Aestiva 5 Operation Manual Part 1 sw rev 4.X Oct 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

1/Introduction i

How to use this manual... 1-2 What is an Aestiva?... 1-2 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... 2-9 Ventilator controls...2-11 Optional features...2-11 Control panel...2-11 How to set controls...2-14 How to use the menu...2-15 Menu map...2-16 More about menu functions...2-17 How to change menu settings...2-18 Optional flowmeter and suction regulators...2-19 Suction regulator controls...2-20 External flowmeter controls...2-20 Optional CO2 Bypass mode operation...2-21

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 Set an audible alarm for circuit leaks...3-11 Set Cardiac Bypass...3-12

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Aestiva

Start mechanical ventilation... 3-14 ii

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 mode)... 3-22 Set SIMV and PSVPro controls... 3-24 Silence alarms... 3-26 Reading the pressure waveform (Paw)... 3-27 Scales... 3-27 Measure circuit compliance... 3-30 Show the service settings... 3-31 Optional Passive AGSS operation... 3-33 Optional Active AGSS operation... 3-34 Connecting Active AGSS with a flow indicator... 3-35 Connecting Active AGSS without a flow indicator... 3-36

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 Every day before the first patient...A-3 Inspect the System...A-3 Minimize alarms (optional)...A-5

ii

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Table of Contents

Pipeline and cylinder tests... A-5 iii

Flow control tests... A-7 Vaporizer back pressure test... A-8 Power failure test... A-9 Precase steps...A-11 Every time a different clinician uses the system...A-12 Low-pressure leak test...A-12 Before every patient...A-16 Inspect the system...A-16 Minimize alarms (optional)...A-18 Breathing system tests...A-19 Monitor and ventilator tests...A-21

Index Warranty

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1 Introduction

In this section

1-1

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

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Aestiva

How to use this manual The Aestiva 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 checklist. The Aestiva/5 7900 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, and maintenance procedures.

What is an Aestiva? The Aestiva is a flexible, accessible and intuitive anesthesia delivery system. A wide selection of frames, gases, and vaporizers give you full control of the system configuration. Options include pendant mounted systems, extra gas cylinders or vaporizers, and left or right-hand breathing systems. Model

2 Vap. Trolley

3 Vap. Trolley

Pendant

Number of vaporizers

2

3

2

Number of gases

2 or 3

2, 3, or 4

2 or 3

Optional gases (Heliox and CO2 are cylinder only)

Air or Heliox; CO2

Air, Heliox, CO2 (up to two)

Air or Heliox; CO2

Breathing system and ventilator display mounting

Left or right side

Left or right side

Left or right side

Up to 5

Up to 2

Total number of cylinders (maximum 2 Up to 4 per gas)

1-2

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1 Introduction

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. 1-3

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1-3

Three vaporizer positions, left-hand configuration with arm display mount.

Two vaporizer positions, left-hand configuration with arm display mount.

Three vaporizer positions, right-hand configuration with arm display mount.

AA.96.102

AA.96.028

Two vaporizer positions, left-hand configuration with basic display mount.

AA.96.019

1-4

AA.96.016

AA.96.025

Aestiva

Pendant with arm display mount.

Figure 1-1 • Aestiva systems

1-4

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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. 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)

~

Alternating current

x

Protective earth ground

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Off (power) Standby Standby or preparatory state for part of the equipment “ON” only for part of the equipment “OFF” only for part of the equipment Direct current

Í m µ H w wW N N

l O o q p œ †

Not autoclavable Type B equipment Type BF equipment Type CF equipment Caution, ISO 7000-0434 Attention, refer to product instructions, IEC 601-1 This way up Dangerous Voltage

y

Earth ground

Electrical input

Electrical output

Pneumatic inlet

Pneumatic outlet

1-5

Aestiva

1-6

r å Y

Frame or chassis ground

REF

Stock Number

Alarm silence button

SN

Serial Number

Equipotential

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 DatexOhmeda’s Quality Systems.

t

Variability

Read top of float

T

Variability in steps

Vacuum inlet

+

Plus, positive polarity

Suction bottle outlet

P

Minus, negative polarity Lamp, lighting, illumination

Cylinder

N

Movement in one direction

Isolation transformer

ˆ

Movement in two directions

Linkage system

z

Lock

Risk of Explosion

Z

Unlock

Low pressure leak test

1-6

O 2+

O2 Flush button

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1 Introduction

134° C

R u q t

Autoclavable

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

r U Q

1-7

Mechanical ventilation 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.

European Union Representative

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1-7

Aestiva

1-8

1-8

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In this section

Anesthesia system controls... 2-2 Breathing system controls... 2-5 Vaporizer controls... 2-9 Ventilator controls...2-11 Optional flowmeter and suction regulators...2-19 Optional CO2 Bypass mode operation...2-21

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Aestiva

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.

AA.96.054

4

5 3

2

6 1

7 10 8

12

11

9

1. Breathing system (Figure 2-3) 2. Flow controls 3. Ventilator/monitoring display (Figure 2-5) 4. Light switch and Gooseneck lamp connector (some models) 5. Light (some models) 6. Dovetail rails 7. Vaporizers (Figure 2-4) 8. Gauge (cylinder pressure) 9. Gauge (pipeline pressure) 10. System switch 11. Flush button 12. Brake Figure 2-1 • Aestiva (front view) 2-2

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Figure 2-1 shows these controls on the front of the Aestiva. 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.

Light switch

Turns the light on and off.

AA.96.106

O2 flush

On AA.96.107

Off

Push down to lock. Lift to release.

AA.96.100

Brake

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2

Aestiva

The circuit breakers are on the rear panel of the Aestiva. Item

Description (Figure 2-2)

Circuit Breakers

System circuit breaker AA.96.108

Open (No Power)

Closed (Power)

Open (No Power)

AA.96.109

Outlet circuit breakers

Closed (Power)

3

4

5 2 1

6 7

AA.96.053

8

1. 2. 3. 4. 5. 6. 7. 8.

Circuit Breaker for Electrical Outlet Electrical Outlet Circuit Breaker for Total Outlet Current Circuit Breaker for Mains Inlet Mains Inlet Ventilator fuse Pneumatic Outlet Pipeline Connection

Figure 2-2 • Aestiva rear view

2-4

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2 System Controls and Menus

Breathing system controls 9

8 10 2 7 11

6

5a 12 4 5b

3

2

AB.23.003

13

1

1. Canister release 2. Auxiliary common gas outlet (optional) 3. Outlet switch (Auxiliary Common Gas Outlet) 4. Door 5. Flow sensor /patient connection (circuit connections) a.Inspiratory (Circle circuit module) or to-fro connection (Mapleson/Bain circuit module) b.Expiratory (Circle circuit module) or fresh gas connection (Mapleson/Bain circuit module) 6. Breathing circuit module (Circle) 7. Bag arm 8. Bag/Vent switch 9. APL valve 10.Bellows 11.Pressure gauge 12.Check valves 13. O2 sensor Figure 2-3 • Breathing system parts 1006-0938-000

2-5

Aestiva

. Item

Description

Bag/Vent switch

, When you first turn on the system, mechanical ventilation is always off. To start mechanical ventilation, move the switch from Bag to Vent.

AB.23.059

Mechanical ventilation On (gas to bellows)

AB.23.060

Mechanical ventilation Off (gas to bag arm)

APL valve

Limits breathing system pressure during manual ventilation. The scale shows approximate pressures. Above 30 cmH2O, you will feel clicks as the knob turns.

Increase 70

20 5

20

~0 cmH2O

~20 cmH2O

One arm is adjustable (push in and turn). The other is not.

Adjustable

AB.23.023

Not adjustable

2-6

AB.23.024

Bag arm

AB.23.064

30

5

30 70

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Item

Description

Canister release

Open to replace soda lime or remove the canisters. Note, this also opens the breathing system.

Pull

Turn 2

Turn

Push

AB.23.061

Open

Close

AB.23.179

CO2 bypass (optional) Pulling and turning the canister release opens the canisters and activates the CO 2 bypass mode. The CO2 bypass seals the breathing circuit when the canisters are open. This permits continued ventilation and rebreathing of exhaled gases.

Unscrew the plug to remove condensate.

AB.23.062

Drain plug

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