Aisys CS² Users Reference Manual Sw Rev 12

User responsibility Datex-Ohmeda, Inc. a General Electric Company, doing business as GE Healthcare. 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 instruction 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 DatexOhmeda 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 the local laws for any restriction that may apply.

Table of Contents 1 Introduction Intended use... 1-2 Indications for use... 1-2 General information... 1-2 Serial numbers...1-4 Trademarks... 1-6 Symbols used in the manual or on the equipment... 1-7 Symbols used on the equipment...1-7 Symbols used on the user interface... 1-10 Abbreviations... 1-12 System information... 1-15 System classification... 1-15 Device standards IEC 60601-1:2005 (+A1:2012)...1-15 Device standards IEC 60601-1:1988... 1-15 Integral system components... 1-16 Not integral system components...1-16 System accessories...1-16 System safety... 1-17 Preparing for use... 1-17 Inspecting the system... 1-18 Electrical safety... 1-19

2 System controls and menus System overview... 2-2 Using the brake... 2-4 Using the O2 flush button... 2-4 Positioning the display...2-4 Advanced breathing system components... 2-6 Using the bag support arm... 2-7 Aladin cassette controls... 2-8

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Aisys CS² Display controls... 2-9 Touch points...2-10 Measured value touch points... 2-10 Active alarm touch points... 2-11 Anesthesia system display... 2-12 Digit fields... 2-13 Waveform fields... 2-13 Split screen field... 2-13 Display navigation... 2-15 Using menus... 2-15 Using the ComWheel... 2-16 Using quick keys... 2-16

3 Operation System operation safety... 3-3 Turning on the system... 3-5 Start a case... 3-6 Minimum Alveolar Concentration... 3-6 Start anesthesia...3-7 Patient/Case ID... 3-8 Start monitoring only... 3-9 End a case...3-10 Turning off the system... 3-11 Ventilator setup... 3-12 Changing ventilator mode... 3-12 Changing ventilator setting... 3-12 Optional ventilator procedures... 3-12 Auto limits... 3-13 Setting auto limits... 3-13 Gas setup... 3-14 Changing gas settings...3-14 Changing balance gas...3-14 Changing circuit type...3-14

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Table of Contents System setup... 3-17 Patient demographics... 3-17 Screen setup menu... 3-18 Fresh gas usage... 3-21 System status... 3-21 Alarm setup... 3-23 Setting CO2 alarms... 3-23 Setting volume apnea alarm... 3-23 Setting MV/TV alarms... 3-24 Setting alarm limits... 3-24 Viewing alarm history... 3-25 Setting alarm volume...3-25 Setting apnea delay...3-25 Silencing leak audio alarms... 3-26 Setting auto MV limits... 3-26 Setting to default limits... 3-27 Alarms On/Off... 3-28 Disable alarm limits... 3-28 Next page... 3-29 Trends... 3-30 Setting trends... 3-30 Spirometry... 3-31 Setting loop type... 3-31 Setting loop graph scaling... 3-32 Setting patient and sensor type...3-32 Setting the data source... 3-32 Setting spirometry volume type...3-33 Saving, viewing, and deleting spirometry loops... 3-33 Procedures... 3-34 Pause gas flow... 3-34 Cardiac bypass... 3-34 Vital capacity... 3-35 Cycling... 3-36 Monitoring only... 3-37

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Aisys CS² Timer function... 3-39 Using the timer... 3-39 ecoFLOW...3-40 Using ecoFLOW... 3-41 Alternate O2 control...3-42 Using Alternate O2 control... 3-42 EZchange canister mode... 3-44 Using EZchange canister mode... 3-45 Condenser... 3-46 Draining the condenser... 3-46 Auxiliary Common Gas Outlet...3-48 Using the ACGO... 3-49

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 Full test... 5-6 Vent and gas... 5-6 Circuit leak... 5-6 Circuit O2 cell... 5-7 External gas monitor... 5-7 Individual tests... 5-8 Vent and gas... 5-8 Circuit leak... 5-8 Circuit O2 cell... 5-8 Low P leak... 5-8 Low P leak (machines with ACGO)...5-9

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Table of Contents Agent delivery... 5-9 Positive low pressure leak test (ACGO systems only)... 5-10

6 Airway modules Airway modules... 6-2 CARESCAPE airway modules... 6-3 Connecting the airway module... 6-4 Data source... 6-5 Automatic agent identification... 6-6 Calibrating the airway module...6-7

7 Alarms and troubleshooting Alarms... 7-2 Alarm priorities...7-2 Pausing alarms... 7-2 Cancelling audio pause... 7-3 Display changes during alarms... 7-3 De-escalating alarms...7-3 Battery indicator...7-3 Internal failure... 7-4 Informational tones... 7-4 List of alarms... 7-5 Sustained pressure threshold... 7-12 Alarm ranges... 7-14 Alarm tests...7-16 Breathing system problems...7-18 Electrical problems... 7-19 Pneumatic problems... 7-20

8 Setup and connections Setup safety...8-2 Moving and transporting the system... 8-4

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Aisys CS² Setting up the absorber canister... 8-5 When to change the absorbent... 8-6 Removing a canister... 8-7 Removing an EZchange canister... 8-7 Filling the Reusable Multi Absorber canister... 8-8 Electrical connections... 8-10 Mains inlet... 8-10 Equipotential stud... 8-10 Outlets... 8-10 Serial port...8-11 Pneumatic connections... 8-12 Pipeline inlets... 8-12 Scavenging... 8-12 Sample gas return port... 8-14 Pneumatic power outlet...8-15 Vacuum suction regulator (optional)... 8-15 Venturi suction regulator (optional)... 8-16 Auxiliary O2 flowmeter (optional)... 8-16 Installing gas cylinders... 8-18 Installing cylinders with pin indexed yokes... 8-18 Installing cylinders with DIN connections... 8-18 Performing a high-pressure leak test... 8-18 Attaching equipment to the top of the machine... 8-20 Passive AGSS... 8-21 Connecting passive AGSS... 8-21 Active AGSS... 8-22 Connecting active AGSS with a flow indicator... 8-22 Connecting active adjustable AGSS... 8-23

9 User maintenance Maintenance safety... 9-2 Repair policy... 9-3 Maintenance summary and schedule... 9-4

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Table of Contents Authorized service personnel... 9-5 Circuit O2 cell replacement... 9-6 Calibration menu... 9-7 Flow and pressure calibration... 9-7 Circuit O2 cell... 9-7 Airway gas calibration... 9-8 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... 10-10 Condenser... 10-11 Test tools and system parts...10-12

11 Specifications and theory of operation System pnuematic circuit...11-2 Gas supplies... 11-4 O2 flow... 11-4 Air and N2O... 11-4 Mixed gas...11-5 EZchange canister...11-5 Condenser... 11-5 Pneumatic specifications... 11-6 Gas supplies... 11-6 ACGO port relief... 11-6 Non-circle circuit relief... 11-6 Pneumatic power outlet... 11-6

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Aisys CS² Electrical block diagram...11-8 Electrical power... 11-10 Power cord...11-10 Battery information...11-10 Flow specifications...11-12 Breathing system specifications... 11-13 Gas scavenging... 11-15 Physical specifications...11-16 Lower dovetail loading...11-16 Upper dovetail loading...11-17 Environmental requirements... 11-18 Airway gas module specifications... 11-19 Gas specifications for CARESCAPE modules... 11-19 Typical performance... 11-20 Suction regulators (optional)... 11-21 Ventilator theory...11-22 O2 monitoring theory of operation...11-22 ecoFLOW theory of operation... 11-23 Ventilation modes... 11-23 Ventilation modes factory default settings...11-34 Ventilation mode transition... 11-35 Ventilator operating specifications...11-36 Pneumatics... 11-36 Fresh gas compensation... 11-36 Pressure...11-36 Volume... 11-36 Oxygen...11-37 Ventilator accuracy data... 11-38 Electronically controlled vaporizer and cassette... 11-39 Aladin2 cassettes...11-43 Electromagnetic compatibility (EMC)... 11-44 Essential performance...11-44 Cables... 11-44

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Table of Contents Guidance and manufacturer's declaration electromagnetic emissions... 11-45 Guidance and manufacturer's declaration electromagnetic immunity... 11-46

12 Super user mode Super user mode... 12-2 Gas usage... 12-3 Resetting cumulative gas usage... 12-3 Setting ecoFLOW... 12-3 Setting agent costs... 12-3 System configuration... 12-5 Setting colors and units... 12-5 Time zone... 12-5 Ventilator settings... 12-6 Alarm settings... 12-6 Parameter settings... 12-7 Trends setup... 12-9 Page setup...12-9 Case defaults... 12-11 Configuring case defaults... 12-11 Setting case name... 12-11 Setting volume apnea defaults... 12-11 Default case type settings... 12-12 Gas controls...12-16 Setting gas preset values... 12-16 Setting fresh gas controls... 12-16 Procedures setup... 12-17 Setting vital capacity defaults... 12-17 Setting cycling controls and settings...12-17 Network configuration... 12-18 Port 1... 12-19 Port 2... 12-20 Clock Sync... 12-21

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Aisys CS² Log Transfer... 12-21 Connectivity Test... 12-22 Network connection troubleshooting...12-22 Super User password... 12-24

13 Vaporizer cassettes Vaporizer... 13-2 Aladin2 cassette variants... 13-2 Changing a cassette during a case...13-5 Removing a cassette... 13-6 Installing a cassette... 13-7 Cassette maintenance...13-8 Cleaning...13-8 Draining cassettes... 13-8 Draining halothane cassettes... 13-9 Filling Aladin2 cassettes... 13-10 Filling with Easy-Fil system or SAFE-T-SEAL adapter system... 13-10 Filling with Quik-Fil, SAFE-T-SEAL, or Piramal Fill system... 13-12 Filling with SAFE-FIL bottle...13-13

Index

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1 Introduction

Introduction

In this section

Intended use... 1-2 Trademarks... 1-6 Symbols used in the manual or on the equipment...1-7 Abbreviations... 1-12 System information... 1-15 System safety... 1-17

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Aisys CS²

Intended use The Aisys CS2 is scalable, flexible, and functionally integrated, featuring the most advanced design, ventilation, respiratory monitoring, and breathing system. 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), Continuous 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 a broad patient range.

Indications for use The Aisys CS2 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonate, pediatric, and adult). The device is intended for volume or pressure control ventilation.

General information This anesthesia system uses the Advanced Breathing System (ABS). This integrated breathing system is easy to remove and disassemble and is autoclavable. Its fully integrated design

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1 Introduction 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. The anesthesia system is suitable for use in a professional healthcare facility environment. The system must only be operated by personnel trained and qualified in the administration of general anesthesia. The User’s Reference manual is intended to provide training on the operation of the system. Operate the system from the front with a clear view of the display. It must be operated according to the instructions in this User’s Reference manual. Make sure that all user documents are obtained from the manufacturer.

WARNING Note

MR unsafe. This system is not suitable for use in a magnetic resonance imaging (MRI) environment. This system is not suitable for use near active high-frequency surgical equipment where the electromagnetic disturbance is high. Keep high-frequency surgical equipment more than 1 m away from this system. Refer to the Technical Reference manual for service information including: special installation instructions, installation checklist, means of isolating the supply mains, and replacement of fuses, supply cord, and other parts.

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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, and not all accessories and options are included with every system. Some accessories may not be available in all markets. Refer to the accessory documentation for further information.

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AB.75.253

Aisys CS²

Figure 1-1 • Front view

Serial numbers 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.

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AAAX11111

AAAXX111111AA

The X represents an alpha character The XX represents a number indicating the year the product was indicating the year the product was manufactured; H = 2004, J = 2005, manufactured; 04 = 2004, 05 = 2005, etc. I and O are not used. etc.

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Aisys CS²

Trademarks Aisys, Carestation, CARESCAPE, D-fend, D-lite, PSVPro, SmartVent, Easy-Fil, Aladin These terms are trademarks of General Electric Company and its subsidiaries. All other brand names or product names used in this manual are trademarks or registered trademarks of their respective holders.

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1 Introduction

Symbols used in the manual or on the equipment Symbols replace words on the equipment, on the display, or in product 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.

Symbols used on the equipment .

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O2 Flush button

O2 cell connection

Air

Air

APL settings are approximate

Anesthetic Gas Scavenging System

Maximum

Vacuum

Serial number

Stock number

Exhaust

Bellows volumes are approximate

Plus, positive polarity

Minus, negative polarity

Maximum mass of configured mobile equipment

Caution: federal law prohibits dispensing without prescription.

Autoclavable

Variability, rotational adjustment

On (power)

Off (power)

Standby

Non-ionizing electromagnetic radiation

Type BF equipment

Type B equipment

Dangerous voltage

Frame or chassis ground

Protective earth ground

Earth ground

Direct current

Alternating current

Caution

Refer to instruction manual or booklet (blue background)

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Operating instructions

General warning (yellow background)

Electrical input/output

Sample gas inlet to scavenging

Pneumatic inlet

Pneumatic outlet

Equipotential

Lamp, lighting, illumination

Variability

Variability in steps

Suction bottle outlet

Vacuum inlet

Bag position/manual ventilation

Mechanical ventilation

Inspiratory flow

Expiratory flow

Movement in one direction

Movement in two directions

Lock

Unlock

Open drain (remove liquid)

Low pressure leak test

This way up

Not autoclavable

Read to center of float

EZchange canister (CO2 bypass)

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

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