Aespire View Users Reference Manual Sw Rev 7 Rev D

User responsibility Datex-Ohmeda, Inc. a General Electric Company, doing business as GE Healthcare. 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 instruction 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 DatexOhmeda 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.

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 the local laws for any restriction that may apply.

Table of Contents 1 Introduction Intended use... 1-2 Indications for use... 1-2 General information... 1-2 Serial numbers...1-3 Trademarks... 1-3 Symbols used in the manual or on the equipment... 1-4 Symbols used on the equipment...1-4 Abbreviations... 1-7 System information... 1-9 System classification... 1-9 Device standards IEC 60601-1:1988... 1-9 Device standards IEC 60601-1:2005... 1-9 Integral system components... 1-10 Not integral system components...1-10 System safety... 1-11 Preparing for use... 1-11 Inspecting the system... 1-12 Electrical safety... 1-13

2 System controls and menus System overview... 2-2 Using the brake... 2-4 Using the O2 flush button... 2-4 Using flow controls... 2-5 Advanced breathing system components... 2-6 Using the bag support arm... 2-7 Vaporizer controls... 2-8 Display controls... 2-9 Anesthesia system display... 2-10

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Aespire View Display navigation... 2-11 Using menus... 2-11 Using quick keys... 2-12 Using the ComWheel... 2-12

3 Operation System operation safety... 3-2 Turning on the system... 3-3 Starting manual ventilation... 3-4 Starting mechanical ventilation... 3-5 End a case...3-6 Turning off the system... 3-7 Ventilator setup... 3-8 Changing ventilator mode... 3-8 Changing ventilator settings... 3-9 Alarm setup... 3-10 Setting MV/TV alarms... 3-10 Setting alarm limits... 3-10 Setup/Calibration... 3-11 Setting time and date... 3-11 Screen and audio setup... 3-12 Setting display brightness... 3-12 Setting alarm volume...3-12 Showing alarm limits... 3-12 Showing units of measure... 3-13 Setting display scale... 3-13 Spirometry Loops... 3-15 Setting loop type... 3-15 Saving, viewing, and deleting spirometry loops... 3-16 Alarm History... 3-17 Viewing alarm history... 3-17 Cardiac Bypass... 3-18 Using cardiac bypass... 3-18

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Table of Contents EZchange canister mode... 3-19 Using EZchange canister mode... 3-20 Condenser... 3-21 Draining the condenser... 3-21 Total flow sensing (optional)... 3-23 Auxiliary Common Gas Outlet...3-24 Using the ACGO... 3-25

4 Preoperative checkout Every day before your first patient... 4-2 Before every patient... 4-3

5 Preoperative tests Power failure alarm test...5-2 Pipeline test... 5-3 Cylinder test...5-4 Total flow sensing test... 5-5 Flow control test... 5-6 Vaporizer installation... 5-8 Vaporizer installation procedure... 5-8 Vaporizer back pressure test... 5-9 Low-pressure leak test... 5-10 Negative low-pressure leak test... 5-10 Positive low-pressure leak test... 5-11 Alarm tests...5-13 Breathing system tests... 5-15 Bellows test... 5-15 Breathing circuit test... 5-15 APL valve test... 5-16 Monitor and ventilator tests... 5-17 Measuring circuit compliance... 5-18

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6 Alarms and troubleshooting Alarms... 6-2 Alarm priorities...6-2 Pausing alarms... 6-2 Latching alarms... 6-3 Special alarms... 6-3 List of alarms... 6-5 Sustained pressure threshold... 6-10 Alarm ranges... 6-12 Alarm tests...6-13 Breathing system problems...6-15 Electrical problems... 6-16 Pneumatic problems... 6-17

7 Setup and connections Setup safety...7-2 Moving and transporting the system... 7-4 Setting up the absorber canister... 7-5 When to change the absorbent... 7-6 Removing a canister... 7-7 Removing an EZchange canister... 7-7 Filling the Reusable Multi Absorber canister... 7-8 Electrical connections... 7-10 Mains inlet... 7-10 Equipotential stud... 7-10 Outlets... 7-10 Serial port... 7-10 Pneumatic connections... 7-12 Pipeline inlets... 7-12 Scavenging... 7-12 Sample gas return port... 7-14 Vacuum suction regulator (optional)... 7-14

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Table of Contents Venturi suction regulator (optional)... 7-15 Auxiliary O2 flowmeter (optional)... 7-17 Installing gas cylinders... 7-18 Installing cylinders with pin indexed yokes... 7-18 Installing cylinders with DIN connections... 7-18 Installing large cylinders... 7-18 Performing a high-pressure leak test... 7-19 Attaching equipment to the top of the machine... 7-20 Passive AGSS... 7-21 Connecting passive AGSS... 7-21 Active AGSS... 7-22 Connecting active AGSS with a flow indicator... 7-22 Connecting active adjustable AGSS... 7-23

8 User maintenance Maintenance safety... 8-2 Repair policy... 8-3 Maintenance summary and schedule... 8-4 Authorized service personnel... 8-4 Circuit O2 cell replacement... 8-6 O2 cell calibration... 8-7 21% O2 calibration... 8-7 100% O2 calibration... 8-7 Zeroing flow sensors... 8-9 Water buildup...8-10 How to help prevent water buildup... 8-10

9 Parts Flow sensor module... 9-2 Breathing circuit module... 9-3 Bellows...9-4 Absorber canister... 9-5 Exhalation valve assembly... 9-7

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Aespire View AGSS... 9-8 EZchange canister system... 9-10 Condenser... 9-11 Test tools and system parts... 9-12

10 Specifications and theory of operation System pneumatic circuit... 10-2 Gas supplies... 10-3 O2 flow...10-4 N2O flow... 10-4 Air flow... 10-4 Mixed gas... 10-5 EZchange canister...10-5 Condenser... 10-5 Pneumatic specifications...10-6 Gas supplies... 10-6 ACGO port relief... 10-6 Electrical block diagram... 10-7 Electrical power... 10-9 Power cord...10-9 Battery information... 10-9 Flow specifications... 10-11 Pneumatic flow... 10-11 Total flow sensing... 10-11 Breathing system specifications... 10-12 Gas scavenging...10-13 Physical specifications... 10-15 Lower dovetail loading...10-15 Upper dovetail loading...10-16 Environmental requirements... 10-17 Suction regulators (optional)... 10-18 Ventilator theory... 10-19 O2 monitoring theory of operation... 10-19

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Table of Contents Ventilation modes... 10-20 Ventilator operating specifications... 10-28 Pneumatics... 10-28 Fresh gas compensation... 10-28 Pressure... 10-28 Volume...10-29 Oxygen... 10-29 Ventilator accuracy data... 10-30 Electromagnetic compatibility (EMC)... 10-31 Essential performance...10-31 Cables... 10-31 Guidance and manufacturer’s declaration electromagnetic emissions... 10-32 Guidance and manufacturer’s declaration electromagnetic immunity... 10-32 Recommended separation distances... 10-34

Index

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1 Introduction

Introduction

In this section

Intended use... 1-2 Symbols used in the manual or on the equipment...1-4 Abbreviations... 1-7 System information... 1-9 System safety... 1-11

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Intended use The Aespire View anesthesia system is a compact, integrated, and intuitive anesthesia delivery system. The 7900 Ventilator provides mechanical ventilation for patients during surgery as well as monitoring and displaying various patient parameters. This anesthesia system uses SmartVent ventilation technology offering Volume Control Ventilation with tidal volume compensation and electronic PEEP. SmartVent technology also features optional Pressure Control Ventilation, Pressure Support Ventilation with Apnea Backup (PSVPro) that is used for spontaneously breathing patients, Synchronized Intermittent Mandatory Ventilation (SIMV) modes, and Pressure Control Ventilation-Volume Guarantee (PCVVG). This anesthesia system is designed for mixing and delivering inhalation anesthetics, Air, O2, and N2O.

WARNING

MR unsafe. This system is not suitable for use in a magnetic resonance imaging (MRI) environment.

Indications for use The Aespire View anesthesia system is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation.

General information This anesthesia system uses the Advanced Breathing System (ABS). This integrated breathing system is easy to remove and disassemble and is autoclavable. Its fully integrated design enhances the system’s elegance while minimizing tube connections, minimizing circuit volume, and increasing the work surface area. This anesthesia system is designed for expansion and upgrades, so it is easy to add new technologies and ventilation capabilities without investing in a new system. The anesthesia system is suitable for use in a patient environment, such as hospitals, surgical centers, or clinics. The system must only be operated by personnel trained and qualified in the administration of general anesthesia. The User’s Reference manual is intended to provide training on the operation of the system. Operate the system from the front with a clear view of the display. It must be operated according to the instructions in this User’s Reference manual. Make sure that all user documents are obtained from the manufacturer.

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1 Introduction Refer to the Technical Reference manual for service information including: special installation instructions, installation checklist, means of isolating the supply mains, and replacement of fuses, supply cord, and other parts.

WARNING

Explosion Hazard. Do not use this system with flammable anesthetic agents.

Note

Configurations available for this product depend on local market and standards requirements. Illustrations in this manual may not represent all configurations of the product. This manual does not cover the operation of every accessory, and not all accessories and options are included with every system. Refer to the accessory documentation for further information.

Serial numbers 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. The serial number can be in one of two formats. AAAX11111

AAAXX111111AA

The X represents an alpha character The XX represents a number indicating the year the product was indicating the year the product was manufactured; H = 2004, J = 2005, manufactured; 04 = 2004, 05 = 2005, etc. I and O are not used. etc.

Trademarks Aespire, PSVPro, SmartVent, Medisorb, Selectatec, and Tec are trademarks of General Electric or one of its subsidiaries. Other brand names or product names used in this manual are trademarks or registered trademarks of their respective holders.

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Symbols used in the manual or on the equipment Symbols replace words on the equipment, on the display, or in product manuals. Warnings and 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.

Symbols used on the equipment .

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O2 flush button

O2 cell connection

Air

Air

APL settings are approximate

Anesthetic Gas Scavenging System

Maximum

Vacuum

Serial number

Stock number

Exhaust

Bellows volumes are approximate

Maximum mass of configured mobile equipment

Caution: federal law prohibits dispensing without a prescription

Autoclavable

Selectatec Series Vaporizers Tec 6 Plus or greater

On (power)

Off (power)

Standby

Non-ionizing electromagnetic radiation

Variability

Type B equipment

Protective earth ground

Earth ground

Direct current

Alternating current

Caution

General warning (yellow background)

Refer to instruction manual or booklet (blue background)

Operating instructions

Electrical input/output

Sample gas inlet to scavenging

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Pneumatic inlet

Pneumatic outlet

Equipotential

Lamp, lighting, illumination

This way up

Not autoclavable

Read to top of float

EZchange canister (CO2 bypass)

Read to center of float

Manual ventilation

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

Authorized representative in the European Community

Date of manufacture

Manufacturer

Suction bottle outlet

Vacuum inlet

Open drain (remove liquid)

Low pressure leak test

Bag position/manual ventilation

Mechanical ventilation

Lock

Unlock

Inspiratory flow

Expiratory flow

Movement in one direction

Single use device

GOST R Russian certification

When moving or transporting anesthesia machine, place the display arm and shelf in the transport position as shown.

Union made

Stacking limit by mass

Keep dry

Do not stack

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Aespire View Indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of equipment.

Device contains phthalates. XXX indicates phthalate. Possible phthalates include: DEHP: Bis(2-ethylhexyl) phthalate; Di-(2-ethylhexyl) phthalate

Temperature limitation

Fragile, handle with care

Protect from heat and radioactive sources

Recyclable material

Atmospheric limitation

Use by date

Humidity limitation

Electrical test certification

MR unsafe MRI not compatible (red circle and slash)

Cylinder

Menus

Volume alarms On/Off

End case

Audio pause

Eurasian conformity

Ukraine national conformity

Unique device identifier

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Abbreviations Abbreviation

Definition

A ABS

Advanced breathing system

ACGO

Auxiliary common gas outlet

AGSS

Anesthetic gas scavenging system

APL

Adjustable pressure-limiting

ATPD

Ambient temperature and pressure, dry humidity conditions

B BTPS

Body temperature, ambient pressure, saturated humidity conditions

C CGO

Common gas outlet

CO2

Carbon dioxide

E EMC

Electromagnetic compatibility

Exp

Expiratory

F FiO2

Fraction of inspired oxygen

Flow-Vol

Flow-volume loop

I:E

Inspiratory-expiratory ratio

Insp

Inspiratory

K kg

Kilogram

M MIN

Minimum

MV

Minute volume

MVexp

Expired minute volume

MVinsp

Inspired minute volume

N N2

Nitrogen

N2O

Nitrous oxide

O O2

Oxygen

P

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Paw

Patient airway pressure

Paw-Flow

Pressure-flow loop

Paw-Vol

Pressure-volume loop

PCV

Pressure controlled ventilation

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Aespire View PCV-VG

Pressure controlled ventilation - volume guaranteed

PEEP

Positive end expiratory pressure

Pinsp

Inspiratory pressure

Pmax

Maximum pressure

Pmean

Mean pressure

Pplat

Positive airway pressure measured at the end of Tpause

Ppeak

Peak pressure

Psupport

Support pressure

PSVPro

Pressure support ventilation with apnea backup

R RF

Radio frequency

RR

Respiratory rate

S SIMV-PC

Synchronized intermittent ventilation - pressure controlled

SIMV/PSV

Synchronized intermittant ventilation/pressure supported ventilation

T Texp

Expiratory time

Tinsp

Inspiratory time

Tpause

Time where breath is paused with no flow

TV

Tidal volume

TVexp

Expired tidal volume

TVinsp

Inspired tidal volume

V VCV

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Volume control ventilation

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System information System classification This system is classified as follows: • • • • •

Class I Equipment. Type B Equipment. Ordinary Equipment. Not for use with flammable anesthetics. Continuous operation.

Device standards IEC 60601-1:1988 Devices used with this anesthesia system shall comply with the following standards where applicable: • • • • • • •

Breathing system and breathing system components ISO 8835-2. Anesthetic gas scavenging systems ISO 8835-3 Anesthetic vapor delivery devices ISO 8835-4. Anesthetic agent monitors ISO 21647. Oxygen monitors ISO 21647. Carbon dioxide monitors ISO 21647. Exhaled volume monitors IEC 60601-2-13.

Device standards IEC 60601-1:2005 Devices used with this anesthesia system shall comply with the following standards where applicable: • • • • • • •

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Breathing system and breathing system components ISO 80601-2-13. Anesthetic gas scavenging systems ISO 80601-2-13 Anesthetic vapor delivery devices ISO 80601-2-13. Anesthetic agent monitors ISO 80601-2-55. Oxygen monitors ISO 80601-2-55. Carbon dioxide monitors ISO 80601-2-55. Exhaled volume monitors ISO 80601-2-13.

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Integral system components This anesthesia system contains the following integral components, monitoring devices, alarm systems, and protection devices that comply with European, international, and national standards: • • • • • • • • •

Breathing system pressure-measuring device. Airway pressure-limitation device. Exhaled-volume monitor. Breathing system integrity alarm. Breathing system continuing-pressure alarm. O2 monitor. Anesthesia ventilator. Breathing system. AGSS

Not integral system components These devices are not integral to this anesthesia system: • • • • • • •

CO2 monitor. Anesthetic agent monitor. O2 monitor (when O2 cell is not installed). Suction regulator. EZchange canister system. Condenser. Anesthetic vapor delivery device.

When adding devices to the anesthesia system, follow the installation instructions provided by the device manufacturer. Whoever adds individual devices to the anesthesia system shall provide instructions on how to enable the individual devices. For example, a preoperative checklist.

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