Aestiva 5 7900 Anesthesia Ventilator Technical Reference Manual May 2004

Aestiva 7900 Anesthesia Ventilator 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 A 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 SmartVent 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.

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1006-0453-000

Technical Reference Manual

Aestiva 7900 Anesthesia Ventilator Software Revisions 1.X, 3.X, and 4.X

This document is not to be reproduced in any manner, nor are the contents to be disclosed to anyone, without the express authorization of the product service department, Datex-Ohmeda, Ohmeda Drive, PO Box 7550, Madison, Wisconsin, 53707.

©

1006-0453-000 05/04

2004 Datex-Ohmeda Inc.

i

Aestiva 7900 Anesthesia Ventilator

Important The information contained in this service manual pertains only to those models of products which are marketed by Datex-Ohmeda as of the effective date of this manual or the latest revision thereof. This service manual was prepared for exclusive use by Datex-Ohmeda service personnel in light of their training and experience as well as the availability to them of parts, proper tools and test equipment. Consequently, Datex-Ohmeda provides this service manual to its customers purely as a business convenience and for the customer's general information only without warranty of the results with respect to any application of such information. Furthermore, because of the wide variety of circumstances under which maintenance and repair activities may be performed and the unique nature of each individual's own experience, capacity, and qualifications, the fact that customer has received such information from Datex-Ohmeda does not imply in anyway that Datex-Ohmeda deems said individual to be qualified to perform any such maintenance or repair service. Moreover, it should not be assumed that every acceptable test and safety procedure or method, precaution, tool, equipment or device is referred to within, or that abnormal or unusual circumstances, may not warrant or suggest different or additional procedures or requirements. This manual is subject to periodic review, update and revision. Customers are cautioned to obtain and consult the latest revision before undertaking any service of the equipment. Comments and suggestions on this manual are invited from our customers. Send your comments and suggestions to the Manager of Technical Communications, Datex-Ohmeda, Ohmeda Drive, PO Box 7550, Madison, Wisconsin 53707.

w CAUTION

Servicing of this product in accordance with this service manual should never be undertaken in the absence of proper tools, test equipment and the most recent revision to this service manual which is clearly and thoroughly understood.

Technical Competence The procedures described in this service manual should be performed by trained and authorized personnel only. Maintenance should only be undertaken by competent individuals who have a general knowledge of and experience with devices of this nature. No repairs should ever be undertaken or attempted by anyone not having such qualifications. Datex-Ohmeda strongly recommends using only genuine replacement parts, manufactured or sold by Datex-Ohmeda for all repair parts replacements. Read completely through each step in every procedure before starting the procedure; any exceptions may result in a failure to properly and safely complete the attempted procedure.

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Table of Contents

Important...ii Technical Competence...ii

1 Introduction 1.1 What this manual includes...1-2 1.1.1 Software versions...1-2 1.2 Standard service procedures...1-3 1.2.1 Operation manuals...1-3 1.2.2 Service manuals...1-3 1.2.3 Ventilator tests...1-3 1.3 Symbols used in the manual or on the equipment...1-4

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Table of Contents

2 Theory of Operation 2.1 General description...2-2 2.2 Aestiva 7900 Ventilator features...2-2 2.2.1 Safety features...2-3 2.3 Aestiva 7900 Ventilator components...2-3 2.3.1 Ventilator control electronics...2-4 2.3.2 Control panel and display...2-6 2.3.3 Sensor Interface Board (SIB)...2-7 2.3.4 Pneumatic Engine...2-7 2.4 Electrical...2-8 2.4.1 Electrical (original)...2-8 2.4.2 Electrical (integrated)...2-9 2.4.3 Power supply (original)... 2-10 2.4.4 Power supply (integrated CPU)... 2-11 2.4.5 Sealed lead acid battery... 2-12 2.4.6 CPU assembly... 2-13 2.4.7 Sensor Interface Board (SIB)... 2-20 2.5 Mechanical subsystems... 2-23 2.5.1 Supply gas... 2-23 2.5.2 Gas Inlet Valve (GIV)... 2-24 2.5.3 Flow control valve... 2-24 2.5.4 Drive Gas Check Valve (DGCV)... 2-25 2.5.5 Bellows Pressure Relief Valve... 2-25 2.5.6 Exhalation valve... 2-26 2.5.7 Mechanical Overpressure Valve... 2-26 2.5.8 Bleed resistor... 2-26 2.5.9 Free breathing valve... 2-27 2.5.10 Breathing circuit flow sensors... 2-27

3 Post-Service Checkout 3.1 Post-service checkout...3-2 3.1.1 Test the Aestiva 7900 Ventilator...3-2 3.1.2 Test the Aestiva Anesthesia Machine...3-2

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Table of Contents

4a Tests and Calibration - Software Revision 4.X 4a.1 Self tests...4a-3 4a.2 Service Mode Confirmation menu...4a-4 4a.3 Main Menu - Service Mode...4a-5 4a.3.1 Alarm Log...4a-6 4a.3.2 Error Log...4a-7 4a.3.3 System Configuration...4a-8 4a.3.4 User Select Defaults... 4a-12 4a.3.5 Test CPU and Memory... 4a-14 4a.3.6 Test EEPROM... 4a-15 4a.3.7 Test GIV... 4a-16 4a.3.8 Test Flow Valve... 4a-17 4a.3.9 Test Drive Pressure Limit Switch... 4a-18 4a.3.10 Test 5V Fail Alarm... 4a-19 4a.3.11 Test Serial Ports... 4a-20 4a.3.12 Breathing System Leak Test... 4a-21 4a.3.13 Display A/D Channels... 4a-22 4a.3.14 Display Discrete I/O Signals... 4a-24 4a.3.15 Display Battery Status... 4a-25 4a.3.16 Test Panel Switches... 4a-26 4a.3.17 Flow Valve Test Tool... 4a-27 4a.3.18 Adjust Drive Gas Regulator... 4a-28 4a.3.19 O2 Calibrations... 4a-29 4a.3.20 Calibrate Flow Sensors... 4a-30 4a.3.21 Pressure Sensitivity... 4a-31 4a.3.22 Calibrate Flow Valve... 4a-32 4a.3.23 Bleed Resistor Calibration... 4a-33 4a.3.24 Service Calibrations Required... 4a-34

4b Tests and Calibration - Software Revisions 1.X and 3.X 4b.1 Self tests... 4b-3 4b.2 Service Mode Confirmation menu... 4b-4 4b.2.1 Set the altitude... 4b-5 4b.2.2 Set the language... 4b-5 4b.2.3 Set the serial connection... 4b-5 4b.3 Main Menu - Service Calibration Mode... 4b-6

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Table of Contents 4b.4 Diagnostic Tests... 4b-7 4b.4.1 Test CPU... 4b-7 4b.4.2 Test External RAM... 4b-7 4b.4.3 Test Display RAM... 4b-8 4b.4.4 Test Flash ROM... 4b-8 4b.4.5 Test EEPROM... 4b-9 4b.4.6 Test Panel Switches... 4b-9 4b.4.7 Test Serial Ports... 4b-10 4b.4.8 Test Flow Valve... 4b-11 4b.4.9 Test GIV (Gas Inlet Valve)... 4b-12 4b.4.10 Test DPL (Drive Pressure Limit) switch... 4b-13 4b.4.11 Test 5V Fail Alarm... 4b-14 4b.5 Diagnostic Tools... 4b-15 4b.5.1 Display A/D channels... 4b-15 4b.5.2 Display I/O signals... 4b-17 4b.5.3 Battery Charge Status... 4b-18 4b.5.4 System Error Log... 4b-19 4b.5.5 Alarm log... 4b-19 4b.6 Flow Valve Test Tool... 4b-20 4b.7 Test Breathing System For Leak... 4b-21 4b.8 Adjust Drive Gas Regulator... 4b-22 4b.9 Calibrations... 4b-23 4b.9.1 Calibrate O2 Sensor... 4b-23 4b.9.2 Calibrate Flow Sensors... 4b-24 4b.9.3 Pressure Sensitivity Calibration... 4b-25 4b.9.4 Calibrate Flow Valve... 4b-26 4b.9.5 Calibrate Bleed Resistor... 4b-27 4b.10 Schedule Service Calibration - Software 3.X... 4b-28 4b.11 Sensor(s) cal due - Software 1.X... 4b-29 4b.12 User Settings... 4b-30 4b.12.1 Select Altitude... 4b-30 4b.12.2 Select Drive Gas... 4b-30 4b.12.3 Adjust Brightness... 4b-31 4b.12.4 Select Heliox Mode... 4b-31 4b.12.5 VE Alarm Limits... 4b-32 4b.12.6 User Select Defaults... 4b-32

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Table of Contents

5 Troubleshooting 5.1 Troubleshooting instructions...5-2 5.2 System Error Log...5-3 5.2.1 Error messages for Software Revision 4.X... 5-3 5.2.2 Error codes for Software Revisions 1.X and 3.X... 5-3 5.3 Alarm messages...5-7 5.4 Mechanical/electrical troubleshooting guide... 5-24 5.5 Troubleshooting Flowcharts... 5-26 5.5.1 Ventilator assessment process... 5-26 5.5.2 No display troubleshooting... 5-27 5.5.3 Inaccurate volume ventilation troubleshooting... 5-28 5.5.4 No ventilation troubleshooting... 5-29 5.5.5 High intrinsic PEEP troubleshooting... 5-30 5.6 Power supply test points... 5-31 5.6.1 Power supply board (original CPU)... 5-31 5.6.2 Original CPU... 5-32 5.6.3 Power supply (Integrated CPU)... 5-33

6 Maintenance 6.1 Supply gas inlet filter...6-3 6.2 Free breathing valve maintenance...6-4 6.3 MOPV differential relief valve test...6-5 6.4 MOPV pressure relief valve test...6-6

7 Repair Procedures 7.1 Control panel assembly...7-2 7.2 Keyboard and EL display...7-3 7.3 Encoder switch...7-4 7.4 Alarm speaker...7-5 7.5 Access to electrical enclosure components...7-6 7.5.1 CPU Board...7-8 7.5.2 Firmware replacement procedure... 7-9 7.5.3 Power supply board (for original CPU)... 7-10 7.5.4 Power supply (for Integrated CPU)... 7-11 7.5.5 Toroid (original CPU only)... 7-12 7.5.6 Battery... 7-13 7.6 Vent Engine... 7-14 7.7 Non-relieving regulator... 7-16

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Table of Contents 7.8 Flow control valve 7-17 7.9 Gas inlet valve 7-18 7.10 Mechanical Overpressure Valve (MOPV assembly) 7-20 7.10.1 To service the original MOPV assembly: 7-20 7.10.2 To service the MOPV assembly with the molded housing: 7-22 7.11 Drive gas check valve assembly 7-23

8 Illustrated Parts 8.1 Special instructions 8-2 8.2 Service tools 8-2 8.3 Ventilator Harnesses 8-3 8.4 Electrical enclosure parts (original CPU) 8-4 8.5 Electrical enclosure parts (integrated CPU) 8-6 8.6 Display Module 8-8 8.6.1 Rear housing parts 8-8 8.6.2 Front housing parts 8-9 8.7 Aestiva 7900 Vent Engine 8-10 8.7.1 Gas Inlet Valve 8-11 8.7.2 Mechanical Over Pressure Valve (MOPV) 8-12 8.7.3 Inlet filter 8-13 8.7.4 Free Breathing Valve 8-14 8.7.5 Manifold 8-15 8.7.6 Tube Assembly 8-16 8.7.7 Twin Tube Lifter 8-17 8.8 Vent Engine mounting bracket 8-18 8.9 Sensor Interface Board (SIB) 8-19

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1 Introduction

In this section

1.1 What this manual includes...1-2 1.1.1 Software versions...1-2 1.2 Standard service procedures...1-3 1.2.1 Operation manuals...1-3 1.2.2 Service manuals...1-3 1.2.3 Ventilator tests...1-3 1.3 Symbols used in the manual or on the equipment...1-4

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1-1

1 Introduction

1.1 What this manual includes This manual covers the service information for the Aestiva 7900 SmartVent Anesthesia Ventilator which is an integral component in the Aestiva Anesthesia Machine. The Aestiva Anesthesia Machine has its own service manual (Stock Number 1006-0452-000).

Special notice

Some information in this manual can possibly point the reader to electronic troubleshooting and component/repair replacement level of service. This information, when supplied, is only supplied to add clarity to service or troubleshooting statements. Datex-Ohmeda Service Personnel are mandated by Company Policy to service electronic equipment to a board replacement level only. • Read completely through each step in every procedure before starting the procedure; any exceptions can result in a failure to properly and safely complete the attempted procedure. • Unless otherwise specified, values in this manual are nominal. • Sections in this manual begin on odd numbered or right-hand pages. If there is no text on the preceding, backup even numbered page, it is labeled “Notes” for your use if you wish. • Figures that require more than one page have the title and main text on the left (even numbered) page. Additional figure information is on the facing (odd numbered) page.

1.1.1 Software versions

1-2

The revision level is displayed on the ventilator start-up menu. This manual includes test and calibration procedures for Revision 1.X, 3.X, and 4.X software.

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1 Introduction

1.2 Standard service procedures 1.2.1 Operation manuals

You must have, and be familiar with, the Operation manuals for this product. Study the Aestiva Operation manuals if you need further information about the operation of the system.

1.2.2 Service manuals

You must determine where a problem is located before you can determine which service manual to use: • Use this manual for 7900 Ventilator related problems. • Use the Anesthesia Machine service manual (1006-0452-000) for all other components of the Aestiva Anesthesia Machine.

1.2.3 Ventilator tests

Service calibration functions let Datex-Ohmeda trained users and DatexOhmeda service personnel perform ventilator setup functions, tests, calibration and measurements from the front panel display. Normal operational tests, calibration, and troubleshooting can be performed on your Aestiva 7900 Ventilator without removing components from the system. Repair may require removing the ventilator components from the anesthesia machine.

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w WARNING

Section 4, “Service Mode Tests and Calibration” must be performed whenever you access any internal component of the Ventilator to verify that all critical parts of the Ventilator are still operational and within specification.

w WARNING

After the Ventilator has been serviced, you must perform “Post -Service Checkout” to verify the entire Anesthesia System is properly functioning before the system can be returned to clinical use.

w WARNING

Do not perform testing or maintenance on this instrument while it is being used to ventilate a patient, possible injury may result.

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1 Introduction

1.3 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.

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:

m

On (power)

L

Off (power)

l n M N † p x y P Y + 1-4

A

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 Frame or chassis ground Equipotential

D Type CF equipment w Caution, ISO 7000-0434 refer to product wW Attention, instructions, IEC 601-1 O Dangerous Voltage h Input G Output k Movement in one direction E Movement in two directions

Plus, positive polarity

REF

Stock Number

Minus, negative polarity

SN

Serial Number

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1 Introduction

t

Variability

Read top of float.

T

Variability in steps

Vacuum inlet

g

This way up

Suction bottle outlet

o

Lamp, lighting, illumination Cylinder

z

Lock

Z

Unlock

Isolation transformer

U

Close drain

u

Open drain (remove liquid)

134°C

Autoclavable

Í

Not autoclavable

q t

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Linkage system

Risk of Explosion.

Inspiratory flow

O2 sensor connection.

Low pressure leak test

r R Q O2 +

Mechanical ventilation

Bag position/ manual ventilation

Expiratory flow O2 Flush button

Alarm silence touch key.

Volume alarms On/Off touch key.

End case touch key

Menu touch key.

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1 Introduction

Absorber on. < 345 kPa

Absorber off (CO2 Bypass active).

European Union Representative.

1-6

< 414 kPa

The primary regulator is set to pressure less than 345 kPa (50 psi). The primary regulator is set to pressure less than 414 kPa (60 psi). 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.

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2 Theory of Operation

In this section

This section provides functional descriptions and theory of operation for the major components of the Aestiva 7900 Ventilator. 2.1 General description...2-2 2.2 Aestiva 7900 Ventilator features...2-2 2.2.1 Safety features...2-3 2.3 Aestiva 7900 Ventilator components...2-3 2.3.1 Ventilator control electronics...2-4 2.3.2 Control panel and display...2-6 2.3.3 Sensor Interface Board (SIB)...2-7 2.3.4 Pneumatic Engine...2-7 2.4 Electrical...2-8 2.4.1 Electrical (original)...2-8 2.4.2 Electrical (integrated)...2-9 2.4.3 Power supply (original)... 2-10 2.4.4 Power supply (integrated CPU)... 2-11 2.4.5 Sealed lead acid battery... 2-12 2.4.6 CPU assembly... 2-13 2.4.7 Sensor Interface Board (SIB)... 2-20 2.5 Mechanical subsystems... 2-23 2.5.1 Supply gas... 2-23 2.5.2 Gas Inlet Valve (GIV)... 2-24 2.5.3 Flow control valve... 2-24 2.5.4 Drive Gas Check Valve (DGCV)... 2-25 2.5.5 Bellows Pressure Relief Valve... 2-25 2.5.6 Exhalation valve... 2-26 2.5.7 Mechanical Overpressure Valve... 2-26 2.5.8 Bleed resistor... 2-26 2.5.9 Free breathing valve... 2-27 2.5.10 Breathing circuit flow sensors... 2-27

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2-1

2 Theory of Operation

2.1 General description The Aestiva 7900 Ventilator is a microprocessor based, electronicallycontrolled, pneumatically-driven ventilator with built in monitoring systems for inspired oxygen, airway pressure and exhaled volume. The ventilator is designed to be used as a medical device assisting in the delivery of anesthesia and is part of the Aestiva Anesthesia Machine.

2.2 Aestiva 7900 Ventilator features • Sensors in the breathing circuit are used to control and monitor patient ventilation and measure inspired oxygen concentration. This lets the ventilator compensate for compression losses, fresh gas contribution, valve and regulator drift and small leakages in the breathing absorber, bellows and system. • Positive End Expiratory Pressure (PEEP) is regulated electronically. During mechanical ventilation the software maintains the set airway pressure. PEEP is not active when mechanical ventilation is off. • User settings and microprocessor calculations control breathing patterns. User interface settings are kept in non-volatile memory. • Mechanical ventilation is started with the Bag/Vent switch on the breathing system. • The Aestiva 7900 Ventilator reads the status of the Bag/Vent switch and the breathing circuit type (Circle, Bain-Mapleson D). The operator does not have to set the breathing circuit type from a menu. • The Aestiva 7900 Ventilator has an operator-selectable Heliox mode to permit gas composition compensation when Heliox gas is used. • All Aestiva 7900 Ventilators have minimum monitoring and alarms managed on the ventilator panel (there is no other panel for safety relevant alarm management, etc.). • Ventilator hardware is regularly monitored by software tests. • An RS-232 serial digital communications port connects to and communicates with external devices. • An exhalation valve modulates flow in the pressure mode. • Pressure and volume modes are selectable by the operator. • All pneumatic components are located on one manifold. • Exhausted drive gas and bellows pressure relief valve gases are mixed and go through the ventilator exhalation valve. • Exhalation valve block is autoclavable. • Excess fresh gas released from the bellows and ventilator drive gas is transferred from the exhalation valve to the Anesthesia Gas Scavenging System (AGSS). • Optimized for service with a low number of components.

2-2

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2.2.1 Safety features

• Dual redundant airway overpressure protection, linked to Pmax setting. • Volume over-delivery limits and protection. • Proprietary hose connections and fixed manifolds. • 10 VA electrical power limiting to potential oxygen enriched environment. • 150 psi burst overpressure protection.

2.3 Aestiva 7900 Ventilator components Components of the ventilator are found in different locations on the Aestiva Anesthesia Machine. The ventilator package consists of: 1. Ventilator control electronics 2. Control panel and display (two mounting options shown) 3. Sensor interface board (SIB) 4. Pneumatic engine

Note

For the Aestiva/5 MRI machine, the display is centrally mounted above the flowhead.

1

1

2 2

3

3

4

4

Figure 2-1 • Aestiva Anesthesia Machine with hinged and outboard arm options

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2 Theory of Operation

2.3.1 Ventilator control electronics

The ventilator control electronics is found in the electrical enclosure of the Aestiva machine behind the AC Inlet module. In the original Aestiva machines, the power supply and the CPU are on separate boards, as shown in Figure 2-2. The ventilator control electronics includes the power supply and the CPU. The power supply receives AC power from the machine’s AC Inlet module. All the power necessary to operate the ventilator and light package comes from the power supply. The CPU controls operation of the ventilator.

100-120 VAC 220-240 VAC 50/60 Hz Tec6 Outlet

AC Inlet Module -Fuses -Voltage Selector -Filter

Battery

Toroid

Power Supply Board

Task Light

Proprietary RS232C

AB.29.087

CPU Board

Connector Board

Connector Board

Front Panel Assembly

Pneumatic Engine

Primary RS232C On/StandBy Vent On/StandBy Switch O2 Supply Switch and O2 Flush Switch

BCID

Sensor Interface Board

Patient Interface Harness ACGO Oxygen Sensor

Figure 2-2 • Aestiva 7900 Ventilator functional block diagram (Original CPU)

2-4

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