Aisys Users Reference Manual Part 1 of 2 Sw Rev 4.X

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. AAA X 11111

AAA XX 111111AA

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

Aisys, Carestation, Advanced Breathing System, Aladin, Aladin 2, ComWheel, D-fend, Disposable Multi Absorber, Easy-Fil, Reusable Multi Absorber, PSVPro, and SmartVent 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 What is an Aisys Carestation?... 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 Aladin cassette controls... 2-5 Advanced breathing system (ABS) components... 2-6 Optional ABS components... 2-8 Non-circle circuit... 2-9 ACGO (optional)... 2-9 Scavenging the ACGO sample flow...2-10 Scavenging from an auxiliary manual breathing circuit...2-10 Scavenging a gas monitor sample flow...2-10 Display controls...2-11 Anesthesia system display...2-12 Using menus...2-14

3 Operation Turning on the system... 3-2 Start gas flow (start case)... 3-3 Using quick start... 3-3 Using default settings... 3-3 Presetting ventilator and alarm settings... 3-4 End case... 3-5 Ventilator setup... 3-6 Using quick keys... 3-6 Using Vent Setup menu... 3-6

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Aisys Carestation Changing ventilator modes and settings... 3-7 Manual ventilation cardiac bypass... 3-7 VCV cardiac bypass (optional)... 3-7 Gas setup... 3-8 Using quick keys... 3-8 Using Gas Setup menu... 3-8 Changing gas and settings... 3-8 Changing circuit type... 3-8 Spirometry setup... 3-9 Setting patient and sensor type... 3-9 Selecting a data source...3-10 Setting spirometry split screen...3-10 Setting loop type...3-10 Viewing spirometry loops...3-11 Screen configuration...3-12 Split screen...3-12 Setting gas controls and screen configuration...3-12 Alarm setup...3-13 Setting alarm limits...3-13 Volume apnea...3-13 MV/TV Alarms...3-13 CO2 Alarms...3-14 Auto MV Limit...3-14 Viewing trends...3-14 Alternate O2 control...3-15 EZchange Canister (optional)...3-16 Condenser (optional)...3-17 Passive AGSS (optional)...3-18 Active AGSS (optional)...3-19 Connecting active AGSS with a flow indicator...3-20 Connecting active adjustable AGSS...3-20

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

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Table of Contents

5 Preoperative Tests Inspect the system... 5-2 Circuit compliance compensation... 5-3 Leak < 250 ml... 5-3 No... 5-3 Yes... 5-3 Machine Check... 5-4 Machine Check - System... 5-4 Machine Check - Circuit... 5-5 Machine Check - Circuit O2... 5-5 Machine Check - Monitor... 5-5 Individual Checks... 5-6 System... 5-6 Circuit... 5-6 Circuit O2 Cell... 5-7 Low P Leak... 5-7 Low P Leak (machines with ACGO)... 5-7 Agent Delivery... 5-8 Positive low-pressure leak test (ACGO systems only)... 5-9 Aladin cassette installation...5-10 Flow sensor calibration...5-10

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

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Aisys Carestation

7 Vaporizer Vaporizer... 7-2 Aladin2 cassette variants... 7-2 Aladin cassette variants... 7-4 Installing cassettes... 7-6 Cleaning... 7-6 Service... 7-6 Draining halothane cassettes... 7-6 Filling Aladin2 cassettes... 7-7 Filling with Easy-Fil system... 7-7 Filling with Quik-Fil system... 7-9 Filling with Saf-T-Fil bottle...7-10 Filling Aladin cassettes...7-12 Filling with keyed filler system...7-12 Filling with Quik-Fil system...7-14 Filling with Saf-T-Fil bottle...7-15

8 Alarms and Troubleshooting Alarms... 8-2 Alarm priorities... 8-2 Apnea alarms... 8-2 Display changes during alarms... 8-3 Battery indicator... 8-3 Internal failure... 8-3 List of alarms... 8-4 Alarm ranges and default values...8-10 Alarm tests...8-11 Breathing system problems...8-12 Electrical problems...8-13 Pneumatic problems...8-13

Index Warranty

iv

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1 Introduction

In this section

What is an Aisys Carestation?... 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 Carestation

What is an Aisys Carestation? 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. Aisys Carestation manages the complexity of anesthesia while supporting a broad range of patients from neonates and compromised patients to routine cases. 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. Aisys Carestation uses SmartVent ventilation technology offering Volume Control Ventilation with tidal volume compensation, Pressure Control Ventilation, and electronic PEEP. The proven SmartVent also features optional Pressure Support Ventilation with an Apnea Backup (PSVPro) that is used for spontaneously breathing patients, Synchronized Intermittent Mandatory Ventilation (SIMV), Pressure control ventilation-volume guarantee (PCV-VG), and VCV cardiac bypass. The Advanced Breathing System (ABS) has a small circuit volume, optimized for low and minimal flow applications. The ABS, designed to provide a larger work surface, is elegantly integrated and easy to remove and clean. The Aisys Carestation is designed for expansion and upgrades, so it is easy to add new technologies and ventilation capabilities without investing in a new system. The Aisys Carestation is not suitable for use in a MRI environment. Note

1-2

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 • Aisys Carestation

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Aisys Carestation

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

SN

1-4

Off (power)

O2+

O2 Flush button

Type BF equipment

Type B equipment

Dangerous voltage

Alternating current

Caution, ISO 7000-0434

Attention, refer to product instructions, IEC 60601-1

Electrical input

Electrical output

Pneumatic inlet

Pneumatic outlet

Serial number

REF

Stock number

Equipotential

Lamp, lighting, illumination

Variability

Variability in steps

Suction bottle outlet

Vacuum inlet

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1 Introduction Maximum

+

134°C

Plus, positive polarity

VACUUM

-

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

O2%

No battery/battery failure

APL settings are approximate

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Vacuum

O2 cell connection

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

AGSS

Anesthetic Gas Scavenging System

Alarm silence

Submenu

Caution: federal law prohibits dispensing without prescription.

Pinch hazard

Pipeline

Cylinder

Read to center of float

EZchange Canister (CO2 bypass)

1-5

Aisys Carestation 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

Manufacturer

Date of manufacture

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

Bellows volumes are approximate

Exhaust

Electrical input/output

Sample gas inlet to scavenging

Refer to product instructions, ISO 15223

RS-232 connection

Enhanced temperature sensing

Agent level unknown

Open drain (remove liquid)

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1 Introduction

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

C Compl

Compliance

E ET

End-tidal concentration

EtCO2

End-tidal carbon dioxide

EtO2

End-tidal oxygen

F F-V

Flow-Volume loop

FI

Fraction of inspired gas

FI-ET

Difference between inspiratory and expiratory concentrations

FiO2

Fraction of inspired oxygen

I I:E

Inspiratory-expiratory ratio

Insp Pause

Inspiratory pause time

M MV

Minute volume

MVexp

Expired minute volume

MVinsp

Inspired minute volume

O O2

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Oxygen

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Aisys Carestation

Abbreviation

Definition

P P-F

Pressure-Flow loop

P-V

Pressure-Volume loop

Pair

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

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

PSVPro

Pressure supported ventilation with apnea backup

R Rate

Respiratory rate

Raw

Airway resistance

RR

Respiratory rate

S

1-8

SIMV-PC

Synchronized intermittent mandatory ventilation-pressure controlled

SIMV-VC

Synchronized intermittent mandatory ventilation-volume controlled

SIMV/PSV

Synchronized intermittent mandatory ventilation/pressure supported ventilation

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1 Introduction

Abbreviation

Definition

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

Aisys Carestation

1-10

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2 System Controls and Menus

In this section

System overview... 2-2 Advanced breathing system (ABS) components... 2-6 Display controls...2-11 Anesthesia system display...2-12 Using menus...2-14

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Aisys Carestation

System overview WARNING

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

16

15 1

14

2

13 12

3 4

11

5 6

10

9

AB.75.097

8

7

1. Airway module (optional) 2. Datex-Ohmeda patient monitoring modules (optional) 3. Dovetail/GCX rails 4. Light switch 5. Alternate O2 control* 6. Mains indicator* 7. Brake* 8. Aladin cassette storage bay

9. O2 flush button* 10. System switch* 11. Integrated suction (optional)* 12. Advanced breathing system 13. Auxiliary O2 flow control (optional)* 14. Aladin cassette and active bay 15. Anesthesia display 16. Datex-Ohmeda patient monitoring display (optional)

Figure 2-1 • Front view *These items are described in further detail in the following table.

2-2

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2 System Controls and Menus

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Item, Figure 2-1 5 Alternate O2 control

Description Alternate O2 control activates automatically in the case of certain failures or errors. It can also be activated manually by pushing the Alternate O2 control button if the display fails. Turn the knob counterclockwise to increase the flow. Turn the knob clockwise to decrease the flow. See “Alternate O2 Control” in the Operation section of this manual.

6 7

Mains indicator Brake

The mains indicator will come on when AC power is connected. Push down to lock. Lift to release.

9

O2 flush button

Push the O2 flush button to supply high flows of O2 to the breathing system.

10

System switch

Set the switch to the On (|) position to permit gas flow and to turn on the system.

11

Integrated suction

Turn the switch to Max for full vacuum. Turn the switch to Off for no vacuum. Turn the switch to On for adjustable vacuum. When in adjustable vacuum, turn the knob clockwise to increase the vacuum and counterclockwise to decrease the vacuum.

13

Auxiliary O2 flow control Turn the knob counterclockwise to increase the flow. Turn the knob clockwise to decrease the flow.

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Aisys Carestation

1

2 3 4 5 6

7 8

9 1. Serial port 2. Collection bottle connection 3. Cylinder wrench (key) storage 4. Cylinder yoke 5. AGSS (Anesthesia Gas Scavenging System) 6. Pipeline connections

AB.75.046

11 10

7. Mains inlet 8. System circuit breaker 9. Equipotential stud 10. Outlet circuit breaker 11. Isolated electrical outlet

Figure 2-2 • Rear view

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