Aisys Users Reference Manual Sw Rev 8.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... 1-8 Abbreviations... 1-9 System information... 1-11 System classification... 1-11 Device standards... 1-11 Integral system components... 1-11 Not integral system components... 1-11 System safety... 1-12 Preparing for use... 1-12 Inspecting the system... 1-13 Electrical safety... 1-14

2 System controls and menus System overview... 2-2 Using the brakes... 2-4 Using the O2 flush button... 2-4 Advanced breathing system components... 2-5 Using the bag support arm... 2-6 Aladin cassette controls... 2-7 Display controls... 2-8 Menu Keys... 2-9 Anesthesia system display... 2-10 Waveform fields... 2-11 Digit field... 2-11 Display navigation... 2-12 Using menus... 2-13

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Aisys Using the ComWheel... 2-13 Using quick keys... 2-13 Using Select Page menu... 2-14

3 Operation System operation safety... 3-2 Turning on the system... 3-4 Start a case... 3-5 Minimum Alveolar Concentration... 3-6 Starting a case using default settings... 3-6 Starting a case using custom settings... 3-6 End a case... 3-8 Ventilator setup... 3-9 Changing ventilator settings... 3-9 Changing ventilation mode and ventilator settings... 3-9 Gas setup... 3-11 Changing gas settings... 3-11 Changing balance gas and gas settings... 3-11 Changing circuit type... 3-11 Using the circle circuit... 3-12 Using the non-circle circuit... 3-12 Main Menu... 3-14 Cardiac bypass... 3-14 Fresh gas usage... 3-15 Screen setup... 3-15 Trends... 3-19 Setting trends... 3-19 Alarm setup... 3-20 Setting alarm limits... 3-20 Setting volume apnea alarm... 3-20 Setting MV/TV alarms... 3-21 Silencing leak audio alarms... 3-21 Setting CO2 alarms... 3-21 Setting auto MV limit... 3-22 Setting alarm volume... 3-22

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Table of Contents Setting apnea time... 3-22 Viewing alarm history... 3-22 Spirometry... 3-24 Setting loop type... 3-25 Setting loop graph scaling... 3-25 Spirometry setup... 3-26 Storing, viewing, erasing spirometry loops... 3-27 Procedures... 3-28 Pause gas flow... 3-28 Vital capacity... 3-29 Cycling... 3-30 Alternate O2 control... 3-32 Using Alternate O2 control... 3-33 EZchange canister mode... 3-34 Using EZchange canister mode... 3-34 Condenser... 3-36 Draining the condenser... 3-36 Auxiliary Common Gas Outlet... 3-37 Using the ACGO... 3-37

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

5 Preoperative tests Aladin cassette installation... 5-2 Flow and pressure calibration... 5-3 Circuit compliance compensation... 5-4 Checkout menu... 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

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Aisys 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

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... 6-7

7 Alarms and troubleshooting Alarms... 7-2 Alarm priorities... 7-2 Silencing alarms... 7-2 Display changes during alarms... 7-3 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

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Table of Contents 8 Setup and connections Setup safety... 8-2 Setting up the absorber canister... 8-4 When to change the absorbent... 8-5 Removing a canister... 8-6 Removing an EZchange canister... 8-6 Filling the Reusable Multi Absorber canister... 8-7 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... 8-13 Pneumatic power outlet... 8-13 Vacuum suction regulator (optional)... 8-14 Venturi suction regulator (optional)... 8-14 Auxiliary O2 flowmeter (optional)... 8-15 Installing gas cylinders... 8-16 Installing cylinders with pin indexed yokes... 8-16 Installing cylinders with DIN connections... 8-16 Performing a high-pressure leak test... 8-17 Attaching equipment to the top of the machine... 8-18 Passive AGSS... 8-19 Connecting passive AGSS... 8-19 Active AGSS... 8-20 Connecting active AGSS with a flow indicator... 8-20 Connecting active adjustable AGSS... 8-21

9 User maintenance Maintenance safety... 9-2 Repair policy... 9-3

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Aisys Maintenance summary and schedule... 9-4 Datex-Ohmeda approved service... 9-4 Circuit O2 cell replacement... 9-5 Calibration menu... 9-6 Flow and pressure calibration... 9-6 Circuit O2 cell... 9-6 Airway gas calibration... 9-7 Backlight test... 9-7 How to help prevent water buildup... 9-8

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

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Table of Contents 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 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... 11-27 Ventilation mode transition... 11-28 Ventilator operating specifications... 11-29 Pneumatics... 11-29 Fresh gas compensation... 11-29 Pressure... 11-29 Volume... 11-29 Oxygen... 11-29 Ventilator accuracy data... 11-30 Electronically controlled vaporizer and Aladin cassette . . 11-31 Aladin2 cassettes... 11-32 Aladin cassettes... 11-33 Electromagnetic compatibility (EMC)... 11-34 Guidance and manufacturer’s declaration electromagnetic emissions... 11-34 Guidance and manufacturer’s declaration electromagnetic immunity... 11-35 Recommended separation distances... 11-37

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Aisys 12 Super user mode Super user menu... 12-2 Cumulative gas usage... 12-3 Reset cumulative gas usage... 12-3 Trends setup... 12-4 Setting the default trend type... 12-4 Setting graphical trends pages... 12-4 Display settings... 12-6 Setting colors and units... 12-6 Page setup... 12-7 Ventilator settings... 12-9 Alarm settings... 12-10 Volume apnea setup... 12-10 Parameter settings... 12-12 Setting volume conditions and humidity compensation... 12-12 Defaults... 12-13 Configuring case defaults... 12-13 Lung mechanics... 12-17

13 Vaporizer cassettes Vaporizer... 13-2 Aladin2 cassette variants... 13-2 Aladin cassette variants... 13-4 Using vaporizer cassettes... 13-6 Changing a cassette during a case... 13-6 Removing a cassette... 13-6 Installing a cassette... 13-6 Cassette maintenance... 13-8 Cleaning... 13-8 Draining cassettes... 13-8 Draining halothane cassettes... 13-8 Filling Aladin2 cassettes... 13-9 Filling with Easy-Fil system... 13-10 Filling with Quik-Fil system... 13-11

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Table of Contents Filling with Saf-T-Fil bottle... 13-12 Filling Aladin cassettes... 13-14 Filling with keyed filler system... 13-14 Filling with Quik-Fil system

... 13-15

Filling with Saf-T-Fil bottle... 13-16

Index Warranty

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1 Introduction

In this section

Intended use... 1-2 Symbols used in the manual or on the equipment... 1-4 Typeface conventions used... 1-8 Abbreviations... 1-9 System information... 1-11 System safety... 1-12

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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 is designed for mixing and delivering inhalation anesthetics, Air, O2, and N2O. The anesthesia system’s small breathing system volume allows an anesthetic agent delivery response time of less than 7 seconds. (Agent response time defined as achieving 90% of the setting change measured while in non-circle circuit with a 2 l/min fresh gas flow.) 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), Constant Positive Airway Pressure/ Pressure Support Ventilation (CPAP/PSV), and VCV cardiac bypass. In Volume Control Ventilation, a patient can be ventilated using a minimal tidal volume of 20 ml. In Pressure Control Ventilation, volumes as low as 5 ml can be measured. These advanced features allow for the ventilation of neonates to adult patients. 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.

WARNING

1-2

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

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1 Introduction 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.

AB.75.240

Note

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

Pneumatic inlet

Pneumatic outlet

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1 Introduction

SN

+

134°C

Serial number

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

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REF

O2%

O2 cell connection

APL settings are approximate

Anesthetic Gas Scavenging System

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

Gas indicator. Color associated with gas settings.

1-5

Aisys

1-6

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.

Device contains phthalates

Single use device

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1 Introduction Enhanced temperature sensing

Agent level unknown

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

When moving or transporting anesthesia machine, place the display arm in the transport position as shown.

Maximum mass of configured mobile equipment

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Aisys

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.”

1-8

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1 Introduction

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

CPAP/PSV

Constant Positive Airway Pressure/Pressure Support Ventilation

E ET

End-tidal concentration

EtCO2

End-tidal carbon dioxide

EtO2

End-tidal oxygen

Exp

Expiratory

F FI

Fraction of inspired gas

FiCO2

Fraction of inspired carbon dioxide

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

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Nitrous oxide

1-9