Aestiva 5 MRI Operation Manual Part 2 Rev 4.X March 2003

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.

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 iii

1/Introduction How to use this manual...1-2 Symbols used in the manual or on the equipment...1-3 Maintenance summary and schedule...1-6 Operator maintenance...1-6 Datex-Ohmeda approved service...1-7

2/Cleaning and Sterilization Summary...2-2 Patient path...2-2 Scavenging path...2-3 Clean and sterilize...2-4 To wash (by hand or machine)...2-4 To Autoclave...2-5 Special requirements...2-6 Assemble...2-6 Disassemble the patient path...2-7 Canister disassembly... 2-10 Disassemble the scavenging path... 2-12 How to clean and disinfect the flow sensors... 2-13 CIDEX sterilization... 2-13 Procedure (Figure 2-3)... 2-13 How to clean and sterilize the optional CO2 bypass assembly... 2-15

3/Setup and Connections Warnings...3-1 Breathing system setup...3-3 Canister Setup...3-7 Pneumatic and electrical connections...3-9 How to install gas cylinders (high pressure leak test)... 3-11 Cylinder yokes... 3-11 DIN connections... 3-12 Installation Notes... 3-13

1006-0960-000

iii

Aestiva/5 MRI

4/User maintenance iv

Repair policy... 4-2 Manifold maintenance... 4-3 Expiratory valve maintenance... 4-6 Receiver maintenance (active gas scavenging only)... 4-8 Flow sensor maintenance... 4-9 Breathing circuit maintenance... 4-10 Bellows maintenance... 4-12 Bellows tests... 4-15 O2 sensor calibration - 21% O2... 4-18 O2 sensor calibration - 100% O2... 4-21 Flow sensor calibration... 4-24 How to prevent water build-up... 4-25

5/Troubleshooting About alarms... 5-2 Alphabetical list... 5-4 Breathing system problems (no alarm)... 5-15 Electrical problems (power failure, etc.)... 5-16 Pneumatic problems... 5-18

6/Illustrated Parts Main manifold... 6-2 Breathing system parts... 6-4 Exhalation valve... 6-7 Breathing circuit modules... 6-8 Bellows... 6-9 Test tools and system parts... 6-10

iv

1006-0960-000

Table of Contents

7/Specifications and Theory of Operation v

Ventilator Theory...7-2 Modes...7-3 Breathing system schematic...7-7 Electrical block diagram...7-8 Pneumatic circuits...7-9 Breathing system... 7-12 Breathing system specifications... 7-14 Gas scavenging... 7-15 Pneumatic specifications... 7-16 Flow specifications... 7-17 Electrical power... 7-18 Power cord... 7-18 Battery information... 7-18 Electro-magnetic compatibility... 7-19 Gauss alarm... 7-19 Physical specifications... 7-20 Environmental requirements... 7-20 MRI environment... 7-20 Temperature... 7-20 Humidity... 7-20 Altitude... 7-20 Ventilation Operating Specifications... 7-21 Aestiva/5 MRI Ventilator Accuracy Data... 7-23

Index Warranty

1006-0960-000

v

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.

1006-0960-000

i

Aestiva/5 MRI

ii

1006-0960-000

1-1

1 Introduction

In this section

How to use this manual... 1-2 Symbols used in the manual or on the equipment... 1-3 Maintenance summary and schedule... 1-6

1006-0960-000

1-1

Aestiva/5 MRI

1-2

How to use this manual This is part two of the Aestiva™/5 MRI operation and maintenance manual. It tells you how to: • Remove and clean parts • Set up the system • Identify and replace worn or damaged parts • Calibrate the O2 sensor The second half of this chapter is a maintenance schedule. The last section, troubleshooting, tells you what causes each alarm and what you can do about it. Use this manual together with part 1, which includes the operating instructions and preoperative checkout.

w WARNING

1-2

If an alarm occurs, safeguard the patient first, before troubleshooting or repair procedures.

1006-0960-000

1 Introduction

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. 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

1006-0960-000

Í m µ H

“ON” only for part of the equipment

Direct current

w wW N N

l O o q

π REF

Caution, ISO 7000-0434 Attention, refer to product instructions, IEC 601-1 This way up

Dangerous Voltage

Stock Number

Earth ground

1-3

1-3

Aestiva/5 MRI

1-4

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

1-4

O2 +

Z

O2 Flush button

Unlock Low pressure leak test

1006-0960-000

1 Introduction

R u q t

< 345 kPa

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

r U Q

Mechanical ventilation

1-5

Close drain 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

1006-0960-000

1-5

Aestiva/5 MRI

1-6

Maintenance summary and schedule These schedules show the minimum frequency. You will have to service the equipment more frequently if you use it: • In unusual conditions (dirty gas supplies, high temperature, high humidity, etc.) • More frequently than normal.

Operator maintenance

Examine all components and do the maintenance procedures more frequently if necessary. Minimum Frequency

Maintenance

Daily

• Clean the external surfaces. • 21% O2 calibration (circuit O2 sensor). • Flow sensor calibration

Two weeks

• Drain the vaporizers and discard the agent.

Monthly

• 100% O2 calibration (cIrcuit O2 sensor). • Put Krytox (or a lubricant approved for use with 100% O2) on all tee handle threads.

During cleaning • Inspect the parts for damage. Replace or repair and setup as necessary Annually

• Replace the external o-rings on the vaporizer ports.

As necessary

• Install new cylinder gaskets on cylinder yokes. • Replace the absorbent in the absorber. • Drain the breathing system. • Drain the breathing circuit module.1 • Drain the overflow trap on the optional suction regulator. • Replace the circuit O2 sensor. • Replace the disposable flow sensors (plastic)2 • Replace the receiver filter (active gas scavenging only).

1. This is included in the preoperative test procedure. 2. Under typical use the sensor meets specifications for 3 months.

1-6

1006-0960-000

1 Introduction

Datex-Ohmeda approved service

1-7

Minimum Frequency

6 months

1006-0960-000

Maintenance

Have an approved service person do the service tests and scheduled service maintenance.

1-7

Aestiva/5 MRI

1-8

1-8

1006-0960-000

2 Cleaning and Sterilization w WARNING Obey applicable safety precautions: • Read the material data sheet for each cleaning agent. • Read the operation and maintenance manual for all sterilization equipment. • Wear gloves and safety glasses. A damaged O2 sensor can leak and cause burns (contains potassium hydroxide). • Do not breathe the fumes.

w CAUTION To prevent damage: • Refer to the manufacturer’s data if you have questions about a cleaning agent. • Do not use organic, halogenated, or petroleum based solvents, anesthetic agents, glass cleaners, acetone, or other harsh cleaning agents. • Do not use abrasive cleaning agents (such as steel wool, silver polish or cleanser). • Keep all electronic parts away from liquids. • Do not permit liquid to go into the equipment housings. • Do not soak synthetic rubber parts for more than 15 minutes. Swelling or faster aging can occur. • Only autoclave parts that are marked 134°C.

In this section

Summary... 2-2 Clean and sterilize... 2-4 Disassemble the patient path... 2-7 Canister disassembly... 2-10 Disassemble the scavenging path... 2-12 How to clean and disinfect the flow sensors... 2-13 How to clean and sterilize the optional CO2 bypass assembly... 2-15

1006-0960-000

2-1

2-1

Aestiva/5 MRI

Summary Patient path

The parts in Figure 2-1 send exhaled gas back to the patient. They may require more frequent cleaning/sterilization than parts in Figure 2-2. Refer to your hospital’s infection control policy.

Autoclave (134°C) or wash (mild detergent pH <10.5).

AB.23.003

2-2

*

Refer to cleaning/disinfection procedure.

AB.23.079

Wipe with a damp cloth.

*

Figure 2-1 • These parts return exhaled gas to the patient

2-2

1006-0960-000

2 Cleaning and Sterilization

Autoclave (134°C) or wash (mild detergent pH <10.5).

AB.23.080

AB.23.003

Scavenging path

Figure 2-2 • These parts do not send gas back to the patient

1006-0960-000

2-3

Aestiva/5 MRI

Clean and sterilize The Disassembly part of this section tells you how to remove parts for cleaning

2-4

To wash (by hand or machine)

AB.23.085

Patient path

AB.23.083

Scavenging path

Use a mild detergent (pH <10.5). Then, rinse and dry completely. All parts except the O2 sensor, and flow sensors can be washed. User maintenance tells you how to disassemble parts and clean inside them if necessary.

2-4

1006-0960-000

2 Cleaning and Sterilization

To Autoclave

AB.23.087

Patient path

AB.23.086

Shown upside down

AB.23.083

Scavenging path

Autoclave at 134°C. Inspect the parts for deterioration. The user maintenance section tells you how to do this.

1006-0960-000

2-5