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OPERATION MANUAL

ATLANTA VENTILATOR

Equipment Code: 201050027

MS Registration No.: AM 10229820082

Manual Code: 204010157_000

Date: (OUT/2004)

Operation

Manual

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This Operation Manual has the information that is necessary for the proper usage of the ATLANTA ventilator.

Manufacturer:

K. Takaoka Indstria e Comrcio LTDA

Av. Bosque da Sade, 519

So Paulo SP

ZIP: 04142-091

Telephone: (11) 5586 1000

Fax: (11) 5589 7313

Website: www.takaoka.com.br

E-mail: kt@takaoka.com.br

CGC: 61.489.381/0001-09

I.E.: 103.735.350.115

Suggestions, doubts or complaints:

Call Center: (11) 5586 1010

Product Registration at the Health Ministry:

Technical Name: Pressure Pulmonary Ventilator

Trade Name: ATLANTA Ventilator

Registration Number at the Health Ministry: AM 10229820082

Product Classification:

NBR IEC 60601-1/1997, NBR IEC 60601-2-12/1998

Equipment Class 1 Energized Internally

Type B IPX1 Continual Operation

Technician in charge:

Ing. Mauricio Chiarioni

CREA (Cdigo Regional de Ingeniera, Arquitectura y Agronoma de Brasil): Registro N 5061714921

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Product Installation Form

EQUIPMENT: ___________________________ Code: ____________ Serial Number: ___________

DESCRIPTION CODE SERIAL NUMBER1

23456789

ACCESSORIES

10

INVOICE: Original K. Takaoka [ ] YES ______________ [ ] NO ________________________Invoice Number* Representation Name

INSTITUTION:

Corporate Name: ___________________________________Tax Payers ID*:________________________

Address: _______________________________________________________________________________

City: __________________________________________State:_____________ ZIP: __________________

Person in charge of the information*:_____________________________Position: _____________________

Sector: _______________________Tel*: ____________________ e-mail: __________________________(*) Mandatory Fie lds

YOUR OPINION:

1. Was the product delivered punctually, within the period that was agreed on? Yes No2. Did the products and accessories match the order? Yes No3. Was the package damaged in any way? Yes No4. Was there any difficulty to install the equipment? Yes No5. Is the equipment and are the accessories working properly? Yes No6. Were there any accessory, tube and cable connection problems? Yes No

7. Were the data, values, product description, amount, and payment conditions correct? Yes No8. Mention any possible inconveniences:

Installation by: ___________________________ Date ____/ ____ /_____ Sig.: ___________________(Technician Name)

Representation: ________________________ Data ____/ ____ /_____ Sig.: _____________________

Send this form to Fax (11) 5589 8072, or via registered mail, to K. Takaoka.

ATTENTION: THE WARRANTEE WILL GO INTO EFFECT AS OF THE CONFIRMATION OF THE

INFORMATION CONTAINED IN THIS TERM. THIS TERM MUST BE SENT IN NO MORE THAN 30 DAYS,AS SET FORTH IN THE OPERATION MANUAL.If you have any doubts, or for more information, contact: SAC (11) 5586 1010

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TABLE OF CONTENTS

DEFINITIONS.................................................................................................................................... 8

THE COMPANY ................................................................................................................................ 9

1 INTRODUCTION ......................................................................................................................11

2 IMPORTANT INFORMATION....................................................................................................12

3 GENERAL DESCRIPTION ........ ......... ........ ......... ......... ........ ......... ........ ......... ........ ......... ........ ..15

4 TECHNICAL SPECIFICATIONS......... ........ ......... ......... ........ ......... ........ ......... ........ ......... ........ ..17

5 OPERATING PRINCIPLE .........................................................................................................19

5.1 CONTINUOUS FLOW.............................................................................................................195.2 FLOW VALVE......................................................................................................................195.3 MECHANICAL MIXER ............................................................................................................195.4 ELECTROMAGNETIC VALVE...................................................................................................19

6 CONTROLS AND COMPONENTS ............................................................................................20

6.1 LIST OF COMPONENTS .........................................................................................................20

6.2 FRONT V IEW ......................................................................................................................206.3 REAR VIEW........................................................................................................................256.4 EXPIRATORY VALVE ............................................................................................................276.5 ELECTRONIC HEATED HUMIDIFIER .........................................................................................286.6 DRAINS .............................................................................................................................296.7 BATTERY ...........................................................................................................................296.8 MOBILE BASE.....................................................................................................................30

7 CONTROL DISPLAY ................................................................................................................31

7.1 START-UPSCREEN .............................................................................................................317.2 MAIN SCREEN ....................................................................................................................327.3 ALARM ADJUSTMENT SCREEN................................................................................................327.4 CONFIGURATION SCREEN.....................................................................................................33

7.5 SETUP PROCEDURE ............................................................................................................347.6 ALARMSYSTEM ..................................................................................................................34

8 ASSEMBLING AND PREPARING THE VENTILATOR...............................................................36

8.1 SUPPLY .............................................................................................................................368.2 RESPIRATORY CIRCUIT ........................................................................................................37

9 INSPECTION ROUTINE............................................................................................................40

9.1 BEFORE EACH VENTILATION ..................................................................................................409.2 DURING VENTILATION...........................................................................................................40

10 OPERATION ........................................................................................................................41

10.1 SELECTING VENTILATION MODES ...........................................................................................41

10.2 CYCLING PARAMETERS REGULATION ......................................................................................4110.2.1 CMV Regulation - Controlled Mandatory Ventilation ........ ........ ......... ........ ......... ........ ..4210.2.2 SIMV Regulation - Synchronized Intermittent Mandatory Ventilation ......... ........ ......... ...4310.2.3 Regulating CPAP - Constant Positive Airway Pressure Ventilation ........ ......... ......... ....4410.2.4 Regulating APRV - Airway Pressure Relief Ventilation.................................................45

11 CLEANING AND STERILIZATION........................................................................................46

12 MAINTENANCE ...................................................................................................................51

13 SYMBOLS ...........................................................................................................................52

14 EMERGENCY ACTIONS ......................................................................................................57

15 TERMS OF WARRANTY ......................................................................................................58

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DEFINITIONS

WarningWarns the user about the possibil i ty of injury , death or other serious adverse react ions assoc iated with misuse of

the equipm ent.

AttentionWarns the user about pos sible problem s with the equipm ent associated with its misuse, such as equipm ent

malfunct ion or failure, damage to the equipm ent or damage to third-party property.

Note:Emphasizes important information

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THE COMPANY

K. TAKAOKA is a company that for more than 48 years has dedicated to the hospital equipment industry, always in close

cooperation with physicians. Operating mainly in the Anesthesia, Intensive Medicine, Monitoring, and Oxygen Therapy areas, K.

TAKAOKA is proud of its leading position in the market and has a wide range of products.

Having as one of its priorities ongoing investments in the research and development of new ideas and solutions, K. TAKAOKA has

distinguished itself through the constant introduction of technological advancements and industrial innovations in its product line,

which puts it on par with its main national and international competitors.

Using sophisticated equipment, K. TAKAOKA designs and manufactures most of the components for its apparatus, which explains

the strict quality control they are submitted to. The company is also concerned with supplying all customers with top-quality

assistance by means of its Sales and Technical Assistance departments.

With representatives throughout Brazil and also having a firm foothold in the international market, K. TAKAOKA has deserved its

customers confidence over the years, in its high-quality standards and the great efficiency of its products and services.

Vision:

Being a global company.

Mission:

Being the national leader in manufacturing anesthesia, pulmonary ventilator, vital sign monitors, and oxygen therapy devices,

contributing to the preservation of life, offering high technology and better service to our clients.

Quality Policy:

Continually improving our PRODUCTS, SERVICES and PROCESSES, involving our EMPLOYEES and VENDORS, and obtaining

our CLIENT and SHAREHOLDER satisfaction.

K. TAKAOKA IND. E COM. LTDA.

Av. Bosque da Sade, 519

So Paulo - SP - CEP:04142-091

Tel:(0xx11)5586-1000

Fax:(0xx11)5589-7313

E-mail: kt@takaoka.com.br

Site: http://www.takaoka.com.br

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Figure 1: ATLANTA Ventilator

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1 INTRODUCTION

The ATLANTA Ventilator is a microprocessed electronic respirator designed for respiratory insufficiency applications in neonatal and

infant patients (from 0.2 kg to 50 kg) in intra/extra hospital transportation, emergency care and support therapy. The Ventilator has

time-cycled, pressure-limited continuous flow.

The device is very practical, since it has direct digital controls for the main ventilation parameters. Cycle triggering occurs viapressure and the trachea frontal outlet allows one to position the ventilator on both sides of the hospital bed.

As its ventilation monitor is incorporated, it allows a wide-ranging follow-up of the patients conditions, increasing security.

Furthermore, a complete audiovisual alarm system, with messages written on the control screen allows for immediate alarm

condition identification.

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2 IMPORTANT INFORMATION

The ATLANTA Ventilator is a medical device that includes sophisticated mechanical and electronic components. Qualified, specially

trained professionals in its design should only operate it. Carefully review the warnings and recommendations provided below.

Biocompatibility

According to the ISO 10993-1, the equipment is classified as a device that doesnt have direct and/or indirect contact with thepatients body; therefore it is not included in this norms scope (Clause 4.2.1).

Ventilation

Once you switch the Ventilator on, enter the patient's weight so the equipment can pre-calculate the appropriate ventilation

parameters.

After starting ventilation check that the ventilation parameters indicated on the screen are correct.

Check the proper adjustment of all alarm limits.

To ensure all condensed water in the breathing circuit flows back to the drains, and does not reach the patient, tube support

must be placed near the Y-shaped connector and placed in a position below the patient's mouth level.

To prevent accidental disconnection or gas leakage in the breathing circuit, make sure all connections are tightly secured.

Tightly close the 6060 Heated Humidifier caps threaded lid.

Frequently check the endotracheal tube connection tightness.

Do not use the ATLANTA Ventilator if there are any abnormalities. Solve the problem by calling a TAKAOKA authorized

representative.

Electric Supply and Internal Battery

Only attach the power cord to an outlet that is properly grounded and approved for hospital use. The female tap should be a 3-pin Nema 5-15P type (item 8.1).

The Ventilator should be operated using the internal electrical power supply when there is any doubt as to the reliability of the

safety ground conductor installation.

Keep the internal battery charged at all times so the Ventilator keeps working even if the electric mains fail or for transport. To

do this, the Ventilator must be continuously connected to the electric distribution network, even when it is switched off.

Recharge the battery after using the Ventilator for a few hours with no mains supply so that it is ready for the next use.

Fully recharge the battery when the Ventilator is left unused and disconnected from the electric mains for more than 20

(twenty) days.

The internal rechargeable battery must not be removed, and to maintain its charge, the Ventilator must be connected

continually to the electric network.

If the internal battery is supplying energy to the Ventilator and the low battery alarm sounds, the Ventilator must be immediately

connected to the mains, because there is an imminent risk of total Ventilator failure.

The Heated Humidifier is not supplied by the Ventilators internal battery or the 12VDC inlet.

Connecting other devices to the auxiliary power supply when the safety ground conductor is faulty may increase the leakage

current through the patient in amounts that exceed those permitted.

The detachable power cord (supply cable) should be attached with a clamp to prevent accidental disconnection.

The internal rechargeable battery may only be replaced by K. TAKAOKAs authorized Technical Assistance.

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Miscellaneous

Remove the plastic display cover from the Ventilator prior to use.

This Ventilators operation is not affected by the use of nearby equipment, such as high-frequency surgical equipment

(diathermy), defibrillators or short-wave therapy equipment.

Based on electromagnetic compatibility assays, this Ventilator is not susceptible to electromagnetic interference.

This Ventilator does not emit electromagnetic radiation that may interfere with the operation of nearby equipment.

Do not press any key using surgical instruments or tools. Only use your fingertips to press the keys. Hard or sharp objects may

damage them.

To avoid the risk of explosion, do not use the Ventilator in the presence of flammable anesthetic agents and do not put oil or

flammable grease on the equipment.

Anti-static or electrically conductive hoses should not be used.

Make sure the Ventilator is set-up properly and that the alarms have been adjusted correctly before using the equipment.

While the Ventilator is on stand by, all alarms will be muted.

Establish an appropriate cleaning and sterilization routine for the Ventilator components .

The Ventilator must undergo an annual revision by a K. TAKAOKA authorized technician to be re-calibrated.

The parts used are defibrillation-proof, except for the temperature cable, which must be removed when the defibrillator is used

near the Ventilator.

Some pressure units indicated in millibars (mbar), and hectopascals (hPa) are used by some institutions instead of cmH2O.

Since 1 mbar is equal to 1 hPa, which in turn is equal to 1.016 cmH2O, these units can be freely interchanged.

A few flow units are in ml, as this is the form that is most commonly used in the medical area; 1000 ml equals 1 l.

Limited stability: the ventilators inclination during normal usage must not surpass 5o (degrees).

Read this Operation Manual very carefully so you can use the equipment correctly and obtain maximum benefit from all of its

features.

Any repair that may be required for the Ventilator should only be performed by K. TAKAOKAS specialized and authorized

technicians.

The connection to the patient must be securely fastened.

Check the condition and periodically replace the breathing circuits corrugated tubes, as these are components subject to

normal wear and tear.

Use only the sensors, cables and tubes TAKAOKA specifies for the Atlanta Ventilator.

If exposed to reasonably foreseeable environmental conditions, the device must be used in an environment at a temperature of

+10C to +70C, atmospheric pressure of 500 to 1060 hPa, and a relative humidity of 10 to 100% (non-condensed).

This device is not to be used to administer any type of drug or substance.

Waste ("trash")

All parts and components that had contact with any fluids originating from patients (e.g.: breathing circuits, etc.) are potentially

contaminated. Known as semi-critical, they must undergo a high-level disinfection or sterilization before being discarded (at the end

of their service lives) or otherwise be discarded as potentially infected hospital waste.

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Discard all parts removed from the equipment in accordance with your organizations part and component disposal protocol.

Follow local government recommendations regarding environmental protection, particularly for electronic waste or parts.

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3 GENERAL DESCRIPTION

The ATLANTA Ventilator is a microprocessed electronic respirator designed for respiratory insufficiency applications in neonatal and

infant patients (from 0.2 kg to 50 kg) in intra/extra hospital transportation, emergency care and support therapy. The Ventilator has

time-cycled, pressure-limited continuous flow.

The ATLANTA Ventilator has the following ventilation modes: CMV (controlled ventilation), SIMV (synchronized intermittentmandatory ventilation), CPAP (continuous positive airway pressure ventilation) and APRV (airway pressure relief ventilation). It also

has PEEP (positive expiratory end pressure) controls and maximum inspiratory pressure controls (allowing an inspiratory plateau).

The ATLANTA Ventilator cycling is directly controlled through independent respiratory rate and inspiratory duration controls. This

regulating method makes it much easier to adjust the device, since the main ventilation parameters are obtained directly.

Some additional features of the ATLANTA Ventilator are described below:

Direct digital controls for the main ventilation parameters, highlighting Inspiratory Flow , Inspiratory Time, Respiratory Rate,

Pressure Limit and PEEP.

Pre-adjustment of the ventilation parameters for the weight informed when the Ventilator is switched on.

Only the active controls in each ventilation mode appear.The liquid crystal display shows the controls and ventilation monitoring in an integrated manner.

Electronic endotracheal pressure manometer, with graphic display through a linear bar graph manometer. The pressure gauge

shows the last inhalations maximum pressure value during the expiratory phase, allowing for better viewing of this parameter.

Complete system of audio-visual alarms for ventilation parameters with adjustable limits set by the operator. These alarms can

indicate a number of irregularities during ventilation, which significantly increases therapy safety.

STAND BY condition activated manually at any time to prevent audible alarms during patient preparation or any other special

event.

Pre-adjustment of the ventilation parameters for WEIGHT as informed when the Ventilator is switched on.

EasyTouch Button that allows access and easy, quick adjustment of the ventilation parameters.

Electronic servo-controlled expiratory valve for pressure control in the respiratory circuit, allowing for active pressure control in

any ventilation mode.Built-in pressure control valves for oxygen and compressed air.

Air/O2 mixer integrated to the ventilator with a 21% to 100% O2 adjustment.

Electronic button for manual inspiratory (cycle synchronization).

Main on/off switch.

Incorporated pressure-regulating valve.

Safety valves to prevent asphyxia and high pressure.

Rechargeable internal battery for power failure situations or during transportation, when the battery will automatically supply

the Ventilator.

Internal switching power supply with 110 or 220 VAC input for Ventilator operation and internal battery re-charging.

Heated Humidifier with electronic temperature control and digital thermometer.

Articulated arm with corrugated tube support that can be set up on either side of the Ventilator, depending on which side the

patient is on.

Ergonomic panel with membrane keyboard and advanced design.

Silent operation.

3.1 Ventilation Monitor

The Ventilation Monitor built into the ATLANTA Ventilator has multiple functions to monitor mechanical ventilation. The monitors

graphic display shows numeric values of some measured parameters in real time, in addition to the endotracheal pressure flow

curve as a function of time for a more detailed ventilation analysis. The knowledge of the parameters displayed by the monitor

allows for a more comprehensive monitoring of the patient's ventilation.

Some other important features of the Ventilation Monitor are described below.

Audio-visual alarms for PEEP and maximum pressure with minimum and maximum limits set by the operator.

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Real-time Pxt graphs with automatic dial adjustment.

Monitoring of inhalation pressure and average pressure.

I:E relation shown, plus expiration duration time.

RESET key for 2-minute alarm muting.

Graduated bar graph from -10 cmH2O to 100 cmH2O incorporated in the display.

Serial port interface to the computer to display graphs, writing data to disk or printing information (this item is optional).

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4 TECHNICAL SPECIFICATIONS

Classification

The ATLANTA Ventilator is a microprocessed electronic respirator designed for respiratory insufficiency applications in pediatric and

neonatal patients in intra/extra hospital transportation, emergency care and support therapy. This is a Class-I equipment with a type

B internal energy source for continuous operation and is water droplet resistant (IPX1).

Ventilation Modes

CMV ............................................................................ controlled mandatory ventilation

CPAP ......................................................................... Continuous Positive Airway Pressure ventilation

SIMV .......................................................................... synchronized intermittent mandatory ventilation

APRV .........................................................................airway pressure relief ventilation

AttentionIn CPAP, set the PPEP alarm to detect a possible dis conn ect ion.

Ventilation Parameters

Rate ............................................................................................................................................................................ 1 to 180 rpm

Inspiratory time..............................................................................................................................................................0.1 to 3 sec

Oxygen concentration ............................................................................................................................................. 21 to 100% O2

Inspiratory pressure............................................................................................................................................... 1 to 99 cm H2O

PEEP/CPAP.............................................................................................................................................................0 to 30 cmH20

Inspiratory Flow.................... ...................................................................................................................................... 0 to 50 L/min

Base flow................................................................................................................................................................fixed at 4 L/min

Sensitivity by flow (optional)........................................................................................................................... OFF, 1 to 20 L/min

Sensitivity per pressure........................................................................................................................... OFF, -1 to -20 cm H2O

Sound alarm silencer.........................................................................................................................................................2 minutes

Manual Inspiration................ ..................................................................................................................................... synchronized

Patient Weight............................................................................. 0.2 Kg to 5.0 Kg............................................ increment: 0.1 Kg

.................................................................................................... 5.0 Kg to 20 Kg............................................. increment: 0.5 Kg

.................................................................................................... greater than 20 Kg........................................ increment: 1.0 kg

Special Features

Electronic inspiratory pressure manometer with a bar graph, and a scale ranging from -10 to 100 cmH2O.

On/off key.

O2 pressure and compressed air pressure regulating valves.

Safety valves to prevent asphyxia and high pressure.

Synchronized, manual inspiratory key.

Ventilation Monitor Specifications

Parameter Unit

Maximum Pressure.................................................................................................................................. ............................... cmH2O

Average pressure.................................................................................................................................................................... cmH2O

Inhalation time ....................................................................................................................................................................... seconds

Exhaling time......................................................................................................................................................................... seconds

Gas Supply

Gases .........................................................................................................................................oxygen and compressed air

Supply pressure..............................................................................................................45 to 100 psi (310 to 690 kPa)Pressure regulated by the equipment................................................................................................34.5 PSI (238 kPa)

Threaded connection......................................................................................................according to norm NBR 12188

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Notes:The ATLANTA ventilator is equipped with an internal pressure-regulating valve that may be connected directly to hospital

network gas outlets installed according to the norms in force. Therefore, using an external regulating valve is not

recommended.

Electrical Features

Supply..................................................................................................................................................................... .90 to 220 Vac

Respiratory Rate.................. .............................................................................................................................................. 50/60 Hz

Power..................................................................................................................................................10 VA from the Ventilator

.....................................................................................................................................90 VA from the Humidifier (maximum)

Fully energized.......................................................................................................................................................................Battery

Rechargeable battery.............................. .Sealed, Lead/acid, 12 VDC and 2.3 Amp - Takaoka number 437010003

Graphic Display.......................................... .liquid crystal equipped with self-contrast with a cold cathode light bulb.

Fuse..................................... ...................................................................................................................... 20 mm glass, normal:

Ventilador input...........................................................................................................................................................1.0 A / 250 V

humidifier outlet...........................................................................................................................................................2.0 A / 250 V

Battery autonomy ............................................................................................................................Approximately 180 minutes

External power supply........................................................................................................................................12 VDC and 3.0A

Dimensions and Weight

Ventilator With mobile base and accessories

Height................................... .................................................260 mm ...............................................................................1240 mm

Width..................................................................................... 244 mm ..................................................................................400 mm

Depth.....................................................................................350 mm ..................................................................................430 mm

Weight...................................................................................10.5 kgf...................................................................................25.6 kgf

Packaging

Individual packaging developed to withstand transportation and storage at a temperature from -10C to +70C, at atmospheric

pressures of 500 to 1060 hPa and at relative humidity of 10% to 100% (non-condensed).

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5 OPERATING PRINCIPLE

5.1 Continuous Flow

Oxygen and compressed air flow into the Ventilator through their respective threaded connections. Pressure is reduced by means of

a set of regulating valves. Each gas travels to its own equalization valve, which prevents differing network gas pressures from

influencing the gas mixture.

The oxygen and compressed air flows are then mixed in the blender, where O2 concentration is adjusted.

The oxygen/compressed air mixture passes through the flow control valve where it is electronically controlled to provide the exact

quantity of gas during the inspiratory phase (inspiratory flow).

The flow continues through the booster valve until finally reaching the patient respiratory circuit. The magnetic valve causes a flow

exhaust to the outside atmosphere when the maximum pressure is reached.

During the expiratory phase, an expiratory flow will be sent to the patient circuit depending on the inspiratory flow set on the

Ventilator.

5.2 Flow Valve

A pace motor changes its flow position when there is a pressurized gas at its inlet. When the motor is positioned at zero, its outlet

flow is zero. Changing the motor position allows the passage of the gas at the inlet to the outlet, thereby regulating the inspiratory

flow.

Each motor position corresponds to a certain inspiratory flow and this position is determined by means of an electronic control,

which obeys this parameters value as set on the ventilator.

5.3 Mechanical Mixer

Gas is mixed mechanically through a needle valve.

5.4 Electromagnetic Valve

Inspiratory pressure is controlled by means of an electromagnetic valve operating in the respiratory circuit, which is run by an

electronic microprocessed system.

Figure 5.1 shows a cross-section of the electromagnetic valve construction, the operating principles which are very simple and safe.

The diaphragm controls the flow passage and isolates the inner part of the valve to prevent contamination. The diaphragm is

controlled by means of the pin that moves with the mobile coil, which in turn moves inside a magnet. The closing force of the

diaphragm depends on the electric current applied to the coil. This is controlled electronically by means of a servo-controlled

pressure system.

Figure 5.1: Electromagnetic valve.

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6 CONTROLS AND COMPONENTS

6.1 List of Components

The following components are supplied with the ATLANTA Ventilator:

Description Code

Complete infant respiratory circuit 202011033

Complete neonatal respiratory circuit 202010632

Oxygen extension 202011182

Compressed air extension 202012068

Removable power cord 429020003

Spare diaphragm for expiratory valve 202011152

Articulated support arm for corrugated tubes 202010612

Compressed air Filter 202011152

O2 Filter 202011938

Infant flow sensor 203100150

6060 Heated Humidifier 201060003ATLANTA Ventilator Operation Manual 204010157

Notes:When you receive the material, if one of the components above is missing or damaged, contact the K. TAKAOKA

authorized representative immediately, as there are different warranty periods for the various components. See Chapter

15.

To purchase optional or replacement accessories, contact the authorizedK.TAKAOKA distributor.

6.2 Front View

The items listed below refer to the front view of the ATLANTA Ventilator.

Ventilators Control Display

Liquid crystal display that centralizes the regulating functions for the ventilation parameters,

alarm messages and other information related to the Ventilator's operating conditions. This displays functions are described in

detail in the Chapter "Control Display."

Inspiratory Limit Pressure Key

Key to adjust the maximum inspiratory pressure limit. When pressed, this key highlights the maximum inspiratory

pressure value on the screen so that the number value can be adjusted using the Easy Touch (12) programming dial. Turn the dial

clockwise to increase or counter -clockwise to decrease the value and press Easy Touch (12) or the Inspiratory Pressure key (2) key

to confirm. The adjustment is made directly in cmH2O.

Note:Set the maximum pressure desired in this parameter to perform cycling (with plateau) in the CMV and SIMV modes.

In the APRV mode this parameter corresponds to the lowest airway pressure during the decompression phase.

In the CPAP mode this parameter is adjusted only as a safety limit against barotrauma.

If during the inspiratory cycle the actual measured pressure exceeds 5 cmH2O above the value set, the Ventilator

automatically interrupts inhaling, resetting the inspiratory flow to zero to avoid excess pressure from occurring.

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Figure 6.1: ATLANTA Ventilator - Front view.

PEEP/CPAP Key

Key to adjust the PEEP/CPAP value. When pressed, this key highlights the PEEP/CPAP value in the display so this

numerical value can be adjusted using the Easy Touch(12) programming dial. Turn the dial clockwise to increase or counter-

clockwise to decrease the value and press Easy Touch (12) or the PEEP (3) key to confirm. The adjustment is made directly in

cmH2O.

Note:In the CPAP mode, this parameter regulates the continuous positive airway pressure (CPAP).

In the APRV mode, this parameter regulates the continuous positive airway pressure (CPAP).

In other modes, this control regulates the positive end-expiratory pressure (PEEP) value.

8

9

13

12

11

10

3

2

1

14

15

16

18

4

17

7

5

6

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Breathing Rate Key

Key to adjust the breathing rate. When pressed, this key highlights the respiratory rate value in the display so this

numerical value can be adjusted using the Easy Touch (12) programming dial. Turn the dial clockwise to increase or counter-

clockwise to decrease the value and press Easy Touch (12) or the respiratory rate (4) key to confirm. The adjustment is made

directly in breaths per minute.

Notes:In some modes, the patients themselves will normally determine the breathing rate.

The breathing rate determines the I/E ratio according to the following equation TinspTf

+=

exp60

, in which

the rate (f), and the inspiratory time (Tinsp), is adjustable and the exhalation time results from such adjustments.

The Tinsp +Texp sum is never below 0.30 second.

Connector for Blue Flow Sensor Tube (optional)

Inlet for the flow sensor tube that has a blue stripe. The other end of the tube must be attached to the flow sensor nozzle, next tothe side of the sensor that has the largest diameter (female). Only use the sensor supplied by TAKAOKA.

Connector for Transparent Flow Sensor Tube (optional)

Inlet for the transparent flow sensor tube. The other end of the tube must be attached to the flow sensor nozzle on the side of the

sensor that has the smallest diameter (male). Only use the sensor supplied by TAKAOKA.

AttentionThe two tubes must be assembled in the correct posit io n in accordance with the color co des located on the main

body o f the f low sensor and on the Vent ilator connectors. The tubes have dif ferent colors for quic k ident if icat ion.

Breathing System Connector (PATIENT)

22-m male conical connection for interconnection of the corrugated tube (tracheal), which takes the inspiration gases from

the ventilator to the patient or to the humidifier depending on the usage.

Expiratory Valve Block

Block containing the expiratory valve and a conical connector for the corrugated tubing (tracheal) that carries the gases

exhaled by the patient. The expiratory valve controls the inspiratory and expiratory phases. This set can be disassembled for

cleaning and sterilization of its diaphragm and must be correctly assembled in accordance with the instructions in item 6.4.

O2 Concentration Button

Control that adjusts the oxygen concentration directly, ranging form 21% to 100%, in the inhaled gases.

Grip to Position the Ventilator

Front grip allowing for easy positioning of the ATLANTA Ventilator.

Inspiratory Time Key

Key to adjust the inspiratory time. When pressed, this key highlights the inspiratory time value in the display so this

numerical value can be adjusted using the Easy Touch (12) programming dial. Turn the dial clockwise to increase or counter-

clockwise to decrease the value and press Easy Touch (12) or the inspiratory time (11) key to confirm. The adjustment is directly

performed in seconds.

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Notes:The inspiratory time will determine the I/E ratio and consequently the expiratory time. After starting ventilation check if the

I/E ratio as shown on the Ventilator display is appropriate.

The maximum adjustment permitted for inspiratory time is 3 seconds.

Programming Dial (Easy Touch)

This dial allows simple, fast adjustment of ventilation parameters on the main screen of the ATLANTA Ventilator. This

button should be operated in the sequence described below to adjust each of the ventilation parameters displayed highlighted on

the display:

Press the button once. The parameter that was changed last will be highlighted.

Turn the button clockwise or counter-clockwise until the parameter you desire to change is highlighted.

Press the button once again. The parameter will be highlighted in the display.

Turn the button to adjust the numerical value desired for the parameter. Turning the button clockwise increases the value,

while turning it counter-clockwise decreases it.

Press the button again to confirm the adjustment made, activating this value as the new parameter. The parameter will be

removed from the highlight in the display.

If the Easy Touch (12) dial is not used to confirm the selection or change of any ventilation parameter within 10 seconds, the

parameter in question will reset to its initial value.

On the Ventilator's set-up screen (item 7.4), this button selects and confirms the adjusted value and highlights the next parameter.

Turn the button clockwise or counter-clockwise until the parameter you desire to change is highlighted.

Press the button to confirm parameter selection.

Turn the button to adjust the numerical value desired for the parameter. Turning the button clockwise increases the

value, while turning it counter-clockwise decreases it.

Press the button again to confirm the adjustment made, activating this value as the new parameter value and

highlighting the next parameter.

Inspiratory Flow Key

Key to adjust the maximum flow value during the inspiratory phase. When pressed, this key highlights the maximum

inspiratory flow value so this numerical value can be adjusted using the Easy Touch (12) programming dial. Turn the dial clockwise

to increase or counter-clockwise to decrease the value and press Easy Touch (12) or the inspiratory time (13) key to confirm. The

adjustment is performed directly in liters per minute.

The expiratory flow that passes through the breathing circuit during the expiratory phase will depend on the inspiratory flow

adjustment, in other words:

If the inspiratory flow adjustment is more than 4 lpm, the expiratory flow will be set at 4 lpm.If the inspiratory adjustment is less than or equal to 4 lpm, the expiratory flow will match the inspiratory value.

The main applications of this flow, such as flow washing, are to eliminate carbon dioxide from the respiratory cir cuit during

exhaling and to help maintain the PEEP/CPAPlevel.

Note:The base flow (expiratory flow) will never be greater than the value set in the maximum inspiratory flow control.

Note:When the inspiratory flow value is set at zero, the ventilator will enter anesthesia mode (ANES), and this condition will

show in the inspiratory flow parameter position. In this mode, in order to ventilate the patient, it is necessary to introduce a

Fresh Gas Flow into the inspi ratory branch through a connector as shown in the figure below.

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Operation of the ATLANTA Ventilator in Anesthesia mode

Change Screen Key - MENU

This key puts the Ventilators control screen in the set-up mode. The detailed procedure for performing these

adjustments can be found in items 7.3,7.4, and 7.5. Return to the main screen by pressing the MENU key again.

Manual Cycle Key

This button triggers a new synchronized inspiratory phase as soon as it is pressed. The manual message will

momentarily appear on the display every time the operator initiates a Ventilator cycle.

Two-minute Silence Key

Key with two different functions:

By pressing this key when any alarm is triggered, the alarm system will be muted for 2 minutes. In case there is any other

alarm condition during this two-minute period, the muting will be canceled and a new alarm will sound. The visual ALARM indicator

(17) w ill remain on continuously as long as there is a temporary mute alarm condition.

When pressed again during the mute alarm period, the alarm will return to its normal function.

Pressing this key for 5 seconds during an ELECTRICITY MAINS FAILURE, CHECK THE O2 NETWORK of CHECK THE AIR

NETWORK, the message shown in the middle of the screen disappears, being replaced by the pressure graphics, and this

message is then shown together with the bar graph. The visual alarm indicator (17) only flashes one LED at a time.

Alarm Indicator

When an alarm condition occurs, this indicator will flash continuously.

When the SILENCE key (16) activates an alarm muting condition, this indicator will remain on.

ATLANTAVentilator

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Mode Key - MODE

This key selects the ventilation mode from among the following options: CMV, SIMV, CPAP, APRV and STAND BY.

Press this key repeatedly until the desired mode is highlighted in the Ventilator display and then press the Easy Touch (12) dial to

confirm the selection.

When the STAND-BY mode is selected, the Ventilator will go into stand-by mode. The Ventilator will remain inactive until the

operator cancels this condition by selecting another mode. The STAND BY mode may be used during patient preparation or other

special events, when you want to perform the monitoring but do not want the alarms activated.

Notes:The keys only highlight the parameter values so that they may be adjusted and confirmed by the Easy Touch (12)

programming dial, thus forming a security system that does not allow involuntary adjustments.

6.3 Rear View

The items listed below refer to the back view of the ATLANTA Ventilator.

Figure 6.2: ATLANTA Ventilator - Back View

2

5

1

3

4

6

7

14

15

16

17

8

9

10

11

12

13

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AttentionControls (5), (6) (10) and (11) should only be adjusted by technic ians who have been trained and authorized by

TAKAOKA.

Fuse

Compartment with a fuse to protect the Ventilators electrical parts. The fuse holder has a bayonet type system that totally removes

the fuse, making changing easier and avoiding electric shock (Chapter 12 Maintenance).

On/off key

General electric switch which, on the OFF position switches the Ventilators electrical part off automatically.

Power Cord Inlet 110 or 220 VAC

Inlet to attach the Ventilator to a 110 to 220 VAC power supply by means of a removable power cord provided with the Ventilator.

This cable has a 3-pin connector to be coupled to a properly grounded distribution network.

Note:The Ventilator can be supplied with voltage between 110 and 220 VAC as it has automatic voltage conversion.

Strap

Nylon strap used for fixing the power supply cable to avoid accidental disconnection.

Compressed Air Pressure Feedback Valve

Valve that re-supplies the compressed air pressure regulating valve (6) that supplies the Ventilator at 34.5 PSI - 238 Kpa.

Compressed Air Pressure Regulating Valve

This valve reduces the compressed air pressure that supplies the Ventilator to 36 psi - 248 kPa.

Inlet Connection - Compressed Air

Threaded connection for the compressed air filter supplied with the Ventilator. The filter inlet must be attached to this gas power supply

by means of the compressed air extension supplied with the equipment. The compressed air supply pressure must be in the range

between 45 and 100 psi (310 and 690 kPa).

Identification Tag

Tag showing the Ventilators model and serial number for identification purposes.

Oxygen Inlet Connection

Threaded connection for the oxygen extension tube supplied with the Ventilator to attach it to the oxygen gas supply. The oxygen

supply pressure must be within the range of 45 and 100 psi (310 and 690 kPa).

Oxygen Calibrator Valve

This valve reduces the Oxygen pressure that supplies the Ventilator to 36 PSI -248 Kpa.

Oxygen Pressure Feedback Valve

Valve that re-supplies the Oxygen pressure regulating valve (10), which supplies the Ventilator at 34.5 PSI - 238 Kpa.

Auxiliary electric outlet for the Heated Humidifier

Electric outlet to run the 6060 heated humidifier. The humidifier is not supplied by the internal battery or by the 12-VDC electric

outlet.

Grounding connector

Connector used to ensure the Ventilator is correctly grounded when electricity is being supplied by means of an external 12 VDC

battery. In this case, attach the ground wire plug (optionally provided with the Ventilator) to this connector. The clamp on the other

end of this wire should be attached to a suitable grounding point at the location where the Ventilator is being used. It is essential

that the Ventilator be properly grounded to ensure the safety of the patient and to avoid damage to the equipment.

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12 VDC Electric Outlet

Electrical socket to supply electricity to the ATLANTA Ventilator by means of an external 12 VDC rechargeable battery. This is

useful for transportation or as a spare source of energy. The ventilator will not charge the battery connected to this outlet.

Note:The heated humidifier will not work when the ATLANTA Ventilator is being supplied by its battery.

Serial Outlet for PC (optional)

Serial outlet to connect the Ventilator to a microcomputer by means of an appropriate serial cable to transmit monitoring data. This

resource is one of the Ventilators optional items and must be specified in the purchase order.

Note:The serial cable and the microcomputer are not supplied with the ATLANTA Ventilator. They are optional accessories. For

information on the hardware and software requirements, contact an authorized K. TAKAOKA distributor.

Humidifier Outlet Fuses

Fuse box (two), one for each supply phase, to protect the auxiliary electric outlet that supplies the 6060 Humidifier. The fuse holder

has a bayonet-type system that totally removes the fuse, making changing easier and avoiding electric shock (Chapter 12

Maintenance).

Contrast Button for the Control Display

Button to adjust the Ventilators display contrast. This button should be adjusted until you get the best screen view.

6.4 Expiratory Valve

The expiratory valve is an electromagnetic valve that sets the inspiratory and expiratory phases of the ATLANTA Ventilator, as well

as control the pressures during these phases. During the expiratory phase, the valve is opened to allow the release of exhaled

gases.

The expiratory valve block is fixed to the front of the Ventilator. This allows the breathing circuit's tubes to be directed to either side

of the Ventilator depending on which side the patient is.

The expiratory valve should be periodically disassembled to disinfect its components and inspect or replace its diaphragm .

After each assembly of the exhalation valve, when its diaphragm is correctly placed, switch the Ventilator on and perform a testing

procedure to check its perfect operation.

AttentionPeriodically check the cleanliness and the condit ion of the expiratory valve diaphragm. In case there is any

f issure or other abnormal i ty in this c ompon ent , replace i t with a new one.

The block m ust be attached to the front of the Vent ilator extremely t ight ly to avoid gas leaks.

Figure 6.3 shows the cross-section assembly of the components from the expiratory valve block.

In the body of this block there is: a diaphragm housing, a conical connection for the expiratory branchs corrugated tubing and two

different sized locks to prevent upside-down mounting. Insert the block onto the ventilator by matching the block locks with the

ventilator housings. Rotate the block to the right until it locks, observing for possible leaks.

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Figure 6.3: Assembling the expiratory valve.

6.5 Electronic Heated Humidifier

Note:Read the 6060 Heated Humidifier Instruction Manual carefully.

The 6060 Heated Humidifier was designed specifically for use with respiratory circuits. It has an electronic temperature control, adigital thermometer, pilot and electric resistance operation lights, on/off switch, and a transparent chamber with capacity for 400ml

of sterile water. Gas temperatures are measured at the patients mouth area.

The Heated Humidifier warms and saturates the inspiratory flow that passes through its chamber with water steam. The gases then

flow through a path between the chamber outlet and the patient by means of two corrugated tubes supplied with drains.

Condensation commonly forms in the corrugated tube leading to the patient due to the cooling of the gases between the humidifier

outlet and the Y-shaped connector. The amount of condensed water in the circuit will increase as the humidifier heating adjustment

increases.

SAFETY MEASURES TO USE HEATED HUMIDIFIER 6060

It is necessary to prevent the water condensed in the circuit from reaching the patient, as it would therefore reach the patient's lungs. To

ensure that all the water condensed in the circuit flows towards the drains, the corrugated tubes should slope up to the patient or be

horizontal (Figure 6.4).

If the water condensation in the circuit exceeds the allowed limits, decrease the humidifier's heating setting.

The Heated Humidifiers chamber can easily be disassembled for disinfection since the cap is merely screwed onto the container. When

assembling the chamber again, make sure the rubber mounting on the cap is correctly positioned and in perfect condition so no gas

leaks during ventilation. Close the cap, fastening it tightly.

Ventilator

Diaphragm

Lock

Connection

Housing

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Figure 6.4: 6060 Heated Humidifier

6.6 Drains

The ATLANTA Ventilators respiratory circuit has 2 (two) drains for collecting the water which accumulates in the corrugated tubes.

One drain is for the inspiratory branch and the other for the expiratory branch.

Using drains is very important to avoid the problems caused by water accumulation in the breathing circuit.

Emptying

To empty the drain, simply remove the threaded container and pour the accumulated water. Screw the container back onto the drain

afterwards. This operation does not interfere with patient ventilation since the drain closes automatically when the container is

removed.

Disinfection or Sterilization

The drain is easily disassembled for disinfection or sterilization by unscrewing the container and removing the piston mechanism

(Figure 6.5).

Figure 6.5: Breathing circuit drain.

6.7 Battery

The ATLANTA Ventilator has an internal battery that allows it to keep working even when there is a mains power failure.

The ATLANTA Ventilators internal battery can be recharged and is sealed. It need not be removed even when the equipment is not

used for extended periods of time.

Autonomy

The Ventilators internal battery lifecycle, when fully charged, will depend on the mode that is used and on ventilation parameter

adjustments.

203030332

202010709

203010620

1. Chamber Outlet Connection (Patient)

2. Humidifying Chamber Cap

3. Humidifying Chamber

4. Chamber Attaching Clamps

5. Chamber Placing Button

6. Temperature Display7. Heating Control

8. Heating Lamp (Power On)

9. Pilot Lamp (Heater On)

Body 203030332

Piston 202010709

Cup 203010620

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Example: When fully charged, the battery can keep the Ventilator working for about 120 minutes under average ventilation

conditions.

Recharging

Fully recharging the battery takes about 10 (ten) hours when the Ventilator is switched off and connected to the distribution network.

For a longer battery life always keep it fully charged when possible. Constantly discharging the battery will decrease its life

span.

When there is a failure of the electric mains that supplies the Ventilator, it will automatically switch to its internal battery power

supply.

When the battery is supplying the device, the mains failure alarm shows on the display, activating the alarm indication LED

informing the device is being supplied by the battery.

AttentionKeep the internal battery charged at all t imes. To accom plish th is, the Vent ilator can be kept conn ected to the

mains even wh en its on/off key is on the OFF posit io n.

Recharge the battery after using th e Vent ilator while unc onnected from the electr ic mains.

Fully recharge the battery when the Vent ilator is lef t unus ed and disco nnected from the electr ic mains for more

than 20 (twenty) days.

The Heated Humidif ier wil l no t work u nt il its internal battery supplies the Vent ilator.

6.8 Mobile Base

The ATLANTA Ventilators mobile base (Figure 6.6) has four mobile trolleys for smooth sliding that ensure excellent mobility, hooks to

support extension tubes, a handle to make it easier to move the device and pins to anchor the humidifier.

The Ventilator is fixed to the top of the mobile base by a set of four screws. The Heated Humidifier is fixed to the front part of the

mobile base by means of coupling pins.

Figure 6.6: Mobile Base

1

2

3

6

4

5

1.1 Humidifier Placement2.2 Transportation handle3.3 Extension support

4.4 Column5.5 Mobile trolleys6.6 Articulated Arm Support

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7 CONTROL DISPLAY

The control screen is located on the front panel of the ATLANTA Ventilator and has the following screen options:

Start-up screen

Main Screen

Alarm adjustment screen

Configuration screen

Moving from one screen to another is accomplished by means of the front panels MENU key (14).

To return to the main screen from the configuration screen, press the MENU (14) key again.

7.1 Start-Up Screen

As soon as the Ventilator is switched on, the control display shows a system start-up screen, indicating the Ventilators software

release (Figure 7.1). This information is used for equipment maintenance.

Figure 7.1: Start-up screen.

The Ventilator will show a screen asking the operator to enter the patients weight in kilograms (Figure 7.2).

Patient Weight..0.2 Kg to 5.0 Kg..increment: 0.1 Kg

5,0 Kg to 20 Kgincrement: 0.5 Kggreater than 20 Kg increment: 1.0 kg

Figure 7.2: Screen for weight information.

Carry out the following procedure:

Use the easy touch (12) programming button to adjust the weight value for the patient. Turn the dial clockwise to increase or

counter-clockwise to decrease and press to confirm. The adjustment is made directly in kilograms.

The Ventilator will perform a calculation to pre-adjust the ventilation parameters in accordance with the weight informed considering

7ml/kg.

AttentionDo not us e the Vent ilator if there are any abnorm alit ies. Solve the problem by call ing a TAK AOKA authorized

representat ive.

The operator mus t not necessarily c onsid er the automatic vent i lat ion parameter start-up adjustm ent as a f inaland ideal adjustment for the pat ient. Before start ing vent ilat ion, be sure to perform an opt imal adjustm ent for

each parameter.

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The Ventilator will then open the main screen initiating ventilation and monitoring.

7.2 Main Screen

This is the screen that is normally displayed during ventilation, as illustrated in Figure 7.3. The main screens most importantfunctions are described below and consist in the adjustment of ventilation parameters, mode indication, and alarm messages.

Figure 7.3: ATLANTA Ventilators main screen.

The screen is divided into four parts:

Monitor

Bar graph linear manometer, indicating the changes in the endotracheal pressure through a horizontal bar on a scale from 10to 100 cm H2O. The pressure gauge continues showing the maximum pressure value of the last inhalation during the expiratory

phase allowing this parameter to be better seen.

The inspiratory and expiratory pressures are shown digitally and graphically on the Ventilator display.

Average Pressure

General information

Values resulting from the expiration time (Te) and I:E ratio.

Mode indication on the Ventilator display, among the options: CMV, SIMV, APRV and CPAP. Chapter 10 - Operation -

describes in detail all of the ventilation modes available.

Alarm messages:

At the center of the display

Ventilation parameter adjustment

The ventilation parameters, as set by the operator, are shown continuously in the lower row of the Ventilator display. Next to the

display values, the respective parameters are identified as well as the quick access keys for their adjustment. The following items

should be adjusted:

Limit Pressure

PEEP CPAP

Rate

Inspiratory Time

Inspiratory Flow

Notes:For more information on these ventilation parameters see the description of the respective quick-access adjustment keys

in item 6.2 Front View. Chapter 4Technical Specifications provides the variation ranges for adjusting ventilation

parameters.

7.3 Alarm adjustment screen

The ATLANTA Ventilator has an audio-visual alarm system for the ventilation parameters, ensuring increased safety during

ventilation. On the alarm adjustment screen (Figure 7.4) the graphic is substituted by a menu that allows lower limit (LOW) and

upper limit (HIGH) maximum inspiratory pressure and PEEP alarm setting adjustments.

The bar graph continues showing so that monitoring is not interrupted.

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Figure 7.4: Alarm configuration screen.

To perform adjustments to this screen, follow the procedure described in item 7.5. The following values should be adjusted.

PRESSURE

Adjusts the limits for high and low maximum inspiratory pressure alarms.

PEEP

Adjust the limits for high and low PEEP (end-expiratory pressure) alarms.

Notes:When the Ventilator is switched off, the alarm adjustments are not stored in the memory. When the ventilator is turned on again,

such adjustments remain in the default values (set at the factory).

The adjustment intervals for each of the parameters above are described in Chapter 4 - "Technical Specifications".

7.4 Configuration Screen

In the set-up screen, the graph is substituted by a menu that allows the selection of some of the Ventilators operating conditions

(Figure 7.5).

Figure 7.5: Parameter configuration screen.

The bar graph continues showing so that monitoring is not interrupted.

To perform adjustments to this screen, follow the procedure described in item 7.5. The following values can be adjusted.

APNEA

Adjusts the delay time for triggering the apnea alarm in the CPAP mode. The apnea alarm will sound if the patient does not breathe

for a period of time above than this value. The message APNEA will appear flashing on the Ventilator display. The time adjustment

range is from 5 to 45 seconds. ( Default= 10 seconds).

GRAPHThe options shown for this parameter are:

ON activates the Pxt graph on the Ventilator display.

OFF deactivates the Pxt graph on the Ventilator display, and begins to show the maximum pressure and average pressure

numerical values.

TRIGGER PRESSURE

Adjusts the required level of negative pressure (Trigger) for the patient to trigger a Ventilator cycle. The adjustment is made directly

in cmH2O.

Notes:The value adjusted by this control refers to the level of negative pressure below the PEEP value.

In order to facilitate the correct sensitivity adjustment, the Trigger message appears for a moment on the display

whenever the patient is able to trigger a Ventilator cycle.

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7.5 Setup Procedure

Follow the procedure below to perform the desired adjustments to the configuration and alarm screens on the Ventilator display:

Press the MENU key (14) for the configuration screen to appear in the display (1). The first value will then be highlighted

(Figure 7.6).

Rotate the Easy Touch programming button until the value to be adjusted is highlighted on the screen. After the last item in the

first screen, the second screen will appear.Press the Easy Touch programming button to confirm selection of this parameter.

Use the Easy Touch programming dial to adjust each value individually. If you turn the button clockwise the value increases

and counter-clockwise, it decreases.

Press the Easy Touch programming dial again to confirm the adjustment made, activating this new parameter value and

highlighting the next parameter on the display.

Press the MENU key (14) to return to the main screen.

Figure 7.6: Configuration screen with the high pressure parameter highlighted on the display.

7.6 Alarm System

The ATLANTA Ventilator has a complete system of audiovisual alarms that provide a high level of safety during ventilation. If an

alarm condition occurs, the Ventilator will react in one of the following reactions:

a) A flashing written message appearing in the middle part of the screen to help the operator quickly identify the condition, which

has generated the alarm.

b) A flashing red light appears for immediate visual identification.

c) Intermittent audio signal (5 seconds later).

Note:If more than one alarm condition occurs at the same time, the highest priority will appear on the screen.

Should any one of the reactions above not occur with an alarm condition, call a K. TAKAOKA authorized technical

assistance representative.

Figure 7.7: Main screen with the alarm event EXP OBSTRUCTION highlighted on the display.

Lighted signal

Written message

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The alarms linked to the ATLANTA Ventilators control screen are:

CHECK O2 NETWORK

This indicates that there is low pressure in the oxygen system supplying the Ventilator. Pressure in the mains supply of oxygen is

below 29 PSI.

CHECK AIR SYSTEM

This indicates that there is low pressure in the compressed air system supplying the Ventilator. Pressure in the mains supply of air isbelow 29 PSI.

DISCONNECTION

This indicates a breathing circuit disconnection.

APNEA

This indicates that the patient has stopped breathing spontaneously. Immediate action by the operator is required.

FAILURE IN THE MAINS POWER SUPPLY

This indicates that the internal battery is supplying the Ventilator and no energy is coming from the distribution network. It is

necessary to connect the Ventilator to some other external electric source before the battery charge runs out.

LOW BATTERY

This indicates that the internal battery charge is low and that it must be urgently recharged.

AttentionThe Vent ilator must be conn ected immediately to the mains when this alarm occurs so the internal battery can be

recharged.

I f even while co nnected to the mains the alarm cont inues, call an authorized K. TAKAOKA technical assistance

representat ive.

HIGH PRESSURE

Indicates that the inspiratory pressure exceeded the upper limit value adjusted for the ventilation monitors alarm. This is an active

alarm that will interrupt inhalation automatically to avoid excess pressure.

LOW PRESSURE

This indicates that pressure is below the lower limit adjusted on the alarm configuration screen.

HIGH PEEP

This indicates that the PEEP is above the upper limit set on the alarm configuration screen.

LOW PEEP

This indicates that the PEEP is below the lower limit set on the alarm configuration screen.

EXPIRATORY OBSTRUCTION

This indicates that there has been an obstruction of the expiratory valve. This situation compromises exhalation and may be caused

by secretion in the corrugated tube or in the expiratory valves diaphragm.

Alarm Muting

The SILENCE key (16) temporarily mutes the alarms for 2 minutes. When this key is pressed while an alarm is sounding, the

Ventilator alarm system will be muted for 2 minutes. The visual ALARM indicator (17) will remain on continuously as long as there is

a temporary mute alarm condition.

Pressing this key for 5 seconds during an ELECTRICITY MAINS FAILURE, CHECK THE O2 NETWORK or CHECK THE AIR

NETWORK, the message shown in the middle of the screen disappears, being replaced by the pressure graphics, and this

message is then shown together with the bar graph. The visual alarm indicator (17) only flashes one LED at a time.This feature allows one to monitor the pressure curve even when the three alarms mentioned above occur.

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8 ASSEMBLING AND PREPARING THE VENTILATOR

8.1 Supply

Initially, check the general on/off switch located on the ATLANTA Ventilator back panel.

Interconnect the O2 and Compressed Air input connections located on the ATLANTA Ventilator rear panel to their respective supply

sources. Use the extensions provided with the Ventilator.

Supply the ATLANTA Ventilator with a electric network of 110 to 220 VAC and 50/60 Hz by means of the power cord provided with

the equipment or with a 12 VDC 3.0 A h source (external battery).

Note:The Ventilator can use either 110 or 220 VAC since it has automatic voltage selection.

The detachable network cord (power cord) should be fixed with a nylon clamp to prevent accidental disconnection.

The Ventilator has an internal rechargeable battery that allows the equipment to be used temporarily without being connected to the

electric distribution network. In the event of an electric mains network failure, the Ventilator will shift automatically to its internal

battery supply and Ventilation will not be interrupted.

Assemble the 6060 Heated Humidifier (optional) on the column and supply it with the electric outlet plug located on the rear panel of

the ATLANTA Ventilator. The heated humidifier will only operate if the Ventilator is supplied by an electric main from 110 to 220

VAC.

AttentionKeep the internal battery charged at all times. To accomp lish this, the Vent ilator can be kept connected to the

mains cont inuously even when its on/of f key is in the OFF posi t ion.

RECOMMENDATIONS ON POWER SUPPLY (*):

Only connect the power cord to an outlet that is properly grounded and approved for hospital use and to a power supply that

complies with the ABNT NBR 13534 norm - Instalaes eltricas em estabelecimentos assistenciais de sade - Requisitos de

segurana. The three-pin female plug must be of the Nema 5-15P type in which the middle round pin is the ground, as indicated in

Figure 8.1.

Keep the internal battery charged at all times so the Ventilator keeps working even when the electric mains fails. To do this, the

Ventilator must be connected to the mains , even when it is switched off.

Recharge the battery after using the Ventilator with no electric network supply so it is ready for the next use.

Fully recharge the battery when the Ventilator is left unused and disconnected from the electric mains for more than 20

(twenty) days.

The Heated Humidifier will not be fed by either the Ventilator's internal battery or the 12-VDC inlet.

If the Ventilators internal battery is powering it and the low battery alarm goes off, the Ventilator must immediately be

connected to the mains.

If the equipment is connected to the auxiliary power supply when the ground conductor is faulty, there may be an increase in

the leakage current flowing through the patient that exceeds the amount permitted.

When installing the Ventilator, attach the 429020003 power cord to the rear panel with bracket 203060266 and screw

314020013.

(*) Failure to comply with this electrical recommendations can result in injury to the patient, operator or equipment, and it will void

the Ventilators warranty.

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Figure 8.1: Three-pin Nema 5-15P type electrical plug.

8.2 Respiratory Circuit

The ATLANTA Ventilator comes with two types of respiratory circuits: pediatric, and neonatal. The neonatal circuit has tubes with a

reduced diameter, which, therefore, reduce its tolerance for use with the low flow of neonatal and premature patients.

The ATLANTA Ventilators breathing circuit is comprised of a set of corrugated tubes, two drains and a Y-shaped connector. The

drains built into the inspiratory and expiratory branches avoid the accumulation of water in the circuit.

1. Check that the drain containers are empty. Otherwise, empty them (item 6.6).

2. Check that the expiratory valve block is correctly and tightly coupled to the Ventilator's front connection panel (item 6.4).

3. Check that all the breathing circuit components have undergone the correct disinfecting procedures. This includes the corrugated

tubes, connectors, drains, humidifier chamber, etc.

4. For correct 6060 Heated Humidifier assembly and use, read its instruction manual.

5. Place the articulated arm on one of the respective Ventilator column side supports so the corrugated tubes fit properly. The

articulated arm can be assembled on either side of the Ventilator, according to the side the patient is on.

Assemble the ATLANTA Ventilator respiratory circuit according to the diagrams in Figures 8.2 and 8.3.

Figure 8.2: INFANT respiratory circuit.

202011018

202011018

202010997

202010997

202010146

202011018

202010253

PATIENT

TEMPERATURE

SENSOR

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Figure 8.3: NEONATE respiratory circuit.

Check that the 6060 Humidifiers electronic temperature sensor is correctly and firmly connected to the Y-shaped connector of the

breathing circuit.

The drain containers can be easily emptied without discontinuing ventilation as there is an automatic closing mechanism in the drain

for use when the container is removed. Empty the drains before they are full of water (item 6.6).

AttentionTo prevent accidental disconnect ion o r gas leakage in the breathing circ uit , make sure all con nect ions are t ight ly

secured.

Tight ly clos e the threaded 6060 Heated Humidif ier cap, making su re the rubber seal is p resent.

To ensure that all water that condenses in the respiratory circuit f lows b ack to th e drains and does not reach the

pat ient, the tube sup port sh ould be placed near the Y-shaped conn ector and in a posit ion b elow the level of the

patient's m outh (Figure 8.4).

Do not use ant i -static or electr ically conduc t ive hoses or tubes.

202011017

202011008

202011008

202010998

202010998

202010146

202010021

PATIENT

TEMPERATURE

SENSOR R

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Figure 8.4: Positioning of the corrugated tubes.

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9 INSPECTION ROUTINE

Perform the procedure described below before each use of the ATLANTA Ventilator to make sure it is operating perfectly and that

its power supplies are adequate.

Do not use the equipment if the inspection routine reveals any irregularity whatsoever. In this case, take the necessary steps to

solve the problem or contact authorized technical assistance.

9.1 Before each ventilation

Carry out the assembly procedures described in Chapter 8.

Carry out a complete visual inspection of the ATLANTA Ventilator and of its components, making sure there is no apparent

damage.

Verify that all of the breathing circuit components; expiratory valve and Heated Humidifier chamber have been sterilized.

Verify that the expiratory valve set has been assembled correctly with a clean diaphragm in good condition.

Check that the Ventilator on/off key is on the OFF position.

Verify that the Oxygen and compressed air supply pressures are normal.

Verify the mains supply for the Ventilator.

Checks that the breathing circuits drain containers are empty.Check that the Heated Humidifier has been assembled and regulated correctly and that it is filled with sterile water.

Ensure that the Heated Humidifier cap is firmly tightened, and check that there are no perforated tracheas to avoid gas

leakage.

Make sure all breathing circuit components have been assembled correctly before connecting them to the patient.

Make sure all circuit connections are tightly closed to avoid the risk of accidental disconnection.

Switch the Ventilator on, select the patient weight and watch the Ventilator cycles.

Confirm the Ventilator controls are functioning correctly in all modes.

Disconnect the inlet cable from the distribution network. Listen for the audio alarm and observe the visual display alarm (NO

POWER NETWORK). Re-connect the electricity.

Disconnect the main O2 supply and verify the audible and visual alarms (CHECK O2). Reconnect the O2 supply.

Disconnect the trachea and verify the audio and visual alarms for (DISCONNECTION). Reconnect the trachea.

Aseptically block the trachea branch and verify the audible and visual alarms (EXPIRATORY OBSTRUCTION). The system

will depressurize after reaching the pressure limit. Reconnect the trachea.

Adjust the high-pressure alarm on the Ventilator to 30 cmH2O. Adjust the pressure limit to 50cmH2O and verify the audio

and visual alarms (HIGH PRESSURE). Adjust the limit pressure to 20 cmH2O.

Adjust the Ventilator PEEP alarm to 10 cmH2O. Adjust the PEEP to 15cmH2O and verify the audio and visual alarms (HIGH

PEEP). Adjust the PEEP to 5cmH2

Confirm that all alarms are correctly regulated.

Switch the Ventilator off.

AttentionDo no t use the ATLA NTA Vent ilator if the start-up tests detect any abnorm ality. Solve the problem before using

the equipm ent.

9.2 During ventilation

Maintain all monitor alarms that may be in use turned on.

Frequently verify that there is an adequate level of sterile water and that the Heated Humidifier is heating correctly.

Continually verify the maximum pressure that is reached.

Frequently check that the endotracheal tube is firmly connected to the breathing circuit.

Monitor the patient constantly. Observe the patient's pulmonary expansion and free exhalation.

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10 OPERATION

Special Product Storage, Conservation, and/or Handling Conditions

The device must be used in an environment where there is: temperature of +10oC to +70oC, atmospheric pressure of 500 to 1060

hPa, and a relative humidity of 10% to 100% (non-condensed).

10.1 Selecting Ventilation Modes

To select the ventilation mode, press the MODE key (14) located on the front panel of the ATLANTA Ventilator. By following the

procedure described below, you can use this key to select the desired mode from the options CMV, SIMV, CPAP and APRV.

1. Press the MODE key (14).

2. Press the MODE key (14) repeatedly until the desired mode appears in the Ventilator display (1).

3. Press the Easy Touch (12) programming button to confirm selection of the mode.

4. The control display will then enter the ventilation parameters adjustment mode.

5. Use the Easy Touch (12) programming dial to individually adjust each value. Turning the button clockwise increases the value,

while turning it counter-clockwise decreases it.

6. Press the Easy Touch (12) programming dial again to confirm the adjustment made, activating this new parameter value and

highlighting the next parameter on the display, repeating the procedure up to the last parameter.

Active controls

For each ventilation mode selected in the ATLANTA Ventilator, the control display will only show values for the active parameters in

the selected mode. The spaces referring to inactive parameters will be filled in with ----. This feature means that adjusting the

Ventilator is an extremely easy, quick and safe procedure.

The table below shows the ventilation modes available with the ATLANTA Ventilator.

Adjusted mode Description

1. CMV Controlled Mandatory Ventilation

2. SIMV Synchronized Intermittent Mandatory Ventilation

3. APRV Airway Pressure Relief Ventilation

4. CPAP Continuous Positive Airway Pressure Ventilation

Note:After adjusting the last ventilation parameter in the control display, press the Easy Touch dial (12) oncewhen you are

ready to start the mechanical ventilation in the selected mode.

10.2 Cycling parameters regulation

Key (11) directly controls inspiratory time. This parameter value is shown in the Ventilator display. Key (4) directly controls

respiration rate. The parameter value set is also shown in the Ventilator display. When these two values are changed, the values

resulting from expiration time and the I:E ratio are automatically updated on the Ventilator display .

Note:There is a minimum expiratory time limit of 0.3 seconds to avoid auto-PEEP from occurring during ventilation. Therefore it

is not possible to regulate the aforementioned parameters above the limits that would result in this minimum expiratory

time.

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Turn the ATLANTA Ventilator on and select the patients weight without connecting the Ventilator to the patient. Initially, the

Ventilator will enter into the CMV mode. Follow the procedures below to regulate the different modes available in the ATLANTA

Ventilator.

10.2.1 CMV Regulation - Controlled Mandatory Ventilation

During controlled ventilation, the mandatory cycles to begin inhaling may be of two different types:

Controlled cycles: The patient will be passive and the device controls ventilation totally.Assisted cycles: The beginning of each cycle and the respiratory rate are determined by the patient's inspiratory effort, which

triggers breathing. If the patient goes into a state of apnea or cannot trigger the equipment because the sensitivity setting is too

heavy, the Ventilator will start supplying controlled cycles with the rate value set in the corresponding control. If the patient reacts,

then ventilation will automatically return to the assisted cycles.

Controlled ventilation may aim both a