 Guidance and manufacturer’s declaration electromagnetic emissions... 11-32 Guidance and manufacturer’s declaration electromagnetic immunity... 11-33 Recommended separation distances... 11-35 Electrical safety... 11-36 IEC 60601-1 Classification... 11-37 Standards... 11-37 System components... 11-38 Integral... 11-38 Not integral... 11-38

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Aisys 12 Super User Mode Install/Service menu... 12-2 Using super user mode... 12-3 Menus... 12-4 Cumulative gas usage... 12-4 Volume apnea setup... 12-5 Setting time and date... 12-6 Trends setup... 12-7 Setting colors and units... 12-9 Parameter settings... 12-10 Page Setup... 12-10 Configuring case defaults... 12-12

13 Vaporizer cassettes Vaporizer... 13-2 Aladin2 cassette variants... 13-2 Aladin cassette variants... 13-4 Installing cassettes... 13-6 Cleaning... 13-6 Draining cassettes... 13-6 Draining halothane cassettes... 13-7 Filling Aladin2 cassettes... 13-7 Filling with Easy-Fil system... 13-8 Filling with Quik-Fil system... 13-9 Filling with Saf-T-Fil bottle... 13-10 Filling Aladin cassettes... 13-12 Filling with keyed filler system... 13-12 Filling with Quik-Fil system

... 13-14

Filling with Saf-T-Fil bottle... 13-15

Index Warranty

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1 Introduction

WARNING

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In this section

Read each component’s User’s Reference manual and understand the following before using this system: •

All system connections.

•

All warnings and cautions.

•

How to use each system component.

•

How to test each system component.

Before using the system: •

Complete all of the tests in the “Preoperative Tests” section.

•

Test all other system components.

If a test fails, do not use the equipment. Have a Datex-Ohmeda trained service representative repair the equipment. Intended use... 1-2 Symbols used in the manual or on the equipment... 1-4 Typeface conventions used... 1-7 Abbreviations... 1-7

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Aisys

Intended use Aisys means Anesthesia Integrated System. The Aisys Carestation is scalable, flexible, and functionally integrated, featuring the most advanced design, ventilation, respiratory monitoring, and breathing system. In addition, module bays allow for the physical integration of legacy Datex-Ohmeda patient monitors and supports mounting of other GE Healthcare monitors. Optionally, the open architecture design supports mounting of non-Datex-Ohmeda patient monitors, record keeping, and connections to the hospital information system. The INview movable display arm helps keep the anesthetist’s focus on the patient by offering control of all hemodynamic, gas delivery, anesthetic agent, and ventilation parameters. This anesthesia system uses SmartVent ventilation technology offering Volume Control Ventilation with tidal volume compensation and electronic PEEP. The proven SmartVent technology also features optional Pressure Control Ventilation, Pressure Support Ventilation with an Apnea Backup (PSVPro) that is used for spontaneously breathing patients, Synchronized Intermittent Mandatory Ventilation (SIMV) modes, Pressure Control VentilationVolume Guarantee (PCV-VG), and VCV cardiac bypass. These advanced features allow for the ventilation of a broad patient range. This anesthesia system uses the Advanced Breathing System (ABS). This integrated breathing system is easy to remove and disassemble and is fully autoclavable. Its fully integrated design enhances the system’s elegance while minimizing tube connections, minimizing circuit volume, and increasing the work surface area. This anesthesia system is designed for expansion and upgrades, so it is easy to add new technologies and ventilation capabilities without investing in a new system. This anesthesia system is not suitable for use in an MRI environment. This system must only be operated by authorized medical personnel well trained in the use of this product. It must be operated according to the instructions in this User’s Reference manual.

1-2

WARNING

Explosion Hazard. Do not use this system with flammable anesthetic agents.

Note

Configurations available for this product depend on local market and standards requirements. Illustrations in this manual may not represent all configurations of the product. This manual does not cover the operation of every accessory. Refer to the accessory documentation for further information.

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AB.75.100

1 Introduction

Figure 1-1 • Front view

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Aisys

Symbols used in the manual or on the equipment Symbols replace words on the equipment, on the display, or in Datex-Ohmeda manuals. Warnings and Cautions tell you about dangerous conditions that can occur if you do not follow all instructions in this manual. Warnings tell about a condition that can cause injury to the operator or the patient. Cautions tell about a condition that can cause damage to the equipment. Read and follow all warnings and cautions.

On (power)

Standby

1-4

Off (power)

O2 +

O2 Flush button

Type BF equipment

Type B equipment

Airway module indicator

ACGO active

Dangerous voltage

Frame or chassis ground

Protective earth ground

Earth ground

Direct current

Alternating current

Caution/Warning

Attention, refer to product instructions

Refer to product instructions

Pinch hazard

Electrical input

Electrical output

Electrical input/output

Sample gas inlet to scavenging

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1 Introduction Pneumatic inlet

SN

+

134°C

Serial number

REF

Stock number

Equipotential

Lamp, lighting, illumination

Variability

Variability in steps

Suction bottle outlet

Vacuum inlet

Maximum

Vacuum

Exhaust

Bellows volumes are approximate

Plus, positive polarity

-

Minus, negative polarity

Bag position/manual ventilation

Mechanical ventilation

Inspiratory flow

Expiratory flow

Movement in one direction

Movement in two directions

Lock

Unlock

Isolation transformer

Low pressure leak test

Autoclavable

Not autoclavable

This way up

APL settings are approximate

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Pneumatic outlet

O2%

O2 cell connection

Anesthetic Gas Scavenging System

1-5

Aisys

1-6

O2% indicator on left and balance gas indictor on right. Colors associated with gas settings.

Gas indicator. Color associated with gas settings.

Alarm silence

Submenu

No battery/battery failure

Battery in use. Bar indicates amount of battery power remaining.

Read to center of float

EZchange canister (CO2 bypass)

Open drain (remove liquid)

Close drain

Pipeline

Cylinder

Systems with this mark agree with the European Council Directive (93/42/ EEC) for Medical Devices when they are used as specified in their User’s Reference manuals. The xxxx is the certification number of the Notified Body used by Datex-Ohmeda’s Quality Systems.

Authorized representative in the European Community

Date of manufacture

Manufacturer

Indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of equipment.

GOST R Russian certification

This product consists of devices that may contain mercury, which must be recycled or disposed of in accordance with local, state, or country laws. (Within this system, the backlight lamps in the monitor display contain mercury.

Caution: federal law prohibits dispensing without prescription.

Enhanced temperature sensing

Agent level unknown

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1 Introduction Agent level sensing supported. Bar indicates amount of agent remaining.

Typeface conventions used Names of hard keys on the display and modules are written in bold typeface; for example, Normal Screen. Menu items are written in bold italic typeface; for example, Vent Setup. Messages that are displayed on the screen are enclosed in single quotes; for example, ‘Check sample gas out.’ When referring to different sections and other documents, the names are written in italic typeface and enclosed in double quotes; for example, “System Controls and Menus.”

Abbreviations Abbreviation

Definition

A AA

Anesthetic agent

ABS

Advanced breathing system

ACGO

Auxiliary Common Gas Outlet

AGSS

Anesthesia Gas Scavenging System

Alt O2

Alternate O2

APL

Adjustable pressure-limiting

APN

Apnea

C CGO

Common Gas Outlet

CO2

Carbon dioxide

Compl

Compliance

E ET

End-tidal concentration

EtCO2

End-tidal carbon dioxide

EtO2

End-tidal oxygen

Exp

Expiratory

F

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FI

Fraction of inspired gas

FiCO2

Fraction of inspired carbon dioxide

1-7

Aisys Abbreviation

Definition

FI-ET

Difference between inspiratory and expiratory concentrations

FiO2

Fraction of inspired oxygen

F-V

Flow-volume loop

I I:E

Inspiratory-expiratory ratio

Insp

Inspiratory

Insp Pause

Inspriatory pause time

M MAC

Minimum Alveolar Concentration

MV

Minute volume

MVexp

Expired minute volume

MVinsp

Inspired minute volume

N N2O

Nitrous oxide

O O2

Oxygen

P Pair

1-8

Air supply pressure

Paux

Auxiliary pressure

Paw

Airway pressure

PCV

Pressure controlled ventilation

PCV-VG

Pressure controlled ventilation - volume guaranteed

PEEP

Positive end expiratory pressure

PEEPe

Extrinsic positive end expiratory pressure

Pexp

Expiratory pressure

P-F

Pressure-flow loop

Pinsp

Inspiratory pressure

Plimit

High pressure limit

Pmax

Maximum pressure

Pmean

Mean pressure

PO2

Oxygen supply pressure

Ppeak

Peak pressure

Pplat

Plateau pressure

Psupp

Support pressure

PSV

Pressure supported ventilation

PSVPro

Pressure supported ventilation with apnea backup

P-V

Pressure-volume loop

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1 Introduction Abbreviation

Definition

R Rate

Respiratory rate

Raw

Airway resistance

RR

Respiratory rate

S SIMV/PSV

Synchronized intermittent mandatory ventilation with pressure supported ventilation

SIMV-PC

Synchronized intermittent mandatory ventilation pressure controlled

T TV

Tidal volume

TVexp

Expired tidal volume

TVinsp

Inspired tidal volume

V

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VCO2

Carbon dioxide production

VCV

Volume controlled ventilation

Vol

Volume

1-9

2 System Controls and Menus

WARNING

Do not use antistatic or electrically-conductive breathing tubes or masks. They can cause burns if used near highfrequency surgical equipment.

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Explosion Hazard. Do not use this system with flammable anesthetic agents.

In this section

System overview... 2-2 Advanced breathing system (ABS) components... 2-5 Display controls... 2-12 Anesthesia system display... 2-13 Using menus... 2-16

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