Aestiva 5 7900 Operation Manual Part 2 Feb 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 How to use this manual... 1-2

i

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 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 How to clean and sterilize the optional CO2 bypass assembly...2-15

3/Setup and Connections Breathing system setup... 3-2 Canister setup... 3-6 Pneumatic and electrical connections... 3-8 How to install gas cylinders (high-pressure leak test)...3-11 Cylinder yokes...3-11 DIN connections...3-12 How to install the gooseneck lamp (12 V)...3-14 How to attach equipment to the top shelves...3-15 How to install equipment on the foldout shelf...3-17 Installation notes...3-18

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4/User Maintenance ii

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/Alarms and 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 Breathing system parts...6-2 Top level...6-2 Main manifold...6-5 Exhalation valve...6-7 Bellows...6-9 Test tools and system parts... 6-10

7/Theory of Operation and Specifications Ventilator Theory...7-2 Modes...7-3

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2/17/03 1006-0402-000

Table of Contents

Breathing system schematic... 7-7 iii

Electrical block diagram... 7-8 Pneumatic circuits... 7-9 Suction regulators (optional)...7-12 O2 flowmeter (optional)...7-12 Breathing system...7-13 Breathing system specifications...7-15 Pneumatic specifications...7-17 Flow specifications...7-18 Electrical power...7-19 Power cord...7-20 Electrical fuses...7-20 Battery information...7-20 Electro-magnetic compatibility...7-20 Physical specifications...7-21 Environmental requirements...7-22 Ventilation operating specifications...7-23 Aestiva ventilator accuracy data...7-25

Index Warranty

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iii

1 Introduction

In this section

1-1

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

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Aestiva

How to use this manual This is part two of the Aestiva 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 section 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.

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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. 1-3

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

1-3

Aestiva

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

1-4

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

1-5

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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Aestiva

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. This is not necessary for Tec 6 vaporizers.

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 as and setup 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 autoclavable flow sensors (metal)3. • 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 3. Under typical use the sensor meets specifications for 1 year.

1-6

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1 Introduction

Datex-Ohmeda approved service Minimum Frequency

6 months

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1-7 Maintenance

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

1-7

Aestiva

1-8

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2 Cleaning and Sterilization 2-1

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

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Aestiva

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

*

If plastic, refer to cleaning/disinfection procedure. If metal, autoclave (134°C)

AB.23.079

Wipe with a damp cloth.

*

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

2-2

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2 Cleaning and Sterilization

2-3

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

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Aestiva

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

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2 Cleaning and Sterilization

Autoclave Patient path 2-5

AB.23.087

Metal Only

AB.23.086

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.

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Aestiva

Special requirements

*

AB.23.088

2-6

* Hang the bellows upside down (extended) to dry. If not, the convolutions can stick together.

• To clean the circuit O2 sensor, wipe it with a damp cloth. Do not put the sensor in liquid. • To clean/disinfect metal/or plastic flow sensors, use the flow sensor cleaning procedure. Do not get the connectors wet. • Disassemble the bellows before you wash it. If not, it will take a very long time to dry. Hang the bellows upside down to dry. • Assemble the bellows before you autoclave. Autoclave the bellows upside down.

w WARNING

Do not use talc, zinc stearate, calcium carbonate, corn starch or equivalent materials to prevent tackiness. These materials can go into the patient’s lungs and airways and cause irritation or injury.

w CAUTION

Do not put the circuit O2 sensor or flow sensor connector in liquid.

w

Do not autoclave the Circuit O2 sensor or the plastic flow sensors.

w

Do not clean the interior surfaces of the flow sensors. Use a damp cloth on external surfaces only.

Assemble

The Setup section tells you how to assemble the breathing system. Inspect all parts for deterioration. Replace them if necessary. The Preoperative tests in Part 1 (the first half of this manual), tell you how to test the system for correct operation.

2-6

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2 Cleaning and Sterilization

Disassemble the patient path 2-7

Step 1

AA.96p.009

Open the access panel.

Step 2 AA.96p.010

Push up on the latch located under the flow sensor module.

Step 3

AA.96p.011

Remove the flow sensor module. You will feel some resistance. Continue to pull.

Step 4

AA.96p013, 014

Disconnect the cable and remove the O2 sensor.

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