Aestiva 5 MRI Operation Manual Part 1 Rev 4.X March 2003

User Responsibility This Product will perform in conformity with the description thereof contained in this Operation 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.

w 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. AAA F 12345

This alpha character indicates the year of product manufacture and when the serial number was assigned; “D” = 2000, “E” = 2001, “F” = 2002, etc. “I” and “O” are not used.

Aestiva, S/5, PSVPro, Tec 5, Tec 6 and Tec 7 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

Important MRI Compatibility Information... i i

1/Introduction How to use this manual...1-2 What is an Aestiva/5 MRI?...1-2 MRI compatibility...1-2 Gauss alarm...1-3 Ventilators and monitors...1-3 Symbols used in the manual or on the equipment...1-5

2/System Controls and Menus Anesthesia system controls...2-2 Breathing system controls...2-5 Vaporizer controls...2-8 Ventilator controls... 2-10 Optional features... 2-10 Control panel... 2-10 How to set controls... 2-13 How to use the menu... 2-14 Menu map... 2-15 More about menu functions... 2-16 How to change menu settings (example)... 2-17 Gauss alarm... 2-18 Optional CO2 bypass mode... 2-19

3/Operation and Tutorial Turn On the system...3-2 Set the alarm loudness...3-3 Show or hide alarm limits and units...3-5 Adjust patient data for Heliox...3-7 Turn the Volume Alarms on or off...3-8 Set alarm limits...3-9

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Aestiva/5 MRI

Set an audible alarm for circuit leaks... 3-11 Set Cardiac Bypass... 3-12 Start mechanical ventilation... 3-14 Stop mechanical ventilation... 3-15 Set the ventilation mode... 3-16 Set ventilator controls... 3-18 Optional features... 3-18 Ventilator controls... 3-19 Volume Control mode... 3-20 Pressure Control mode... 3-20 SIMV mode... 3-20 PSVPro mode... 3-21 Set inspiratory pause (volume modes)... 3-22 Set SIMV and PSVPro controls... 3-24 Silence alarms... 3-26 Use the pressure waveform (Paw)... 3-27 Scales... 3-27 Measure circuit compliance... 3-30 Show the service settings... 3-31

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4/Preoperative Checklist Every day before the first patient... 4-2 Every time a different clinician uses the system... 4-3 Before every patient... 4-3

Appendix – Preoperative Tests Test Intervals... A-2 Outside the MRI room... A-3 MRI compatibility check... A-3 Low-pressure leak test... A-4 Negative low-pressure leak test... A-4 Inside the MRI room... A-8 Inspect the system... A-8 Minimize alarms (optional)... A-10

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Checking vaporizer installation...A-10 Pipeline and cylinder tests...A-11 Flow control tests...A-13 Vaporizer back pressure test...A-14 Power failure test...A-15 Ventilator alarm tests...A-16 Breathing system tests...A-17 Monitor and ventilator tests...A-20 Gauss alarm tests...A-22

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Index Warranty

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Important

Important MRI Compatibility Information Any electronic medical device intended for use in the MRI suite requires special design considerations to ensure MRI compatibility. Care was taken during the design of the Aestiva/5 MRI to help ensure that the performance specifications were the same as the existing Aestiva/5 Anesthesia System. However, while the performance specifications have not changed, you as users must take special precautions when using the Aestiva/5 MRI in the MRI Suite. This section of the Aestiva/5 MRI Operation and Maintenance Manual is designed to provide you with the additional precautions you must take when using this device in the MRI suite.

Important

The Aestiva/5 MRI is MRI Compatible. The machine was tested in an active shielded 1.5 Tesla MRI unit with a magnetic fringe field equal to or less than 300 gauss. The machine was tested in an active shielded 3.0 Tesla MRI unit with a magnetic fringe field equal to or less than 300 gauss. The Aestiva/5 MRI will function to specifications in an MRI environment that does not exceed 300 gauss. Do not store or operate the Aestiva/5 MRI within the 300 gauss line for your unit.

w WARNING

Use only MRI compatible cylinders Do not set up or service this machine in the MRI room. Do not add or remove accessories or components in the MRI room. Do not use or mount monitors or other accessories that are not MRI compatible at the 300 gauss line. Check with the manufacturer of the monitor or accessory equipment for MRI compatibility information. Do not store any items in the drawer that are not MRI compatible. The Aestiva/5 MRI does contain some ferromagnetic material and will be attracted to the MR Imager if positioned closer than 300 gauss. Always keep the Aestiva/5 MRI in magnetic fringe field of 300 gauss or less. Set the brake during use or storage in MRI room.

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1 Introduction

w WARNING

In this section

1-1

Using an MRI system in conjunction with general anesthesia on cardiac patients, febrile patients, and patients with impaired ability to perspire may present a patient health hazard.

How to use this manual... 1-2 What is an Aestiva™/5 MRI?... 1-2 Symbols used in the manual or on the equipment... 1-5

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How to use this manual The Aestiva/5 MRI comes with several user manuals. This manual describes the controls and how to use them.

1-2

Section 1 shows the different models and supplies information about the symbols used on the equipment. Section 2 shows control locations. Section 3 tells you how to use the controls. Section 4 is a two-page, preoperative checklist. The appendix provides complete instructions for the preoperative tests shown on the check list. The Aestiva/5 MRI can be equipped with several optional ventilation functions. References made in this manual to Heliox mode, and SIMV and PSVPro modes, are only applicable to systems equipped with these functions. Use this manual together with part 2, which includes setup, troubleshooting, calibration, or maintenance procedures.

What is an Aestiva/5 MRI? The Aestiva/5 MRI is a flexible, accessible, and intuitive anesthesia delivery system. It provides the functional features of the Aestiva with the added ability of use in an MRI environment. The standard Aestiva features are the Datex-Ohmeda user interface, ventilation parameters of the SmartVent, and the Aestiva breathing circuit. Safety features and devices within the Aestiva/5 MRI decrease the risk of hypoxic mixtures, agent mixing, complete power failure, and sudden gas supply failures. Options include extra gas cylinders and extra vaporizers.

MRI compatibility

1-2

Model

2 Vap.Trolley

Number of vaporizers

2

Number of gases

2 or 3

Optional gases (Heliox and CO2 are cylinder only)

Air or Heliox; CO2

Total number of cylinders (maximum 2 per gas)

Up to 4

The Aestiva/5 MRI is constructed primarily of non-ferrous materials to help prevent attraction to the cryogenic magnets in MRI systems. The Aestiva/5 MRI will function to specifications in an MRI environment that does not exceed 300 gauss. Do not store or operate the Aestiva/5 MRI within the 300 gauss line for your unit.

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1 Introduction

The Aestiva/5 MRI is MRI compatible. The machine was tested in an active shielded 1.5 Tesla MRI unit with a magnetic fringe field equal to or less than 300 gauss. The machine was tested in an active shielded 3.0 Tesla MRI unit with a magnetic fringe field equal to or less than 300 gauss. An integral gauss alarm warns the operator when the machine is located in an MRI magnetic fringe field in excess of 300 gauss.

w WARNING

Important

Store only MRI compatible items in the drawer. Storage of non-MRI compatible items in the drawer may result in injury to the patient or user. Set brake during use or storage in MRI room.

Gauss alarm

The system includes an integral gauss alarm that monitors the strength of the magnetic fringe field in which the machine is located. The alarm warns the operator if the machine is moved into a magnetic fringe field that is greater than 300 gauss.

Ventilators and monitors

The system uses a microprocessor-controlled ventilator with: internal monitors, electronic PEEP, multiple modes of ventilation, and a pressure waveform display. Built-in connectors and communication software permit optional cardiovascular and respiratory gas monitoring.

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1-3

Aestiva/5 MRI

AA.96.254

1-4

Figure 1-1 • Aestiva/5 MRI system

1-4

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Symbols used in the manual or on the equipment wWarnings and wCautions tell you about dangerous conditions that can occur if you do not follow all instructions in this manual.

1-5

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. Other symbols replace words on the equipment or in Datex-Ohmeda manuals. No one device or manual uses all of the symbols. These symbols include:

On (power) Off (power) Standby Standby or preparatory state for part of the equipment

Not autoclavable Type B equipment Type BF equipment Type CF equipment

Electrical input

Electrical output

Pneumatic inlet

Pneumatic outlet

p œ †

“OFF” only for part of the equipment

∏

Alternating current

x y

Protective earth ground

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“ON” only for part of the equipment

Direct current

w wW

Caution, ISO 7000-0434

N N

l O o q

This way up

π REF

Attention, refer to product instructions, IEC 601-1

Dangerous Voltage

Stock Number

Earth ground

1-5

Aestiva/5 MRI

1-6

r å

Frame or chassis ground

SN

Alarm silence button XXXX

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

Y

Equipotential

Read top of float

t

Variability

Vacuum inlet

T

Variability in steps

Suction bottle outlet

+ -

Plus, positive polarity Minus, negative polarity

Cylinder

P

Lamp, lighting, illumination

Isolation transformer

N

Movement in one direction

Linkage system

ˆ

Movement in two directions

Risk of Explosion

z

Lock

134°C C

Autoclavable

1-6

O2 +

Z

O2 Flush button

Unlock Low pressure leak test

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R u q t

< 345 kPa

Bag position/ manual ventilation Open drain (remove liquid) Inspiratory flow

r U Q

Mechanical ventilation Close drain 1-7

Expiratory flow

O2 sensor connection

End case

The primary regulator is set to pressure less than 345 kPa

The primary regulator is set to pressure less than 414 kPa

< 414 kPa

Absorber on European Union Representative

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Aestiva/5 MRI

1-8

1-8

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In this section

Anesthesia system controls... 2-2 Breathing system controls... 2-5 Vaporizer controls... 2-8 Ventilator controls...2-10 Gauss alarm...2-18 Optional CO2 bypass mode...2-19

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Aestiva/5 MRI

Anesthesia system controls w WARNING

Explosion Hazard. Do not use Aestiva/5 MRI systems with flammable anesthetic agents.

w WARNING

Do not use antistatic breathing tubes or masks. They can cause burns if you use them near high frequency surgical equipment.

2-2

AA.96.253

3

12

4

2

5

8 7

6

9 1 11

10 1. Breathing system (Figure 2-3) 2. Flow controls 3. Ventilator/monitoring display (Figure 2-5) 4. Dovetail rails 5. Vaporizers (Figure 2-4) 6. Gauge (cylinder pressure) 7. Gauge (pipeline pressure) 8. System switch 9. Flush button 10. Brake 11. Handle 12. Gauss alarm Figure 2-1 • Aestiva/5 MRI (front view) 2-2

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Figure 2-1 shows these controls on the front of the Aestiva/5 MRI. Description

System switch

Set the switch to on to permit gas flow and to turn on the monitoring. On

Flow controls

Standby

AA.96.103

Item

Turn the control counterclockwise to increase the flow and clockwise to decrease. The system switch must be on. Decrease AA.96.105

Increase

Push O2 Flush to supply high flows of O2 to the breathing system.

Brake

Push down to lock. Lift to release.

AA.96.100

AA.96.106

O2 flush

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Aestiva/5 MRI

The circuit breaker is on the rear panel of the Aestiva/5 MRI. Description (Figure 2-2)

Circuit Breaker

System circuit breaker Open (No Power)

2-4

AA.96.108

Item

Closed (Power)

1

2

3

AA.96.261

4

1. 2. 3. 4.

Circuit Breaker for Mains Inlet Mains Inlet Pneumatic Outlet Pipeline Connection

Figure 2-2 • Aestiva/5 MRI rear view

2-4

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Breathing system controls 9

8 10 2-5 7 11

6

5a 12 4 5b

3

2

AB.23.003

13

1

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13.

Canister release Auxiliary common gas outlet (optional) Outlet switch (Auxiliary Common Gas Outlet) Door Flow sensor /patient connection (circuit connections) a. Inspiratory (Open or circle circuit module) or to-fro connection (Mapleson/Bain circuit module) b. Expiratory (Open or circle circuit module) or fresh gas connection (Mapleson/Bain circuit module) Breathing circuit module (Circle) Bag arm Bag/vent switch APL valve Bellows Pressure gauge Check valves O2 sensor Figure 2-3 • Breathing system parts

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