Aestiva 5 Users Reference Manual May 2002

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 and Link-25 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 How to use this manual... 1-2 What is an Aestiva/5 Induction?... 1-2 Symbols used in the manual or on the equipment... 1-3

2 System Controls Anesthesia system controls... 2-2 Vaporizer controls... 2-5

3 Setup and Connections (Trolley Base) Pneumatic connections... 3-2 How to install gas cylinders (high-pressure leak test)... 3-3 Cylinder yokes... 3-3 DIN connections... 3-5 How to attach equipment to the top surface... 3-6

4 Setup and Connections (Wall/Rail Mount) System configuration... 4-2 Rail systems for wall/rail mount Aestiva Induction machine... 4-4 Site Plan... 4-4 Rail positions for optional accessories... 4-6 Pivot bracket for wall/rail mount Aestiva Induction machine... 4-7 Site plan... 4-7 Rail Positions for optional accessories... 4-8 How to attach the wall/rail mount Aestiva Induction to a pivot bracket... 4-9 How to use the pivot bracket...4-11 Gas Packs...4-12 Typical ISO Gas Pack...4-12 How to install gas cylinders...4-13 Yoke connection...4-13

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Aestiva/5 Induction

5 Preoperative Checklist Every day - before the first patient... 5-2 Every time a different clinician uses the system... 5-2 Before every patient... 5-2

6 Preoperative Tests Aestiva/5 Induction preoperative tests schedule... 6-2 Test intervals... 6-2 Test devices... 6-3 Inspect the system... 6-4 Pipeline and cylinder tests... 6-5 Flow control tests... 6-7 Vaporizer installation... 6-9 Vaporizer back pressure test...6-10 Low-pressure leak test...6-11 Negative low-pressure leak test...6-11 ISO 5358 or BSI standard positive low-pressure leak test...6-13

7 User Maintenance Maintenance summary and schedule... 7-2 Operator maintenance... 7-2 Datex-Ohmeda approved service... 7-2 Cleaning and Sterilization... 7-3 External cleaning... 7-3

8 Parts Test tools and system parts... 8-2 Wall/rail mount Aestiva Induction parts... 8-3

9 Troubleshooting Repair policy... 9-2 Pneumatic problems... 9-3

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Table of Contents

10 Theory of Operation and Specifications Pneumatic circuit description...10-2 Gas supplies...10-2 O2 flow...10-2 Air, N2O, and CO2 flow...10-3 Mixed gas...10-3 System pneumatic circuits...10-4 Pneumatic circuit diagram (trolley base)...10-4 Pneumatic circuit diagram (Wall-mount)...10-7 System specifications...10-8 Pneumatic...10-8 Flow...10-10 Physical specifications...10-11 Environmental requirements...10-12

Index Warranty

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Aestiva/5 Induction

iv

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1 Introduction

In this section

How to use this manual... 1-2 What is an Aestiva/5 Induction?... 1-2 Symbols used in the manual or on the equipment... 1-3

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1-1

Aestiva/5 Induction

How to use this manual The Aestiva/5 Induction comes with several user manuals. This Operation Manual: • Supplies information about the symbols used on the equipment. • Describes the system controls and how to use them. • Instructs you on how to set up the system. • Provides complete instructions for the preoperative tests. • Includes a maintenance schedule, troubleshooting, and parts information.

What is an Aestiva/5 Induction? The Aestiva/5 Induction has the pneumatic characteristics of the Aestiva/5 without a ventilator or breathing system. It is designed for use in an induction environment. The Aestiva/5 Induction comes in trolley base or wall/rail mount variants. Gas supply options include: Trolley base

Wall/Rail mount

Number of gases

2 or 3

2 or 3

Optional gases

Air or CO2 (CO2 cylinder only)

Air

Total number of cylinders

Up to 3 (maximum 2 per gas)

Up to 2 (O2 and N2O only)

Figure 1-1 • Aestiva/5 Induction system

1-2

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1 Introduction

Symbols used in the manual or on the equipment w WARNINGS and w CAUTIONS tell you about dangerous conditions that can occur if you do not follow all instructions in this manual. Read and follow all warnings and cautions. 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. A Note provides additional information to clarify a statement in text. An Important statement is similar to a Note, but provides a comment of greater emphasis. 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:

m

L l n M N † p x y

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On (power)

A

Off (power)

Alarm silence button

Alarm silence touch key (Tec 6).

Standby

j

Type B equipment

Standby or preparatory state for part of the equipment

J

Type BF equipment

“On” only for part of the equipment “Off” only for part of the equipment Direct current Alternating current Protective earth ground Earth ground

D Type CF equipment w Caution, ISO 7000-0434 refer to product instructions, wW Attention, IEC 601-1. O Dangerous Voltage h Input G Output

1-3

Aestiva/5 Induction

P Y + t

Frame or chassis ground Equipotential

k E

Movement in one direction Movement in two directions

Plus, positive polarity

REF

Stock Number

Minus, negative polarity

SN

Serial Number

Variability

Read top of float

T

Variability in steps

Vacuum inlet

g

This way up

Suction bottle outlet

o

Lamp, lighting, illumination

z

Lock

Z

Unlock

Cylinder

Isolation transformer

U

Close drain

u

Open drain (remove liquid)

134°C

Autoclavable

Í

Not autoclavable

q

Inspiratory flow

1-4

Linkage system

Risk of Explosion. Low-pressure leak test

r R Q

Mechanical ventilation

Bag position/manual ventilation

Expiratory flow

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1 Introduction

t

< 345 kPa

O2 sensor connection

O2 Flush button

Alarm silence touch key

Volume alarms On/Off touch key

End Case touch key

Menu touch key

Circle breathing circuit module

Bain/Mapleson D breathing circuit module

The primary regulator is set to pressure less than 345 kPa (50 psi).

Absorber on

Absorber off (CO2 Bypass active)

European Union Representative

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O2 +

< 414 kPa

The primary regulator is set to pressure less than 414 kPa (60 psi).

CO2 Bypass Option

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 Manual. The xxxx is the certification number of the Notified Body used by Datex-Ohmeda’s Quality Systems.

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Aestiva/5 Induction

1-6

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2 System Controls

In this section

Anesthesia system controls... 2-2 Vaporizer controls... 2-5

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Aestiva/5 Induction

Anesthesia system controls w WARNING

Explosion Hazard. Do not use Aestiva 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

1 9

3 4

8 7

5

1 2 9 7

4 5

6

1. Flow controls 2. Common gas outlet 3. Dovetail rails 4. Vaporizers 5. System switch 6. Brake lever 7. O2 flush button 8. Cylinder pressure gauges 9. Pipeline pressure gauges

Figure 2-1 • Aestiva/5 Induction (front view)

2-2

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2 System Controls Figure 2-1 shows these controls on the front of the Aestiva machine. Item

Description

6.

Brake Push down to lock. Lift to release. (Trolley base only)

5.

System switch

Set the switch to the on (l) position to permit gas flow. (On)

1.

Flow controls

Turn the control counterclockwise to increase the flow and clockwise to decrease. The system switch must be on for gas to flow. Increase

7.

O2 flush button

Decrease

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

(trolley base)

(wall/rail mount)

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Aestiva/5 Induction

2

1

1. Pipeline connections 2. Pneumatic power outlet (optional)

Figure 2-2 • Trolley base gas connections

1

3 2

1. Pipeline connections 2. Checked Y-adapter (to connect pipeline and regulated cylinder supply) 3. Pneumatic power outlet (optional)

Figure 2-3 • Wall/Rail mount gas connections

2-4

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2 System Controls

Vaporizer controls Refer to the description in this section and the vaporizer operation and maintenance manual for more detailed information on the vaporizer.

5

4 3

2

4

3 2

6

1

6

Tec 5 8 Tec 6 series

6

7

1. Power cable (Tec 6 series only) 2. Concentration control 3. Concentration control release 4. Lock lever 5. Alarm silence switch (Tec 6 series only) 6. Filler port controls 7. Indicators (Tec 6 series only) 8. Battery cover (Tec 6 series only)

Figure 2-4 • Vaporizer controls

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Figure 2-4 shows the vaporizer controls. Item

Description

4.

Lock lever

Turn the lever fully clockwise to lock the vaporizer in position.

2. and 3.

Concentration control and release

Push the release and turn the concentration control to set the agent concentration. The Tec 6 series concentration control does not turn as long as the warm-up indicator is on.

5.

Alarm Silence Push to silence alarms. Hold for four seconds to start Switch the speaker and light all indicators (alarm test). (Tec 6 series only) > 4 sec = Alarm test < 4 sec = Alarm silence

7.

2-6

Indicators All indicators come on at the start. The warm-up (Tec 6 series only) indicator goes off after approximately ten minutes when the operational indicator comes on. Other indicators come on to advise the user of required action.

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3 Setup and Connections (Trolley Base) Important

Datex-Ohmeda strongly recommends that you use O2 monitoring with this equipment. Refer to local standards for mandatory monitoring.

Important

European Standard EN 740 requires anesthetic agent monitoring when anesthetic vaporizers are in use, and O2 and CO2 monitoring when a breathing circuit is in use.

w WARNINGS

Always make sure that the pipeline supply hoses are not toxic and will not: • Cause an allergic reaction in the patient. • React with the anesthetic gases or agent to produce dangerous by-products.

w

To help prevent incorrect values or equipment malfunction, use only Datex-Ohmeda cables, hoses and tubing.

w

To protect the patient when electrosurgical equipment is used: • Monitor the correct operation of all life support and monitoring equipment. • Do not use conductive masks or hoses.

w

In this section

Datex-Ohmeda has not validated any stand-alone ventilator or absorber for use with this system. Pneumatic connections... 3-2 How to install gas cylinders (high-pressure leak test)... 3-3 How to attach equipment to the top surface... 3-6

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Pneumatic connections w CAUTION

Use only medical grade gas supplies. Other types of gas supplies may contain water, oil, or other contaminants. The Aestiva gas supplies also supply the pneumatic power outlet (optional) through internal connections.

Pipeline inlets Label identifies the gas.

Pneumatic power outlet (O2)

3-2

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